Effects of script-based role play in cardiopulmonary resuscitation team training.

PubMed

Chung, Sung Phil; Cho, Junho; Park, Yoo Seok; Kang, Hyung Goo; Kim, Chan Woong; Song, Keun Jeong; Lim, Hoon; Cho, Gyu Chong

2011-08-01

The purpose of this study is to compare the cardiopulmonary resuscitation (CPR) team dynamics and performance between a conventional simulation training group and a script-based training group. This was a prospective randomised controlled trial of educational intervention for CPR team training. Fourteen teams, each consisting of five members, were recruited. The conventional group (C) received training using a didactic lecture and simulation with debriefing, while the script group (S) received training using a resuscitation script. The team activity was evaluated with checklists both before and after 1 week of training. The videotaped simulated resuscitation events were compared in terms of team dynamics and performance aspects. Both groups showed significantly higher leadership scores after training (C: 58.2 ± 9.2 vs. 67.2 ± 9.5, p=0.007; S: 57.9 ± 8.1 vs. 65.4 ± 12.1, p=0.034). However, there were no significant improvements in performance scores in either group after training. There were no differences in the score improvement after training between the two groups in dynamics (C: 9.1 ± 12.6 vs. S: 7.4 ± 13.7, p=0.715), performance (C: 5.5 ± 11.4 vs. S: 4.7 ± 9.6, p=0.838) and total scores (C: 14.6 ± 20.1 vs. S: 12.2 ± 19.5, p=0.726). Script-based CPR team training resulted in comparable improvements in team dynamics scores compared with conventional simulation training. Resuscitation scripts may be used as an adjunct for CPR team training.

Clinical disease registries in acute myocardial infarction.

PubMed

Ashrafi, Reza; Hussain, Hussain; Brisk, Robert; Boardman, Leanne; Weston, Clive

2014-06-26

Disease registries, containing systematic records of cases, have for nearly 100 years been valuable in exploring and understanding various aspects of cardiology. This is particularly true for myocardial infarction, where such registries have provided both epidemiological and clinical information that was not readily available from randomised controlled trials in highly-selected populations. Registries, whether mandated or voluntary, prospective or retrospective in their analysis, have at their core a common study population and common data definitions. In this review we highlight how registries have diversified to offer information on epidemiology, risk modelling, quality assurance/improvement and original research-through data mining, transnational comparisons and the facilitation of enrolment in, and follow-up during registry-based randomised clinical trials.

Similar early migration when comparing CR and PS in Triathlon™ TKA: A prospective randomised RSA trial.

PubMed

Molt, Mats; Toksvig-Larsen, Sören

2014-10-01

The objective of this study was to compare the early migration of the cruciate retaining and posterior stabilising versions of the recently introduced Triathlon™ total knee system, with a view to predicting long term fixation performance. Sixty patients were prospectively randomised to receive either Triathlon™ posterior stabilised cemented knee prosthesis or Triathlon™ cruciate retaining cemented knee prosthesis. Tibial component migration was measured by radiostereometric analysis postoperatively and at three months, one year and two years. Clinical outcome was measured by the American Knee Society Score and Knee Osteoarthritis and Injury Outcome Score. There were no differences in rotation around the three coordinal axes or in the maximum total point motion (MTPM) during the two year follow-up. The posterior stabilised prosthesis had more posterior-anterior translation at three months and one year and more caudal-cranial translation at one year and two years. There were no differences in functional outcome between the groups. The tibial tray of the Triathlon™ cemented knee prosthesis showed similar early stability. Level I. Article focus: This was a prospective randomised trial aiming to compare the single radius posterior stabilised (PS) Triathlon™ total knee arthroplasty (TKA) to the cruciate retaining Triathlon™ TKA system with regard to fixation. Strengths and limitations of this study: Strength of this study was that it is a randomised prospective trial using an objective measuring tool. The sample size of 25-30 patients was reportedly sufficient for the screening of implants using RSA [1]. ClinicalTrials.gov Identifier: NCT00436982. Copyright © 2014 Elsevier B.V. All rights reserved.

Intelligence and Persisting with Medication for Two Years: Analysis in a Randomised Controlled Trial

ERIC Educational Resources Information Center

Deary, Ian J.; Gale, Catharine R.; Stewart, Marlene C. W.; Fowkes, F. Gerald R.; Murray, Gordon D.; Batty, G. David; Price, Jacqueline F.

2009-01-01

The study examined whether verbal intelligence is associated with persisting to take medication for up to two years. The design is a prospective follow-up of compliance with taking medication in high-risk individuals participating in a randomised, placebo-controlled trial set in Central Scotland. Participants were 1993 people aged between 50 and…

The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

PubMed Central

2013-01-01

Background Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder. PMID:23289935

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR)

PubMed Central

Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-01-01

Introduction Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. Methods and analysis This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). Ethics and dissemination Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. Trial registration number NCT02632500. PMID:29674365

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial

PubMed Central

2010-01-01

Background This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Methods and Design Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. Discussion This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. Trial registration ISRCTN24952438 PMID:20964860

Study protocol for the evaluation of an Infant Simulator based program delivered in schools: a pragmatic cluster randomised controlled trial.

PubMed

Brinkman, Sally A; Johnson, Sarah E; Lawrence, David; Codde, James P; Hart, Michael B; Straton, Judith A Y; Silburn, Sven

2010-10-21

This paper presents the study protocol for a pragmatic randomised controlled trial to evaluate the impact of a school based program developed to prevent teenage pregnancy. The program includes students taking care of an Infant Simulator; despite growing popularity and an increasing global presence of such programs, there is no published evidence of their long-term impact. The aim of this trial is to evaluate the Virtual Infant Parenting (VIP) program by investigating pre-conceptual health and risk behaviours, teen pregnancy and the resultant birth outcomes, early child health and maternal health. Fifty-seven schools (86% of 66 eligible secondary schools) in Perth, Australia were recruited to the clustered (by school) randomised trial, with even randomisation to the intervention and control arms. Between 2003 and 2006, the VIP program was administered to 1,267 participants in the intervention schools, while 1,567 participants in the non-intervention schools received standard curriculum. Participants were all female and aged between 13-15 years upon recruitment. Pre and post-intervention questionnaires measured short-term impact and participants are now being followed through their teenage years via data linkage to hospital medical records, abortion clinics and education records. Participants who have a live birth are interviewed by face-to-face interview. Kaplan-Meier survival analysis and proportional hazards regression will test for differences in pregnancy, birth and abortion rates during the teenage years between the study arms. This protocol paper provides a detailed overview of the trial design as well as initial results in the form of participant flow. The authors describe the intervention and its delivery within the natural school setting and discuss the practical issues in the conduct of the trial, including recruitment. The trial is pragmatic and will directly inform those who provide Infant Simulator based programs in school settings. ISRCTN24952438.

Design of simulation-based medical education and advantages and disadvantages of in situ simulation versus off-site simulation.

PubMed

Sørensen, Jette Led; Østergaard, Doris; LeBlanc, Vicki; Ottesen, Bent; Konge, Lars; Dieckmann, Peter; Van der Vleuten, Cees

2017-01-21

Simulation-based medical education (SBME) has traditionally been conducted as off-site simulation in simulation centres. Some hospital departments also provide off-site simulation using in-house training room(s) set up for simulation away from the clinical setting, and these activities are called in-house training. In-house training facilities can be part of hospital departments and resemble to some extent simulation centres but often have less technical equipment. In situ simulation, introduced over the past decade, mainly comprises of team-based activities and occurs in patient care units with healthcare professionals in their own working environment. Thus, this intentional blend of simulation and real working environments means that in situ simulation brings simulation to the real working environment and provides training where people work. In situ simulation can be either announced or unannounced, the latter also known as a drill. This article presents and discusses the design of SBME and the advantage and disadvantage of the different simulation settings, such as training in simulation-centres, in-house simulations in hospital departments, announced or unannounced in situ simulations. Non-randomised studies argue that in situ simulation is more effective for educational purposes than other types of simulation settings. Conversely, the few comparison studies that exist, either randomised or retrospective, show that choice of setting does not seem to influence individual or team learning. However, hospital department-based simulations, such as in-house simulation and in situ simulation, lead to a gain in organisational learning. To our knowledge no studies have compared announced and unannounced in situ simulation. The literature suggests some improved organisational learning from unannounced in situ simulation; however, unannounced in situ simulation was also found to be challenging to plan and conduct, and more stressful among participants. The importance of setting, context and fidelity are discussed. Based on the current limited research we suggest that choice of setting for simulations does not seem to influence individual and team learning. Department-based local simulation, such as simulation in-house and especially in situ simulation, leads to gains in organisational learning. The overall objectives of simulation-based education and factors such as feasibility can help determine choice of simulation setting.

Acute uncomplicated appendicitis study: rationale and protocol for a multicentre, prospective randomised controlled non-inferiority study to evaluate the safety and effectiveness of non-operative management in children with acute uncomplicated appendicitis.

PubMed

Xu, Jane; Liu, Yingrui Cyril; Adams, Susan; Karpelowsky, Jonathan

2016-12-21

This article presents an overview of a prospective randomised controlled non-inferiority study designed to evaluate the safety and effectiveness of non-operative management (NOM) with operative management in children with acute uncomplicated appendicitis (AUA). Here, we present the study protocol for this APRES study, a multicentre Australian study. The rationale and details of future analysis, in particular, non-inferiority calculations, cost-effectiveness, feasibility and acceptability of each intervention. A multicentre, prospective randomised controlled clinical trial, conducted in 2 Australian tertiary paediatric hospitals. Children who meet the inclusion criteria of an age between 5 and 15 years and a clinical diagnosis of AUA will be invited to participate, and after consent will be randomised via a computer-based program into treatment groups. The study started in June 2016, and the target recruitment is 220 patients. Children in the control group will be treated with prophylactic antibiotics and appendicectomy, and those in the intervention group will be treated with antibiotic therapy alone. Primary outcome measures include unplanned or unnecessary operation and complications at 30 days. Secondary outcomes include longer term complications within 1 year, length of stay, time off work and school analgesic requirements and cost. Data analyses will be on the intention-to-treat principle using non-inferiority analysis. Analysis will include the Pearson χ 2 test for categorical variables and independent sample t-test or Mann-Whitney test for continuous variables. Non-inferiority for NOM will be tested using 1-sided Wald tests with an α level of 0.05. The research has been approved by the Human Research Ethics Committee of the Sydney Children's Hospital Network. In addition, results will be reported through academic journals, seminars and conference presentations. NCT02795793; ACTRN12616000788471. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Study design and rationale for Optimal aNtiplatelet pharmacotherapy guided by bedSIDE genetic or functional TESTing in elective percutaneous coronary intervention patients (ONSIDE TEST): a prospective, open-label, randomised parallel-group multicentre trial (NCT01930773).

PubMed

Kołtowski, Łukasz; Aradi, Daniel; Huczek, Zenon; Tomaniak, Mariusz; Sibbing, Dirk; Filipiak, Krzysztof J; Kochman, Janusz; Balsam, Paweł; Opolski, Grzegorz

2016-01-01

High platelet reactivity (HPR) and presence of CYP2C19 loss-of-function alleles are associated with higher risk for periprocedural myocardial infarction in clopidogrel-treated patients undergoing percutaneous coronary intervention (PCI). It is unknown whether personalised treatment based on platelet function testing or genotyping can prevent such complications. The ONSIDE-TEST is a multicentre, prospective, open-label, randomised controlled clinical trial aiming to assess if optimisation of antiplatelet therapy based on either phenotyping or genotyping is superior to conventional care. Patients will be randomised into phenotyping, genotyping, or control arms. In the phenotyping group, patients will be tested with the VerifyNow P2Y12 assay before PCI, and patients with a platelet reactivity unit greater than 208 will be switched over to prasugrel, while others will continue on clopidogrel therapy. In the genotyping group, carriers of the *2 loss-of-function allele will receive prasugrel for PCI, while wild-type subjects will be treated with clopidogrel. Patients in the control arm will be treated with standard-dose clopidogrel. The primary endpoint of the study is the prevalence of periprocedural myocardial injury within 24 h after PCI in the controls as compared to the phenotyping and genotyping group. Secondary endpoints include cardiac death, myocardial infarction, definite or probable stent thrombosis, or urgent repeat revascularisation within 30 days of PCI. Primary safety outcome is Bleeding Academic Research Consortium (BARC) type 3 and 5 bleeding during 30 days of PCI. The ONSIDE TEST trial is expected to verify the clinical utility of an individualised antiplatelet strategy in preventing periprocedural myocardial injury by either phenotyping or genotyping. ClinicalTrials.gov: NCT01930773.

Timing of oral anticoagulant therapy in acute ischemic stroke with atrial fibrillation: study protocol for a registry-based randomised controlled trial.

PubMed

Åsberg, Signild; Hijazi, Ziad; Norrving, Bo; Terént, Andreas; Öhagen, Patrik; Oldgren, Jonas

2017-12-02

Oral anticoagulation therapy is recommended for the prevention of recurrent ischemic stroke in patients with atrial fibrillation (AF). Current guidelines do not provide evidence-based recommendations on optimal time-point to start anticoagulation therapy after an acute ischemic stroke. Non-vitamin K antagonist oral anticoagulants (NOACs) may offer advantages compared to warfarin because of faster and more predictable onset of action and potentially a lower risk of intracerebral haemorrhage also in the acute phase after an ischemic stroke. The TIMING study aims to establish the efficacy and safety of early vs delayed initiation of NOACs in patients with acute ischemic stroke and AF. The TIMING study is a national, investigator-led, registry-based, multicentre, open-label, randomised controlled study. The Swedish Stroke Register is used for enrolment, randomisation and follow-up of 3000 patients, who are randomised (1:1) within 72 h from ischemic stroke onset to either early (≤ 4 days) or delayed (≥ 5-10 days) start of NOAC therapy. The primary outcome is the composite of recurrent ischemic stroke, symptomatic intracerebral haemorrhage, or all-cause mortality within 90 days after randomisation. Secondary outcomes include: individual components of the primary outcome at 90 and 365 days; major haemorrhagic events; functional outcome by the modified Rankin Scale at 90 days; and health economics. In an optional biomarker sub-study, blood samples will be collected after randomisation from approximately half of the patients for central analysis of cardiovascular biomarkers after study completion. The study is funded by the Swedish Medical Research Council. Enrolment of patients started in April 2017. The TIMING study addresses the ongoing clinical dilemma of when to start NOAC after an acute ischemic stroke in patients with AF. By the inclusion of a randomisation module within the Swedish Stroke Register, the advantages of a prospective randomised study design are combined with the strengths of a national clinical quality register in allowing simplified enrolment and follow-up of study patients. In addition, the register adds the possibility of directly assessing the external validity of the study findings. ClinicalTrials.gov, NCT02961348 . Registered on 8 November 2016.

Simulation-based team training for multi-professional obstetric care teams to improve patient outcome: a multicentre, cluster randomised controlled trial.

PubMed

Fransen, A F; van de Ven, J; Schuit, E; van Tetering, Aac; Mol, B W; Oei, S G

2017-03-01

To investigate whether simulation-based obstetric team training in a simulation centre improves patient outcome. Multicentre, open, cluster randomised controlled trial. Obstetric units in the Netherlands. Women with a singleton pregnancy beyond 24 weeks of gestation. Random allocation of obstetric units to a 1-day, multi-professional, simulation-based team training focusing on crew resource management (CRM) in a simulation centre or to no such team training. Intention-to-treat analyses were performed at the cluster level, including a measurement 1 year prior to the intervention. Primary outcome was a composite outcome of obstetric complications during the first year post-intervention, including low Apgar score, severe postpartum haemorrhage, trauma due to shoulder dystocia, eclampsia and hypoxic-ischaemic encephalopathy. Maternal and perinatal mortality were also registered. Each study group included 12 units with a median unit size of 1224 women, combining for a total of 28 657 women. In total, 471 medical professionals received the training course. The composite outcome of obstetric complications did not differ between study groups [odds ratio (OR) 1.0, 95% confidence interval (CI) 0.80-1.3]. Team training reduced trauma due to shoulder dystocia (OR 0.50, 95% CI 0.25-0.99) and increased invasive treatment for severe postpartum haemorrhage (OR 2.2, 95% CI 1.2-3.9) compared with no intervention. Other outcomes did not differ between study groups. A 1-day, off-site, simulation-based team training, focusing on teamwork skills, did not reduce a composite of obstetric complications. 1-day, off-site, simulation-based team training did not reduce a composite of obstetric complications. © 2016 Royal College of Obstetricians and Gynaecologists.

The REstart or STop Antithrombotics Randomised Trial (RESTART) after stroke due to intracerebral haemorrhage: study protocol for a randomised controlled trial.

PubMed

Al-Shahi Salman, Rustam; Dennis, Martin S; Murray, Gordon D; Innes, Karen; Drever, Jonathan; Dinsmore, Lynn; Williams, Carol; White, Philip M; Whiteley, William N; Sandercock, Peter A G; Sudlow, Cathie L M; Newby, David E; Sprigg, Nikola; Werring, David J

2018-03-05

For adults surviving stroke due to spontaneous (non-traumatic) intracerebral haemorrhage (ICH) who had taken an antithrombotic (i.e. anticoagulant or antiplatelet) drug for the prevention of vaso-occlusive disease before the ICH, it is unclear whether starting antiplatelet drugs results in an increase in the risk of recurrent ICH or a beneficial net reduction of all serious vascular events compared to avoiding antiplatelet drugs. The REstart or STop Antithrombotics Randomised Trial (RESTART) is an investigator-led, randomised, open, assessor-blind, parallel-group, randomised trial comparing starting versus avoiding antiplatelet drugs for adults surviving antithrombotic-associated ICH at 122 hospital sites in the United Kingdom. RESTART uses a central, web-based randomisation system using a minimisation algorithm, with 1:1 treatment allocation to which central research staff are masked. Central follow-up includes annual postal or telephone questionnaires to participants and their general (family) practitioners, with local provision of information about adverse events and outcome events. The primary outcome is recurrent symptomatic ICH. The secondary outcomes are: symptomatic haemorrhagic events; symptomatic vaso-occlusive events; symptomatic stroke of uncertain type; other fatal events; modified Rankin Scale score; adherence to antiplatelet drug(s). The magnetic resonance imaging (MRI) sub-study involves the conduct of brain MRI according to a standardised imaging protocol before randomisation to investigate heterogeneity of treatment effect according to the presence of brain microbleeds. Recruitment began on 22 May 2013. The target sample size is at least 720 participants in the main trial (at least 550 in the MRI sub-study). Final results of RESTART will be analysed and disseminated in 2019. ISRCTN71907627 ( www.isrctn.com/ISRCTN71907627 ). Prospectively registered on 25 April 2013.

Adjusting for multiple prognostic factors in the analysis of randomised trials

PubMed Central

2013-01-01

Background When multiple prognostic factors are adjusted for in the analysis of a randomised trial, it is unclear (1) whether it is necessary to account for each of the strata, formed by all combinations of the prognostic factors (stratified analysis), when randomisation has been balanced within each stratum (stratified randomisation), or whether adjusting for the main effects alone will suffice, and (2) the best method of adjustment in terms of type I error rate and power, irrespective of the randomisation method. Methods We used simulation to (1) determine if a stratified analysis is necessary after stratified randomisation, and (2) to compare different methods of adjustment in terms of power and type I error rate. We considered the following methods of analysis: adjusting for covariates in a regression model, adjusting for each stratum using either fixed or random effects, and Mantel-Haenszel or a stratified Cox model depending on outcome. Results Stratified analysis is required after stratified randomisation to maintain correct type I error rates when (a) there are strong interactions between prognostic factors, and (b) there are approximately equal number of patients in each stratum. However, simulations based on real trial data found that type I error rates were unaffected by the method of analysis (stratified vs unstratified), indicating these conditions were not met in real datasets. Comparison of different analysis methods found that with small sample sizes and a binary or time-to-event outcome, most analysis methods lead to either inflated type I error rates or a reduction in power; the lone exception was a stratified analysis using random effects for strata, which gave nominal type I error rates and adequate power. Conclusions It is unlikely that a stratified analysis is necessary after stratified randomisation except in extreme scenarios. Therefore, the method of analysis (accounting for the strata, or adjusting only for the covariates) will not generally need to depend on the method of randomisation used. Most methods of analysis work well with large sample sizes, however treating strata as random effects should be the analysis method of choice with binary or time-to-event outcomes and a small sample size. PMID:23898993

The Effect of Simulation-Based Learning on Prospective Teachers' Inference Skills in Teaching Probability

ERIC Educational Resources Information Center

Koparan, Timur; Yilmaz, Gül Kaleli

2015-01-01

The effect of simulation-based probability teaching on the prospective teachers' inference skills has been examined with this research. In line with this purpose, it has been aimed to examine the design, implementation and efficiency of a learning environment for experimental probability. Activities were built on modeling, simulation and the…

A systematic review of models to predict recruitment to multicentre clinical trials.

PubMed

Barnard, Katharine D; Dent, Louise; Cook, Andrew

2010-07-06

Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision. A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enroll, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form. Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder. To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used.

No effect of forearm band and extensor strengthening exercises for the treatment of tennis elbow: a prospective randomised study.

PubMed

Luginbühl, Rolf; Brunner, Florian; Schneeberger, Alberto G

2008-01-01

The objective of this prospective randomised study was to analyse the effect of the forearm support band and of strengthening exercises for the treatment of tennis elbow. Twenty-nine patients with 30 tennis elbows were randomised into 3 groups of treatment: (I) forearm support band, (II) strengthening exercises and (III) both methods. The patients had a standardised examination at their first visit, and then after 6 weeks, 3 months and 1 year. At the latest follow-up, there was a significant improvement of the symptoms compared to before treatment (p<0.0001), considering all patients independently of the methods of treatment. However, no differences in the scores were found between the 3 groups of treatment (p=0.27), indicating that no beneficial influence was found either for the strengthening exercises or for the forearm support band. Improvement seems to occur with time, independent of the method of treatment used.

A prospective randomised trial of PIN versus conventional stripping in varicose vein surgery.

PubMed Central

Durkin, M. T.; Turton, E. P.; Scott, D. J.; Berridge, D. C.

1999-01-01

A prospective, randomised trial was carried out to examine the efficacy of perforate invagination (PIN, Credenhill Ltd, Derbyshire, UK) stripping of the long saphenous vein (LSV) in comparison to conventional stripping (Astratech AB, Sweden) in the surgical management of primary varicose veins. Eighty patients with primary varicosities secondary to sapheno-femoral junction (SFJ) incompetence and LSV reflux were recruited. Patients were randomised to PIN or conventional stripping with all other operative techniques remaining constant. Follow-up was performed at 1 and 6 weeks postoperatively. There were no statistically significant differences between the two techniques in terms of time taken to strip the vein, percentage of vein stripped or the area of bruising at 1 week. The size of the exit site was significantly smaller with the PIN device (P < or = 0.01). Optimal use of the conventional stripper provides results comparable to the PIN device. Choice of stripping device remains the surgeon's, bearing in mind that the PIN stripper achieves slightly better cosmesis. PMID:10364948

Comparison between the use of an ultrasonic tip and a microhead handpiece in periradicular surgery: a prospective randomised trial.

PubMed

Shearer, Jane; McManners, Joseph

2009-07-01

Innovations in periradicular surgery for failed treatment of orthograde root canal disease have been well-documented. We know of no prospective studies that have compared success rates of conventional methods with these presumed advances. In this prospective randomised trial we compare the use of an ultrasonic retrotip with a microhead bur in the preparation of a retrograde cavity. Outcome was estimated clinically by estimation of pain, swelling, and sinus, and radiographically by looking at infill of bone and retrograde root filling 2 weeks and 6 months postoperatively. Both methods used other surgical techniques including microinstruments to place the retrograde root filling. The success rate of the ultrasonic method was higher (all patients, n=26) than that of the microhead method (n=19 of 21). A larger study with longer follow up is required to consolidate this evidence.

Laser in Glaucoma and Ocular Hypertension (LiGHT) trial. A multicentre, randomised controlled trial: design and methodology.

PubMed

Gazzard, Gus; Konstantakopoulou, Evgenia; Garway-Heath, David; Barton, Keith; Wormald, Richard; Morris, Stephen; Hunter, Rachael; Rubin, Gary; Buszewicz, Marta; Ambler, Gareth; Bunce, Catey

2018-05-01

The Laser in Glaucoma and Ocular Hypertension (LiGHT) Trial aims to establish whether initial treatment with selective laser trabeculoplasty (SLT) is superior to initial treatment with topical medication for primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The LiGHT Trial is a prospective, unmasked, multicentre, pragmatic, randomised controlled trial. 718 previously untreated patients with POAG or OHT were recruited at six collaborating centres in the UK between 2012 and 2014. The trial comprises two treatment arms: initial SLT followed by conventional medical therapy as required, and medical therapy without laser therapy. Randomisation was provided online by a web-based randomisation service. Participants will be monitored for 3 years, according to routine clinical practice. The target intraocular pressure (IOP) was set at baseline according to an algorithm, based on disease severity and lifetime risk of loss of vision at recruitment, and subsequently adjusted on the basis of IOP control, optic disc and visual field. The primary outcome measure is health-related quality of life (HRQL) (EQ-5D five-level). Secondary outcomes are treatment pathway cost and cost-effectiveness, Glaucoma Utility Index, Glaucoma Symptom Scale, Glaucoma Quality of Life, objective measures of pathway effectiveness, visual function and safety profiles and concordance. A single main analysis will be performed at the end of the trial on an intention-to-treat basis. The LiGHT Trial is a multicentre, pragmatic, randomised clinical trial that will provide valuable data on the relative HRQL, clinical effectiveness and cost-effectiveness of SLT and topical IOP-lowering medication. ISRCTN32038223, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Use of an embedded, micro-randomised trial to investigate non-compliance in telehealth interventions.

PubMed

Law, Lisa M; Edirisinghe, Nuwani; Wason, James Ms

2016-08-01

Many types of telehealth interventions rely on activity from the patient in order to have a beneficial effect on their outcome. Remote monitoring systems require the patient to record regular measurements at home, for example, blood pressure, so clinicians can see whether the patient's health changes over time and intervene if necessary. A big problem in this type of intervention is non-compliance. Most telehealth trials report compliance rates, but they rarely compare compliance among various options of telehealth delivery, of which there may be many. Optimising telehealth delivery is vital for improving compliance and, therefore, clinical outcomes. We propose a trial design which investigates ways of improving compliance. For efficiency, this trial is embedded in a larger trial for evaluating clinical effectiveness. It employs a technique called micro-randomisation, where individual patients are randomised multiple times throughout the study. The aims of this article are (1) to verify whether the presence of an embedded secondary trial still allows valid analysis of the primary research and (2) to demonstrate the usefulness of the micro-randomisation technique for comparing compliance interventions. Simulation studies were used to simulate a large number of clinical trials, in which no embedded trial was used, a micro-randomised embedded trial was used, and a factorial embedded trial was used. Each simulation recorded the operating characteristics of the primary and secondary trials. We show that the type I error rate of the primary analysis was not affected by the presence of an embedded secondary trial. Furthermore, we show that micro-randomisation is superior to a factorial design as it reduces the variation caused by within-patient correlation. It therefore requires smaller sample sizes - our simulations showed a requirement of 128 patients for a micro-randomised trial versus 760 patients for a factorial design, in the presence of within-patient correlation. We believe that an embedded, micro-randomised trial is a feasible technique that can potentially be highly useful in telehealth trials. © The Author(s) 2016.

Protocol of a Multicenter International Randomized Controlled Manikin Study on Different Protocols of Cardiopulmonary Resuscitation for laypeople (MANI-CPR).

PubMed

Baldi, Enrico; Contri, Enrico; Burkart, Roman; Borrelli, Paola; Ferraro, Ottavia Eleonora; Tonani, Michela; Cutuli, Amedeo; Bertaia, Daniele; Iozzo, Pasquale; Tinguely, Caroline; Lopez, Daniel; Boldarin, Susi; Deiuri, Claudio; Dénéréaz, Sandrine; Dénéréaz, Yves; Terrapon, Michael; Tami, Christian; Cereda, Cinzia; Somaschini, Alberto; Cornara, Stefano; Cortegiani, Andrea

2018-04-19

Out-of-hospital cardiac arrest is one of the leading causes of death in industrialised countries. Survival depends on prompt identification of cardiac arrest and on the quality and timing of cardiopulmonary resuscitation (CPR) and defibrillation. For laypeople, there has been a growing interest on hands-only CPR, meaning continuous chest compression without interruption to perform ventilations. It has been demonstrated that intentional interruptions in hands-only CPR can increase its quality. The aim of this randomised trial is to compare three CPR protocols performed with different intentional interruptions with hands-only CPR. This is a prospective randomised trial performed in eight training centres. Laypeople who passed a basic life support course will be randomised to one of the four CPR protocols in an 8 min simulated cardiac arrest scenario on a manikin: (1) 30 compressions and 2 s pause; (2) 50 compressions and 5 s pause; (3) 100 compressions and 10 s pause; (4) hands-only. The calculated sample size is 552 people. The primary outcome is the percentage of chest compression performed with correct depth evaluated by a computerised feedback system (Laerdal QCPR). ETHICS AND DISSEMINATION: . Due to the nature of the study, we obtained a waiver from the Ethics Committee (IRCCS Policlinico San Matteo, Pavia, Italy). All participants will sign an informed consent form before randomisation. The results of this study will be published in peer-reviewed journal. The data collected will also be made available in a public data repository. NCT02632500. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A prospective, randomised trial of different matching procedures for structured mentoring programmes in medical education.

PubMed

Schäfer, Matthias; Pander, Tanja; Pinilla, Severin; Fischer, Martin R; von der Borch, Philip; Dimitriadis, Konstantinos

2016-09-01

Spontaneous formation of mentoring relationships can be seen as the gold standard in mentoring. Unfortunately, it happens very infrequently. The purpose of structured mentoring programmes is to facilitate the formation of mentoring relationships. This remains a challenging task, especially for large institutions. We set out to investigate and compare three methods of matchmaking in the setting of our structured mentoring programme. In a prospective, randomised trial we compared personal matching (PM) by an experienced expert to two different electronic data processing (EDP)-supported matching procedures: "online algorithm" (OA) versus "online search" (OS). PM was performed after structured interviews of prospective protégés by one founder of our mentoring programme. The OA provides students with a choice of 10 potential mentors based on comparison of online profiles. OS lets students filter and search through all available mentor profiles. One hundred and ninty medical students were randomised into the three groups. One year later, we evaluated the endpoints 1. "establishment of a mentoring relationship" and 2. "satisfaction with the mentoring relationship". Satisfaction with the mentoring relationship was assessed using Munich-Evaluation-of-Mentoring-Questionnaire (MEMeQ). One hundred sixty-five out of the 190 study participants found a mentor. With regards to endpoint one we found an advantage of PM compared to both EDP-supported matching procedures. There was no significant difference between OA and OS. Concerning endpoint two the differences between the investigated matching procedures were not significant. PM is superior as to the number of mentoring relationships formed per participating student compared to EDP-supported methods. In our data, there was no significant difference in the level of satisfaction. Considering the high investments associated with PM of mentors and protégés, EDP-supported matching procedures seem a viable compromise between effectiveness and efficiency especially for large-scale structured mentoring programmes in medical education.

Effects of an interactive mHealth innovation for early detection of patient-reported symptom distress with focus on participatory care: protocol for a study based on prospective, randomised, controlled trials in patients with prostate and breast cancer.

PubMed

Langius-Eklöf, Ann; Crafoord, Marie-Therése; Christiansen, Mats; Fjell, Maria; Sundberg, Kay

2017-07-04

Cancer patients are predominantly treated as out-patients and as they often experience difficult symptoms and side effects it is important to facilitate and improve patient-clinician communication to support symptom management and self-care. Although the number of projects within supportive cancer care evaluating mobile health is increasing, few evidence-based interventions are described in the literature and thus there is a need for good quality clinical studies with a randomised design and sufficient power to guide future implementations. An interactive information and communications technology platform, including a smartphone/computer tablet app for reporting symptoms during cancer treatment was created in collaboration with a company specialising in health care management. The aim of this paper is to evaluate the effects of using the platform for patients with breast cancer during neo adjuvant chemotherapy treatment and patients with locally advanced prostate cancer during curative radiotherapy treatment. The main hypothesis is that the use of the platform will improve clinical management, reduce costs, and promote safe and participatory care. The study is a prospective, randomised, controlled trial for each patient group and it is based on repeated measurements. Patients are consecutively included and randomised. The intervention groups report symptoms via the app daily, during treatment and up to three weeks after end of treatment, as a complement to standard care. Patients in the control groups receive standard care alone. Outcomes targeted are symptom burden, quality of life, health literacy (capacity to understand and communicate health needs and promote healthy behaviours), disease progress and health care costs. Data will be collected before and after treatment by questionnaires, registers, medical records and biomarkers. Lastly, participants will be interviewed about participatory and meaningful care. Results will generate knowledge to enhance understanding about how to develop person-centred care using mobile technology. Supporting patients' involvement in their care to identify problems early, promotes more timely initiation of necessary treatment. This can benefit patients treated outside the hospital setting in regard to maintaining their safety. June 12 2015 NCT02477137 (Prostate cancer) and June 12 2015 NCT02479607 (Breast cancer).

A novel method to enhance informed consent: a prospective and randomised trial of form-based versus electronic assisted informed consent in paediatric endoscopy.

PubMed

Friedlander, Joel A; Loeben, Greg S; Finnegan, Patricia K; Puma, Anita E; Zhang, Xuemei; de Zoeten, Edwin F; Piccoli, David A; Mamula, Petar

2011-04-01

To evaluate the adequacy of paediatric informed consent and its augmentation by a supplemental computer-based module in paediatric endoscopy. The Consent-20 instrument was developed and piloted on 47 subjects. Subsequently, parents of 101 children undergoing first-time, diagnostic upper endoscopy performed under moderate IV sedation were prospectively and consecutively, blinded, randomised and enrolled into two groups that received either standard form-based informed consent or standard form-based informed consent plus a commercial (Emmi Solutions, Inc, Chicago, Il), sixth grade level, interactive learning module (electronic assisted consent). Anonymously and electronically, the subjects' anxiety (State Trait Anxiety Inventory), satisfaction (Modified Group Health Association of America), number of questions asked, and attainment of informed consent were assessed (Consent-20). Statistics were calculated using t test, paired t test, and Mann Whitney tests. The ability to achieve informed consent, as measured by the new instrument, was 10% in the control form-based consent group and 33% in the electronic assisted consent group (p<0.0001). Electronically assisting form-based informed consent did not alter secondary outcome measures of subject satisfaction, anxiety or number of questions asked in a paediatric endoscopy unit. This study demonstrates the limitations of form-based informed consent methods for paediatric endoscopy. It also shows that even when necessary information was repeated electronically in a comprehensive and standardised video, informed consent as measured by our instrument was incompletely achieved. The supplemental information did, however, significantly improve understanding in a manner that did not negatively impact workflow, subject anxiety or subject satisfaction. Additional study of informed consent is required.

Anterior transversalis fascia approach versus preperitoneal space approach for inguinal hernia repair in residents in northern China: study protocol for a prospective, multicentre, randomised, controlled trial

PubMed Central

Fan, Qing; Zhang, De-wei; Yang, Da-ye; Li, Hong-wu; Wei, Shi-bo; Yang, Liang; Yang, Fu-quan; Zhang, Shao-jun; Wu, Yao-qiang; An, Wei-de; Dai, Zhong-shu; Jiang, Hui-yong; Wang, Fu-rong; Qiao, Shi-feng; Li, Hang-yu

2017-01-01

Introduction Many surgical techniques have been used to repair abdominal wall defects in the inguinal region based on the anatomic characteristics of this region and can be categorised as ‘tension’ repair or ‘tension-free’ repair. Tension-free repair is the preferred technique for inguinal hernia repair. Tension-free repair of inguinal hernia can be performed through either the anterior transversalis fascia approach or the preperitoneal space approach. There are few large sample, randomised controlled trials investigating the curative effects of the anterior transversalis fascia approach versus the preperitoneal space approach for inguinal hernia repair in patients in northern China. Methods and analysis This will be a prospective, large sample, multicentre, randomised, controlled trial. Registration date is 1 December 2016. Actual study start date is 6 February 2017. Estimated study completion date is June 2020. A cohort of over 720 patients with inguinal hernias will be recruited from nine institutions in Liaoning Province, China. Patient randomisation will be stratified by centre to undergo inguinal hernia repair via the anterior transversalis fascia approach or the preperitoneal approach. Primary and secondary outcome assessments will be performed at baseline (prior to surgery), predischarge and at postoperative 1 week, 1 month, 3 months, 1 year and 2 years. The primary outcome is the incidence of postoperative chronic inguinal pain. The secondary outcome is postoperative complications (including rates of wound infection, haematoma, seroma and hernia recurrence). Ethics and dissemination This trial will be conducted in accordance with the Declaration of Helsinki and supervised by the institutional review board of the Fourth Affiliated Hospital of China Medical University (approval number 2015–027). All patients will receive information about the trial in verbal and written forms and will give informed consent before enrolment. The results will be published in peer-reviewed journals or disseminated through conference presentations. Trial registration number NCT02984917; preresults. PMID:28860228

Health-related quality of life from a prospective randomised clinical trial of robot-assisted laparoscopic vs open radical cystectomy.

PubMed

Messer, Jamie C; Punnen, Sanoj; Fitzgerald, John; Svatek, Robert; Parekh, Dipen J

2014-12-01

To compare health-related quality-of-life (HRQoL) outcomes for robot-assisted laparoscopic radical cystectomy (RARC) with those of traditional open radical cystectomy (ORC) in a prospective randomised fashion. This was a prospective randomised clinical trial evaluating the HRQoL for ORC vs RARC in consecutive patients from July 2009 to June 2011. We administered the Functional Assessment of Cancer Therapy-Vanderbilt Cystectomy Index questionnaire, validated to assess HRQoL, preoperatively and then at 3, 6, 9 and 12 months postoperatively. Scores for each domain and total scores were compared in terms of deviation from preoperative values for both the RARC and the ORC cohorts. Multivariate linear regression was used to assess the association between the type of radical cystectomy and HRQoL. At the time of the study, 47 patients had met the inclusion criteria, with 40 patients being randomised for analysis. The cohorts consisted of 20 patients undergoing ORC and 20 undergoing RARC, who were balanced with respect to baseline demographic and clinical features. Univariate analysis showed a return to baseline scores at 3 months postoperatively in all measured domains with no statistically significant difference among the various domains between the RARC and the ORC cohorts. Multivariate analysis showed no difference in HRQoL between the two approaches in any of the various domains, with the exception of a slightly higher physical well-being score in the RARC group at 6 months. There were no significant differences in the HRQoL outcomes between ORC and RARC, with a return of quality of life scores to baseline scores 3 months after radical cystectomy in both cohorts. © 2014 The Authors. BJU International © 2014 BJU International.

The effectiveness of simulation activities on the cognitive abilities of undergraduate third-year nursing students: a randomised control trial.

PubMed

Secomb, Jacinta; McKenna, Lisa; Smith, Colleen

2012-12-01

To provide evidence on the effectiveness of simulation activities on the clinical decision-making abilities of undergraduate nursing students. Based on previous research, it was hypothesised that the higher the cognitive score, the greater the ability a nursing student would have to make informed valid decisions in their clinical practice. Globally, simulation is being espoused as an education method that increases the competence of health professionals. At present, there is very little evidence to support current investment in time and resources. Following ethical approval, fifty-eight third-year undergraduate nursing students were randomised in a pretest-post-test group-parallel controlled trial. The learning environment preferences (LEP) inventory was used to test cognitive abilities in order to refute the null hypothesis that activities in computer-based simulated learning environments have a negative effect on cognitive abilities when compared with activities in skills laboratory simulated learning environments. There was no significant difference in cognitive development following two cycles of simulation activities. Therefore, it is reasonable to assume that two simulation tasks, either computer-based or laboratory-based, have no effect on an undergraduate student's ability to make clinical decisions in practice. However, there was a significant finding for non-English first-language students, which requires further investigation. More longitudinal studies that quantify the education effects of simulation on the cognitive, affective and psychomotor attributes of health science students and professionals from both English-speaking and non-English-speaking backgrounds are urgently required. It is also recommended that to achieve increased participant numbers and prevent non-participation owing to absenteeism, further studies need to be imbedded directly into curricula. This investigation confirms the effect of simulation activities on real-life clinical practice, and the comparative learning benefits with traditional clinical practice and university education remain unknown. © 2012 Blackwell Publishing Ltd.

Efficacy of simulation-based trauma team training of non-technical skills. A systematic review.

PubMed

Gjeraa, K; Møller, T P; Østergaard, D

2014-08-01

Trauma resuscitation is a complex situation, and most organisations have multi-professional trauma teams. Non-technical skills are challenged during trauma resuscitation, and they play an important role in the prevention of critical incidents. Simulation-based training of these is recommended. Our research question was: Does simulation-based trauma team training of non-technical skills have effect on reaction, learning, behaviour or patient outcome? The authors searched PubMed, EMBASE and the Cochrane Library and found 13 studies eligible for analysis. We described and compared the educational interventions and the evaluations of effect according to the four Kirkpatrick levels: reaction, learning (knowledge, skills, attitudes), behaviour (in a clinical setting) and patient outcome. No studies were randomised, controlled and blinded, resulting in a moderate to high risk of bias. The multi-professional trauma teams had positive reactions to simulation-based training of non-technical skills. Knowledge and skills improved in all studies evaluating the effect on learning. Three studies found improvements in team performance (behaviour) in the clinical setting. One of these found difficulties in maintaining these skills. Two studies evaluated on patient outcome, of which none showed improvements in mortality, complication rate or duration of hospitalisation. A significant effect on learning was found after simulation-based training of the multi-professional trauma team in non-technical skills. Three studies demonstrated significantly increased clinical team performance. No effect on patient outcome was found. All studies had a moderate to high risk of bias. More comprehensive randomised studies are needed to evaluate the effect on patient outcome. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial

PubMed Central

Sørensen, Jette Led; van der Vleuten, Cees; Rosthøj, Susanne; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Starkopf, Liis; Lindschou, Jane; Gluud, Christian; Weikop, Pia; Ottesen, Bent

2015-01-01

Objective To investigate the effect of in situ simulation (ISS) versus off-site simulation (OSS) on knowledge, patient safety attitude, stress, motivation, perceptions of simulation, team performance and organisational impact. Design Investigator-initiated single-centre randomised superiority educational trial. Setting Obstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark. Participants 100 participants in teams of 10, comprising midwives, specialised midwives, auxiliary nurses, nurse anaesthetists, operating theatre nurses, and consultant doctors and trainees in obstetrics and anaesthesiology. Interventions Two multiprofessional simulations (clinical management of an emergency caesarean section and a postpartum haemorrhage scenario) were conducted in teams of 10 in the ISS versus the OSS setting. Primary outcome Knowledge assessed by a multiple choice question test. Exploratory outcomes Individual outcomes: scores on the Safety Attitudes Questionnaire, stress measurements (State-Trait Anxiety Inventory, cognitive appraisal and salivary cortisol), Intrinsic Motivation Inventory and perceptions of simulations. Team outcome: video assessment of team performance. Organisational impact: suggestions for organisational changes. Results The trial was conducted from April to June 2013. No differences between the two groups were found for the multiple choice question test, patient safety attitude, stress measurements, motivation or the evaluation of the simulations. The participants in the ISS group scored the authenticity of the simulation significantly higher than did the participants in the OSS group. Expert video assessment of team performance showed no differences between the ISS versus the OSS group. The ISS group provided more ideas and suggestions for changes at the organisational level. Conclusions In this randomised trial, no significant differences were found regarding knowledge, patient safety attitude, motivation or stress measurements when comparing ISS versus OSS. Although participant perception of the authenticity of ISS versus OSS differed significantly, there were no differences in other outcomes between the groups except that the ISS group generated more suggestions for organisational changes. Trial registration number NCT01792674. PMID:26443654

Antibiotic prophylaxis in permanent pacemaker implantation: a prospective randomised trial.

PubMed Central

Mounsey, J P; Griffith, M J; Tynan, M; Gould, F K; MacDermott, A F; Gold, R G; Bexton, R S

1994-01-01

BACKGROUND--Pacemaker pocket infection is a potentially serious problem after permanent pacemaker implantation. Antibiotic prophylaxis is commonly prescribed to reduce the incidence of this complication, but current trial evidence of its efficacy is conflicting. A large prospective randomised trial was therefore performed of antibiotic prophylaxis in permanent pacemaker implantation. The intention was firstly to determine whether antibiotic prophylaxis is efficacious in these patients and secondly to identify which patients are at the highest risk of infection. METHODS--A prospective randomised open trial of flucloxacillin (clindamycin if the patient was allergic to penicillin) v no antibiotic was performed in a cohort of patients undergoing first implantation of a permanent pacing system over a 17 month period. Intravenous antibiotics were started at the time of implantation and continued for 48 hours. The trial endpoint was a repeat operation for an infective complication. RESULTS--473 patients were entered into a randomised trial. 224 received antibiotic prophylaxis and 249 received no antibiotics. A further 183 patients were not randomised but were treated according to the operator's preference (64 antibiotics, 119 no antibiotics); these patients are included only in the analysis of predictors of infection. Patients were followed up for a mean (SD) of 19(5) months. Among the patients in the randomised group there were nine infections requiring a repeat operation, all in the group not receiving antibiotic (P = 0.003). In the total patient cohort there were 13 infections, all but one in the non-antibiotic group (P = 0.006). Nine of the infections presented as erosion of the pulse generator or electrode, three as septicaemia secondary to Staphylococcus aureus, and one as a pocket abscess secondary to Staphylococcus epidermidis. Infections were significantly more common when the operator was inexperienced (< or = 100 previous patients), the operation was prolonged, or after a repeat operation for non-infective complications (principally lead displacement). Infection was not significantly more common in patients identified preoperatively as being at high risk (for example patients with diabetes mellitus, patients receiving long term steroid treatment), although there was a trend in this direction. CONCLUSIONS--Antibiotic prophylaxis significantly reduced the incidence of infective complications requiring a repeat operation after permanent pacemaker implantation. It is suggested that antibiotics should be used routinely. PMID:7833191

Systematic Review of Voluntary Participation in Simulation-Based Laparoscopic Skills Training: Motivators and Barriers for Surgical Trainee Attendance.

PubMed

Gostlow, Hannah; Marlow, Nicholas; Babidge, Wendy; Maddern, Guy

To examine and report on evidence relating to surgical trainees' voluntary participation in simulation-based laparoscopic skills training. Specifically, the underlying motivators, enablers, and barriers faced by surgical trainees with regard to attending training sessions on a regular basis. A systematic search of the literature (PubMed; CINAHL; EMBASE; Cochrane Collaboration) was conducted between May and July 2015. Studies were included on whether they reported on surgical trainee attendance at voluntary, simulation-based laparoscopic skills training sessions, in addition to qualitative data regarding participant's perceived barriers and motivators influencing their decision to attend such training. Factors affecting a trainee's motivation were categorized as either intrinsic (internal) or extrinsic (external). Two randomised control trials and 7 case series' met our inclusion criteria. Included studies were small and generally poor quality. Overall, voluntary simulation-based laparoscopic skills training was not well attended. Intrinsic motivators included clearly defined personal performance goals and relevance to clinical practice. Extrinsic motivators included clinical responsibilities and available free time, simulator location close to clinical training, and setting obligatory assessments or mandated training sessions. The effect of each of these factors was variable, and largely dependent on the individual trainee. The greatest reported barrier to attending voluntary training was the lack of available free time. Although data quality is limited, it can be seen that providing unrestricted access to simulator equipment is not effective in motivating surgical trainees to voluntarily participate in simulation-based laparoscopic skills training. To successfully encourage participation, consideration needs to be given to the factors influencing motivation to attend training. Further research, including better designed randomised control trials and large-scale surveys, is required to provide more definitive answers to the degree in which various incentives influence trainees' motivations and actual attendance rates. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

A systematic review of models to predict recruitment to multicentre clinical trials

PubMed Central

2010-01-01

Background Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision. Methods A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enrol, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form. Results Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder. Conclusions To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used. PMID:20604946

Tonsillitis: MedlinePlus Health Topic

MedlinePlus

... Library of Medicine) Article: The debate continues: a prospective, randomised, single-blind study comparing Coblation... Article: Overnight in-hospital observation following tonsillectomy: retrospective study of post-operative intervention. Article: Immune thrombocytopenia ...

Virtual reality simulator training of laparoscopic cholecystectomies - a systematic review.

PubMed

Ikonen, T S; Antikainen, T; Silvennoinen, M; Isojärvi, J; Mäkinen, E; Scheinin, T M

2012-01-01

Simulators are widely used in occupations where practice in authentic environments would involve high human or economic risks. Surgical procedures can be simulated by increasingly complex and expensive techniques. This review gives an update on computer-based virtual reality (VR) simulators in training for laparoscopic cholecystectomies. From leading databases (Medline, Cochrane, Embase), randomised or controlled trials and the latest systematic reviews were systematically searched and reviewed. Twelve randomised trials involving simulators were identified and analysed, as well as four controlled studies. Furthermore, seven studies comparing black boxes and simulators were included. The results indicated any kind of simulator training (black box, VR) to be beneficial at novice level. After VR training, novice surgeons seemed to be able to perform their first live cholecystectomies with fewer errors, and in one trial the positive effect remained during the first ten cholecystectomies. No clinical follow-up data were found. Optimal learning requires skills training to be conducted as part of a systematic training program. No data on the cost-benefit of simulators were found, the price of a VR simulator begins at EUR 60 000. Theoretical background to learning and limited research data support the use of simulators in the early phases of surgical training. The cost of buying and using simulators is justified if the risk of injuries and complications to patients can be reduced. Developing surgical skills requires repeated training. In order to achieve optimal learning a validated training program is needed.

Virtual reality simulation training for health professions trainees in gastrointestinal endoscopy.

PubMed

Walsh, Catharine M; Sherlock, Mary E; Ling, Simon C; Carnahan, Heather

2012-06-13

Traditionally, training in gastrointestinal endoscopy has been based upon an apprenticeship model, with novice endoscopists learning basic skills under the supervision of experienced preceptors in the clinical setting. Over the last two decades, however, the growing awareness of the need for patient safety has brought the issue of simulation-based training to the forefront. While the use of simulation-based training may have important educational and societal advantages, the effectiveness of virtual reality gastrointestinal endoscopy simulators has yet to be clearly demonstrated. To determine whether virtual reality simulation training can supplement and/or replace early conventional endoscopy training (apprenticeship model) in diagnostic oesophagogastroduodenoscopy, colonoscopy and/or sigmoidoscopy for health professions trainees with limited or no prior endoscopic experience. Health professions, educational and computer databases were searched until November 2011 including The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, Scopus, Web of Science, Biosis Previews, CINAHL, Allied and Complementary Medicine Database, ERIC, Education Full Text, CBCA Education, Career and Technical Education @ Scholars Portal, Education Abstracts @ Scholars Portal, Expanded Academic ASAP @ Scholars Portal, ACM Digital Library, IEEE Xplore, Abstracts in New Technologies and Engineering and Computer & Information Systems Abstracts. The grey literature until November 2011 was also searched. Randomised and quasi-randomised clinical trials comparing virtual reality endoscopy (oesophagogastroduodenoscopy, colonoscopy and sigmoidoscopy) simulation training versus any other method of endoscopy training including conventional patient-based training, in-job training, training using another form of endoscopy simulation (e.g. low-fidelity simulator), or no training (however defined by authors) were included.  Trials comparing one method of virtual reality training versus another method of virtual reality training (e.g. comparison of two different virtual reality simulators) were also included. Only trials measuring outcomes on humans in the clinical setting (as opposed to animals or simulators) were included. Two authors (CMS, MES) independently assessed the eligibility and methodological quality of trials, and extracted data on the trial characteristics and outcomes. Due to significant clinical and methodological heterogeneity it was not possible to pool study data in order to perform a meta-analysis. Where data were available for each continuous outcome we calculated standardized mean difference with 95% confidence intervals based on intention-to-treat analysis. Where data were available for dichotomous outcomes we calculated relative risk with 95% confidence intervals based on intention-to-treat-analysis. Thirteen trials, with 278 participants, met the inclusion criteria. Four trials compared simulation-based training with conventional patient-based endoscopy training (apprenticeship model) whereas nine trials compared simulation-based training with no training. Only three trials were at low risk of bias. Simulation-based training, as compared with no training, generally appears to provide participants with some advantage over their untrained peers as measured by composite score of competency, independent procedure completion, performance time, independent insertion depth, overall rating of performance or competency error rate and mucosal visualization. Alternatively, there was no conclusive evidence that simulation-based training was superior to conventional patient-based training, although data were limited. The results of this systematic review indicate that virtual reality endoscopy training can be used to effectively supplement early conventional endoscopy training (apprenticeship model) in diagnostic oesophagogastroduodenoscopy, colonoscopy and/or sigmoidoscopy for health professions trainees with limited or no prior endoscopic experience. However, there remains insufficient evidence to advise for or against the use of virtual reality simulation-based training as a replacement for early conventional endoscopy training (apprenticeship model) for health professions trainees with limited or no prior endoscopic experience. There is a great need for the development of a reliable and valid measure of endoscopic performance prior to the completion of further randomised clinical trials with high methodological quality.

Comparative evaluation of postoperative pain after using endodontic needle and EndoActivator during root canal irrigation: A randomised controlled trial.

PubMed

Ramamoorthi, Surendar; Nivedhitha, Malli Sureshbabu; Divyanand, Madras Jeyaprakash

2015-08-01

The purpose of this study was to evaluate and compare the postoperative level of pain after activation of irrigants using EndoActivator with conventional needle irrigation during root canal therapy. In this prospective randomised clinical trial, 72 symptomatic irreversible pulpitis patients were selected. Based on block randomisation after routine root canal preparation, patients were assigned to two groups. In group EN, procedures were performed with endodontic irrigating needle (n = 36) while group EA received activation using EndoActivator (n = 36) in the final irrigation protocol. All the participants were called through phone at 8, 24 and 48 h to analyse pain score using visual analogue scale. Those patients who developed pain were prescribed ibuprofen 200 mg. Pain score and frequency of tablet intake were recorded and statistically analysed. Results showed that group EA resulted in significantly less postoperative pain and analgesics intake than group EN. In conclusion, within the limitations of this study, the activation of irrigants using EndoActivator can be considered an effective method for reducing postoperative pain. © 2014 Australian Society of Endodontology.

Safety and feasibility of xenon as an adjuvant to sevoflurane anaesthesia in children undergoing interventional or diagnostic cardiac catheterization: study protocol for a randomised controlled trial.

PubMed

Devroe, Sarah; Lemiere, Jurgen; Van de Velde, Marc; Gewillig, Marc; Boshoff, Derize; Rex, Steffen

2015-03-04

Xenon has minimal haemodynamic side effects when compared to volatile or intravenous anaesthetics. Moreover, in in vitro and in animal experiments, xenon has been demonstrated to convey cardio- and neuroprotective effects. Neuroprotection could be advantageous in paediatric anaesthesia as there is growing concern, based on both laboratory studies and retrospective human clinical studies, that anaesthetics may trigger an injury in the developing brain, resulting in long-lasting neurodevelopmental consequences. Furthermore, xenon-mediated neuroprotection could help to prevent emergence delirium/agitation. Altogether, the beneficial haemodynamic profile combined with its putative organ-protective properties could render xenon an attractive option for anaesthesia of children undergoing cardiac catheterization. In a phase-II, mono-centre, prospective, single-blind, randomised, controlled study, we will test the hypothesis that the administration of 50% xenon as an adjuvant to general anaesthesia with sevoflurane in children undergoing elective cardiac catheterization is safe and feasible. Secondary aims include the evaluation of haemodynamic parameters during and after the procedure, emergence characteristics, and the analysis of peri-operative neuro-cognitive function. A total of 40 children ages 4 to 12 years will be recruited and randomised into two study groups, receiving either a combination of sevoflurane and xenon or sevoflurane alone. Children undergoing diagnostic or interventional cardiac catheterization are a vulnerable patient population, one particularly at risk for intra-procedural haemodynamic instability. Xenon provides remarkable haemodynamic stability and potentially has cardio- and neuroprotective properties. Unfortunately, evidence is scarce on the use of xenon in the paediatric population. Our pilot study will therefore deliver important data required for prospective future clinical trials. EudraCT: 2014-002510-23 (5 September 2014).

Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial

PubMed Central

Price, Brandee A; Bednarski, Brian K; You, Y Nancy; Manandhar, Meryna; Dean, E Michelle; Alawadi, Zeinab M; Bryce Speer, B; Gottumukkala, Vijaya; Weldon, Marla; Massey, Robert L; Wang, Xuemei; Qiao, Wei; Chang, George J

2017-01-01

Introduction Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation. Methods and analysis In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology (TeleRecovery) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. Ethics and dissemination RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial. Trial registration number NCT02613728; Pre-results. PMID:28729319

Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial

PubMed Central

2013-01-01

Background Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the ‘holistic’ approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people. Methods/design A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed. Discussion This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting seniors recognises the heterogeneity of multicultural populations and may further increase the number of taking part in exercise. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12612000889853 The trial is now in progress with 12 villages already have been randomised. PMID:23675705

Can social dancing prevent falls in older adults? a protocol of the Dance, Aging, Cognition, Economics (DAnCE) fall prevention randomised controlled trial.

PubMed

Merom, Dafna; Cumming, Robert; Mathieu, Erin; Anstey, Kaarin J; Rissel, Chris; Simpson, Judy M; Morton, Rachael L; Cerin, Ester; Sherrington, Catherine; Lord, Stephen R

2013-05-15

Falls are one of the most common health problems among older people and pose a major economic burden on health care systems. Exercise is an accepted stand-alone fall prevention strategy particularly if it is balance training or regular participation in Tai chi. Dance shares the 'holistic' approach of practices such as Tai chi. It is a complex sensorimotor rhythmic activity integrating multiple physical, cognitive and social elements. Small-scale randomised controlled trials have indicated that diverse dance styles can improve measures of balance and mobility in older people, but none of these studies has examined the effect of dance on falls or cognition. This study aims to determine whether participation in social dancing: i) reduces the number of falls; and ii) improves cognitive functions associated with fall risk in older people. A single-blind, cluster randomised controlled trial of 12 months duration will be conducted. Approximately 450 participants will be recruited from 24 self-care retirement villages that house at least 60 residents each in Sydney, Australia. Village residents without cognitive impairment and obtain medical clearance will be eligible. After comprehensive baseline measurements including physiological and cognitive tests and self-completed questionnaires, villages will be randomised to intervention sites (ballroom or folk dance) or to a wait-listed control using a computer randomisation method that minimises imbalances between villages based on two baseline fall risk measures. Main outcome measures are falls, prospectively measured, and the Trail Making cognitive function test. Cost-effectiveness and cost-utility analyses will be performed. This study offers a novel approach to balance training for older people. As a community-based approach to fall prevention, dance offers older people an opportunity for greater social engagement, thereby making a major contribution to healthy ageing. Providing diversity in exercise programs targeting seniors recognises the heterogeneity of multicultural populations and may further increase the number of taking part in exercise. Australian New Zealand Clinical Trials Registry ACTRN12612000889853The trial is now in progress with 12 villages already have been randomised.

Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study

PubMed Central

2011-01-01

Background The rapidly increasing number of activity-induced musculoskeletal injuries among adolescents and young adults is currently a true public health burden. The objective of this study was to investigate whether a neuromuscular training programme with injury prevention counselling is effective in preventing acute musculoskeletal injuries in young men during military service. Methods The trial design was a population-based, randomised study. Two successive cohorts of male conscripts in four companies of one brigade in the Finnish Defence Forces were first followed prospectively for one 6-month term to determine the baseline incidence of injury. After this period, two new successive cohorts in the same four companies were randomised into two groups and followed prospectively for 6 months. Military service is compulsory for about 90% of 19-year-old Finnish men annually, who comprised the cohort in this study. This randomised, controlled trial included 968 conscripts comprising 501 conscripts in the intervention group and 467 conscripts in the control group. A neuromuscular training programme was used to enhance conscripts' motor skills and body control, and an educational injury prevention programme was used to increase knowledge and awareness of acute musculoskeletal injuries. The main outcome measures were acute injuries of the lower and upper limbs. Results In the intervention groups, the risk for acute ankle injury decreased significantly compared to control groups (adjusted hazards ratio (HR) = 0.34, 95% confidence interval (95% CI) = 0.15 to 0.78, P = 0.011). This risk decline was observed in conscripts with low as well as moderate to high baseline fitness levels. In the latter group of conscripts, the risk of upper-extremity injuries also decreased significantly (adjusted HR = 0.37, 95% CI 0.14 to 0.99, P = 0.047). In addition, the intervention groups tended to have less time loss due to injuries (adjusted HR = 0.55, 95% CI 0.29 to 1.04). Conclusions A neuromuscular training and injury prevention counselling programme was effective in preventing acute ankle and upper-extremity injuries in young male army conscripts. A similar programme could be useful for all young individuals by initiating a regular exercise routine. Trial registration ClinicalTrials.gov identifier number NCT00595816. PMID:21481230

Neuromuscular training with injury prevention counselling to decrease the risk of acute musculoskeletal injury in young men during military service: a population-based, randomised study.

PubMed

Parkkari, Jari; Taanila, Henri; Suni, Jaana; Mattila, Ville M; Ohrankämmen, Olli; Vuorinen, Petteri; Kannus, Pekka; Pihlajamäki, Harri

2011-04-11

The rapidly increasing number of activity-induced musculoskeletal injuries among adolescents and young adults is currently a true public health burden. The objective of this study was to investigate whether a neuromuscular training programme with injury prevention counselling is effective in preventing acute musculoskeletal injuries in young men during military service. The trial design was a population-based, randomised study. Two successive cohorts of male conscripts in four companies of one brigade in the Finnish Defence Forces were first followed prospectively for one 6-month term to determine the baseline incidence of injury. After this period, two new successive cohorts in the same four companies were randomised into two groups and followed prospectively for 6 months. Military service is compulsory for about 90% of 19-year-old Finnish men annually, who comprised the cohort in this study. This randomised, controlled trial included 968 conscripts comprising 501 conscripts in the intervention group and 467 conscripts in the control group. A neuromuscular training programme was used to enhance conscripts' motor skills and body control, and an educational injury prevention programme was used to increase knowledge and awareness of acute musculoskeletal injuries. The main outcome measures were acute injuries of the lower and upper limbs. In the intervention groups, the risk for acute ankle injury decreased significantly compared to control groups (adjusted hazards ratio (HR) = 0.34, 95% confidence interval (95% CI) = 0.15 to 0.78, P = 0.011). This risk decline was observed in conscripts with low as well as moderate to high baseline fitness levels. In the latter group of conscripts, the risk of upper-extremity injuries also decreased significantly (adjusted HR = 0.37, 95% CI 0.14 to 0.99, P = 0.047). In addition, the intervention groups tended to have less time loss due to injuries (adjusted HR = 0.55, 95% CI 0.29 to 1.04). A neuromuscular training and injury prevention counselling programme was effective in preventing acute ankle and upper-extremity injuries in young male army conscripts. A similar programme could be useful for all young individuals by initiating a regular exercise routine. ClinicalTrials.gov identifier number NCT00595816.

Vision after trans-sylvian or temporobasal selective amygdalohippocampectomy: a prospective randomised trial.

PubMed

Delev, Daniel; Wabbels, Bettina; Schramm, Johannes; Nelles, Michael; Elger, Christian E; von Lehe, Marec; Clusmann, Hans; Grote, Alexander

2016-09-01

Selective amygdalohippocampectomy (SAH) is an accepted surgical procedure for treatment of pharmacoresistant mesial temporal lobe epilepsy, but it may lead to postoperative visual field deficits (VFDs). Here we present a prospective randomised trial comparing the postoperative VFDs after either a trans-sylvian or temporobasal approach for SAH. Forty-eight patients were randomly assigned to trans-sylvian (n = 24) or temporobasal (n = 24) SAH. Postoperative VFD were quantitatively evaluated using automated static and kinetic perimetry. In 24 cases, diffusion tensor imaging-based deterministic fibre-tracking of the optic radiation was performed. The primary endpoint was absence of postoperative VFD. The secondary endpoint was seizure outcome and driving ability. Three patients (13 %) from the trans-sylvian group showed no VFD, compared to 11 patients (46 %) from the temporobasal group without VFD (p = 0.01, RR = 3.7; CI = 1.2-11.5). Fifteen patients from each group (63 %) became completely seizure-free (ILAE1). Among those seizure-free cases, five trans-sylvian (33 %) and ten temporobasal (66 %) patients could apply for a driving licence (NNT = 3) when VFDs were considered. Although the trans-sylvian group experienced more frequent VFDs, the mean functional visual impairment showed a tendency to be less pronounced compared with the temporobasal group. DTI-based tracking of the optic radiation revealed that a lower distance of optic radiation to the temporal base correlated with increased rate of VFD in the temporobasal group. Temporobasal SAH shows significantly fewer VFDs and equal seizure-free rate compared with the trans-sylvian SAH. However, in patients in whom the optic radiation is close to the temporal base, the trans-sylvian approach may be a preferred alternative.

A Bayesian Hybrid Adaptive Randomisation Design for Clinical Trials with Survival Outcomes.

PubMed

Moatti, M; Chevret, S; Zohar, S; Rosenberger, W F

2016-01-01

Response-adaptive randomisation designs have been proposed to improve the efficiency of phase III randomised clinical trials and improve the outcomes of the clinical trial population. In the setting of failure time outcomes, Zhang and Rosenberger (2007) developed a response-adaptive randomisation approach that targets an optimal allocation, based on a fixed sample size. The aim of this research is to propose a response-adaptive randomisation procedure for survival trials with an interim monitoring plan, based on the following optimal criterion: for fixed variance of the estimated log hazard ratio, what allocation minimizes the expected hazard of failure? We demonstrate the utility of the design by redesigning a clinical trial on multiple myeloma. To handle continuous monitoring of data, we propose a Bayesian response-adaptive randomisation procedure, where the log hazard ratio is the effect measure of interest. Combining the prior with the normal likelihood, the mean posterior estimate of the log hazard ratio allows derivation of the optimal target allocation. We perform a simulation study to assess and compare the performance of this proposed Bayesian hybrid adaptive design to those of fixed, sequential or adaptive - either frequentist or fully Bayesian - designs. Non informative normal priors of the log hazard ratio were used, as well as mixture of enthusiastic and skeptical priors. Stopping rules based on the posterior distribution of the log hazard ratio were computed. The method is then illustrated by redesigning a phase III randomised clinical trial of chemotherapy in patients with multiple myeloma, with mixture of normal priors elicited from experts. As expected, there was a reduction in the proportion of observed deaths in the adaptive vs. non-adaptive designs; this reduction was maximized using a Bayes mixture prior, with no clear-cut improvement by using a fully Bayesian procedure. The use of stopping rules allows a slight decrease in the observed proportion of deaths under the alternate hypothesis compared with the adaptive designs with no stopping rules. Such Bayesian hybrid adaptive survival trials may be promising alternatives to traditional designs, reducing the duration of survival trials, as well as optimizing the ethical concerns for patients enrolled in the trial.

The impact of constructive feedback on training in gastrointestinal endoscopy using high-fidelity Virtual-Reality simulation: a randomised controlled trial.

PubMed

Kruglikova, Irina; Grantcharov, Teodor P; Drewes, Asbjorn M; Funch-Jensen, Peter

2010-02-01

Recently, virtual reality computer simulators have been used to enhance traditional endoscopy teaching. Previous studies have demonstrated construct validity of these systems and transfer of virtual skills to the operating room. However, to date no simulator-training curricula have been designed and there is very little evidence on the impact of external feedback on acquisition of endoscopic skills. The aim of the present study was to assess the impact of external feedback on the learning curves on a VR colonoscopy simulator using inexperienced trainees. 22 trainees, without colonoscopy experience were randomised to a group which received structured feedback provided by an experienced supervisor and a controlled group. All participants performed 15 repetitions of task 3 from the Introduction colonoscopy module of the Accu Touch Endoscopy simulator. Retention/transfer tests on simulator were performed 4-6 weeks after the last repetition. The proficiency levels were based on the performance of eight experienced colonoscopists. All subjects were able to complete the procedure on the simulator. There were no perforations in the feedback group versus seven in the non-feedback group. Subjects in the feedback group reached expert proficiency levels in percentage of mucosa visualised and time to reach the caecum significantly faster compared with the control group. None of the groups demonstrated significant degradation of performance in simulator retention/transfer tests. Concurrent feedback given by supervisor concur an advantage in acquisition of basic colonoscopy skills and achieving of proficiency level as compared to independent training.

Computer-Based Instruction for Improving Student Nurses' General Numeracy: Is It Effective? Two Randomised Trials

ERIC Educational Resources Information Center

Ainsworth, Hannah; Gilchrist, Mollie; Grant, Celia; Hewitt, Catherine; Ford, Sue; Petrie, Moira; Torgerson, Carole J.; Torgerson, David J.

2012-01-01

In response to concern over the numeracy skills deficit displayed by student nurses, an online computer programme, "Authentic World[R]", which aims to simulate a real-life clinical environment and improve the medication dosage calculation skills of users, was developed (Founded in 2004 Authentic World Ltd is a spin out company of…

Simulation-based multiprofessional obstetric anaesthesia training conducted in situ versus off-site leads to similar individual and team outcomes: a randomised educational trial.

PubMed

Sørensen, Jette Led; van der Vleuten, Cees; Rosthøj, Susanne; Østergaard, Doris; LeBlanc, Vicki; Johansen, Marianne; Ekelund, Kim; Starkopf, Liis; Lindschou, Jane; Gluud, Christian; Weikop, Pia; Ottesen, Bent

2015-10-06

To investigate the effect of in situ simulation (ISS) versus off-site simulation (OSS) on knowledge, patient safety attitude, stress, motivation, perceptions of simulation, team performance and organisational impact. Investigator-initiated single-centre randomised superiority educational trial. Obstetrics and anaesthesiology departments, Rigshospitalet, University of Copenhagen, Denmark. 100 participants in teams of 10, comprising midwives, specialised midwives, auxiliary nurses, nurse anaesthetists, operating theatre nurses, and consultant doctors and trainees in obstetrics and anaesthesiology. Two multiprofessional simulations (clinical management of an emergency caesarean section and a postpartum haemorrhage scenario) were conducted in teams of 10 in the ISS versus the OSS setting. Knowledge assessed by a multiple choice question test. Individual outcomes: scores on the Safety Attitudes Questionnaire, stress measurements (State-Trait Anxiety Inventory, cognitive appraisal and salivary cortisol), Intrinsic Motivation Inventory and perceptions of simulations. Team outcome: video assessment of team performance. Organisational impact: suggestions for organisational changes. The trial was conducted from April to June 2013. No differences between the two groups were found for the multiple choice question test, patient safety attitude, stress measurements, motivation or the evaluation of the simulations. The participants in the ISS group scored the authenticity of the simulation significantly higher than did the participants in the OSS group. Expert video assessment of team performance showed no differences between the ISS versus the OSS group. The ISS group provided more ideas and suggestions for changes at the organisational level. In this randomised trial, no significant differences were found regarding knowledge, patient safety attitude, motivation or stress measurements when comparing ISS versus OSS. Although participant perception of the authenticity of ISS versus OSS differed significantly, there were no differences in other outcomes between the groups except that the ISS group generated more suggestions for organisational changes. NCT01792674. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Simulation-based ureteroscopy skills training curriculum with integration of technical and non-technical skills: a randomised controlled trial.

PubMed

Brunckhorst, Oliver; Shahid, Shahab; Aydin, Abdullatif; McIlhenny, Craig; Khan, Shahid; Raza, Syed Johar; Sahai, Arun; Brewin, James; Bello, Fernando; Kneebone, Roger; Khan, Muhammad Shamim; Dasgupta, Prokar; Ahmed, Kamran

2015-09-01

Current training modalities within ureteroscopy have been extensively validated and must now be integrated within a comprehensive curriculum. Additionally, non-technical skills often cause surgical error and little research has been conducted to combine this with technical skills teaching. This study therefore aimed to develop and validate a curriculum for semi-rigid ureteroscopy, integrating both technical and non-technical skills teaching within the programme. Delphi methodology was utilised for curriculum development and content validation, with a randomised trial then conducted (n = 32) for curriculum evaluation. The developed curriculum consisted of four modules; initially developing basic technical skills and subsequently integrating non-technical skills teaching. Sixteen participants underwent the simulation-based curriculum and were subsequently assessed, together with the control cohort (n = 16) within a full immersion environment. Both technical (Time to completion, OSATS and a task specific checklist) and non-technical (NOTSS) outcome measures were recorded with parametric and non-parametric analyses used depending on the distribution of our data as evaluated by a Shapiro-Wilk test. Improvements within the intervention cohort demonstrated educational value across all technical and non-technical parameters recorded, including time to completion (p < 0.01), OSATS scores (p < 0.001), task specific checklist scores (p = 0.011) and NOTSS scores (p < 0.001). Content validity, feasibility and acceptability were all demonstrated through curriculum development and post-study questionnaire results. The current developed curriculum demonstrates that integrating both technical and non-technical skills teaching is both educationally valuable and feasible. Additionally, the curriculum offers a validated simulation-based training modality within ureteroscopy and a framework for the development of other simulation-based programmes.

Determination of prospective displacement-based gate threshold for respiratory-gated radiation delivery from retrospective phase-based gate threshold selected at 4D CT simulation

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

Vedam, S.; Archambault, L.; Starkschall, G.

2007-11-15

Four-dimensional (4D) computed tomography (CT) imaging has found increasing importance in the localization of tumor and surrounding normal structures throughout the respiratory cycle. Based on such tumor motion information, it is possible to identify the appropriate phase interval for respiratory gated treatment planning and delivery. Such a gating phase interval is determined retrospectively based on tumor motion from internal tumor displacement. However, respiratory-gated treatment is delivered prospectively based on motion determined predominantly from an external monitor. Therefore, the simulation gate threshold determined from the retrospective phase interval selected for gating at 4D CT simulation may not correspond to the deliverymore » gate threshold that is determined from the prospective external monitor displacement at treatment delivery. The purpose of the present work is to establish a relationship between the thresholds for respiratory gating determined at CT simulation and treatment delivery, respectively. One hundred fifty external respiratory motion traces, from 90 patients, with and without audio-visual biofeedback, are analyzed. Two respiratory phase intervals, 40%-60% and 30%-70%, are chosen for respiratory gating from the 4D CT-derived tumor motion trajectory. From residual tumor displacements within each such gating phase interval, a simulation gate threshold is defined based on (a) the average and (b) the maximum respiratory displacement within the phase interval. The duty cycle for prospective gated delivery is estimated from the proportion of external monitor displacement data points within both the selected phase interval and the simulation gate threshold. The delivery gate threshold is then determined iteratively to match the above determined duty cycle. The magnitude of the difference between such gate thresholds determined at simulation and treatment delivery is quantified in each case. Phantom motion tests yielded coincidence of simulation and delivery gate thresholds to within 0.3%. For patient data analysis, differences between simulation and delivery gate thresholds are reported as a fraction of the total respiratory motion range. For the smaller phase interval, the differences between simulation and delivery gate thresholds are 8{+-}11% and 14{+-}21% with and without audio-visual biofeedback, respectively, when the simulation gate threshold is determined based on the mean respiratory displacement within the 40%-60% gating phase interval. For the longer phase interval, corresponding differences are 4{+-}7% and 8{+-}15% with and without audio-visual biofeedback, respectively. Alternatively, when the simulation gate threshold is determined based on the maximum average respiratory displacement within the gating phase interval, greater differences between simulation and delivery gate thresholds are observed. A relationship between retrospective simulation gate threshold and prospective delivery gate threshold for respiratory gating is established and validated for regular and nonregular respiratory motion. Using this relationship, the delivery gate threshold can be reliably estimated at the time of 4D CT simulation, thereby improving the accuracy and efficiency of respiratory-gated radiation delivery.« less

Determination of prospective displacement-based gate threshold for respiratory-gated radiation delivery from retrospective phase-based gate threshold selected at 4D CT simulation.

PubMed

Vedam, S; Archambault, L; Starkschall, G; Mohan, R; Beddar, S

2007-11-01

Four-dimensional (4D) computed tomography (CT) imaging has found increasing importance in the localization of tumor and surrounding normal structures throughout the respiratory cycle. Based on such tumor motion information, it is possible to identify the appropriate phase interval for respiratory gated treatment planning and delivery. Such a gating phase interval is determined retrospectively based on tumor motion from internal tumor displacement. However, respiratory-gated treatment is delivered prospectively based on motion determined predominantly from an external monitor. Therefore, the simulation gate threshold determined from the retrospective phase interval selected for gating at 4D CT simulation may not correspond to the delivery gate threshold that is determined from the prospective external monitor displacement at treatment delivery. The purpose of the present work is to establish a relationship between the thresholds for respiratory gating determined at CT simulation and treatment delivery, respectively. One hundred fifty external respiratory motion traces, from 90 patients, with and without audio-visual biofeedback, are analyzed. Two respiratory phase intervals, 40%-60% and 30%-70%, are chosen for respiratory gating from the 4D CT-derived tumor motion trajectory. From residual tumor displacements within each such gating phase interval, a simulation gate threshold is defined based on (a) the average and (b) the maximum respiratory displacement within the phase interval. The duty cycle for prospective gated delivery is estimated from the proportion of external monitor displacement data points within both the selected phase interval and the simulation gate threshold. The delivery gate threshold is then determined iteratively to match the above determined duty cycle. The magnitude of the difference between such gate thresholds determined at simulation and treatment delivery is quantified in each case. Phantom motion tests yielded coincidence of simulation and delivery gate thresholds to within 0.3%. For patient data analysis, differences between simulation and delivery gate thresholds are reported as a fraction of the total respiratory motion range. For the smaller phase interval, the differences between simulation and delivery gate thresholds are 8 +/- 11% and 14 +/- 21% with and without audio-visual biofeedback, respectively, when the simulation gate threshold is determined based on the mean respiratory displacement within the 40%-60% gating phase interval. For the longer phase interval, corresponding differences are 4 +/- 7% and 8 +/- 15% with and without audiovisual biofeedback, respectively. Alternatively, when the simulation gate threshold is determined based on the maximum average respiratory displacement within the gating phase interval, greater differences between simulation and delivery gate thresholds are observed. A relationship between retrospective simulation gate threshold and prospective delivery gate threshold for respiratory gating is established and validated for regular and nonregular respiratory motion. Using this relationship, the delivery gate threshold can be reliably estimated at the time of 4D CT simulation, thereby improving the accuracy and efficiency of respiratory-gated radiation delivery.

Antenatal small-class education versus auditorium-based lectures to promote positive transitioning to parenthood - A randomised trial.

PubMed

Koushede, Vibeke; Brixval, Carina Sjöberg; Thygesen, Lau Caspar; Axelsen, Solveig Forberg; Winkel, Per; Lindschou, Jane; Gluud, Christian; Due, Pernille

2017-01-01

Prospective parents widely use education to gain information about, e.g., labour and parenting skills. It is unknown if antenatal education in small classes is more beneficial for parenting stress and parenting alliance compared with other types of antenatal education. In the present randomised trial, we examined the effect of antenatal education in small classes versus auditorium-based lectures on perceived stress, parenting stress, and parenting alliance. A total of 1,766 pregnant women were randomised to receive: antenatal education in small classes three times in pregnancy and one time after delivery, each session lasted 2.5 hours, versus standard care consisting of two times two hours auditorium-based lectures. Previous analysis of the primary outcome showed no difference between intervention and control group. Here we conduct an exploratory analysis of three secondary outcomes. Effects of the interventions on parents' global feelings of stress at 37 weeks gestation and nine weeks and six months postpartum and parenting stress nine weeks and six months postpartum were examined using linear regression analyses and mixed models with repeated measurements. The effect on parenting alliance six months postpartum was examined using the non-parametric Wilcoxon rank-sum test. Antenatal education in small classes had a small beneficial main effect on global feelings of stress six months postpartum and a statistically significant interaction between time and group favoring antenatal education in small classes. The P values of intervention effects on parenting stress and parenting alliance were all larger than the threshold value (0.05).

Prospective, controlled assessment of the impact of formal evidence-based medicine teaching workshop on ability to appraise the medical literature.

PubMed

Harewood, G C; Hendrick, L M

2010-03-01

The ability to critically appraise the calibre of studies in medical literature is increasingly important for medical professionals. This prospective controlled study evaluated the impact of a 6-h Evidence Based Medicine (EBM) Workshop on the critical appraisal skills of medical trainees. Individuals attended three 2-h workshops over a 3-week period, incorporating didactic lectures in statistics, clinical trial design, appraising research papers and practical examples. Appraisal skills were assessed pre- and post-training based on grading the quality of randomised control studies (level 1 evidence), cohort studies (level 2 evidence) and case-control studies (level 3 evidence) [From Oxford Centre for Evidence Based Medicine Levels of Evidence (2001), http://www.cebm.net/critical_appraisal.asp ]. Overall grading improved from 39% (pre-course) to 74% (post-course), P = 0.002, with grading of levels 1, 2 and 3 studies improving from 42 to 75%, 53 to 61% and 21 to 84%, respectively. We conclude that a 6-h formal EBM workshop is effective in enhancing the critical appraisal skills of medical trainees.

Efficacy of infant simulator programmes to prevent teenage pregnancy: a school-based cluster randomised controlled trial in Western Australia.

PubMed

Brinkman, Sally A; Johnson, Sarah E; Codde, James P; Hart, Michael B; Straton, Judith A; Mittinty, Murthy N; Silburn, Sven R

2016-11-05

Infant simulator-based programmes, which aim to prevent teenage pregnancy, are used in high-income as well as low-income and middle-income countries but, despite growing popularity, no published evidence exists of their long-term effect. The aim of this trial was to investigate the effect of such a programme, the Virtual Infant Parenting (VIP) programme, on pregnancy outcomes of birth and induced abortion in Australia. In this school-based pragmatic cluster randomised controlled trial, eligible schools in Perth, Western Australia, were enrolled and randomised 1:1 to the intervention and control groups. Randomisation using a table of random numbers without blocking, stratification, or matching was done by a researcher who was masked to the identity of the schools. Between 2003 and 2006, the VIP programme was administered to girls aged 13-15 years in the intervention schools, while girls of the same age in the control schools received the standard health education curriculum. Participants were followed until they reached 20 years of age via data linkage to hospital medical and abortion clinic records. The primary endpoint was the occurrence of pregnancy during the teenage years. Binomial and Cox proportional hazards regression was used to test for differences in pregnancy rates between study groups. This study is registered as an international randomised controlled trial, number ISRCTN24952438. 57 (86%) of 66 eligible schools were enrolled into the trial and randomly assigned 1:1 to the intervention (28 schools) or the control group (29 schools). Then, between Feb 1, 2003, and May 31, 2006, 1267 girls in the intervention schools received the VIP programme while 1567 girls in the control schools received the standard health education curriculum. Compared with girls in the control group, a higher proportion of girls in the intervention group recorded at least one birth (97 [8%] of 1267 in the intervention group vs 67 [4%] of 1567 in the control group) or at least one abortion as the first pregnancy event (113 [9%] vs 101 [6%]). After adjustment for potential confounders, the intervention group had a higher overall pregnancy risk than the control group (relative risk 1·36 [95% CI 1·10-1·67], p=0·003). Similar results were obtained with the use of proportional hazard models (hazard ratio 1·35 [95% CI 1·10-1·67], p=0·016). The infant simulator-based VIP programme did not achieve its aim of reducing teenage pregnancy. Girls in the intervention group were more likely to experience a birth or an induced abortion than those in the control group before they reached 20 years of age. Western Australian Health Promotion Foundation (Healthway), Lotteries WA, the Western Australian Department of Education and Training, and the Western Australian Department of Health. Copyright © 2016 Elsevier Ltd. All rights reserved.

Psychometric and Evidentiary Advances, Opportunities, and Challenges for Simulation-Based Assessment

ERIC Educational Resources Information Center

Levy, Roy

2013-01-01

This article characterizes the advances, opportunities, and challenges for psychometrics of simulation-based assessments through a lens that views assessment as evidentiary reasoning. Simulation-based tasks offer the prospect for student experiences that differ from traditional assessment. Such tasks may be used to support evidentiary arguments…

Time matters--realism in resuscitation training.

PubMed

Krogh, Kristian B; Høyer, Christian B; Ostergaard, Doris; Eika, Berit

2014-08-01

The advanced life support guidelines recommend 2min of cardiopulmonary resuscitation (CPR) and minimal hands-off time to ensure sufficient cardiac and cerebral perfusion. We have observed doctors who shorten the CPR intervals during resuscitation attempts. During simulation-based resuscitation training, the recommended 2-min CPR cycles are often deliberately decreased in order to increase the number of scenarios. The aim of this study was to test if keeping 2-min CPR cycles during resuscitation training ensures better adherence to time during resuscitation in a simulated setting. This study was designed as a randomised control trial. Fifty-four 4th-year medical students with no prior advanced resuscitation training participated in an extra-curricular one-day advanced life support course. Participants were either randomised to simulation-based training using real-time (120s) or shortened CPR cycles (30-45s instead of 120s) in the scenarios. Adherence to time was measured using the European Resuscitation Council's Cardiac Arrest Simulation Test (CASTest) in retention tests conducted one and 12 weeks after the course. The real-time group adhered significantly better to the recommended 2-min CPR cycles (time-120s) (mean 13; standard derivation (SD) 8) than the shortened CPR cycle group (mean 45; SD 19) when tested (p<0.001.) This study indicates that time is an important part of fidelity. Variables critical for performance, like adherence to time in resuscitation, should therefore be kept realistic during training to optimise outcome. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Plate fixation versus intramedullary nailing of completely displaced midshaft fractures of the clavicle: a prospective randomised controlled trial.

PubMed

Fuglesang, H F S; Flugsrud, G B; Randsborg, P H; Oord, P; Benth, J Š; Utvåg, S E

2017-08-01

This is a prospective randomised controlled trial comparing the functional outcomes of plate fixation and elastic stable intramedullary nailing (ESIN) of completely displaced mid-shaft fractures of the clavicle in the active adult population. We prospectively recruited 123 patients and randomised them to either plate fixation or ESIN. Patients completed the Quick Disabilities of the Arm, Shoulder and Hand (DASH) score at one to six weeks post-operatively. They were followed up at six weeks, three and six months and one year with radiographs, and their clinical outcome was assessed using both the DASH and the Constant Score. Plate fixation provided a faster functional recovery during the first six months compared with ESIN, but there was no difference after one year. The duration of surgery was shorter for ESIN (mean 53.4 minutes, 22 to 120) than for plate fixation (mean 69.7 minutes, 35 to 106, p < 0.001). The recovery after ESIN was slower with increasing fracture comminution and with open reduction (p < 0.05). Both methods return the patients to their pre-injury functional levels, but plate fixation has a faster recovery period in comminuted fractures than ESIN. ESIN has a shorter operative time and lower infection and implant rates of failure when using 2.5 mm nails or wider, suggesting that this is the preferred method in mid-shaft fractures with no comminution, whereas plate fixation is the superior method in comminuted fractures. Cite this article: Bone Joint J 2017;99-B:1095-1101. ©2017 The British Editorial Society of Bone & Joint Surgery.

Extended preoperative patient education using a multimedia DVD-impact on patients receiving a laparoscopic cholecystectomy: a randomised controlled trial.

PubMed

Wilhelm, D; Gillen, S; Wirnhier, H; Kranzfelder, M; Schneider, A; Schmidt, A; Friess, H; Feussner, H

2009-03-01

The informed consent is a legal requirement prior to surgery and should be based on an extensive preoperative interview. Multimedia productions can therefore be utilised as supporting tool. In a prospective randomised trial, we evaluated the impact of an extended education on patients undergoing cholecystectomy. For extended patient information, a professionally built DVD was used. After randomisation to either the DVD or the control group, patients were informed with or without additional presentation of the DVD. The quality of education was evaluated using a purpose-built questionnaire. One hundred fourteen patients were included in the DVD and 98 in the control group. Patient characteristics did not differ significantly despite a higher educational level in the DVD group. The score of correctly answered questions was higher in the DVD group (19.88 vs. 17.58 points, p < 0.001). As subgroup analysis revealed, particular patient characteristics additionally impacted on results. Patients should be informed the most extensively prior to any surgical procedure. Multimedia productions therefore offer a suitable instrument. In the presented study, we could prove the positive impact of an information DVD on patients knowledge. Nevertheless, multimedia tools cannot replace personal interaction and should only be used to support daily work.

Six years of evidence-based adult dissection tonsillectomy with ultrasonic scalpel, bipolar electrocautery, bipolar radiofrequency or 'cold steel' dissection.

PubMed

Ragab, S M

2012-10-01

To conduct an adequately powered, prospective, randomised, controlled trial comparing adult dissection tonsillectomy using either ultrasonic scalpel, bipolar electrocautery, bipolar radiofrequency or 'cold steel' dissection. Three hundred patients were randomised into four tonsillectomy technique groups. The operative time, intra-operative bleeding, post-operative pain, tonsillar fossa healing, return to full diet, return to work and post-operative complications were recorded. The bipolar radiofrequency group had a shorter mean operative time. The mean intra-operative blood loss during bipolar radiofrequency tonsillectomy was significantly less compared with cold dissection and ultrasonic scalpel tonsillectomy. Pain scores were significantly higher after bipolar electrocautery tonsillectomy. Patients undergoing bipolar electrocautery tonsillectomy required significantly more days to return to full diet and work. The bipolar electrocautery group showed significantly reduced tonsillar fossa healing during the first and second post-operative weeks. In this adult series, bipolar radiofrequency tonsillectomy was superior to ultrasonic, bipolar electrocautery and cold dissection tonsillectomies. This method combines the advantages of 'hot' and 'cold' tonsillectomy.

Sclerotherapy for hydrocele revisited: a prospective randomised study.

PubMed

Agrawal, M S; Yadav, H; Upadhyay, A; Jaiman, R; Singhal, J; Singh, A K

2009-02-01

A prospective randomised trial to study the efficacy and safety of hydrocele sclerotherapy with phenol and polidocanol. Eighty-six patients with unilateral primary vaginal hydroceles were randomised into three groups: group 1 (phenol sclerotherapy) - 29 patients, group 2 (polidocanol sclerotherapy) - 29 patients and group 3 (operative treatment) - 28 patients. Sclerotherapy was performed on outpatient basis using either 5-10 ml of 5% phenol or 2-4 ml of 1% polidocanol, while patients in group 3 underwent surgical repair of hydrocele (Jaboulay's procedure). Statistical analysis was performed using ANOVA. The cure rates in group 1, 2 and 3 were 96.5%, 51.7% and 100%, respectively. The pain scores (visual analogue scale) in group 1, 2 and 3 at 1 week and 1 month were 14.5 and 1.8; 10.1 and 1.3; 64.0 and 10.6, respectively. There was significant difference among the three groups in mean hospital stay (1.8, 1.5 and 9.7 hours, respectively) and time to work resumption (1.3, 1.1 and 12.7 days, respectively). Statistically significant differences in pain scores and complications were observed between sclerotherapy and operative groups. Five percent phenol is a better sclerosant than 1% polidocanol and is as efficacious as operative treatment, with lesser morbidity and similar safety profile.

Prospective randomised trial of early cytotoxic therapy for recurrent colorectal carcinoma detected by serum CEA.

PubMed Central

Hine, K R; Dykes, P W

1984-01-01

Of 663 patients treated with radical surgery for colorectal cancer, 52 showed a progressive rise in serum carcinoembryonic antigen (CEA) with no other evidence of recurrent disease and were randomised in a prospective study of chemotherapy. Twenty six patients in the treatment group received 5FU and methyl CCNU from the time of randomisation and the remaining 26 controls were given further therapy only if there were clinical indications. All patients were followed for five years or until their death and all but one (control) developed clinical evidence of recurrence. Overall there was no significant difference between the two groups with respect to disease free interval and survival. Whereas the rise in CEA in controls was generally progressive, marked inflections on the CEA curves were seen in the majority of patients receiving early treatment. Eight of 26 treated patients showed a fall in CEA of greater than 20% two months after starting therapy. These patients had a median disease free interval of 90 weeks and a median survival of 107 weeks, these figures being longer than those of treated patients who did not show a fall in CEA and control patients. The serum CEA therefore appeared to give important prognostic information in patients receiving cytotoxic treatment. Early therapy was generally well tolerated. PMID:6376291

Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis.

PubMed

White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

2016-04-01

Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04-1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08-1·29), 1·10 (1·00-1·22), and 1·05 (0·92-1·20), respectively, per 1 SD increment in plasma urate. Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for pleiotropy but has less statistical power, suggests there might be no causal effect. These results might help investigators to determine the priority of trials of urate lowering for the prevention of coronary heart disease compared with other potential interventions. UK National Institute for Health Research, British Heart Foundation, and UK Medical Research Council. Copyright © 2016 White et al. Open Access article distributed under the terms of CC BY. Published by Elsevier Ltd.. All rights reserved.

Plasma urate concentration and risk of coronary heart disease: a Mendelian randomisation analysis

PubMed Central

White, Jon; Sofat, Reecha; Hemani, Gibran; Shah, Tina; Engmann, Jorgen; Dale, Caroline; Shah, Sonia; Kruger, Felix A; Giambartolomei, Claudia; Swerdlow, Daniel I; Palmer, Tom; McLachlan, Stela; Langenberg, Claudia; Zabaneh, Delilah; Lovering, Ruth; Cavadino, Alana; Jefferis, Barbara; Finan, Chris; Wong, Andrew; Amuzu, Antoinette; Ong, Ken; Gaunt, Tom R; Warren, Helen; Davies, Teri-Louise; Drenos, Fotios; Cooper, Jackie; Ebrahim, Shah; Lawlor, Debbie A; Talmud, Philippa J; Humphries, Steve E; Power, Christine; Hypponen, Elina; Richards, Marcus; Hardy, Rebecca; Kuh, Diana; Wareham, Nicholas; Ben-Shlomo, Yoav; Day, Ian N; Whincup, Peter; Morris, Richard; Strachan, Mark W J; Price, Jacqueline; Kumari, Meena; Kivimaki, Mika; Plagnol, Vincent; Whittaker, John C; Smith, George Davey; Dudbridge, Frank; Casas, Juan P; Holmes, Michael V; Hingorani, Aroon D

2016-01-01

Summary Background Increased circulating plasma urate concentration is associated with an increased risk of coronary heart disease, but the extent of any causative effect of urate on risk of coronary heart disease is still unclear. In this study, we aimed to clarify any causal role of urate on coronary heart disease risk using Mendelian randomisation analysis. Methods We first did a fixed-effects meta-analysis of the observational association of plasma urate and risk of coronary heart disease. We then used a conventional Mendelian randomisation approach to investigate the causal relevance using a genetic instrument based on 31 urate-associated single nucleotide polymorphisms (SNPs). To account for potential pleiotropic associations of certain SNPs with risk factors other than urate, we additionally did both a multivariable Mendelian randomisation analysis, in which the genetic associations of SNPs with systolic and diastolic blood pressure, HDL cholesterol, and triglycerides were included as covariates, and an Egger Mendelian randomisation (MR-Egger) analysis to estimate a causal effect accounting for unmeasured pleiotropy. Findings In the meta-analysis of 17 prospective observational studies (166 486 individuals; 9784 coronary heart disease events) a 1 SD higher urate concentration was associated with an odds ratio (OR) for coronary heart disease of 1·07 (95% CI 1·04–1·10). The corresponding OR estimates from the conventional, multivariable adjusted, and Egger Mendelian randomisation analysis (58 studies; 198 598 individuals; 65 877 events) were 1·18 (95% CI 1·08–1·29), 1·10 (1·00–1·22), and 1·05 (0·92–1·20), respectively, per 1 SD increment in plasma urate. Interpretation Conventional and multivariate Mendelian randomisation analysis implicates a causal role for urate in the development of coronary heart disease, but these estimates might be inflated by hidden pleiotropy. Egger Mendelian randomisation analysis, which accounts for pleiotropy but has less statistical power, suggests there might be no causal effect. These results might help investigators to determine the priority of trials of urate lowering for the prevention of coronary heart disease compared with other potential interventions. Funding UK National Institute for Health Research, British Heart Foundation, and UK Medical Research Council. PMID:26781229

Adjusting for treatment switching in randomised controlled trials - A simulation study and a simplified two-stage method.

PubMed

Latimer, Nicholas R; Abrams, K R; Lambert, P C; Crowther, M J; Wailoo, A J; Morden, J P; Akehurst, R L; Campbell, M J

2017-04-01

Estimates of the overall survival benefit of new cancer treatments are often confounded by treatment switching in randomised controlled trials (RCTs) - whereby patients randomised to the control group are permitted to switch onto the experimental treatment upon disease progression. In health technology assessment, estimates of the unconfounded overall survival benefit associated with the new treatment are needed. Several switching adjustment methods have been advocated in the literature, some of which have been used in health technology assessment. However, it is unclear which methods are likely to produce least bias in realistic RCT-based scenarios. We simulated RCTs in which switching, associated with patient prognosis, was permitted. Treatment effect size and time dependency, switching proportions and disease severity were varied across scenarios. We assessed the performance of alternative adjustment methods based upon bias, coverage and mean squared error, related to the estimation of true restricted mean survival in the absence of switching in the control group. We found that when the treatment effect was not time-dependent, rank preserving structural failure time models (RPSFTM) and iterative parameter estimation methods produced low levels of bias. However, in the presence of a time-dependent treatment effect, these methods produced higher levels of bias, similar to those produced by an inverse probability of censoring weights method. The inverse probability of censoring weights and structural nested models produced high levels of bias when switching proportions exceeded 85%. A simplified two-stage Weibull method produced low bias across all scenarios and provided the treatment switching mechanism is suitable, represents an appropriate adjustment method.

Metformin and dietary advice to improve insulin sensitivity and promote gestational restriction of weight among pregnant women who are overweight or obese: the GRoW Randomised Trial.

PubMed

Dodd, Jodie M; Grivell, Rosalie M; Deussen, Andrea R; Dekker, Gustaaf; Louise, Jennie; Hague, William

2016-11-21

Obesity is a significant global health problem, with approximately 50% of women entering pregnancy having a body mass index greater than or equal to 25 kg/m 2 . Obesity during pregnancy is associated with a well-recognised increased risk of adverse health outcomes both for the woman and her infant. Currently available data from large scale randomised trials and systematic reviews highlight only modest effects of antenatal dietary and lifestyle interventions in limiting gestational weight gain, with little impact on clinically relevant pregnancy outcomes. Further information evaluating alternative strategies is required. The aims of this randomised controlled trial are to assess whether the use of metformin as an adjunct therapy to dietary and lifestyle advice for overweight and obese women during pregnancy is effective in improving maternal, fetal and infant health outcomes. Design: Multicentre randomised, controlled trial. 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/m 2 ), at the first antenatal visit. Trial Entry & Randomisation: Eligible, consenting women will be randomised between 10 +0 and 20 +0 weeks gestation using an online computer randomisation system, 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 Metformin Group will receive a supply of 500 mg oral metformin tablets. Women randomised to the Placebo Group will receive a supply of identical appearing and tasting placebo tablets. Women will be instructed to commence taking one tablet daily for a period of one week, increasing to a maximum of two tablets twice daily over four weeks and then continuing until birth. Women, clinicians, researchers and outcome assessors will be blinded to the allocated treatment group. All women will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant), and three telephone calls over the course of their pregnancy, in which they will be provided with dietary and lifestyle advice, and encouraged to make change utilising a SMART goals approach. Primary Study Outcome: infant birth weight >4000 grams. 524 women to detect a difference from 15.5% to 7.35% reduction in infants with birth weight >4000 grams (p = 0.05, 80% power, two-tailed). This is a protocol for a randomised trial. The findings will contribute to the development of evidence based clinical practice guidelines. Australian and New Zealand Clinical Trials Registry ACTRN12612001277831 , prospectively registered 10 th of December, 2012.

Evaluation of high-intensity focused ultrasound ablation for uterine fibroids: an IDEAL prospective exploration study.

PubMed

Chen, J; Li, Y; Wang, Z; McCulloch, P; Hu, L; Chen, W; Liu, G; Li, J; Lang, J

2018-02-01

To evaluate the clinical outcomes of high-intensity focused ultrasound (HIFU) and surgery in treating uterine fibroids, and prepare for a definitive randomised trial. Prospective multicentre patient choice cohort study (IDEAL Exploratory study) of HIFU, myomectomy or hysterectomy for treating symptomatic uterine fibroids. 20 Chinese hospitals. 2411 Chinese women with symptomatic fibroids. Prospective non-randomised cohort study with learning curve analysis (IDEAL Stage 2b Prospective Exploration Study). Complications, hospital stay, return to normal activities, and quality of life (measured with UFS-Qol and SF-36 at baseline, 6 and 12 months), and need for further treatment. Quality-of-life outcomes were adjusted using regression modelling. HIFU treatment quality was evaluated using LC-CUSUM to identify operator learning curves. A health economic analysis of costs was performed. 1353 women received HIFU, 472 hysterectomy and 586 myomectomy. HIFU patients were significantly younger (P < 0.001), slimmer (P < 0.001), better educated (P < 0.001), and wealthier (P = 0.002) than surgery patients. Both UFS and QoL improved more rapidly after HIFU than after surgery (P = 0.002 and P = 0.001, respectively at 6 months), but absolute differences were small. Major adverse events occurred in 3 (0.2%) of HIFU and in 133 (12.6%) of surgical cases (P < 0.001). Median time for hospital stay was 4 days (interquartile range, 0-5 days), 10 days (interquartile range, 8-12.5 days) and 8 days (interquartile range, 7-10 days). HIFU caused substantially less morbidity than surgery, with similar longer-term QoL. Despite group baseline differences and lack of blinding, these findings support the need for a randomised controlled trial (RCT) of HIFU treatment for fibroids. The IDEAL Exploratory design facilitated RCT protocol development. HIFU had much better short-term outcomes than surgery for fibroids in 2411-patient Chinese IDEAL format study. © 2017 Royal College of Obstetricians and Gynaecologists.

Randomised controlled trial to assess the effect of a Just-in-Time training on procedural performance: a proof-of-concept study to address procedural skill decay.

PubMed

Branzetti, Jeremy B; Adedipe, Adeyinka A; Gittinger, Matthew J; Rosenman, Elizabeth D; Brolliar, Sarah; Chipman, Anne K; Grand, James A; Fernandez, Rosemarie

2017-11-01

A subset of high-risk procedures present significant safety threats due to their (1) infrequent occurrence, (2) execution under time constraints and (3) immediate necessity for patient survival. A Just-in-Time (JIT) intervention could provide real-time bedside guidance to improve high-risk procedural performance and address procedural deficits associated with skill decay. To evaluate the impact of a novel JIT intervention on transvenous pacemaker (TVP) placement during a simulated patient event. This was a prospective, randomised controlled study to determine the effect of a JIT intervention on performance of TVP placement. Subjects included board-certified emergency medicine physicians from two hospitals. The JIT intervention consisted of a portable, bedside computer-based procedural adjunct. The primary outcome was performance during a simulated patient encounter requiring TVP placement, as assessed by trained raters using a technical skills checklist. Secondary outcomes included global performance ratings, time to TVP placement, number of critical omissions and System Usability Scale scores (intervention only). Groups were similar at baseline across all outcomes. Compared with the control group, the intervention group demonstrated statistically significant improvement in the technical checklist score (11.45 vs 23.44, p<0.001, Cohen's d effect size 4.64), the global rating scale (2.27 vs 4.54, p<0.001, Cohen's d effect size 3.76), and a statistically significant reduction in critical omissions (2.23 vs 0.68, p<0.001, Cohen's d effect size -1.86). The difference in time to procedural completion was not statistically significant between conditions (11.15 min vs 12.80 min, p=0.12, Cohen's d effect size 0.65). System Usability Scale scores demonstrated excellent usability. A JIT intervention improved procedure perfromance, suggesting a role for JIT interventions in rarely performed procedures. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Simulation-based training in flexible fibreoptic intubation: A randomised study.

PubMed

Nilsson, Philip M; Russell, Lene; Ringsted, Charlotte; Hertz, Peter; Konge, Lars

2015-09-01

Flexible fibreoptic intubation (FOI) is a key element in difficult airway management. Training of FOI skills is an important part of the anaesthesiology curriculum. Simulation-based training has been shown to be effective when learning FOI, but the optimal structure of the training is debated. The aspect of dividing the training into segments (part-task training) or assembling into one piece (whole-task training) has not been studied. The aims of this study were to compare the effect of training the motor skills of FOI as part-task training or as whole-task training and to relate the performance levels achieved by the novices to the standard of performance of experienced FOI practitioners. A randomised controlled study. Centre for Clinical Education, University of Copenhagen and the Capital Region of Denmark, between January and April 2013. Twenty-three anaesthesia residents in their first year of training in anaesthesiology with no experience in FOI, and 10 anaesthesia consultants experienced in FOI. The novices to FOI were allocated randomly to receive either part-task or whole-task training of FOI on virtual reality simulators. Procedures were subsequently trained on a manikin and assessed by an experienced anaesthesiologist. The experienced group was assessed in the same manner with no prior simulation-based training. The primary outcome measure was the score of performance on testing FOI skills on a manikin. A positive learning effect was observed in both the part-task training group and the whole-task training group. There was no statistically significant difference in final performance scores of the two novice groups (P = 0.61). Furthermore, both groups of novices were able to improve their skill level significantly by the end of manikin training to levels comparable to the experienced anaesthesiologists. Part-task training did not prove more effective than whole-task training when training novices in FOI skills. FOI is very suitable for simulation-based training and segmentation of the procedure during training is not necessary.

Coping with Unusual ExperienceS for 12-18 year olds (CUES+): a transdiagnostic randomised controlled trial of the effectiveness of cognitive therapy in reducing distress associated with unusual experiences in adolescent mental health services: study protocol for a randomised controlled trial.

PubMed

Jolley, Suzanne; Browning, Sophie; Corrigall, Richard; Laurens, Kristin R; Hirsch, Colette; Bracegirdle, Karen; Gin, Kimberley; Muccio, Francesca; Stewart, Catherine; Banerjea, Partha; Kuipers, Elizabeth; Garety, Philippa; Byrne, Majella; Onwumere, Juliana; Achilla, Evanthia; McCrone, Paul; Emsley, Richard

2017-12-04

Childhood 'unusual experiences' (such as hearing voices that others cannot, or suspicions of being followed) are common, but can become more distressing during adolescence, especially for young people in contact with Child and Adolescent Mental Health Services (CAMHS). Unusual experiences that are distressing or have adverse life impact (UEDs) are associated with a range of current and future emotional, behavioural and mental health difficulties. Recommendations for psychological intervention are based on evidence from adult studies, with some support from small, pilot, child-specific evaluations. Research is needed to ensure that the recommendations suit children as well as adults. The CUES+ study (Coping with Unusual ExperienceS for 12-18 year olds) aims to find out whether cognitive behaviour therapy for UEDs (CBT-UED) is a helpful and cost-effective addition to usual community care for 12-18 year olds presenting to United Kingdom National Health Service Child and Adolescent Mental Health Services in four London boroughs. The CUES+ study is a randomised controlled trial comparing CBT-UED plus routine care to routine care alone. CBT-UED comprises up to 16 sessions, including up to 12 individual and up to four family support meetings, each lasting around 45-60 min, delivered weekly. The primary outcome is emotional distress. Secondary outcomes are change in UEDs, risk events (self-harm, attendance at emergency services, other adverse events) and health economic outcomes. Participants will be randomised in a 1:1 ratio after baseline assessment. Randomisation will be stratified by borough and by severity of mental health presentation: 'severe' (an identified psychotic or bipolar disorder) or any 'other' condition. Outcomes will be assessed by a trained assessor blind to treatment condition at 0, 16 and 24 weeks. Recruitment began in February, 2015 and is ongoing until the end of March, 2017. The CUES+ study will contribute to the currently limited child-specific evidence base for psychological interventions for UEDs occurring in the context of psychosis or any other mental health presentation. International Standard Randomised Controlled Trials, ID: ISRCTN21802136 . Prospectively registered on 12 January 2015. Protocol V3 31 August 2015 with screening amended.

A nested mechanistic sub-study into the effect of tranexamic acid versus placebo on intracranial haemorrhage and cerebral ischaemia in isolated traumatic brain injury: study protocol for a randomised controlled trial (CRASH-3 Trial Intracranial Bleeding Mechanistic Sub-Study [CRASH-3 IBMS]).

PubMed

Mahmood, Abda; Roberts, Ian; Shakur, Haleema

2017-07-17

Tranexamic acid prevents blood clots from breaking down and reduces bleeding. However, it is uncertain whether tranexamic acid is effective in traumatic brain injury. The CRASH-3 trial is a randomised controlled trial that will examine the effect of tranexamic acid (versus placebo) on death and disability in 13,000 patients with traumatic brain injury. The CRASH-3 trial hypothesizes that tranexamic acid will reduce intracranial haemorrhage, which will reduce the risk of death. Although it is possible that tranexamic acid will reduce intracranial bleeding, there is also a potential for harm. In particular, tranexamic acid may increase the risk of cerebral thrombosis and ischaemia. The protocol detailed here is for a mechanistic sub-study nested within the CRASH-3 trial. This mechanistic sub-study aims to examine the effect of tranexamic acid (versus placebo) on intracranial bleeding and cerebral ischaemia. The CRASH-3 Intracranial Bleeding Mechanistic Sub-Study (CRASH-3 IBMS) is nested within a prospective, double-blind, multi-centre, parallel-arm randomised trial called the CRASH-3 trial. The CRASH-3 IBMS will be conducted in a cohort of approximately 1000 isolated traumatic brain injury patients enrolled in the CRASH-3 trial. In the CRASH-3 IBMS, brain scans acquired before and after randomisation are examined, using validated methods, for evidence of intracranial bleeding and cerebral ischaemia. The primary outcome is the total volume of intracranial bleeding measured on computed tomography after randomisation, adjusting for baseline bleeding volume. Secondary outcomes include progression of intracranial haemorrhage (from pre- to post-randomisation scans), new intracranial haemorrhage (seen on post- but not pre-randomisation scans), intracranial haemorrhage following neurosurgery, and new focal ischaemic lesions (seen on post-but not pre-randomisation scans). A linear regression model will examine whether receipt of the trial treatment can predict haemorrhage volume. Bleeding volumes and new ischaemic lesions will be compared across treatment groups using relative risks and 95% confidence intervals. The CRASH-3 IBMS will provide an insight into the mechanism of action of tranexamic acid in traumatic brain injury, as well as information about the risks and benefits. Evidence from this trial could inform the management of patients with traumatic brain injury. The CRASH-3 trial was prospectively registered and the CRASH-3 IBMS is an addition to the original protocol registered at the International Standard Randomised Controlled Trials registry ( ISRCTN15088122 ) 19 July 2011, and ClinicalTrials.gov on 25 July 2011 (NCT01402882).

Randomised prospective parallel trial of therapeutic versus subtherapeutic nasal continuous positive airway pressure on simulated steering performance in patients with obstructive sleep apnoea

PubMed Central

Hack, M.; Davies, R.; Mullins, R.; Choi, S. J.; Ramdassingh-Dow, S.; Jenkinson, C.; Stradling, J.

2000-01-01

BACKGROUND—Obstructive sleep apnoea (OSA) impairs vigilance and may lead to an increased rate of driving accidents. In uncontrolled studies accident rates and simulated steering performance improve following treatment with nasal continuous positive airway pressure (NCPAP). This study seeks to confirm the improvement in steering performance in a randomised controlled trial using subtherapeutic NCPAP as a control treatment.
METHODS—Fifty nine men with OSA (Epworth Sleepiness Score (ESS) of ⩾10, and ⩾10/h dips in SaO2 of >4% due to OSA) received therapeutic or subtherapeutic NCPAP (≈1 cm H2O) for one month. Simulated steering performance over three 30-minute "drives" was quantified as: standard deviation (SD) of road position, deterioration in SD across the drive, length of drive before "crashing", and number of off-road events. The reaction times to peripheral target stimuli during the drive were also measured.
RESULTS—Subtherapeutic NCPAP did not improve overnight >4% SaO2 dips/h compared with baseline values, thus acting as a control. The SD of the steering position improved from 0.36 to 0.21 on therapeutic NCPAP, and from 0.35 to 0.30 on subtherapeutic NCPAP (p = 0.03). Deterioration in SD of the steering position improved from 0.18to 0.06 SD/h with therapeutic NCPAP and worsened from 0.18 to 0.24 with subtherapeutic NCPAP (p = 0.04). The reaction time to target stimuli was quicker after therapeutic than after subtherapeutic NCPAP (2.3 versus 2.7 seconds, p = 0.04).
CONCLUSIONS—Therapeutic NCPAP improves steering performance and reaction time to target stimuli in patients with OSA, lending further support to the hypothesis that OSA impairs driving, increases driving accident rates, and that these improve following treatment with NCPAP.

 PMID:10679542

Expert Opinion: Optimising Stent Deployment in Contemporary Practice: The Role of Intracoronary Imaging and Non-compliant Balloons.

PubMed

Seth, Ashok; Gupta, Sajal; Pratap Singh, Vivudh; Kumar, Vijay

2017-09-01

Final stent dimensions remain an important predictor of restenosis, target vessel revascularisation (TVR) and subacute stent thrombosis (ST), even in the drug-eluting stent (DES) era. Stent balloons are usually semi-compliant and thus even high-pressure inflation may not achieve uniform or optimal stent expansion. Post-dilatation with non-compliant (NC) balloons after stent deployment has been shown to enhance stent expansion and could reduce TVR and ST. Based on supporting evidence and in the absence of large prospective randomised outcome-based trials, post-dilatation with an NC balloon to achieve optimal stent expansion and maximal luminal area is a logical technical recommendation, particularly in complex lesion subsets.

General vs. neuraxial anaesthesia in hip fracture patients: a systematic review and meta-analysis.

PubMed

Van Waesberghe, Julia; Stevanovic, Ana; Rossaint, Rolf; Coburn, Mark

2017-06-28

Hip fracture is a trauma of the elderly. The worldwide number of patients in need of surgery after hip fracture will increase in the coming years. The 30-day mortality ranges between 4 and 14%. Patients' outcome may be improved by anaesthesia technique (general vs. neuraxial anaesthesia). There is a dearth of evidence from randomised studies regarding to the optimal anaesthesia technique. However, several large non-randomised studies addressing this question have been published from the onset of 2010. To compare the 30-day mortality rate, in-hospital mortality rate and length of hospital stay after neuraxial (epidural/spinal) or general anaesthesia in hip fracture patients (≥ 18 years old) we prepared a systematic review and meta-analysis. A systematic search for appropriate retrospective observational and prospective randomised studies in Embase and PubMed databases was performed in the time-period from 01.01.2010 to 21.11.2016. Additionally a forward searching in google scholar, a level one reference list searching and a formal searching of trial registries was performed. Twenty retrospective observational and three prospective randomised controlled studies were included. There was no difference in the 30-day mortality [OR 0.99; 95% CI (0.94 to 1.04), p = 0.60] between the general and the neuraxial anaesthesia group. The in-hospital mortality [OR 0.85; 95% CI (0.76 to 0.95), p = 0.004] and the length of hospital stay were significantly shorter in the neuraxial anaesthesia group [MD -0.26; 95% CI (-0.36 to -0.17); p < 0.00001]. Neuraxial anaesthesia is associated with a reduced in-hospital mortality and length of hospitalisation. However, type of anaesthesia did not influence the 30-day mortality. In future there is a need for large randomised studies to examine the association between the type of anaesthesia, post-operative complications and mortality.

Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

PubMed Central

2014-01-01

Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations include avoidance of cluster merges where possible, discontinuation of clusters following heterogeneous merges, allowance for potential loss of clusters and additional variability in cluster size in the original sample size calculation, and use of appropriate ICC estimates that reflect cluster size. PMID:24884591

Osteopathic manipulative treatment and pain in preterms: study protocol for a randomised controlled trial.

PubMed

Cerritelli, Francesco; Cicchitti, Luca; Martelli, Marta; Barlafante, Gina; Renzetti, Cinzia; Pizzolorusso, Gianfranco; Lupacchini, Mariacristina; D'Orazio, Marianna; Marinelli, Benedetta; Cozzolino, Vincenzo; Fusilli, Paola; D'Incecco, Carmine

2015-03-08

Recent evidence proved the necessity to improve health care and pain management in newborns. Osteopathic manipulative treatment (OMT) has been largely used to treat painful syndromes as well as term and preterm newborns. Recent studies have demonstrated positive results of osteopathy in reducing length of stay and costs. However, no trials were carried out on pain in newborns. The aim of the present clinical trial is to explore the effectiveness of osteopathic treatment in reducing pain in a sample of preterms. A three-armed single blinded placebo-control randomised controlled trial protocol has been designed to primarily evaluate the extent to which OMT is effective in reducing pain in preterms. One hundred and twenty newborns will be enrolled from one tertiary neonatal intensive care unit in central Italy and randomised in three groups: study, sham and control. The study group will be further prospectively randomised in two subgroups: experienced osteopaths and students. All preterms will receive standard medical care. Osteopathic treatment will be applied to the study group only whilst 'soft touch' will be administer to the sham group only. Newborns will undergo manual sessions once a week for the entire period of hospitalisation. Blinding will be assured for neonatal staff and outcome assessor. Primary outcome will be the mean difference in baseline score changes of PIPP questionnaire between discharge and entry among the three groups. Secondary outcomes will be: mean difference in length of stay and costs between groups. Statistical analyses will use per-protocol analysis method. Missing data will be handled using last observation carried forward imputation technique. The present single blinded randomised controlled trial has been designed to explore potential advantages of OMT in the management of newborns' pain. Currently, based on a patient-centred need-based approach, this research will be looking at the benefit of osteopathic care rather than the efficacy of a specific technique or a pre-determined protocol. The protocol has been registered on ClinicalTrials.gov ( NCT02146677 ) on 20 May 2014.

A randomised control trial of walking to ameliorate brain injury fatigue: a NIDRR TBI model system centre-based study.

PubMed

Kolakowsky-Hayner, Stephanie A; Bellon, Kimberly; Toda, Ketra; Bushnik, Tamara; Wright, Jerry; Isaac, Linda; Englander, Jeffrey

2017-10-01

Fatigue is one of the most commonly reported sequelae after traumatic brain injury (TBI). This study evaluated the impact of a graduated physical activity programme on fatigue after TBI. Using a prospective randomised single-blind crossover design, 123 individuals with TBI, over the age of 18, were enrolled. Interventions included a home-based walking programme utilising a pedometer to track daily number of steps at increasing increments accompanied by tapered coaching calls over a 12-week period. Nutritional counselling with the same schedule of coaching calls served as the control condition. Main outcome measures included: the Global Fatigue Index (GFI), the Barrow Neurological Institute (BNI) Fatigue Scale Overall Severity Index Score, and the Multidimensional Fatigue Inventory (MFI). Step counts improved over time regardless of group assignment. The walking intervention led to a decrease in GFI, BNI Total, and MFI General scores. Participants reported less fatigue at the end of the active part of the intervention (24 weeks) and after a wash out period (36 weeks) as measured by the BNI Overall. The study suggests that walking can be used as an efficient and cost-effective tool to improve fatigue in persons who have sustained a TBI.

Positive impact of crisis resource management training on no-flow time and team member verbalisations during simulated cardiopulmonary resuscitation: a randomised controlled trial.

PubMed

Fernandez Castelao, Ezequiel; Russo, Sebastian G; Cremer, Stephan; Strack, Micha; Kaminski, Lea; Eich, Christoph; Timmermann, Arnd; Boos, Margarete

2011-10-01

To evaluate the impact of video-based interactive crisis resource management (CRM) training on no-flow time (NFT) and on proportions of team member verbalisations (TMV) during simulated cardiopulmonary resuscitation (CPR). Further, to investigate the link between team leader verbalisation accuracy and NFT. The randomised controlled study was embedded in the obligatory advanced life support (ALS) course for final-year medical students. Students (176; 25.35±1.03 years, 63% female) were alphabetically assigned to 44 four-person teams that were then randomly (computer-generated) assigned to either CRM intervention (n=26), receiving interactive video-based CRM-training, or to control intervention (n=18), receiving an additional ALS-training. Primary outcomes were NFT and proportions of TMV, which were subdivided into eight categories: four team leader verbalisations (TLV) with different accuracy levels and four follower verbalisation categories (FV). Measurements were made of all groups administering simulated adult CPR. NFT rates were significantly lower in the CRM-training group (31.4±6.1% vs. 36.3±6.6%, p=0.014). Proportions of all TLV categories were higher in the CRM-training group (p<0.001). Differences in FV were only found for one category (unsolicited information) (p=0.012). The highest correlation with NFT was found for high accuracy TLV (direct orders) (p=0.06). The inclusion of CRM training in undergraduate medical education reduces NFT in simulated CPR and improves TLV proportions during simulated CPR. Further research will test how these results translate into clinical performance and patient outcome. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Accelerated enhanced Recovery following Minimally Invasive colorectal cancer surgery (RecoverMI): a study protocol for a novel randomised controlled trial.

PubMed

Price, Brandee A; Bednarski, Brian K; You, Y Nancy; Manandhar, Meryna; Dean, E Michelle; Alawadi, Zeinab M; Bryce Speer, B; Gottumukkala, Vijaya; Weldon, Marla; Massey, Robert L; Wang, Xuemei; Qiao, Wei; Chang, George J

2017-07-20

Definitive treatment of localised colorectal cancer involves surgical resection of the primary tumour. Short-stay colectomies (eg, 23-hours) would have important implications for optimising the efficiency of inpatient care with reduced resource utilisation while improving the overall recovery experience with earlier return to normalcy. It could permit surgical treatment of colorectal cancer in a wider variety of settings, including hospital-based ambulatory surgery environments. While a few studies have shown that discharge within the first 24 hours after minimally invasive colectomy is possible, the safety, feasibility and patient acceptability of a protocol for short-stay colectomy for colorectal cancer have not previously been evaluated in a prospective randomised study. Moreover, given the potential for some patients to experience a delay in recovery of bowel function after colectomy, close outpatient monitoring may be necessary to ensure safe implementation. In order to address this gap, we propose a prospective randomised trial of accelerated enhanced Recover y following M inimally I nvasive colorectal cancer surgery ( RecoverMI ) that leverages the combination of minimally invasive surgery with enhanced recovery protocols and early coordinated outpatient remote televideo conferencing technology ( TeleRecovery ) to improve postoperative patien-provider communication, enhance postoperative treatment navigation and optimise postdischarge care. We hypothesise that RecoverMI can be safely incorporated into multidisciplinary practice to improve patient outcomes and reduce the overall 30-day duration of hospitalisation while preserving the quality of the patient experience. ETHICS AND DISSEMINATION: RecoverMI has received institutional review board approval and funding from the American Society of Colorectal Surgeons (ASCRS; LPG103). Results from RecoverMI will be published in a peer-reviewed publication and be used to inform a multisite trial. NCT02613728; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Exercise-based cardiac rehabilitation increases daily physical activity of patients following myocardial infarction: subanalysis of two randomised controlled trials.

PubMed

Ribeiro, F; Oliveira, N L; Silva, G; Campos, L; Miranda, F; Teixeira, M; Alves, A J; Oliveira, J

2017-03-01

To assess the effects of an exercise-based cardiac rehabilitation programme on daily physical activity levels of patients following myocardial infarction. Subanalysis of two randomised, prospective controlled trials. Outpatient clinic of a secondary hospital. Fifty consecutive patients randomised to the exercise group {n=25; 23 males; mean age 54 [standard deviation (SD) 9] years} or the control group [n=25; 20 males; mean age 58 (SD 9) years]. The exercise group participated in an 8-week aerobic exercise programme plus usual medical care and follow-up. The control group received usual medical care and follow-up. The primary outcome measure was change in time spent undertaking moderate-to-vigorous physical activity per day, assessed by accelerometer over 7 consecutive days. Secondary outcome measures were cardiorespiratory fitness, body mass, and resting blood pressure and heart rate. Moderate-to-vigorous physical activity levels increased significantly in the exercise group [43.2 (SD 36.3) to 53.5 (SD 31.9) minutes/day, P=0.030], and remained unchanged in the control group [40.8 (SD 26.2) to 36.8 (SD 26.5) minutes/day, P=0.241] from baseline to the end of the programme. Cardiorespiratory fitness increased significantly in the exercise group (mean difference 2.8; 95% of the difference 1.3 to 4.4ml/kg/minute, P=0.001) after the 8-week programme. In patients under optimal medication following myocardial infarction, participation in an 8-week exercise-based cardiac rehabilitation programme was found to improve physical activity levels consistent with health-related benefits. Future studies are needed to determine whether the increase in physical activity is maintained in the long term. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Development of the teaching simulator based on animated film to strengthening pedagogical competencies of prospective teachers

NASA Astrophysics Data System (ADS)

Fatimah, Siti; Setiawan, Wawan; Kusnendar, Jajang; Rasim, Junaeti, Enjun; Anggraeni, Ria

2017-05-01

Debriefing of pedagogical competence through both theory and practice which became a requirement for prospective teachers were through micro teaching and teaching practice program. But, some reports from the partner schools stated that the participants of teaching practice program have not well prepared on implementing the learning in the classroom because of lacking the debriefing. In line with the development of information technology, it is very possible to develop a media briefing of pedagogical competencies for prospective teachers through an application so that they can use it anytime and anywhere. This study was one answer to the problem of unpreparedness participants of the teaching practice program. This study developed a teaching simulator, which was an application for learning simulation with the animated film to enhance the professional pedagogical competence prospective teachers. By the application of this teaching simulator, students as prospective teacher could test their own pedagogic competence through learning models with different varied characteristics of students. Teaching Simulator has been equipped with features that allow users to be able to explore the quality of teaching techniques that they employ for the teaching and learning activities in the classroom. These features included the election approaches, the student's character, learning materials, questioning techniques, discussion, and evaluation. Teaching simulator application provided the ease of prospective teachers or teachers in implementing the development of lessons for practice in the classroom. Applications that have been developed to apply simulation models allow users to freely manage a lesson. Development of teaching simulator application was passed through the stages which include needs assessment, design, coding, testing, revision, improvement, grading, and packaging. The application of teaching simulator was also enriched with some real instructional video as a comparison for the user. Based on the two experts, the media expert and education expert, stated that the application of teaching simulator is feasible to be used as an instrument for the debriefing of students as potential participants of the teaching practice program. The results of the use of the application to the students as potential participants of teaching practice program, showed significant increases in the pedagogic competence. This study was presented at an international seminar and in the process of publishing in international reputated journals. Applications teaching simulator was in the process of registration to obtain the copyright of the Ministry of Justice and Human Rights. Debriefing for prospective teachers to use teaching simulator application could improve the mastery of pedagogy, give clear feedback, and perform repetitions at anytime.

Centre-based day care for children younger than five years of age in low- and middle-income countries.

PubMed

Brown, Taylor W; van Urk, Felix C; Waller, Rebecca; Mayo-Wilson, Evan

2014-09-25

Because of poverty, children and families in low- and middle-income countries often face significant impediments to health and well-being. Centre-based day care services may influence the development of children and the economic situation of parents by providing good quality early childhood care and by freeing parents to participate in the labour force. To assess the effects of centre-based day care without additional interventions (e.g. psychological or medical services, parent training) on the development, health and well-being of children and families in low- and middle-income countries (as defined by the World Bank 2011). In April 2014, we searched CENTRAL, Ovid MEDLINE, EMBASE, PsycINFO, ERIC and 16 other sources, including several World Health Organization (WHO) regional databases. We also searched two trials registers, websites of government and non-government agencies and reference lists of relevant studies. We included randomised and quasi-randomised controlled trials and prospective non-randomised studies with contemporaneous control groups and assessments both before and after intervention. We considered non-randomised controlled trials, as centre-based care in low- and middle-income countries is unlikely to be studied using randomised controlled trials (Higgins 2011). We included the following outcomes: child intellectual development, child psychosocial development, maternal and family outcomes and incidence of infectious diseases. Two review authors independently assessed risk of bias and extracted data from the single included study. Only one trial, involving 256 children, met the inclusion criteria for this review. This study was assessed as having high risk of bias because of non-random allocation, incomplete outcome data and insufficient control of confounding factors. Results from this study suggest that centre-based day care may have a positive effect on child cognitive ability compared with no treatment (care at home) (assessed using a modified version of the British Ability Scale-II (BAS-II) (standardised mean difference (SMD) 0.74, 95% confidence interval (CI) 0.48 to 1.00, 256 participants, 1 study, very low-quality evidence). This study did not measure other variables relevant to this review. The single study included in this review provides limited evidence on the effects of centre-based day care for children younger than five years of age in low- and middle-income countries. This study was at high risk of bias and may have limited generalisability to other low- and middle-income countries. Many of the studies excluded from this review paired day care attendance with co-interventions that are unlikely to be provided in normal day care centres. Effectiveness studies on centre-based day care without these co-interventions are few, and the need for such studies is significant. In future studies, comparisons might include home visits or alternative day care arrangements.

Epidurals in Pancreatic Resection Outcomes (E-PRO) study: protocol for a randomised controlled trial

PubMed Central

Pak, Linda Ma; Haroutounian, Simon; Hawkins, William G; Worley, Lori; Kurtz, Monika; Frey, Karen; Karanikolas, Menelaos; Swarm, Robert A; Bottros, Michael M

2018-01-01

Introduction Epidural analgesia provides an important synergistic method of pain control. In addition to reducing perioperative opioid consumption, the deliverance of analgesia into the epidural space, effectively creating a sympathetic blockade, has a multitude of additional potential benefits, from decreasing the incidence of postoperative delirium to reducing the development of persistent postsurgical pain (PPSP). Prior studies have also identified a correlation between the use of epidural analgesia and improved oncological outcomes and survival. The aim of this study is to evaluate the effect of epidural analgesia in pancreatic operations on immediate postoperative outcomes, the development of PPSP and oncological outcomes in a prospective, single-blind, randomised controlled trial. Methods The Epidurals in Pancreatic Resection Outcomes (E-PRO) study is a prospective, single-centre, randomised controlled trial. 150 patients undergoing either pancreaticoduodenectomy or distal pancreatectomy will be randomised to receive an epidural bupivacaine infusion following anaesthetic induction followed by continued epidural bupivacaine infusion postoperatively in addition to the institutional standardised pain regimen of hydromorphone patient-controlled analgesia (PCA), acetaminophen and ketorolac (intervention group) or no epidural infusion and only the standardised postoperative pain regimen (control group). The primary outcome was the postoperative opioid consumption, measured in morphine or morphine-equivalents. Secondary outcomes include patient-reported postoperative pain numerical rating scores, trend and relative ratios of serum inflammatory markers (interleukin (IL)-1β, IL-6, tumour necrosis factor-α, IL-10), occurrence of postoperative delirium, development of PPSP as determined by quantitative sensory testing, and disease-free and overall survival. Ethics and dissemination The E-PRO trial has been approved by the institutional review board. Recruitment began in May 2016 and will continue until the end of May 2018. Dissemination plans include presentations at scientific conferences and scientific publications. Trial registration number NCT02681796. PMID:29374667

A prospective randomised trial comparing nasogastric with intravenous hydration in children with bronchiolitis (protocol) The comparative rehydration in bronchiolitis study (CRIB)

PubMed Central

2010-01-01

Background Bronchiolitis is the most common reason for admission of infants to hospital in developed countries. Fluid replacement therapy is required in about 30% of children admitted with bronchiolitis. There are currently two techniques of fluid replacement therapy that are used with the same frequency-intravenous (IV) or nasogastric (NG). The evidence to determine the optimum route of hydration therapy for infants with bronchiolitis is inadequate. This randomised trial will be the first to provide good quality evidence of whether nasogastric rehydration (NGR) offers benefits over intravenous rehydration (IVR) using the clinically relevant continuous outcome measure of duration of hospital admission. Methods/Design A prospective randomised multi-centre trial in Australia and New Zealand where children between 2 and 12 months of age with bronchiolitis, needing non oral fluid replacement, are randomised to receive either intravenous (IV) or nasogastric (NG) rehydration. 750 patients admitted to participating hospitals will be recruited, and will be followed daily during the admission and by telephone 1 week after discharge. Patients with chronic respiratory, cardiac, or neurological disease; choanal atresia; needing IV fluid resuscitation; needing an IV for other reasons, and those requiring CPAP or ventilation are excluded. The primary endpoint is duration of hospital admission. Secondary outcomes are complications, need for ICU admission, parental satisfaction, and an economic evaluation. Results will be analysed using t-test for continuous data, and chi squared for categorical data. Non parametric data will be log transformed. Discussion This trial will define the role of NGR and IVR in bronchiolitis Trail registration The trial is registered with the Australian and New Zealand Clinical Trials Registry - ACTRN12605000033640 PMID:20515467

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

Treatment strategies in colorectal cancer patients with initially unresectable liver-only metastases, a study protocol of the randomised phase 3 CAIRO5 study of the Dutch Colorectal Cancer Group (DCCG).

PubMed

Huiskens, Joost; van Gulik, Thomas M; van Lienden, Krijn P; Engelbrecht, Marc R W; Meijer, Gerrit A; van Grieken, Nicole C T; Schriek, Jonne; Keijser, Astrid; Mol, Linda; Molenaar, I Quintus; Verhoef, Cornelis; de Jong, Koert P; Dejong, Kees H C; Kazemier, Geert; Ruers, Theo M; de Wilt, Johanus H W; van Tinteren, Harm; Punt, Cornelis J A

2015-05-06

Colorectal cancer patients with unresectable liver-only metastases may be cured after downsizing of metastases by neoadjuvant systemic therapy. However, the optimal neoadjuvant induction regimen has not been defined, and the lack of consensus on criteria for (un)resectability complicates the interpretation of published results. CAIRO5 is a multicentre, randomised, phase 3 clinical study. Colorectal cancer patients with initially unresectable liver-only metastases are eligible, and will not be selected for potential resectability. The (un)resectability status is prospectively assessed by a central panel consisting of at least one radiologist and three liver surgeons, according to predefined criteria. Tumours of included patients will be tested for RAS mutation status. Patients with RAS wild type tumours will be treated with doublet chemotherapy (FOLFOX or FOLFIRI) and randomised between the addition of either bevacizumab or panitumumab, and patients with RAS mutant tumours will be randomised between doublet chemotherapy (FOLFOX or FOLFIRI) plus bevacizumab or triple chemotherapy (FOLFOXIRI) plus bevacizumab. Radiological evaluation to assess conversion to resectability will be performed by the central panel, at an interval of two months. The primary study endpoint is median progression-free survival. Secondary endpoints are the R0/1 resection rate, median overall survival, response rate, toxicity, pathological response of resected lesions, postoperative morbidity, and correlation of baseline and follow-up evaluation with respect to outcomes by the central panel. CAIRO5 is a prospective multicentre trial that investigates the optimal systemic induction therapy for patients with initially unresectable, liver-only colorectal cancer metastases. CAIRO 5 is registered at European Clinical Trials Database (EudraCT) (2013-005435-24). CAIRO 5 is registered at ClinicalTrials.gov: NCT02162563 , June 10, 2014.

Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy in TYpe 2 diabetic patients with normoalbuminuria (PRIORITY): essential study design and rationale of a randomised clinical multicentre trial.

PubMed

Lindhardt, Morten; Persson, Frederik; Currie, Gemma; Pontillo, Claudia; Beige, Joachim; Delles, Christian; von der Leyen, Heiko; Mischak, Harald; Navis, Gerjan; Noutsou, Marina; Ortiz, Alberto; Ruggenenti, Piero Luigi; Rychlik, Ivan; Spasovski, Goce; Rossing, Peter

2016-03-02

Diabetes mellitus affects 9% of the European population and accounts for 15% of healthcare expenditure, in particular, due to excess costs related to complications. Clinical trials aiming for earlier prevention of diabetic nephropathy by renin angiotensin system blocking treatment in normoalbumuric patients have given mixed results. This might reflect that the large fraction of normoalbuminuric patients are not at risk of progression, thereby reducing power in previous studies. A specific risk classifier based on urinary proteomics (chronic kidney disease (CKD)273) has been shown to identify normoalbuminuric diabetic patients who later progressed to overt kidney disease, and may hold the potential for selection of high-risk patients for early intervention. Combining the ability of CKD273 to identify patients at highest risk of progression with prescription of preventive aldosterone blockade only to this high-risk population will increase power. We aim to confirm performance of CKD273 in a prospective multicentre clinical trial and test the ability of spironolactone to delay progression of early diabetic nephropathy. Investigator-initiated, prospective multicentre clinical trial, with randomised double-masked placebo-controlled intervention and a prospective observational study. We aim to include 3280 type 2 diabetic participants with normoalbuminuria. The CKD273 classifier will be assessed in all participants. Participants with high-risk pattern are randomised to treatment with spironolactone 25 mg once daily, or placebo, whereas, those with low-risk pattern will be observed without intervention other than standard of care. Treatment or observational period is 3 years.The primary endpoint is development of confirmed microalbuminuria in 2 of 3 first morning voids urine samples. The study will be conducted under International Conference on Harmonisation - Good clinical practice (ICH-GCP) requirements, ethical principles of Declaration of Helsinki and national laws. This first new biomarker-directed intervention trial aiming at primary prevention of diabetic nephropathy may pave the way for personalised medicine approaches in treatment of diabetes complications. NCT02040441; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

PATCH: platelet transfusion in cerebral haemorrhage: study protocol for a multicentre, randomised, controlled trial.

PubMed

de Gans, Koen; de Haan, Rob J; Majoie, Charles B; Koopman, Maria M; Brand, Anneke; Dijkgraaf, Marcel G; Vermeulen, Marinus; Roos, Yvo B

2010-03-18

Patients suffering from intracerebral haemorrhage have a poor prognosis, especially if they are using antiplatelet therapy. Currently, no effective acute treatment option for intracerebral haemorrhage exists. Limiting the early growth of intracerebral haemorrhage volume which continues the first hours after admission seems a promising strategy. Because intracerebral haemorrhage patients who are on antiplatelet therapy have been shown to be particularly at risk of early haematoma growth, platelet transfusion may have a beneficial effect. The primary objective is to investigate whether platelet transfusion improves outcome in intracerebral haemorrhage patients who are on antiplatelet treatment. The PATCH study is a prospective, randomised, multi-centre study with open treatment and blind endpoint evaluation. Patients will be randomised to receive platelet transfusion within six hours or standard care. The primary endpoint is functional health after three months. The main secondary endpoints are safety of platelet transfusion and the occurrence of haematoma growth. To detect an absolute poor outcome reduction of 20%, a total of 190 patients will be included. To our knowledge this is the first randomised controlled trial of platelet transfusion for an acute haemorrhagic disease.

Physiotherapy Rehabilitation for Osteoporotic Vertebral Fracture (PROVE): study protocol for a randomised controlled trial

PubMed Central

2014-01-01

Background Osteoporosis and vertebral fracture can have a considerable impact on an individual’s quality of life. There is increasing evidence that physiotherapy including manual techniques and exercise interventions may have an important treatment role. This pragmatic randomised controlled trial will investigate the clinical and cost-effectiveness of two different physiotherapy approaches for people with osteoporosis and vertebral fracture, in comparison to usual care. Methods/Design Six hundred people with osteoporosis and a clinically diagnosed vertebral fracture will be recruited and randomly allocated to one of three management strategies, usual care (control - A), an exercise-based physiotherapy intervention (B) or a manual therapy-based physiotherapy intervention (C). Those in the usual care arm will receive a single session of education and advice, those in the active treatment arms (B + C) will be offered seven individual physiotherapy sessions over 12 weeks. The trial is designed as a prospective, adaptive single-blinded randomised controlled trial. An interim analysis will be completed and if one intervention is clearly superior the trial will be adapted at this point to continue with just one intervention and the control. The primary outcomes are quality of life measured by the disease specific QUALLEFO 41 and the Timed Loaded Standing test measured at 1 year. Discussion There are a variety of different physiotherapy packages used to treat patients with osteoporotic vertebral fracture. At present, the indication for each different therapy is not well defined, and the effectiveness of different modalities is unknown. Trial registration Reference number ISRCTN49117867. PMID:24422876

Pre-recorded instructional audio vs. dispatchers' conversational assistance in telephone cardiopulmonary resuscitation: A randomized controlled simulation study.

PubMed

Birkun, Alexei; Glotov, Maksim; Ndjamen, Herman Franklin; Alaiye, Esther; Adeleke, Temidara; Samarin, Sergey

2018-01-01

To assess the effectiveness of the telephone chest-compression-only cardiopulmonary resuscitation (CPR) guided by a pre-recorded instructional audio when compared with dispatcher-assisted resuscitation. It was a prospective, blind, randomised controlled study involving 109 medical students without previous CPR training. In a standardized mannequin scenario, after the step of dispatcher-assisted cardiac arrest recognition, the participants performed compression-only resuscitation guided over the telephone by either: (1) the pre-recorded instructional audio ( n =57); or (2) verbal dispatcher assistance ( n =52). The simulation video records were reviewed to assess the CPR performance using a 13-item checklist. The interval from call reception to the first compression, total number and rate of compressions, total number and duration of pauses after the first compression were also recorded. There were no significant differences between the recording-assisted and dispatcher-assisted groups based on the overall performance score (5.6±2.2 vs. 5.1±1.9, P >0.05) or individual criteria of the CPR performance checklist. The recording-assisted group demonstrated significantly shorter time interval from call receipt to the first compression (86.0±14.3 vs. 91.2±14.2 s, P <0.05), higher compression rate (94.9±26.4 vs. 89.1±32.8 min -1 ) and number of compressions provided (170.2±48.0 vs. 156.2±60.7). When provided by untrained persons in the simulated settings, the compression-only resuscitation guided by the pre-recorded instructional audio is no less efficient than dispatcher-assisted CPR. Future studies are warranted to further assess feasibility of using instructional audio aid as a potential alternative to dispatcher assistance.

Pre-recorded instructional audio vs. dispatchers’ conversational assistance in telephone cardiopulmonary resuscitation: A randomized controlled simulation study

PubMed Central

Birkun, Alexei; Glotov, Maksim; Ndjamen, Herman Franklin; Alaiye, Esther; Adeleke, Temidara; Samarin, Sergey

2018-01-01

BACKGROUND: To assess the effectiveness of the telephone chest-compression-only cardiopulmonary resuscitation (CPR) guided by a pre-recorded instructional audio when compared with dispatcher-assisted resuscitation. METHODS: It was a prospective, blind, randomised controlled study involving 109 medical students without previous CPR training. In a standardized mannequin scenario, after the step of dispatcher-assisted cardiac arrest recognition, the participants performed compression-only resuscitation guided over the telephone by either: (1) the pre-recorded instructional audio (n=57); or (2) verbal dispatcher assistance (n=52). The simulation video records were reviewed to assess the CPR performance using a 13-item checklist. The interval from call reception to the first compression, total number and rate of compressions, total number and duration of pauses after the first compression were also recorded. RESULTS: There were no significant differences between the recording-assisted and dispatcher-assisted groups based on the overall performance score (5.6±2.2 vs. 5.1±1.9, P>0.05) or individual criteria of the CPR performance checklist. The recording-assisted group demonstrated significantly shorter time interval from call receipt to the first compression (86.0±14.3 vs. 91.2±14.2 s, P<0.05), higher compression rate (94.9±26.4 vs. 89.1±32.8 min-1) and number of compressions provided (170.2±48.0 vs. 156.2±60.7). CONCLUSION: When provided by untrained persons in the simulated settings, the compression-only resuscitation guided by the pre-recorded instructional audio is no less efficient than dispatcher-assisted CPR. Future studies are warranted to further assess feasibility of using instructional audio aid as a potential alternative to dispatcher assistance.

One year outcomes in patients with acute lung injury randomised to initial trophic or full enteral feeding: prospective follow-up of EDEN randomised trial.

PubMed

Needham, Dale M; Dinglas, Victor D; Bienvenu, O Joseph; Colantuoni, Elizabeth; Wozniak, Amy W; Rice, Todd W; Hopkins, Ramona O

2013-03-19

To evaluate the effect of initial low energy permissive underfeeding ("trophic feeding") versus full energy enteral feeding ("full feeding") on physical function and secondary outcomes in patients with acute lung injury. Prospective longitudinal follow-up evaluation of the NHLBI ARDS Clinical Trials Network's EDEN trial 41hospitals in the United States. 525 patients with acute lung injury. Randomised assignment to trophic or full feeding for up to six days; thereafter, all patients still receiving mechanical ventilation received full feeding. Blinded assessment of the age and sex adjusted physical function domain of the SF-36 instrument at 12 months after acute lung injury. Secondary outcome measures included survival; physical, psychological, and cognitive functioning; quality of life; and employment status at six and 12 months. After acute lung injury, patients had substantial physical, psychological, and cognitive impairments, reduced quality of life, and impaired return to work. Initial trophic versus full feeding did not affect mean SF-36 physical function at 12 months (55 (SD 33) v 55 (31), P=0.54), survival to 12 months (65% v 63%, P=0.63), or nearly all of the secondary outcomes. In survivors of acute lung injury, there was no difference in physical function, survival, or multiple secondary outcomes at 6 and 12 month follow-up after initial trophic or full enteral feeding. NCT No 00719446.

The protocol and design of a randomised controlled study on training of attention within the first year after acquired brain injury.

PubMed

Bartfai, Aniko; Markovic, Gabriela; Sargenius Landahl, Kristina; Schult, Marie-Louise

2014-05-08

To describe the design of the study aiming to examine intensive targeted cognitive rehabilitation of attention in the acute (<4 months) and subacute rehabilitation phases (4-12 months) after acquired brain injury and to evaluate the effects on function, activity and participation (return to work). Within a prospective, randomised, controlled study 120 consecutive patients with stroke or traumatic brain injury were randomised to 20 hours of intensive attention training by Attention Process Training or by standard, activity based training. Progress was evaluated by Statistical Process Control and by pre and post measurement of functional and activity levels. Return to work was also evaluated in the post-acute phase. Primary endpoints were the changes in the attention measure, Paced Auditory Serial Addition Test and changes in work ability. Secondary endpoints included measurement of cognitive functions, activity and work return. There were 3, 6 and 12-month follow ups focussing on health economics. The study will provide information on rehabilitation of attention in the early phases after ABI; effects on function, activity and return to work. Further, the application of Statistical Process Control might enable closer investigation of the cognitive changes after acquired brain injury and demonstrate the usefulness of process measures in rehabilitation. The study was registered at ClinicalTrials.gov Protocol. NCT02091453, registered: 19 March 2014.

Efficacy and safety of renal denervation for Chinese patients with resistant hypertension using a microirrigated catheter: study design and protocol for a prospective multicentre randomised controlled trial.

PubMed

Liu, Zongjun; Shen, Li; Huang, Weijian; Zhao, Xianxian; Fang, Weiyi; Wang, Changqian; Yin, Zhaofang; Wang, Jianan; Fu, Guosheng; Liu, Xuebo; Jiang, Jianjun; Zhang, Zhihui; Li, Jingbo; Lu, Yingmin; Ge, Junbo

2017-09-01

Available data show that approximately 8%-18% of patients with primary hypertension will develop resistant hypertension. In recent years, catheter-based renal denervation (RDN) has emerged as a potential treatment option for resistant hypertension. A number of observational studies and randomised controlled trials among non-Chinese patients have demonstrated its potential safety and efficacy. This is a multicentre, randomised, open-label, parallel-group, active controlled trial that will investigate the efficacy and safety of a 5F saline-irrigated radiofrequency ablation (RFA) used for RDN in the treatment of Chinese patients with resistant hypertension. A total of 254 patients who have failed pharmacological therapy will be enrolled. Eligible subjects will be randomised in a 1:1 ratio to undergo RDN using the RFA plus antihypertensive medication or to receive treatment with antihypertensive medication alone. The primary outcome measure is the change in 24 hours average ambulatory systolic blood pressure from baseline to 3 months, comparing the RDN-plus-medication group with the medication-alone group. Important secondary endpoints include the change in office blood pressure from baseline to 6 months after randomisation. Safety endpoints such as changes in renal function will also be evaluated. The full analysis set, according to the intent-to-treat principle, will be established as the primary analysis population. All participants will provide informed consent; the study protocol has been approved by the Independent Ethics Committee for each site. This study is designed to investigate the efficacy and safety of RDN using a 5F saline microirrigated RFA. Findings will be shared with participating hospitals, policymakers and the academic community to promote the clinical management of resistant hypertension in China. ClinicalTrials.gov ID: NCT02900729; pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Rationale and design of a randomised clinical trial comparing vascular closure device and manual compression to achieve haemostasis after diagnostic coronary angiography: the Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial.

PubMed

Xhepa, Erion; Byrne, Robert A; Schulz, Stefanie; Helde, Sandra; Gewalt, Senta; Cassese, Salvatore; Linhardt, Maryam; Ibrahim, Tareq; Mehilli, Julinda; Hoppe, Katharina; Grupp, Katharina; Kufner, Sebastian; Böttiger, Corinna; Hoppmann, Petra; Burgdorf, Christof; Fusaro, Massimiliano; Ott, Ilka; Schneider, Simon; Hengstenberg, Christian; Schunkert, Heribert; Laugwitz, Karl-Ludwig; Kastrati, Adnan

2014-06-01

Vascular closure devices (VCD) have been introduced into clinical practice with the aim of increasing the procedural efficiency and clinical safety of coronary angiography. However, clinical studies comparing VCD and manual compression have yielded mixed results, and large randomised clinical trials comparing the two strategies are missing. Moreover, comparative efficacy studies between different VCD in routine clinical use are lacking. The Instrumental Sealing of ARterial puncture site - CLOSURE device versus manual compression (ISAR-CLOSURE) trial is a prospective, randomised clinical trial designed to compare the outcomes associated with the use of VCD or manual compression to achieve femoral haemostasis. The test hypothesis is that femoral haemostasis after coronary angiography achieved using VCD is not inferior to manual compression in terms of access-site-related vascular complications. Patients undergoing coronary angiography via the common femoral artery will be randomised in a 1:1:1 fashion to receive FemoSeal VCD, EXOSEAL VCD or manual compression. The primary endpoint is the incidence of the composite of arterial access-related complications (haematoma ≥5 cm, pseudoaneurysm, arteriovenous fistula, access-site-related bleeding, acute ipsilateral leg ischaemia, the need for vascular surgical/interventional treatment or documented local infection) at 30 days after randomisation. According to power calculations based on non-inferiority hypothesis testing, enrolment of 4,500 patients is planned. The trial is registered at www.clinicaltrials.gov (study identifier: NCT01389375). The safety of VCD as compared to manual compression in patients undergoing transfemoral coronary angiography remains an issue of clinical equipoise. The aim of the ISAR-CLOSURE trial is to assess whether femoral haemostasis achieved through the use of VCD is non-inferior to manual compression in terms of access-site-related vascular complications.

Improving communication when seeking informed consent: a randomised controlled study of a computer-based method for providing information to prospective clinical trial participants.

PubMed

Karunaratne, Asuntha S; Korenman, Stanley G; Thomas, Samantha L; Myles, Paul S; Komesaroff, Paul A

2010-04-05

To assess the efficacy, with respect to participant understanding of information, of a computer-based approach to communication about complex, technical issues that commonly arise when seeking informed consent for clinical research trials. An open, randomised controlled study of 60 patients with diabetes mellitus, aged 27-70 years, recruited between August 2006 and October 2007 from the Department of Diabetes and Endocrinology at the Alfred Hospital and Baker IDI Heart and Diabetes Institute, Melbourne. Participants were asked to read information about a mock study via a computer-based presentation (n = 30) or a conventional paper-based information statement (n = 30). The computer-based presentation contained visual aids, including diagrams, video, hyperlinks and quiz pages. Understanding of information as assessed by quantitative and qualitative means. Assessment scores used to measure level of understanding were significantly higher in the group that completed the computer-based task than the group that completed the paper-based task (82% v 73%; P = 0.005). More participants in the group that completed the computer-based task expressed interest in taking part in the mock study (23 v 17 participants; P = 0.01). Most participants from both groups preferred the idea of a computer-based presentation to the paper-based statement (21 in the computer-based task group, 18 in the paper-based task group). A computer-based method of providing information may help overcome existing deficiencies in communication about clinical research, and may reduce costs and improve efficiency in recruiting participants for clinical trials.

Randomised clinical trial of chest drainage systems.

PubMed Central

Graham, A N; Cosgrove, A P; Gibbons, J R; McGuigan, J A

1992-01-01

BACKGROUND: Problems in the management of thoracic trauma have stimulated the search for an alternative to underwater seals for drainage of the pleural cavity. A chest drainage bag incorporating a one way flutter valve has been compared with underwater seal drains in a randomised clinical trial. METHODS: During June-December 1989 119 patients undergoing elective thoracotomy were randomised to receive postoperative chest drainage by drainage bags (56 patients, 87 drains) or by underwater seal drains (63 patients, 98 drains). Daily drainage volumes, the requirement for pleural suction, mobility, and complications were recorded prospectively. RESULTS: There was no significant difference between the two groups in the mean volume drained, the requirements for pleural suction, or the occurrence of complications. Patients with drainage bags were fully mobile 23 hours (95% confidence interval 0-47 hours) earlier than the others. CONCLUSIONS: When used after elective thoracotomy drainage bags are safe and effective and permit earlier mobility than underwater seal drains. PMID:1496507

Recruiting to a large-scale physical activity randomised controlled trial - experiences with the gift of hindsight.

PubMed

Copeland, Robert J; Horspool, Kimberley; Humphreys, Liam; Scott, Emma

2016-02-24

Recruitment issues continue to impact a large number of trials. Sharing recruitment information is vital to supporting researchers to accurately predict recruitment and to manage the risk of poor recruitment during study design and implementation. The purpose of this article is to build on the knowledge available to researchers on recruiting to community-based trials. A critical commentary of the recruitment challenges encountered during the Booster Study, a randomised controlled trial in which researchers investigated the effectiveness of a motivational interviewing style intervention on the maintenance of physical activity. An overview of recruitment is provided, as well as strategies employed to recruit prospective participants and possible barriers to recruitment. Two hundred eighty-two people, 47 % of the original target, were recruited through mail-outs, with secondary recruitment pathways yielding no additional participants. The research team encountered problems with recontacting interested participants and providing study materials in non-English languages. A lower response rate to the mail-out and a greater number of non-contactable participants in the full study than in the pilot study resulted in a smaller pool of eligible participants from the brief intervention eligible for recruitment into the randomised controlled trial. Despite using widely accepted recruitment strategies and incorporating new recruitment tactics in response to challenges, the Booster Study investigators failed to randomise a sufficient number of participants. Recruitment in trials of community-based behavioural interventions may have different challenges than trials based on clinical or primary care pathways. Specific challenges posed by the complexity of the study design and problems with staffing and resources were exacerbated by the need to revise upwards the number of mailed invitations as a result of the pilot study. Researchers should ensure study design facilitates recruitment and consider the implications of changing recruitment on the operational aspects of the trial. Where possible, the impact of new strategies should be measured, and recruitment successes and challenges should be shared with those planning similar studies. ISRCTN56495859 (registered on 12 February 2009); NCT00836459 (registered on 3 February 2009).

The effectiveness of current approaches to workplace stress management in the nursing profession: an evidence based literature review

PubMed Central

Mimura, C; Griffiths, P

2003-01-01

The effectiveness of current approaches to workplace stress management for nurses was assessed through a systematic review. Seven randomised controlled trials and three prospective cohort studies assessing the effectiveness of a stress management programmes were identified and reviewed. The quality of research identified was weak. There is more evidence for the effectiveness of programmes based on providing personal support than environmental management to reduce stressors. However, since the number and quality of studies is low, the question as to which, if any, approach is more effective cannot be answered definitively. Further research is required before clear recommendations for the use of particular interventions for nursing work related stress can be made. PMID:12499451

Sample size calculation for stepped wedge and other longitudinal cluster randomised trials.

PubMed

Hooper, Richard; Teerenstra, Steven; de Hoop, Esther; Eldridge, Sandra

2016-11-20

The sample size required for a cluster randomised trial is inflated compared with an individually randomised trial because outcomes of participants from the same cluster are correlated. Sample size calculations for longitudinal cluster randomised trials (including stepped wedge trials) need to take account of at least two levels of clustering: the clusters themselves and times within clusters. We derive formulae for sample size for repeated cross-section and closed cohort cluster randomised trials with normally distributed outcome measures, under a multilevel model allowing for variation between clusters and between times within clusters. Our formulae agree with those previously described for special cases such as crossover and analysis of covariance designs, although simulation suggests that the formulae could underestimate required sample size when the number of clusters is small. Whether using a formula or simulation, a sample size calculation requires estimates of nuisance parameters, which in our model include the intracluster correlation, cluster autocorrelation, and individual autocorrelation. A cluster autocorrelation less than 1 reflects a situation where individuals sampled from the same cluster at different times have less correlated outcomes than individuals sampled from the same cluster at the same time. Nuisance parameters could be estimated from time series obtained in similarly clustered settings with the same outcome measure, using analysis of variance to estimate variance components. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Evaluating the effect of the Helping Mothers Survive Bleeding after Birth (HMS BAB) training in Tanzania and Uganda: study protocol for a randomised controlled trial.

PubMed

Hanson, Claudia; Pembe, Andrea B; Alwy, Fadhlun; Atuhairwe, Susan; Leshabari, Sebalda; Morris, Jessica; Kaharuza, Frank; Marrone, Gaetano

2017-07-06

Postpartum haemorrhage complicates approximately 10% of all deliveries and contributes to at least a quarter of all maternal deaths worldwide. The competency-based Helping Mothers Survive Bleeding after Birth (HMS BAB) training was developed to support evidence-based management of postpartum haemorrhage. This one-day training includes low-cost MamaNatalie® birthing simulators and addresses both prevention and first-line treatment of haemorrhage. While evidence is accumulating that the training improves health provider's knowledge, skills and confidence, evidence is missing as to whether this translates into improved practices and reduced maternal morbidity and mortality. This cluster-randomised trial aims to assess whether this training package - involving a one-day competency-based HMS BAB in-facility training provided by certified trainers followed by 8 weeks of in-service peer-based practice - has an effect on the occurrence of haemorrhage-related morbidity and mortality. In Tanzania and Uganda we randomise 20 and 18 districts (clusters) respectively, with half receiving the training intervention. We use unblinded matched-pair randomisation to balance district health system characteristics and the main outcome, which is in-facility severe morbidity due to haemorrhage defined by the World Health Organizationation-promoted disease and management-based near-miss criteria. Data are collected continuously in the intervention and comparison districts throughout the 6-month baseline and the 9-month intervention phase, which commences after the training intervention. Trained facility midwives or clinicians review severe maternal complications to identify near misses on a daily basis. They abstract the case information from case notes and enter it onto programmed tablets where it is uploaded. Intention-to-treat analysis will be used, taking the matched design into consideration using paired t test statistics to compare the outcomes between the intervention and comparison districts. We also assess the impact pathway from the effects of the training on the health provider's skills, care and interventions and health system readiness. This trial aims to generate evidence on the effect and limitations of this well-designed training package supported by birthing simulations. While the lack of blinding of participants and data collectors provides an inevitable limitation of this trial, the additional evaluation along the pathway of implementation will provide solid evidence on the effects of this HMS BAB training package. Pan African Clinical Trials Registry, PACTR201604001582128 . Registered on 12 April 2016.

Does an electronic cognitive aid have an effect on the management of severe gynaecological TURP syndrome? A prospective, randomised simulation study.

PubMed

St Pierre, Michael; Breuer, Georg; Strembski, Dieter; Schmitt, Christopher; Luetcke, Bjoern

2017-05-30

Lack of familiarity with the content of current guidelines is a major factor associated with non-compliance by clinicians. It is conceivable that cognitive aids with regularly updated medical content can guide clinicians' task performance by evidence-based practices, even if they are unfamiliar with the actual guideline. Acute hyponatraemia as a consequence of TURP syndrome is a rare intraoperative event, and current practice guidelines have changed from slow correction to rapid correction of serum sodium levels. The primary objective of this study was to compare the management of a simulated severe gynaecological transurethral resection of the prostate (TURP) syndrome under spinal anaesthesia with either: an electronic cognitive aid, or with management from memory alone. The secondary objective was to assess the clinical relevance and participant perception of the usefulness of the cognitive aid. Anaesthetic teams were allocated to control (no cognitive aid; n = 10) or intervention (cognitive aid provided; n = 10) groups. We identified eight evidence-based management tasks for severe TURP syndrome from current guidelines and subdivided them into acute heart failure (AHF)/pulmonary oedema tasks (5) and acute hyponatraemia tasks (3). Implementation of the treatment steps was measured by scoring task items in a binary fashion (yes/no). To assess whether or not the cognitive aid had prompted a treatment step, participants from the cognitive aid group were questioned during debriefing on every single treatment step. At the end of the simulation, session participants were asked to complete a survey. Teams in the cognitive aid group considered evidence-based treatment steps significantly more often than teams of the control group (96% vs. 50% for 'AHF/pulmonary oedema' p < 0.001; 79% vs. 12% for 'acute hyponatraemia' p < 0.001). Without the cognitive aid, performance would have been comparable across both groups. Nurses, trainees, and consultants derived equal benefit from the cognitive aid. The cognitive aid improved the implementation of evidence-based practices in a simulated intraoperative scenario. Cognitive aids with current medical content could help to close the translational gap between guideline publication and implementation in acute patient care. It is important that the cognitive aid should be familiar, in a format that has been used in practice and training.

Protocol for Compass: a randomised controlled trial of primary HPV testing versus cytology screening for cervical cancer in HPV-unvaccinated and vaccinated women aged 25-69 years living in Australia.

PubMed

Canfell, Karen; Saville, Marion; Caruana, Michael; Gebski, Val; Darlington-Brown, Jessica; Brotherton, Julia; Heley, Stella; Castle, Philip E

2018-01-26

Australia's National Cervical Screening Program (NCSP) currently recommends 2-year cytology in women aged 18-69 years. Following a review of the NCSP prompted by the implementation of human papillomavirus (HPV) vaccination, the programme will transition in 2017 to 5-year primary HPV screening with partial genotyping for HPV16/18 in women aged 25-74 years. Compass is a sentinel experience for the renewed NCSP and the first prospectively randomised trial of primary HPV screening compared with cytology to be conducted in a population with high uptake of HPV vaccination. This protocol describes the main Compass trial, which commenced after a pilot study of ~5000 women completed recruitment. Women aged 25-69 years will be randomised at a 1:2 allocation to (1) 2.5-year image-read, liquid-based cytology (LBC) screening with HPV triage of low-grade smears (active control Arm A) or (2) 5-year HPV screening with partial genotyping and referral of HPV16/18-positive women to colposcopy (intervention Arm B). Women in Arm B positive for other oncogenic HPV (not 16/18) will undergo secondary randomisation at a 1:1 allocation to either LBC or dual-stained (p16 INK4a and Ki-67) cytology testing (dual-stained cytology). The primary outcome is cumulative CIN3+ (CIN3, adenocarcinoma in situ and invasive cervical cancer) following a 5-year HPV exit testing round in both arms, in women randomised to the HPV arm versus women randomised to the LBC arm, based on an intention-to-treat analysis. The primary outcome will first be tested for non-inferiority and if declared, the primary outcome will be tested for superiority. A total of 36 300 women in birth cohorts not offered vaccination and 84 700 women in cohorts offered vaccination will be recruited, bringing the final sample size to 121 000. The trial is powered for the secondary outcome of cumulative CIN3+ in screen-negative women, adjusted for censoring after CIN2+ treatment and hysterectomy. Approved by the Bellberry Ethics Committee (2014-11-592). Findings will be reported in peer-reviewed journals and presented at scientific meetings. NCT02328872; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Simulation in undergraduate paediatrics: a cluster-randomised trial.

PubMed

Morrissey, Benita; Jacob, Hannah; Harnik, Erika; Mackay, Kate; Moreiras, John

2016-10-01

Medical students lack confidence in recognising, assessing and managing unwell patients, particularly children. Our aim was to evaluate the impact of a 1-day novel paediatric simulation course on medical students' ability to recognise and assess sick children, and to evaluate medical students' views on the use of simulation in child health teaching. We conducted a cluster-randomised trial with a mixed-methods design. Students were cluster randomised into the intervention (simulation) group or control group (standard paediatric attachment). Students in the intervention group attended a 1-day simulation course during the last week of their attachment. The primary outcome measure was students' self-reported ability and confidence in recognising, assessing and managing sick children. There were 61 students in the study: 32 in the intervention group and 29 in the control group. Self-assessed confidence in recognising, assessing and managing a sick child was higher after the simulation course, compared with controls (p < 0.001). Six key themes were identified, including: increased confidence in emergency situations; the value of learning through participation in 'real-life' realistic scenarios in a safe environment; and an appreciation of the importance of human factors. Students found the simulation useful and wanted it offered to all undergraduates during child health attachments. A 1-day simulation course improves medical students' confidence in assessing and managing unwell children, and is highly valued by students. It could be used to complement undergraduate teaching on the management of sick children. Further studies are needed to evaluate its impact on real-life clinical performance and confidence over time. Students lack confidence in managing unwell patients, particularly children. © 2015 John Wiley & Sons Ltd.

Simulation-based training for nurses: Systematic review and meta-analysis.

PubMed

Hegland, Pål A; Aarlie, Hege; Strømme, Hilde; Jamtvedt, Gro

2017-07-01

Simulation-based training is a widespread strategy to improve health-care quality. However, its effect on registered nurses has previously not been established in systematic reviews. The aim of this systematic review is to evaluate effect of simulation-based training on nurses' skills and knowledge. We searched CDSR, DARE, HTA, CENTRAL, CINAHL, MEDLINE, Embase, ERIC, and SveMed+ for randomised controlled trials (RCT) evaluating effect of simulation-based training among nurses. Searches were completed in December 2016. Two reviewers independently screened abstracts and full-text, extracted data, and assessed risk of bias. We compared simulation-based training to other learning strategies, high-fidelity simulation to other simulation strategies, and different organisation of simulation training. Data were analysed through meta-analysis and narrative syntheses. GRADE was used to assess the quality of evidence. Fifteen RCTs met the inclusion criteria. For the comparison of simulation-based training to other learning strategies on nurses' skills, six studies in the meta-analysis showed a significant, but small effect in favour of simulation (SMD -1.09, CI -1.72 to -0.47). There was large heterogeneity (I 2 85%). For the other comparisons, there was large between-study variation in results. The quality of evidence for all comparisons was graded as low. The effect of simulation-based training varies substantially between studies. Our meta-analysis showed a significant effect of simulation training compared to other learning strategies, but the quality of evidence was low indicating uncertainty. Other comparisons showed inconsistency in results. Based on our findings simulation training appears to be an effective strategy to improve nurses' skills, but further good-quality RCTs with adequate sample sizes are needed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Prospective controlled evaluation of the effect of a community based asthma education centre in a multiracial working class neighbourhood.

PubMed Central

Garrett, J.; Fenwick, J. M.; Taylor, G.; Mitchell, E.; Stewart, J.; Rea, H.

1994-01-01

BACKGROUND--Previous work has indicated a high rate of non-attendance at hospital based clinics among young, multiracial asthmatic patients of lower socioeconomic class. The efficacy of delivering asthma education from a community health centre established in a multiracial working class neighbourhood was evaluated. METHODS--A prospective controlled study was performed in which asthmatic subjects aged between two and 55 years attending a hospital emergency room with acute asthma and living within a defined geographical area of high emergency room users were randomised to the usual follow up or the education centre plus usual follow up. Measurements were taken at entry into the study and again nine months later. RESULTS--At nine months patients randomised to the education centre had more preventive medications, more peak expiratory flow meters and better flow meter technique, more self-management plans, better knowledge of appropriate action to take when confronted with worsening asthma, less nocturnal awakening, and better self-reported asthma control than the control group. There was no difference between the study groups in measurements of compliance, hospital admission, days lost from school or work, or emergency room use. CONCLUSIONS--The main effects of education were on asthma knowledge and self-management skills, whilst improvements in asthma morbidity were small. Potential reasons for this include heterogeneous study population (in terms of baseline self-management skills, asthma severity, ethnicity and age), pragmatic study design, insensitivity of many of the measurements of morbidity, the modest effectiveness of a single time limited education programme, and inability to limit the effects of such a large community based study to the intervention group (there was a 67% reduction in asthma admissions during the study period from the geographical area targeted compared with a 22% reduction for the rest of Auckland). Images PMID:7974314

Increasing chlamydia screening tests in general practice: a modified Zelen prospective Cluster Randomised Controlled Trial evaluating a complex intervention based on the Theory of Planned Behaviour.

PubMed

McNulty, Cliodna A M; Hogan, Angela H; Ricketts, Ellie J; Wallace, Louise; Oliver, Isabel; Campbell, Rona; Kalwij, Sebastian; O'Connell, Elaine; Charlett, Andre

2014-05-01

To determine if a structured complex intervention increases opportunistic chlamydia screening testing of patients aged 15-24 years attending English general practitioner (GP) practices. A prospective, Cluster Randomised Controlled Trial with a modified Zelen design involving 160 practices in South West England in 2010. The intervention was based on the Theory of Planned Behaviour (TPB). It comprised of practice-based education with up to two additional contacts to increase the importance of screening to GP staff and their confidence to offer tests through skill development (including videos). Practical resources (targets, posters, invitation cards, computer reminders, newsletters including feedback) aimed to actively influence social cognitions of staff, increasing their testing intention. Data from 76 intervention and 81 control practices were analysed. In intervention practices, chlamydia screening test rates were 2.43/100 15-24-year-olds registered preintervention, 4.34 during intervention and 3.46 postintervention; controls testing rates were 2.61/100 registered patients prior intervention, 3.0 during intervention and 2.82 postintervention. During the intervention period, testing in intervention practices was 1.76 times as great (CI 1.24 to 2.48) as controls; this persisted for 9 months postintervention (1.57 times as great, CI 1.27 to 2.30). Chlamydia infections detected increased in intervention practices from 2.1/1000 registered 15-24-year-olds prior intervention to 2.5 during the intervention compared with 2.0 and 2.3/1000 in controls (Estimated Rate Ratio intervention versus controls 1.4 (CI 1.01 to 1.93). This complex intervention doubled chlamydia screening tests in fully engaged practices. The modified Zelen design gave realistic measures of practice full engagement (63%) and efficacy of this educational intervention in general practice; it should be used more often. The trial was registered on the UK Clinical Research Network Study Portfolio database. UKCRN number 9722.

Improving the care for people with acute low-back pain by allied health professionals (the ALIGN trial): A cluster randomised trial protocol

PubMed Central

2010-01-01

Background Variability between clinical practice guideline recommendations and actual clinical practice exists in many areas of health care. A 2004 systematic review examining the effectiveness of guideline implementation interventions concluded there was a lack of evidence to support decisions about effective interventions to promote the uptake of guidelines. Further, the review recommended the use of theory in the development of implementation interventions. A clinical practice guideline for the management of acute low-back pain has been developed in Australia (2003). Acute low-back pain is a common condition, has a high burden, and there is some indication of an evidence-practice gap in the allied health setting. This provides an opportunity to develop and test a theory-based implementation intervention which, if effective, may provide benefits for patients with this condition. Aims This study aims to estimate the effectiveness of a theory-based intervention to increase allied health practitioners' (physiotherapists and chiropractors in Victoria, Australia) compliance with a clinical practice guideline for acute non-specific low back pain (LBP), compared with providing practitioners with a printed copy of the guideline. Specifically, our primary objectives are to establish if the intervention is effective in reducing the percentage of acute non-specific LBP patients who are either referred for or receive an x-ray, and improving mean level of disability for patients three months post-onset of acute LBP. Methods The design of the study is a cluster randomised trial. Restricted randomisation was used to randomise 210 practices (clusters) to an intervention or control group. Practitioners in the control group received a printed copy of the guideline. Practitioners in the intervention group received a theory-based intervention developed to address prospectively identified barriers to practitioner compliance with the guideline. The intervention primarily consisted of an educational symposium. Patients aged 18 years or older who visit a participating practitioner for acute non-specific LBP of less than three months duration over a two-week data collection period, three months post the intervention symposia, are eligible for inclusion. Sample size calculations are based on recruiting between 15 to 40 patients per practice. Outcome assessors will be blinded to group allocation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12609001022257 (date registered 25th November 2009) PMID:21067614

Recruitment of patients into head and neck clinical trials: acceptability of studies to patients from perspective of the research team.

PubMed

Ho, M W; Pick, A S; Sutton, D N; Dyker, K; Cardale, K; Gilbert, K; Johnson, J; Quantrill, J; McCaul, J A

2018-05-01

We reviewed longitudinal recruitment data to assess recruitment into head and neck cancer trials, and to identify factors that could influence this and affect their acceptability to patients. We retrieved data from the prospective computerised database (2009-2016) to measure acceptability to patients using the recruitment:screening ratio, and compared observational with interventional studies, single specialty (or site) with multispecialty (or site) studies, and "step-up" randomisation with "non-inferiority" randomisation designs. A total of 1283 patients were screened and 583 recruited. The recruitment:screening ratio for all National Institute for Health Research (NIHR) portfolio studies combined was 0.47 (486/1133). Studies that involved treatment by several specialties or at several sites had a significantly adverse impact on acceptability (p=0.01). Recruitment into non-inferiority randomised controlled studies was lower than that into step-up randomised studies (p=0.06). The complexity of a study's design did not compromise recruitment. Treatment across several specialties or several sites and perceived non-inferiority designs, reduced the acceptability of some trials. Crown Copyright © 2018. Published by Elsevier Ltd. All rights reserved.

A EUropean study on effectiveness and sustainability of current Cardiac Rehabilitation programmes in the Elderly: Design of the EU-CaRE randomised controlled trial.

PubMed

Prescott, Eva; Meindersma, Esther P; van der Velde, Astrid E; Gonzalez-Juanatey, Jose R; Iliou, Marie Christine; Ardissino, Diego; Zoccai, Giuseppe Biondi; Zeymer, Uwe; Prins, Leonie F; Van't Hof, Arnoud Wj; Wilhelm, Matthias; de Kluiver, Ed P

2016-10-01

Cardiac rehabilitation (CR) is an evidence-based intervention to increase survival and quality of life. Yet studies consistently show that elderly patients are less frequently referred to CR, show less uptake and more often drop out of CR programmes. The European study on effectiveness and sustainability of current cardiac rehabilitation programmes in the elderly (EU-CaRE) project consists of an observational study and an open prospective, investigator-initiated multicentre randomised controlled trial (RCT) involving mobile telemonitoring guided CR (mCR). The aim of EU-CaRE is to map the efficiency of current CR of the elderly in Europe, and to investigate whether mCR is an effective alternative in terms of efficacy, adherence and sustainability. The EU-CaRE study includes patients aged 65 years or older with ischaemic heart disease or who have undergone heart valve surgery. A total of 1760 patients participating in existing CR programmes in eight regions of Europe will be included. Of patients declining regular CR, 238 will be included in the RCT and randomised in two study arms. The experimental group (mCR) will receive a personalised home-based programme while the control group will receive no advice or coaching throughout the study period. Outcomes will be assessed after the end of CR and at 12 months follow-up. The primary outcome is VO 2peak and secondary outcomes include variables describing CR uptake, adherence, efficacy and sustainability. The study will provide important information to improve CR in the elderly. The EU-CaRE RCT is the first European multicentre study of mCR as an alternative for elderly patients not attending usual CR. © The European Society of Cardiology 2016.

Evaluation of a new chest tube removal protocol using digital air leak monitoring after lobectomy: a prospective randomised trial.

PubMed

Brunelli, Alessandro; Salati, Michele; Refai, Majed; Di Nunzio, Luca; Xiumé, Francesco; Sabbatini, Armando

2010-01-01

The objective of this randomised trial was to assess the effectiveness of a new fast-track chest tube removal protocol taking advantage of digital monitoring of air leak compared to a traditional protocol using visual and subjective assessment of air leak (bubbles). One hundred and sixty-six patients submitted to pulmonary lobectomy for lung cancer were randomised in two groups with different chest tube removal protocols: (1) in the new protocol, chest tube was removed based on digitally recorded measurements of air leak flow; (2) in the traditional protocol, the chest tube removal was based on an instantaneous assessment of air leak during daily rounds. The two groups were compared in terms of chest tube duration, hospital stay and costs. The two groups were well matched for several preoperative and operative variables. Compared to the traditional protocol, the new digital recording protocol showed mean reductions in chest tube duration (p=0.0007), hospital stay (p=0.007) of 0.9 day, and a mean cost saving of euro 476 per patient (p=0.008). In the new chest tube removal protocol, 51% of patients had their chest tube removed by the second postoperative day versus only 12% of those in the traditional protocol. The application of a chest tube removal protocol using a digital drainage unit featuring a continuous recording of air leak was safe and cost effective. Although future studies are warranted to confirm these results in other settings, the use of this new protocol is now routinely applied in our practice. Copyright 2009 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

Fibrinogen concentrate as a treatment for postpartum haemorrhage-induced coagulopathy: A study protocol for a randomised multicentre controlled trial. The fibrinogen in haemorrhage of DELivery (FIDEL) trial.

PubMed

Ducloy-Bouthors, Anne-Sophie; Mignon, Alexandre; Huissoud, Cyril; Grouin, Jean-Marie; Mercier, Frédéric J

2016-08-01

Postpartum haemorrhage (PPH) remains the leading cause for maternal mortality worldwide. Hypofibrinogenaemia has been identified as a major risk factor for progress towards severe PPH. The efficacy of fibrinogen concentrate supplementation in PPH has been shown in various clinical settings but the level of evidence is not sufficient to prove the benefit, evaluate the risks, and determine the value, timing and dose of fibrinogen supplementation in PPH. The FIDEL trial objective is to evaluate the impact of a therapeutic strategy based on the early administration of human fibrinogen concentrate compared to the current practice based on late administration in severe PPH patients requiring second line uterotonics. This is a prospective multicentre, randomised, double-blind, placebo-controlled trial. A total of 412 patients will be randomised if they meet the following criteria: female patients≥18 years old, vaginal delivery, PPH requiring IV administration of prostaglandins (sulprostone) after 20 to 30minutes of oxytocin failure. The participants are assigned to receive either fibrinogen 3g or placebo infusions. The primary endpoint is a composite endpoint defined as the percentage of patients losing at least 4g/dL of Hb, and/or requiring a transfusion of at least 2 units of packed red blood cells, within the 48hours following fibrinogen administration. The purpose of this study is to demonstrate the efficacy and safety of an early fibrinogen concentrate infusion in uncontrolled active PPH. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers.

PubMed

Zelen, Charles M; Serena, Thomas E; Denoziere, Guilhem; Fetterolf, Donald E

2013-10-01

Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32.0% ± 47.3% versus 97.1% ± 7.0% (P < 0.001) after 4 weeks, whereas at 6 weeks wounds were reduced by -1.8% ± 70.3% versus 98.4% ± 5.8% (P < 0.001), standard care versus EpiFix, respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds (P < 0.001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing. ©2013 The Authors. International Wound Journal published by John Wiley & Sons Ltd and Medicalhelplines.com Inc.

Comparing the effectiveness of video self-instruction versus traditional classroom instruction targeted at cardiopulmonary resuscitation skills for laypersons: a prospective randomised controlled trial.

PubMed

Chung, C H; Siu, Axel Y C; Po, Lucia L K; Lam, C Y; Wong, Peter C Y

2010-06-01

To determine whether in the local lay Hong Kong population, video self-instruction about cardiopulmonary resuscitation has comparable results to traditional classroom instructions. Prospective randomised single-blind controlled trial. A first-aid training organisation in Hong Kong. Cantonese applicants for cardiopulmonary resuscitation courses aged between 18 and 70 years were recruited into the study. They were randomised into two groups. Those selected for self-learning were given a kit (consisting of a mini-manikin, a video compact disc, and an instruction manual) and sent home. The other group underwent usual classroom training. Both groups were examined together; the examiners remained blinded to the background training of the subjects. Those who passed were asked to come back for re-examination after 1 year. The examination passing rates initially and after 1 year. During a 1-year period between 1 April 2007 to 31 March 2008, 256 subjects were recruited into this study, 124 for self-learning and 132 for classroom training. The age range was 18 to 62 (mean, 39; standard deviation, 10) years. There was no significant difference in passing rate between the two groups at the initial examination or at the re-examination after 1 year. Notably, 28 (23%) of the participants of the self-learning group taught cardiopulmonary resuscitation to relatives and friends. Video self-learning resulted in cardiopulmonary resuscitation performance as good as traditional classroom training.

Intracameral bevacizumab as an adjunct to trabeculectomy: a 1-year prospective, randomised study.

PubMed

Vandewalle, Evelien; Abegão Pinto, Luís; Van Bergen, Tine; Spielberg, Leigh; Fieuws, Steffen; Moons, Lieve; Spileers, Werner; Zeyen, Thierry; Stalmans, Ingeborg

2014-01-01

To investigate the efficacy and safety of a single intracameral bevacizumab injection to improve the outcome of trabeculectomy. A 12-month, prospective, randomised, double-masked, placebo-controlled trial. Patients with medically uncontrolled open-angle glaucoma scheduled for a primary trabeculectomy were recruited and randomised to receive 50 µL of either bevacizumab (1.25 mg) or placebo (balanced salt solution) peroperatively. Absolute success was defined as intraocular pressure (IOP) ≤18 mm Hg and >5 mm Hg with at least 30% reduction from baseline and no loss of light perception. Success through the use of additional medical and/or surgical IOP-lowering treatments was defined as qualified success. 138 patients completed a 12-month follow-up, 69 of whom were in the bevacizumab treated group. IOP at 1 year postoperatively was significantly lower than baseline (placebo: 25.6±9.9 mm Hg vs 11.5±3.9 mm Hg, p<0.01; bevacizumab: 24.8±8.1 mm Hg vs 11.9±3.8 mm Hg, p<0.01), with no difference between treatment groups (p=0.69). However, absolute success was higher in the bevacizumab group (71% vs 51%, p=0.02), with the need for IOP-lowering interventions (needlings) being lower in this group (12% vs 33%, p=0.003). Complication rates were low and comparable between groups. Peroperative administration of intracameral bevacizumab significantly reduces the need for additional interventions during the follow-up of patients undergoing trabeculectomy.

A randomised trial of high and low pressure level settings on an adjustable ventriculoperitoneal shunt valve for idiopathic normal pressure hydrocephalus: results of the Dutch evaluation programme Strata shunt (DEPSS) trial.

PubMed

Delwel, Ernst J; de Jong, Dirk A; Dammers, Ruben; Kurt, Erkan; van den Brink, Wimar; Dirven, Clemens M F

2013-07-01

In treating idiopathic normal pressure hydrocephalus (INPH) with a shunt there is always a risk of underdrainage or overdrainage. The hypothesis is tested whether patients treated using an adjustable valve preset at the highest opening pressure leads to comparable good clinical results with less subdural effusions than in a control group with an opening pressure preset at a low pressure level. A multicentre prospective randomised trial was performed on a total of 58 patients suspected of INPH. Thirty patients were assigned to (control) group 1 and received a Strata shunt (Medtronic, Goleta, USA) with the valve preset at a performance level (PL) of 1.0, while 28 patients were assigned to group 2 and received a Strata shunt with the valve preset at PL 2.5. In this group the PL was allowed to be lowered until improvement or radiological signs of overdrainage were met. Significantly more subdural effusions were observed in the improved patients of group 1. There was no statistically significant difference in improvement between both groups overall. On the basis of this multicentre prospective randomised trial it is to be recommended to treat patients with INPH with a shunt with an adjustable valve, preset at the highest opening pressure and lowered until clinical improvement or radiological signs of overdrainage occur although slower improvement and more shunt adjustments might be the consequence.

Randomised trials in context: practical problems and social aspects of evidence-based medicine and policy.

PubMed

Pearce, Warren; Raman, Sujatha; Turner, Andrew

2015-09-01

Randomised trials can provide excellent evidence of treatment benefit in medicine. Over the last 50 years, they have been cemented in the regulatory requirements for the approval of new treatments. Randomised trials make up a large and seemingly high-quality proportion of the medical evidence-base. However, it has also been acknowledged that a distorted evidence-base places a severe limitation on the practice of evidence-based medicine (EBM). We describe four important ways in which the evidence from randomised trials is limited or partial: the problem of applying results, the problem of bias in the conduct of randomised trials, the problem of conducting the wrong trials and the problem of conducting the right trials the wrong way. These problems are not intrinsic to the method of randomised trials or the EBM philosophy of evidence; nevertheless, they are genuine problems that undermine the evidence that randomised trials provide for decision-making and therefore undermine EBM in practice. Finally, we discuss the social dimensions of these problems and how they highlight the indispensable role of judgement when generating and using evidence for medicine. This is the paradox of randomised trial evidence: the trials open up expert judgment to scrutiny, but this scrutiny in turn requires further expertise.

[Estimation of forest canopy chlorophyll content based on PROSPECT and SAIL models].

PubMed

Yang, Xi-guang; Fan, Wen-yi; Yu, Ying

2010-11-01

The forest canopy chlorophyll content directly reflects the health and stress of forest. The accurate estimation of the forest canopy chlorophyll content is a significant foundation for researching forest ecosystem cycle models. In the present paper, the inversion of the forest canopy chlorophyll content was based on PROSPECT and SAIL models from the physical mechanism angle. First, leaf spectrum and canopy spectrum were simulated by PROSPECT and SAIL models respectively. And leaf chlorophyll content look-up-table was established for leaf chlorophyll content retrieval. Then leaf chlorophyll content was converted into canopy chlorophyll content by Leaf Area Index (LAD). Finally, canopy chlorophyll content was estimated from Hyperion image. The results indicated that the main effect bands of chlorophyll content were 400-900 nm, the simulation of leaf and canopy spectrum by PROSPECT and SAIL models fit better with the measured spectrum with 7.06% and 16.49% relative error respectively, the RMSE of LAI inversion was 0. 542 6 and the forest canopy chlorophyll content was estimated better by PROSPECT and SAIL models with precision = 77.02%.

Analgesia after feline ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia with buprenorphine or butorphanol, and carprofen or meloxicam: a prospective, randomised clinical trial.

PubMed

Polson, Sally; Taylor, Polly M; Yates, David

2012-08-01

One hundred female cats undergoing routine ovariohysterectomy under midazolam-medetomidine-ketamine anaesthesia were included in a blinded, randomised, prospective clinical study to compare postoperative analgesia produced by four analgesic drug combinations given preoperatively (n = 25 per group). A secondary aim was to assess the effects in kittens and pregnant animals. Buprenorphine 180 µg/m(2) or butorphanol 6 mg/m(2) were given with either carprofen 4 mg/kg (groups BUPC and BUTC, respectively) or meloxicam 0.3 mg/kg (groups BUPM or BUTM, respectively). Medetomidine was not antagonised. A simple, descriptive scale (SDS; 0-4), a dynamic and interactive visual analogue scale (DIVAS; 0-100 mm) and mechanical nociceptive thresholds (MT; 2.5-mm diameter probe) were used to evaluate postoperative pain. All pain scores were low (DIVAS <10 mm, SDS <2 and MT >10 N) and there were no significant differences between the groups. It was concluded that all protocols provided adequate analgesia and when used with midazolam-medetomidine-ketamine are effective for routine feline ovariohysterectomy.

Prospective, randomised, controlled trial comparing suture needle drainage and argon laser drainage of subretinal fluid.

PubMed Central

Aylward, G W; Orr, G; Schwartz, S D; Leaver, P K

1995-01-01

AIMS--This study was designed to compare suture needle drainage (SND) with argon laser drainage (ALD) of subretinal fluid. METHODS--A prospective, randomised, controlled, clinical trial was carried out on 93 patients undergoing external drainage of subretinal fluid during scleral buckling surgery for rhegmatogenous retinal detachment. The incidence of successful drainage, incidence of subretinal haemorrhage, incidence of retinal incarceration, and incidence of retinal perforation were determined. RESULTS--The success rate was 97.9% in the ALD group and 84.8% in the SND group (difference-13.1%, 95% CI-26.4% to 2.0%). The incidence of clinically significant subretinal haemorrhage was 4.3% in the ALD group compared with 28.3% in the SND group (difference 24.0%, 95% CI 7.6% to 40.4%). The incidence of incarceration was comparable in each group. There were no cases of retinal perforation. CONCLUSIONS--The use of ALD was associated with a higher rate of successful SRF drainage, and a lower incidence of clinically significant subretinal haemorrhage than SND. ALD is preferred when an endolaser is available. PMID:7547781

Use of a 22-gauge Whitacre needle to reduce the incidence of side effects after lumbar myelography: a prospective randomised study comparing Whitacre and Quincke spinal needles.

PubMed

Pedersen, O N

1996-01-01

In a prospective study lumbar iohexol myelography was performed in 107 consecutive patients, randomised for lumbar puncture with a Quincke or Whitacre spinal needle. All patients answered a questionnaire about possible side effects. Data from 100 patients (58 men, 42 women) were evaluated. In the Quincke group (n = 53), 23 (43%) reported no side effects. In the 30 patients who reported various side effects, post-dural puncture headache (PDPH) occurred in 22 (42%), of whom 9 had mild, 6 moderate and 7 (13%) severe cephalalgia, 18 (34%) reported increased low back pain/sciatica, 5 nausea and 7 dizziness. In the Whitacre group (n = 47), 33 (70%) had no side effects. PDPH was reported by 9 patients (19%), of whom 2 had mild, 6 moderate and only 1 (2%) severe cephalalgia, 4 (9%) reported increased low back pain/sciatica, 5 nausea and 4 dizziness. The conclusion drawn from this study is that lumbar myelography performed with the Whitacre spinal needle reduces postspinal side effects.

Hydrophilic-coated catheters for intermittent catheterisation reduce urethral micro trauma: a prospective, randomised, participant-blinded, crossover study of three different types of catheters.

PubMed

Stensballe, J; Looms, D; Nielsen, P N; Tvede, M

2005-12-01

To compare two hydrophilic-coated (SpeediCath and LoFric and one uncoated gel-lubricated catheter (InCare Advance Plus) concerning withdrawal friction force and urethral micro trauma. 49 healthy male volunteers participated in this prospective, randomised, blinded, crossover study of three different bladder catheters. The withdrawal friction force was measured, and urine analysis of blood, nitrite and leucocytes, microbiological analysis of urine cultures and subjective evaluation of the catheters were performed. 40 participants completed the study and were included in the analysis. SpeediCath exerted a significantly lower mean withdrawal friction force and work than the gel-lubricated uncoated catheter, whereas LoFric exerted a significantly higher mean friction force than both of the other catheters. The hydrophilic catheters caused less microscopic haematuria and less pain than the gel-lubricated uncoated catheter. Furthermore, 93% of the participants preferred the hydrophilic catheters. Hydrophilic-coated catheters perform better than uncoated catheters with regard to haematuria and preference. SpeediCath, but not LoFric, exerts less withdrawal friction force than InCare Advance Plus.

Vouchers versus Lotteries: What works best in promoting Chlamydia screening? A cluster randomised controlled trial

PubMed Central

Niza, Claudia; Rudisill, Caroline; Dolan, Paul

2014-01-01

In this cluster randomised trial (N=1060), we tested the impact of financial incentives (£5 voucher vs. £200 lottery) framed as a gain or loss to promote Chlamydia screening in students aged 18–24 years, mimicking the standard outreach approach to student in halls of residence. Compared to the control group (1.5%), the lottery increased screening to 2.8% and the voucher increased screening to 22.8%. Incentives framed as gains were marginally more effective (10.5%) that loss-framed incentives (7.1%). This work fundamentally contributes to the literature by testing the predictive validity of Prospect Theory to change health behaviour in the field. PMID:25061507

Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

PubMed Central

2011-01-01

Background Breast-conserving surgery for breast cancer was developed as a method to preserve healthy breast tissue, thereby improving cosmetic outcomes. Thus far, the primary aim of breast-conserving surgery has been the achievement of tumour-free resection margins and prevention of local recurrence, whereas the cosmetic outcome has been considered less important. Large studies have reported poor cosmetic outcomes in 20-40% of patients after breast-conserving surgery, with the volume of the resected breast tissue being the major determinant. There is clear evidence for the efficacy of ultrasonography in the resection of nonpalpable tumours. Surgical resection of palpable breast cancer is performed with guidance by intra-operative palpation. These palpation-guided excisions often result in an unnecessarily wide resection of adjacent healthy breast tissue, while the rate of tumour-involved resection margins is still high. It is hypothesised that the use of intra-operative ultrasonography in the excision of palpable breast cancer will improve the ability to spare healthy breast tissue while maintaining or even improving the oncological margin status. The aim of this study is to compare ultrasound-guided surgery for palpable tumours with the standard palpation-guided surgery in terms of the extent of healthy breast tissue resection, the percentage of tumour-free margins, cosmetic outcomes and quality of life. Methods/design In this prospective multicentre randomised controlled clinical trial, 120 women who have been diagnosed with palpable early-stage (T1-2N0-1) primary invasive breast cancer and deemed suitable for breast-conserving surgery will be randomised between ultrasound-guided surgery and palpation-guided surgery. With this sample size, an expected 20% reduction of resected breast tissue and an 18% difference in tumour-free margins can be detected with a power of 80%. Secondary endpoints include cosmetic outcomes and quality of life. The rationale, study design and planned analyses are described. Conclusion The COBALT trial is a prospective, multicentre, randomised controlled study to assess the efficacy of ultrasound-guided breast-conserving surgery in patients with palpable early-stage primary invasive breast cancer in terms of the sparing of breast tissue, oncological margin status, cosmetic outcomes and quality of life. Trial Registration Number Netherlands Trial Register (NTR): NTR2579 PMID:21410949

ChemVoyage: A Web-Based, Simulated Learning Environment with Scaffolding and Linking Visualization to Conceptualization

ERIC Educational Resources Information Center

McRae, Christopher; Karuso, Peter; Liu, Fei

2012-01-01

The Web is now a standard tool for information access and dissemination in higher education. The prospect of Web-based, simulated learning platforms and technologies, however, remains underexplored. We have developed a Web-based tutorial program (ChemVoyage) for a third-year organic chemistry class on the topic of pericyclic reactions to…

Post-operative pain following coblation or monopolar electrocautery tonsillectomy in children: a prospective, single-blinded, randomised comparison.

PubMed

Parker, N P; Walner, D L

2011-10-01

To compare post-operative pain following tonsillectomy by either coblation or monopolar electrocautery in children. A parallel-designed, prospective, single-blinded, randomised trial. Ambulatory surgical facility. Eighty otherwise healthy paediatric patients undergoing coblation or electrocautery tonsillectomy by a fellowship-trained paediatric otolaryngologist. (i) The number of post-operative days with severe pain based on subjective qualification by the caretaker, (ii) post-operative days with pain rated ≥ 5 on a scale of 1-10, (iii) post-operative days requiring oral paracetamol/acetaminophen with codeine solution and (iv) post-operative days until resumption of a regular diet were assessed and recorded daily using a post-operative pain survey as a form of daily diary that was returned at the 2-week follow-up visit. Patients were consecutively enrolled into two groups of 40 patients. Average ages were 5.2 years for coblation tonsillectomy and 6.0 years for electrocautery tonsillectomy. The average number of post-operative days with severe pain was 4.2 for coblation and 5.9 for electrocautery (P = 0.006), days rating pain ≥ 5 were 3.6 for coblation and 4.8 for electrocautery (P = 0.037), days of codeine use were 2.5 for coblation and 2.9 for electrocautery (P = 0.324), and days until resumption of a regular diet were 5.2 for coblation and 6.2 for electrocautery (0.329). Coblation tonsillectomy may reduce post-operative pain and the time until resumption of a regular diet compared to electrocautery tonsillectomy. © 2011 Blackwell Publishing Ltd.

Feasibility of a prospective, randomised, open-label, international multicentre, phase III, non-inferiority trial to assess the safety of active surveillance for low risk ductal carcinoma in situ - The LORD study.

PubMed

Elshof, Lotte E; Tryfonidis, Konstantinos; Slaets, Leen; van Leeuwen-Stok, A Elise; Skinner, Victoria P; Dif, Nicolas; Pijnappel, Ruud M; Bijker, Nina; Rutgers, Emiel J Th; Wesseling, Jelle

2015-08-01

The current debate on overdiagnosis and overtreatment of screen-detected ductal carcinoma in situ (DCIS) urges the need for prospective studies to address this issue. A substantial number of DCIS lesions will never form a health hazard, particularly if it concerns non- to slow-growing low-grade DCIS. The LORD study aims to evaluate the safety of active surveillance in women with low-risk DCIS. This is a randomised, international multicentre, open-label, phase III non-inferiority trial, led by the Dutch Breast Cancer Research Group (BOOG 2014-04) and the European Organization for Research and Treatment of Cancer (EORTC-BCG 1401). Standard treatment will be compared to active surveillance in 1240 women aged ⩾ 45 years with asymptomatic, screen-detected, pure low-grade DCIS based on vacuum-assisted biopsies of microcalcifications only. Both study arms will be monitored with annual digital mammography for a period of 10 years. The primary end-point is 10-year ipsilateral invasive breast cancer free percentage. Secondary end-points include patient reported outcomes, diagnostic biopsy rate during follow-up, ipsilateral mastectomy rate and translational research. To explore interest in and feasibility of the LORD study we conducted a survey among EORTC and BOOG centres. A vast majority of EORTC and BOOG responding centres expressed interest in participation in the LORD study. The proposed study design is endorsed by nearly all centres. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

Haemodialysis-membrane biocompatibility and mortality of patients with dialysis-dependent acute renal failure: a prospective randomised multicentre trial. International Multicentre Study Group.

PubMed

Jörres, A; Gahl, G M; Dobis, C; Polenakovic, M H; Cakalaroski, K; Rutkowski, B; Kisielnicka, E; Krieter, D H; Rumpf, K W; Guenther, C; Gaus, W; Hoegel, J

1999-10-16

There is controversy as to whether haemodialysis-membrane biocompatibility (ie, the potential to activate complement and neutrophils) influences mortality of patients with acute renal failure. We did a prospective randomised multicentre trial in patients with dialysis-dependent acute renal failure treated with two different types of low-flux membrane. 180 patients with acute renal failure were randomly assigned bioincompatible Cuprophan (n=90) or polymethyl-methacrylate (n=90) membranes. The main outcome was survival 14 days after the end of therapy (treatment success). Odds ratios for survival were calculated and the two groups were compared by Fisher's exact test. Analyses were based on patients treated according to protocol (76 Cuprophan, 84 polymethyl methacrylate). At the start of dialysis, the groups did not differ significantly in age, sex, severity of illness (as calculated by APACHE II scores), prevalence of oliguria, or biochemical measures of acute renal failure. 44 patients (58% [95% CI 46-69]) assigned Cuprophan membranes and 50 patients (60% [48-70]) assigned polymethyl-methacrylate membranes survived. The odds ratio for treatment failure on Cuprophan compared with polymethyl-methacrylate membranes was 1.07 (0.54-2.11; p=0.87). No difference between Cuprophan and polymethyl-methacrylate membranes was detected when the analysis was adjusted for age and APACHE II score. 18 patients in the Cuprophan group and 20 in the polymethyl-methacrylate group had clinical complications of therapy (mainly hypotension). There were no differences in outcome for patients with dialysis-dependent acute renal failure between those treated with Cuprophan membranes and those treated with polymethyl-methacrylate membranes.

Correlation of Simulation Examination to Written Test Scores for Advanced Cardiac Life Support Testing: Prospective Cohort Study.

PubMed

Strom, Suzanne L; Anderson, Craig L; Yang, Luanna; Canales, Cecilia; Amin, Alpesh; Lotfipour, Shahram; McCoy, C Eric; Osborn, Megan Boysen; Langdorf, Mark I

2015-11-01

Traditional Advanced Cardiac Life Support (ACLS) courses are evaluated using written multiple-choice tests. High-fidelity simulation is a widely used adjunct to didactic content, and has been used in many specialties as a training resource as well as an evaluative tool. There are no data to our knowledge that compare simulation examination scores with written test scores for ACLS courses. To compare and correlate a novel high-fidelity simulation-based evaluation with traditional written testing for senior medical students in an ACLS course. We performed a prospective cohort study to determine the correlation between simulation-based evaluation and traditional written testing in a medical school simulation center. Students were tested on a standard acute coronary syndrome/ventricular fibrillation cardiac arrest scenario. Our primary outcome measure was correlation of exam results for 19 volunteer fourth-year medical students after a 32-hour ACLS-based Resuscitation Boot Camp course. Our secondary outcome was comparison of simulation-based vs. written outcome scores. The composite average score on the written evaluation was substantially higher (93.6%) than the simulation performance score (81.3%, absolute difference 12.3%, 95% CI [10.6-14.0%], p<0.00005). We found a statistically significant moderate correlation between simulation scenario test performance and traditional written testing (Pearson r=0.48, p=0.04), validating the new evaluation method. Simulation-based ACLS evaluation methods correlate with traditional written testing and demonstrate resuscitation knowledge and skills. Simulation may be a more discriminating and challenging testing method, as students scored higher on written evaluation methods compared to simulation.

On the Relationship Between Effort Toward an Ongoing Task and Cue Detection in Event-Based Prospective Memory

ERIC Educational Resources Information Center

Marsh, Richard L.; Hicks, Jason L.; Cook, Gabriel I.

2005-01-01

In recent theories of event-based prospective memory, researchers have debated what degree of resources are necessary to identify a cue as related to a previously established intention. In order to simulate natural variations in attention, the authors manipulated effort toward an ongoing cognitive task in which intention-related cues were embedded…

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

PubMed Central

Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

2006-01-01

Background Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. Methods/design A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008). Discussion As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives. PMID:16899123

Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

PubMed

Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

2006-08-09

Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy Audit and the Government's waiting list initiatives.

The use of pH adjusted lignocaine in controlling operative pain in the day surgery unit: a prospective, randomised trial.

PubMed

Fitton, A R; Ragbir, M; Milling, M A

1996-09-01

We report the results of a randomised, case matched, controlled, double blind study on 40 patients undergoing correction of their prominent ears, comparing efficacy of pH adjusted lignocaine to lignocaine alone in controlling operative pain. Each patient received commercial lignocaine in one ear and the same preparation reconstituted with 1 ml of 8.4% sodium bicarbonate in the other ear according to our randomisation protocol. 30 patients were studied to compare the difference between the buffered and commercial preparation infiltrated at room temperature. A further 10 patients were studied to assess the benefit the buffered preparation at room temperature had over commercial lignocaine warmed to body temperature. Linear analogue pain scores for discomfort at infiltration and during the operation itself were analysed. Buffered lignocaine imparts a significant reduction in pain on infiltration, compared to the commercial preparation at both room and body temperature. Both preparations were equally effective in obliterating pain during the operation itself.

The effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D: a prospective randomised trial.

PubMed

Haines, N; Kempton, L B; Seymour, R B; Bosse, M J; Churchill, C; Hand, K; Hsu, J R; Keil, D; Kellam, J; Rozario, N; Sims, S; Karunakar, M A

2017-11-01

To evaluate the effect of a single early high-dose vitamin D supplement on fracture union in patients with hypovitaminosis D and a long bone fracture. Between July 2011 and August 2013, 113 adults with a long bone fracture were enrolled in a prospective randomised double-blind placebo-controlled trial. Their serum vitamin D levels were measured and a total of 100 patients were found to be vitamin D deficient (< 20 ng/ml) or insufficient (< 30 ng/mL). These were then randomised to receive a single dose of vitamin D 3 orally (100 000 IU) within two weeks of injury (treatment group, n = 50) or a placebo (control group, n = 50). We recorded patient demographics, fracture location and treatment, vitamin D level, time to fracture union and complications, including vitamin D toxicity. Outcomes included union, nonunion or complication requiring an early, unplanned secondary procedure. Patients without an outcome at 15 months and no scheduled follow-up were considered lost to follow-up. The t -test and cross tabulations verified the adequacy of randomisation. An intention-to-treat analysis was carried out. In all, 100 (89%) patients had hypovitaminosis D. Both treatment and control groups had similar demographics and injury characteristics. The initial median vitamin D levels were 16 ng/mL (interquartile range 5 to 28) in both groups (p = 0.885). A total of 14 patients were lost to follow-up (seven from each group), two had fixation failure (one in each group) and one control group patient developed an infection. Overall, the nonunion rate was 4% (two per group). No patient showed signs of clinical toxicity from their supplement. Despite finding a high level of hypovitaminosis D, the rate of union was high and independent of supplementation with vitamin D 3 . Cite this article: Bone Joint J 2017;99-B:1520-5. ©2017 The British Editorial Society of Bone & Joint Surgery.

Study protocol for a randomised controlled double-blinded trial of the dose-dependent efficacy and safety of primaquine for clearance of gametocytes in children with uncomplicated falciparum malaria in Uganda.

PubMed

Eziefula, Alice Chijioke; Staedke, Sarah G; Yeung, Shunmay; Webb, Emily; Kamya, Moses; White, Nicholas J; Bousema, Teun; Drakeley, Chris

2013-03-26

For the purpose of blocking transmission of Plasmodium falciparum malaria from humans to mosquitoes, a single dose of primaquine is recommended by the WHO as an addition to artemisinin combination therapy. Primaquine clears gametocytes but causes dose-dependent haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Evidence is needed to inform the optimal dosing of primaquine for malaria elimination programmes and for the purpose of interrupting the spread of artemisinin-resistant malaria. This study investigates the efficacy and safety of reducing doses of primaquine for clearance of gametocytes in participants with normal G6PD status. In this prospective, four-armed randomised placebo-controlled double-blinded trial, children aged 1-10 years, weighing over 10 kg, with haemoglobin ≥8 g/dl and uncomplicated P falciparum malaria are treated with artemether lumefantrine and randomised to receive a dose of primaquine (0.1, 0.4 or 0.75 mg base/kg) or placebo on the third day of treatment. Participants are followed up for 28 days. Gametocytaemia is measured by quantitative nucleic acid sequence-based analysis on days 0, 2, 3, 7, 10 and 14 with a primary endpoint of the number of days to gametocyte clearance in each treatment arm and secondarily the area under the curve of gametocyte density over time. Analysis is for non-inferiority of efficacy compared to the reference dose, 0.75 mg base/kg. Safety is assessed by pair-wise comparisons of the arithmetic mean (±SD) change in haemoglobin concentration per treatment arm and analysed for superiority to placebo and incidence of adverse events. Ethics and dissemination Approval was obtained from the ethical committees of Makerere University School of Medicine, the Ugandan National Council of Science and Technology and the London School of Hygiene and Tropical Medicine. These will be disseminated to inform malaria elimination policy, through peer-reviewed publication and academic presentations.

A randomised controlled trial of an online menu planning intervention to improve childcare service adherence to dietary guidelines: a study protocol

PubMed Central

Yoong, Sze Lin; Grady, Alice; Wiggers, John; Flood, Victoria; Rissel, Chris; Finch, Meghan; Searles, Andrew; Salajan, David; O’Rourke, Ruby; Daly, Jaqueline; Gilham, Karen; Stacey, Fiona; Fielding, Alison; Pond, Nicole; Wyse, Rebecca; Seward, Kirsty; Wolfenden, Luke

2017-01-01

Introduction The implementation of dietary guidelines in childcare settings is recommended to improve child public health nutrition. However, foods provided in childcare services are not consistent with guidelines. The primary aim of the trial is to assess the effectiveness of a web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines regarding food provision to children in care. Methods and analysis A parallel group randomised controlled trial will be undertaken with 54 childcare services that provide food to children within New South Wales, Australia. Services will be randomised to a 12-month intervention or usual care. The experimental group will receive access to a web-based menu planning and decision support tool and online resources. To support uptake of the web program, services will be provided with training and follow-up support. The primary outcome will be the number of food groups, out of 6 (vegetables, fruit, breads and cereals, meat, dairy and ‘discretionary’), on the menu that meet dietary guidelines (Caring for Children) across a 1-week menu at 12-month follow-up, assessed via menu review by dietitians or nutritionists blinded to group allocation. A nested evaluation of child dietary intake in care and child body mass index will be undertaken in up to 35 randomly selected childcare services and up to 420 children aged approximately 3–6 years. Ethics and dissemination Ethical approval has been provided by Hunter New England and University of Newcastle Human Research Ethics Committees. This research will provide high-quality evidence regarding the impact of a web-based menu planning intervention in facilitating the translation of dietary guidelines into childcare services. Trial findings will be disseminated widely through national and international peer-reviewed publications and conference presentations. Trial registration Prospectively registered with Australian New Zealand Clinical Trial Registry (ANZCTR) ACTRN12616000974404. PMID:28893755

The effect of stent coating on stent deliverability: direct randomised comparison of drug eluting and bare metal stents using the same stent platform.

PubMed

Siminiak, Tomasz; Link, Rafał; Wołoszyn, Maciej; Kałmucki, Piotr; Baszko, Artur

2012-01-01

There is certain experimental and clinical evidence indicating that the covering of bare metal stents (BMS) with drug eluting polymers to produce drug eluting stents (DES) results in increased stent stiffness and modifies the mechanical properties of the stent platform. In addition, it has been speculated that the mechanical performance of DES, compared to BMS, may be related to the type of polymer used to cover stents. We aimed at evaluating the deliverability of DES with a lactate based biodegradable polymer and BMS in patients with stable coronary artery disease in a prospective randomised study. One hundred eleven consecutive patients (age: 36-77, mean 58.8 years) scheduled for routine angioplasty due to stable coronary disease were randomised to receive BMS (Chopin II(TM), Balton, Poland) or paclitaxel eluting stent (Chopin Luc(TM), Balton, Poland) using the same metal platform. Only patients scheduled for angioplasty using the direct implantation technique of a single stent were randomised. The exclusion criteria included patients 〉 80 years, multivessel disease and reference diameter of the target vessel 〉 3.5 mm. In the BMS group (n = 55; 35 males and 20 females), the mean diameter of implanted stents was 3.09 ± 0.40 and the mean length was 11.37 ± 2.80, whereas in the DES group (n = 56; 34 males and 22 females) the mean stent sizes were 3.02 ± 0.34 and 17.90 ± 7.38 mm, respectively (p 〉 0.05 for length). The groups did not significantly differ regarding the frequency of stent implantation to particular coronary vessels. The direct stenting technique was attempted and failed, leading to the stents' implantation after predilatation in five patients in the BMS group and six patients in the DES group. Failure of stent implantation and subsequent implantation of another stent type was observed in no BMS patients and in one DES patient (NS). Although stent covering with lactate based drug eluting polymer may increase its stiffness, it does not affect its deliverability in patients with stable coronary disease.

Serious game versus online course for pretraining medical students before a simulation-based mastery learning course on cardiopulmonary resuscitation: A randomised controlled study.

PubMed

Drummond, David; Delval, Paul; Abdenouri, Sonia; Truchot, Jennifer; Ceccaldi, Pierre-François; Plaisance, Patrick; Hadchouel, Alice; Tesnière, Antoine

2017-12-01

Although both recorded lectures and serious games have been used to pretrain health professionals before simulation training on cardiopulmonary resuscitation, they have never been compared. The aim of this study was to compare an online course and a serious game for pretraining medical students before simulation-based mastery learning on the management of sudden cardiac arrest. A randomised controlled trial. Participants were pretrained using the online course or the serious game on day 1 and day 7. On day 8, each participant was evaluated repeatedly on a scenario of cardiac arrest until reaching a minimum passing score. Department of Simulation in Healthcare in a French medical faculty. Eighty-two volunteer second-year medical students participated between June and October 2016 and 79 were assessed for primary outcome. The serious game used was Staying Alive, which involved a 3D realistic environment, and the online course involved a PowerPoint lecture. The median total training time needed for students to reach the minimum passing score on day 8. This same outcome was also assessed 4 months later. The median training time (interquartile range) necessary for students to reach the minimum passing score was similar between the two groups: 20.5 (15.8 to 30.3) minutes in the serious game group versus 23 (15 to 32) minutes in the online course group, P = 0.51. Achieving an appropriate degree of chest compression was the most difficult requirement to fulfil for students in both groups. Four months later, the median training time decreased significantly in both groups, but no correlation was found at an individual level with the training times observed on day 8. The serious game used in this study was not superior to an online course to pretrain medical students in the management of a cardiac arrest. The absence of any correlation between the performances of students evaluated during two training sessions separated by 4 months suggests that some elements in the management of cardiac arrest such as compression depth can only be partially learned and retained after a simulation-based training. ClinicalTrials.gov-NCT02758119.

A pilot study to assess the utility of a freely downloadable mobile application simulator for undergraduate clinical skills training: a single-blinded, randomised controlled trial.

PubMed

Bartlett, Richard D; Radenkovic, Dina; Mitrasinovic, Stefan; Cole, Andrew; Pavkovic, Iva; Denn, Peyton Cheong Phey; Hussain, Mahrukh; Kogler, Magdalena; Koutsopodioti, Natalia; Uddin, Wasima; Beckley, Ivan; Abubakar, Hana; Gill, Deborah; Smith, Daron

2017-12-11

Medical simulators offer an invaluable educational resource for medical trainees. However, owing to cost and portability restrictions, they have traditionally been limited to simulation centres. With the advent of sophisticated mobile technology, simulators have become cheaper and more accessible. Touch Surgery is one such freely downloadable mobile application simulator (MAS) used by over one million healthcare professionals worldwide. Nevertheless, to date, it has never been formally validated as an adjunct in undergraduate medical education. Medical students in the final 3 years of their programme were recruited and randomised to one of three revision interventions: 1) no formal revision resources, 2) traditional revision resources, or 3) MAS. Students completed pre-test questionnaires and were then assessed on their ability to complete an undisclosed male urinary catheterisation scenario. Following a one-hour quarantined revision period, all students repeated the scenario. Both attempts were scored by allocation-blinded examiners against an objective 46-point mark scheme. A total of 27 medical students were randomised (n = 9 per group). Mean scores improved between baseline and post-revision attempts by 8.7% (p = 0.003), 19.8% (p = 0.0001), and 15.9% (p = 0.001) for no resources, traditional resources, and MAS, respectively. However, when comparing mean score improvements between groups there were no significant differences. Mobile simulators offer an unconventional, yet potentially useful adjunct to enhance undergraduate clinical skills education. Our results indicate that MAS's perform comparably to current gold-standard revision resources; however, they may confer significant advantages in terms of cost-effectiveness and practice flexibility. Not applicable.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

PubMed

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

PubMed Central

Eichhorn, Eric J; Bristow, Michael R

2001-01-01

Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

An imbalance in cluster sizes does not lead to notable loss of power in cross-sectional, stepped-wedge cluster randomised trials with a continuous outcome.

PubMed

Kristunas, Caroline A; Smith, Karen L; Gray, Laura J

2017-03-07

The current methodology for sample size calculations for stepped-wedge cluster randomised trials (SW-CRTs) is based on the assumption of equal cluster sizes. However, as is often the case in cluster randomised trials (CRTs), the clusters in SW-CRTs are likely to vary in size, which in other designs of CRT leads to a reduction in power. The effect of an imbalance in cluster size on the power of SW-CRTs has not previously been reported, nor what an appropriate adjustment to the sample size calculation should be to allow for any imbalance. We aimed to assess the impact of an imbalance in cluster size on the power of a cross-sectional SW-CRT and recommend a method for calculating the sample size of a SW-CRT when there is an imbalance in cluster size. The effect of varying degrees of imbalance in cluster size on the power of SW-CRTs was investigated using simulations. The sample size was calculated using both the standard method and two proposed adjusted design effects (DEs), based on those suggested for CRTs with unequal cluster sizes. The data were analysed using generalised estimating equations with an exchangeable correlation matrix and robust standard errors. An imbalance in cluster size was not found to have a notable effect on the power of SW-CRTs. The two proposed adjusted DEs resulted in trials that were generally considerably over-powered. We recommend that the standard method of sample size calculation for SW-CRTs be used, provided that the assumptions of the method hold. However, it would be beneficial to investigate, through simulation, what effect the maximum likely amount of inequality in cluster sizes would be on the power of the trial and whether any inflation of the sample size would be required.

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial.

PubMed

Emmett, Christopher; Close, Helen; Mason, James; Taheri, Shiva; Stevens, Natasha; Eldridge, Sandra; Norton, Christine; Knowles, Charles; Yiannakou, Yan

2017-03-31

Constipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK GP consultations per annum. The effect of symptoms on measured quality of life (QOL) is significant, and CC consumes significant health care resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation. Trans-anal irrigation therapy has become a widely used treatment despite a lack of robust efficacy data to support its use. The long-term outcome of treatment is also unclear. A randomised comparison of two different methods of irrigation (high- and low-volume) will provide valuable evidence of superiority of one system over the other, as well as providing efficacy data for the treatment as a whole. Participants will be recruited based on predetermined eligibility criteria. Following informed consent, they will be randomised to either high-volume (HV) or low-volume (LV) irrigation and undergo standardised radiological and physiological investigations. Following training, they will commence home irrigation with the allocated device. Data will be collected at 1, 3, 6 and 12 months according to a standardised outcomes framework. The primary outcome is PAC-QOL, measured at 3 months. The study is powered to detect a 10% difference in outcome between systems at 3 months; this means that 300 patients will need to be recruited. This study will be the first randomised comparison of two different methods of trans-anal irrigation. It will also be the largest prospective study of CC patients treated with irrigation. It will provide evidence for the effectiveness of irrigation in the treatment of CC, as well as the comparative effectiveness of the two methods. This will enable more cost-effective and evidence-based use of irrigation. Also, the results will be combined with the other studies in the CapaCiTY programme to generate an evidence-based treatment algorithm for CC in adults. ISRCTN, identifier: ISRCTN11093872 . Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).

Accelerating clinical development of HIV vaccine strategies: methodological challenges and considerations in constructing an optimised multi-arm phase I/II trial design.

PubMed

Richert, Laura; Doussau, Adélaïde; Lelièvre, Jean-Daniel; Arnold, Vincent; Rieux, Véronique; Bouakane, Amel; Lévy, Yves; Chêne, Geneviève; Thiébaut, Rodolphe

2014-02-26

Many candidate vaccine strategies against human immunodeficiency virus (HIV) infection are under study, but their clinical development is lengthy and iterative. To accelerate HIV vaccine development optimised trial designs are needed. We propose a randomised multi-arm phase I/II design for early stage development of several vaccine strategies, aiming at rapidly discarding those that are unsafe or non-immunogenic. We explored early stage designs to evaluate both the safety and the immunogenicity of four heterologous prime-boost HIV vaccine strategies in parallel. One of the vaccines used as a prime and boost in the different strategies (vaccine 1) has yet to be tested in humans, thus requiring a phase I safety evaluation. However, its toxicity risk is considered minimal based on data from similar vaccines. We newly adapted a randomised phase II trial by integrating an early safety decision rule, emulating that of a phase I study. We evaluated the operating characteristics of the proposed design in simulation studies with either a fixed-sample frequentist or a continuous Bayesian safety decision rule and projected timelines for the trial. We propose a randomised four-arm phase I/II design with two independent binary endpoints for safety and immunogenicity. Immunogenicity evaluation at trial end is based on a single-stage Fleming design per arm, comparing the observed proportion of responders in an immunogenicity screening assay to an unacceptably low proportion, without direct comparisons between arms. Randomisation limits heterogeneity in volunteer characteristics between arms. To avoid exposure of additional participants to an unsafe vaccine during the vaccine boost phase, an early safety decision rule is imposed on the arm starting with vaccine 1 injections. In simulations of the design with either decision rule, the risks of erroneous conclusions were controlled <15%. Flexibility in trial conduct is greater with the continuous Bayesian rule. A 12-month gain in timelines is expected by this optimised design. Other existing designs such as bivariate or seamless phase I/II designs did not offer a clear-cut alternative. By combining phase I and phase II evaluations in a multi-arm trial, the proposed optimised design allows for accelerating early stage clinical development of HIV vaccine strategies.

Lack of effect of nitrates on exercise tolerance in patients with mild to moderate heart failure caused by coronary disease already treated with captopril.

PubMed

Wieshammer, S; Hetzel, M; Hetzel, J; Kochs, M; Hombach, V

1993-07-01

To test the hypothesis that the addition of nitrates improves exercise tolerance in patients with heart failure caused by coronary artery disease already treated with an angiotensin converting enzyme inhibitor and diuretics. Randomised, double blind, placebo controlled, 16 week treatment periods. Outpatient clinic at a university hospital. 54 patients with previous myocardial infarction, symptoms of mild to moderate heart failure, left ventricular ejection fraction below 40%, no exercise-induced angina or electrocardiographic signs of ischaemia. Four patients in the nitrate group (n = 24) and one patient of the placebo group (n = 25) were withdrawn from the study. After the patients had been on constant doses of captopril and diuretics for at least 2 weeks, they were randomised to receive a target dose of 40 mg isosorbide dinitrate twice daily or placebo in addition to the continuation of captopril and diuretics. Bicycle exercise tests with measurement of gas exchange were carried out before randomisation and after 1, 6, 12, and 16 weeks of the double blind treatment. The change in peak oxygen uptake from control to week 16 was prospectively defined as the main outcome measure. The increase in peak oxygen uptake from before randomisation tended to be greater in the placebo group (before randomisation 17.4 (3.4) ml/min/kg) than in the nitrate group (before randomisation 17.1 (3.5) ml/min/kg) after 12 weeks (mean increase 1.1 (2.7) v 0.0 (2.7) ml/min/kg, p < 0.12) and 16 weeks (1.7 (3.0) v 0.3 (2.6) ml/min/kg, p < 0.14) of treatment. The addition of nitrates to a baseline treatment consisting of captopril and diuretics did not improve exercise tolerance.

A comparison of proximal and distal Chevron osteotomy, both with lateral soft-tissue release, for moderate to severe hallux valgus in patients undergoing simultaneous bilateral correction: a prospective randomised controlled trial.

PubMed

Lee, K B; Cho, N Y; Park, H W; Seon, J K; Lee, S H

2015-02-01

Moderate to severe hallux valgus is conventionally treated by proximal metatarsal osteotomy. Several recent studies have shown that the indications for distal metatarsal osteotomy with a distal soft-tissue procedure could be extended to include moderate to severe hallux valgus. The purpose of this prospective randomised controlled trial was to compare the outcome of proximal and distal Chevron osteotomy in patients undergoing simultaneous bilateral correction of moderate to severe hallux valgus. The original study cohort consisted of 50 female patients (100 feet). Of these, four (8 feet) were excluded for lack of adequate follow-up, leaving 46 female patients (92 feet) in the study. The mean age of the patients was 53.8 years (30.1 to 62.1) and the mean duration of follow-up 40.2 months (24.1 to 80.5). After randomisation, patients underwent a proximal Chevron osteotomy on one foot and a distal Chevron osteotomy on the other. At follow-up, the American Orthopedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal interphalangeal (MTP-IP) score, patient satisfaction, post-operative complications, hallux valgus angle, first-second intermetatarsal angle, and tibial sesamoid position were similar in each group. Both procedures gave similar good clinical and radiological outcomes. This study suggests that distal Chevron osteotomy with a distal soft-tissue procedure is as effective and reliable a means of correcting moderate to severe hallux valgus as proximal Chevron osteotomy with a distal soft-tissue procedure. ©2015 The British Editorial Society of Bone & Joint Surgery.

A prospective randomised comparative parallel study of amniotic membrane wound graft in the management of diabetic foot ulcers

PubMed Central

Zelen, Charles M; Serena, Thomas E; Denoziere, Guilhem; Fetterolf, Donald E

2013-01-01

Our purpose was to compare healing characteristics of diabetic foot ulcers treated with dehydrated human amniotic membrane allografts (EpiFix®, MiMedx, Kennesaw, GA) versus standard of care. An IRB-approved, prospective, randomised, single-centre clinical trial was performed. Included were patients with a diabetic foot ulcer of at least 4-week duration without infection having adequate arterial perfusion. Patients were randomised to receive standard care alone or standard care with the addition of EpiFix. Wound size reduction and rates of complete healing after 4 and 6 weeks were evaluated. In the standard care group (n = 12) and the EpiFix group (n = 13) wounds reduced in size by a mean of 32·0% ± 47·3% versus 97·1% ± 7·0% (P < 0·001) after 4 weeks, whereas at 6 weeks wounds were reduced by −1·8% ± 70·3% versus 98·4% ± 5·8% (P < 0·001), standard care versus EpiFix, respectively. After 4 and 6 weeks of treatment the overall healing rate with application of EpiFix was shown to be 77% and 92%, respectively, whereas standard care healed 0% and 8% of the wounds (P < 0·001), respectively. Patients treated with EpiFix achieved superior healing rates over standard treatment alone. These results show that using EpiFix in addition to standard care is efficacious for wound healing. PMID:23742102

Impact of a new cryotherapy device on early rehabilitation after primary total knee arthroplasty (TKA): a prospective randomised controlled trial.

PubMed

Sadoghi, Patrick; Hasenhütl, Sandro; Gruber, Gerald; Leitner, Lukas; Leithner, Andreas; Rumpold-Seitlinger, Gudrun; Kastner, Norbert; Poolman, Rudolf W; Glehr, Mathias

2018-06-01

The aim of this prospective, randomised and single blinded study was to evaluate the efficiency and safety of a new cryotherapy device in patients undergoing unilateral, primary total knee arthroplasty (TKA). Our hypothesis was that patients administered to the new cryotherapy device would perform better than patients receiving a conventional standard cold therapy regimen. Ninety-seven patients were randomised into two groups receiving either the cTreatment® (new cryotherapy device) or the standard cold therapy protocol (including cold pack application for six days after the surgical intervention). We evaluated the following endpoints consisting of range of motion (ROM), pain intensity, and knee girth on admission day and the second, fourth, and sixth post-operative day (POD). A statistically significant benefit of the new cryotherapy device was detected regarding the ROM on the sixth POD with an average gain of 7 degrees (p = 0.021). Pain in the numeric rating scale (NRS) score in motion was significantly lower in the cTreatment® group on the second POD (p = 0.034). There were no statistically significant differences between groups regarding the NRS in rest, patient controlled analgesia (PCA) consumption, and girth measurements. No adverse effects were observed in both study groups. The new computer-controlled cooling therapy device provides benefits in terms of early post-operative remobilisation with respect to ROM and pain, which might be attributed to a reduced inflammatory response, as well as reduced secretion and bleeding. The cTreatment® system appears to be a safe and efficient procedure.

Intravenous iron vs blood for acute post-partum anaemia (IIBAPPA): a prospective randomised trial.

PubMed

Chua, Seng; Gupta, Sarika; Curnow, Jennifer; Gidaszewski, Beata; Khajehei, Marjan; Diplock, Hayley

2017-12-19

Acute post-partum anaemia can be associated with significant morbidity including a predisposition for postnatal depression. Lack of clear practice guidelines means a number of women are treated with multiple blood transfusions. Intravenous iron has the potential to limit the need for multiple blood transfusions but its role in the post-partum setting is unclear. IIBAPPA is a multi-centre randomised non-inferiority trial. Women with a primary post-partum haemorrhage (PPH) >1000 mL and resultant haemoglobin (Hb) 5.5-8.0 g/dL after resuscitation with ongoing symptomatic anaemia who are otherwise stable (no active bleeding) are eligible to participate. Patients with sepsis or conditions necessitating rapid Hb restoration are excluded. Eligible participants are randomised to receive a blood transfusion or a single dose of intravenous iron polymaltose calculated using the Ganzoni formula. Primary outcome measures include Hb, Ferritin and C-Reactive Protein levels on Day 7. Secondary outcomes evaluate (i) Hb, Ferritin and CRP levels on Day 14, 28, (ii) anaemia symptoms on Day 0, 7, 14 and 28 using structured health related quality of life questionnaires, (iii) treatment safety by assessing adverse reactions and infection endpoints and (iv) the quantitative impact of anaemia on breast feeding quality using a hospital designed questionnaire. If equivalence in Hb and ferritin levels, symptom scores and safety endpoints is demonstrated, intravenous iron may become the preferred treatment for women with acute post-partum anaemia to minimise transfusion reactions and costs. Australian and New Zealand Clinical Trials Registry: ACTRN12615001370594 on 16th December, 2015 (prospective approval).

Future Modelling and Simulation Challenges (Defis futurs pour la modelisation et la simulation)

DTIC Science & Technology

2002-11-01

Language School Figure 2: Location of the simulation center within the MEC Military operations research section - simulation lab Military operations... language . This logic can be probabilistic (branching is randomised, which is useful for modelling error), tactical (a branch goes to the task with the... language and a collection of simulation tools that can be used to create human and team behaviour models to meet users’ needs. Hence, different ways of

Virtual reality training in laparoscopic surgery: A systematic review & meta-analysis.

PubMed

Alaker, Medhat; Wynn, Greg R; Arulampalam, Tan

2016-05-01

Laparoscopic surgery requires a different and sometimes more complex skill set than does open surgery. Shortened working hours, less training times, and patient safety issues necessitates that these skills need to be acquired outside the operating room. Virtual reality simulation in laparoscopic surgery is a growing field, and many studies have been published to determine its effectiveness. This systematic review and meta-analysis aims to evaluate virtual reality simulation in laparoscopic abdominal surgery in comparison to other simulation models and to no training. A systematic literature search was carried out until January 2014 in full adherence to PRISMA guidelines. All randomised controlled studies comparing virtual reality training to other models of training or to no training were included. Only studies utilizing objective and validated assessment tools were included. Thirty one randomised controlled trials that compare virtual reality training to other models of training or to no training were included. The results of the meta-analysis showed that virtual reality simulation is significantly more effective than video trainers, and at least as good as box trainers. The use of Proficiency-based VR training, under supervision with prompt instructions and feedback, and the use of haptic feedback, has proven to be the most effective way of delivering the virtual reality training. The incorporation of virtual reality training into surgical training curricula is now necessary. A unified platform of training needs to be established. Further studies to assess the impact on patient outcomes and on hospital costs are necessary. (PROSPERO Registration number: CRD42014010030). Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

The effect of pre-course e-learning prior to advanced life support training: a randomised controlled trial.

PubMed

Perkins, Gavin D; Fullerton, James N; Davis-Gomez, Nicole; Davies, Robin P; Baldock, Catherine; Stevens, Harry; Bullock, Ian; Lockey, Andrew S

2010-07-01

The role of e-learning in contemporary healthcare education is quickly developing. The aim of this study was to examine the relationship between the use of an e-learning simulation programme (Microsim, Laerdal, UK) prior to attending an Advanced Life Support (ALS) course and the subsequent relationship to candidate performance. An open label, multi-centre randomised controlled study was conducted. The control group received a course manual and pre-course MCQ four weeks prior to the face to face course. The intervention group in addition received the Microsim programme on a CD. The primary outcome was performance during a simulated cardiac arrest at the end of the course. Secondary outcomes were performance during multiple choice exams, resuscitation skills assessments and feedback to Microsim programme. 572 participants were randomised (287 Microsim, 285 control). There were no significant differences in the primary outcome (performance during a standard cardiac arrest simulation) or secondary outcomes. User evaluations were favorable. 79% would recommend it to colleagues. 9% stated Microsim could replace the entire ALS course, 25% parts. Over 70% of participants' perceived that Microsim improved their understanding of the key learning domains of the ALS course. Distributing Microsim to healthcare providers prior to attending an ALS courses did not improve either cognitive or psychomotor skills performance during cardiac arrest simulation testing. The challenge that lies ahead is to identify the optimal way to use e-learning as part of a blended approach to learning for this type of training programme.

'Physical activity at home (PAAH)', evaluation of a group versus home based physical activity program in community dwelling middle aged adults: rationale and study design.

PubMed

Freene, Nicole; Waddington, Gordon; Chesworth, Wendy; Davey, Rachel; Goss, John

2011-11-24

It is well recognised that the adoption and longer term adherence to physical activity by adults to reduce the risk of chronic disease is a challenge. Interventions, such as group and home based physical activity programs, have been widely reported upon. However few studies have directly compared these interventions over the longer term to determine their adherence and effectiveness. Participant preference for home based or group interventions is important. Some evidence suggests that home based physical activity programs are preferred by middle aged adults and provide better long term physical activity adherence. Physiotherapists may also be useful in increasing physical activity adherence, with limited research on their impact. 'Physical Activity at Home' is a 2 year pragmatic randomised control trial, with a non-randomised comparison to group exercise. Middle-aged adults not interested in, or unable to attend, a group exercise program will be targeted. Sedentary community dwelling 50-65 year olds with no serious medical conditions or functional impairments will be recruited via two mail outs using the Australian federal electoral roll. The first mail out will invite participants to a 6 month community group exercise program. The second mail out will be sent to those not interested in the group exercise program inviting them to take part in a home based intervention. Eligible home based participants will be randomised into a 6 month physiotherapy-led home based physical activity program or usual care. Outcome measures will be taken at baseline, 6, 12, 18 and 24 months. The primary outcome is physical activity adherence via exercise diaries. Secondary outcomes include the Active Australia Survey, accelerometry, aerobic capacity (step test), quality of life (SF-12v2), blood pressure, waist circumference, waist-to-hip ratio and body mass index. Costs will be recorded prospectively and qualitative data will be collected. The planned 18 month follow-up post intervention will provide an indication of the effectiveness of the group and home based interventions in terms of adherence to physical activity, health benefits and cost. If the physiotherapy-led home based physical activity program is successful it could provide an alternative option for physical activity program delivery across a number of settings. Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000890932.

The Basilar Artery International Cooperation Study (BASICS): study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Despite recent advances in acute stroke treatment, basilar artery occlusion (BAO) is associated with a death or disability rate of close to 70%. Randomised trials have shown the safety and efficacy of intravenous thrombolysis (IVT) given within 4.5 h and have shown promising results of intra-arterial thrombolysis given within 6 h of symptom onset of acute ischaemic stroke, but these results do not directly apply to patients with an acute BAO because only few, if any, of these patients were included in randomised acute stroke trials. Recently the results of the Basilar Artery International Cooperation Study (BASICS), a prospective registry of patients with acute symptomatic BAO challenged the often-held assumption that intra-arterial treatment (IAT) is superior to IVT. Our observations in the BASICS registry underscore that we continue to lack a proven treatment modality for patients with an acute BAO and that current clinical practice varies widely. Design BASICS is a randomised controlled, multicentre, open label, phase III intervention trial with blinded outcome assessment, investigating the efficacy and safety of additional IAT after IVT in patients with BAO. The trial targets to include 750 patients, aged 18 to 85 years, with CT angiography or MR angiography confirmed BAO treated with IVT. Patients will be randomised between additional IAT followed by optimal medical care versus optimal medical care alone. IVT has to be initiated within 4.5 h from estimated time of BAO and IAT within 6 h. The primary outcome parameter will be favourable outcome at day 90 defined as a modified Rankin Scale score of 0–3. Discussion The BASICS registry was observational and has all the limitations of a non-randomised study. As the IAT approach becomes increasingly available and frequently utilised an adequately powered randomised controlled phase III trial investigating the added value of this therapy in patients with an acute symptomatic BAO is needed (clinicaltrials.gov: NCT01717755). PMID:23835026

An evaluation of the effect of an educational intervention for Australian social workers on competence in delivering brief cognitive behavioural strategies: a randomised controlled trial.

PubMed

Armstrong, G; Blashki, G; Joubert, L; Bland, R; Moulding, R; Gunn, J; Naccarella, L

2010-11-05

Broad community access to high quality evidence-based primary mental health care is an ongoing challenge around the world. In Australia one approach has been to broaden access to care by funding psychologists and other allied health care professionals to deliver brief psychological treatments to general practitioners' patients. To date, there has been a scarcity of studies assessing the efficacy of social worker delivered psychological strategies. This study aims to build the evidence base by evaluating the impact of a brief educational intervention on social workers' competence in delivering cognitive behavioural strategies (strategies derived from cognitive behavioural therapy). A randomised controlled trial design was undertaken with baseline and one-week follow-up measurement of both objective and self-perceived competence. Simulated consultations with standardised depressed patients were recorded on videotape and objective competence was assessed by blinded reviewers using the Cognitive Therapy Scale. Questionnaires completed by participants were used to measure self-perceived competence. The training intervention was a 15 hour face-to-face course involving presentations, video example consultations, written materials and rehearsal of skills in pairs. 40 Melbourne-based (Australia) social workers enrolled and were randomised and 9 of these withdrew from the study before the pre training simulated consultation. 30 of the remaining 31 social workers (97%) completed all phases of the intervention and evaluation protocol (16 from intervention and 14 from control group). The intervention group showed significantly greater improvements than the control group in objective competence (mean improvement of 14.2 (7.38-21.02) on the 66 point Cognitive Therapy Scale) and in subjective confidence (mean improvement of 1.28 (0.84-1.72) on a 5 point Likert scale). On average, the intervention group improved from below to above the base competency threshold on the Cognitive Therapy Scale whilst the control group remained below. Social workers can attain significant improvements in competency in delivering cognitive behavioural strategies from undertaking brief face to face training. This is relevant in the context of health reforms that involve social worker delivery of evidence based psychological care. Further research is required to assess how these improvements in competence translate into performance in practice and clinical outcomes for patients.

An evaluation of the effect of an educational intervention for Australian social workers on competence in delivering brief cognitive behavioural strategies: A randomised controlled trial

PubMed Central

2010-01-01

Background Broad community access to high quality evidence-based primary mental health care is an ongoing challenge around the world. In Australia one approach has been to broaden access to care by funding psychologists and other allied health care professionals to deliver brief psychological treatments to general practitioners' patients. To date, there has been a scarcity of studies assessing the efficacy of social worker delivered psychological strategies. This study aims to build the evidence base by evaluating the impact of a brief educational intervention on social workers' competence in delivering cognitive behavioural strategies (strategies derived from cognitive behavioural therapy). Methods A randomised controlled trial design was undertaken with baseline and one-week follow-up measurement of both objective and self-perceived competence. Simulated consultations with standardised depressed patients were recorded on videotape and objective competence was assessed by blinded reviewers using the Cognitive Therapy Scale. Questionnaires completed by participants were used to measure self-perceived competence. The training intervention was a 15 hour face-to-face course involving presentations, video example consultations, written materials and rehearsal of skills in pairs. Results 40 Melbourne-based (Australia) social workers enrolled and were randomised and 9 of these withdrew from the study before the pre training simulated consultation. 30 of the remaining 31 social workers (97%) completed all phases of the intervention and evaluation protocol (16 from intervention and 14 from control group). The intervention group showed significantly greater improvements than the control group in objective competence (mean improvement of 14.2 (7.38-21.02) on the 66 point Cognitive Therapy Scale) and in subjective confidence (mean improvement of 1.28 (0.84-1.72) on a 5 point Likert scale). On average, the intervention group improved from below to above the base competency threshold on the Cognitive Therapy Scale whilst the control group remained below. Conclusions Social workers can attain significant improvements in competency in delivering cognitive behavioural strategies from undertaking brief face to face training. This is relevant in the context of health reforms that involve social worker delivery of evidence based psychological care. Further research is required to assess how these improvements in competence translate into performance in practice and clinical outcomes for patients. PMID:21050497

Screening and brief interventions for hazardous alcohol use in accident and emergency departments: a randomised controlled trial protocol

PubMed Central

Coulton, Simon; Perryman, Katherine; Bland, Martin; Cassidy, Paul; Crawford, Mike; Deluca, Paolo; Drummond, Colin; Gilvarry, Eilish; Godfrey, Christine; Heather, Nick; Kaner, Eileen; Myles, Judy; Newbury-Birch, Dorothy; Oyefeso, Adenekan; Parrott, Steve; Phillips, Tom; Shenker, Don; Shepherd, Jonathan

2009-01-01

Background There is a wealth of evidence regarding the detrimental impact of excessive alcohol consumption on the physical, psychological and social health of the population. There also exists a substantial evidence base for the efficacy of brief interventions aimed at reducing alcohol consumption across a range of healthcare settings. Primary research conducted in emergency departments has reinforced the current evidence regarding the potential effectiveness and cost-effectiveness. Within this body of evidence there is marked variation in the intensity of brief intervention delivered, from very minimal interventions to more intensive behavioural or lifestyle counselling approaches. Further the majority of primary research has been conducted in single centre and there is little evidence of the wider issues of generalisability and implementation of brief interventions across emergency departments. Methods/design The study design is a prospective pragmatic factorial cluster randomised controlled trial. Individual Emergency Departments (ED) (n = 9) are randomised with equal probability to a combination of screening tool (M-SASQ vs FAST vs SIPS-PAT) and an intervention (Minimal intervention vs Brief advice vs Brief lifestyle counselling). The primary hypothesis is that brief lifestyle counselling delivered by an Alcohol Health Worker (AHW) is more effective than Brief Advice or a minimal intervention delivered by ED staff. Secondary hypotheses address whether short screening instruments are more acceptable and as efficient as longer screening instruments and the cost-effectiveness of screening and brief interventions in ED. Individual participants will be followed up at 6 and 12 months after consent. The primary outcome measure is performance using a gold-standard screening test (AUDIT). Secondary outcomes include; quantity and frequency of alcohol consumed, alcohol-related problems, motivation to change, health related quality of life and service utilisation. Discussion This paper presents a protocol for a large multi-centre pragmatic factorial cluster randomised trial to evaluate the effectiveness and cost-effectiveness of screening and brief interventions for hazardous alcohol users attending emergency departments. Trial Registration ISRCTN 93681536 PMID:19575791

Minimum number of clusters and comparison of analysis methods for cross sectional stepped wedge cluster randomised trials with binary outcomes: A simulation study.

PubMed

Barker, Daniel; D'Este, Catherine; Campbell, Michael J; McElduff, Patrick

2017-03-09

Stepped wedge cluster randomised trials frequently involve a relatively small number of clusters. The most common frameworks used to analyse data from these types of trials are generalised estimating equations and generalised linear mixed models. A topic of much research into these methods has been their application to cluster randomised trial data and, in particular, the number of clusters required to make reasonable inferences about the intervention effect. However, for stepped wedge trials, which have been claimed by many researchers to have a statistical power advantage over the parallel cluster randomised trial, the minimum number of clusters required has not been investigated. We conducted a simulation study where we considered the most commonly used methods suggested in the literature to analyse cross-sectional stepped wedge cluster randomised trial data. We compared the per cent bias, the type I error rate and power of these methods in a stepped wedge trial setting with a binary outcome, where there are few clusters available and when the appropriate adjustment for a time trend is made, which by design may be confounding the intervention effect. We found that the generalised linear mixed modelling approach is the most consistent when few clusters are available. We also found that none of the common analysis methods for stepped wedge trials were both unbiased and maintained a 5% type I error rate when there were only three clusters. Of the commonly used analysis approaches, we recommend the generalised linear mixed model for small stepped wedge trials with binary outcomes. We also suggest that in a stepped wedge design with three steps, at least two clusters be randomised at each step, to ensure that the intervention effect estimator maintains the nominal 5% significance level and is also reasonably unbiased.

Optical Coherence Tomography Substudy of A Prospective Multicenter Randomized Post-Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesions: TARGET All Comers.

PubMed

Baumbach, Andreas; Lansky, Alexandra J; Onuma, Yoshi; Asano, Taku; Johnson, Thomas; Anderson, Richard; Kiemeneij, Ferdinand; Zheng, Ming; Van Royen, Niels; Slagboom, Ton; Vlachojannis, Georg; Xu, Bo; Serruys, Patrick; Wijns, William

2018-06-12

Durable polymer drug-eluting stents (DP DES) may contribute to persistent inflammation, delayed endothelial healing and subsequent late DES thrombosis. The aim of this Optical Coherence Tomography (OCT) sub-study was to compare healing and neointimal coverage of a novel bioabsorbable polymer sirolimus-eluting stent (FIREHAWK®) (BP DES) versus the DP DES (XIENCE) at 90 days in an all comers patient population. The TARGET All Comers study is a prospective multicenter randomised post-market trial of 1656 patients randomised 1:1 to FIREHAWK or XIENCE at 21 centers in 10 European countries. The TARGET OCT sub-study enrolled 36 consecutive patients with 52 lesions at 6 centers proficient in OCT. Follow-up OCT was performed at 3 months or prior to revascularisation when occurring before the 3-month window. The substudy was designed for non-inferiority of the primary endpoint of neointimal thickness. At follow-up, the mean neointimal thickness by OCT (52 lesions, Firehawk, n=24; Xience, n=28), was not significantly different between groups (Firehawk 75.5μm vs Xience V 82.3 μm) meeting the primary endpoint of non-inferiority (Pnoninferiority<0.001). The percentage of stent strut coverage was high in both groups (strut level: 99.9% ± 0.3 vs 100% ± 0.1, p=0.26), and the proportion of malapposed struts (1.0±1.6% vs. 1.2±2.0%, p=0.51) was low in both groups. Based on OCT, the FIREHAWK BP DES has a similar healing response 3 months after implantation compared to the DP DES, with near complete strut coverage, moderate neointima formation and minimal strut malapposition.

Omitting elective nodal irradiation during thoracic irradiation in limited-stage small cell lung cancer--evidence from a phase II trial.

PubMed

Colaco, Rovel; Sheikh, Hamid; Lorigan, Paul; Blackhall, Fiona; Hulse, Paul; Califano, Raffaele; Ashcroft, Linda; Taylor, Paul; Thatcher, Nicholas; Faivre-Finn, Corinne

2012-04-01

Omitting elective nodal irradiation (ENI) in limited-stage disease small cell lung cancer (LD-SCLC) is expected to result in smaller radiation fields. We report on data from a randomised phase II trial that omitted ENI in patients receiving concurrent chemo-radiotherapy for LD-SCLC. 38 patients with LD-SCLC were randomised to receive once-daily (66 Gy in 33 fractions) or twice-daily (45 Gy in 30 fractions) radiotherapy (RT). 3D-conformal RT was given concurrently with cisplatin and etoposide starting with the second cycle of a total of four cycles. The gross tumour volume was defined as primary tumour with involved lymph nodes (nodes ≥1 cm in short axis) identifiable with CT imaging. ENI was not used. Six recurrence patterns were identified: recurrence within planning target volume (PTV) only, recurrence within PTV+regional nodal recurrence and/or distant recurrence, isolated nodal recurrence outside PTV, nodal recurrence outside PTV+distant recurrence, distant metastases only and no recurrence. At median follow-up 16.9 months, 31/38 patients were evaluable and 14/31 patients had relapsed. There were no isolated nodal recurrences. Eight patients relapsed with intra-thoracic disease: 2 within PTV only, 4 within PTV and distantly and 2 with nodal recurrence outside PTV plus distant metastases. Rates of grade 3+ acute oesophagitis and pneumonitis in the 31 evaluable patients were 23 and 3% respectively. In our study of LD-SCLC, omitting ENI based on CT imaging was not associated with a high risk of isolated nodal recurrence, although further prospective studies are needed to confirm this. Routine ENI omission will be further evaluated prospectively in the ongoing phase III CONVERT trial (NCT00433563). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Association between organic food consumption and metabolic syndrome: cross-sectional results from the NutriNet-Santé study.

PubMed

Baudry, Julia; Lelong, Hélène; Adriouch, Solia; Julia, Chantal; Allès, Benjamin; Hercberg, Serge; Touvier, Mathilde; Lairon, Denis; Galan, Pilar; Kesse-Guyot, Emmanuelle

2017-08-02

Metabolic syndrome (MetS), a multicomponent condition, is a cardiovascular disease predictor. Although exposure to agricultural pesticides has been suggested as a potential contributor to the rising rates of obesity, type 2 diabetes, and other features of metabolic disorders, no studies have focused on the association between consumption of organic food (produced without synthetic pesticides) and MetS. We aimed to investigate the cross-sectional association between organic food consumption and MetS in French adults to determine whether it would be worth conducting further studies, particularly large prospective and randomised trials. A total of 8174 participants from the NutriNet-Santé study who attended a clinical visit and completed an organic food frequency questionnaire were included in this cross-sectional analysis. We evaluated the association between the proportion of organic food in the diet (overall and by food group) and MetS using Poisson regression models while adjusting for potential confounders. Higher organic food consumption was negatively associated with the prevalence of MetS: adjusted prevalence ratio was 0.69 (95% CI 0.61, 0.78) when comparing the third tertile of proportion of organic food in the diet with the first one (p value <0.0001). Higher consumption of organic plant-based foods was also related to a lower probability of having MetS. In addition, when stratifying by lifestyle factors (nutritional quality of the diet, smoking status, and physical activity), a significant negative association was detected in each subgroup (p values <0.05), except among smokers. Our results showed that a higher organic food consumption was associated with a lower probability of having MetS. Additional prospective studies and randomised trials are required to ascertain the relationship between organic food consumption and metabolic disorders.

Comparison of outcomes between proximal and distal chevron osteotomy, both with supplementary lateral soft-tissue release, for severe hallux valgus deformity: A prospective randomised controlled trial.

PubMed

Park, H-W; Lee, K-B; Chung, J-Y; Kim, M-S

2013-04-01

Severe hallux valgus deformity is conventionally treated with proximal metatarsal osteotomy. Distal metatarsal osteotomy with an associated soft-tissue procedure can also be used in moderate to severe deformity. We compared the clinical and radiological outcomes of proximal and distal chevron osteotomy in severe hallux valgus deformity with a soft-tissue release in both. A total of 110 consecutive female patients (110 feet) were included in a prospective randomised controlled study. A total of 56 patients underwent a proximal procedure and 54 a distal operation. The mean follow-up was 39 months (24 to 54) in the proximal group and 38 months (24 to 52) in the distal group. At follow-up the hallux valgus angle, intermetatarsal angle, distal metatarsal articular angle, tibial sesamoid position, American Orthopaedic Foot and Ankle Society (AOFAS) hallux metatarsophalangeal-interphalangeal score, patient satisfaction level, and complications were similar in each group. Both methods showed significant post-operative improvement and high levels of patient satisfaction. Our results suggest that the distal chevron osteotomy with an associated distal soft-tissue procedure provides a satisfactory method for correcting severe hallux valgus deformity.

A prospective randomised double-blind placebo-controlled trial to assess the effect of diuretics on shockwave lithotripsy of calculi.

PubMed

Sabharwal, Sagar; Jeyaseelan, L; Panda, Arabind; Gnanaraj, Lionel; Kekre, Nitin S; Devasia, Antony

2017-12-01

To assess the effect of diuretics with shockwave lithotripsy (SWL) on the treatment of renal and upper ureteric calculi. Adult patients with a solitary non-obstructive radio-opaque renal or upper ureteric calculus with normal renal function were included. They were prospectively randomised to receive either SWL with placebo or SWL with diuretics (40 mg parenteral furosemide) in a double-blind manner with a sample size of 48 patients in each arm. The primary outcomes were the SWL success and failure rates. The secondary outcomes were the number of shocks and sessions. Complete fragmentation was achieved in 89.6% of the patients in the furosemide arm as compared to 81.3% in the placebo arm. Clearance was achieved in 77.1% of the patients in the furosemide arm as compared to 70.8% in the placebo arm. The number of shocks and the number of sessions were higher in the placebo arm. These differences were not statistically significant. The use of diuretics along with SWL treatment of renal and upper ureteric calculi does not show a statistically significant improvement in fragmentation or clearance.

Early experience with stretch polytetrafluoroethylene grafts for haemodialysis access surgery: results of a prospective randomised study.

PubMed

Tordoir, J H; Hofstra, L; Leunissen, K M; Kitslaar, P J

1995-04-01

The purpose of this study was to evaluate the results and complications of standard ePTFE versus stretch ePTFE AV fistulas. Prospective randomised trial. University Hospital. During a 2-year period 37 patients received 17 stretch and 20 standard ePTFE graft AV fistulas. Patients were evaluated for the occurrence of complications and graft patency. Regular Duplex scans were performed to detect stenoses in the fistula circuit. Thrombotic events occurred in 40% of the standard ePTFE grafts, compared to 12% of the stretch ePTFE prostheses (p < 0.001). The incidence of puncture complications was similar in both groups. The cumulative primary patency rate in the stretch ePTFE group was significantly higher compared to the standard ePTFE group (1-year patency rates of 59% and 29%, respectively; p < 0.01). No differences in the duration of puncture site bleeding were observed. Duplex scanning showed a significantly greater number of stenoses in the standard ePTFE grafts. The new stretch ePTFE prosthesis has better primary patency rates and less stenoses due to intimal hyperplasia as compared to standard ePTFE grafts.

Randomised studies of income supplementation: a lost opportunity to assess health outcomes.

PubMed

Connor, J; Rodgers, A; Priest, P

1999-11-01

Despite the wealth of evidence linking low income to ill health, there is little information from randomised studies on how much and how quickly these risks can be reversed by improvements in income. To conduct a systematic review of randomised studies of income supplementation, with particular reference to health outcomes. Extensive searches of electronic databases and contact with previous authors. As well as searching for trials that were specifically designed to assess the effects of increased income, studies of winners and losers of lotteries were also sought: if winning is purely chance, such studies are, in effect, randomised trials of increased income. Ten relevant studies were identified, all conducted in North America, mostly in the late 1960s and 1970s. Five trials were designed to assess the effects of income supplementation on workforce participation and randomised a total of 10,000 families to 3-5 years of various combinations of minimum income guarantees and reduced tax rates. Two trials were designed to assess re-offending rates in recently released prisoners and randomised a total of 2400 people to 3-6 months of benefits. One trial was designed to assess housing allowances and randomised 3500 families to three years of income supplements. One trial assessed the health effects of 12 months of income supplementation in 54 people with severe mental illness. Finally, one study compared three groups of people who won different amounts of money in a state lottery. In all these studies the interventions resulted in increases in income of at least one fifth. However, no reliable analyses of health outcome data are available. Extensive opportunities to reliably assess the effects of increases in income on health outcomes have been missed. Such evidence might have increased the consideration of potential health effects during deliberations about policies that have major implications for income, such as taxation rates, benefit policies, and minimum wage levels. Randomised evidence could still be obtained with innovative new studies, such as trials of full benefit uptake or prospective studies of lottery winners in which different sized winnings are paid in monthly installments over many years.

What are the health benefits of active travel? A systematic review of trials and cohort studies.

PubMed

Saunders, Lucinda E; Green, Judith M; Petticrew, Mark P; Steinbach, Rebecca; Roberts, Helen

2013-01-01

Increasing active travel (primarily walking and cycling) has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. The study design was a systematic review of (i) non-randomised and randomised controlled trials, and (ii) prospective observational studies examining either (a) the effects of interventions to promote active travel or (b) the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes.

What Are the Health Benefits of Active Travel? A Systematic Review of Trials and Cohort Studies

PubMed Central

Saunders, Lucinda E.; Green, Judith M.; Petticrew, Mark P.; Steinbach, Rebecca; Roberts, Helen

2013-01-01

Background Increasing active travel (primarily walking and cycling) has been widely advocated for reducing obesity levels and achieving other population health benefits. However, the strength of evidence underpinning this strategy is unclear. This study aimed to assess the evidence that active travel has significant health benefits. Methods The study design was a systematic review of (i) non-randomised and randomised controlled trials, and (ii) prospective observational studies examining either (a) the effects of interventions to promote active travel or (b) the association between active travel and health outcomes. Reports of studies were identified by searching 11 electronic databases, websites, reference lists and papers identified by experts in the field. Prospective observational and intervention studies measuring any health outcome of active travel in the general population were included. Studies of patient groups were excluded. Results Twenty-four studies from 12 countries were included, of which six were studies conducted with children. Five studies evaluated active travel interventions. Nineteen were prospective cohort studies which did not evaluate the impact of a specific intervention. No studies were identified with obesity as an outcome in adults; one of five prospective cohort studies in children found an association between obesity and active travel. Small positive effects on other health outcomes were found in five intervention studies, but these were all at risk of selection bias. Modest benefits for other health outcomes were identified in five prospective studies. There is suggestive evidence that active travel may have a positive effect on diabetes prevention, which may be an important area for future research. Conclusions Active travel may have positive effects on health outcomes, but there is little robust evidence to date of the effectiveness of active transport interventions for reducing obesity. Future evaluations of such interventions should include an assessment of their impacts on obesity and other health outcomes. PMID:23967064

Antiplatelet therapy with aspirin, clopidogrel, and dipyridamole versus clopidogrel alone or aspirin and dipyridamole in patients with acute cerebral ischaemia (TARDIS): a randomised, open-label, phase 3 superiority trial.

PubMed

Bath, Philip M; Woodhouse, Lisa J; Appleton, Jason P; Beridze, Maia; Christensen, Hanne; Dineen, Robert A; Duley, Lelia; England, Timothy J; Flaherty, Katie; Havard, Diane; Heptinstall, Stan; James, Marilyn; Krishnan, Kailash; Markus, Hugh S; Montgomery, Alan A; Pocock, Stuart J; Randall, Marc; Ranta, Annemarei; Robinson, Thompson G; Scutt, Polly; Venables, Graham S; Sprigg, Nikola

2018-03-03

Intensive antiplatelet therapy with three agents might be more effective than guideline treatment for preventing recurrent events in patients with acute cerebral ischaemia. We aimed to compare the safety and efficacy of intensive antiplatelet therapy (combined aspirin, clopidogrel, and dipyridamole) with that of guideline-based antiplatelet therapy. We did an international, prospective, randomised, open-label, blinded-endpoint trial in adult participants with ischaemic stroke or transient ischaemic attack (TIA) within 48 h of onset. Participants were assigned in a 1:1 ratio using computer randomisation to receive loading doses and then 30 days of intensive antiplatelet therapy (combined aspirin 75 mg, clopidogrel 75 mg, and dipyridamole 200 mg twice daily) or guideline-based therapy (comprising either clopidogrel alone or combined aspirin and dipyridamole). Randomisation was stratified by country and index event, and minimised with prognostic baseline factors, medication use, time to randomisation, stroke-related factors, and thrombolysis. The ordinal primary outcome was the combined incidence and severity of any recurrent stroke (ischaemic or haemorrhagic; assessed using the modified Rankin Scale) or TIA within 90 days, as assessed by central telephone follow-up with masking to treatment assignment, and analysed by intention to treat. This trial is registered with the ISRCTN registry, number ISRCTN47823388. 3096 participants (1556 in the intensive antiplatelet therapy group, 1540 in the guideline antiplatelet therapy group) were recruited from 106 hospitals in four countries between April 7, 2009, and March 18, 2016. The trial was stopped early on the recommendation of the data monitoring committee. The incidence and severity of recurrent stroke or TIA did not differ between intensive and guideline therapy (93 [6%] participants vs 105 [7%]; adjusted common odds ratio [cOR] 0·90, 95% CI 0·67-1·20, p=0·47). By contrast, intensive antiplatelet therapy was associated with more, and more severe, bleeding (adjusted cOR 2·54, 95% CI 2·05-3·16, p<0·0001). Among patients with recent cerebral ischaemia, intensive antiplatelet therapy did not reduce the incidence and severity of recurrent stroke or TIA, but did significantly increase the risk of major bleeding. Triple antiplatelet therapy should not be used in routine clinical practice. National Institutes of Health Research Health Technology Assessment Programme, British Heart Foundation. Copyright © 2018 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.

Thermal build-up, decay and retention responses to local therapeutic application of 448 kHz capacitive resistive monopolar radiofrequency: A prospective randomised crossover study in healthy adults.

PubMed

Kumaran, Binoy; Watson, Tim

2015-01-01

Radiofrequency-based electrophysical agents are widely used in therapy-related clinical practice for their thermal effects, mainly relieving pain and inflammation and improving tissue extensibility. The most commonly used and researched are shortwave therapies that operate at 27.12 MHz. Although relatively new, electrophysical agents employing much lower frequencies have also emerged. Capacitive resistive monopolar radiofrequency employing 448 kHz is one such therapy. This laboratory-based study was aimed to investigate the skin thermal responses to 448 kHz radiofrequency-based therapy in healthy adults. In a two-group randomised crossover study, 15 volunteers attended two modes (capacitive and resistive) of 448 kHz radiofrequency-based therapy (using 'Indiba Activ 902') administered locally to the lower thigh region. Starting at minimum, the intensity was increased incrementally until thermal discomfort was felt. Participants reported three time points: thermal onset, definite thermal sensation, and onset of thermal discomfort. Local skin temperature was measured before, immediately post-treatment and up to 45 min post-treatment. Both capacitive and resistive modes of therapy significantly increased the skin temperature and sustained it over the 45-min follow-up. There was statistically significant difference between the thermal response patterns produced by the two modes. Peak post-treatment temperatures attained were not significantly different between the two; however, the retention rate at follow-up was significantly higher for the resistive mode. This study confirms that radiofrequency-based therapy at 448 kHz can significantly increase and sustain skin temperature. The study also provides useful baseline data for further research in the low frequency ranges of radiofrequency-based therapy that remain largely unexplored.

A prospective gating method to acquire a diverse set of free-breathing CT images for model-based 4DCT

NASA Astrophysics Data System (ADS)

O'Connell, D.; Ruan, D.; Thomas, D. H.; Dou, T. H.; Lewis, J. H.; Santhanam, A.; Lee, P.; Low, D. A.

2018-02-01

Breathing motion modeling requires observation of tissues at sufficiently distinct respiratory states for proper 4D characterization. This work proposes a method to improve sampling of the breathing cycle with limited imaging dose. We designed and tested a prospective free-breathing acquisition protocol with a simulation using datasets from five patients imaged with a model-based 4DCT technique. Each dataset contained 25 free-breathing fast helical CT scans with simultaneous breathing surrogate measurements. Tissue displacements were measured using deformable image registration. A correspondence model related tissue displacement to the surrogate. Model residual was computed by comparing predicted displacements to image registration results. To determine a stopping criteria for the prospective protocol, i.e. when the breathing cycle had been sufficiently sampled, subsets of N scans where 5  ⩽  N  ⩽  9 were used to fit reduced models for each patient. A previously published metric was employed to describe the phase coverage, or ‘spread’, of the respiratory trajectories of each subset. Minimum phase coverage necessary to achieve mean model residual within 0.5 mm of the full 25-scan model was determined and used as the stopping criteria. Using the patient breathing traces, a prospective acquisition protocol was simulated. In all patients, phase coverage greater than the threshold necessary for model accuracy within 0.5 mm of the 25 scan model was achieved in six or fewer scans. The prospectively selected respiratory trajectories ranked in the (97.5  ±  4.2)th percentile among subsets of the originally sampled scans on average. Simulation results suggest that the proposed prospective method provides an effective means to sample the breathing cycle with limited free-breathing scans. One application of the method is to reduce the imaging dose of a previously published model-based 4DCT protocol to 25% of its original value while achieving mean model residual within 0.5 mm.

Evaluating the effect of metronidazole plus amoxicillin-clavulanate versus amoxicillin-clavulanate alone in canine haemorrhagic diarrhoea: a randomised controlled trial in primary care practice.

PubMed

Ortiz, V; Klein, L; Channell, S; Simpson, B; Wright, B; Edwards, C; Gilbert, R; Day, R; Caddy, S L

2018-06-07

To investigate the benefit of supplementing amoxicillin-clavulanic acid therapy with metronidazole in dogs presenting to a primary care veterinary practice with severe haemorrhagic diarrhoea. Prospective randomised blinded trial on dogs presenting with haemorrhagic diarrhoea of less than 3 days duration to a primary care veterinary hospital and also requiring intravenous fluid therapy. Cases were randomised to receive either metronidazole or saline, in addition to standard supportive therapy consisting of amoxicillin-clavulanic acid, intravenous fluid therapy, buprenorphine and omeprazole. Treatment efficacy was measured by duration of hospitalisation and daily scoring of disease severity. Thirty-four cases successfully completed the trial. There was no significant difference in hospitalisation time between treatment groups (mean for dogs receiving metronidazole was 29.6 hours and for controls was 26.3 hours) nor in daily clinical scores. This study strongly suggests that addition of metronidazole is not an essential addition to amoxicillin-clavulanic acid therapy for treatment of severe cases of haemorrhagic diarrhoea in dogs. © 2018 British Small Animal Veterinary Association.

Comparison of interventional cardiology in two European countries: a nationwide Internet based registry study.

PubMed

Gudnason, T; Gudnadottir, G S; Lagerqvist, B; Eyjolfsson, K; Nilsson, T; Thorgeirsson, G; Thorgeirsson, G; Andersen, K; James, S

2013-09-30

The practice of interventional cardiology differs between countries and regions. In this study we report the results of the first nation-wide long-term comparison of interventional cardiology in two countries using a common web-based registry. The Swedish Coronary Angiography and Angioplasty Registry (SCAAR) was used to prospectively and continuously collect background-, quality-, and outcome parameters for all coronary angiographies (CA) and percutaneous coronary interventions (PCI) performed in Iceland and Sweden during one year. The rate of CA per million inhabitants was higher in Iceland than in Sweden. A higher proportion of patients had CA for stable angina in Iceland than in Sweden, while the opposite was true for ST elevation myocardial infarction. Left main stem stenosis was more commonly found in Iceland than in Sweden. The PCI rate was similar in the two countries as was the general success rate of PCI, achievement of complete revascularisation and the overall stent use. Drug eluting stents were more commonly used in Iceland (23% vs. 19%). The use of fractional flow reserve (0.2% vs. 10%) and the radial approach (0.6% vs. 33%) was more frequent in Sweden than in Iceland. Serious complications and death were very rare in both countries. By prospectively comparing interventional cardiology in two countries, using a common web based registry online, we have discovered important differences in technique and indications. A discovery such as this can lead to a change in clinical practice and inspire prospective multinational randomised registry trials in unselected, real world populations. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A randomised controlled trial of extended immersion in multi-method continuing simulation to prepare senior medical students for practice as junior doctors

PubMed Central

2014-01-01

Background Many commencing junior doctors worldwide feel ill-prepared to deal with their new responsibilities, particularly prescribing. Simulation has been widely utilised in medical education, but the use of extended multi-method simulation to emulate the junior doctor experience has rarely been reported. Methods A randomised controlled trial compared students who underwent two, week-long, extended simulations, several months apart (Intervention), with students who attended related workshops and seminars alone (Control), for a range of outcome measures. Results Eighty-four third year students in a graduate-entry medical program were randomised, and 82 completed the study. At the end of the first week, Intervention students scored a mean of 75% on a prescribing test, compared with 70% for Control students (P = 0.02) and Intervention teams initiated cardiac compressions a mean of 29.1 seconds into a resuscitation test scenario, compared with 70.1 seconds for Control teams (P < 0.01). At the beginning of the second week, an average of nine months later, a significant difference was maintained in relation to the prescribing test only (78% vs 70%, P < 0.01). At the end of the second week, significant Intervention vs Control differences were seen on knowledge and reasoning tests, a further prescribing test (71% vs 63% [P < 0.01]) and a paediatric resuscitation scenario test (252 seconds to initiation of fluid resuscitation vs 339 seconds [P = 0.05]). Conclusions The study demonstrated long-term retention of improved prescribing skills, and an immediate effect on knowledge acquisition, reasoning and resuscitation skills, from contextualising learning activities through extended multi-method simulation. PMID:24886098

Maternal and neonatal consequences of treated and untreated asymptomatic bacteriuria in pregnancy: a prospective cohort study with an embedded randomised controlled trial.

PubMed

Kazemier, Brenda M; Koningstein, Fiona N; Schneeberger, Caroline; Ott, Alewijn; Bossuyt, Patrick M; de Miranda, Esteriek; Vogelvang, Tatjana E; Verhoeven, Corine J M; Langenveld, Josje; Woiski, Mallory; Oudijk, Martijn A; van der Ven, Jeanine E M; Vlegels, Manita T W; Kuiper, Petra N; Feiertag, Nicolette; Pajkrt, Eva; de Groot, Christianne J M; Mol, Ben W J; Geerlings, Suzanne E

2015-11-01

Existing approaches for the screening and treatment of asymptomatic bacteriuria in pregnancy are based on trials that were done more than 30 years ago. In this study, we reassessed the consequences of treated and untreated asymptomatic bacteriuria in pregnancy. In this multicentre prospective cohort study with an embedded randomised controlled trial, we screened women (aged ≥18 years) at eight hospitals and five ultrasound centres in the Netherlands with a singleton pregnancy between 16 and 22 weeks' gestation for asymptomatic bacteriuria. Screening was done with a single dipslide and two culture media. Dipslides were judged positive when the colony concentration was at least 1×10(5) colony-forming units (CFU) per mL of a single microorganism or when two different colony types were present but one had a concentration of at least 1×10(5) CFU per mL. Asymptomatic bacteriuria-positive women were eligible to participate in the randomised controlled trial comparing nitrofurantoin with placebo treatment. In this trial, participants were randomly assigned 1:1 to receive either nitrofurantoin 100 mg or identical placebo tablets, and were instructed to self-administer these tablets twice daily for 5 consecutive days. Randomisation was done by a web-based application with a computer-generated list with random block sizes of two, four, or six participants rendered by an independent data manager. 1 week after the end of treatment, they provided us with a follow-up dipslide. Women, treating physicians, and researchers all remained unaware of the bacteriuria status and treatment allocation. Women who refused to participate in the randomised controlled trial did not receive any antibiotics, but their outcomes were collected for analysis in the cohort study. We compared untreated and placebo-treated asymptomatic bacteriuria-positive women with asymptomatic bacteriuria-negative women and nitrofurantoin-treated asymptomatic bacteriuria-positive women. The primary endpoint was a composite of pyelonephritis with or without preterm birth at less than 34 weeks, analysed by intention to treat at 6 weeks post-partum. This trial is registered with the Dutch Trial Registry, number NTR3068. Between Oct 11, 2011, and June 10, 2013, we enrolled 5621 women into our screening cohort, of whom 5132 were eligible for screening. After exclusions for contaminated dipslides and patients lost to follow-up, in our final cohort of 4283 women, 248 were asymptomatic bacteriuria positive, of whom 40 were randomly assigned to nitrofurantoin and 45 to placebo for the randomised controlled trial, whereas the other 163 asymptomatic bacteriuria-positive women were followed without treatment. The proportion of women with pyelonephritis, preterm birth, or both did not differ between untreated or placebo-treated asymptomatic bacteriuria-positive women and asymptomatic bacteriuria-negative women (6 [2·9%] of 208 vs 77 [1·9%] of 4035; adjusted odds ratio [OR] 1·5, 95% CI 0·6-3·5) nor between asymptomatic bacteriuria-positive women treated with nitrofurantoin versus those who were untreated or received placebo (1 [2·5%] of 40 vs 6 [2·9%] of 208; risk difference -0·4, 95% CI -3·6 to 9·4). Untreated or placebo-treated asymptomatic bacteriuria-positive women developed pyelonephritis in five [2·4%] of 208 cases, compared with 24 [0·6%] of 4035 asymptomatic bacteriuria-negative women (adjusted OR 3·9, 95% CI 1·4-11·4). In women with an uncomplicated singleton pregnancy, asymptomatic bacteriuria is not associated with preterm birth. Asymptomatic bacteriuria showed a significant association with pyelonephritis, but the absolute risk of pyelonephritis in untreated asymptomatic bacteriuria is low. These findings question a routine screen-treat-policy for asymptomatic bacteriuria in pregnancy. ZonMw (the Netherlands Organisation for Health Research and Development). Copyright © 2015 Elsevier Ltd. All rights reserved.

Does the age of acute care physicians impact their (1) crisis management performance and (2) learning after simulation-based education? A protocol for a multicentre prospective cohort study in Toronto and Ottawa, Canada.

PubMed

Alam, Fahad; LeBlanc, Vicki R; Baxter, Alan; Tarshis, Jordan; Piquette, Dominique; Gu, Yuqi; Filipkowska, Caroline; Krywenky, Ashley; Kester-Greene, Nicole; Cardinal, Pierre; Au, Shelly; Lam, Sandy; Boet, Sylvain; Clinical Trials Group, Perioperative Anesthesia

2018-04-21

The proportion of older acute care physicians (ACPs) has been steadily increasing. Ageing is associated with physiological changes and prospective research investigating how such age-related physiological changes affect clinical performance, including crisis resource management (CRM) skills, is lacking. There is a gap in the literature on whether physician's age influences baseline CRM performance and also learning from simulation. We aim to investigate whether ageing is associated with baseline CRM skills of ACPs (emergency, critical care and anaesthesia) using simulated crisis scenarios and to assess whether ageing influences learning from simulation-based education. This is a prospective cohort multicentre study recruiting ACPs from the Universities of Toronto and Ottawa, Canada. Each participant will manage an advanced cardiovascular life support crisis-simulated scenario (pretest) and then be debriefed on their CRM skills. They will then manage another simulated crisis scenario (immediate post-test). Three months after, participants will return to manage a third simulated crisis scenario (retention post-test). The relationship between biological age and chronological age will be assessed by measuring the participants CRM skills and their ability to learn from high-fidelity simulation. This protocol was approved by Sunnybrook Health Sciences Centre Research Ethics Board (REB Number 140-2015) and the Ottawa Health Science Network Research Ethics Board (#20150173-01H). The results will be disseminated in a peer-reviewed journal and at scientific meetings. NCT02683447; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Impact of movie-based simulation training, with or without conventional verbal demonstration on observed OSPE scores in medical undergraduates: a double control study.

PubMed

Malik, Samina; Zaheer, Reema; Bilal, Muhammad

2013-01-01

Movie-based simulation training may be useful in delivering the preclinical observed OSPE curriculum, minimising the need of subjects/patients: however, a double-control trial needs to be performed and optimal timing and duration of training is yet to be defined. Likewise, gender-based response and students' feedback has to be assessed. The objective of this study was to compare the movie-based and traditional verbal demonstration teaching methodologies. Second-year medical undergraduates (n = 90) of Avicenna Medical College were randomised to movie-based simulation training (group B, n = 30), traditional verbal training alone (group C, n=30), and a combination (group A, n = 30). The scores were marked by observers using a standardised key and were compared for performance at 2 observed OSPE stations. Group B and A performed significantly better than group C on station 1 and 2. Gender factor did not seem to influence the score. A total of 99% students reported that combination of the 2 teaching modes is the best option. They believed it offers more clear understanding with interest (61%), long term memory (21%), use of both senses; seeing & hearing (10%) & better focus of attention (3%). Even half an hour of movie-based simulation training with traditional instructor-based training may improve student performance significantly, and the students prefer a combination of the both.

The treatment of adolescent idiopathic scoliosis (AIS) according to present evidence. A systematic review.

PubMed

Weiss, H-R; Goodall, D

2008-06-01

Traditionally, the treatment options for adolescent idiopathic scoliosis (AIS), the most common form of scoliosis, are exercises; in-patient rehabilitation; braces and surgery. The outcomes of treatments are usually compared with the natural history or observation (non-intervention). The aim of this paper was to provide a synopsis of all treatment options in the light of evidence based practice (EBP). A systematic review was carried out using the most encompassing databases available. Literature has been searched for the outcome parameter ''rate of progression'' and only prospective controlled studies that have considered the treatment versus the natural history have been included. The search strategy included the following terms: ''adolescent idiopathic scoliosis''; ''idiopathic scoliosis''; ''natural history''; ''observation''; ''physiotherapy''; ''physical therapy''; ''rehabilitation''; ''bracing''; ''orthotics'' and ''surgery''. Prospective short-term studies have been found to support outpatient physiotherapy. One prospective controlled study was found to support scoliosis in-patient rehabilitation (SIR). One prospective multi-centre study, a long-term prospective controlled study and a meta-analysis have been found to support bracing. No controlled study, neither short, mid nor long-term, was found to reveal any substantial evidence to support surgery as a treatment for this condition. There is some evidence supporting the conservative treatment for AIS. No substantial evidence has been found in terms of prospective controlled studies to support surgical intervention. In light of the unknown long-term effects of surgery, a randomised controlled trial (RCT) seems necessary. Due to the presence of evidence to support conservative treatments, a plan to compose a RCT for conservative treatment options seems unethical. But it is also important to conclude that the evidence for conservative treatments is weak in number and length.

Evaluation of a theory-informed implementation intervention for the management of acute low back pain in general medical practice: the IMPLEMENT cluster randomised trial.

PubMed

French, Simon D; McKenzie, Joanne E; O'Connor, Denise A; Grimshaw, Jeremy M; Mortimer, Duncan; Francis, Jill J; Michie, Susan; Spike, Neil; Schattner, Peter; Kent, Peter; Buchbinder, Rachelle; Page, Matthew J; Green, Sally E

2013-01-01

This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Australian New Zealand Clinical Trials Registry ACTRN012606000098538.

Evaluation of a Theory-Informed Implementation Intervention for the Management of Acute Low Back Pain in General Medical Practice: The IMPLEMENT Cluster Randomised Trial

PubMed Central

French, Simon D.; McKenzie, Joanne E.; O'Connor, Denise A.; Grimshaw, Jeremy M.; Mortimer, Duncan; Francis, Jill J.; Michie, Susan; Spike, Neil; Schattner, Peter; Kent, Peter; Buchbinder, Rachelle; Page, Matthew J.; Green, Sally E.

2013-01-01

Introduction This cluster randomised trial evaluated an intervention to decrease x-ray referrals and increase giving advice to stay active for people with acute low back pain (LBP) in general practice. Methods General practices were randomised to either access to a guideline for acute LBP (control) or facilitated interactive workshops (intervention). We measured behavioural predictors (e.g. knowledge, attitudes and intentions) and fear avoidance beliefs. We were unable to recruit sufficient patients to measure our original primary outcomes so we introduced other outcomes measured at the general practitioner (GP) level: behavioural simulation (clinical decision about vignettes) and rates of x-ray and CT-scan (medical administrative data). All those not involved in the delivery of the intervention were blinded to allocation. Results 47 practices (53 GPs) were randomised to the control and 45 practices (59 GPs) to the intervention. The number of GPs available for analysis at 12 months varied by outcome due to missing confounder information; a minimum of 38 GPs were available from the intervention group, and a minimum of 40 GPs from the control group. For the behavioural constructs, although effect estimates were small, the intervention group GPs had greater intention of practising consistent with the guideline for the clinical behaviour of x-ray referral. For behavioural simulation, intervention group GPs were more likely to adhere to guideline recommendations about x-ray (OR 1.76, 95%CI 1.01, 3.05) and more likely to give advice to stay active (OR 4.49, 95%CI 1.90 to 10.60). Imaging referral was not statistically significantly different between groups and the potential importance of effects was unclear; rate ratio 0.87 (95%CI 0.68, 1.10) for x-ray or CT-scan. Conclusions The intervention led to small changes in GP intention to practice in a manner that is consistent with an evidence-based guideline, but it did not result in statistically significant changes in actual behaviour. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN012606000098538 PMID:23785427

Design and rationale of the ATHENA study--A 12-month, multicentre, prospective study evaluating the outcomes of a de novo everolimus-based regimen in combination with reduced cyclosporine or tacrolimus versus a standard regimen in kidney transplant patients: study protocol for a randomised controlled trial.

PubMed

Sommerer, Claudia; Suwelack, Barbara; Dragun, Duska; Schenker, Peter; Hauser, Ingeborg A; Nashan, Björn; Thaiss, Friedrich

2016-02-17

Immunosuppression with calcineurin inhibitors remains the mainstay of treatment after kidney transplantation; however, long-term use of these drugs may be associated with nephrotoxicity. In this regard, the current approach is to optimise available immunosuppressive regimens to reduce the calcineurin inhibitor dose while protecting renal function without affecting the efficacy. The ATHENA study is designed to evaluate renal function in two regimens: an everolimus and reduced calcineurin inhibitor-based regimen versus a standard treatment protocol with mycophenolic acid and tacrolimus in de novo kidney transplant recipients. ATHENA is a 12-month, multicentre, open-label, prospective, randomised, parallel-group study in de novo kidney transplant recipients (aged 18 years or older) receiving renal allografts from deceased or living donors. Eligible patients are randomised (1:1:1) prior to transplantation to one of the following three treatment arms: everolimus (starting dose 1.5 mg/day; C0 3-8 ng/mL) with cyclosporine or everolimus (starting dose 3 mg/day; C0 3-8 ng/mL) with tacrolimus or mycophenolic acid (enteric-coated mycophenolate sodium at 1.44 g/day or mycophenolate mofetil at 2 g/day) with tacrolimus; in combination with corticosteroids. All patients receive induction therapy with basiliximab. The primary objective is to demonstrate non-inferiority of renal function (eGFR by the Nankivell formula) in one of the everolimus arms compared with the standard group at month 12 post transplantation. The key secondary objective is to assess the incidence of treatment failure, defined as biopsy-proven acute rejection, graft loss, or death, among the treatment groups. Other objectives include assessment of the individual components of treatment failure, incidence and severity of viral infections, incidence and duration of delayed graft function, incidence of indication biopsies, slow graft function and wound healing complications, and overall safety and tolerability. Exploratory objectives include evaluation of left ventricular hypertrophy assessed by the left ventricular mass index, evolution of human leukocyte antigen and non-human leukocyte antigen antibodies, and a cytomegalovirus substudy. As one of the largest European multicentre kidney transplant studies, ATHENA will determine whether a de novo everolimus-based regimen can preserve renal function versus the standard of care. This study further assesses a number of clinical issues which impact long-term outcomes post transplantation; hence, its results will have a major clinical impact. Clinicaltrials.gov: NCT01843348, date of registration--18 April 2013; EUDRACT number: 2011-005238-21, date of registration--20 March 2012.

Systematic reviews of randomised clinical trials examining the effects of psychotherapeutic interventions versus "no intervention" for acute major depressive disorder and a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment for acute major depressive disorder.

PubMed

Jakobsen, Janus Christian

2014-10-01

Major depressive disorder afflicts an estimated 17% of individuals during their lifetimes at tremendous suffering and costs. Cognitive therapy and psychodynamic therapy may be effective treatment options for major depressive disorder, but the effects have only had limited assessment in systematic reviews. The two modern forms of psychotherapy, "third wave" cognitive therapy and mentalization-based treatment, have both gained some ground as treatments of psychiatric disorders. No randomised trial has compared the effects of these two interventions for major depressive disorder. We performed two systematic reviews with meta-analyses and trial sequential analyses using The Cochrane Collaboration methodology examining the effects of cognitive therapy and psycho-dynamic therapy for major depressive disorder. We developed a thorough treatment protocol for a randomised trial with low risks of bias (systematic error) and low risks of random errors ("play of chance") examining the effects of third wave' cognitive therapy versus mentalization-based treatment for major depressive disorder. We conducted a randomised trial according to good clinical practice examining the effects of "third wave" cognitive therapy versus mentalisation-based treatment for major depressive disorder. The first systematic review included five randomised trials examining the effects of psychodynamic therapy versus "no intervention' for major depressive disorder. Altogether the five trials randomised 365 participants who in each trial received similar antidepressants as co-interventions. All trials had high risk of bias. Four trials assessed "interpersonal psychotherapy" and one trial "short psychodynamic supportive psychotherapy". Both of these interventions are different forms of psychodynamic therapy. Meta-analysis showed that psychodynamic therapy significantly reduced depressive symptoms on the Hamilton Depression Rating Scale (HDRS) compared with "no intervention" (mean difference -3.01 (95% confidence interval -3.98 to -2.03; p = 0.00001), no significant heterogeneity between trials). Trial sequential analysis confirmed this result. The second systematic review included 12 randomised trials examining the effects of cognitive therapy versus "no intervention" for major depressive disorder. Altogether a total of 669 participants were randomised. All trials had high risk of bias. Meta-analysis showed that cognitive therapy significantly reduced depressive symptoms on the HDRS compared with "no intervention" (four trials; mean difference -3.05 (95% confidence interval, -5.23 to -0.87; p = 0.006)). Trial sequential analysis could not confirm this result. The trial protocol showed that it seemed feasible to conduct a randomised trial with low risks of bias and low risks of random errors examining the effects of "third wave" cognitive therapy versus mentalization-based therapy in a setting in the Danish healthcare system. It turned out to be much more difficult to recruit participants in the randomised trial than expected. We only included about half of the planned participants. The results from the randomised trial showed that participants randomised to "third wave" therapy compared with participants randomised to mentalization-based treatment had borderline significantly lower HDRS scores at 18 weeks in an unadjusted analysis (mean difference -4.14 score; 95% CI -8.30 to 0.03; p = 0.051). In the adjusted analysis, the difference was significant (p = 0.039). Five (22.7%) of the participants randomised to "third wave" cognitive therapy had remission at 18 weeks versus none of the participants randomised to mentalization-based treatment (p = 0.049). Sequential analysis showed that these findings could be due to random errors. No significant differences between the two groups was found regarding Beck's Depression Inventory (BDI II), Symptom Checklist 90 Revised (SCL 90-R), and The World Health Organization-Five Well-being Index 1999 (WHO 5). We concluded that cognitive therapy and psychodynamic therapy might be effective interventions for depression measured on HDRS and BDI, but the review results might be erroneous due to risks of bias and random errors. Furthermore, the effects seem relatively small. The trial protocol showed that it was possible to develop a protocol for a randomised trial examining the effects of "third wave" cognitive therapy versus mentalization-based treatment with low risks of bias and low risks of random errors. Our trial results showed that "third wave" cognitive therapy might be a more effective intervention for depressive symptoms measured on the HDRS compared with mentalization-based treatment. The two interventions did not seem to differ significantly regarding BDI II, SCL 90-R, and WHO 5. More randomised trials with low risks of bias and low risks of random errors are needed to assess the effects of cognitive therapy, psychodynamic therapy, "third wave" cognitive therapy, and mentalization-based treatment.

Making randomised trials more efficient: report of the first meeting to discuss the Trial Forge platform.

PubMed

Treweek, Shaun; Altman, Doug G; Bower, Peter; Campbell, Marion; Chalmers, Iain; Cotton, Seonaidh; Craig, Peter; Crosby, David; Davidson, Peter; Devane, Declan; Duley, Lelia; Dunn, Janet; Elbourne, Diana; Farrell, Barbara; Gamble, Carrol; Gillies, Katie; Hood, Kerry; Lang, Trudie; Littleford, Roberta; Loudon, Kirsty; McDonald, Alison; McPherson, Gladys; Nelson, Annmarie; Norrie, John; Ramsay, Craig; Sandercock, Peter; Shanahan, Daniel R; Summerskill, William; Sydes, Matt; Williamson, Paula; Clarke, Mike

2015-06-05

Randomised trials are at the heart of evidence-based healthcare, but the methods and infrastructure for conducting these sometimes complex studies are largely evidence free. Trial Forge ( www.trialforge.org ) is an initiative that aims to increase the evidence base for trial decision making and, in doing so, to improve trial efficiency.This paper summarises a one-day workshop held in Edinburgh on 10 July 2014 to discuss Trial Forge and how to advance this initiative. We first outline the problem of inefficiency in randomised trials and go on to describe Trial Forge. We present participants' views on the processes in the life of a randomised trial that should be covered by Trial Forge.General support existed at the workshop for the Trial Forge approach to increase the evidence base for making randomised trial decisions and for improving trial efficiency. Agreed upon key processes included choosing the right research question; logistical planning for delivery, training of staff, recruitment, and retention; data management and dissemination; and close down. The process of linking to existing initiatives where possible was considered crucial. Trial Forge will not be a guideline or a checklist but a 'go to' website for research on randomised trials methods, with a linked programme of applied methodology research, coupled to an effective evidence-dissemination process. Moreover, it will support an informal network of interested trialists who meet virtually (online) and occasionally in person to build capacity and knowledge in the design and conduct of efficient randomised trials.Some of the resources invested in randomised trials are wasted because of limited evidence upon which to base many aspects of design, conduct, analysis, and reporting of clinical trials. Trial Forge will help to address this lack of evidence.

Establishing the effectiveness, cost-effectiveness and student experience of a Simulation-based education Training program On the Prevention of Falls (STOP-Falls) among hospitalised inpatients: a protocol for a randomised controlled trial

PubMed Central

Williams, Cylie; Kiegaldie, Debra; Kaplonyi, Jessica; Haines, Terry

2016-01-01

Introduction Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards. Methods and analysis The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data. Ethics and dissemination The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the Australian and New Zealand Clinical Trials Registry: ACTRN12615000817549. This study protocol has been prepared according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. Trial registration number ACTRN12615000817549; Pre-results. PMID:27256087

Outcome of physiotherapy after surgery for cervical disc disease: a prospective randomised multi-centre trial

PubMed Central

2014-01-01

Background Many patients with cervical disc disease require leave from work, due to long-lasting, complex symptoms, including chronic pain and reduced levels of physical and psychological function. Surgery on a few segmental levels might be expected to resolve disc-specific pain and reduce neurological deficits, but not the non-specific neck pain and the frequent illness. No study has investigated whether post-surgery physiotherapy might improve the outcome of surgery. The main purpose of this study was to evaluate whether a well-structured rehabilitation programme might add benefit to the customary post-surgical treatment for cervical disc disease, with respect to function, disability, work capability, and cost effectiveness. Methods/Design This study was designed as a prospective, randomised, controlled, multi-centre study. An independent, blinded investigator will compare two alternatives of rehabilitation. We will include 200 patients of working age, with cervical disc disease confirmed by clinical findings and symptoms of cervical nerve root compression. After providing informed consent, study participants will be randomised to one of two alternative physiotherapy regimes; (A) customary treatment (information and advice on a specialist clinic); or (B) customary treatment plus active physiotherapy. Physiotherapy will follow a standardised, structured programme of neck-specific exercises combined with a behavioural approach. All patients will be evaluated both clinically and subjectively (with questionnaires) before surgery and at 6 weeks, 3 months, 6 months, 12 months, and 24 months after surgery. The main outcome variable will be neck-specific disability. Cost-effectiveness will also be calculated. Discussion We anticipate that the results of this study will provide evidence to support physiotherapeutic rehabilitation applied after surgery for cervical radiculopathy due to cervical disc disease. Trial registration ClinicalTrials.gov identifier: NCT01547611 PMID:24502414

A prospective, randomised comparative study of weekly versus biweekly application of dehydrated human amnion/chorion membrane allograft in the management of diabetic foot ulcers

PubMed Central

Zelen, Charles M; Serena, Thomas E; Snyder, Robert J

2014-01-01

The aim of this study is to determine if weekly application of dehydrated human amnion/chorion membrane allograft reduce time to heal more effectively than biweekly application for treatment of diabetic foot ulcers. This was an institutional review board-approved, registered, prospective, randomised, comparative, non-blinded, single-centre clinical trial. Patients with non-infected ulcers of ≥ 4 weeks duration were included for the study. They were randomised to receive weekly or biweekly application of allograft in addition to a non-adherent, moist dressing with compressive wrapping. All wounds were offloaded. The primary study outcome was mean time to healing. Overall, during the 12-week study period, 92·5% (37/40) ulcers completely healed. Mean time to complete healing was 4·1 ± 2·9 versus 2·4 ± 1·8 weeks (P = 0·039) in the biweekly versus weekly groups, respectively. Complete healing occurred in 50% versus 90% by 4 weeks in the biweekly and weekly groups, respectively (P = 0·014). Number of grafts applied to healed wounds was similar at 2·4 ± 1·5 and 2·3 ± 1·8 for biweekly versus weekly groups, respectively (P = 0·841). These results validate previous studies showing that the allograft is an effective treatment for diabetic ulcers and show that wounds treated with weekly application heal more rapidly than with biweekly application. More rapid healing may decrease clinical operational costs and prevent long-term medical complications. PMID:24618401

Benefits of Aldosterone Receptor Antagonism in Chronic Kidney Disease (BARACK D) trial-a multi-centre, prospective, randomised, open, blinded end-point, 36-month study of 2,616 patients within primary care with stage 3b chronic kidney disease to compare the efficacy of spironolactone 25 mg once daily in addition to routine care on mortality and cardiovascular outcomes versus routine care alone: study protocol for a randomized controlled trial.

PubMed

Hill, Nathan R; Lasserson, Daniel; Thompson, Ben; Perera-Salazar, Rafael; Wolstenholme, Jane; Bower, Peter; Blakeman, Thomas; Fitzmaurice, David; Little, Paul; Feder, Gene; Qureshi, Nadeem; Taal, Maarten; Townend, Jonathan; Ferro, Charles; McManus, Richard; Hobbs, Fd Richard

2014-05-08

Chronic kidney disease (CKD) is common and increasing in prevalence. Cardiovascular disease (CVD) is a major cause of morbidity and death in CKD, though of a different phenotype to the general CVD population. Few therapies have proved effective in modifying the increased CVD risk or rate of renal decline in CKD. There are accumulating data that aldosterone receptor antagonists (ARA) may offer cardio-protection and delay renal impairment in patients with the CV phenotype in CKD. The use of ARA in CKD has therefore been increasingly advocated. However, no large study of ARA with renal or CVD outcomes is underway. The study is a prospective randomised open blinded endpoint (PROBE) trial set in primary care where patients will mainly be identified by their GPs or from existing CKD lists. They will be invited if they have been formally diagnosed with CKD stage 3b or there is evidence of stage 3b CKD from blood results (eGFR 30-44 mL/min/1.73 m2) and fulfil the other inclusion/exclusion criteria. Patients will be randomised to either spironolactone 25 mg once daily in addition to routine care or routine care alone and followed-up for 36 months. BARACK D is a PROBE trial to determine the effect of ARA on mortality and cardiovascular outcomes (onset or progression of CVD) in patients with stage 3b CKD. EudraCT: 2012-002672-13ISRTN: ISRCTN44522369.

A Prospective Study of Pravastatin in the Elderly at Risk (PROSPER): Screening Experience and Baseline Characteristics

PubMed Central

Ford, Ian; Blauw, Gerard Jan; Murphy, Michael B; Shepherd, James; Cobbe, Stuart M; Bollen, Edward LEM; Buckley, Brendan M; Jukema, J Wouter; Hyland, Michael; Gaw, Allan; Lagaay, A Margot; Perry, Ivan J; Macfarlane, Peter; Norrie, John; Meinders, A Edo; Sweeney, Brian J; Packard, Chris J; Westendorp, Rudi GJ; Twomey, Cillian; Stott, David J

2002-01-01

Background PROSPER was designed to investigate the benefits of treatment with pravastatin in elderly patients for whom a typical doctor might consider the prescription of statin therapy to be a realistic option. Methods The PROspective Study of Pravastatin in the Elderly at Risk (PROSPER) is a randomised, double blind, placebo-controlled trial to test the hypothesis that treatment with pravastatin (40 mg/day) will reduce the risk of coronary heart disease death, non-fatal myocardial infarction, and fatal or non-fatal stroke in elderly men and women with pre-existing vascular disease or with significant risk of developing this condition. Results In Scotland, Ireland, and the Netherlands, 23,770 individuals were screened, and 5,804 subjects (2,804 men and 3,000 women), aged 70 to 82 years (average 75 years) and with baseline cholesterol 4.0–9.0 mmol/l, were randomised. Randomised subjects had similar distributions with respect to age, blood pressure, and body mass index when compared to the entire group of screenees, but had a higher prevalence of smoking, diabetes, hypertension, and a history of vascular disease. The average total cholesterol level at baseline was 5.4 mmol/l (men) and 6.0 mmol/l (women). Conclusions Compared with previous prevention trials of cholesterol-lowering drugs, the PROSPER cohort is significantly older and for the first time includes a majority of women. The study, having achieved its initial goal of recruiting more than 5,500 elderly high-risk men and women, aims to complete all final subject follow-up visits in the first half of 2002 with the main results being available in the fourth quarter of 2002. PMID:12097148

Sacroiliac joint pain: Prospective, randomised, experimental and comparative study of thermal radiofrequency with sacroiliac joint block.

PubMed

Cánovas Martínez, L; Orduña Valls, J; Paramés Mosquera, E; Lamelas Rodríguez, L; Rojas Gil, S; Domínguez García, M

2016-05-01

To compare the analgesic effects between the blockade and bipolar thermal radiofrequency in the treatment of sacroiliac joint pain. Prospective, randomised and experimental study conducted on 60 patients selected in the two hospitals over a period of nine months, who had intense sacroiliac joint pain (Visual Analogue Scale [VAS]>6) that lasted more than 3 months. Patients were randomised into three groups (n=20): Group A (two intra-articular sacroiliac injections of local anaesthetic/corticosteroid guided by ultrasound in 7 days). Group B: conventional bipolar radiofrequency "palisade". Target points were the lateral branch nerves of S1, S2, and S3, distance needles 1cm. Group C: modified bipolar radiofrequency "palisade" (needle distance >1cm). Patients were evaluated at one month, three months, and one year. Demographic data, VAS reduction, and side effects of the techniques were assessed. One month after the treatment, pain reduction was >50% in the three groups P<.001. Three and 12 months after the technique, the patients of the group A did not have a significant reduction in pain. At 3 months, almost 50% patients of the group B referred to improvement of the pain (P=.03), and <25% at 12 months, and those results were statistically significant (P=.01) compared to the baseline. Group C showed an improvement of 50% at 3 and 12 months (P<.001). All patients completed the study. Bipolar radiofrequency "palisade", especially when the distance between the needles was increased, was more effective and lasted longer, compared to join block and steroids, in relieving pain sacroiliac joint. Copyright © 2015 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Publicado por Elsevier España, S.L.U. All rights reserved.

Laparoscopic cholecystectomy under spinal anaesthesia: A prospective, randomised study

PubMed Central

Tiwari, Sangeeta; Chauhan, Ashutosh; Chaterjee, Pallab; Alam, Mohammed T

2013-01-01

CONTEXT: Spinal anaesthesia has been reported as an alternative to general anaesthesia for performing laparoscopic cholecystectomy (LC). AIMS: Study aimed to evaluate efficacy, safety and cost benefit of conducting laparoscopic cholecystectomy under spinal anaesthesia (SA) in comparison to general anaesthesia(GA) SETTINGS AND DESIGN: A prospective, randomised study conducted over a two year period at an urban, non teaching hospital. MATERIALS AND METHODS: Patients meeting inclusion criteria e randomised into two groups. Group A and Group B received general and spinal anaesthesia by standardised techniques. Both groups underwent standard four port laparoscopic cholecystectomy. Mean anaesthesia time, pneumoperitoneum time and surgery time defined primary outcome measures. Intraoperative events and post operative pain score were secondary outcome measure. STATISTICAL ANALYSIS USED: The Student t test, Pearson′s chi-square test and Fisher exact test. RESULTS: Out of 235 cases enrolled in the study, 114 cases in Group A and 110 in Group B analysed. Mean anaesthesia time appeared to be more in the GA group (49.45 vs. 40.64, P = 0.02) while pneumoperitoneum time and corresponding the total surgery time was slightly longer in the SA group. 27/117 cases who received SA experienced intraoperative events, four significant enough to convert to GA. No postoperative complications noted in either group. Pain relief significantly more in SA group in immediate post operative period (06 and 12 hours) but same as GA group at time of discharge (24 hours). No late postoperative complication or readmission noted in either group. CONCLUSION: Laparoscopic cholecystectomy done under spinal anaesthesia as a routine anaesthesia of choice is feasible and safe. Spinal anaesthesia can be recommended to be the anaesthesia technique of choice for conducting laparoscopic cholecystectomy in hospital setups in developing countries where cost factor is a major factor. PMID:23741111

Postoperative analgesic efficacy of ultrasound-guided ilioinguinal-iliohypogastric nerve block compared with medial transverse abdominis plane block in inguinal hernia repair: A prospective, randomised trial.

PubMed

Bhatia, Nidhi; Sen, Indu Mohini; Mandal, Banashree; Batra, Ankita

2018-03-29

Analgesic efficacy of ultrasound-guided transverse abdominis plane block, administered a little more medially, just close to the origin of the transverse abdominis muscle has not yet been investigated in patients undergoing unilateral inguinal hernia repair. We hypothesised that medial transverse abdominis plane block would provide comparable postoperative analgesia to ilioinguinal-iliohypogastric nerve block in inguinal hernia repair patients. This prospective, randomised trial was conducted in 50 ASA I and II male patients≥18 years of age. Patients were randomised into two groups to receive either pre-incisional ipsilateral ultrasound-guided ilioinguinal-iliohypogastric nerve block or medial transverse abdominis plane block, with 0.3ml/kg of 0.25% bupivacaine. Our primary objective was postoperative 24-hour analgesic consumption and secondary outcomes included pain scores, time to first request for rescue analgesic and side effects, if any, in the postoperative period. There was no significant difference in the total postoperative analgesic consumption [group I: 66.04mg; group II: 68.33mg (P value 0.908)]. Time to first request for rescue analgesic was delayed, though statistically non-significant (P value 0.326), following medial transverse abdominis plane block, with excellent pain relief seen in 58.3% patients as opposed to 45.8% patients in ilioinguinal-iliohypogastric nerve block group. Medial transverse abdominis plane block being a novel, simple and easily performed procedure can serve as an useful alternative to ilioinguinal-iliohypogastric nerve block for providing postoperative pain relief in inguinal hernia repair patients. Copyright © 2018 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

One-year follow-up of tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of female stress urinary incontinence: a prospective randomised trial.

PubMed

Zullo, Marzio Angelo; Plotti, Francesco; Calcagno, Marco; Marullo, Elettra; Palaia, Innocenza; Bellati, Filippo; Basile, Stefano; Muzii, Ludovico; Angioli, Roberto; Panici, Pierluigi Benedetti

2007-05-01

To compare tension-free vaginal tape (TVT) and trans-obturator suburethral tape from inside to outside (TVT-O) for surgical treatment of stress urinary incontinence (SUI) for complications (primary end point) and success rate (secondary end point). Seventy-two consecutive patients, with a mean age of 53.2 yr (range: 38-69 yr) and affected by SUI, were included in this randomised controlled trial. After preoperative assessment, patients were randomly allocated to the TVT or TVT-O procedure. Operative time, perioperative complications, and hospital stay were prospectively recorded. Cure of SUI was defined as no leakage of urine during the stress test at urodynamic testing at the 12-mo evaluation. The Wilcoxon signed rank sum test, Mann-Whitney U test, McNemar test, and Fisher exact test were used to verify statistical significance, set at p<0.05. All patients were evaluable at the 12-mo follow-up. The characteristics of patients were well balanced between groups after randomisation. The mean operative time was significantly shorter in the TVT-O group. Perioperative complications were significantly more common after the retropubic approach (5% and 27% in TVT-O and TVT groups, respectively, p<0.04). The groups did not differ significantly in intraoperative blood loss, hospital stays, and time to return to normal activities. Sixty-five patients (90%) were successfully treated for SUI 12 mo after the operation (89% and 91% for TVT-O and TVT groups, respectively). Both techniques appear to be equally effective in the surgical treatment of SUI. However, TVT-O had a shorter operative time and lower overall perioperative complication rate.

Peri-interventional antibiotic prophylaxis only vs continuous low-dose antibiotic treatment in patients with JJ stents: a prospective randomised trial analysing the effect on urinary tract infections and stent-related symptoms.

PubMed

Moltzahn, Felix; Haeni, Katharina; Birkhäuser, Frédéric D; Roth, Beat; Thalmann, George N; Zehnder, Pascal

2013-02-01

To evaluate the antibiotic treatment regime in patients with indwelling JJ stents, the benefits and disadvantages of a peri-interventional antibiotic prophylaxis were compared with those of a continuous low-dose antibiotic treatment in a prospective randomised trial. In all, 95 patients were randomised to either receive peri-interventional antibiotic prophylaxis during stent insertion only (group A, 44 patients) or to additionally receive a continuous low-dose antibiotic treatment until stent removal (group B, 51). Evaluations for urinary tract infections (UTI), stent-related symptoms (SRSs) and drug side-effects were performed before stent insertion and consecutively after 1, 2 and 4 weeks and/or at stent withdrawal. All patients received a peri-interventional antibiotic prophylaxis with 1.2 g amoxicillin/clavulanic acid. Amoxicillin/clavulanic acid (625 mg) once daily was administered for continuous low-dose treatment (group B). Primary endpoints were the overall rates of UTIs and SRSs. Secondary endpoints were the rates and severity of drug side-effects. Neither the overall UTI rates (group A: 9% vs group B: 10%), nor the rates of febrile UTIs (group A: 7% vs group B: 6%) were different between the groups. Similarly, SRS rates did not differ (group A: 98% vs group B: 96%). Antibiotic side-effect symptoms were to be increased in patients treated with low-dose antibiotics. A continuous antibiotic low-dose treatment during the entire JJ stent-indwelling time does not reduce the quantity or severity of UTIs and has no effect on SRSs either compared with a peri-interventional antibiotic prophylaxis only. © 2012 BJU International.

Drug treatment of bothersome lower urinary tract symptoms after ureteric JJ-stent insertion: A contemporary, comparative, prospective, randomised placebo-controlled study, single-centre experience.

PubMed

Hekal, Ihab A

2016-12-01

To provide a guide for medication to alleviate bothersome lower urinary tract symptoms (LUTS) in patients after JJ ureteric stenting. Between June 2011 and June 2015, a prospective randomised placebo-controlled study was conducted on 200 consecutive cases of ureteric stones that required JJ stents. All patients had signed informed consent and JJ-stent placement confirmed by X-ray. The patients were randomised into five groups: A, solifenacin 5 mg; B, trospium chloride 20 mg; C, antispasmodic; and E, α-blocker; and a placebo group (D). A standard model was created to lessen patient selection bias. Eligible patients were enrolled and assessed for side-effects and bothersome LUTS using the validated Ureteric Stent Symptoms Questionnaire. Appropriate statistical analysis was carried out. In all, 150 male patients in the five groups were compared. LUTS were less in groups A and B ( P  < 0.05), while dry mouth was significantly reported in Group A. Individual comparisons with the placebo group showed a non-significant difference with Group C, while Group E had significant nocturia improvement. Selective comparison of two best groups (A and B) showed less frequency in Group B, while the other LUTS were less in Group A with comparable side-effects. In symptomatic patients following JJ-stent insertion, anti-muscarinic medication, namely solifenacin 5 mg or trospium chloride 20 mg, was the best. The advantage of trospium over solifenacin is in the control of frequency rather than the other symptoms. Addition of an α-blocker (alfuzosin 10 mg) is valuable when nocturia is the predominant symptom.

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital

PubMed Central

Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-01-01

Objectives To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Design Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Results Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more ‘real’ RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. Conclusion There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. PMID:29420230

Detailed systematic analysis of recruitment strategies in randomised controlled trials in patients with an unscheduled admission to hospital.

PubMed

Rowlands, Ceri; Rooshenas, Leila; Fairhurst, Katherine; Rees, Jonathan; Gamble, Carrol; Blazeby, Jane M

2018-02-02

To examine the design and findings of recruitment studies in randomised controlled trials (RCTs) involving patients with an unscheduled hospital admission (UHA), to consider how to optimise recruitment in future RCTs of this nature. Studies within the ORRCA database (Online Resource for Recruitment Research in Clinical TriAls; www.orrca.org.uk) that reported on recruitment to RCTs involving UHAs in patients >18 years were included. Extracted data included trial clinical details, and the rationale and main findings of the recruitment study. Of 3114 articles populating ORRCA, 39 recruitment studies were eligible, focusing on 68 real and 13 hypothetical host RCTs. Four studies were prospectively planned investigations of recruitment interventions, one of which was a nested RCT. Most recruitment papers were reports of recruitment experiences from one or more 'real' RCTs (n=24) or studies using hypothetical RCTs (n=11). Rationales for conducting recruitment studies included limited time for informed consent (IC) and patients being too unwell to provide IC. Methods to optimise recruitment included providing patients with trial information in the prehospital setting, technology to allow recruiters to cover multiple sites, screening logs to uncover recruitment barriers, and verbal rather than written information and consent. There is a paucity of high-quality research into recruitment in RCTs involving UHAs with only one nested randomised study evaluating a recruitment intervention. Among the remaining studies, methods to optimise recruitment focused on how to improve information provision in the prehospital setting and use of screening logs. Future research in this setting should focus on the prospective evaluation of the well-developed interventions to optimise recruitment. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Five-year follow-up of a prospective non-randomised study comparing duodenum-preserving pancreatic head resection with classic Whipple procedure in the treatment of chronic pancreatitis.

PubMed

Möbius, C; Max, D; Uhlmann, D; Gumpp, K; Behrbohm, J; Horvath, K; Hauss, J; Witzigmann, H

2007-05-01

Three prospective randomised studies were conducted to compare pancreatoduodenectomy (PD) with duodenum-preserving pancreatic head resection (DPPHR) in patients suffering from chronic pancreatitis (cP). In these three series, the superiority of the duodenum-preserving technique with regard to quality of life (QOL) and pain relief has been demonstrated. Long-term follow-up investigations have not been published so far. The present paper reports on a 5-year follow-up study of a prospective, non-randomised trial comparing classic Whipple procedure (PD) with Beger DPPHR. Seventy patients were initially enrolled in this study. Fifty-one patients were left for the present long-term outcome analysis (PD, n = 24; DPPHR, n = 27). The follow-up included the following parameters: QOL, pain intensity, endocrine and exocrine function, and body mass index (BMI). The median follow-up was 63.5 (range 56-67) months. Two patients in the DPPHR group and none in the PD group underwent a re-operation. The QOL scores of the relevant symptom scales (nausea, pain, diarrhoea) and functional parameters (physical status, working ability, global QOL) were significantly better in the DPPHR group than in the PD group. Pain intensity as self-assessed by the patients was less pronounced in the DPPHR group (P < 0.001), whereas the frequency of acute episodes and analgesic medication did not differ between the two groups. No difference was observed between the two groups with regard to endocrine and exocrine function. The values of the median body mass index (BMI) in the PD group [23.4 (range 18.5-25.0) kg/m(2)] and in the DPPHR group [24.2 (range 17.9-27.8) kg/m(2)] were comparable. The 5-year outcome remained stable compared to the early post-operative data published elsewhere. This 5-year long-term outcome analysis documents the superiority of the Beger duodenum-preserving technique over the classic Whipple procedure in terms of QOL and pain intensity as self-assessed by the patients.

Interpretation of health news items reported with or without spin: protocol for a prospective meta-analysis of 16 randomised controlled trials

PubMed Central

Haneef, Romana; Yavchitz, Amélie; Ravaud, Philippe; Baron, Gabriel; Oranksy, Ivan; Schwitzer, Gary; Boutron, Isabelle

2017-01-01

Introduction We aim to compare the interpretation of health news items reported with or without spin. ‘Spin’ is defined as a misrepresentation of study results, regardless of motive (intentionally or unintentionally) that overemphasises the beneficial effects of the intervention and overstates safety compared with that shown by the results. Methods and analysis We have planned a series of 16 randomised controlled trials (RCTs) to perform a prospective meta-analysis. We will select a sample of health news items reporting the results of four types of study designs, evaluating the effect of pharmacological treatment and containing the highest amount of spin in the headline and text. News items reporting four types of studies will be included: (1) preclinical studies; (2) phase I/II (non-randomised) trials; (3) RCTs and (4) observational studies. We will rewrite the selected news items and remove the spin. The original news and rewritten news will be appraised by four types of populations: (1) French-speaking patients; (2) French-speaking general public; (3) English-speaking patients and (4) English-speaking general public. Each RCT will explore the interpretation of news items reporting one of the four study designs by each type of population and will include a sample size of 300 participants. The primary outcome will be participants’ interpretation of the benefit of treatment after reading the news items: (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 (very unlikely) to 10 (very likely)). This study will evaluate the impact of spin on the interpretation of health news reporting results of studies by patients and the general public. Ethics and dissemination This study has obtained ethics approval from the Institutional Review Board of the Institut national de la santé et de la recherche médicale (INSERM) (registration no: IRB00003888). The description of all the steps and the results of this prospective meta-analysis will be available online and will be disseminated as a published article. On the completion of this study, the results will be sent to all participants. PROSPERO registration number CRD42017058941. PMID:29151047

Prospective randomised controlled trial of nanocrystalline silver dressing versus plain gauze as the initial post-debridement management of military wounds on wound microbiology and healing.

PubMed

Fries, C A; Ayalew, Y; Penn-Barwell, J G; Porter, K; Jeffery, S L A; Midwinter, M J

2014-07-01

Recent conflicts have been characterised by the use of improvised explosive devices causing devastating injuries, including heavily contaminated wounds requiring meticulous surgical debridement. After being rendered surgical clean, these wounds are dressed and the patient transferred back to the UK for on-going treatment. A dressing that would prevent wounds from becoming colonised during transit would be desirable. The aim of this study was to establish whether using nanocrystalline silver dressings, as an adjunct to the initial debridement, would positively affect wound microbiology and wound healing compared to standard plain gauze dressings. Patients were prospectively randomised to receive either silver dressings, in a nanocrystalline preparation (Acticoat™), or standard of care dressings (plain gauze) following their initial debridement in the field hospital. On repatriation to the UK microbiological swabs were taken from the dressing and the wound, and an odour score recorded. Wounds were followed prospectively and time to wound healing was recorded. Additionally, patient demographic data were recorded, as well as the mechanism of injury and Injury Severity Score. 76 patients were recruited to the trial between February 2010 and February 2012. 39 received current dressings and 37 received the trial dressings. Eleven patients were not swabbed. There was no difference (p=0.1384, Fishers) in the primary outcome measure of wound colonisation between the treatment arm (14/33) and the control arm (20/32). Similarly time to wound healing was not statistically different (p=0.5009, Mann-Whitney). Wounds in the control group were scored as being significantly more malodorous (p=0.002, Mann-Whitney) than those in the treatment arm. This is the first randomised controlled trial to report results from an active theatre of war. Performing research under these conditions poses additional challenges to military clinicians. Meticulous debridement of wounds remains the critical determinant in wound healing and infection and this study did not demonstrate a benefit of nanocrystaline silver dressing in respect to preventing wound colonisation or promoting healing, these dressings do however seem to significantly reduce the unpleasant odour commonly associated with battlefield wounds. Crown Copyright © 2013. Published by Elsevier Ltd. All rights reserved.

The potential for improvement of outcomes by personalized insulin treatment of type 1 diabetes as assessed by analysis of single-patient data from a randomized controlled cross-over insulin trial.

PubMed

Pedersen-Bjergaard, Ulrik; Kristensen, Peter L; Beck-Nielsen, Henning; Nørgaard, Kirsten; Perrild, Hans; Christiansen, Jens S; Jensen, Tonny; Parving, Hans-Henrik; Thorsteinsson, Birger; Tarnow, Lise

2017-01-01

The evidence for optimal insulin treatment in type 1 diabetes is mainly based on randomised controlled trials applying a parallel-group design. Such trials yield robust general results but crucial individual treatment effects cannot be extracted. We aimed to assess the potential for further improvement of outcomes by personalized insulin therapy by analyzing data from a cross-over trial at individual level. Post hoc analysis of data from a two-year multicentre, prospective, randomised, open, blinded endpoint (PROBE) trial (the HypoAna trial). In a cross-over design 114 patients with type 1 diabetes and recurrent severe hypoglycemia were treated with basal-bolus therapy based on analog (detemir/aspart) or human (NPH/regular) insulin aiming at maintenance of baseline HbA1c levels. For each patient a superior outcome was defined as fewer events of severe hypoglycemia defined by need for third party treatment assistance or a more than 0.4% (4.4mmol/mol) lower HbA1c. Only one quarter had comparable outcome of the two treatments in terms of rate of severe hypoglycemia or HbA1c. Twice as many patients had superior outcome of analog-based as compared to human insulin-based insulin treatment. The rate of severe hypoglycemia with the superior treatment was lower compared to the rates obtained with analog insulin and with human insulin (0.67, 1.09, and 1.57 episode per patient-year, respectively (p<0.0001)). Personalized insulin treatment of type 1 diabetes based on single-patient evidence may improve outcomes significantly compared to a general treatment approach. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Novel electrogram device with web-based service centre for ambulatory ECG monitoring.

PubMed

Tan, B Y; Ho, K L; Ching, C K; Teo, W S

2010-07-01

Arrhythmias are often intermittent, and a normal electrocardiogram (ECG) may not be diagnostic. The purpose of this study was to evaluate the usefulness of HeartWave500 (HW), a novel web-based ambulatory ECG monitoring device. A total of 120 patients from the National Heart Centre, Singapore were prospectively randomised in a three to one ratio to either HW or a standard transtelephonic (TT) event recorder. HW records five leads and transmits to an internet server, while TT transmits audio data to a central station. Monitoring was conducted for two weeks. The diagnostic yield was calculated in two ways: the percentage of patients successfully diagnosed as a function of time, and the absolute number of new diagnoses per patient per week. 33 patients (14 male, 19 female; mean age 49.6 + or - 11.1 years) were randomised to TT. 87 patients (32 male, 55 female; mean age 43.7 + or - 12.2 years) were randomised to HW. At the end of two weeks, the percentage of patients diagnosed with any arrhythmia was similar for both groups (66.7 percent for TT versus 67.8 percent for HW). There was a trend toward significance for the number of diagnoses per patient per week for Week 2 between TT and HW (0.58 + or - 0.75 versus 0.34 + or - 0.55, p is 0.06). Transmitted ECGs were read earlier for HW (18 minutes versus 1107 minutes, Mann-Whitney non-parametric test, p is less than 0.05). Transmitted recordings that were unreadable were also significantly lower for HW (8.0 percent versus 17.6 percent, chi-square test, p is less than 0.05). HW and TT have similar diagnostic yields. There is a trend toward a shorter monitoring time for HW. The ability of HW to record and transmit via the web, the earlier review of data and low unreadable data make HW an attractive alternative to TT.

Targeted rehabilitation to improve outcome after total knee replacement (TRIO): study protocol for a randomised controlled trial.

PubMed

Simpson, A Hamish R W; Hamilton, David F; Beard, David J; Barker, Karen L; Wilton, Timothy; Hutchison, James D; Tuck, Chris; Stoddard, Andrew; Macfarlane, Gary J; Murray, Gordon D

2014-02-01

Approximately 20% of patients are not satisfied with the outcome of total knee replacement, great volumes of which are carried out yearly. Physiotherapy is often provided by the NHS to address dysfunction following knee replacement; however the efficacy of this is unknown. Although clinically it is accepted that therapy is useful, provision of physiotherapy to all patients post-operatively does not enhance outcomes at one year. No study has previously assessed the effect of targeting therapy to individuals struggling to recover in the early post-operative phase.The aim of the TRIO study is to determine whether stratifying care by targeting physiotherapy to those individuals performing poorly following knee replacement is effective in improving the one year outcomes. We are also investigating whether the structure of the physiotherapy provision itself influences outcomes. The study is a multi-centre prospective randomised controlled trial (RCT) of patients undergoing primary total knee replacement, with treatment targeted at those deemed most susceptible to gain from it. Use of the national PROMS programme for pre-operative data collection allows us to screen all patients at initial post-operative clinical review, and recruit only those deemed to be recovering slowly.We aim to recruit 440 patients through various NHS orthopaedic centres who will undergo six weeks of physiotherapy. The intervention will be either 'intensive' involving both hospital and home-based functional exercise rehabilitation, or 'standard of care' consisting of home exercises. Patients will be randomised to either group using a web-based system. Both groups will receive pre and post-intervention physiotherapy review. Patients will be followed-up to one year post-operation. The primary outcome measure is the Oxford Knee Score. Secondary outcomes are patient satisfaction, functional ability, pain scores and cost-effectiveness. Current Controlled Trials ISRCTN23357609. ClinicalTrials.gov NCT01849445.

The use of instrumented gait analysis for individually tailored interdisciplinary interventions in children with cerebral palsy: a randomised controlled trial protocol.

PubMed

Rasmussen, Helle Mätzke; Pedersen, Niels Wisbech; Overgaard, Søren; Hansen, Lars Kjaersgaard; Dunkhase-Heinl, Ulrike; Petkov, Yanko; Engell, Vilhelm; Baker, Richard; Holsgaard-Larsen, Anders

2015-12-07

Children with cerebral palsy (CP) often have an altered gait. Orthopaedic surgery, spasticity management, physical therapy and orthotics are used to improve the gait. Interventions are individually tailored and are planned on the basis of clinical examinations and standardised measurements to assess walking ('care as usual'). However, these measurements do not describe features in the gait that reflect underlying neuro-musculoskeletal impairments. This can be done with 3-dimensional instrumented gait analysis (IGA). The aim of this study is to test the hypothesis that improvements in gait following individually tailored interventions when IGA is used are superior to those following 'care as usual'. A prospective, single blind, randomised, parallel group study will be conducted. Children aged 5 to 8 years with spastic CP, classified at Gross Motor Function Classification System levels I or II, will be included. The interventions under investigation are: 1) individually tailored interdisciplinary interventions based on the use of IGA, and 2) 'care as usual'. The primary outcome is gait measured by the Gait Deviation Index. Secondary outcome measures are: walking performance (1-min walk test) and patient-reported outcomes of functional mobility (Pediatric Evaluation of Disability Inventory), health-related quality of life (The Pediatric Quality of Life Inventory Cerebral Palsy Module) and overall health, pain and participation (The Pediatric Outcome Data Collection Instrument). The primary endpoint for assessing the outcome of the two interventions will be 52 weeks after start of intervention. A follow up will also be performed at 26 weeks; however, exclusively for the patient-reported outcomes. To our knowledge, this is the first randomised controlled trial comparing the effects of an individually tailored interdisciplinary intervention based on the use of IGA versus 'care as usual' in children with CP. Consequently, the study will provide novel evidence for the use of IGA. ClinicalTrials.gov NCT02160457 . Registered June 2, 2014.

Increasing organ donation via anticipated regret (INORDAR): protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Throughout the world there is an insufficient supply of donor organs to meet the demand for organ transplantations. This paper presents a protocol for a randomised controlled trial, testing whether a simple, theory-based anticipated regret manipulation leads to a significant increase in posthumous organ donor registrations. Methods We will use a between-groups, prospective randomised controlled design. A random sample of 14,520 members of the adult Scottish general public will be contacted via post. These participants will be randomly allocated into 1 of the 4 conditions. The no questionnaire control (NQC) group will simply receive a letter and donor registration form. The questionnaire control (QC) arm will receive a questionnaire measuring their emotions and non-cognitive affective attitudes towards organ donation. The theory of planned behavior (TPB) group will complete the emotions and affective attitudes questionnaire plus additional items assessing their cognitive attitudes towards organ donation, perceived control over registration and how they think significant others view this action. Finally, the anticipated regret (AR) group will complete the same indices as the TPB group, plus two additional anticipated regret items. These items will assess the extent to which the participant anticipates regret for not registering as an organ donor in the near future. The outcome variable will be NHS Blood and Transplant verified registrations as an organ donor within 6 months of receiving our postal intervention. Discussion This study will assess whether simply asking people to reflect on the extent to which they may anticipate regret for not registering as an organ donor increases organ donor registration 6 months later. If successful, this simple and easy to administer theory-based intervention has the potential to save lives and money for the NHS by reducing the number of people receiving treatments such as dialysis. This intervention may also be incorporated into future organ donor campaigns. Trial registration number ISRCTN: ISRCTN92204897 PMID:22401534

Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia

PubMed Central

MacDonald, Thomas M; Ford, Ian; Nuki, George; Mackenzie, Isla S; De Caterina, Raffaele; Findlay, Evelyn; Hallas, Jesper; Hawkey, Christopher J; Ralston, Stuart; Walters, Matthew; Webster, John; McMurray, John; Perez Ruiz, Fernando; Jennings, Claudine G

2014-01-01

Introduction Gout affects 2.5% of the UK's adult population and is now the most common type of inflammatory arthritis. The long-term management of gout requires reduction of serum urate levels and this is most often achieved with use of xanthine oxidase inhibitors, such as allopurinol. Febuxostat is the first new xanthine oxidase inhibitor since allopurinol and was licensed for use in 2008. The European Medicines Agency requested a postlicensing cardiovascular safety study of febuxostat versus allopurinol, which has been named the Febuxostat versus Allopurinol Streamlined trial (FAST). Methods and analysis FAST is a cardiovascular safety study using the prospective, randomised, open, blinded endpoint design. FAST is recruiting in the UK and Denmark. Recruited patients are aged over 60 years, prescribed allopurinol for symptomatic hyperuricaemia and have at least one additional cardiovascular risk factor. After an allopurinol lead-in phase where the dose of allopurinol is optimised to achieve European League against Rheumatism (EULAR) urate targets (serum urate <357 µmol/L), patients are randomised to either continue optimal dose allopurinol or to use febuxostat. Patients are followed-up for an average of 3 years. The primary endpoint is first occurrence of the Anti-Platelet Trialists’ Collaboration (APTC) cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary endpoints are all cause mortality and hospitalisations for heart failure, unstable, new or worsening angina, coronary or cerebral revascularisation, transient ischaemic attack, non-fatal cardiac arrest, venous and peripheral arterial vascular thrombotic event and arrhythmia with no evidence of ischaemia. The primary analysis is a non-inferiority analysis with a non-inferiority upper limit for the HR for the primary outcome of 1.3. Ethics and dissemination FAST (ISRCTN72443728) has ethical approval in the UK and Denmark, and results will be published in a peer reviewed journal. Trial Registration number FAST is registered in the EU Clinical Trials Register (EUDRACT No: 2011-001883-23) and International Standard Randomised Controlled Trial Number Register (ISRCTN No: ISRCTN72443728). PMID:25011991

Methods of a large prospective, randomised, open-label, blinded end-point study comparing morning versus evening dosing in hypertensive patients: the Treatment In Morning versus Evening (TIME) study.

PubMed

Rorie, David A; Rogers, Amy; Mackenzie, Isla S; Ford, Ian; Webb, David J; Willams, Bryan; Brown, Morris; Poulter, Neil; Findlay, Evelyn; Saywood, Wendy; MacDonald, Thomas M

2016-02-09

Nocturnal blood pressure (BP) appears to be a better predictor of cardiovascular outcome than daytime BP. The BP lowering effects of most antihypertensive therapies are often greater in the first 12 h compared to the next 12 h. The Treatment In Morning versus Evening (TIME) study aims to establish whether evening dosing is more cardioprotective than morning dosing. The TIME study uses the prospective, randomised, open-label, blinded end-point (PROBE) design. TIME recruits participants by advertising in the community, from primary and secondary care, and from databases of consented patients in the UK. Participants must be aged over 18 years, prescribed at least one antihypertensive drug taken once a day, and have a valid email address. After the participants have self-enrolled and consented on the secure TIME website (http://www.timestudy.co.uk) they are randomised to take their antihypertensive medication in the morning or the evening. Participant follow-ups are conducted after 1 month and then every 3 months by automated email. The trial is expected to run for 5 years, randomising 10,269 participants, with average participant follow-up being 4 years. The primary end point is hospitalisation for the composite end point of non-fatal myocardial infarction (MI), non-fatal stroke (cerebrovascular accident; CVA) or any vascular death determined by record-linkage. Secondary end points are: each component of the primary end point, hospitalisation for non-fatal stroke, hospitalisation for non-fatal MI, cardiovascular death, all-cause mortality, hospitalisation or death from congestive heart failure. The primary outcome will be a comparison of time to first event comparing morning versus evening dosing using an intention-to-treat analysis. The sample size is calculated for a two-sided test to detect 20% superiority at 80% power. TIME has ethical approval in the UK, and results will be published in a peer-reviewed journal. UKCRN17071; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Bevacizumab plus paclitaxel versus placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): A double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation.

PubMed

Miles, David; Cameron, David; Bondarenko, Igor; Manzyuk, Lyudmila; Alcedo, Juan Carlos; Lopez, Roberto Ivan; Im, Seock-Ah; Canon, Jean-Luc; Shparyk, Yaroslav; Yardley, Denise A; Masuda, Norikazu; Ro, Jungsil; Denduluri, Neelima; Hubeaux, Stanislas; Quah, Cheng; Bais, Carlos; O'Shaughnessy, Joyce

2017-01-01

MERiDiAN evaluated plasma vascular endothelial growth factor-A (pVEGF-A) prospectively as a predictive biomarker for bevacizumab efficacy in metastatic breast cancer (mBC). In this double-blind placebo-controlled randomised phase III trial, eligible patients had HER2-negative mBC previously untreated with chemotherapy. pVEGF-A was measured before randomisation to paclitaxel 90 mg/m 2 on days 1, 8 and 15 with either placebo or bevacizumab 10 mg/kg on days 1 and 15, repeated every 4 weeks until disease progression, unacceptable toxicity or consent withdrawal. Stratification factors were baseline pVEGF-A, prior adjuvant chemotherapy, hormone receptor status and geographic region. Co-primary end-points were investigator-assessed progression-free survival (PFS) in the intent-to-treat and pVEGF-A high populations. Of 481 patients randomised (242 placebo-paclitaxel; 239 bevacizumab-paclitaxel), 471 received study treatment. The stratified PFS hazard ratio was 0.68 (99% confidence interval, 0.51-0.91; log-rank p = 0.0007) in the intent-to-treat population (median 8.8 months with placebo-paclitaxel versus 11.0 months with bevacizumab-paclitaxel) and 0.64 (96% confidence interval, 0.47-0.88; log-rank p = 0.0038) in the pVEGF-A high subgroup. The PFS treatment-by-VEGF-A interaction p value (secondary end-point) was 0.4619. Bevacizumab was associated with increased incidences of bleeding (all grades: 45% versus 27% with placebo), neutropenia (all grades: 39% versus 29%; grade ≥3: 25% versus 13%) and hypertension (all grades: 31% versus 13%; grade ≥3: 11% versus 4%). The significant PFS improvement with bevacizumab is consistent with previous placebo-controlled first-line trials in mBC. Results do not support using baseline pVEGF-A to identify patients benefitting most from bevacizumab. ClinicalTrials.gov NCT01663727. Copyright © 2016. Published by Elsevier Ltd.

Nutritional supplementation and artificial reproductive technique (ART) outcomes.

PubMed

Kermack, A J; Macklon, N S

2015-05-01

Approximately one in six couples suffer from subfertility, and many seek treatment with artificial reproductive technologies (ART). Despite improvements in laboratory techniques and ovarian stimulation, ongoing pregnancy rates per cycle remain at ~25%. Couples wanting to improve their chances may turn to adjuvant therapies, such as nutritional supplements. There is growing evidence that periconceptional nutritional status is a key determinant of fertility and long-term health of the offspring, and a lucrative market has developed to meet the demand based on these benefits. However, the practice of routine dietary supplementation before and during IVF treatment has not been subject to well-powered prospective randomised trials. In this article, the potential roles of specific nutritional supplements in the context of improving IVF outcomes are reviewed and an assessment is made of the evidence base supporting their clinical use in this context. Finally, current research needs in the field are outlined.

The management of patients with early Parkinson's disease.

PubMed

Rascol, O; Payoux, P; Ferreira, J; Brefel-Courbon, C

2002-10-01

A major problem in the management of early Parkinson's disease is to choose the first medication to prescribe. This decision should rely on the level of available clinical evidence, largely based, at least for efficacy, on the results of randomised clinical trials. Safety and costs are also crucial to consider. Other factors like for example pathophysiological concepts, individual experience, marketing pressure, socio-economical environment, patients needs and expectations have, however, also their own influence. Levodopa is efficacious and cheap, but induces long-term motor complications. The early use of dopamine agonists is more and more frequently promoted, because large prospective L-dopa-controlled trials demonstrated that this strategy reduces the risk of such long-term complications. Integrating individual clinical expertise to the best available external clinical evidence (evidence-based medicine) is the best strategy in making decisions about the care of individual patients. Copyright 2002 Elsevier Science Ltd.

Multiple imputation methods for bivariate outcomes in cluster randomised trials.

PubMed

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. © 2016 The Authors. Statistics in Medicine Published by John Wiley & Sons Ltd.

Comparison of 2 resident learning tools-interactive screen-based simulated case scenarios versus problem-based learning discussions: a prospective quasi-crossover cohort study.

PubMed

Rajan, Shobana; Khanna, Ashish; Argalious, Maged; Kimatian, Stephen J; Mascha, Edward J; Makarova, Natalya; Nada, Eman M; Elsharkawy, Hesham; Firoozbakhsh, Farhad; Avitsian, Rafi

2016-02-01

Simulation-based learning is emerging as an alternative educational tool in this era of a relative shortfall of teaching anesthesiologists. The objective of the study is to assess whether screen-based (interactive computer simulated) case scenarios are more effective than problem-based learning discussions (PBLDs) in improving test scores 4 and 8 weeks after these interventions in anesthesia residents during their first neuroanesthesia rotation. Prospective, nonblinded quasi-crossover study. Cleveland Clinic. Anesthesiology residents. Two case scenarios were delivered from the Anesoft software as screen-based sessions, and parallel scripts were developed for 2 PBLDs. Each resident underwent both types of training sessions, starting with the PBLD session, and the 2 cases were alternated each month (ie, in 1 month, the screen-based intervention used case 1 and the PBLD used case 2, and vice versa for the next month). Test scores before the rotation (baseline), immediately after the rotation (4 weeks after the start of the rotation), and 8 weeks after the start of rotation were collected on each topic from each resident. The effect of training method on improvement in test scores was assessed using a linear mixed-effects model. Compared to the departmental standard of PBLD, the simulation method did not improve either the 4- or 8-week mean test scores (P = .41 and P = .40 for training method effect on 4- and 8-week scores, respectively). Resident satisfaction with the simulation module on a 5-point Likert scale showed subjective evidence of a positive impact on resident education. Screen-based simulators were not more effective than PBLD for education during the neuroanesthesia rotation in anesthesia residency. Copyright © 2016 Elsevier Inc. All rights reserved.

Prospective memory impairments in heavy social drinkers are partially overcome by future event simulation.

PubMed

Platt, Bradley; Kamboj, Sunjeev K; Italiano, Tommaso; Rendell, Peter G; Curran, H Valerie

2016-02-01

Recent research suggests that alcohol acutely impairs prospective memory (PM), and this impairment can be overcome using a strategy called 'future event simulation' (FES). Impairment in event-based PM found in detoxifying alcohol-dependent participants is reversed through FES. However, the impact of the most common problematic drinking patterns that do not involve alcohol dependence on PM remains unclear. Here, we examine the impact of frequent heavy drinking on PM and the degree to which any impairments can be reversed through FES. PM was assessed in 19 heavy drinkers (AUDIT scores ≥ 15) and 18 matched control participants (AUDIT scores ≤ 7) using the 'Virtual Week' task both at baseline and again following FES. Heavy drinkers performed significantly worse than controls on regular and irregular time-based PM tasks. FES improved the performance of controls but not of heavy drinkers on time-based tasks. In contrast, FES improved heavy drinkers' performance on event-based PM tasks. These findings suggest that heavy drinkers experience deficits in strategic monitoring processing associated with time-based PM tasks which do not abate after FES. That the same strategy improves their event-based PM suggests that FES may be helpful for individuals with problematic drinking patterns in improving their prospective memory.

Assessing risk-adjustment approaches under non-random selection.

PubMed

Luft, Harold S; Dudley, R Adams

2004-01-01

Various approaches have been proposed to adjust for differences in enrollee risk in health plans. Because risk-selection strategies may have different effects on enrollment, we simulated three types of selection--dumping, skimming, and stinting. Concurrent diagnosis-based risk adjustment, and a hybrid using concurrent adjustment for about 8% of the cases and prospective adjustment for the rest, perform markedly better than prospective or demographic adjustments, both in terms of R2 and the extent to which plans experience unwarranted gains or losses. The simulation approach offers a valuable tool for analysts in assessing various risk-adjustment strategies under different selection situations.

A randomised controlled intervention trial evaluating the efficacy of a Mediterranean dietary pattern on cognitive function and psychological wellbeing in healthy older adults: the MedLey study.

PubMed

Knight, Alissa; Bryan, Janet; Wilson, Carlene; Hodgson, Jonathan; Murphy, Karen

2015-04-28

The incidence of age-related cognitive decline is rising considerably around the world. There is evidence from a number of recent cross-sectional and prospective studies indicating positive associations between the Mediterranean dietary pattern (MedDiet) and improved cognitive outcomes among the elderly including, reduced age-related cognitive decline and enhanced age-related cognitive performance. However, to date no study has validated these associations in healthy older adult populations (≥65 years and above) with randomised evidence. The main aim of the present study is to provide justified evidence regarding the efficacy of a MedDiet approach to safely reduce the onset of cognitive decline, and promote optimal cognitive performance among healthy older adults using rigorous, randomised intervention methodology. MedLey is a 6-month, randomised controlled 2-cohort parallel group intervention trial, with initial assessment at baseline and repeated every three months. A sample of 166 healthy Australian men and women aged 65 years and above, with normal cognitive function and proficient in English language were recruited from metropolitan Adelaide, South Australia for the study. Participants randomly allocated to the experimental group are required to maintain an intervention dietary pattern based from the traditional Cretan MedDiet (i.e. vegetables, fruits, olive oil, legumes, fish, whole grain cereals, nuts and seeds and low consumption of processed foods, dairy products, red meat and vegetable oils) for six months, while those participants allocated to the control group are asked to maintain their customary lifestyle and diet. The primary outcome of interest is the quantitative difference in age-related cognitive performance, as measured by latent variables (cognitive constructs) sensitive to normal ageing and diet (i.e. speed of processing, memory, attention, executive functions, visual spatial and visuomotor ability). Secondary outcomes include change in biomarkers of inflammation, oxidative stress, lipid metabolism, glucose, insulin, blood flow velocity, and psychological well-being factors (i.e. stress, sleep, anxiety, depression). To our knowledge this will be one of the first randomised clinical trials worldwide to provide evidence for the cause-effect relationship between the MedDiet and age-related cognitive function in a healthy older adult population (≥65 years and over). Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12613000602729.

Rituximab versus cyclophosphamide for the treatment of connective tissue disease-associated interstitial lung disease (RECITAL): study protocol for a randomised controlled trial.

PubMed

Saunders, Peter; Tsipouri, Vicky; Keir, Gregory J; Ashby, Deborah; Flather, Marcus D; Parfrey, Helen; Babalis, Daphne; Renzoni, Elisabetta A; Denton, Christopher P; Wells, Athol U; Maher, Toby M

2017-06-15

Interstitial lung disease (ILD) frequently complicates systemic autoimmune disorders resulting in considerable morbidity and mortality. The connective tissue diseases (CTDs) most frequently resulting in ILD include: systemic sclerosis, idiopathic inflammatory myositis (including dermatomyositis, polymyositis and anti-synthetase syndrome) and mixed connective tissue disease. Despite the development, over the last two decades, of a range of biological therapies which have resulted in significant improvements in the treatment of the systemic manifestations of CTD, the management of CTD-associated ILD has changed little. At present there are no approved therapies for CTD-ILD. Following trials in scleroderma-ILD, cyclophosphamide is the accepted standard of care for individuals with severe or progressive CTD-related ILD. Observational studies have suggested that the anti-CD20 monoclonal antibody, rituximab, is an effective rescue therapy in the treatment of refractory CTD-ILD. However, before now, there have been no randomised controlled trials assessing the efficacy of rituximab in this treatment population. RECITAL is a UK, multicentre, prospective, randomised, double-blind, double-dummy, controlled trial funded by the Efficacy and Mechanism Evaluation Programme of the Medical Research Council and National Institute for Health Research. The trial will compare rituximab 1 g given intravenously, twice at an interval of 2 weeks, with intravenously administered cyclophosphamide given monthly at a dose of 600 mg/m 2 body surface area in individuals with ILD due to systemic sclerosis, idiopathic inflammatory myositis (including anti-synthetase syndrome) or mixed connective tissue disease. A total of 116 individuals will be randomised 1:1 to each of the two treatment arms, with stratification based on underlying CTD, and will be followed for a total of 48 weeks from first dose. The primary endpoint for the study will be change in forced vital capacity (FVC) at 24 weeks. Key secondary endpoints include: safety, change in FVC at 48 weeks as well as survival, change in oxygen requirements, total 48-week corticosteroid exposure and utilisation of health care resources. This is the first randomised control trial to study the efficacy of rituximab as first-line treatment in CTD-associated ILD. The results generated should provide important information on the treatment of a life-threatening complication affecting a rare group of CTDs. ClinicalTrials.gov, NCT01862926. Registered on 22 May 2013.

Simulation in Occupational Therapy Curricula: A literature review.

PubMed

Bennett, Sally; Rodger, Sylvia; Fitzgerald, Cate; Gibson, Libby

2017-08-01

Simulated learning experiences are increasingly being used in health-care education to enhance student engagement and provide experiences that reflect clinical practice; however, simulation has not been widely investigated in occupational therapy curricula. The aim of this paper was to: (i) describe the existing research about the use and evaluation of simulation over the last three decades in occupational therapy curricula and (ii) consider how simulation has been used to develop competence in students. A literature review was undertaken with searches of MEDLINE, CINAHL and ERIC to locate articles that described or evaluated the use of simulation in occupational therapy curricula. Fifty-seven papers were identified. Occupational therapy educators have used the full scope of simulation modalities, including written case studies (22), standardised patients (13), video case studies (15), computer-based and virtual reality cases (7), role-play (8) and mannequins and part-task trainers (4). Ten studies used combinations of these modalities and two papers compared modalities. Most papers described the use of simulation for foundational courses, as for preparation for fieldwork, and to address competencies necessary for newly graduating therapists. The majority of studies were descriptive, used pre-post design, or were student's perceptions of the value of simulation. Simulation-based education has been used for a wide range of purposes in occupational therapy curricula and appears to be well received. Randomised controlled trials are needed to more accurately understand the effects of simulation not just for occupational therapy students but for longer term outcomes in clinical practice. © 2017 Occupational Therapy Australia.

Neck-specific training with a cognitive behavioural approach compared with prescribed physical activity in patients with cervical radiculopathy: a protocol of a prospective randomised clinical trial.

PubMed

Dedering, Åsa; Halvorsen, Marie; Cleland, Joshua; Svensson, Mikael; Peolsson, Anneli

2014-08-12

Patients with cervical radiculopathy often have neck- and arm pain, neurological changes, activity limitations and difficulties in returning to work. Most patients are not candidates for surgery but are often treated with different conservative approaches and may be sick-listed for long periods. The purpose of the current study is to compare the effectiveness of neck-specific training versus prescribed physical activity. The current protocol is a two armed intervention randomised clinical trial comparing the outcomes of patients receiving neck specific training or prescribed physical activity. A total of 144 patients with cervical radiculopathy will be randomly allocated to either of the two interventions. The interventions will be delivered by experienced physiotherapists and last 14 weeks. The primary outcome variable is neck- and arm pain intensity measured with a Visual Analogue Scale accompanied with secondary outcome measures of impairments and subjective health measurements collected before intervention and at 3, 6, 12 and 24 months after base-line assessment. We anticipate that the results of this study will provide evidence to support recommendations as to the effectiveness of conservative interventions for patients with cervical radiculopathy. ClinicalTrials.gov identifier: NCT01831271.

Prospective randomized comparison of standard didactic lecture versus high-fidelity simulation for radiology resident contrast reaction management training.

PubMed

Wang, Carolyn L; Schopp, Jennifer G; Petscavage, Jonelle M; Paladin, Angelisa M; Richardson, Michael L; Bush, William H

2011-06-01

The objective of our study was to assess whether high-fidelity simulation-based training is more effective than traditional didactic lecture to train radiology residents in the management of contrast reactions. This was a prospective study of 44 radiology residents randomized into a simulation group versus a lecture group. All residents attended a contrast reaction didactic lecture. Four months later, baseline knowledge was assessed with a written test, which we refer to as the "pretest." After the pretest, the 21 residents in the lecture group attended a repeat didactic lecture and the 23 residents in the simulation group underwent high-fidelity simulation-based training with five contrast reaction scenarios. Next, all residents took a second written test, which we refer to as the "posttest." Two months after the posttest, both groups took a third written test, which we refer to as the "delayed posttest," and underwent performance testing with a high-fidelity severe contrast reaction scenario graded on predefined critical actions. There was no statistically significant difference between the simulation and lecture group pretest, immediate posttest, or delayed posttest scores. The simulation group performed better than the lecture group on the severe contrast reaction simulation scenario (p = 0.001). The simulation group reported improved comfort in identifying and managing contrast reactions and administering medications after the simulation training (p ≤ 0.04) and was more comfortable than the control group (p = 0.03), which reported no change in comfort level after the repeat didactic lecture. When compared with didactic lecture, high-fidelity simulation-based training of contrast reaction management shows equal results on written test scores but improved performance during a high-fidelity severe contrast reaction simulation scenario.

High volume image-guided Injections for patellar tendinopathy: a combined retrospective and prospective case series.

PubMed

Morton, Sarah; Chan, Otto; King, John; Perry, David; Crisp, Tom; Maffulli, Nicola; Morrissey, Dylan

2014-04-01

the aim was to quantify the effect of a novel high volume-image guided injection (HVIGI) technique for recalcitrant patellar tendinopathy (PT). twenty patients (8 prospective; 12 retrospective) with ultrasonographically confirmed proximal PT were recruited. A HVIGI under ultra-sound guidance of 10 ml 0.5% Bupivacaine, 25 mg Hydrocortisone and 30 ml normal saline at the interface of the patellar tendon and Hoffa's fat pad was administered. A standardised eccentric loading rehabilitation protocol was prescribed. the VISA-P score improved from 45.0 to 64.0 (p<0.01) for all subjects, likely to be clinically significant. There was no statistically significant difference between the increase in the retrospective group of 19.9 (± 23.5) and the prospective of 16.4 (± 11.3) p = 0.7262.5% of prospective subjects agreed that they had significantly improved, with 37.5% returning to sport within 12 weeks. HVIGI should be considered in the management of recalcitrant PT. Randomised controlled trials are warranted.

Effects of 45-day -6° head-down bed rest on the time-based prospective memory

NASA Astrophysics Data System (ADS)

Chen, SiYi; Zhou, RenLai; Xiu, LiChao; Chen, ShanGuang; Chen, XiaoPing; Tan, Cheng

2013-03-01

The research explored the effects of 45-day -6° head-down bed rest (HDBR) simulation of microgravity on the time-based prospective memory (PM) with 16 males. The time-based prospective memory task was performed on the 2nd day before HDBR, on the 11th, 20th, 32nd, and 40th days during HDBR, and on the 8th day after HDBR, and subjects' anxiety and depression feelings were recorded simultaneously using Beck Anxiety Inventory (BAI) and Beck Depression Inventory (BDI). The results demonstrated that it showed decreased accuracy of PM responses and frequency of clock checks during and after bed rest; long term bed rest did not induce significant emotional changes. The deficit of prospective memory performance induced by long term HDBR may result from a lack of aerobic physical activity or changes in the prefrontal cortex, but it remains to be determined.

Exploring threats to generalisability in a large international rehabilitation trial (AVERT).

PubMed

Bernhardt, Julie; Raffelt, Audrey; Churilov, Leonid; Lindley, Richard I; Speare, Sally; Ancliffe, Jacqueline; Katijjahbe, Md Ali; Hameed, Shahul; Lennon, Sheila; McRae, Anna; Tan, Dawn; Quiney, Jan; Williamson, Hannah C; Collier, Janice; Dewey, Helen M; Donnan, Geoffrey A; Langhorne, Peter; Thrift, Amanda G

2015-08-17

The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT). AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. Acute stroke units at 44 hospitals in 8 countries. The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised. We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment. The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65). A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials. Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial.

PubMed

Häussinger, K; Becker, H; Stanzel, F; Kreuzer, A; Schmidt, B; Strausz, J; Cavaliere, S; Herth, F; Kohlhäufl, M; Müller, K-M; Huber, R-M; Pichlmeier, U; Bolliger, Ch T

2005-06-01

The potential of autofluorescence bronchoscopy (AFB) to detect precancerous lesions in the central airways and its role in lung cancer screening is uncertain. A study was undertaken to evaluate the prevalence of moderate/severe dysplasia (dysplasia II-III) and carcinoma in situ (CIS) using a newly developed AFB system in comparison with conventional white light bronchoscopy (WLB) alone. In a prospective randomised multicentre trial, smokers > or = 40 years of age (> or = 20 pack-years) were stratified into four different risk groups and investigated with either WLB+AFB (arm A) or WLB alone (arm B). 1173 patients (916 men) of mean age 58.7 years were included. Overall (arms A and B), preinvasive lesions (dysplasia II-III and CIS) were detected in 3.9% of the patients. The prevalence of patients with preinvasive lesions in the WLB arm was 2.7% compared with 5.1% in the WLB+AFB arm (p = 0.037). For patients with dysplasia II-III, WLB+AFB increased the detection rate by a factor of 2.1 (p = 0.03), while for CIS the factor was only 1.24 (p = 0.75). The biopsy based sensitivity of WLB alone and WLB+AFB for detecting dysplasia II-III and CIS was 57.9% compared with 82.3% (1.42-fold increase). The corresponding specificity was 62.1% compared with 58.4% (0.94-fold decrease). This first randomised study of AFB showed that the combination of WLB+AFB was significantly superior to WLB alone in detecting preneoplastic lesions. Our findings do not support the general use of AFB as a screening tool for lung cancer, but suggest that it may be of use in certain groups. The precise indications await further study.

Cognitive rehabilitation and mindfulness in multiple sclerosis (REMIND-MS): a study protocol for a randomised controlled trial.

PubMed

Nauta, Ilse M; Speckens, Anne E M; Kessels, Roy P C; Geurts, Jeroen J G; de Groot, Vincent; Uitdehaag, Bernard M J; Fasotti, Luciano; de Jong, Brigit A

2017-11-21

Cognitive problems frequently occur in patients with multiple sclerosis (MS) and profoundly affect their quality of life. So far, the best cognitive treatment options for MS patients are a matter of debate. Therefore, this study aims to investigate the effectiveness of two promising non-pharmacological treatments: cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT). Furthermore, this study aims to gain additional knowledge about the aetiology of cognitive problems among MS patients, since this may help to develop and guide effective cognitive treatments. In a dual-centre, single-blind randomised controlled trial (RCT), 120 MS patients will be randomised into one of three parallel groups: CRT, MBCT or enhanced treatment as usual (ETAU). Both CRT and MBCT consist of a structured 9-week program. ETAU consists of one appointment with an MS specialist nurse. Measurements will be performed at baseline, post-intervention and 6 months after the interventions. The primary outcome measure is the level of subjective cognitive complaints. Secondary outcome measures are objective cognitive function, functional brain network measures (using magnetoencephalography), psychological symptoms, well-being, quality of life and daily life functioning. To our knowledge, this will be the first RCT that investigates the effect of MBCT on cognitive function among MS patients. In addition, studying the effect of CRT on cognitive function may provide direction to the contradictory evidence that is currently available. This study will also provide information on changes in functional brain networks in relation to cognitive function. To conclude, this study may help to understand and treat cognitive problems among MS patients. This trial was prospectively registered at the Dutch Trial Registration (number NTR6459 , registered on 31 May 2017).

Moderate alcohol drinking in pregnancy increases risk for children's persistent conduct problems: causal effects in a Mendelian randomisation study.

PubMed

Murray, Joseph; Burgess, Stephen; Zuccolo, Luisa; Hickman, Matthew; Gray, Ron; Lewis, Sarah J

2016-05-01

Heavy alcohol use during pregnancy can cause considerable developmental problems for children, but effects of light-moderate drinking are uncertain. This study examined possible effects of moderate drinking in pregnancy on children's conduct problems using a Mendelian randomisation design to improve causal inference. A prospective cohort study (ALSPAC) followed children from their mother's pregnancy to age 13 years. Analyses were based on 3,544 children whose mothers self-reported either not drinking alcohol during pregnancy or drinking up to six units per week without binge drinking. Children's conduct problem trajectories were classified as low risk, childhood-limited, adolescence-onset or early-onset-persistent, using six repeated measures of the Strengths and Difficulties Questionnaire between ages 4-13 years. Variants of alcohol-metabolising genes in children were used to create an instrumental variable for Mendelian randomisation analysis. Children's genotype scores were associated with early-onset-persistent conduct problems (OR = 1.29, 95% CI = 1.04-1.60, p = .020) if mothers drank moderately in pregnancy, but not if mothers abstained from drinking (OR = 0.94, CI = 0.72-1.25, p = .688). Children's genotype scores did not predict childhood-limited or adolescence-onset conduct problems. This quasi-experimental study suggests that moderate alcohol drinking in pregnancy contributes to increased risk for children's early-onset-persistent conduct problems, but not childhood-limited or adolescence-onset conduct problems. © 2015 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

Early add-on treatment vs alternative monotherapy in patients with partial epilepsy.

PubMed

Semah, Franck; Thomas, Pierre; Coulbaut, Safia; Derambure, Philippe

2014-06-01

The aim of this study was to evaluate the impact of two different therapeutic strategies in patients with partial seizures who were intractable to the first prescribed antiepileptic drug (AED); alternative monotherapy vs early add-on treatment. We conducted an open, cluster-randomised, prospective, controlled trial in patients with persistent partial seizures, despite treatment with one AED, who were never administered any other AEDs. Neurologists were randomised to two strategies: in group A, an alternative monotherapy with a second AED was employed; in group B, add-on treatment with a second AED was employed. The primary outcome was the percentage of seizure-free patients during a two-month period after six months of treatment. The secondary outcomes were: (i) the percentage of patients achieving a 50% reduction in the number of seizures at six months; (ii) the quality of life based on the Quality Of Life In Epilepsy scale; and (iii) tolerability. A total of 143 neurologists were included and randomised, and 264 patients were evaluated. At six months, the primary outcome was 51% in group A and 45% in group B (p=0.34). The percentage of patients achieving a 50% reduction in the number of seizures at six months was 76% in group A and 84% in group B (p=0.53). The quality of life and the tolerability did not significantly differ between the two groups. Alternative monotherapy or early treatment initiation with another AED drug resulted in similar efficacy, and the side effects associated with monotherapy and combined therapies were similar, which suggests that individual susceptibility is more important than the number and burden of AEDs used.

Exploring threats to generalisability in a large international rehabilitation trial (AVERT)

PubMed Central

Bernhardt, Julie; Raffelt, Audrey; Churilov, Leonid; Lindley, Richard I; Speare, Sally; Ancliffe, Jacqueline; Katijjahbe, Md Ali; Hameed, Shahul; Lennon, Sheila; McRae, Anna; Tan, Dawn; Quiney, Jan; Williamson, Hannah C; Collier, Janice; Dewey, Helen M; Donnan, Geoffrey A; Langhorne, Peter; Thrift, Amanda G

2015-01-01

Objective The purpose of this paper is to examine potential threats to generalisability of the results of a multicentre randomised controlled trial using data from A Very Early Rehabilitation Trial (AVERT). Design AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT. Setting Acute stroke units at 44 hospitals in 8 countries. Participants The first 20 000 patients screened for AVERT, of whom 1158 were recruited and randomised. Model We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment. Results The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65). Conclusions A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials. Trial registration number Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247). PMID:26283667

Effect of an interactive cardiopulmonary resuscitation assist device with an automated external defibrillator synchronised with a ventilator on the CPR performance of emergency medical service staff: a randomised simulation study.

PubMed

Nitzschke, Rainer; Doehn, Christoph; Kersten, Jan F; Blanz, Julian; Kalwa, Tobias J; Scotti, Norman A; Kubitz, Jens C

2017-04-04

The present study evaluates whether the quality of advanced cardiac life support (ALS) is improved with an interactive prototype assist device. This device consists of an automated external defibrillator linked to a ventilator and provides synchronised visual and acoustic instructions for guidance through the ALS algorithm and assistance for face-mask ventilations. We compared the cardiopulmonary resuscitation (CPR) quality of emergency medical system (EMS) staff members using the study device or standard equipment in a mannequin simulation study with a prospective, controlled, randomised cross-over study design. Main outcome was the effect of the study device compared to the standard equipment and the effect of the number of prior ALS trainings of the EMS staff on the CPR quality. Data were analysed using analyses of covariance (ANCOVA) and binary logistic regression, accounting for the study design. In 106 simulations of 56 two-person rescuer teams, the mean hands-off time was 24.5% with study equipment and 23.5% with standard equipment (Difference 1.0% (95% CI: -0.4 to 2.5%); p = 0.156). With both types of equipment, the hands-off time decreased with an increasing cumulative number of previous CPR trainings (p = 0.042). The study equipment reduced the mean time until administration of adrenaline (epinephrine) by 23 s (p = 0.003) and that of amiodarone by 17 s (p = 0.016). It also increased the mean number of changes in the person doing chest compressions (0.6 per simulation; p < 0.001) and decreased the mean number of chest compressions (2.8 per minute; p = 0.022) and the mean number of ventilations (1.8 per minute; p < 0.001). The chance of administering amiodarone at the appropriate time was higher, with an odds ratio of 4.15, with the use of the study equipment CPR.com compared to the standard equipment (p = 0.004). With an increasing number of prior CPR trainings, the time intervals in the ALS algorithm until the defibrillations decreased with standard equipment but increased with the study device. EMS staff with limited training in CPR profit from guidance through the ALS algorithm by the study device. However, the study device somehow reduced the ALS quality of well-trained rescuers and thus can only be recommended for ALS provider with limited experience.

Role of Google Glass in improving patient satisfaction for otolaryngology residents: a pilot study.

PubMed

Son, E; Halbert, A; Abreu, S; Hester, R; Jefferson, G; Jennings, K; Pine, H; Watts, T

2017-04-01

To demonstrate the feasibility and efficacy of the Google Glass as a tool to improve patient satisfaction and patient-physician communication for otolaryngology residents in the outpatient clinic setting. The primary outcome of the study was to improve patient satisfaction scores based on physician communication-related questions from Consumer Assessment of Healthcare Providers and Systems (CAHPS) surveys. Prospective randomised trial. Tertiary care hospital. To evaluate the effect on patient satisfaction, five residents were recorded using the Google Glass in an outpatient clinic setting by 50 randomised patients. Modified surveys based on the CG-CAHPS survey were completed by patients at the conclusion of each clinic encounter. The recorded videos were evaluated by two independent faculties. Summarised data and video were distributed to each resident for review as the intervention. The residents were recorded again by 45 additional patients with evaluation by patients and faculties. After intervention, the scores from faculty surveys regarding patient satisfaction including the subject of better explanations (P > 0.001), listening carefully (P > 0.001), addressing patient questions (P > 0.001), displaying respect (P > 0.001) and spending adequate time (P = 0.0005) all significantly improved, as well as overall performance (P = 0.014). The scores from patient surveys did significantly improve. This study demonstrates the improvements in patient satisfaction and patient-physician communication can be achieved with the use of Google Glass as a first-person recording device in the outpatient otolaryngology clinic setting. © 2016 John Wiley & Sons Ltd.

Supplemental parenteral nutrition in critically ill patients: a study protocol for a phase II randomised controlled trial.

PubMed

Ridley, Emma J; Davies, Andrew R; Parke, Rachael; Bailey, Michael; McArthur, Colin; Gillanders, Lyn; Cooper, David J; McGuinness, Shay

2015-12-24

Nutrition is one of the fundamentals of care provided to critically ill adults. The volume of enteral nutrition received, however, is often much less than prescribed due to multiple functional and process issues. To deliver the prescribed volume and correct the energy deficit associated with enteral nutrition alone, parenteral nutrition can be used in combination (termed "supplemental parenteral nutrition"), but benefits of this method have not been firmly established. A multi-centre, randomised, clinical trial is currently underway to determine if prescribed energy requirements can be provided to critically ill patients by using a supplemental parenteral nutrition strategy in the critically ill. This prospective, multi-centre, randomised, stratified, parallel-group, controlled, phase II trial aims to determine whether a supplemental parenteral nutrition strategy will reliably and safely increase energy intake when compared to usual care. The study will be conducted for 100 critically ill adults with at least one organ system failure and evidence of insufficient enteral intake from six intensive care units in Australia and New Zealand. Enrolled patients will be allocated to either a supplemental parenteral nutrition strategy for 7 days post randomisation or to usual care with enteral nutrition. The primary outcome will be the average energy amount delivered from nutrition therapy over the first 7 days of the study period. Secondary outcomes include protein delivery for 7 days post randomisation; total energy and protein delivery, antibiotic use and organ failure rates (up to 28 days); duration of ventilation, length of intensive care unit and hospital stay. At both intensive care unit and hospital discharge strength and health-related quality of life assessments will be undertaken. Study participants will be followed up for health-related quality of life, resource utilisation and survival at 90 and 180 days post randomisation (unless death occurs first). This trial aims to determine if provision of a supplemental parenteral nutrition strategy to critically ill adults will increase energy intake compared to usual care in Australia and New Zealand. Trial outcomes will guide development of a subsequent larger randomised controlled trial. NCT01847534 (First registered 5 February 2013, last updated 14 October 2015).

Web-based cognitive rehabilitation for survivors of adult cancer: A randomised controlled trial.

PubMed

Mihuta, Mary E; Green, Heather J; Shum, David H K

2018-04-01

Cognitive dysfunction associated with cancer is frequently reported and can reduce quality of life. This study evaluated a Web-based cognitive rehabilitation therapy program (eReCog) in cancer survivors compared with a waitlist control group. Adult cancer survivors with self-reported cognitive symptoms who had completed primary treatment at least 6 months prior were recruited. Participants completed telephone screening and were randomly allocated to the 4-week online intervention or waitlist. Primary outcome was perceived cognitive impairment assessed with the Functional Assessment of Cancer Therapy-Cognitive Function version 3. Secondary outcomes were additional measures of subjective cognitive functioning, objective cognitive functioning, and psychosocial variables. Seventy-six women were allocated to the intervention (n = 40) or waitlist (n = 36). A significant interaction was found on the instrumental activities of daily living measure of self-reported prospective memory whereby the intervention group reported a greater reduction in prospective memory failures than the waitlist group. Interaction trends were noted on perceived cognitive impairments (P = .089) and executive functioning (P = .074). No significant interactions were observed on other measures of objective cognitive functioning or psychosocial variables. The Web-based intervention shows promise for improving self-reported cognitive functioning in adult cancer survivors. Further research is warranted to better understand the mechanisms by which the intervention might contribute to improved self-reported cognition. Copyright © 2017 John Wiley & Sons, Ltd.

Pilot study comparing simulation-based and didactic lecture-based critical care teaching for final-year medical students.

PubMed

Solymos, Orsolya; O'Kelly, Patrick; Walshe, Criona M

2015-10-21

Simulation-based medical education has rapidly evolved over the past two decades, despite this, there are few published reports of its use in critical care teaching. We hypothesised that simulation-based teaching of a critical care topic to final-year medical students is superior to lecture-based teaching. Thirty-nine final-year medical students were randomly assigned to either simulation-based or lecture-based teaching in the chosen critical care topic. The study was conducted over a 6-week period. Efficacy of each teaching method was compared through use of multiple choice questionnaires (MCQ) - baseline, post-teaching and 2 week follow-up. Student satisfaction was evaluated by means of a questionnaire. Feasibility and resource requirements were documented by teachers. Eighteen students were randomised to simulation-based, and 21 to lecture-based teaching. There were no differences in age and gender between groups (p > 0.05). Simulation proved more resource intensive requiring specialised equipment, two instructors, and increased duration of teaching sessions (126.7 min (SD = 4.71) vs 68.3 min (SD = 2.36)). Students ranked simulation-based teaching higher with regard to enjoyment (p = 0.0044), interest (p = 0.0068), relevance to taught subject (p = 0.0313), ease of understanding (p = 0.0476) and accessibility to posing questions (p = 0.001). Both groups demonstrated improvement in post-teaching MCQ from baseline (p = 0.0002), with greater improvement seen among the simulation group (p = 0.0387), however, baseline scores were higher among the lecture group. The results of the 2-week follow-up MCQ and post-teaching MCQ were not statistically significant when each modality were compared. Simulation was perceived as more enjoyable by students. Although there was a greater improvement in post-teaching MCQ among the simulator group, baseline scores were higher among lecture group which limits interpretation of efficacy. Simulation is more resource intensive, as demonstrated by increased duration and personnel required, and this may have affected our results. The current pilot may be of use in informing future studies in this area.

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial

PubMed Central

Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

2012-01-01

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 370/7 (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone. PMID:22778774

Preoperative bowel preparation with meglumine and sodium diatrizoate (Gastrografin): a prospective randomised comparison.

PubMed

Koussidis, G A; Koussidis, A

2001-12-01

To test the use of meglumine and sodium diatrizoate (Gastrografin) as an agent for preoperative mechanical bowel preparation. Prospective randomised comparison. County general hospital, Greece. 58 patients listed for elective colorectal operations were randomly divided into 2 groups. The first (n = 30) was given Gastrografin 200 ml orally for 2 consecutive days before operation, and the second (n = 28) was given Ringer's solution through a nasogastric tube. Tolerability, acceptability, quality of cleansing, and complications. There were no disturbances in electrolyte concentrations, and other laboratory variables also remained unchanged. Two patients treated with Ringer's solution had appreciable increases in arterial blood pressure, but there were no significant overall changes. About half the patients given Ringer's felt nauseated and a third vomited. Such symptoms were uncommon in patients treated with Gastrografin (p < 0.01). 28/30 and 26/28 (93%) had a clean colonic lumen at operation, whereas in the reminder the lumen was evaluated as containing "slight residue". There were no operation-related complications. Gastrografin can be used successfully as an agent for mechanical bowel preparation before elective colorectal surgery, as it gives equally good cleansing results compared with the established method of whole gut irrigation. It also seems to be better tolerated and accepted by patients.

Intermittent catheterisation with hydrophilic-coated catheters (SpeediCath) reduces the risk of clinical urinary tract infection in spinal cord injured patients: a prospective randomised parallel comparative trial.

PubMed

De Ridder, D J M K; Everaert, K; Fernández, L García; Valero, J V Forner; Durán, A Borau; Abrisqueta, M L Jauregui; Ventura, M G; Sotillo, A Rodriguez

2005-12-01

To compare the performance of SpeediCath hydrophilic-coated catheters versus uncoated polyvinyl chloride (PVC) catheters, in traumatic spinal cord injured patients presenting with functional neurogenic bladder-sphincter disorders. A 1-year, prospective, open, parallel, comparative, randomised, multi centre study included 123 male patients, > or =16 y and injured within the last 6 months. Primary endpoints were occurrence of symptomatic urinary tract infection (UTI) and hematuria. Secondary endpoints were development of urethral strictures and convenience of use. The main hypothesis was that coated catheters cause fewer complications in terms of symptomatic UTIs and hematuria. 57 out of 123 patients completed the 12-month study. Fewer patients using the SpeediCath hydrophilic-coated catheter (64%) experienced 1 or more UTIs compared to the uncoated PVC catheter group (82%) (p = 0.02). Thus, twice as many patients in the SpeediCath group were free of UTI. There was no significant difference in the number of patients experiencing bleeding episodes (38/55 SpeediCath; 32/59 PVC) and no overall difference in the occurrence of hematuria, leukocyturia and bacteriuria. The results indicate that there is a beneficial effect regarding UTI when using hydrophilic-coated catheters.

The Effects of Clinical Hypnosis versus Neurolinguistic Programming (NLP) before External Cephalic Version (ECV): A Prospective Off-Centre Randomised, Double-Blind, Controlled Trial.

PubMed

Reinhard, Joscha; Peiffer, Swati; Sänger, Nicole; Herrmann, Eva; Yuan, Juping; Louwen, Frank

2012-01-01

Objective. To examine the effects of clinical hypnosis versus NLP intervention on the success rate of ECV procedures in comparison to a control group. Methods. A prospective off-centre randomised trial of a clinical hypnosis intervention against NLP of women with a singleton breech fetus at or after 37(0/7) (259 days) weeks of gestation and normal amniotic fluid index. All 80 participants heard a 20-minute recorded intervention via head phones. Main outcome assessed was success rate of ECV. The intervention groups were compared with a control group with standard medical care alone (n = 122). Results. A total of 42 women, who received a hypnosis intervention prior to ECV, had a 40.5% (n = 17), successful ECV, whereas 38 women, who received NLP, had a 44.7% (n = 17) successful ECV (P > 0.05). The control group had similar patient characteristics compared to the intervention groups (P > 0.05). In the control group (n = 122) 27.3% (n = 33) had a statistically significant lower successful ECV procedure than NLP (P = 0.05) and hypnosis and NLP (P = 0.03). Conclusions. These findings suggest that prior clinical hypnosis and NLP have similar success rates of ECV procedures and are both superior to standard medical care alone.

L-arginine plus drospirenone-ethinyl estradiol in the treatment of patients with PCOS: a prospective, placebo controlled, randomised, pilot study.

PubMed

Battaglia, Cesare; Mancini, Fulvia; Battaglia, Bruno; Facchinetti, Fabio; Artini, Paolo G; Venturoli, Stefano

2010-12-01

To verify the effects of a pill containing drospirenone on the surrogate markers of arterial function and to evaluate the possible improvements induced by the addition of L-arginine. A prospective, placebo controlled, randomised, pilot study. University of Bologna. Twenty-eight young women with PCOS. Random submission to: drospirenone + ethinylestradiol+ a placebo (Group I; n = 15) or drospirenone + ethinylestradiol + oral L-arginine (4 g × 2/daily) (Group II, n = 13). Medical examination; blood measurement of nitrites/nitrates, biochemical and hormonal parameters; ultrasonographic analysis and colour Doppler evaluation of uterine, stromal ovarian and ophthalmic arteries; analysis of brachial artery flow-mediated vasodilatation; and 24-h ambulatory blood pressure monitoring. The above parameters were evaluated before and after 6 months. The low dose oral contraceptive containing drospirenone favoured a pre-hypertensive state. The L-arginine supplementation increased the circulating levels of nitrites/nitrates and improved the endothelium-dependent vasodilatation counteracting the negative effect of the contraceptive pill. Although, the present pilot study was conducted in a limited number of patients, it seems that the L-arginine co-treatment may improve the long-term side effects of the pill reducing the risk of cardiovascular diseases.

A randomised controlled trial of an online menu planning intervention to improve childcare service adherence to dietary guidelines: a study protocol.

PubMed

Yoong, Sze Lin; Grady, Alice; Wiggers, John; Flood, Victoria; Rissel, Chris; Finch, Meghan; Searles, Andrew; Salajan, David; O'Rourke, Ruby; Daly, Jaqueline; Gilham, Karen; Stacey, Fiona; Fielding, Alison; Pond, Nicole; Wyse, Rebecca; Seward, Kirsty; Wolfenden, Luke

2017-09-11

The implementation of dietary guidelines in childcare settings is recommended to improve child public health nutrition. However, foods provided in childcare services are not consistent with guidelines. The primary aim of the trial is to assess the effectiveness of a web-based menu planning intervention in increasing the mean number of food groups on childcare service menus that comply with dietary guidelines regarding food provision to children in care. A parallel group randomised controlled trial will be undertaken with 54 childcare services that provide food to children within New South Wales, Australia. Services will be randomised to a 12-month intervention or usual care. The experimental group will receive access to a web-based menu planning and decision support tool and online resources. To support uptake of the web program, services will be provided with training and follow-up support. The primary outcome will be the number of food groups, out of 6 (vegetables, fruit, breads and cereals, meat, dairy and 'discretionary'), on the menu that meet dietary guidelines (Caring for Children) across a 1-week menu at 12-month follow-up, assessed via menu review by dietitians or nutritionists blinded to group allocation. A nested evaluation of child dietary intake in care and child body mass index will be undertaken in up to 35 randomly selected childcare services and up to 420 children aged approximately 3-6 years. Ethical approval has been provided by Hunter New England and University of Newcastle Human Research Ethics Committees. This research will provide high-quality evidence regarding the impact of a web-based menu planning intervention in facilitating the translation of dietary guidelines into childcare services. Trial findings will be disseminated widely through national and international peer-reviewed publications and conference presentations. Prospectively registered with Australian New Zealand Clinical Trial Registry (ANZCTR) ACTRN12616000974404. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Three-dimensional visualisation improves understanding of surgical liver anatomy.

PubMed

Beermann, Judith; Tetzlaff, Ralf; Bruckner, Thomas; Schöebinger, Max; Müller-Stich, Beat P; Gutt, Carsten N; Meinzer, Hans-Peter; Kadmon, Martina; Fischer, Lars

2010-09-01

Three-dimensional (3-D) representation is thought to improve understanding of complex spatial interactions and is being used more frequently in diagnostic and therapeutic procedures. It has been suggested that males benefit more than females from 3-D presentations. There have been few randomised trials to confirm these issues. We carried out a randomised trial, based on the identification of complex surgical liver anatomy, to evaluate whether 3-D presentation has a beneficial impact and if gender differences were evident. A computer-based teaching module (TM) was developed to test whether two-dimensional (2-D) computed tomography (CT) images or 3-D presentations result in better understanding of liver anatomy. Following a PowerPoint lecture, students were randomly selected to participate in computer-based testing which used either 2-D images presented as consecutive transversal slices, or one of two 3-D variations. In one of these the vessel tree of portal and hepatic veins was shown in one colour (3-D) and in the other the two vessel systems were coloured differently (3-Dc). Participants were asked to answer 11 medical questions concerning surgical anatomy and four questions on their subjective assessment of the TM. Of the 160 Year 4 and 5 medical students (56.8% female) who participated in this prospective randomised trial, students exposed to 3-D presentation performed significantly better than those exposed to 2-D images (p < 0.001). Comparison of the number of correct answers revealed no significant differences between the 3-D and 3-Dc modalities p > 0.1). Male students gave significantly more correct answers in the 3-D and 3-Dc modalities than female students (p < 0.03). The gender difference observed in both 3-D modalities was not evident in the 2-D group (p = 0.21). This study showed that 3-D imaging significantly improved the identification of complex surgical liver anatomy. Male students benefited significantly more than female students from 3-D presentations. Use of colour in 3-D presentation did not improve student performance.

Standardised simulation-based emergency and intensive care nursing curriculum to improve nursing students' performance during simulated resuscitation: A quasi-experimental study.

PubMed

Chen, Jie; Yang, Jian; Hu, Fen; Yu, Si-Hong; Yang, Bing-Xiang; Liu, Qian; Zhu, Xiao-Ping

2018-06-01

Simulation-based curriculum has been demonstrated as crucial to nursing education in the development of students' critical thinking and complex clinical skills during a resuscitation simulation. Few studies have comprehensively examined the effectiveness of a standardised simulation-based emergency and intensive care nursing curriculum on the performance of students in a resuscitation simulation. To evaluate the impact of a standardised simulation-based emergency and intensive care nursing curriculum on nursing students' response time in a resuscitation simulation. Two-group, non-randomised quasi-experimental design. A simulation centre in a Chinese University School of Nursing. Third-year nursing students (N = 39) in the Emergency and Intensive Care course were divided into a control group (CG, n = 20) and an experimental group (EG, n = 19). The experimental group participated in a standardised high-technology, simulation-based emergency and intensive care nursing curriculum. The standardised simulation-based curriculum for third-year nursing students consists of three modules: disaster response, emergency care, and intensive care, which include clinical priorities (e.g. triage), basic resuscitation skills, airway/breathing management, circulation management and team work with eighteen lecture hours, six skill-practice hours and twelve simulation hours. The control group took part in the traditional curriculum. This course included the same three modules with thirty-four lecture hours and two skill-practice hours (trauma). Perceived benefits included decreased median (interquartile ranges, IQR) seconds to start compressions [CG 32 (25-75) vs. EG 20 (18-38); p < 0.001] and defibrillation [CG 204 (174-240) vs. EG 167 (162-174); p < 0.001] at the end of the course, compared with compressions [CG 41 (32-49) vs. EG 42 (33-46); p > 0.05] and defibrillation [CG 222 (194-254) vs. EG 221 (214-248); p > 0.05] at the beginning of the course. A simulation-based emergency and intensive care nursing curriculum was created and well received by third-year nursing students and associated with decreased response time in a resuscitation simulation. Copyright © 2018 Elsevier Ltd. All rights reserved.

Non-invasive versus invasive management in patients with prior coronary artery bypass surgery with a non-ST segment elevation acute coronary syndrome: study design of the pilot randomised controlled trial and registry (CABG-ACS)

PubMed Central

Lee, Matthew M Y; Petrie, Mark C; Rocchiccioli, Paul; Simpson, Joanne; Jackson, Colette; Brown, Ammani; Corcoran, David; Mangion, Kenneth; McEntegart, Margaret; Shaukat, Aadil; Rae, Alan; Hood, Stuart; Peat, Eileen; Findlay, Iain; Murphy, Clare; Cormack, Alistair; Bukov, Nikolay; Balachandran, Kanarath; Papworth, Richard; Ford, Ian; Briggs, Andrew; Berry, Colin

2016-01-01

Introduction There is an evidence gap about how to best treat patients with prior coronary artery bypass grafts (CABGs) presenting with non-ST segment elevation acute coronary syndromes (NSTE-ACS) because historically, these patients were excluded from pivotal randomised trials. We aim to undertake a pilot trial of routine non-invasive management versus routine invasive management in patients with NSTE-ACS with prior CABG and optimal medical therapy during routine clinical care. Our trial is a proof-of-concept study for feasibility, safety, potential efficacy and health economic modelling. We hypothesise that a routine invasive approach in patients with NSTE-ACS with prior CABG is not superior to a non-invasive approach with optimal medical therapy. Methods and analysis 60 patients will be enrolled in a randomised clinical trial in 4 hospitals. A screening log will be prospectively completed. Patients not randomised due to lack of eligibility criteria and/or patient or physician preference and who give consent will be included in a registry. We will gather information about screening, enrolment, eligibility, randomisation, patient characteristics and adverse events (including post-discharge). The primary efficacy outcome is the composite of all-cause mortality, rehospitalisation for refractory ischaemia/angina, myocardial infarction and hospitalisation for heart failure. The primary safety outcome is the composite of bleeding, stroke, procedure-related myocardial infarction and worsening renal function. Health status will be assessed using EuroQol 5 Dimensions (EQ-5D) assessed at baseline and 6 monthly intervals, for at least 18 months. Trial registration number NCT01895751 (ClinicalTrials.gov). PMID:27110377

[Comparative study of combined local treatment (sulfadimidine, metronidazole and nystatin) and the standard monotherapy in uncomplicated bacterial vaginosis].

PubMed

Milánkovits, Márton; Baksay, László; Plachy, János

2002-12-22

Comparative, in vivo, human, prospective, single blind, clinical and microbiological diagnoses based and randomised study of the treatment of uncomplicated bacterial vaginosis with two forms of combined (metronidazole + nystatin + sulfadimidin) vaginal suppositories (laminated and mixed containing the same ingredients) and the standard preparations available in the Hungarian market (Dalacin vaginal cream and Klion vaginal suppository). The examinations involved 60 volunteers and were performed in the Gynecological Outpatient Clinic of the Council of Erd, the microbiological samples were examined at Saint Rókus Hospital in Budapest. The combined treatment was better tolerated and resulted in normal vaginal pH significantly more often at the same rate of recovery. The combined treatment is simultaneously effective in cases of the most prevalent coinfections too.

The Rivalry between Simulation and Problem-Based Learning: A Study of Learning Transfer in Physician Assistant Students

ERIC Educational Resources Information Center

Meyer, Kimberly E.

2010-01-01

The purpose of this dissertation was to evaluate learning transfer achieved by physician assistant students comparing two instructional methods, human patient simulation and electronic clinical case studies. This prospective, randomized, mixed-methods study utilized first and second-year physician assistant student volunteers taking a pretest and…

Linking quality of care and training costs: cost-effectiveness in health professions education.

PubMed

Tolsgaard, Martin G; Tabor, Ann; Madsen, Mette E; Wulff, Camilla B; Dyre, Liv; Ringsted, Charlotte; Nørgaard, Lone N

2015-12-01

To provide a model for conducting cost-effectiveness analyses in medical education. The model was based on a randomised trial examining the effects of training midwives to perform cervical length measurement (CLM) as compared with obstetricians on patients' waiting times. (CLM), as compared with obstetricians. The model included four steps: (i) gathering data on training outcomes, (ii) assessing total costs and effects, (iii) calculating the incremental cost-effectiveness ratio (ICER) and (iv) estimating cost-effectiveness probability for different willingness to pay (WTP) values. To provide a model example, we conducted a randomised cost-effectiveness trial. Midwives were randomised to CLM training (midwife-performed CLMs) or no training (initial management by midwife, and CLM performed by obstetrician). Intervention-group participants underwent simulation-based and clinical training until they were proficient. During the following 6 months, waiting times from arrival to admission or discharge were recorded for women who presented with symptoms of pre-term labour. Outcomes for women managed by intervention and control-group participants were compared. These data were then used for the remaining steps of the cost-effectiveness model. Intervention-group participants needed a mean 268.2 (95% confidence interval [CI], 140.2-392.2) minutes of simulator training and a mean 7.3 (95% CI, 4.4-10.3) supervised scans to attain proficiency. Women who were scanned by intervention-group participants had significantly reduced waiting time compared with those managed by the control group (n = 65; mean difference, 36.6 [95% CI 7.3-65.8] minutes; p = 0.008), which corresponded to an ICER of 0.45 EUR minute(-1) . For WTP values less than EUR 0.26 minute(-1) , obstetrician-performed CLM was the most cost-effective strategy, whereas midwife-performed CLM was cost-effective for WTP values above EUR 0.73 minute(-1) . Cost-effectiveness models can be used to link quality of care to training costs. The example used in the present study demonstrated that different training strategies could be recommended as the most cost-effective depending on administrators' willingness to pay per unit of the outcome variable. © 2015 Medical Education Published by John Wiley & Sons Ltd.

Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial

PubMed Central

Freeman, Daniel; Waite, Felicity; Startup, Helen; Myers, Elissa; Lister, Rachel; McInerney, Josephine; Harvey, Allison G; Geddes, John; Zaiwalla, Zenobia; Luengo-Fernandez, Ramon; Foster, Russell; Clifton, Lei; Yu, Ly-Mee

2015-01-01

Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6·1, 95% CI 3·0–9·2, effect size d=1·9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0·3, 95% CI −2·0 to 2·6) and hallucinations (−1·9, −6·5 to 2·7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment. Interpretation Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences. Funding Research for Patient Benefit Programme, National Institute for Health Research. PMID:26363701

Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

PubMed

Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

2012-09-01

We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

Does peer-assisted learning improve academic performance? A scoping review.

PubMed

Williams, Brett; Reddy, Priya

2016-07-01

Due to the diverse and ever-changing nature of the healthcare industry, teaching pedagogies such as peer-assisted learning (PAL) are being implemented to align with external competency standards. A scoping review was conducted in order to map the breadth of literature available on PAL and its impact on student performance. This review used Arksey and O'Malley's six stage scoping methodology. The databases searched included: Cinahl, Ovid Medline, Proquest and Embase as well as grey literature sites and dissertations. 22 articles were included in this review, 10 of which were mixed methods randomised controlled trials, one retrospective study, four controlled trials, two randomised cross over controlled trial, three prospective randomised controlled trials, one thesis and one comparative research design. Analysis of the included articles identified three major themes outlining student performance. Student teachers themselves showed the most significant improvement in objective outcomes. The predominant healthcare field addressed were medical students with very few studies being completed on other professions. The search indicated an overall positive response to PAL with the measurable outcome of student tutors being of most significance. Further research is required to determine the relevance for the wider healthcare community. Copyright © 2016 Elsevier Ltd. All rights reserved.

Changing Behavior by Memory Aids: A Social Psychological Model of Prospective Memory and Habit Development Tested with Dynamic Field Data

ERIC Educational Resources Information Center

Tobias, Robert

2009-01-01

This article presents a social psychological model of prospective memory and habit development. The model is based on relevant research literature, and its dynamics were investigated by computer simulations. Time-series data from a behavior-change campaign in Cuba were used for calibration and validation of the model. The model scored well in…

Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial.

PubMed

Herrero, Pablo; Asensio, Angel; García, Elena; Marco, Alvaro; Oliván, Barbara; Ibarz, Alejandro; Gómez-Trullén, Eva M; Casas, Roberto

2010-04-16

Although hippotherapy treatment has been demonstrated to have therapeutic effects on children with cerebral palsy, the samples used in research studies have been very small. In the case of hippotherapy simulators, there are no studies that either recommend or advise against their use in the treatment of children with cerebral palsy. The aim of this randomised clinical study is to analyse the therapeutic effects or the contraindications of the use of a commercial hippotherapy simulator on several important factors relating to children with cerebral palsy such as their motor development, balance control in the sitting posture, hip abduction range of motion and electromyographic activity of adductor musculature. The study is a randomised controlled trial. It will be carried out with a sample of 37 children with cerebral palsy divided into two treatment groups. Eligible participants will be randomly allocated to receive either (a) Treatment Group with hippotherapy simulator, maintaining sitting posture, with legs in abduction and rhythmic movement of the simulator or (b) Treatment Group maintaining sitting posture, with legs in abduction and without rhythmic movement of the simulator. all measurements will be carried out by a specially trained blind assessor. To ensure standardization quality of the assessors, an inter-examiner agreement will be worked out at the start of the study. The trial is funded by the Department of Research, Innovation and Development of the Regional Government of Aragon (Official Bulletin of Aragon 23 July 2007), project number PM059/2007. Interest in this project is due to the following factors: Clinical originality (there are no previous studies analysing the effect of simulators on the population group of children with CP, nor any studies using as many variables as this project); Clinical impact (infantile cerebral palsy is a chronic multisystemic condition that affects not only the patient but also the patient's family and their close circle of friends); Practical benefits (the development of an effective treatment is very important for introducing this element into the rehabilitation of these children). Current Controlled Trials ISRCTN03663478.

Conceptual modeling for Prospective Health Technology Assessment.

PubMed

Gantner-Bär, Marion; Djanatliev, Anatoli; Prokosch, Hans-Ulrich; Sedlmayr, Martin

2012-01-01

Prospective Health Technology Assessment (ProHTA) is a new and innovative approach to analyze and assess new technologies, methods and procedures in health care. Simulation processes are used to model innovations before the cost-intensive design and development phase. Thus effects on patient care, the health care system as well as health economics aspects can be estimated. To generate simulation models a valid information base is necessary and therefore conceptual modeling is most suitable. Project-specifically improved methods and characteristics of simulation modeling are combined in the ProHTA Conceptual Modeling Process and initially implemented for acute ischemic stroke treatment in Germany. Additionally the project aims at simulation of other diseases and health care systems as well. ProHTA is an interdisciplinary research project within the Cluster of Excellence for Medical Technology - Medical Valley European Metropolitan Region Nuremberg (EMN), which is funded by the German Federal Ministry of Education and Research (BMBF), project grant No. 01EX1013B.

Investigating the relationship between predictability and imbalance in minimisation: a simulation study

PubMed Central

2013-01-01

Background The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Methods Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Results Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. Conclusions In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design. PMID:23537389

Investigating the relationship between predictability and imbalance in minimisation: a simulation study.

PubMed

McPherson, Gladys C; Campbell, Marion K; Elbourne, Diana R

2013-03-27

The use of restricted randomisation methods such as minimisation is increasing. This paper investigates under what conditions it is preferable to use restricted randomisation in order to achieve balance between treatment groups at baseline with regard to important prognostic factors and whether trialists should be concerned that minimisation may be considered deterministic. Using minimisation as the randomisation algorithm, treatment allocation was simulated for hypothetical patients entering a theoretical study having values for prognostic factors randomly assigned with a stipulated probability. The number of times the allocation could have been determined with certainty and the imbalances which might occur following randomisation using minimisation were examined. Overall treatment balance is relatively unaffected by reducing the probability of allocation to optimal treatment group (P) but within-variable balance can be affected by any P <1. This effect is magnified by increased numbers of prognostic variables, the number of categories within them and the prevalence of these categories within the study population. In general, for smaller trials, probability of treatment allocation to the treatment group with fewer numbers requires a larger value P to keep treatment and variable groups balanced. For larger trials probability of allocation values from P = 0.5 to P = 0.8 can be used while still maintaining balance. For one prognostic variable there is no significant benefit in terms of predictability in reducing the value of P. However, for more than one prognostic variable, significant reduction in levels of predictability can be achieved with the appropriate choice of P for the given trial design.

Protocol for a pilot, randomised, double-blinded, placebo-controlled trial of prophylactic use of tranexamic acid for preventing postpartum haemorrhage (TAPPH-1)

PubMed Central

Alam, Asim; Bopardikar, Ameya; Au, Shelly; Barrett, Jon; Callum, Jeannie; Kiss, Alex; Choi, Stephen

2017-01-01

Introduction Postpartum haemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Despite the availability of multiple uterotonic agents, the incidence of PPH continues to rise. Tranexamic acid (TXA) has been shown to be a safe, effective and inexpensive therapeutic option for the treatment of PPH, however, its use prophylactically in mitigating the risk of PPH is unknown. This pragmatic randomised prospective trial assesses the feasibility and safety of administering TXA at the time of delivery for the prevention of PPH. Methods and analysis A pilot pragmatic randomised double-blinded placebo-controlled trial will be performed. 58 singleton parturients at term >32 weeks, undergoing either spontaneous vaginal delivery, or caesarean section will be randomised to receive 1 g of TXA or placebo (0.9% saline) intravenously. The primary outcome assessed will be the feasibility of administrating TXA, along with collecting data regarding safety of drug administration. The groups will also be analysed on efficacy of mitigating the onset of PPH and clinically relevant variables. Demographic, feasibility, safety and clinical endpoints will be summarised and the appropriate measures of central tendency and dispersion will be presented. Ethics and dissemination This protocol was approved by the Sunnybrook Health Sciences Centre Research Ethics Board (number: 418-2016). The results will be disseminated in a peer-reviewed journal and at scientific meetings. Trial registration number NCT03069859; Pre-results. PMID:29025850

Does high sugar consumption exacerbate cardiometabolic risk factors and increase the risk of type 2 diabetes and cardiovascular disease?

PubMed Central

Sonestedt, Emily; Øverby, Nina Cecilie; Laaksonen, David E.; Birgisdottir, Bryndis Eva

2012-01-01

Consumption of sugar has been relatively high in the Nordic countries; the impact of sugar intake on metabolic risk factors and related diseases has been debated. The objectives were to assess the effect of sugar intake (sugar-sweetened beverages, sucrose and fructose) on association with type 2 diabetes, cardiovascular disease and related metabolic risk factors (impaired glucose tolerance, insulin sensitivity, dyslipidemia, blood pressure, uric acid, inflammation markers), and on all-cause mortality, through a systematic review of prospective cohort studies and randomised controlled intervention studies published between January 2000 and search dates. The methods adopted were as follows: the first search was run in PubMed in October 2010. A second search with uric acid as risk marker was run in April 2011. The total search strategy was rerun in April 2011 in SveMed+. An update was run in PubMed in January 2012. Two authors independently selected studies for inclusion from the 2,743 abstracts according to predefined eligibility criteria. The outcome was that out of the 17 studies extracted, 15 were prospective cohort studies and two were randomised controlled crossover trials. All of the studies included only adults. With respect to incident type 2 diabetes (nine studies), four of six prospective cohort studies found a significant positive association for sugar-sweetened beverage intake. In general, larger cohort studies with longer follow-up more often reported positive associations, and BMI seemed to mediate part of the increased risk. For other metabolic or cardiovascular risk factors or outcomes, too few studies have been published to draw conclusions. In conclusion, data from prospective cohort studies published in the years 2000–2011 suggest that sugar-sweetened beverages probably increase the risk of type 2 diabetes. For related metabolic risk factors, cardiovascular disease or all-cause mortality and other types of sugars, too few studies were available to draw conclusions. PMID:22855643

Effect of the rate of chest compression familiarised in previous training on the depth of chest compression during metronome-guided cardiopulmonary resuscitation: a randomised crossover trial

PubMed Central

Bae, Jinkun; Chung, Tae Nyoung; Je, Sang Mo

2016-01-01

Objectives To assess how the quality of metronome-guided cardiopulmonary resuscitation (CPR) was affected by the chest compression rate familiarised by training before the performance and to determine a possible mechanism for any effect shown. Design Prospective crossover trial of a simulated, one-person, chest-compression-only CPR. Setting Participants were recruited from a medical school and two paramedic schools of South Korea. Participants 42 senior students of a medical school and two paramedic schools were enrolled but five dropped out due to physical restraints. Intervention Senior medical and paramedic students performed 1 min of metronome-guided CPR with chest compressions only at a speed of 120 compressions/min after training for chest compression with three different rates (100, 120 and 140 compressions/min). Friedman's test was used to compare average compression depths based on the different rates used during training. Results Average compression depths were significantly different according to the rate used in training (p<0.001). A post hoc analysis showed that average compression depths were significantly different between trials after training at a speed of 100 compressions/min and those at speeds of 120 and 140 compressions/min (both p<0.001). Conclusions The depth of chest compression during metronome-guided CPR is affected by the relative difference between the rate of metronome guidance and the chest compression rate practised in previous training. PMID:26873050

Clarifying the learning experiences of healthcare professionals with in situ and off-site simulation-based medical education: a qualitative study

PubMed Central

Sørensen, Jette Led; Navne, Laura Emdal; Martin, Helle Max; Ottesen, Bent; Albrecthsen, Charlotte Krebs; Pedersen, Berit Woetmann; Kjærgaard, Hanne; van der Vleuten, Cees

2015-01-01

Objective To examine how the setting in in situ simulation (ISS) and off-site simulation (OSS) in simulation-based medical education affects the perceptions and learning experience of healthcare professionals. Design Qualitative study using focus groups and content analysis. Participants Twenty-five healthcare professionals (obstetricians, midwives, auxiliary nurses, anaesthesiologists, a nurse anaesthetist and operating theatre nurse) participated in four focus groups and were recruited due to their exposure to either ISS or OSS in multidisciplinary obstetric emergencies in a randomised trial. Setting Departments of obstetrics and anaesthesia, Rigshospitalet, Copenhagen, Denmark. Results Initially participants preferred ISS, but this changed after the training when the simulation site became of less importance. There was a strong preference for simulation in authentic roles. These perceptions were independent of the ISS or OSS setting. Several positive and negative factors in simulation were identified, but these had no relation to the simulation setting. Participants from ISS and OSS generated a better understanding of and collaboration with the various health professionals. They also provided individual and team reflections on learning. ISS participants described more experiences that would involve organisational changes than the OSS participants did. Conclusions Many psychological and sociological aspects related to the authenticity of the learning experience are important in simulation, but the physical setting of the simulation as an ISS and OSS is the least important. Based on these focus groups OSS can be used provided that all other authenticity elements are taken into consideration and respected. The only difference was that ISS had an organisational impact and ISS participants talked more about issues that would involve practical organisational changes. ISS and OSS participants did, however, go through similar individual and team learning experiences. PMID:26443655

Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: protocol for a randomised controlled trial.

PubMed

O'Grady, Kerry-Ann F; Grimwood, Keith; Toombs, Maree; Sloots, Theo P; Otim, Michael; Whiley, David; Anderson, Jennie; Rablin, Sheree; Torzillo, Paul J; Buntain, Helen; Connor, Anne; Adsett, Don; Meng Kar, Oon; Chang, Anne B

2017-03-03

Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4 weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care. A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged <15 years will be enrolled and followed weekly for 8 weeks after presenting with an ARI with cough. 214 children from this cohort with persistent cough at day 28 will be randomised to either early initiation of a cough management algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (<6 and ≥6 weeks). Demographic details, risk factors, clinical histories, examination findings, cost-of-illness data, an anterior nasal swab and parent and child exhaled carbon monoxide levels (when age appropriate) are collected at enrolment. Weekly contacts will collect cough status and cost-of-illness data. Additional nasal swabs are collected at days 28 and 56. The primary outcome is time-to-cough resolution. Secondary outcomes include direct and indirect costs of illness and the predictors of chronic cough postpresentation. The Children's Health Queensland (HREC/15/QRCH/15) and the Queensland University of Technology University (1500000132) Research Ethics Committees have approved the study. The study will inform best-practice management of cough in children. ACTRN12615000132549. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

A pilot study to evaluate the efficacy of adding a structured home visiting intervention to improve outcomes for high-risk families attending the Incredible Years Parent Programme: study protocol for a randomised controlled trial.

PubMed

Lees, Dianne G; Fergusson, David M; Frampton, Christopher M; Merry, Sally N

2014-02-25

Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child's life using evidence-based treatments such as the 'Incredible Years Parent Programme'. However, families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes. Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention (Home Parent Support) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention. This study will inform the design of a larger prospective randomised controlled trial. A pilot single-blind, parallel, superiority, randomised controlled trial. Randomisation will be undertaken using a computer-generated sequence in a 1:1 ratio to the two treatments arranged in permuted blocks with stratification by age, sex, and ethnicity. One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support, or the Incredible Years Parent Programme alone. The Home Parent Support is a 10-session structured home visiting intervention provided by a trained therapist, alongside the usual Incredible Years Parent Programme, to enhance the adoption of key parenting skills. The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale. This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes. We anticipate that the intervention will help vulnerable families stay engaged, strengthen the adoption of effective parenting strategies, and improve outcomes for both the children and families. Australian New Zealand Clinical Trials Registry ACTRN12612000878875.

PAin SoluTions In the Emergency Setting (PASTIES); a protocol for two open-label randomised trials of patient-controlled analgesia (PCA) versus routine care in the emergency department

PubMed Central

Smith, Jason E; Rockett, Mark; Squire, Rosalyn; Hayward, Christopher J; Creanor, Siobhan; Ewings, Paul; Barton, Andy; Pritchard, Colin; Benger, Jonathan Richard

2013-01-01

Introduction Pain is the commonest reason that patients present to an emergency department (ED), but it is often not treated effectively. Patient controlled analgesia (PCA) is used in other hospital settings but there is little evidence to support its use in emergency patients. We describe two randomised trials aiming to compare PCA to nurse titrated analgesia (routine care) in adult patients who present to the ED requiring intravenous opioid analgesia for the treatment of moderate to severe pain and are subsequently admitted to hospital. Methods and analysis Two prospective multi-centre open-label randomised trials of PCA versus routine care in emergency department patients who require intravenous opioid analgesia followed by admission to hospital; one trial involving patients with traumatic musculoskeletal injuries and the second involving patients with non-traumatic abdominal pain. In each trial, 200 participants will be randomised to receive either routine care or PCA, and followed for the first 12 h of their hospital stay. The primary outcome measure is hourly pain score recorded by the participant using a visual analogue scale (VAS) over the 12 h study period, with the primary statistical analyses based on the area under the curve of these pain scores. Secondary outcomes include total opioid use, side effects, time spent asleep, patient satisfaction, length of hospital stay and incremental cost effectiveness ratio. Ethics and dissemination The study is approved by the South Central—Southampton A Research Ethics Committee (REC reference 11/SC/0151). Data collection will be completed by August 2013, with statistical analyses starting after all final data queries are resolved. Dissemination plans include presentations at local, national and international scientific meetings held by relevant Colleges and societies. Publications should be ready for submission during 2014. A lay summary of the results will be available to study participants on request, and disseminated via a publically accessible website. Registration details The study is registered with the European Clinical Trials Database (EudraCT Number: 2011-000194-31) and is on the ISCRTN register (ISRCTN25343280). PMID:23418302

[The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany].

PubMed

Gysan, D B; Latsch, J; Bjarnason-Wehrens, B; Albus, C; Falkowski, G; Herold, G; Mey, E; Heinzler, R; Montiel, G; Schneider, C A; Stützer, H; Türk, S; Weisbrod, M; Predel, H G

2004-02-01

The PreFord Study is a multicenter prospective cohort study to evaluate guideline based risk management on primary prevention of cardiovascular diseases. Furthermore a randomised controlled trial (RCT) will be designed to analyse the effect of a special intervention program. 40,000 employees of the Ford Motor Company, Visteon Company and Deutz Company in Germany will be included, monitored for ten years and the following primary endpoints will be investigated: 1. evaluation and comparison of established and newly developed risk-scores, 2. the relative impact of single and combined cardiovascular risk factors on cardiovascular diseases, 3. the influence of a novel occupationally integrated ambulant rehabilitation program in combination with a guideline oriented optimal drug therapy within a high risk group on the primary endpoint: risk reduction by, 4. the influence of this intervention on secondary endpoints: death, myocardial infarction and stroke, combined appearance of angina pectoris and hospitalisation, occurrence of cerebral circulatory disorder and hospitalisation, occurrence of peripheral occlusive arterial disease and hospitalisation and single cardiovascular risk factors and cost-benefit-analysis. Beginning with an cross sectional study there will be a systemic screening of cardiovascular risk profiles, of anthropometric data and different lifestyle-factors. Based on these data participants will be differentiated into three risk-groups according to the risk score of the European Society of Cardiology (risk of a lethal primary acute cardiovascular event: I < or = 1%; II > 1-< 5% and III > or = 5%). In the following longitudinal study different strategies will be applied: Group I: low risk (< 0.5% per year): repetition of the investigation after five and ten years. Group II: middle risk, (0.6% to 1.4% per year), repetition of the investigation every two years, instruction of the patients general practitioner (GP) with respect to a risk factor oriented and evidence based treatment. Group III: high risk, (> 1.5% per year or >15% within the next 10 years) will be randomised into two interventional groups. The first one, the intervention-group "PreFord" will perform an occupational integrated rehabilitation program (2,5-3 hours twice a week, for 15 weeks according to the BAR guidelines) with a following engagement in heart-groups and an annual repetition of the check-ups. The second group, the "classic" intervention-group will be treated evidence based in cooperation with their GP. As a result of this long term interventional study efficient, area wide implementable and economically feasible prevention concepts with special regards to operational healthcare will be developed and evaluated. Core elements will be exercise- and lifestyle-oriented concepts as well as guideline-based pharmacotherapy.

Gas Hydrate Petroleum System Modeling in western Nankai Trough Area

NASA Astrophysics Data System (ADS)

Tanaka, M.; Aung, T. T.; Fujii, T.; Wada, N.; Komatsu, Y.

2017-12-01

Since 2003, we have been conducting Gas Hydrate (GH) petroleum system models covering the eastern Nankai Trough, Japan, and results of resource potential from regional model shows good match with the value depicted from seismic and log data. In this year, we have applied this method to explore GH potential in study area. In our study area, GH prospects have been identified with aid of bottom simulating reflector (BSR) and presence of high velocity anomalies above the BSR interpreted based on 3D migration seismic and high density velocity cubes. In order to understand the pathway of biogenic methane from source to GH prospects 1D-2D-3D GH petroleum system models are built and investigated. This study comprises lower Miocene to Pleistocene, deep to shallow marine sedimentary successions of Pliocene and Pleistocene layers overlain the basement. The BSR were interpreted in Pliocene and Pleistocene layers. Based on 6 interpreted sequence boundaries from 3D migration seismic and velocity data, construction of a depth 3D framework model is made and distributed by a conceptual submarine fan depositional facies model derived from seismic facies analysis and referring existing geological report. 1D models are created to analyze lithology sensitivity to temperature and vitrinite data from an exploratory well drilled in the vicinity of study area. The PSM parameters are applied in 2D and 3D modeling and simulation. Existing report of the explanatory well reveals that thermogenic origin are considered to exist. For this reason, simulation scenarios including source formations for both biogenic and thermogenic reaction models are also investigated. Simulation results reveal lower boundary of GH saturation zone at pseudo wells has been simulated with sensitivity of a few tens of meters in comparing with interpreted BSR. From sensitivity analysis, simulated temperature was controlled by different peak generation temperature models and geochemical parameters. Progressive folding and updipping layers including paleostructure can effectively assist biogenic gas migration to upward. Biogenic and Thermogenic mixing model shows that kitchen center only has a potential for generating thermogenic hydrocarbon. Our Prospect based on seismic interpretation is consistent with high GH saturation area based on 3D modeling results.

Better imagined: Neural correlates of the episodic simulation boost to prospective memory performance.

PubMed

Spreng, R Nathan; Madore, Kevin P; Schacter, Daniel L

2018-05-01

Episodic simulation is an adaptive process that can support goal-directed activity and planning success. We investigated the neural architecture associated with the episodic simulation improvement to the likelihood of carrying out future actions by isolating the brain regions associated with this facilitation in a prospective memory paradigm. Participants performed a lexical decision task by making word/non-word judgments, with rarely occurring prospective memory target words requiring a pre-specified manual response. Prior to scanning, participants were given exposure to two lists of prospective memory targets: animals and tools. In a fully counterbalanced design, participants generated a rhyme to one target list and imagined their subsequent encounter (episodic simulation) with target words on the other list. Replicating prior behavioral work, episodic simulation improved subsequent prospective memory performance. Brain activation was assessed in a multivariate partial least squares analysis. Relative to lexical decision blocks with no prospective memory demand, sustained prospective memory replicated prior observations of frontal polar activation. Critically, maintaining the intention to respond to simulated targets, over and above rhyme targets, engaged middle frontal and angular gyri, and medial parietal and prefrontal cortices. Transient activity associated with prospective memory target hits revealed activation for simulated targets in medial prefrontal cortex, posterior cingulate, lateral temporal lobe and inferior parietal lobule. In contrast, rhyme target hits engaged more left lateralized dorsolateral prefrontal cortex and anterior insula. Episodic simulation, thus effectively shifts executive control strategy and boosts task performance. These results are consistent with a growing body of evidence implicating executive control and default network region interactions in adaptive, goal-directed behavior. Copyright © 2018 Elsevier Ltd. All rights reserved.

Celecoxib versus ibuprofen in the prevention of heterotopic ossification following total hip replacement: a prospective randomised trial.

PubMed

Saudan, M; Saudan, P; Perneger, T; Riand, N; Keller, A; Hoffmeyer, P

2007-02-01

We examined whether a selective cyclooxygenase-2 (COX-2) inhibitor (celecoxib) was as effective as a non-selective inhibitor (ibuprofen) for the prevention of heterotopic ossification following total hip replacement. A total of 250 patients were randomised to receive celecoxib (200 mg b/d) or ibuprofen (400 mg t.d.s) for ten days after surgery. Anteroposterior radiographs of the pelvis were examined for heterotopic ossification three months after surgery. Of the 250 patients, 240 were available for assessment. Heterotopic ossification was more common in the ibuprofen group (none 40.7% (50), Brooker class I 46.3% (57), classes II and III 13.0% (16)) than in the celecoxib group (none 59.0% (69), Brooker class I 35.9% (42), classes II and III 5.1% (6), p=0.002). Celecoxib was more effective than ibuprofen in preventing heterotopic bone formation after total hip replacement.

So you want to conduct a randomised trial? Learnings from a 'failed' feasibility study of a Crisis Resource Management prompt during simulated paediatric resuscitation.

PubMed

Teis, Rachel; Allen, Jyai; Lee, Nigel; Kildea, Sue

2017-02-01

No study has tested a Crisis Resource Management prompt on resuscitation performance. We conducted a feasibility, unblinded, parallel-group, randomised controlled trial at one Australian paediatric hospital (June-September 2014). Eligible participants were any doctor, nurse, or nurse manager who would normally be involved in a Medical Emergency Team simulation. The unit of block randomisation was one of six scenarios (3 control:3 intervention) with or without a verbal prompt. The primary outcomes tested the feasibility and utility of the intervention and data collection tools. The secondary outcomes measured resuscitation quality and team performance. Data were analysed from six resuscitation scenarios (n=49 participants); three control groups (n=25) and three intervention groups (n=24). The ability to measure all data items on the data collection tools was hindered by problems with the recording devices both in the mannequins and the video camera. For a pilot study, greater training for the prompt role and pre-briefing participants about assessment of their cardio-pulmonary resuscitation quality should be undertaken. Data could be analysed in real time with independent video analysis to validate findings. Two cameras would strengthen reliability of the methods. Copyright © 2016 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

Benefits of home-based multidisciplinary exercise and supportive care in inoperable non-small cell lung cancer - protocol for a phase II randomised controlled trial.

PubMed

Edbrooke, Lara; Aranda, Sanchia; Granger, Catherine L; McDonald, Christine F; Krishnasamy, Mei; Mileshkin, Linda; Irving, Louis; Braat, Sabine; Clark, Ross A; Gordon, Ian; Denehy, Linda

2017-09-29

Lung cancer is one of the most commonly diagnosed cancers, and is a leading cause of cancer mortality world-wide. Due to lack of early specific symptoms, the majority of patients present with advanced, inoperable disease and five-year relative survival across all stages of non-small cell lung cancer (NSCLC) is 14%. People with lung cancer also report higher levels of symptom distress than those with other forms of cancer. Several benefits for survival and patient reported outcomes are reported from physical activity and exercise in other tumour groups. We report the protocol for a study investigating the benefits of exercise, behaviour change and symptom self-management for patients with recently diagnosed, inoperable, NSCLC. This multi-site, parallel-group, assessor-blinded randomised controlled trial, powered for superiority, aims to assess functional and patient-reported outcomes of a multi-disciplinary, home-based exercise and supportive care program for people commencing treatment. Ninety-two participants are being recruited from three tertiary-care hospitals in Melbourne, Australia. Following baseline testing, participants are randomised using concealed allocation, to receive either: a) 8 weeks of home-based exercise (comprising an individualised endurance and resistance exercise program and behaviour change coaching) and nurse-delivered symptom self-management intervention or b) usual care. The primary outcome is the between-group difference in the change in functional exercise capacity (six-minute walk distance) from baseline to post-program assessment. Secondary outcomes include: objective and self-reported physical activity levels, physical activity self-efficacy, behavioural regulation of motivation to exercise and resilience, muscle strength (quadriceps and grip), health-related quality of life, anxiety and depression and symptom interference. There is a lack of evidence regarding the benefit of exercise intervention for people with NSCLC, particularly in those with inoperable disease receiving treatment. This trial will contribute to evidence currently being generated in national and international trials by implementing and evaluating a home-based program including three components not yet combined in previous research, for people with inoperable NSCLC receiving active treatment and involving longer-term follow-up of outcomes. This trial is ongoing and currently recruiting. This trial was prospectively registered on the Australian New Zealand Clinical Trials Registry ( ACTRN12614001268639 : (4/12/14).

Learning communication from erroneous video-based examples: A double-blind randomised controlled trial.

PubMed

Schmitz, Felix Michael; Schnabel, Kai Philipp; Stricker, Daniel; Fischer, Martin Rudolf; Guttormsen, Sissel

2017-06-01

Appropriate training strategies are required to equip undergraduate healthcare students to benefit from communication training with simulated patients. This study examines the learning effects of different formats of video-based worked examples on initial communication skills. First-year nursing students (N=36) were randomly assigned to one of two experimental groups (correct v. erroneous examples) or to the control group (no examples). All the groups were provided an identical introduction to learning materials on breaking bad news; the experimental groups also received a set of video-based worked examples. Each example was accompanied by a self-explanation prompt (considering the example's correctness) and elaborated feedback (the true explanation). Participants presented with erroneous examples broke bad news to a simulated patient significantly more appropriately than students in the control group. Additionally, they tended to outperform participants who had correct examples, while participants presented with correct examples tended to outperform the control group. The worked example effect was successfully adapted for learning in the provider-patient communication domain. Implementing video-based worked examples with self-explanation prompts and feedback can be an effective strategy to prepare students for their training with simulated patients, especially when examples are erroneous. Copyright © 2017 Elsevier B.V. All rights reserved.

A conceptual prediction model for seasonal drought processes using atmospheric and oceanic standardized anomalies and its application to four recent severe regional drought events in China

NASA Astrophysics Data System (ADS)

Liu, Z.; LU, G.; He, H.; Wu, Z.; He, J.

2017-12-01

Reliable drought prediction is fundamental for seasonal water management. Considering that drought development is closely related to the spatio-temporal evolution of large-scale circulation patterns, we develop a conceptual prediction model of seasonal drought processes based on atmospheric/oceanic Standardized Anomalies (SA). It is essentially the synchronous stepwise regression relationship between 90-day-accumulated atmospheric/oceanic SA-based predictors and 3-month SPI updated daily (SPI3). It is forced with forecasted atmospheric and oceanic variables retrieved from seasonal climate forecast systems, and it can make seamless drought prediction for operational use after a year-to-year calibration. Simulation and prediction of four severe seasonal regional drought processes in China were forced with the NCEP/NCAR reanalysis datasets and the NCEP Climate Forecast System Version 2 (CFSv2) operationally forecasted datasets, respectively. With the help of real-time correction for operational application, model application during four recent severe regional drought events in China revealed that the model is good at development prediction but weak in severity prediction. In addition to weakness in prediction of drought peak, the prediction of drought relief is possible to be predicted as drought recession. This weak performance may be associated with precipitation-causing weather patterns during drought relief. Based on initial virtual analysis on predicted 90-day prospective SPI3 curves, it shows that the 2009/2010 drought in Southwest China and 2014 drought in North China can be predicted and simulated well even for the prospective 1-75 day. In comparison, the prospective 1-45 day may be a feasible and acceptable lead time for simulation and prediction of the 2011 droughts in Southwest China and East China, after which the simulated and predicted developments clearly change.

Fortuitous phenomena: on complexity, pragmatic randomised controlled trials, and knowledge for evidence-based practice.

PubMed

Thompson, Carl

2004-01-01

Many of the interventions that nurses develop and implement are in themselves complex and have to operate in situations of irreducible complexity and uncertainty. This article argues that the primary means of generating knowledge for the evidence-based deployment of complex interventions should be the pragmatic randomised controlled trial. Randomised controlled trials represent the only research design to adequately deal with that which we know and (far more importantly) that which we do not. Using the example of practice development as an exemplar for complexity, and drawing on the objections often voiced as a response to calls to make use of randomised controlled trials in nursing and nursing research, the article presents a developmental framework and some methodological solutions to problems often encountered. Randomised controlled trials, whilst undoubtedly methodologically and strategically challenging, offer the most robust basis for developing primary research knowledge on the effects of complex interventions in nursing and their active components.

Sleeping Well Trial: Increasing the effectiveness of treatment with continuous positive airway pressure using a weight management program in overweight adults with obstructive sleep apnoea-A stepped wedge randomised trial protocol.

PubMed

Truby, Helen; Edwards, Bradley A; O'Driscoll, Denise M; Young, Alan; Ghazi, Ladan; Bristow, Claire; Roem, Kerryn; Bonham, Maxine P; Murgia, Chiara; Day, Kaitlin; Haines, Terry P; Hamilton, Garun S

2018-05-24

The majority of adults diagnosed with obstructive sleep apnoea (OSA) are overweight or obese. Continuous positive airway pressure (CPAP) is the most common effective therapy for OSA. However, adherence declines over time with only 50% of patients prescribed CPAP continuing to use it long term. Furthermore, a recent prospective analysis indicated that those more adherent with CPAP therapy have enhanced weight gain trajectories which in turn may negatively impact their OSA. The Sleeping Well Trial aims to establish whether the timing of starting a lifestyle weight loss intervention impacts on weight trajectory in those with moderate-severe OSA treated at home with CPAP, while testing the potential for smart phone technology to improve adherence with lifestyle interventions. A stepped wedge design with randomisation of individuals from 1 to 6 months post-enrolment, with 5 months of additional prospective follow up after completion of the stepped wedge. This design will investigate the effect of the 6-month lifestyle intervention on people undergoing CPAP on body weight, body composition and health-related quality of life. This trial tests whether the timing of supporting the patient through a weight loss intervention is important in obtaining the maximum benefit of a lifestyle change and CPAP usage, and identify how best to support patients through this critical period. The protocol (v1) is registered prospectively with the International Clinical Trials Registry (CTR) ACTRN12616000203459 (public access). Any amendments to protocol will be documented via the CTR. Recruitment commenced in March 2016 with data collection scheduled to finish by May 2018. © 2018 Dietitians Association of Australia.

Complex proximal humeral fractures: a prospective study of 22 cases treated using the "Bilboquet" device.

PubMed

Doursounian, L; Kilinc, A; Cherrier, B; Nourissat, G

2011-02-01

Despite recent improvements in surgical devices, complex proximal humerus fractures internal fixation still encounters frequent mechanical failures. The aim of this study was to confirm that the Bilboquet device (a design mimicking the cup-and-ball game) helps solving mechanical difficulties associated with these fractures internal fixation and to present a simplified version of the original surgical procedure. This non-randomised prospective study included 22 fractures in 22 patients, mean age: 70 years. According to the Neer classification there were three-part fractures in seven cases and four-part fractures in 15 cases. Fractures were all reduced and treated by internal fixation in a simplified surgical procedure using the Bilboquet device. Mean postoperative follow-up was 34 months. The mean Constant score was 66 and the weighted Constant score was 86. Mean active forward elevation was 108° and mean active external rotation was 28°. No per- or postoperative complications occurred. Initial reduction of the tuberosity was incomplete in four cases. Union was obtained in all fractures. There was no secondary tilting of the head, and no migration or pseudarthrosis of the tuberosities. Five patients developed postoperative avascular necrosis of the humeral head. The Bilboquet staple component provides a supporting platform for the entire humeral head area. This peripheral stabilization associated with tension band wiring explains the lack of secondary displacement in these cases. Although the Bilboquet device provides a solution to the mechanical problems of complex fractures of the proximal humerus, it does not solve the problem of secondary avascular necrosis of the humeral head, which occurred in 23% of the patients in this series and in 33% of patients in the four-part fractures subgroup. IV (non-randomised prospective study). Copyright © 2010 Elsevier Masson SAS. All rights reserved.

Pain management after laparoscopic cholecystectomy-a randomized prospective trial of low pressure and standard pressure pneumoperitoneum.

PubMed

Singla, Sanjeev; Mittal, Geeta; Raghav; Mittal, Rajinder K

2014-02-01

Abdominal pain and shoulder tip pain after laparoscopic cholecystectomy are distressing for the patient. Various causes of this pain are peritoneal stretching and diaphragmatic irritation by high intra-abdominal pressure caused by pneumoperitoneum . We designed a study to compare the post operative pain after laparoscopic cholecystectomy at low pressure (7-8 mm of Hg) and standard pressure technique (12-14 mm of Hg). Aim : To compare the effect of low pressure and standard pressure pneumoperitoneum in post laparoscopic cholecystectomy pain . Further to study the safety of low pressure pneumoperitoneum in laparoscopic cholecystectomy. A prospective randomised double blind study. A prospective randomised double blind study was done in 100 ASA grade I & II patients. They were divided into two groups -50 each. Group A patients underwent laparoscopic cholecystectomy with low pressure pneumoperitoneum (7-8 mm Hg) while group B underwent laparoscopic cholecystectomy with standard pressure pneumoperitoneum (12-13 mm Hg). Both the groups were compared for pain intensity, analgesic requirement and complications. Demographic data and intraoperative complications were analysed using chi-square test. Frequency of pain, intensity of pain and analgesics consumption was compared by applying ANOVA test. Post-operative pain score was significantly less in low pressure group as compared to standard pressure group. Number of patients requiring rescue analgesic doses was more in standard pressure group . This was statistically significant. Also total analgesic consumption was more in standard pressure group. There was no difference in intraoperative complications. This study demonstrates the use of simple expedient of reducing the pressure of pneumoperitoneum to 8 mm results in reduction in both intensity and frequency of post-operative pain and hence early recovery and better outcome.This study also shows that low pressure technique is safe with comparable rate of intraoperative complications.

[Research Progress and Prospect of Applications of Finite Element Method in Lumbar Spine Biomechanics].

PubMed

Zhang, Zhenjun; Li, Yang; Liao, Zhenhua; Liu, Weiqiang

2016-12-01

Based on the application of finite element analysis in spine biomechanics,the research progress of finite element method applied in lumbar spine mechanics is reviewed and the prospect is forecasted.The related works,including lumbar ontology modeling,clinical application research,and occupational injury and protection,are summarized.The main research areas of finite element method are as follows:new accurate modeling process,the optimized simulation method,diversified clinical effect evaluation,and the clinical application of artificial lumbar disc.According to the recent research progress,the application prospects of finite element method,such as automation and individuation of modeling process,evaluation and analysis of new operation methods and simulation of mechanical damage and dynamic response,are discussed.The purpose of this paper is to provide the theoretical reference and practical guidance for the clinical lumbar problems by reviewing the application of finite element method in the field of the lumbar spine biomechanics.

Interpretation of health news items reported with or without spin: protocol for a prospective meta-analysis of 16 randomised controlled trials.

PubMed

Haneef, Romana; Yavchitz, Amélie; Ravaud, Philippe; Baron, Gabriel; Oransky, Ivan; Schwitzer, Gary; Boutron, Isabelle

2017-11-17

We aim to compare the interpretation of health news items reported with or without spin. 'Spin' is defined as a misrepresentation of study results, regardless of motive (intentionally or unintentionally) that overemphasises the beneficial effects of the intervention and overstates safety compared with that shown by the results. We have planned a series of 16 randomised controlled trials (RCTs) to perform a prospective meta-analysis. We will select a sample of health news items reporting the results of four types of study designs, evaluating the effect of pharmacological treatment and containing the highest amount of spin in the headline and text. News items reporting four types of studies will be included: (1) preclinical studies; (2) phase I/II (non-randomised) trials; (3) RCTs and (4) observational studies. We will rewrite the selected news items and remove the spin. The original news and rewritten news will be appraised by four types of populations: (1) French-speaking patients; (2) French-speaking general public; (3) English-speaking patients and (4) English-speaking general public. Each RCT will explore the interpretation of news items reporting one of the four study designs by each type of population and will include a sample size of 300 participants. The primary outcome will be participants' interpretation of the benefit of treatment after reading the news items: (What do you think is the probability that treatment X would be beneficial to patients? (scale, 0 (very unlikely) to 10 (very likely)).This study will evaluate the impact of spin on the interpretation of health news reporting results of studies by patients and the general public. This study has obtained ethics approval from the Institutional Review Board of the Institut national de la santé et de la recherche médicale (INSERM) (registration no: IRB00003888). The description of all the steps and the results of this prospective meta-analysis will be available online and will be disseminated as a published article. On the completion of this study, the results will be sent to all participants. CRD42017058941. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

PubMed

Fajadet, Jean; Neumann, Franz-Josef; Hildick-Smith, David; Petronio, Sonia; Zaman, Azfar; Spence, Mark; Wöhrle, Jochen; Elhadad, Simon; Roberts, David; Hovasse, Thomas; Valdés, Mariano; Silber, Sigmund

2017-01-20

The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES. We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44). At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.

Is there a causal link between knee loading and knee osteoarthritis progression? A systematic review and meta-analysis of cohort studies and randomised trials

PubMed Central

Henriksen, Marius; Creaby, Mark W; Lund, Hans; Juhl, Carsten; Christensen, Robin

2014-01-01

Objective We performed a systematic review, meta-analysis and assessed the evidence supporting a causal link between knee joint loading during walking and structural knee osteoarthritis (OA) progression. Design Systematic review, meta-analysis and application of Bradford Hill's considerations on causation. Data sources We searched MEDLINE, Scopus, AMED, CINAHL and SportsDiscus for prospective cohort studies and randomised controlled trials (RCTs) from 1950 through October 2013. Study eligibility criteria We selected cohort studies and RCTs in which estimates of knee joint loading during walking were used to predict structural knee OA progression assessed by X-ray or MRI. Data analyses Meta-analysis was performed to estimate the combined OR for structural disease progression with higher baseline loading. The likelihood of a causal link between knee joint loading and OA progression was assessed from cohort studies using the Bradford Hill guidelines to derive a 0–4 causation score based on four criteria and examined for confirmation in RCTs. Results Of the 1078 potentially eligible articles, 5 prospective cohort studies were included. The studies included a total of 452 patients relating joint loading to disease progression over 12–72 months. There were very serious limitations associated with the methodological quality of the included studies. The combined OR for disease progression was 1.90 (95% CI 0.85 to 4.25; I2=77%) for each one-unit increment in baseline knee loading. The combined causation score was 0, indicating no causal association between knee loading and knee OA progression. No RCTs were found to confirm or refute the findings from the cohort studies. Conclusions There is very limited and low-quality evidence to support for a causal link between knee joint loading during walking and structural progression of knee OA. Trial registration number CRD42012003253 PMID:25031196

Is there a causal link between knee loading and knee osteoarthritis progression? A systematic review and meta-analysis of cohort studies and randomised trials.

PubMed

Henriksen, Marius; Creaby, Mark W; Lund, Hans; Juhl, Carsten; Christensen, Robin

2014-07-15

We performed a systematic review, meta-analysis and assessed the evidence supporting a causal link between knee joint loading during walking and structural knee osteoarthritis (OA) progression. Systematic review, meta-analysis and application of Bradford Hill's considerations on causation. We searched MEDLINE, Scopus, AMED, CINAHL and SportsDiscus for prospective cohort studies and randomised controlled trials (RCTs) from 1950 through October 2013. We selected cohort studies and RCTs in which estimates of knee joint loading during walking were used to predict structural knee OA progression assessed by X-ray or MRI. Meta-analysis was performed to estimate the combined OR for structural disease progression with higher baseline loading. The likelihood of a causal link between knee joint loading and OA progression was assessed from cohort studies using the Bradford Hill guidelines to derive a 0-4 causation score based on four criteria and examined for confirmation in RCTs. Of the 1078 potentially eligible articles, 5 prospective cohort studies were included. The studies included a total of 452 patients relating joint loading to disease progression over 12-72 months. There were very serious limitations associated with the methodological quality of the included studies. The combined OR for disease progression was 1.90 (95% CI 0.85 to 4.25; I(2)=77%) for each one-unit increment in baseline knee loading. The combined causation score was 0, indicating no causal association between knee loading and knee OA progression. No RCTs were found to confirm or refute the findings from the cohort studies. There is very limited and low-quality evidence to support for a causal link between knee joint loading during walking and structural progression of knee OA. CRD42012003253. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Management of generalised convulsive status epilepticus (SE): A prospective randomised controlled study of combined treatment with intravenous lorazepam with either phenytoin, sodium valproate or levetiracetam--Pilot study.

PubMed

Mundlamuri, R C; Sinha, S; Subbakrishna, D K; Prathyusha, P V; Nagappa, M; Bindu, P S; Taly, A B; Umamaheswara Rao, G S; Satishchandra, P

2015-08-01

This study was conducted to compare the efficacy of phenytoin, valproate and levetiracetam in patients with GCSE. This randomised controlled prospective study was conducted on 150 patients to compare the efficacy of phenytoin (n = 50), valproate (n = 50) and levetiracetam (n = 50) along with lorazepam in patients with GCSE. All recruited patients received i.v. lorazepam (0.1mg/kg) followed by one of the 3 AEDs viz. phenytoin (20 mg/kg), valproate (30 mg/kg), and levetiracetam (25 mg/kg). Those who remained uncontrolled with 1st AED, received the other two AEDs sequentially. Clinical, imaging, EEG, etiological factors were analysed. Predictors of poor seizure control and outcome at discharge and at one month follow-up were assessed. In the phenytoin subgroup, the seizures could be controlled in 34 (68%) with lorazepam+phenytoin infusion. In the valproate subgroup (n = 50), seizures could be controlled in 34 (68%) with lorazepam+valproate infusion. In the levetiracetam subgroup (n = 50), seizures could be controlled in 39 (78%) with lorazepam+levetiracetam infusion. There was no statistically significant difference between the subgroups (p = 0.44). Overall, following lorazepam and 1st AED, 107/150 (71.3%) were controlled; with addition of 2nd AED, 130/150 (86.7%) and by adding 3rd AED, 138/150 (92%) were controlled. Fifteen out of 110 (13.6%) expired within 1 month of SE: phenytoin-6; valproate-4; and levetiracetam-5. Interestingly, 3 patients in the levetiracetam had post-ictal psychosis. Phenytoin, valproate, and levetiracetam are safe and equally efficacious following lorazepam in GCSE. The choice of AEDs could be individualised based on co-morbidities. SE could be controlled in 92% of patients with AEDs only and anaesthetics were not required in them. Copyright © 2015 Elsevier B.V. All rights reserved.

Intra-articular corticosteroids versus intra-articular corticosteroids plus methotrexate in oligoarticular juvenile idiopathic arthritis: a multicentre, prospective, randomised, open-label trial.

PubMed

Ravelli, Angelo; Davì, Sergio; Bracciolini, Giulia; Pistorio, Angela; Consolaro, Alessandro; van Dijkhuizen, Evert Hendrik Pieter; Lattanzi, Bianca; Filocamo, Giovanni; Verazza, Sara; Gerloni, Valeria; Gattinara, Maurizio; Pontikaki, Irene; Insalaco, Antonella; De Benedetti, Fabrizio; Civino, Adele; Presta, Giuseppe; Breda, Luciana; Marzetti, Valentina; Pastore, Serena; Magni-Manzoni, Silvia; Maggio, Maria Cristina; Garofalo, Franco; Rigante, Donato; Gattorno, Marco; Malattia, Clara; Picco, Paolo; Viola, Stefania; Lanni, Stefano; Ruperto, Nicolino; Martini, Alberto

2017-03-04

Little evidence-based information is available to guide the treatment of oligoarticular juvenile idiopathic arthritis. We aimed to investigate whether oral methotrexate increases the efficacy of intra-articular corticosteroid therapy. We did this prospective, open-label, randomised trial at ten hospitals in Italy. Using a concealed computer-generated list, children younger than 18 years with oligoarticular-onset disease were randomly assigned (1:1) to intra-articular corticosteroids alone or in combination with oral methotrexate (15 mg/m 2 ; maximum 20 mg). Corticosteroids used were triamcinolone hexacetonide (shoulder, elbow, wrist, knee, and tibiotalar joints) or methylprednisolone acetate (ie, subtalar and tarsal joints). We did not mask patients or investigators to treatment assignments. Our primary outcome was the proportion of patients in the intention-to-treat population who had remission of arthritis in all injected joints at 12 months. This trial is registered with European Union Clinical Trials Register, EudraCT number 2008-006741-70. Between July 7, 2009, and March 31, 2013, we screened 226 participants and randomly assigned 102 to intra-articular corticosteroids alone and 105 to intra-articular corticosteroids plus methotrexate. 33 (32%) patients assigned to intra-articular corticosteroids alone and 39 (37%) assigned to intra-articular corticosteroids and methotrexate therapy had remission of arthritis in all injected joints (p=0·48). Adverse events were recorded for 20 (17%) patients who received methotrexate, which led to permanent treatment discontinuation in two patients (one due to increased liver transaminases and one due to gastrointestinal discomfort). No patient had a serious adverse event. Concomitant administration of methotrexate did not augment the effectiveness of intra-articular corticosteroid therapy. Future studies are needed to define the optimal therapeutic strategies for oligoarticular juvenile idiopathic arthritis. Italian Agency of Drug Evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Nontechnical skills training for the operating room: A prospective study using simulation and didactic workshop.

PubMed

Pena, Guilherme; Altree, Meryl; Field, John; Sainsbury, David; Babidge, Wendy; Hewett, Peter; Maddern, Guy

2015-07-01

The best surgeons demonstrate skills beyond those required for the performance of technically competent surgery. These skills are described under the term nontechnical skills. Failure in these domains has been associated with adverse events inside the operating room. These nontechnical skills are not learned commonly in a structured manner during surgery training. The main purpose of this study was to explore the effects of participation in simulation-based training, either as a sole strategy or as part of a combined approach on surgeons and surgical trainees nontechnical skills performance in simulation environment. The study consisted of a single-blinded, prospective comparative trial. Forty participants were enrolled, all participating in 2 simulation sessions challenging nontechnical skills comprising 3 surgical scenarios. Seventeen participants attended a 1-day, nontechnical skills workshop between simulation sessions. Scenarios were video-recorded for assessment and debriefing purposes. Assessment was made by 2 observers using the Non-Technical Skills for Surgeons (NOTSS) scoring system. There was a significant improvement in nontechnical skills performance of both groups from the first to the second simulation session, for 2 of the 3 scenarios. No difference in performance between the simulation and the simulation plus workshop groups was noted. This study provides evidence that formal training in nontechnical skills is feasible and can impact positively participants' nontechnical performance in a simulated environment. The addition of a 1-day didactic workshop does not seem to provide additional benefit over simulation-based training as a sole strategy for nontechnical skills training. Copyright © 2015 Elsevier Inc. All rights reserved.

Rationale and design of the SMaRT trial: A randomised, prospective, parallel, non-blinded, one-centre trial to evaluate the use of magnetic resonance imaging in acute setting in patients presenting with suspected scaphoid fracture.

PubMed

Rua, Tiago; Vijayanathan, Sanjay; Parkin, David; Goh, Vicky; McCrone, Paul; Gidwani, Sam

2018-04-01

Background Wrist injury is a common presentation to the Emergency Department in the United Kingdom. Among these injuries, the scaphoid is the most common fractured carpal bone. However, given the limited ability of conventional radiography to accurately diagnose a suspected scaphoid fracture on presentation, its diagnosis and management remain challenging. Despite the vast clinical evidence supporting the superior accuracy of magnetic resonance imaging, there is little to no evidence around the real-world clinical and economic impact of immediate magnetic resonance imaging in the management of suspected scaphoid fractures. Methods Review of design and implementation challenges associated with the identification and subsequent recruitment of eligible patients, implementation of a novel clinical pathway in an acute setting, rationale behind the primary and secondary outcomes selected and measurement of the primary outcome. Results The Scaphoid Magnetic Resonance Imaging in Trauma trial is a single-site prospective, randomised, non-blinded, parallel design trial that aims to evaluate the use of immediate magnetic resonance imaging in the management of patients presenting to the acute setting with suspected scaphoid fractures. The primary outcome is the total 3-month cost per patient associated with the diagnosis and treatment of suspected scaphoid fractures. It is hypothesised that the immediate use of magnetic resonance imaging, a more accurate but expensive imaging modality, in patients with negative findings in the initial four-view radiography, will reduce the overall National Health Service costs by promoting definitive care and avoiding unnecessary diagnostic and treatment procedures. Other rationale design considerations in the recruitment, randomisation, data acquisition and intervention implementation are also discussed. Several of these challenges derive from real-world operational issues associated with the provision of magnetic resonance imaging in an intrinsically complex acute setting. Staff engagement during the trial's planning phase, combined with an extensive training programme rolled out prior to the trial's launch, were essential to raise staff awareness and engagement. Given the acute nature of the clinical condition, the latter was deemed essential as the eligibility assessment, recruitment, randomisation and treatment allocation processes all need to happen in a very tight time frame. Limitations Findings from the Scaphoid Magnetic Resonance Imaging in Trauma trial might not be generalisable to other National Health Service hospitals, foreign healthcare systems nor patient presentations outside normal magnetic resonance imaging working hours. Conclusion The Scaphoid Magnetic Resonance Imaging in Trauma trial was designed to evaluate the costs, patient satisfaction and clinical outcomes around the management of suspected scaphoid fractures and ultimately provide solid evidence on which to base the United Kingdom and international clinical practice. This article discusses the steps considered in the design of this novel trial, with particular emphasis on the issues and lessons learned during the planning and implementation stages.

Randomised clinical trial: the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for Helicobacter pylori in Korea.

PubMed

Kim, Y S; Kim, S J; Yoon, J H; Suk, K T; Kim, J B; Kim, D J; Kim, D Y; Min, H J; Park, S H; Shin, W G; Kim, K H; Kim, H Y; Baik, G H

2011-11-01

The eradication rates of Helicobacter pylori (H. pylori) using a proton pump inhibitor (PPI)-based triple therapy have declined due to antibiotic resistance worldwide. To compare the eradication rate of the 10-day sequential therapy for H. pylori infection with that of the 14-day standard PPI-based triple therapy. This was a prospective, randomised, controlled study. A total of 409 patients with H. pylori infection were randomly assigned to receive either the 10-day sequential therapy regimen, which consisted of pantoprazole (40 mg) plus amoxicillin (1000 mg) twice a day for 5 days, then pantoprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for another five consecutive days or the 14-day PPI-based triple therapy regimen, which consisted of pantoprazole (40 mg) with amoxicillin (1000 mg) and clarithromycin (500 mg) twice a day for 14 days. The pre- and post-treatment H. pylori status were assessed by rapid urease test, urea breath test, or histology. Successful eradication was confirmed at least 4 weeks after finishing the treatment. In the intention-to-treat analysis, the eradication rates of the 10-day sequential therapy and of the 14-day PPI-based triple therapy were 85.9% (176/205) and 75.0% (153/205), respectively (P = 0.006). In the per-protocol analysis, the eradication rates were 92.6% (175/205) and 85% (153/204), respectively (P = 0.019). There was no statistically significant difference between the two investigated groups regarding the occurrence of adverse event rates (18.9% vs. 13.3%, P = 0.143). The 10-day sequential therapy achieved significantly higher eradication rates than the 14-day standard PPI-based triple therapy in Korea. © 2011 Blackwell Publishing Ltd.

Establishing the effectiveness, cost-effectiveness and student experience of a Simulation-based education Training program On the Prevention of Falls (STOP-Falls) among hospitalised inpatients: a protocol for a randomised controlled trial.

PubMed

Williams, Cylie; Bowles, Kelly-Ann; Kiegaldie, Debra; Maloney, Stephen; Nestel, Debra; Kaplonyi, Jessica; Haines, Terry

2016-06-02

Simulation-based education (SBE) is now commonly used across health professional disciplines to teach a range of skills. The evidence base supporting the effectiveness of this approach for improving patient health outcomes is relatively narrow, focused mainly on the development of procedural skills. However, there are other simulation approaches used to support non-procedure specific skills that are in need of further investigation. This cluster, cross-over randomised controlled trial with a concurrent economic evaluation (cost per fall prevented) trial will evaluate the effectiveness, cost-effectiveness and student experience of health professional students undertaking simulation training for the prevention of falls among hospitalised inpatients. This research will target the students within the established undergraduate student placements of Monash University medicine, nursing and allied health across Peninsula Health acute and subacute inpatient wards. The intervention will train the students in how to provide the Safe Recovery program, the only single intervention approach demonstrated to reduce falls in hospitals. This will involve redevelopment of the Safe Recovery program into a one-to-many participant SBE program, so that groups of students learn the communication skills and falls prevention knowledge necessary for delivery of the program. The primary outcome of this research will be patient falls across participating inpatient wards, with secondary outcomes including student satisfaction with the SBE and knowledge gain, ward-level practice change and cost of acute/rehabilitation care for each patient measured using clinical costing data. The Human Research Ethics Committees of Peninsula Health (LRR/15/PH/11) and Monash University (CF15/3523-2015001384) have approved this research. The participant information and consent forms provide information on privacy, storage of results and dissemination. Registration of this trial has been completed with the Australian and New Zealand Clinical Trials Registry: ACTRN12615000817549. This study protocol has been prepared according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. ACTRN12615000817549; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Protocol of the Febuxostat versus Allopurinol Streamlined Trial (FAST): a large prospective, randomised, open, blinded endpoint study comparing the cardiovascular safety of allopurinol and febuxostat in the management of symptomatic hyperuricaemia.

PubMed

MacDonald, Thomas M; Ford, Ian; Nuki, George; Mackenzie, Isla S; De Caterina, Raffaele; Findlay, Evelyn; Hallas, Jesper; Hawkey, Christopher J; Ralston, Stuart; Walters, Matthew; Webster, John; McMurray, John; Perez Ruiz, Fernando; Jennings, Claudine G

2014-07-10

Gout affects 2.5% of the UK's adult population and is now the most common type of inflammatory arthritis. The long-term management of gout requires reduction of serum urate levels and this is most often achieved with use of xanthine oxidase inhibitors, such as allopurinol. Febuxostat is the first new xanthine oxidase inhibitor since allopurinol and was licensed for use in 2008. The European Medicines Agency requested a postlicensing cardiovascular safety study of febuxostat versus allopurinol, which has been named the Febuxostat versus Allopurinol Streamlined trial (FAST). FAST is a cardiovascular safety study using the prospective, randomised, open, blinded endpoint design. FAST is recruiting in the UK and Denmark. Recruited patients are aged over 60 years, prescribed allopurinol for symptomatic hyperuricaemia and have at least one additional cardiovascular risk factor. After an allopurinol lead-in phase where the dose of allopurinol is optimised to achieve European League against Rheumatism (EULAR) urate targets (serum urate <357 µmol/L), patients are randomised to either continue optimal dose allopurinol or to use febuxostat. Patients are followed-up for an average of 3 years. The primary endpoint is first occurrence of the Anti-Platelet Trialists' Collaboration (APTC) cardiovascular endpoint of non-fatal myocardial infarction, non-fatal stroke or cardiovascular death. Secondary endpoints are all cause mortality and hospitalisations for heart failure, unstable, new or worsening angina, coronary or cerebral revascularisation, transient ischaemic attack, non-fatal cardiac arrest, venous and peripheral arterial vascular thrombotic event and arrhythmia with no evidence of ischaemia. The primary analysis is a non-inferiority analysis with a non-inferiority upper limit for the HR for the primary outcome of 1.3. FAST (ISRCTN72443728) has ethical approval in the UK and Denmark, and results will be published in a peer reviewed journal. FAST is registered in the EU Clinical Trials Register (EUDRACT No: 2011-001883-23) and International Standard Randomised Controlled Trial Number Register (ISRCTN No: ISRCTN72443728). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Open three-stage transthoracic oesophagectomy versus minimally invasive thoraco-laparoscopic oesophagectomy for oesophageal cancer: protocol for a multicentre prospective, open and parallel, randomised controlled trial.

PubMed

Mu, Juwei; Gao, Shugeng; Mao, Yousheng; Xue, Qi; Yuan, Zuyang; Li, Ning; Su, Kai; Yang, Kun; Lv, Fang; Qiu, Bin; Liu, Deruo; Chen, Keneng; Li, Hui; Yan, Tiansheng; Han, Yongtao; Du, Ming; Xu, Rongyu; Wen, Zhaoke; Wang, Wenxiang; Shi, Mingxin; Xu, Quan; Xu, Shun; He, Jie

2015-11-17

Oesophageal cancer is the eighth most common cause of cancer worldwide. In 2009 in China, the incidence and death rate of oesophageal cancer was 22.14 per 100 000 person-years and 16.77 per 100 000 person-years, respectively, the highest in the world. Minimally invasive oesophagectomy (MIO) was introduced into clinical practice with the aim of reducing the morbidity rate. The mechanisms of MIO may lie in minimising the reaction to surgical injury and inflammation. There are some randomised trials regarding minimally invasive versus open oesophagectomy, with 100-850 subjects enrolled. To date, no large randomised controlled trial comparing minimally invasive versus open oesophagectomy has been reported in China, where squamous cell carcinoma predominated over adenocarcinoma of the oesophagus. This is a 3 year multicentre, prospective, randomised, open and parallel controlled trial, which aims to compare the effectiveness of minimally invasive thoraco-laparoscopic oesophagectomy to open three-stage transthoracic oesophagectomy for resectable oesophageal cancer. Group A patients receive MIO which involves thoracoscopic oesophagectomy and laparoscopic gastric mobilisation with cervical anastomosis. Group B patients receive the open three-stage transthoracic oesophagectomy which involves a right thoracotomy and laparotomy with cervical anastomosis. Primary endpoints include respiratory complications within 30 days after operation. The secondary endpoints include other postoperative complications, influences on pulmonary function, intraoperative data including blood loss, operative time, the number and location of lymph nodes dissected, and mortality in hospital, the length of hospital stay, total expenses in hospital, mortality within 30 days, survival rate after 2 years, postoperative pain, and health-related quality of life (HRQoL). Three hundred and twenty-four patients in each group will be needed and a total of 648 patients will finally be enrolled into the study. The study protocol has been approved by the Institutional Ethics Committees of all participating institutions. The findings of this trial will be disseminated to patients and through peer-reviewed publications and international presentations. NCT02355249. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

[The reduction of stroke risk, risk of myocardial infarction and death by healthy diet and physical activity].

PubMed

Droste, D W; Keipes, M

2013-01-01

There is no doubt that a healthy diet and regular physical activity improve risk factors for cerebro-cardio-vascular disease and death. However, there is less evidence from prospective randomised controlled trials that they also reduce the actual risk of stroke, myocardial infarction and death. The only evidence from randomised controlled trials is, that a mediterranean diet with nuts and/or native olive oil considerably reduces stroke risk by 47% respectively 31%, however not the risk of myocardial infarction and death. A low-fat diet, a low-salt diet, and the addition of omega-3 fatty acids have no influence. In case of severe obesity with a BMI of > 34-38 kg/m2, weight reduction is the priority, if necessary by means of bariatric surgery. In longitudinal studies mortality (-29%), stroke (-34%), and myocardial infarction (-29%) could thus be reduced. Regular physical activity, whether endurance or more intense activity, leads to weight loss and improved vascular risk factors. An independent impact on stroke, myocardial infarction and mortality has not yet been demonstrated in prospective studies (double-blinding being impossible). Nevertheless, several epidemiological meta-analyses with observation durations of 4 to 28 years using data of up to 880 000 persons, indicate that there is a 2-3 fold risk reduction of cerebro-cardio-vascular death and global mortality in people with regular physical activity versus sedentary behaviour.

Hypobaric Unilateral Spinal Anaesthesia versus General Anaesthesia in Elderly Patients Undergoing Hip Fracture Surgical Repair: A Prospective Randomised Open Trial.

PubMed

Meuret, Pascal; Bouvet, Lionel; Villet, Benoit; Hafez, Mohamed; Allaouchiche, Bernard; Boselli, Emmanuel

2018-04-01

Intraoperative hypotension during hip fracture surgery is frequent in the elderly. No study has compared the haemodynamic effect of hypobaric unilateral spinal anaesthesia (HUSA) and standardised general anaesthesia (GA) in elderly patients undergoing hip fracture surgical repair. We performed a prospective, randomised open study, including 40 patients aged over 75 years, comparing the haemodynamic effects of HUSA (5 mg isobaric bupivacaine with 5 μg sufentanil and 1 mL sterile water) and GA (induction with etomidate/remifentanil and maintenance with desflurane/remifentanil). An incidence of severe hypotension, defined by a decrease in systolic blood pressure of >40% from baseline, was the primary endpoint. The incidence of severe hypotension was lower in the HUSA group compared with that in the GA group (32% vs. 71%, respectively, p=0.03). The median [IQR] ephedrine consumption was lower (p=0.001) in the HUSA group (6 mg, 0-17 mg) compared with that in the GA group (36 mg, 21-57 mg). Intraoperative muscle relaxation and patients' and surgeons' satisfaction were similar between groups. No difference was observed in 5-day complications or 30-day mortality. This study shows that HUSA provides better haemodynamic stability than GA, with lower consumption of ephedrine and similar operating conditions. This new approach of spinal anaesthesia seems to be safe and effective in elderly patients undergoing hip fracture surgery.

Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

PubMed

Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

2014-02-01

Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

A prospective, randomised, within-subject study of ALA-PDT for actinic keratoses using different irradiation regimes.

PubMed

Zaar, O; Sjöholm Hylén, A; Gillstedt, M; Paoli, J

2018-05-12

Photodynamic therapy (PDT) can be used to treat large fields of actinic keratoses (AKs) with high clearance rates. A notable downside is the amount of pain that accompany the treatment. This study aimed to optimise the illumination protocol during conventional PDT in order to reduce pain without compromising treatment effectiveness. In this prospective, randomised study with a split-face design, patients with, symmetrically distributed AKs were included. All patients were treated using a ALA 78 mg/g gel. One side was illuminated with the Aktilite ® CL-128 lamp and the other side with the RhodoLED ® lamp in which the light intensity gradually increased to a maximum of 60%. Both sides received a total light dose of 37 J/cm 2 . Pain during the treatment was measured using a visual analogue scale. The clinical effectiveness of the two treated sides was assessed after 12 weeks. 29 patients with 399 AKs were included. Illumination with the gradually increasing light intensity resulted in a decrease of the median VAS score by 1.1 points. Clearance rates were similar between the two lamps. Minimising the light intensity during the illumination phase of PDT reduces pain, while still preserving a high clearance rate of AKs. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A randomised trial of sheathed versus standard forceps for obtaining uncontaminated biopsy specimens of microbiota from the terminal ileum.

PubMed

Dave, Maneesh; Johnson, Laura A; Walk, Seth T; Young, Vincent B; Stidham, Ryan W; Chaudhary, Meghana N; Funnell, Jessica; Higgins, Peter D R

2011-08-01

The study of intestinal microbiota has been revolutionised by the use of molecular methods, including terminal restriction fragment length polymorphism (T-RFLP) analysis. Microbiota studies of Crohn's disease patients have examined samples from stool or from the neoterminal ileum with a standard biopsy forceps, which could be contaminated by colonic bacteria when the forceps passes through the colonoscope channel. To determine whether sheathed biopsy forceps are able to obtain terminal ileal microbiota samples with less colonic bacterial contamination compared with unsheathed (standard) biopsy forceps. Prospective randomised single-centre study. Four (paired) biopsy specimens were obtained from adjacent locations in the terminal ileum using the sheathed and standard forceps of 27 consecutive subjects undergoing colonoscopy and the microbiota were characterised using T-RFLP. The Bray-Curtis similarity index between samples (sheathed vs unsheathed forceps) was calculated within patients and significant differences were tested for across all patients. There was not a significant difference in the microbial diversity of samples obtained using sheathed versus unsheathed forceps. The difference in microbial diversity between patients was much greater than the variability within patients by proximal versus distal site or by forceps type. T-RFLP is based on PCR amplification, so it is not always sensitive to rare bacterial species. Standard unsheathed forceps appear to be sufficient for microbiota sample collection from the terminal ileum.

Bicycling to school improves the cardiometabolic risk factor profile: a randomised controlled trial

PubMed Central

Østergaard, Lars; Børrestad, Line A B; Tarp, Jakob; Andersen, Lars Bo

2012-01-01

Objectives To investigate whether bicycling to school improves cardiometabolic risk factor profile and cardiorespiratory fitness among children. Design Prospective, blinded, randomised controlled trial. Setting Single centre study in Odense, Denmark Participants 43 children previously not bicycling to school were randomly allocated to control group (n=20) (ie, no change in lifestyle) or intervention group (ie, bicycling to school) (n=23). Primary and secondary outcome measures Change in cardiometabolic risk factor score and change in cardiorespiratory fitness. Results All participants measured at baseline returned at follow-up. Based upon intention-to-treat (ITT) analyses, clustering of cardiometabolic risk factors was lowered by 0.58 SD (95% CI −1.03 to −0.14, p=0.012) in the bicycling group compared to the control group. Cardiorespiratory fitness (l O2/min) per se did not increase significantly more in the intervention than in the control group (β=0.0337, 95% CI −0.06 to 0.12, p=0.458). Conclusions Bicycling to school counteracted a clustering of cardiometabolic risk factors and should thus be recognised as potential prevention of type 2 diabetes mellitus and cardiovascular disease (CVD). The intervention did, however, not elicit a larger increase in cardiorespiratory fitness in the intervention group as compared with the control group. Trial registration Registered at http://www.clinicaltrials.gov (NCT01236222). PMID:23117560

An Overview of the use of Bromelain-Based Enzymatic Debridement (Nexobrid®) in Deep Partial & Full Thickness Burns: Appraising the Evidence.

PubMed

Loo, Yew L; Goh, Benjamin K L; Jeffery, S

2018-03-22

Recent introduction of rapid bromelain-based enzymatic debridement has been increasingly popular in its use in non-surgical debridement in deep partial and full thickness burns. We designed this study to evaluate the evidence suggested by current studies on the perceived benefits of using Nexobrid® as compared to traditional surgical standard of care (SOC) in burns wound debridement. A comprehensive search on electronic databases Pubmed, Embase and Web of Science was done to identify studies published between 1986 to 2017 involving the use of Nexobrid in deep partial and full thickness burns. Studies were evaluated for proposed benefits and categorised under supporting evidence, contradicting evidence and anecdotal opinions. 7 well designed prospective studies met the inclusion comprising of 4 randomised controlled trials. 6 proposed benefits associated with the use of Nexobrid were extracted including reduced time to complete debridement, need for surgery, area of burns excised, need for autograft, time to wound closure and improved scar quality. Most proposed benefits have strong supporting evidences with minimal anecdotal opinions from controlled trials except the proposed improvement in scar quality and reduced time to wound healing that had at least 3 refuting evidence and 1 anecdotal evidence. Incidence of pain was also evaluated and were mainly anecdotal lacking formal objective assessment or cohort study. Despite the lack of literatures available, the benefits of Nexobrid is evident in published randomised and single arm studies. Large number of studies are needed to aid further evaluating the proposed benefits of Nexobrid.

Effect of incorporating a 10 minute point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme: randomised controlled trial.

PubMed

Barnfather, Kristian D; Cope, Graham F; Chapple, Iain L

2005-10-29

To investigate the effect of immediate feedback from a point of care test for salivary nicotine metabolites in promoting smoking cessation and reduction in tobacco use. Prospective, operator blinded, randomised controlled trial. General dental practice, London. 100 adult smokers. Participants completed a questionnaire on smoking, undertook a clinical examination, and received counselling in smoking cessation. Saliva samples were analysed at presentation and at eight weeks for salivary nicotine metabolites using a 10 minute semiquantitative point of care test. Smoking cessation measured by salivary nicotine metabolite values (scale 0-6), patient feedback on the perceived value of the test (visual analogue scale) in quitting, and reduction in tobacco use. A higher smoking quit rate was achieved with the point of care test (23% cases v 7% controls; P < 0.039), and overall tobacco use also decreased (68% cases v 28% controls; P < 0.001). Baseline values for salivary nicotine metabolites did not differ between the groups (cases, mean 4.1, SD 1.3 and 4.3, 1.4; P = 0.51). 87 participants reattended at eight weeks (44 cases, 43 controls). Mean nicotine metabolite values at eight weeks were 2.58 (2.0) for cases and 4.29 (1.8) for controls (P < 0.001). Incorporation of individualised personal feedback using a point of care test for salivary nicotine metabolites into a general practice based smoking cessation programme increased quit rates by 17% at eight weeks and reduced tobacco use.

Navigating the fine line between benefit and risk in chronic atrial fibrillation: rationale and design of the Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY).

PubMed

Carrington, Melinda J; Ball, Jocasta; Horowitz, John D; Marwick, Thomas H; Mahadevan, Gnanadevan; Wong, Chiew; Abhayaratna, Walter P; Haluska, Brian; Thompson, David R; Scuffham, Paul A; Stewart, Simon

2013-06-20

Health outcomes associated with atrial fibrillation (AF) continue to be poor and standard management often does not provide clinical stability. The Standard versus Atrial Fibrillation spEcific managemenT studY (SAFETY) compares the efficacy of a post-discharge, nurse-led, multi-disciplinary programme to optimise AF management with usual care. SAFETY is a prospective, multi-centre, randomised controlled trial with blinded-endpoint adjudication. A target of 320 hospitalised patients with a chronic form of AF will be randomised (stratified by "rate" versus "rhythm" control) to usual post-discharge care or the SAFETY Intervention (SI). The SI involves home-based assessment, extensive clinical profiling and the application of optimal gold-standard pharmacology which is individually tailored according to a "traffic light" framework based on clinical stability, risk profile and therapeutic management. The primary endpoint is event-free survival from all-cause death or unplanned readmission during 18-36 months follow-up. Secondary endpoints include rate of recurrent hospital stay, treatment success (i.e. maintenance of rhythm or rate control and/or application of anti-thrombotic therapy without a bleeding event) and cost-efficacy. With study recruitment to be completed in early 2012, the results of this study will be available in early 2014. If positive, SAFETY will represent a potentially cost-effective and readily applicable strategy to improve health outcomes in high risk individuals discharged from hospital with chronic AF. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

When and how should multiple imputation be used for handling missing data in randomised clinical trials - a practical guide with flowcharts.

PubMed

Jakobsen, Janus Christian; Gluud, Christian; Wetterslev, Jørn; Winkel, Per

2017-12-06

Missing data may seriously compromise inferences from randomised clinical trials, especially if missing data are not handled appropriately. The potential bias due to missing data depends on the mechanism causing the data to be missing, and the analytical methods applied to amend the missingness. Therefore, the analysis of trial data with missing values requires careful planning and attention. The authors had several meetings and discussions considering optimal ways of handling missing data to minimise the bias potential. We also searched PubMed (key words: missing data; randomi*; statistical analysis) and reference lists of known studies for papers (theoretical papers; empirical studies; simulation studies; etc.) on how to deal with missing data when analysing randomised clinical trials. Handling missing data is an important, yet difficult and complex task when analysing results of randomised clinical trials. We consider how to optimise the handling of missing data during the planning stage of a randomised clinical trial and recommend analytical approaches which may prevent bias caused by unavoidable missing data. We consider the strengths and limitations of using of best-worst and worst-best sensitivity analyses, multiple imputation, and full information maximum likelihood. We also present practical flowcharts on how to deal with missing data and an overview of the steps that always need to be considered during the analysis stage of a trial. We present a practical guide and flowcharts describing when and how multiple imputation should be used to handle missing data in randomised clinical.

The use of head-mounted display eyeglasses for teaching surgical skills: A prospective randomised study.

PubMed

Peden, Robert G; Mercer, Rachel; Tatham, Andrew J

2016-10-01

To investigate whether 'surgeon's eye view' videos provided via head-mounted displays can improve skill acquisition and satisfaction in basic surgical training compared with conventional wet-lab teaching. A prospective randomised study of 14 medical students with no prior suturing experience, randomised to 3 groups: 1) conventional teaching; 2) head-mounted display-assisted teaching and 3) head-mounted display self-learning. All were instructed in interrupted suturing followed by 15 minutes' practice. Head-mounted displays provided a 'surgeon's eye view' video demonstrating the technique, available during practice. Subsequently students undertook a practical assessment, where suturing was videoed and graded by masked assessors using a 10-point surgical skill score (1 = very poor technique, 10 = very good technique). Students completed a questionnaire assessing confidence and satisfaction. Suturing ability after teaching was similar between groups (P = 0.229, Kruskal-Wallis test). Median surgical skill scores were 7.5 (range 6-10), 6 (range 3-8) and 7 (range 1-7) following head-mounted display-assisted teaching, conventional teaching, and head-mounted display self-learning respectively. There was good agreement between graders regarding surgical skill scores (rho.c = 0.599, r = 0.603), and no difference in number of sutures placed between groups (P = 0.120). The head-mounted display-assisted teaching group reported greater enjoyment than those attending conventional teaching (P = 0.033). Head-mounted display self-learning was regarded as least useful (7.4 vs 9.0 for conventional teaching, P = 0.021), but more enjoyable than conventional teaching (9.6 vs 8.0, P = 0.050). Teaching augmented with head-mounted displays was significantly more enjoyable than conventional teaching. Students undertaking self-directed learning using head-mounted displays with pre-recorded videos had comparable skill acquisition to those attending traditional wet-lab tutorials. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

A prospective randomised cross-over study of the effect of insulin analogues and human insulin on the frequency of severe hypoglycaemia in patients with type 1 diabetes and recurrent hypoglycaemia (the HypoAna trial): study rationale and design

PubMed Central

2012-01-01

Background Severe hypoglycaemia still represents a significant problem in insulin-treated diabetes. Most patients do not experience severe hypoglycaemia often. However, 20% of patients with type 1 diabetes experience recurrent severe hypoglycaemia corresponding to at least two episodes per year. The effect of insulin analogues on glycaemic control has been documented in large trials, while their effect on the frequency of severe hypoglycaemia is less clear, especially in patients with recurrent severe hypoglycaemia. The HypoAna Trial is designed to investigate whether short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing the occurrence of severe hypoglycaemic episodes in patients with recurrent hypoglycaemia. This paper reports the study design of the HypoAna Trial. Methods/design The study is a Danish two-year investigator-initiated, prospective, randomised, open, blinded endpoint (PROBE), multicentre, cross-over trial investigating the effect of insulin analogues versus human insulin on the frequency of severe hypoglycaemia in subjects with type 1 diabetes. Patients are randomised to treatment with basal-bolus therapy with insulin detemir / insulin aspart or human NPH insulin / human regular insulin in random order. The major inclusion criterion is history of two or more episodes of severe hypoglycaemia in the preceding year. Discussion In contrast to almost all other studies in this field the HypoAna Trial includes only patients with major problems with hypoglycaemia. The HypoAna Trial will elucidate whether basal-bolus regimen with short-acting and long-acting insulin analogues in comparison with human insulin are superior in reducing occurrence of severe hypoglycaemic episodes in hypoglycaemia prone patients with type 1 diabetes. http://www.clinicaltrials.gov: NCT00346996. PMID:22727048

Effect of a single prophylactic preoperative oral antibiotic dose on surgical site infection following complex dermatological procedures on the nose and ear: a prospective, randomised, controlled, double-blinded trial.

PubMed

Rosengren, Helena; Heal, Clare F; Buttner, Petra G

2018-04-19

There is limited published research studying the effect of antibiotic prophylaxis on surgical site infection (SSI) in dermatological surgery, and there is no consensus for its use in higher-risk cases. The objective of this study was to determine the effectiveness of a single oral preoperative 2 g dose of cephalexin in preventing SSI following flap and graft dermatological closures on the nose and ear. Prospective double-blinded, randomised, placebo-controlled trial testing for difference in infection rates. Primary care skin cancer clinics in North Queensland, Australia, were randomised to 2 g oral cephalexin or placebo 40-60 min prior to skin incision. 154 consecutive eligible patients booked for flap or graft closure following skin cancer excision on the ear and nose. 2 g dose of cephalexin administered 40-60 min prior to surgery. Overall 8/69 (11.6%) controls and 1/73 (1.4%) in the intervention group developed SSI (p=0.015; absolute SSI reduction 10.2%; number needed to treat (NNT) for benefit 9.8, 95% CI 5.5 to 45.5). In males, 7/44 controls and 0/33 in the intervention group developed SSI (p=0.018; absolute SSI reduction 15.9%; NNT for benefit 6.3, 95% CI 3.8 to 19.2). SSI was much lower in female controls (1/25) and antibiotic prophylaxis did not further reduce this (p=1.0). There was no difference between the study groups in adverse symptoms attributable to high-dose antibiotic administration (p=0.871). A single oral 2 g dose of cephalexin given before complex skin closure on the nose and ear reduced SSI. ANZCTR 365115; Post-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A prospective randomised trial of four-layer versus short stretch compression bandages for the treatment of venous leg ulcers.

PubMed Central

Scriven, J. M.; Taylor, L. E.; Wood, A. J.; Bell, P. R.; Naylor, A. R.; London, N. J.

1998-01-01

This trial was undertaken to examine the safety and efficacy of four-layer compared with short stretch compression bandages for the treatment of venous leg ulcers within the confines of a prospective, randomised, ethically approved trial. Fifty-three patients were recruited from a dedicated venous ulcer assessment clinic and their individual ulcerated limbs were randomised to receive either a four-layer bandage (FLB)(n = 32) or a short stretch bandage (SSB)(n = 32). The endpoint was a completely healed ulcer. However, if after 12 weeks of compression therapy no healing had been achieved, that limb was withdrawn from the study and deemed to have failed to heal with the prescribed bandage. Leg volume was measured using the multiple disc model at the first bandaging visit, 4 weeks later, and on ulcer healing. Complications arising during the study were recorded. Data from all limbs were analysed on an intention to treat basis; thus the three limbs not completing the protocol were included in the analysis. Of the 53 patients, 50 completed the protocol. At 1 year the healing rate was FLB 55% and SSB 57% (chi 2 = 0.0, df = 1, P = 1.0). Limbs in the FLB arm of the study sustained one minor complication, whereas SSB limbs sustained four significant complications. Leg volumes reduced significantly after 4 weeks of compression, but subsequent volume changes were insignificant. Ulcer healing rates were not influenced by the presence of deep venous reflux, post-thrombotic deep vein changes nor by ulcer duration. Although larger ulcers took longer to heal, the overall healing rates for large (> 10 cm2) and small (10 cm2 or less) ulcers were comparable. Four-layer and short stretch bandages were equally efficacious in healing venous ulcers independent of pattern of venous reflux, ulcer area or duration. FLB limbs sustained fewer complications than SSB. PMID:9682649

Analysis of bedside entertainment services' effect on post cardiac surgery physical activity: a prospective, randomised clinical trial.

PubMed

Papaspyros, Sotiris; Uppal, Shitansu; Khan, Shakeeb A; Paul, Sanjoy; O'Regan, David J

2008-11-01

A rising number of acute hospitals in the UK have been providing patients with bedside entertainment services (BES) since 1995. However, their effect on postoperative patient mobility has not been explored. The aim of this prospective randomised clinical trial was to compare the level of postoperative physical activity and length of in-hospital stay of patients undergoing cardiac surgery depending on whether they had access to BES or not. One hundred patients requiring elective cardiac surgery were randomised to receive access to BES (52 patients) or not (48 patients). Pedometers were used to quantify postoperative physical activity for 5 days. To assess the significance of the effect of intervention (TV off or on) on the pedometer counts over time a mixed effect Poisson regression model is used, with the time varying aspect as random component. The potential influence of gender difference and age on pedometer counts were assessed by incorporating these two factors as covariates in the Poisson model. On average, patients with no access to BES walked more than those with BES access. This difference ranged between 192 and 609 steps in favour of the first group for each individual postoperative day. Patients with no access to BES were 84% more likely (risk ratio: 1.84, 95% CI: 1.29-2.63) to walk higher number of steps than patients with access to BES. On average, participants with access to BES were likely to stay longer in hospital (median of 7 days with interquartile range 6-7 days), than participants with no access to BES (median of 6 days with interquartile range 5-7 days), however the difference did not reach statistical significance. We have demonstrated that the bedside entertainment systems may have an adverse effect on post cardiac surgery patient ambulation and may contribute to an increase in hospital stay.

The benefit of tissue contact monitoring with an electrical coupling index during ablation of typical atrial flutter--a prospective randomised control trial.

PubMed

Jones, Michael A; Webster, David; Wong, Kelvin C K; Hayes, Christopher; Qureshi, Norman; Rajappan, Kim; Bashir, Yaver; Betts, Timothy R

2014-12-01

We sought to investigate the use of tissue contact monitoring by means of the electrical coupling index (ECI) in a prospective randomised control trial of patients undergoing cavotricuspid isthmus (CTI) ablation for atrial flutter. Patients with ECG-documented typical flutter undergoing their first CTI ablation were randomised to ECI™-guided or non-ECI™-guided ablation. An irrigated-tip ablation catheter was used in all cases. Consecutive 50-W, 60-s radiofrequency lesions were applied to the CTI, from the tricuspid valve to inferior vena cava, with no catheter movement permitted during radiofrequency (RF) delivery. The ablation endpoint was durable CTI block at 20 min post-ablation. Patients underwent routine clinic follow-up post-operatively. A total of 101 patients (79 male), mean age 66 (+/-11), 50 ECI-guided and 51 control cases were enrolled in the study. CTI block was achieved in all. There were no acute complications. All patients were alive at follow-up. CTI block was achieved in a single pass in 36 ECI-guided and 30 control cases (p = 0.16), and at 20 min post-ablation, re-conduction was seen in 5 and 12 cases, respectively (p = 0.07). There was no significant difference in total procedure time (62.7 ± 33 vs. 62.3 ± 33 min, p = 0.92), RF requirement (580 ± 312 vs. 574 ± 287 s, p = 0.11) or fluoroscopy time (718 ± 577 vs. 721 ± 583 s, p = 0.78). After 6 ± 4 months, recurrence of flutter had occurred in 1 (2 %) ECI vs. 8 (16 %) control cases (OR 0.13, 95 % CI 0.01-1.08, p = 0.06). ECI-guided CTI ablation demonstrated a non-statistically significant reduction in late recurrence of atrial flutter, at no cost to procedural time, radiation exposure or RF requirement.

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

PubMed

Powell, G A; Bonnett, L J; Tudur-Smith, C; Hughes, D A; Williamson, P R; Marson, A G

2017-08-23

In the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs. Setting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy. 98 participants have provided written consent to permit the request of routinely recorded data. Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed. Secondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful. Recommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research. International Standard Randomised Controlled Trials, ISRCTN30294119 . Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012.

Effects of dabigatran on the cellular and protein phase of coagulation in patients with coronary artery disease on dual antiplatelet therapy with aspirin and clopidogrel. Results from a prospective, randomised, double-blind, placebo-controlled study.

PubMed

Franchi, Francesco; Rollini, Fabiana; Cho, Jung Rae; King, Rhodri; Phoenix, Fladia; Bhatti, Mona; DeGroat, Christopher; Tello-Montoliu, Antonio; Zenni, Martin M; Guzman, Luis A; Bass, Theodore A; Ajjan, Ramzi A; Angiolillo, Dominick J

2016-03-01

There is growing interest in understanding the effects of adding an oral anticoagulant in patients on dual antiplatelet therapy (DAPT). Vitamin K antagonists (VKAs) and clopidogrel represent the most broadly utilised oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, VKAs can interfere with clopidogrel metabolism via the cytochrome P450 (CYP) system which in turn may result in an increase in platelet reactivity. Dabigatran is a direct acting (anti-II) oral anticoagulant which does not interfere with CYP and has favourable safety and efficacy profiles compared with VKAs. The pharmacodynamic (PD) effects on platelet reactivity and clot kinetic of adjunctive dabigatran therapy in patients on DAPT are poorly explored. In this prospective, randomised, double-blind, placebo-controlled PD study, patients (n=30) on maintenance DAPT with aspirin and clopidogrel were randomised to either dabigatran 150 mg bid or placebo for seven days. PD testing was performed before and after treatment using four different assays exploring multiple pathways of platelet aggregation and fibrin clot kinetics: light transmittance aggregometry (LTA), multiple electrode aggregometry (MEA), kaolin-activated thromboelastography (TEG) and turbidimetric assays. There were no differences in multiple measures of platelet reactivity investigating purinergic and non-purinergic signaling pathways assessed by LTA, MEA and TEG platelet mapping. Dabigatran significantly increased parameters related to thrombin activity and thrombus generation, and delayed fibrin clot formation, without affecting clot structure or fibrinolysis. In conclusion, in patients on DAPT with aspirin and clopidogrel, adjunctive dabigatran therapy is not associated with modulation of profiles of platelet reactivity as determined by several assays assessing multiple platelet signalling pathways. However, dabigatran significantly interferes with parameters related to thrombin activity and delays fibrin clot formation.

Multinational, double-blind, randomised, placebo-controlled, prospective study of esomeprazole in the prevention of recurrent peptic ulcer in low-dose acetylsalicylic acid users: the LAVENDER study.

PubMed

Sugano, Kentaro; Choi, Myung-Gyu; Lin, Jaw-Town; Goto, Shinya; Okada, Yasushi; Kinoshita, Yoshikazu; Miwa, Hiroto; Chiang, Chern-En; Chiba, Tsutomu; Hori, Masatsugu; Fukushima, Yasushi; Kim, Hyun-Soo; Chang, Chi-Yang; Date, Masataka

2014-07-01

To evaluate if esomeprazole prevents recurrent peptic ulcer in adult patients with a history of peptic ulcer receiving low-dose acetylsalicylic acid (ASA, aspirin) for cardiovascular protection in East Asia. In this prospective, randomised, double-blind, placebo-controlled trial conducted in Japan, Korea and Taiwan, eligible patients receiving low-dose ASA for cardiovascular protection (81-324 mg/day) were randomised to esomeprazole 20 mg/day or placebo for ≤72 weeks. All patients received concomitant mucosal protection (gefarnate 100 mg/day). The primary endpoint was time to ulcer recurrence (Kaplan-Meier analysis). Efficacy findings are presented up to week 48, as per a planned interim analysis within the study protocol. A total of 364 patients (79.9% men; mean age, 67.1 years) comprised the full analysis set (esomeprazole, n=182; placebo, n=182). There was a statistically significant difference in the time to ulcer recurrence between esomeprazole and placebo (HR 0.09; 96.65% CI 0.02 to 0.41; p<0.001). The estimated ulcer-free rate at week 12 was 99.3% (esomeprazole) and 89.0% (placebo). The high estimated ulcer-free rate for esomeprazole was maintained through to week 48 (98.3% vs. 81.2% of placebo-treated patients). No factors, other than female gender, reduced time to ulcer recurrence in addition to the effect of esomeprazole (p<0.001). Treatment with esomeprazole was generally well tolerated. Daily esomeprazole 20 mg is efficacious and well tolerated in reducing the recurrence of peptic ulcer in East-Asian patients with a history of ulcers who are taking low-dose ASA for cardiovascular protection. NCT01069939. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Simulation-based educational curriculum for fluoroscopically guided lumbar puncture improves operator confidence and reduces patient dose.

PubMed

Faulkner, Austin R; Bourgeois, Austin C; Bradley, Yong C; Hudson, Kathleen B; Heidel, R Eric; Pasciak, Alexander S

2015-05-01

Fluoroscopically guided lumbar puncture (FGLP) is a commonly performed procedure with increased success rates relative to bedside technique. However, FGLP also exposes both patient and staff to ionizing radiation. The purpose of this study was to determine if the use of a simulation-based FGLP training program using an original, inexpensive lumbar spine phantom could improve operator confidence and efficiency, while also reducing patient dose. A didactic and simulation-based FGLP curriculum was designed, including a 1-hour lecture and hands-on training with a lumbar spine phantom prototype developed at our institution. Six incoming post-graduate year 2 (PGY-2) radiology residents completed a short survey before taking the course, and each resident practiced 20 simulated FGLPs using the phantom before their first clinical procedure. Data from the 114 lumbar punctures (LPs) performed by the six trained residents (prospective cohort) were compared to data from 514 LPs performed by 17 residents who did not receive simulation-based training (retrospective cohort). Fluoroscopy time (FT), FGLP success rate, and indication were compared. There was a statistically significant reduction in average FT for the 114 procedures performed by the prospective study cohort compared to the 514 procedures performed by the retrospective cohort. This held true for all procedures in aggregate, LPs for myelography, and all procedures performed for a diagnostic indication. Aggregate FT for the prospective group (0.87 ± 0.68 minutes) was significantly lower compared to the retrospective group (1.09 ± 0.65 minutes) and resulted in a 25% reduction in average FT (P = .002). There was no statistically significant difference in the number of failed FGLPs between the two groups. Our simulation-based FGLP curriculum resulted in improved operator confidence and reduced FT. These changes suggest that resident procedure efficiency was improved, whereas patient dose was reduced. The FGLP training program was implemented by radiology residents and required a minimal investment of time and resources. The LP spine phantom used during training was inexpensive, durable, and effective. In addition, the phantom is compatible with multiple modalities including fluoroscopy, computed tomography, and ultrasound and could be easily adapted to other applications such as facet injections or joint arthrograms. Copyright © 2015 AUR. Published by Elsevier Inc. All rights reserved.

A multicentre prospective randomised study of single-incision mini-sling (Ajust®) versus tension-free vaginal tape-obturator (TVT-O™) in the management of female stress urinary incontinence: pain profile and short-term outcomes.

PubMed

Mostafa, Alyaa; Agur, Wael; Abdel-All, Mohamed; Guerrero, Karen; Lim, Chi; Allam, Mohamed; Yousef, Mohamed; N'Dow, James; Abdel-fattah, Mohamed

2012-11-01

To compare the postoperative pain profile, peri-operative details, and short-term patient-reported and objective success rates of single-incision mini-slings (SIMS) versus standard mid-urethral slings (SMUS). In a multicentre prospective randomised trial in six UK centres in the period between October 2009 and October 2010, 137 women were randomised to either adjustable SIMS (Ajust®, C. R. Bard Inc., NJ, USA), performed under local anaesthesia as an opt-out policy (n=69), or SMUS (TVT-O™, Ethicon Inc., Somerville, USA) performed under general anaesthesia (n=68). Randomisation was done through number-allocation software and using telephone randomisation. Postoperative pain profile (primary outcome) was assessed on a ten-point visual analogue scale at fixed time-points. Pre- and post operatively (4-6 months) women completed symptom severity, urgency perception scale (UPS), quality of life and sexual function questionnaires. In addition, women completed a Patient Global Impression of Improvement Questionnaire and underwent a cough stress test at 4-6 months follow up. Sample size calculation was performed and data were analysed using SPSS 18. Descriptive analyses are given and between-group comparisons were performed using chi-square, Fischer exact test and Mann-Whitney test as appropriate. Significance level was set at 5%. Women in the SIMS Ajust® group had a significantly lower postoperative pain profile up to 4 weeks (p=<0.001, 95% CI 1.151, 2.480). There was no significant difference in peri-operative complications between groups. All 137 women completed the 4-6 months follow-up. Patient-reported and objective cure rates were not significantly different: 85.5% versus 91.2% (p=0.443) and 90% versus 97% (p=0.165) between the SIMS Ajust® and TVT-O™ groups respectively. There was a trend towards higher rates of de novo urgency or worsening of pre-existing urgency in the SIMS Ajust® group (21.7% versus 8.8%) but this did not reach statistical significance (p=0.063). Women in the SIMS Ajust® group had shorter hospital stay (median (IQR) 3.65 (2.49, 4.96)) compared to (4.42 (3.16, 5.56)) the TVT-O™ group 95% CI (-0.026, 1.326), with significantly earlier return to normal activities (p=0.025) and to work (p=0.006). The adjustable single-incision mini-sling (Ajust®) is associated with a significantly improved postoperative pain profile and earlier return to work when compared to standard mid-urethral slings (TVT-O™), with encouraging results in patient-reported and objective success rates at short-term follow-up. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Teaching childbirth with high-fidelity simulation. Is it better observing the scenario during the briefing session?

PubMed

Cuerva, Marcos J; Piñel, Carlos S; Martin, Lourdes; Espinosa, Jose A; Corral, Octavio J; Mendoza, Nicolás

2018-02-12

The design of optimal courses for obstetric undergraduate teaching is a relevant question. This study evaluates two different designs of simulator-based learning activity on childbirth with regard to respect to the patient, obstetric manoeuvres, interpretation of cardiotocography tracings (CTG) and infection prevention. This randomised experimental study which differs in the content of their briefing sessions consisted of two groups of undergraduate students, who performed two simulator-based learning activities on childbirth. The first briefing session included the observations of a properly performed scenario according to Spanish clinical practice guidelines on care in normal childbirth by the teachers whereas the second group did not include the observations of a properly performed scenario, and the students observed it only after the simulation process. The group that observed a properly performed scenario after the simulation obtained worse grades during the simulation, but better grades during the debriefing and evaluation. Simulator use in childbirth may be more fruitful when the medical students observe correct performance at the completion of the scenario compared to that at the start of the scenario. Impact statement What is already known on this subject? There is a scarcity of literature about the design of optimal high-fidelity simulation training in childbirth. It is known that preparing simulator-based learning activities is a complex process. Simulator-based learning includes the following steps: briefing, simulation, debriefing and evaluation. The most important part of high-fidelity simulations is the debriefing. A good briefing and simulation are of high relevance in order to have a fruitful debriefing session. What do the results of this study add? Our study describes a full simulator-based learning activity on childbirth that can be reproduced in similar facilities. The findings of this study add that high-fidelity simulation training in childbirth is favoured by a short briefing session and an abrupt start to the scenario, rather than a long briefing session that includes direct instruction in the scenario. What are the implications of these findings for clinical practice and/or further research? The findings of this study reveal what to include in the briefing of simulator-based learning activities on childbirth. These findings have implications in medical teaching and in medical practice.

Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials.

PubMed

Tattersall, Martin H N; Jefford, Michael; Martin, Andrew; Olver, Ian; Thompson, John F; Brown, Richard F; Butow, Phyllis N

2017-03-01

To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials. Tertiary cancer referral hospitals in three state capital cities in Australia. 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial. We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial. Questionnaires were completed at baseline and within 3 weeks of deciding on treatment trial participation. scores on the Quality of Informed Consent questionnaire (QuIC). 88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups. Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006. Results, ACTRN12606000214538. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Modification of cervical length after cervical pessary insertion: correlation weeks of gestation.

PubMed

Mendoza, Manel; Goya, Maria; Gascón, Andrea; Pratcorona, Laia; Merced, Carme; Rodó, Carlota; Valle, Leonor; Romero, Azahar; Juan, Miquel; Rodríguez, Alberto; Muñoz, Begoña; Santacruz, Bele N; Carreras, Elena; Cabero, Luis

2017-07-01

To observe the modifications in cervical length (CL) in patients with and without cervical pessary (Arabin® ASQ 65/25/32) and correlate these modifications with gestational age at delivery. Prospective study of asymptomatic singleton pregnancies (PECEP-Trial) between weeks 20 + 0 and 23 + 6 with maternal short cervix (<25 mm) randomised into two groups: expectant management and cervical pessary. This study included 380 pregnant women: 190 with pessary and 190 without pessary. Mean CL in both groups at the time of randomisation showed no statistically-significant differences (pessary group: 19.0 mm and management group: 19.0 mm; p = 0.9). Mean CL measured after randomisation was 15.4 mm in patients of the expectant management group and 21.5 mm in the pessary group. These differences were statistically significant (p < 0.0001). When means at randomisation and at the second measurement were compared, CL had decreased by 3.6 mm in the expectant management group and increased by 2.6 mm in the pessary group; this difference was statistically significant (p < 0.0001). Coefficients of correlation showed that among patients of both groups with the same CL at 20 weeks of gestation, those with a pessary gave birth later. Insertion of an Arabin cervical pessary increased CL in asymptomatic patients with a short cervix, which correlated with shorter gestational age at delivery. The cervical pessary halted the progressive decrease in CL, which correlated with longer gestational age at delivery.

A comparison of three induction regimens using succinylcholine, vecuronium, or no muscle relaxant: impact on the intraoperative monitoring of the lateral spread response in hemifacial spasm surgery: study protocol for a randomised controlled trial

PubMed Central

2012-01-01

Background Surgical microvascular decompression (MVD) is the curative treatment for hemifacial spasm (HFS). Monitoring MVD by recording the lateral spread response (LSR) intraoperatively can predict a successful clinical outcome. However, the rate of the LSR varies between trials, and the reason for this variation is unclear. The aim of our trial is to evaluate the rate of the LSR after intubation following treatment with succinylcholine, vecuronium, or no muscle relaxant. Methods and design This trial is a prospective randomised controlled trial of 96 patients with HFS (ASA status I or II) undergoing MVD under general anaesthesia. Patients are randomised to receive succinylcholine, vecuronium, or no muscle relaxant before intubation. Intraoperative LSR will be recorded until dural opening. The primary outcome of this study is the rate of the LSR, and the secondary outcomes are post-intubation pharyngolaryngeal symptoms, the rate of difficult intubations, the rate of adverse haemodynamic events and the relationship between the measurement of LSR or not, and clinical success rates at 30 days after surgery. Discussion This study aims to evaluate the impact of muscle relaxants on the rate of the LSR, and the study may provide evidence supporting the use of muscle relaxants before intubation in patients with HFS undergoing MVD surgery. Trials registration http://www.chictr.org/ ChiCTR-TRC-11001504 Date of registration: 24 June, 2011. The date the first patient was randomised: 30 September, 2011. PMID:22958580

Microwave endometrial ablation versus thermal balloon endometrial ablation (MEATBall): 5-year follow up of a randomised controlled trial.

PubMed

Sambrook, A M; Elders, A; Cooper, K G

2014-05-01

To compare long-term outcomes following microwave endometrial ablation (MEA™) and thermal balloon ablation (TBall). Follow up of a prospective, double-blind randomised controlled trial at 5 years. A teaching hospital in the UK. A total of 320 women eligible for and requesting endometrial ablation. Eligible women were randomised in a 1:1 ratio to undergo MEA or Tball. Postal questionnaires were sent to participants at a minimum of 5 years postoperatively to determine satisfaction with outcome, menstrual status, bleeding scores and quality of life measurement. Subsequent surgery was ascertained from the women and the hospital operative database. The primary outcome measure was overall satisfaction with treatment. Secondary outcomes included evaluation of menstrual loss, change in quality of life scores and subsequent surgery. Of the women originally randomised 217/314 (69.1%) returned questionnaires. Nonresponders were assumed to be treatment failures for data analysis. The primary outcome of satisfaction was similar in both groups (58% for MEA™ versus 53% for TBall, difference 5%; 95% CI -6 to 16%). Amenorrhoea rates were high following both techniques (51% versus 45%, difference 6%; 95% CI -5 to 17%). There was no significant difference in the hysterectomy rates between the two arms (9% versus 7%, difference 2%; 95% CI -5 to 9%). At 5 years post-treatment there were no significant clinical differences in patient satisfaction, menstrual status, quality of life scores or hysterectomy rates between MEA™ and Thermachoice 3, thermal balloon ablation. © 2014 Royal College of Obstetricians and Gynaecologists.

A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome.

PubMed

Klupp, Nerida L; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z; Chang, Dennis H

2016-08-11

This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [-0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [-0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705.

A double-blind, randomised, placebo-controlled trial of Ganoderma lucidum for the treatment of cardiovascular risk factors of metabolic syndrome

PubMed Central

Klupp, Nerida L.; Kiat, Hosen; Bensoussan, Alan; Steiner, Genevieve Z.; Chang, Dennis H.

2016-01-01

This study aimed to evaluate the efficacy and safety of Ganoderma lucidum for the treatment of hyperglycaemia and other cardiovascular risk components of metabolic syndrome using a prospective, double-blind, randomised, placebo-controlled trial. Eighty-four participants with type 2 diabetes mellitus and metabolic syndrome were randomised to one of three intervention groups: Ganoderma lucidum, Ganoderma lucidum with Cordyceps sinensis, or placebo. The dosage was 3 g/day of Ganoderma lucidum, with or without Cordyceps sinensis, for 16 weeks. The primary outcome measure was blood glucose (glycosylated haemoglobin [HbA1c] and fasting plasma glucose [FPG]); a number of secondary outcome measures were also tested. Data from the two intervention groups were combined. The combined intervention had no effect on any of the primary (baseline-adjusted difference in means: HbA1c = 0.13%, 95% CI [−0.35, 0.60], p = 0.60; FPG = 0.03 mmol/L, 95% CI [−0.90, 0.96], p = 0.95) or secondary outcome measures over the course of the 16-week trial, and no overall increased risk of adverse events with either active treatment. Evidence from this randomised clinical trial does not support the use of Ganoderma lucidum for treatment of cardiovascular risk factors in people with diabetes mellitus or metabolic syndrome. This Clinical Trial was registered with the Australian New Zealand Clinical Trials Registry on November 23, 2006. Trial ID: ACTRN12606000485538 and can be accessed here: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=81705. PMID:27511742

A randomised comparison of two postoperative fluid regimens.

PubMed

Cook, J A; Fraser, I A; Sandhu, D; Everson, N W; Rossard, D P

1989-01-01

Postoperative paralytic ileus follows all significant gastrointestinal surgery. Its duration is variable and has led to a variety of empirical and time-consuming oral fluid regimens. We have compared a traditional method of fluid administration with an unstructured, simpler, patient-determined approach. A series of 102 patients on a general surgical ward who required intravenous fluids on the day after surgery were randomised by a closed envelope system to one of two protocols and followed prospectively. Of these, 12 patients were erroneously randomised or unable to fulfil trial requirements. The first, 'regulated' group (n = 41) received hourly aliquots of oral fluid as determined by twice daily ward rounds according to ward routine. The second, 'unregulated' group (n = 49) were given a jug of water and instructed to drink as desired. Patients in the regulated group received less of their postoperative fluids by the oral route at all stages of recovery but there were no significant differences in the mean durations of intravenous therapy, nasogastric intubation or hospital stay. Postoperative complication and mortality rates were also similar. Patients who underwent gastric or duodenal procedures (n = 14) showed a similar pattern of results. We conclude that 'patient-determined' regulation of postoperative oral fluid intake is safe and effective and may greatly simplify ward management.

The MRC CRASH trial--a large, simple randomised trial of steroids in head injury.

PubMed

Wasserberg, J

2004-01-01

CRASH (Corticosteroid randomisation after significant head injury) is a prospective multi-centre randomised double blind study of methylprednisolone versus placebo in mild, moderate and severe head injury. Patients are eligible up to 8 hours from injury. To date the CRASH trial has recruited 9000 patients. The trial is recruiting from 200 hospitals in 50 countries with another 100 centres planning to join the trial. The target for recruitment is 20,000 patients by 2006. The trial is wholly funded by the Medical Research Council of Great Britain and is multidisciplinary, involving doctors and nurses from a range of specialities. A recent systematic review of corticosteroids in head injury demonstrated a risk of death in the corticosteroid treated group 2% lower than in the control group. The 95% confidence interval ranges from a 60%, lower mortality to a 2% higher mortality. This result is compatible with there being no real benefit, but it is also compatible with there being a small benefit of a few percent. An improvement in mortality of 2% would theoretically save 10,000 lives per 500,000 patients treated. The global impact of such a treatment effect would be significant as the number of head injuries world-wide continues to rise.

Efficacy of the FIFA 11+ Warm-Up Programme in Male Youth Football: A Cluster Randomised Controlled Trial

PubMed Central

Owoeye, Oluwatoyosi B. A.; Akinbo, Sunday R. A.; Tella, Bosede A.; Olawale, Olajide A.

2014-01-01

The FIFA 11+ is a structured warm-up programme specially designed to prevent injuries among football players from age 14 years and above. However, studies to prove its efficacy are generally few and it is yet to be tested in male youth footballers and among African players. The purpose of the study was to examine the efficacy of the FIFA 11+ programme in reducing the risk of injuries among male youth football players of the Lagos Junior League. A cluster randomised controlled trial was conducted. All the 20 teams (414 players aged 14 -19 years) in the Premier League division were block-randomised into either an intervention (INT) or a control (CON) group. The INT group performed the FIFA 11+ exercises as warm-up during training sessions and the CON group performed usual warm-up. Participating teams were prospectively followed through an entire league season of 6 months in which they were visited every week to assess injured players for time-loss injuries in both groups. The primary outcomes were any injury to the players, injuries by type of exposure and injuries specific to the lower extremities. The secondary outcomes were injuries reported by body location, aetiology, mechanism and severity. In total, 130 injuries were recorded affecting 104 (25%) of the 416 players. Team and player compliance with the INT was 60% and 74% respectively. Based on the primary outcome measures of the study, the FIFA 11+ programme significantly reduced the overall rate of injury in the INT group by 41% [RR = 0.59 (95% CI: 0.40 – 0.86; p = 0.006)] and all lower extremity injuries by 48% [RR = 0.52 (95% CI: 0.34 – 0.82; p = 0.004)]. However, the rate of injury reduction based on secondary outcomes mostly did not reach the level of statistical significance. The FIFA 11+ programme is effective in reducing the rates of injuries in male youth football players. Key points The FIFA 11+ has only been tested in randomised controlled trials conducted on female youth football players; this study reports its efficacy in male youth football for the first time The FIFA 11+ programme significantly reduced the overall rate of injuries and lower extremity injuries in male youth football players Youth football administrators in Africa and other parts of the world should pursue the implementation of the FIFA 11+ in order to minimize the incidence of injuries among players PMID:24790486

A simulation model of hospital management based on cost accounting analysis according to disease.

PubMed

Tanaka, Koji; Sato, Junzo; Guo, Jinqiu; Takada, Akira; Yoshihara, Hiroyuki

2004-12-01

Since a little before 2000, hospital cost accounting has been increasingly performed at Japanese national university hospitals. At Kumamoto University Hospital, for instance, departmental costs have been analyzed since 2000. And, since 2003, the cost balance has been obtained according to certain diseases for the preparation of Diagnosis-Related Groups and Prospective Payment System. On the basis of these experiences, we have constructed a simulation model of hospital management. This program has worked correctly at repeated trials and with satisfactory speed. Although there has been room for improvement of detailed accounts and cost accounting engine, the basic model has proved satisfactory. We have constructed a hospital management model based on the financial data of an existing hospital. We will later improve this program from the viewpoint of construction and using more various data of hospital management. A prospective outlook may be obtained for the practical application of this hospital management model.

Cost-Consequence Analysis Alongside a Randomised Controlled Trial of Hospital Versus Telephone Follow-Up after Treatment for Endometrial Cancer.

PubMed

Dixon, Padraig; Beaver, Kinta; Williamson, Susan; Sutton, Chris; Martin-Hirsch, Pierre; Hollingworth, William

2018-06-01

Regular outpatient follow-up programmes are usually offered to patients following treatment for gynaecological and other cancers. Despite the substantial resources involved in providing these programmes, there is evidence that routine follow-up programmes do not affect survival or the likelihood of detecting recurrence and may not meet patient needs. Alternative follow-up modalities may offer the same outcomes at lower cost. We examined the costs of using telephone-based routine follow-up of women treated for endometrial cancer undertaken by specialist gynaecology oncology nurses in comparison to routine hospital-based follow-up. The ENDCAT trial randomised 259 women at five centres in the north west of England with a known diagnosis of Stage I endometrial cancer who had completed primary treatment on a 1:1 basis to receive either standard hospital outpatient follow-up or a telephone follow-up intervention administered by specialist nurses. A cost-consequence analysis was undertaken in which we compared costs to the health system and to individuals with the trial's co-primary outcomes of psychological morbidity and participant satisfaction with information received. Psychological morbidity, psychosocial needs, patient satisfaction and quality of life did not differ between arms. Patients randomised to telephone follow-up underwent more and longer consultations. There was no difference in total health service mean per patient costs at 6 months (mean difference £8, 95% percentile confidence interval: - £147 to £141) or 12 months (mean difference: - £77, 95% percentile confidence interval: - £334 to £154). Estimated return journey costs per patient for hospital consultations were £11.47. Productivity costs were approximately twice as high under hospital follow-up. Telephone follow-up was estimated to be cost-neutral for the NHS and may free up clinic time for other patients. There was some evidence that telephone follow-up may be more efficient for patients and wider society, and is not associated with additional psychological morbidity, lower patient satisfaction or reduced quality of life. ISRCTN: 75220876, prospectively registered 28 October 2011.

Early closure of temporary ileostomy—the EASY trial: protocol for a randomised controlled trial

PubMed Central

Correa-Marinez, Adiela; Angenete, Eva; Skullmann, Stefan; Haglind, Eva; Rosenberg, Jacob

2011-01-01

Objective The objective is to evaluate efficiency based on data on morbidity and mortality, health-related quality of life and healthcare-related costs after early reversal of temporary ileostomy after rectal resection for cancer compared with the standard procedure (late reversal). Background Reversal of a temporary ileostomy is generally associated with a low morbidity and mortality. However, ostomy reversal may cause complications requiring reoperation with subsequent major complications, in ranges from 0% to 7–9% and minor complications varying from 4–5% to 30%. Based on studies exploring and describing the time of closure in previous studies which are mostly of low quality, a recent review concluded that closing a temporary stoma within 2 weeks did not seem to be associated with an increase in morbidity and mortality. Design and methods Early closure of temporary ileostomy (EASY), a randomised controlled trial, is a prospective randomised controlled multicentre study which is performed within the framework of the Scandinavian Surgical Outcomes Research Group (http://www.ssorg.net/) and plans to include 200 patients from Danish and Swedish hospitals. The primary end-point of the study is the frequency of complications 0–12 months after surgery (the stoma creation operation). The secondary end-points of the study are (1) comparison of the total costs of the two groups at 6 and 12 months after surgery (stoma creation); (2) comparison of health-related quality of life in the two groups evaluated with the 36-item short-form and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29/CR30 at 3, 6 and 12 months after surgery (stoma creation); and (3) comparison of disease-specific quality of life in the two groups at 3, 6 and 12 months after surgery (stoma creation). Discussion The aim of the EASY trial is to evaluate the efficiency of early reversal of temporary ileostomy after surgery for rectal cancer versus late reversal. The EASY trial is expected to have a huge impact on patient safety as well as an improvement in patient-reported outcome. Clinical trials identifier NCT01287637. PMID:22021780

Study Protocol: The Norfolk Diabetes Prevention Study [NDPS]: a 46 month multi - centre, randomised, controlled parallel group trial of a lifestyle intervention [with or without additional support from lay lifestyle mentors with Type 2 diabetes] to prevent transition to Type 2 diabetes in high risk groups with non - diabetic hyperglycaemia, or impaired fasting glucose.

PubMed

Pascale, Melanie; Murray, Nikki; Bachmann, Max; Barton, Garry; Clark, Allan; Howe, Amanda; Greaves, Colin; Sampson, Mike

2017-01-06

This 7 year NIHR programme [2011-2018] tests the primary hypothesis that the NDPS diet and physical activity intervention will reduce the risk of transition to type 2 diabetes (T2DM) in groups at high risk of Type 2 diabetes. The NDPS programme recognizes the need to reduce intervention costs through group delivery and the use of lay mentors with T2DM, the realities of normal primary care, and the complexity of the current glycaemic categorisation of T2DM risk. NDPS identifies people at highest risk of T2DM on the databases of 135 general practices in the East of England for further screening with ab fasting plasma glucose and glycosylated haemoglobin [HbA1c]. Those with an elevated fasting plasma glucose [impaired fasting glucose or IFG] with or without an elevated HbA1c [non -diabetic hyperglycaemia; NDH] are randomised into three treatment arms: a control arm receiving no trial intervention, an arm receiving an intensive bespoke group-based diet and physical activity intervention, and an arm receiving the same intervention with enhanced support from people with T2DM trained as diabetes prevention mentors [DPM]. The primary end point is cumulative transition rates to T2DM between the two intervention groups, and between each intervention group and the control group at 46 months. Participants with screen detected T2DM are randomized into an equivalent prospective controlled trial with the same intervention and control arms with glycaemic control [HbA1c] at 46 months as the primary end point. Participants with NDH and a normal fasting plasma glucose are randomised into an equivalent prospective controlled intervention trial with follow up for 40 months. The intervention comprises six education sessions for the first 12 weeks and then up to 15 maintenance sessions until intervention end, all delivered in groups, with additional support from a DPM in one treatment arm. The NDPS programme reports in 2018 and will provide trial outcome data for a group delivered diabetes prevention intervention, supported by lay mentors with T2DM, with intervention in multiple at risk glycaemic categories, and that takes into account the realities of normal clinical practice. ISRCTN34805606 (Retrospectively registered 16.3.16).

The Importance of Specifying and Studying Causal Mechanisms in School-Based Randomised Controlled Trials: Lessons from Two Studies of Cross-Age Peer Tutoring

ERIC Educational Resources Information Center

Morris, Stephen P.; Edovald, Triin; Lloyd, Cheryl; Kiss, Zsolt

2016-01-01

Based on the experience of evaluating 2 cross-age peer-tutoring interventions, we argue that researchers need to pay greater attention to causal mechanisms within the context of school-based randomised controlled trials. Without studying mechanisms, researchers are less able to explain the underlying causal processes that give rise to results from…

Prospective Evaluation of a Model-Based Dosing Regimen for Amikacin in Preterm and Term Neonates in Clinical Practice

PubMed Central

De Cock, R. F. W.; Allegaert, K.; Vanhaesebrouck, S.; Danhof, M.; Knibbe, C. A. J.

2015-01-01

Based on a previously derived population pharmacokinetic model, a novel neonatal amikacin dosing regimen was developed. The aim of the current study was to prospectively evaluate this dosing regimen. First, early (before and after second dose) therapeutic drug monitoring (TDM) observations were evaluated for achieving target trough (<3 mg/liter) and peak (>24 mg/liter) levels. Second, all observed TDM concentrations were compared with model-predicted concentrations, whereby the results of a normalized prediction distribution error (NPDE) were considered. Subsequently, Monte Carlo simulations were performed. Finally, remaining causes limiting amikacin predictability (i.e., prescription errors and disease characteristics of outliers) were explored. In 579 neonates (median birth body weight, 2,285 [range, 420 to 4,850] g; postnatal age 2 days [range, 1 to 30 days]; gestational age, 34 weeks [range, 24 to 41 weeks]), 90.5% of the observed early peak levels reached 24 mg/liter, and 60.2% of the trough levels were <3 mg/liter (93.4% ≤5 mg/liter). Observations were accurately predicted by the model without bias, which was confirmed by the NPDE. Monte Carlo simulations showed that peak concentrations of >24 mg/liter were reached at steady state in almost all patients. Trough values of <3 mg/liter at steady state were documented in 78% to 100% and 45% to 96% of simulated cases with and without ibuprofen coadministration, respectively; suboptimal trough levels were found in patients with postnatal age <14 days and current weight of >2,000 g. Prospective evaluation of a model-based neonatal amikacin dosing regimen resulted in optimized peak and trough concentrations in almost all patients. Slightly adapted dosing for patient subgroups with suboptimal trough levels was proposed. This model-based approach improves neonatal dosing individualization. PMID:26248375

Effectiveness of mat Pilates or equipment-based Pilates in patients with chronic non-specific low back pain: a protocol of a randomised controlled trial

PubMed Central

2013-01-01

Background Chronic low back pain is an expensive and difficult condition to treat. One of the interventions widely used by physiotherapists in the treatment of chronic non-specific low back pain is exercise therapy based upon the Pilates principles. Pilates exercises can be performed with or without specific equipment. These two types of Pilates exercises have never been compared on a high-quality randomised controlled trial. Methods/design This randomised controlled trial with a blinded assessor will evaluate eighty six patients of both genders with chronic low back pain, aged between 18 and 60 years, from one Brazilian private physiotherapy clinic. The patients will be randomly allocated into two groups: Mat Group will perform the exercises on the ground while the Equipment-based Group will perform the Pilates method exercises on the following equipment: Cadillac, Reformer, Ladder Barrel, and Step Chair. The general and specific disability of the patient, kinesiophobia, pain intensity and global perceived effect will be evaluated by a blinded assessor before randomisation and at six weeks and six months after randomisation. In addition, the expectation of the participants and their confidence with the treatment will be evaluated before randomisation and after the first treatment session, respectively. Discussion This will be the first study aiming to compare the effectiveness of Mat and Equipment-based Pilates exercises in patients with chronic non-specific low back pain. The results may help health-care professionals in clinical decision-making and could potentially reduce the treatment costs of this condition. Trial registration Brazilian Registry of Clinical Trials RBR-7tyg5j PMID:23298183

Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax

PubMed Central

Brown, Simon G A; Ball, Emma L; Perrin, Kyle; Read, Catherine A; Asha, Stephen E; Beasley, Richard; Egerton-Warburton, Diana; Jones, Peter G; Keijzers, Gerben; Kinnear, Frances B; Kwan, Ben C H; Lee, Y C Gary; Smith, Julian A; Summers, Quentin A; Simpson, Graham

2016-01-01

Introduction Current management of primary spontaneous pneumothorax (PSP) is variable, with little evidence from randomised controlled trials to guide treatment. Guidelines emphasise intervention in many patients, which involves chest drain insertion, hospital admission and occasionally surgery. However, there is evidence that conservative management may be effective and safe, and it may also reduce the risk of recurrence. Significant questions remain regarding the optimal initial approach to the management of PSP. Methods and analysis This multicentre, prospective, randomised, open label, parallel group, non-inferiority study will randomise 342 participants with a first large PSP to conservative or interventional management. To maintain allocation concealment, randomisation will be performed in real time by computer and stratified by study site. Conservative management will involve a period of observation prior to discharge, with intervention for worsening symptoms or physiological instability. Interventional treatment will involve insertion of a small bore drain. If drainage continues after 1 hour, the patient will be admitted. If drainage stops, the drain will be clamped for 4 hours. The patient will be discharged if the lung remains inflated. Otherwise, the patient will be admitted. The primary end point is the proportion of participants with complete lung re-expansion by 8 weeks. Secondary end points are as follows: days in hospital, persistent air leak, predefined complications and adverse events, time to resolution of symptoms, and pneumothorax recurrence during a follow-up period of at least 1 year. The study has 95% power to detect an absolute non-inferiority margin of 9%, assuming 99% successful expansion at 8 weeks in the invasive treatment arm. The primary analysis will be by intention to treat. Ethics and dissemination Local ethics approval has been obtained for all sites. Study findings will be disseminated by publication in a high-impact international journal and presentation at major international Emergency Medicine and Respiratory meetings. Trial registration number ACTRN12611000184976; Pre-results. PMID:27625060

The Influence of Simulations on Family Engagement--Prospective Early Childhood Educators' Perceptions

ERIC Educational Resources Information Center

Paz-Albo Prieto, Jesús

2018-01-01

Nurturing experiences in preparation for prospective early childhood educators' work with families during their training are critical for establishing empowering relationships. This article details a qualitative case study of 77 prospective early childhood educators engaged with the Parent, Family and Community Engagement Simulation. An electronic…

A systematic examination of preoperative surgery warm-up routines.

PubMed

Pike, T W; Pathak, S; Mushtaq, F; Wilkie, R M; Mon-Williams, M; Lodge, J P A

2017-05-01

Recent evidence indicates that a preoperative warm-up is a potentially useful tool in facilitating performance. But what factors drive such improvements and how should a warm-up be implemented? In order to address these issues, we adopted a two-pronged approach: (1) we conducted a systematic review of the literature to identify existing studies utilising preoperative simulation techniques; (2) we performed task analysis to identify the constituent parts of effective warm-ups. We identified five randomised control trials, four randomised cross-over trials and four case series. The majority of these studies reviewed surgical performance following preoperative simulation relative to performance without simulation. Four studies reported outcome measures in real patients and the remainder reported simulated outcome measures. All but one of the studies found that preoperative simulation improves operative outcomes-but this improvement was not found across all measured parameters. While the reviewed studies had a number of methodological issues, the global data indicate that preoperative simulation has substantial potential to improve surgical performance. Analysis of the task characteristics of successful interventions indicated that the majority of these studies employed warm-ups that focused on the visual motor elements of surgery. However, there was no theoretical or empirical basis to inform the design of the intervention in any of these studies. There is an urgent need for a more rigorous approach to the development of "warm-up" routines if the potential value of preoperative simulation is to be understood and realised. We propose that such interventions need to be grounded in theory and empirical evidence on human motor performance.

The Effect of Lactation Educators Implementing a Telephone-Based Intervention among Low-Income Hispanics: A Randomised Trial

ERIC Educational Resources Information Center

Efrat, Merav W.; Esparza, Salvador; Mendelson, Sherri G.; Lane, Christianne J.

2015-01-01

Objectives: To assess whether a telephone-based breastfeeding intervention delivered by lactation educators influenced exclusive breastfeeding rates among low-income Hispanic women in the USA. Design: Randomised two-group design. Setting: Pregnant low-income Hispanic women (298) were recruited from community health clinics in Los Angeles County…

The effects of prolonged wear of textured shoe insoles on gait, foot sensation and proprioception in people with multiple sclerosis: study protocol for a randomised controlled trial.

PubMed

Hatton, Anna L; Dixon, John; Rome, Keith; Brauer, Sandra G; Williams, Katrina; Kerr, Graham

2016-04-21

Many people with multiple sclerosis experience problems with walking, which can make daily activities difficult and often leads to falls. Foot sensation plays an important role in keeping the body balanced whilst walking; however, people with multiple sclerosis often have poor sensation on the soles of their feet. Wearing a specially designed shoe insole, which enhances plantar sensory information, could help people with multiple sclerosis to walk better. This study will explore whether long-term wear of a textured insole can improve walking in people with multiple sclerosis. A prospective randomised controlled trial with two parallel groups will be conducted aiming to recruit 176 people with multiple sclerosis living in the community (Brisbane, Australia). Adults with a clinical diagnosis of multiple sclerosis, Disease Steps score 1-4, who are ambulant over 100 m and who meet specific inclusion criteria will be recruited. Participants will be randomised to a smooth control insole (n = 88) or textured insole (n = 88) group. The allocated insole will be worn for 12-weeks within participants' own footwear, with self-report wear diaries and falls calendars being completed over this period. Blinded assessors will conduct two baseline assessments and one post-intervention assessment. Gait tasks will be completed barefoot, wearing standardised footwear only, and wearing standardised footwear with smooth and textured insoles. The primary outcome measure will be mediolateral base of support when walking over even and uneven surfaces. Secondary measures include spatiotemporal gait parameters (stride length, stride time variability, double-limb support time, velocity), gait kinematics (hip, knee, and ankle joint angles, toe clearance, trunk inclination, arm swing, mediolateral pelvis/head displacement), foot sensation (light touch-pressure, vibration, two-point discrimination) and proprioception (ankle joint position sense). Group allocation will be concealed and all analyses will be based on an intention-to-treat principle. This study will explore the effects of wearing textured insoles over 12-weeks on gait, foot sensation and proprioception in people with multiple sclerosis. The study has the potential to identify a new, evidence-based footwear intervention which has the capacity to enhance mobility and independent living in people with multiple sclerosis. Australian New Zealand Clinical Trials Registry ACTRN12615000421538 . Registered 4 May 2015.

Improving outcomes of preschool language delay in the community: protocol for the Language for Learning randomised controlled trial

PubMed Central

2012-01-01

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 yet tailored approach for each child, with a focus on specific language domains known to be associated with later language and literacy. The trial responds to identified evidence gaps, has outcomes of direct relevance to families and the community, includes a well-developed economic analysis, and has the potential to improve long-term consequences of early language delay within a public health framework. Trial registration Current Controlled Trials ISRCTN03981121. PMID:22776103

The effect of an electronic cognitive aid on the management of ST-elevation myocardial infarction during caesarean section: a prospective randomised simulation study.

PubMed

St Pierre, Michael; Luetcke, Bjoern; Strembski, Dieter; Schmitt, Christopher; Breuer, Georg

2017-03-20

Cognitive aids have come to be viewed as promising tools in the management of perioperative critical events. The majority of published simulation studies have focussed on perioperative crises that are characterised by time pressure, rare occurrence, or complex management steps (e.g., cardiac arrest emergencies, management of the difficult airway). At present, there is limited information on the usefulness of cognitive aids in critical situations with moderate time pressure and complexity. Intraoperative myocardial infarction may be an emergency to which these limitations apply. Anaesthetic teams were allocated to control (no cognitive aid; n = 10) or intervention (cognitive aid provided; n = 10) groups. The primary aim of this study was to compare cognitive aid versus memory for intraoperative ST-elevation myocardial infarction (STEMI) management in a simulation of caesarean delivery under spinal anaesthesia. We identified nine evidence-based metrics of essential care from current guidelines and subdivided them into mandatory (high level of evidence; no interference with surgery) and optional (lower class of recommendation; possible impact on surgery) tasks. Six clinically relevant tasks were added by consensus. Implementation of these steps was measured by scoring task items in a binary fashion (yes/no). The interval between the diagnosis of STEMI and the first contact with the cardiac catheterisation lab was measured. To determine whether or not the cognitive aid had prompted an action, participants from the cognitive aid group were interviewed during debriefing on every single treatment step. At the end of the simulation, session participants were asked to complete a survey. The presence of the cognitive aid did not shorten the time interval until the cardiac catheterisation lab was contacted. The availability of the cognitive aid improved task performance in the tasks identified from the guidelines (93% vs. 69%; p < 0.001) as well as overall task performance (87.5% vs. 59%; p < 0.001). The observed difference in performance can be attributed to the use of the cognitive aid, as performance from memory alone would have been comparable across both groups. Trainees appeared to derive greater benefit from the cognitive aid than did consultants and nurses. The management of intraoperative ST-elevation myocardial infarction can be improved if teams use a cognitive aid. Trainees appeared to derive greater benefit from the cognitive aid than did consultants and nurses.

Choosing appropriate analysis methods for cluster randomised cross-over trials with a binary outcome.

PubMed

Morgan, Katy E; Forbes, Andrew B; Keogh, Ruth H; Jairath, Vipul; Kahan, Brennan C

2017-01-30

In cluster randomised cross-over (CRXO) trials, clusters receive multiple treatments in a randomised sequence over time. In such trials, there is usual correlation between patients in the same cluster. In addition, within a cluster, patients in the same period may be more similar to each other than to patients in other periods. We demonstrate that it is necessary to account for these correlations in the analysis to obtain correct Type I error rates. We then use simulation to compare different methods of analysing a binary outcome from a two-period CRXO design. Our simulations demonstrated that hierarchical models without random effects for period-within-cluster, which do not account for any extra within-period correlation, performed poorly with greatly inflated Type I errors in many scenarios. In scenarios where extra within-period correlation was present, a hierarchical model with random effects for cluster and period-within-cluster only had correct Type I errors when there were large numbers of clusters; with small numbers of clusters, the error rate was inflated. We also found that generalised estimating equations did not give correct error rates in any scenarios considered. An unweighted cluster-level summary regression performed best overall, maintaining an error rate close to 5% for all scenarios, although it lost power when extra within-period correlation was present, especially for small numbers of clusters. Results from our simulation study show that it is important to model both levels of clustering in CRXO trials, and that any extra within-period correlation should be accounted for. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Prospective content in the friendship conversations of young adults.

PubMed

Young, Richard A; Marshall, Sheila K; Murray, John

2017-01-01

Prospection is cognitive processes that involve constructing, encoding, and remembering the future. Less is known about the how these processes are evident in the prospective content of conversations. This study sought to identify and describe evidence of the prospective content in the conversations of friends as they transition to adulthood. The present secondary content analysis of the videotaped conversations of 15 young adult friendship dyads (n = 30, 16 females, 14 males, mean age = 21.3 years) in Canada examined these conversations based the following characteristics of prospection: simulation, reasoning about counterfactuals, constructing multiple possible futures, and episodic memory of the past. Four categories of prospective content were evident in these conversations, these processes were used sparingly in all but one conversation, and relatively few of them were collaborative in that dyad partners did not appear to serve to augment, clarify, or disconfirm prospective content. Copyright © 2016 The Foundation for Professionals in Services for Adolescents. Published by Elsevier Ltd. All rights reserved.

Randomised controlled trial comparing hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors: a pilot study

PubMed Central

MacLaughlan David, Shannon; Salzillo, Sandra; Bowe, Patrick; Scuncio, Sandra; Malit, Bridget; Raker, Christina; Gass, Jennifer S; Granai, C O; Dizon, Don S

2013-01-01

Objectives To compare the efficacy of hypnotherapy versus gabapentin for the treatment of hot flashes in breast cancer survivors, and to evaluate the feasibility of conducting a clinical trial comparing a drug with a complementary or alternative method (CAM). Design Prospective randomised trial. Setting Breast health centre of a tertiary care centre. Participants 15 women with a personal history of breast cancer or an increased risk of breast cancer who reported at least one daily hot flash. Interventions Gabapentin 900 mg daily in three divided doses (control) compared with standardised hypnotherapy. Participation lasted 8 weeks. Outcome measures The primary endpoints were the number of daily hot flashes and hot flash severity score (HFSS). The secondary endpoint was the Hot Flash Related Daily Interference Scale (HFRDIS). Results 27 women were randomised and 15 (56%) were considered evaluable for the primary endpoint (n=8 gabapentin, n=7 hypnotherapy). The median number of daily hot flashes at enrolment was 4.5 in the gabapentin arm and 5 in the hypnotherapy arm. HFSS scores were 7.5 in the gabapentin arm and 10 in the hypnotherapy arm. After 8 weeks, the median number of daily hot flashes was reduced by 33.3% in the gabapentin arm and by 80% in the hypnotherapy arm. The median HFSS was reduced by 33.3% in the gabapentin arm and by 85% in the hypnotherapy arm. HFRDIS scores improved by 51.6% in the gabapentin group and by 55.2% in the hypnotherapy group. There were no statistically significant differences between groups. Conclusions Hypnotherapy and gabapentin demonstrate efficacy in improving hot flashes. A definitive trial evaluating traditional interventions against CAM methods is feasible, but not without challenges. Further studies aimed at defining evidence-based recommendations for CAM are necessary. Trial registration clinicaltrials.gov (NCT00711529). PMID:24022390

Protocol for a multicentred randomised controlled trial investigating the use of personalised golimumab dosing tailored to inflammatory load in ulcerative colitis: the GOAL-ARC study (GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis) led by the INITIAtive group (NCT 0268772)

PubMed Central

Sheridan, Juliette; Coe, Carol Ann; Doran, Peter; Egan, Laurence; Cullen, Garret; Kevans, David; Leyden, Jan; Galligan, Marie; O’Toole, Aoibhlinn; McCarthy, Jane; Doherty, Glen

2018-01-01

Introduction Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), often leading to an impaired quality of life in affected patients. Current treatment modalities include antitumour necrosis factor (anti-TNF) monoclonal antibodies (mABs) including infliximab, adalimumab and golimumab (GLM). Several recent retrospective and prospective studies have demonstrated that fixed dosing schedules of anti-TNF agents often fails to consistently achieve adequate circulating therapeutic drug levels (DL) with consequent risk of immunogenicity treatment failure and potential risk of hospitalisation and colectomy in patients with UC. The design of GLM dose Optimisation to Adequate Levels to Achieve Response in Colitis aims to address the impact of dose escalation of GLM immediately following induction and during the subsequent maintenance phase in response to suboptimal DL or persisting inflammatory burden as represented by raised faecal calprotectin (FCP). Aim The primary aim of the study is to ascertain if monitoring of FCP and DL of GLM to guide dose optimisation (during maintenance) improves rates of patient continuous clinical response and reduces disease activity in UC. Methods and analysis A randomised, multicentred two-arm trial studying the effect of dose optimisation of GLM based on FCP and DL versus treatment as per SMPC. Eligible patients will be randomised in a 1:1 ratio to 1 of 2 treatment groups and shall be treated over a period of 46 weeks. Ethics and dissemination The study protocol was approved by the Research Ethics committee of St. Vincent’s University Hospital. The results will be published in a peer-reviewed journal and shared with the worldwide medical community. Trial registration numbers EudraCT number: 2015-004724-62; Clinicaltrials.gov Identifier: NCT0268772; Pre-results. PMID:29379609

Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury

PubMed Central

Koda, Masao; Hanaoka, Hideki; Sato, Takatoshi; Fujii, Yasuhisa; Hanawa, Michiko; Takahashi, Sho; Furuya, Takeo; Ijima, Yasushi; Saito, Junya; Kitamura, Mitsuhiro; Ohtori, Seiji; Matsumoto, Yukei; Abe, Tetsuya; Watanabe, Kei; Hirano, Toru; Ohashi, Masayuki; Shoji, Hirokazu; Mizouchi, Tatsuki; Takahashi, Ikuko; Kawahara, Norio; Kawaguchi, Masahito; Orita, Yugo; Sasamoto, Takeshi; Yoshioka, Masahito; Fujii, Masafumi; Yonezawa, Katsutaka; Soma, Daisuke; Taneichi, Hiroshi; Takeuchi, Daisaku; Inami, Satoshi; Moridaira, Hiroshi; Ueda, Haruki; Asano, Futoshi; Shibao, Yosuke; Aita, Ikuo; Takeuchi, Yosuke; Mimura, Masaya; Shimbo, Jun; Someya, Yukio; Ikenoue, Sumio; Sameda, Hiroaki; Takase, Kan; Ikeda, Yoshikazu; Nakajima, Fumitake; Hashimoto, Mitsuhiro; Ozawa, Tomoyuki; Hasue, Fumio; Fujiyoshi, Takayuki; Kamiya, Koshiro; Watanabe, Masahiko; Katoh, Hiroyuki; Matsuyama, Yukihiro; Yamamoto, Yu; Togawa, Daisuke; Hasegawa, Tomohiko; Kobayashi, Sho; Yoshida, Go; Oe, Shin; Banno, Tomohiro; Arima, Hideyuki; Akeda, Koji; Kawamoto, Eiji; Imai, Hiroshi; Sakakibara, Toshihiko; Sudo, Akihiro; Ito, Yasuo; Kikuchi, Tsuyoshi; Osaki, Shuhei; Tanaka, Nobuhiro; Nakanishi, Kazuyoshi; Kamei, Naosuke; Kotaka, Shinji; Baba, Hideo; Okudaira, Tsuyoshi; Konishi, Hiroaki; Yamaguchi, Takayuki; Ito, Keigo; Katayama, Yoshito; Matsumoto, Taro; Matsumoto, Tomohiro; Idota, Masaru; Kanno, Haruo; Aizawa, Toshimi; Hashimoto, Ko; Eto, Toshimitsu; Sugaya, Takehiro; Matsuda, Michiharu; Fushimi, Kazunari; Nozawa, Satoshi; Iwai, Chizuo; Taguchi, Toshihiko; Kanchiku, Tsukasa; Suzuki, Hidenori; Nishida, Norihiro; Funaba, Masahiro; Yamazaki, Masashi

2018-01-01

Introduction Granulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial. Methods and analysis The objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients). Ethics and dissemination The study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper. Trial registration number UMIN000018752. PMID:29730616

Treatment of Advanced Glaucoma Study: a multicentre randomised controlled trial comparing primary medical treatment with primary trabeculectomy for people with newly diagnosed advanced glaucoma-study protocol.

PubMed

King, Anthony J; Fernie, Gordon; Azuara-Blanco, Augusto; Burr, Jennifer M; Garway-Heath, Ted; Sparrow, John M; Vale, Luke; Hudson, Jemma; MacLennan, Graeme; McDonald, Alison; Barton, Keith; Norrie, John

2017-10-26

Presentation with advanced glaucoma is the major risk factor for lifetime blindness. Effective intervention at diagnosis is expected to minimise risk of further visual loss in this group of patients. To compare clinical and cost-effectiveness of primary medical management compared with primary surgery for people presenting with advanced open-angle glaucoma (OAG). Design : A prospective, pragmatic multicentre randomised controlled trial (RCT). Twenty-seven UK hospital eye services. Four hundred and forty patients presenting with advanced OAG, according to the Hodapp-Parish-Anderson classification of visual field loss. Participants will be randomised to medical treatment or augmented trabeculectomy (1:1 allocation minimised by centre and presence of advanced disease in both eyes). The primary outcome is vision-related quality of life measured by the National Eye Institute-Visual Function Questionnaire-25 at 24 months. Secondary outcomes include generic EQ-5D-5L, Health Utility Index-3 and glaucoma-related health status (Glaucoma Utility Index), patient experience, visual field measured by mean deviation value, logarithm of the mean angle of resolution visual acuity, intraocular pressure, adverse events, standards for driving and eligibility for blind certification. Incremental cost per quality-adjusted life-year (QALY) based on EQ-5D-5L and glaucoma profile instrument will be estimated. The study will report the comparative effectiveness and cost-effectiveness of medical treatment against augmented trabeculectomy in patients presenting with advanced glaucoma in terms of patient-reported health and visual function, clinical outcomes and incremental cost per QALY at 2 years. Treatment of Advanced Glaucoma Study will be the first RCT reporting outcomes from the perspective of those with advanced glaucoma. ISRCTN56878850, Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Autofluorescence bronchoscopy with white light bronchoscopy compared with white light bronchoscopy alone for the detection of precancerous lesions: a European randomised controlled multicentre trial

PubMed Central

Haussinger, K; Becker, H; Stanzel, F; Kreuzer, A; Schmidt, B; Strausz, J; Cavaliere, S; Herth, F; Kohlhaufl, M; Muller, K; Huber, R; Pichlmeier, U; Bolliger, C.

2005-01-01

Background: The potential of autofluorescence bronchoscopy (AFB) to detect precancerous lesions in the central airways and its role in lung cancer screening is uncertain. A study was undertaken to evaluate the prevalence of moderate/severe dysplasia (dysplasia II–III) and carcinoma in situ (CIS) using a newly developed AFB system in comparison with conventional white light bronchoscopy (WLB) alone. Methods: In a prospective randomised multicentre trial, smokers ⩾40 years of age (⩾20 pack-years) were stratified into four different risk groups and investigated with either WLB+AFB (arm A) or WLB alone (arm B). Results: 1173 patients (916 men) of mean age 58.7 years were included. Overall (arms A and B), preinvasive lesions (dysplasia II–III and CIS) were detected in 3.9% of the patients. The prevalence of patients with preinvasive lesions in the WLB arm was 2.7% compared with 5.1% in the WLB+AFB arm (p = 0.037). For patients with dysplasia II–III, WLB+AFB increased the detection rate by a factor of 2.1 (p = 0.03), while for CIS the factor was only 1.24 (p = 0.75). The biopsy based sensitivity of WLB alone and WLB+AFB for detecting dysplasia II–III and CIS was 57.9% compared with 82.3% (1.42-fold increase). The corresponding specificity was 62.1% compared with 58.4% (0.94-fold decrease). Conclusions: This first randomised study of AFB showed that the combination of WLB+AFB was significantly superior to WLB alone in detecting preneoplastic lesions. Our findings do not support the general use of AFB as a screening tool for lung cancer, but suggest that it may be of use in certain groups. The precise indications await further study. PMID:15923251

Evidence for the effectiveness of Alexander Technique lessons in medical and health-related conditions: a systematic review.

PubMed

Woodman, J P; Moore, N R

2012-01-01

Complementary medicine and alternative approaches to chronic and intractable health conditions are increasingly being used, and require critical evaluation. The aim of this review was to systematically evaluate available evidence for the effectiveness and safety of instruction in the Alexander Technique in health-related conditions. PUBMED, EMBASE, PSYCHINFO, ISI Web-of-Knowledge, AMED, CINHAL-plus, Cochrane library and Evidence-based Medicine Reviews were searched to July 2011. Inclusion criteria were prospective studies evaluating Alexander Technique instruction (individual lessons or group delivery) as an intervention for any medical indication/health-related condition. Studies were categorised and data extracted on study population, randomisation method, nature of intervention and control, practitioner characteristics, validity and reliability of outcome measures, completeness of follow-up and statistical analyses.   Of 271 publications identified, 18 were selected: three randomised, controlled trials (RCTs), two controlled non-randomised studies, eight non-controlled studies, four qualitative analyses and one health economic analysis. One well-designed, well-conducted RCT demonstrated that, compared with usual GP care, Alexander Technique lessons led to significant long-term reductions in back pain and incapacity caused by chronic back pain. The results were broadly supported by a smaller, earlier RCT in chronic back pain. The third RCT, a small, well-designed, well-conducted study in individuals with Parkinson's disease, showed a sustained increased ability to carry out everyday activities following Alexander lessons, compared with usual care. The 15 non-RCT studies are also reviewed. Strong evidence exists for the effectiveness of Alexander Technique lessons for chronic back pain and moderate evidence in Parkinson's-associated disability. Preliminary evidence suggests that Alexander Technique lessons may lead to improvements in balance skills in the elderly, in general chronic pain, posture, respiratory function and stuttering, but there is insufficient evidence to support recommendations in these areas. © 2011 Blackwell Publishing Ltd.

Effect of the rate of chest compression familiarised in previous training on the depth of chest compression during metronome-guided cardiopulmonary resuscitation: a randomised crossover trial.

PubMed

Bae, Jinkun; Chung, Tae Nyoung; Je, Sang Mo

2016-02-12

To assess how the quality of metronome-guided cardiopulmonary resuscitation (CPR) was affected by the chest compression rate familiarised by training before the performance and to determine a possible mechanism for any effect shown. Prospective crossover trial of a simulated, one-person, chest-compression-only CPR. Participants were recruited from a medical school and two paramedic schools of South Korea. 42 senior students of a medical school and two paramedic schools were enrolled but five dropped out due to physical restraints. Senior medical and paramedic students performed 1 min of metronome-guided CPR with chest compressions only at a speed of 120 compressions/min after training for chest compression with three different rates (100, 120 and 140 compressions/min). Friedman's test was used to compare average compression depths based on the different rates used during training. Average compression depths were significantly different according to the rate used in training (p<0.001). A post hoc analysis showed that average compression depths were significantly different between trials after training at a speed of 100 compressions/min and those at speeds of 120 and 140 compressions/min (both p<0.001). The depth of chest compression during metronome-guided CPR is affected by the relative difference between the rate of metronome guidance and the chest compression rate practised in previous training. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Patient-specific rehearsal prior to EVAR: a pilot study.

PubMed

Desender, L; Rancic, Z; Aggarwal, R; Duchateau, J; Glenck, M; Lachat, M; Vermassen, F; Van Herzeele, I

2013-06-01

This study aims to evaluate feasibility, face validity, influence on technical factors and subjective sense of utility of patient-specific rehearsal (PsR) prior to endovascular aortic aneurysm repair (EVAR). A prospective, multicentre pilot study. Patients suitable for EVAR were enrolled and a three-dimensional (3D) model of the patient's anatomy was generated. Less than 24 h prior to the real case, rehearsals were conducted in the laboratory or clinical angiosuite. Technical metrics were recorded during both procedures. A subjective questionnaire was used to evaluate realism, technical and human factor aspects (scale 1-5). Ten patients were enrolled. In one case, the treatment plan was altered based on PsR. In 7/9 patients, the rehearsal significantly altered the optimal C-arm position for the proximal landing zone and an identical fluoroscopy angle was chosen in the real procedure. All team members found the rehearsal useful for selecting the optimal fluoroscopy angle (median 4). The realism of the EVAR procedure simulation was rated highly (median 4). All team members found the PsR useful to prepare the individual team members and the entire team (median 4). PsR for EVAR permits creation of realistic case studies. Subjective evaluation indicates that it may influence optimal C-arm angles and be valuable to prepare the entire team. A randomised controlled trial (RCT) is planned to evaluate how this technology may influence technical and team performance, ultimately leading to improved patient safety. Copyright © 2013 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Rank-based testing of equal survivorship based on cross-sectional survival data with or without prospective follow-up.

PubMed

Chan, Kwun Chuen Gary; Qin, Jing

2015-10-01

Existing linear rank statistics cannot be applied to cross-sectional survival data without follow-up since all subjects are essentially censored. However, partial survival information are available from backward recurrence times and are frequently collected from health surveys without prospective follow-up. Under length-biased sampling, a class of linear rank statistics is proposed based only on backward recurrence times without any prospective follow-up. When follow-up data are available, the proposed rank statistic and a conventional rank statistic that utilizes follow-up information from the same sample are shown to be asymptotically independent. We discuss four ways to combine these two statistics when follow-up is present. Simulations show that all combined statistics have substantially improved power compared with conventional rank statistics, and a Mantel-Haenszel test performed the best among the proposal statistics. The method is applied to a cross-sectional health survey without follow-up and a study of Alzheimer's disease with prospective follow-up. © The Author 2015. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Dressings as an adjunct to pressure ulcer prevention: consensus panel recommendations.

PubMed

Black, Joyce; Clark, Michael; Dealey, Carol; Brindle, Christopher T; Alves, Paulo; Santamaria, Nick; Call, Evan

2015-08-01

The formulation of recommendations on the use of wound dressings in pressure ulcer prevention was undertaken by a group of experts in pressure ulcer prevention and treatment from Australia, Portugal, UK and USA. After review of literature, they concluded that there is adequate evidence to recommend the use of five-layer silicone bordered dressings (Mepilex Border Sacrum(®) and 3 layer Mepilex Heel(®) dressings by Mölnlycke Health Care, Gothenburg, Sweden) for pressure ulcer prevention in the sacrum, buttocks and heels in high-risk patients, those in Emergency Department (ED), intensive care unit (ICU) and operating room (OR). Literature on which this recommendation is based includes one prospective randomised control trial, three cohort studies and two case series. Recommendations for dressing use in patients at high risk for pressure injury and shear injury were also provided. © 2014 The Authors. International Wound Journal © 2014 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Background and design of the ACCA-EAPCI registry on ST-segment elevation myocardial infarction of the European Society of Cardiology.

PubMed

Zeymer, Uwe; Ludman, Peter; Danchin, Nicolas; Kala, Petr; Maggioni, Aldo P; Weidinger, Franz

2018-02-01

Treatment of patients with acute ST-segment elevation myocardial infarction has improved over past decades, with reperfusion therapy being the cornerstone in the acute phase. Based on the results of large randomised trials the current ST-segment elevation myocardial infarction guidelines of the European Society of Cardiology (ESC) recommend acute treatments and secondary prevention therapies. However, there are large variations between ESC countries in the treatment of patients presenting with ST-segment elevation myocardial infarction. Therefore the ESC has initiated a prospective registry to evaluate the current treatments and outcomes of these patients with a special focus on adherence to the ESC guidelines and on differences between countries and regions. This paper describes the methodology and design of the ST-segment elevation myocardial infarction registry conducted in collaboration of the Acute Cardiac Care Association and the European Association of Percutaneous Coronary Intervention.

Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial.

PubMed

Rini, Brian I; Melichar, Bohuslav; Ueda, Takeshi; Grünwald, Viktor; Fishman, Mayer N; Arranz, José A; Bair, Angel H; Pithavala, Yazdi K; Andrews, Glen I; Pavlov, Dmitri; Kim, Sinil; Jonasch, Eric

2013-11-01

Population pharmacokinetic data suggest axitinib plasma exposure correlates with efficacy in metastatic renal-cell carcinoma. Axitinib dose titration might optimise exposure and improve outcomes. We prospectively assessed the efficacy and safety of axitinib dose titration in previously untreated patients with metastatic renal-cell carcinoma. In this randomised, double-blind, multicentre, phase 2 study, patients were enrolled from 49 hospitals and outpatient clinics in the Czech Republic, Germany, Japan, Russia, Spain, and USA. Patients with treatment-naive metastatic renal-cell carcinoma received axitinib 5 mg twice daily during a 4 week lead-in period. Those patients with blood pressure 150/90 mm Hg or lower, no grade 3 or 4 treatment-related toxic effects, no dose reductions, and no more than two antihypertensive drugs for 2 consecutive weeks were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1), and then randomly assigned (1:1) to either masked titration with axitinib to total twice daily doses of 7 mg, and then 10 mg, if tolerated, or placebo titration. Patients who did not meet these criteria continued without titration. The primary objective was comparison of the proportion of patients achieving an objective response between randomised groups. Safety analyses were based on all patients who received at least one dose of axitinib. Between Sept 2, 2009, and Feb 28, 2011, we enrolled 213 patients, of whom 112 were randomly assigned to either the axitinib titration group (56 patients) or the placebo titration group (56 patients). 91 were not eligible for titration, and ten withdrew during the lead-in period. 30 patients (54%, 95% CI 40-67) in the axitinib titration group had an objective response, as did 19 patients (34%, 22-48]) in the placebo titration group (one-sided p=0·019). 54 (59%, 95% CI 49-70) of non-randomised patients achieved an objective response. Common grade 3 or worse, all-causality adverse events in treated patients were hypertension (ten [18%] of 56 in the axitinib titration group vs five [9%] of 56 in the placebo titration group vs 45 [49%] of 91 in the non-randomised group), diarrhoea (seven [13%] vs two [4%] vs eight [9%]), and decreased weight (four [7%] vs three [5%] vs six [7%]). One or more all-causality serious adverse events were reported in 15 (27%) patients in the axitinib titration group, 13 (23%) patients in the placebo titration group, and 35 (38%) non-randomised patients. The most common serious adverse events in all 213 patients were disease progression and dehydration (eight each [4%]), and diarrhoea, vomiting, pneumonia, and decreased appetite (four each [2%]). The greater proportion of patients in the axitinib titration group achieving an objective response supports the concept of individual axitinib dose titration in selected patients with metastatic renal-cell carcinoma. Axitinib shows clinical activity with a manageable safety profile in treatment-naive patients with this disease. Copyright © 2013 Elsevier Ltd. All rights reserved.

Relation between burden of disease and randomised evidence in sub-Saharan Africa: survey of research.

PubMed

Isaakidis, Petros; Swingler, George H; Pienaar, Elizabeth; Volmink, Jimmy; Ioannidis, John P A

2002-03-23

To evaluate whether the amount of randomised clinical research on various medical conditions is related to the burden of disease and health needs of the local populations in sub-Saharan Africa. Construction and analysis of comprehensive database of randomised controlled trials in sub-Saharan Africa based on Medline, the Cochrane Controlled Trials Register, and several African databases. Sub-Saharan Africa. Number of trials and randomised subjects for each category of disease in the global burden of disease taxonomy; ratios of disability adjusted life years (DALYs) per amount of randomised evidence. 1179 eligible randomised controlled trials were identified. The number of trials published each year increased over time. Almost half of the trials (n=565) had been done in South Africa. There was relatively good correlation between the estimated burden of disease at year 2000 and the number of trials performed (r=0.53, P=0.024) and the number of participants randomised (r=0.68, P=0.002). However,some conditions-for example, injuries (over 20 000 DALYs per patient ever randomised)-were more neglected than others. Despite recent improvements, few clinical trials are done in sub-Saharan Africa. Clinical research in this part of the world should focus more evenly on the major contributors to burden of disease.

Simulating the impact of case-mix adjusted hospice rates.

PubMed

Mor, V; Laliberte, L

1986-01-01

The Medicare hospice benefit prospectively reimburses hospices based on the inpatient status of the patient, whether or not the patient is at home, and whether the patient is receiving round-the-clock nursing. Using national Hospice Study data, two case-mix adjusters based on patient functioning and living arrangement were found to be significantly related to per diem cost. These were tested by simulating their impact on hospice revenues. Increasing per diem reimbursements 35 percent for nonambulatory patients living alone only increases hospice revenues by 4 percent; hospices with sicker patients benefit the most.

The effects of the Bowen technique on hamstring flexibility over time: a randomised controlled trial.

PubMed

Marr, Michelle; Baker, Julian; Lambon, Nicky; Perry, Jo

2011-07-01

The hamstring muscles are regularly implicated in recurrent injuries, movement dysfunction and low back pain. Links between limited flexibility and development of neuromusculoskeletal symptoms are frequently reported. The Bowen Technique is used to treat many conditions including lack of flexibility. The study set out to investigate the effect of the Bowen Technique on hamstring flexibility over time. An assessor-blind, prospective, randomised controlled trial was performed on 120 asymptomatic volunteers. Participants were randomly allocated into a control group or Bowen group. Three flexibility measurements occurred over one week, using an active knee extension test. The intervention group received a single Bowen treatment. A repeated measures univariate analysis of variance, across both groups for the three time periods, revealed significant within-subject and between-subject differences for the Bowen group. Continuing increases in flexibility levels were observed over one week. No significant change over time was noted for the control group. Copyright © 2010 Elsevier Ltd. All rights reserved.

Adhesive retention dressings are more comfortable than alginate dressings on split-skin-graft donor sites.

PubMed

Hormbrey, E; Pandya, A; Giele, H

2003-07-01

Painful split-skin-graft donor sites remain a common problem for patients. We undertook a prospective randomised trial to examine the comparative comfort and ease of care of two different donor-site dressings. One dressing is the alginate Kaltostat, the standard plastic-surgical dressing in the UK and abroad, and the other is the adhesive retention tape Mefix, a novel use of a readily available dressing. We randomised 50 patients requiring split-skin grafts to receive either alginate (Kaltostat) or retention (Mefix) donor-site dressings. Dressings were assessed by interview and questionnaire at 24, 72 h and 2 weeks, and by wound review at 2 weeks. Retention dressings were found to be more comfortable, required less nursing intervention and allowed patients easier mobility with a greater range of daily activities, especially washing, without compromising wound healing. We recommend adhesive retention dressings as cost-effective comfortable dressings, which readily conform to any donor site.

Impact of autologous and allogeneic stem cell transplantation in peripheral T-cell lymphomas.

PubMed

Reimer, Peter

2010-01-01

Peripheral T/NK-cell lymphomas (PTCLs) are rare malignancies characterized by poor prognosis. So far, no standard therapy has been established, due to the lack of randomised studies. High-dose therapy and autologous stem cell transplantation (HDT-autoSCT) have shown good feasibility with low toxicity in retrospective studies. In relapsing and refractory PTCL several comparison analyses suggest similar efficacy for PTCL when compared with aggressive B-cell lymphoma. In the upfront setting, prospective data show promising results with a long-lasting overall survival in a relevant subset of patients. Achieving a complete remission at transplantation seems to be the most important prognostic factor. Allogeneic stem cell transplantation (alloSCT) has been investigated only as salvage treatment. Especially when using reduced intensity conditioning regimen, eligible patients seem to benefit from this approach. To define the role for upfront stem cell transplantation a randomised trial by the German High-Grade Non-Hodgkin Lymphoma Study Group comparing HDT-autoSCT and alloSCT will be initiated this year.

Wait-and-see policy versus cholecystectomy after endoscopic sphincterotomy for bile-duct stones in high-risk patients with co-existing gallbladder stones: a prospective randomised trial.

PubMed

Zargar, Showkat A; Mushtaq, Mosin; Beg, Mashkoor A; Javaid, Gul; Khan, Bashir A; Hassan, Rayhana; Kasana, Reyaz A; Tabassum, Sameena

2014-03-01

Endoscopic sphincterotomy (ES) is one of the most important advances in the treatment of common bile duct (CBD) stones. However, the use of ES to remove CBD stones in high-risk patients without cholecystectomy is still debatable. The aim of this study was to compare the efficacy of a wait-and-see policy versus cholecystectomy after ES for CBD stones in high-risk patients with co-existing cholelithiasis. A total of 162 patients after undergoing ES with the clearance of CBD stones were randomised after informed consent to cholecystectomy or conservative management of their gallbladder stones. The results indicated that cholecystectomy after ES for CBD stones significantly reduced the biliary complications in high-risk patients. Every patient who has both CBD stones and gallstones with significant co-morbid illnesses, after clearance of CBD stones by ES, should undergo early cholecystectomy. Copyright © 2014 Arab Journal of Gastroenterology. Published by Elsevier Ltd. All rights reserved.

Effectiveness of robot-assisted training added to conventional rehabilitation in patients with humeral fracture early after surgical treatment: protocol of a randomised, controlled, multicentre trial.

PubMed

Nerz, Corinna; Schwickert, Lars; Becker, Clemens; Studier-Fischer, Stefan; Müßig, Janina Anna; Augat, Peter

2017-12-06

The incidence of proximal humeral fractures increases with age. The functional recovery of the upper arm after such fractures is slow, and results are often disappointing. Treatment is associated with long immobilisation periods. Evidence-based exercise guidelines are missing. Loss of muscle mass as well as reduced range of motion and motor performance are common consequences. These losses could be partly counteracted by training interventions using robot-assisted arm support of the affected arm derived from neurorehabilitation. Thus, shorter immobilisation could be reached. Thus far, this approach has been tested in only a few small studies. The aim of the present study is to examine whether assistive robotic training augmenting conventional occupational and physical therapy can improve functional shoulder outcomes. Patients aged between 35 and 66 years with proximal humeral fracture and surgical treatment will be recruited at three different clinics in Germany and randomised into an intervention group and a control group. Participants will be assessed before randomisation and followed after completing an intervention period of 3 weeks and additionally after 3, 6 and 12 months. The baseline assessment will include cognition (Short Orientation-Memory-Concentration Test); level of pain in the affected arm; ability to work; gait speed (10-m walk); disability of the arm, shoulder and hand (Disabilities of the Arm, Shoulder and Hand Outcome Measure [DASH]); range of motion of the affected arm (goniometer measurement); visual acuity; and motor function of orthopaedic patients (Wolf Motor Function Test-Orthopaedic version [WMFT-O]). Clinical follow-up directly after the intervention will include assessment of disability of the arm, shoulder and hand (DASH) as well as range of motion and motor function (WMFT-O). The primary outcome parameter will be the DASH, and the secondary outcome parameter will be the WMFT-O. The long-term results will be assessed prospectively by postal follow-up. All patients will receive conventional occupational and physical therapy. The intervention group will receive additional robot-assisted training using the Armeo®Spring robot for 3 weeks. This study protocol describes a phase II, randomised, controlled, single-blind, multicentre intervention study. The results will guide and possibly improve methods of rehabilitation after proximal humeral fracture. Clinicaltrials.gov, NCT03100201 . Registered on 28 March 2017.

A multicentre randomised controlled trial of levetiracetam versus phenytoin for convulsive status epilepticus in children (protocol): Convulsive Status Epilepticus Paediatric Trial (ConSEPT) - a PREDICT study.

PubMed

Dalziel, Stuart R; Furyk, Jeremy; Bonisch, Megan; Oakley, Ed; Borland, Meredith; Neutze, Jocelyn; Donath, Susan; Sharpe, Cynthia; Harvey, Simon; Davidson, Andrew; Craig, Simon; Phillips, Natalie; George, Shane; Rao, Arjun; Cheng, Nicholas; Zhang, Michael; Sinn, Kam; Kochar, Amit; Brabyn, Christine; Babl, Franz E

2017-06-22

Convulsive status epilepticus (CSE) is the most common life-threatening childhood neurological emergency. Despite this, there is a lack of high quality evidence supporting medication use after first line benzodiazepines, with current treatment protocols based solely on non-experimental evidence and expert opinion. The current standard of care, phenytoin, is only 60% effective, and associated with considerable adverse effects. A newer anti-convulsant, levetiracetam, can be given faster, is potentially more efficacious, with a more tolerable side effect profile. The primary aim of the study presented in this protocol is to determine whether intravenous (IV) levetiracetam or IV phenytoin is the better second line treatment for the emergency management of CSE in children. 200 children aged between 3 months and 16 years presenting to 13 emergency departments in Australia and New Zealand with CSE, that has failed to stop with first line benzodiazepines, will be enrolled into this multicentre open randomised controlled trial. Participants will be randomised to 40 mg/kg IV levetiracetam infusion over 5 min or 20 mg/kg IV phenytoin infusion over 20 min. The primary outcome for the study is clinical cessation of seizure activity five minutes following the completion of the infusion of the study medication. Blinded confirmation of the primary outcome will occur with the primary outcome assessment being video recorded and assessed by a primary outcome assessment team blinded to treatment allocation. Secondary outcomes include: Clinical cessation of seizure activity at two hours; Time to clinical seizure cessation; Need for rapid sequence induction; Intensive care unit (ICU) admission; Serious adverse events; Length of Hospital/ICU stay; Health care costs; Seizure status/death at one-month post discharge. This paper presents the background, rationale, and design for a randomised controlled trial comparing levetiracetam to phenytoin in children presenting with CSE in whom benzodiazepines have failed. This study will provide the first high quality evidence for management of paediatric CSE post first-line benzodiazepines. Prospectively registered with the Australian and New Zealand Clinical Trial Registry (ANZCTR): ACTRN12615000129583 (11/2/2015). UTN U1111-1144-5272. ConSEPT protocol version 4 (12/12/2014).

How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China.

PubMed

Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

2015-01-01

While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. The integrated care system needs collaborative work from different levels of caregivers. So it is extremely important to consider the supplier cooperative behaviour. In this trial, we introduced payment system to help the delivery system integration through providing financial incentives to motivate people to play their roles. Also, the multidisciplinary team, the multi-institutional pathway and system global budget and pay-for-performance payment system could afford as a solution.

Evaluation of the effect of patient education on rates of falls in older hospital patients: Description of a randomised controlled trial

PubMed Central

Hill, Anne-Marie; Hill, Keith; Brauer, Sandra; Oliver, David; Hoffmann, Tammy; Beer, Christopher; McPhail, Steven; Haines, Terry P

2009-01-01

Background Accidental falls by older patients in hospital are one of the most commonly reported adverse events. Falls after discharge are also common. These falls have enormous physical, psychological and social consequences for older patients, including serious physical injury and reduced quality of life, and are also a source of substantial cost to health systems worldwide. There have been a limited number of randomised controlled trials, mainly using multifactorial interventions, aiming to prevent older people falling whilst inpatients. Trials to date have produced conflicting results and recent meta-analyses highlight that there is still insufficient evidence to clearly identify which interventions may reduce the rate of falls, and falls related injuries, in this population. Methods and design A prospective randomised controlled trial (n = 1206) is being conducted at two hospitals in Australia. Patients are eligible to be included in the trial if they are over 60 years of age and they, or their family or guardian, give written consent. Participants are randomised into three groups. The control group continues to receive usual care. Both intervention groups receive a specifically designed patient education intervention on minimising falls in addition to usual care. The education is delivered by Digital Video Disc (DVD) and written workbook and aims to promote falls prevention activities by participants. One of the intervention groups also receives follow up education training visits by a health professional. Blinded assessors conduct baseline and discharge assessments and follow up participants for 6 months after discharge. The primary outcome measure is falls by participants in hospital. Secondary outcome measures include falls at home after discharge, knowledge of falls prevention strategies and motivation to engage in falls prevention activities after discharge. All analyses will be based on intention to treat principle. Discussion This trial will examine the effect of a single intervention (specifically designed patient education) on rates of falls in older patients in hospital and after discharge. The results will provide robust recommendations for clinicians and researchers about the role of patient education in this population. The study has the potential to identify a new intervention that may reduce rates of falls in older hospital patients and could be readily duplicated and applied in a wide range of clinical settings. Trial Registration ACTRN12608000015347 PMID:19393046

How to build and evaluate an integrated health care system for chronic patients: study design of a clustered randomised controlled trial in rural China

PubMed Central

Tang, Wenxi; Sun, Xiaowei; Zhang, Yan; Ye, Ting; Zhang, Liang

2015-01-01

Background While integrated health care system has been proved an effective way to help improving patient health and system efficiency, the exact behaviour model and motivation approach are not so clear in poor rural areas where health human resources and continuous service provision are urgently needed. To gather solid evidence, we initiated a comprehensive intervention project in Qianjiang District, southwest part of rural China in 2012. And after one-year's pilot, we developed an intervention package of team service, comprehensive pathway and prospective- and performance-based payment system. Methods To testify the potential influence of payment interventions, we use clustered randomised controlled trial, 60 clusters are grouped into two treatment groups and one control group to compare the time and group differences. Difference-in-differences model and structural equation modelling will be used to analyse the intervention effects and pathway. The outcomes are: quality of care, disease burden, supplier cooperative behaviour and patient utilisation behaviour and system efficiency. Repeated multivariate variance analysis will be used to statistically examine the outcome differences. Discussion This is the first trial of its kind to prove the effects and efficiency of integrated care. Though we adopted randomised controlled trial to gather the highest rank of evidence, still the fully randomisation was hard to realise in health policy reform experiment. To compensate, the designer should take efforts on control for the potential confounders as much as possible. With this trial, we assume the effects will come from: (1) improvement on the quality of life through risk factors control and lifestyles change on patient's behaviours; (2) improvement on quality of care through continuous care and coordinated supplier behaviours; (3) improvement on the system efficiency through active interaction between suppliers and patients. Conclusion The integrated care system needs collaborative work from different levels of caregivers. So it is extremely important to consider the supplier cooperative behaviour. In this trial, we introduced payment system to help the delivery system integration through providing financial incentives to motivate people to play their roles. Also, the multidisciplinary team, the multi-institutional pathway and system global budget and pay-for-performance payment system could afford as a solution. PMID:26034466

Effectiveness of a multicomponent intervention to enhance implementation of a healthy canteen policy in Australian primary schools: a randomised controlled trial.

PubMed

Nathan, Nicole; Yoong, Sze Lin; Sutherland, Rachel; Reilly, Kathryn; Delaney, Tessa; Janssen, Lisa; Robertson, Katie; Reynolds, Renee; Chai, Li Kheng; Lecathelinais, Christophe; Wiggers, John; Wolfenden, Luke

2016-10-07

The implementation of school nutrition policies, which govern the provision of food in schools, is recommended as a public health strategy to support the development of healthy dietary behaviours in school-aged children. Despite this, research internationally and in Australia indicates that few schools implement such policies. This study aims to examine whether a theoretically designed, multi-strategy intervention was effective in increasing the implementation of a healthy canteen policy in Australian primary schools. A parallel group randomised controlled trial was conducted with all government and Catholic primary schools within one region in New South Wales, Australia who had an operational canteen that provided food to primary school aged children (5-12 years) and were not currently receiving an intervention to change their canteen practices. Schools randomised to the intervention arm received a 9-month multicomponent intervention including ongoing support, provision of resources, performance monitoring and feedback, executive support and recognition. The primary outcomes were the proportion of the schools with a canteen menu that: i) did not include 'red' or 'banned' items according to the healthy canteen policy; and ii) had more than 50 % 'green' items. The primary outcome was assessed via menu audit at baseline and follow up by dietitians blinded to group allocation. Fifty-three eligible schools were randomised to either the intervention or control group (28 intervention; 25 control). Analyses with 51 schools who returned school menus found that intervention schools were significantly more likely relative to control schools to have a menu without 'red' or 'banned' items (RR = 5.78 (1.45-23.05); p = 0.002) and have at least 50 % of menu items classified as green (RR = 2.03 (1.01-4.08); p = 0.03). This study found that a multi-component intervention was effective in improving primary schools' compliance with a healthy canteen policy. Given the lack of evidence regarding how best to support schools with implementing evidence-based policies to improve child diet, this trial for the first time provides high quality evidence to practitioners and policy makers seeking to improve nutrition policy implementation in schools. This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12614001148662 ) 30th October 2014.

The Sternal Management Accelerated Recovery Trial (S.M.A.R.T) - standard restrictive versus an intervention of modified sternal precautions following cardiac surgery via median sternotomy: study protocol for a randomised controlled trial.

PubMed

Katijjahbe, Md Ali; Denehy, Linda; Granger, Catherine L; Royse, Alistair; Royse, Colin; Bates, Rebecca; Logie, Sarah; Clarke, Sandy; El-Ansary, Doa

2017-06-23

The routine implementation of sternal precautions to prevent sternal complications that restrict the use of the upper limbs is currently worldwide practice following a median sternotomy. However, evidence is limited and drawn primarily from cadaver studies and orthopaedic research. Sternal precautions may delay recovery, prolong hospital discharge and be overly restrictive. Recent research has shown that upper limb exercise reduces post-operative sternal pain and results in minimal micromotion between the sternal edges as measured by ultrasound. The aims of this study are to evaluate the effects of modified sternal precautions on physical function, pain, recovery and health-related quality of life after cardiac surgery. This study is a phase II, double-blind, randomised controlled trial with concealed allocation, blinding of patients and assessors, and intention-to-treat analysis. Patients (n = 72) will be recruited following cardiac surgery via a median sternotomy. Sample size calculations were based on the minimal important difference (two points) for the primary outcome: Short Physical Performance Battery. Thirty-six participants are required per group to counter dropout (20%). All participants will be randomised to receive either standard or modified sternal precautions. The intervention group will receive guidelines encouraging the safe use of the upper limbs. Secondary outcomes are upper limb function, pain, kinesiophobia and health-related quality of life. Descriptive statistics will be used to summarise data. The primary hypothesis will be examined by repeated-measures analysis of variance to evaluate the changes from baseline to 4 weeks post-operatively in the intervention arm compared with the usual-care arm. In all tests to be conducted, a p value <0.05 (two-tailed) will be considered statistically significant, and confidence intervals will be reported. The Sternal Management Accelerated Recovery Trial (S.M.A.R.T.) is a two-centre randomised controlled trial powered and designed to investigate whether the effects of modifying sternal precautions to include the safe use of the upper limbs and trunk impact patients' physical function and recovery following cardiac surgery via median sternotomy. Australian and New Zealand Clinical Trials Registry identifier: ACTRN12615000968572 . Registered on 16 September 2015 (prospectively registered).

Sensitivity Observing System Experiment (SOSE)-a new effective NWP-based tool in designing the global observing system

NASA Astrophysics Data System (ADS)

Marseille, Gert-Jan; Stoffelen, Ad; Barkmeijer, Jan

2008-03-01

Lacking an established methodology to test the potential impact of prospective extensions to the global observing system (GOS) in real atmospheric cases we developed such a method, called Sensitivity Observing System Experiment (SOSE). For example, since the GOS is non uniform it is of interest to investigate the benefit of complementary observing systems filling its gaps. In a SOSE adjoint sensitivity structures are used to define a pseudo true atmospheric state for the simulation of the prospective observing system. Next, the synthetic observations are used together with real observations from the existing GOS in a state-of-the-art Numerical Weather Prediction (NWP) model to assess the potential added value of the new observing system. Unlike full observing system simulation experiments (OSSE), SOSE can be applied to real extreme events that were badly forecast operationally and only requires the simulation of the new instrument. As such SOSE is an effective tool, for example, to define observation requirements for extensions to the GOS. These observation requirements may serve as input for the design of an operational network of prospective observing systems. In a companion paper we use SOSE to simulate potential future space borne Doppler Wind Lidar (DWL) scenarios and assess their capability to sample meteorologically sensitive areas not well captured by the current GOS, in particular over the Northern Hemisphere oceans.

Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies

PubMed Central

Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

2014-01-01

Introduction A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). Methods and analysis We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. Ethics and dissemination This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. Protocol registration in PROSPERO The protocol is registered with PROSPERO, registration number CRD42013006518. PMID:24833685

Hypobaric Unilateral Spinal Anaesthesia versus General Anaesthesia in Elderly Patients Undergoing Hip Fracture Surgical Repair: A Prospective Randomised Open Trial

PubMed Central

Meuret, Pascal; Bouvet, Lionel; Villet, Benoit; Hafez, Mohamed; Allaouchiche, Bernard

2018-01-01

Objective Intraoperative hypotension during hip fracture surgery is frequent in the elderly. No study has compared the haemodynamic effect of hypobaric unilateral spinal anaesthesia (HUSA) and standardised general anaesthesia (GA) in elderly patients undergoing hip fracture surgical repair. Methods We performed a prospective, randomised open study, including 40 patients aged over 75 years, comparing the haemodynamic effects of HUSA (5 mg isobaric bupivacaine with 5 μg sufentanil and 1 mL sterile water) and GA (induction with etomidate/remifentanil and maintenance with desflurane/remifentanil). An incidence of severe hypotension, defined by a decrease in systolic blood pressure of >40% from baseline, was the primary endpoint. Results The incidence of severe hypotension was lower in the HUSA group compared with that in the GA group (32% vs. 71%, respectively, p=0.03). The median [IQR] ephedrine consumption was lower (p=0.001) in the HUSA group (6 mg, 0–17 mg) compared with that in the GA group (36 mg, 21–57 mg). Intraoperative muscle relaxation and patients’ and surgeons’ satisfaction were similar between groups. No difference was observed in 5-day complications or 30-day mortality. Conclusion This study shows that HUSA provides better haemodynamic stability than GA, with lower consumption of ephedrine and similar operating conditions. This new approach of spinal anaesthesia seems to be safe and effective in elderly patients undergoing hip fracture surgery. PMID:29744247

Efficacy and safety of the topical application of tranexamic acid in primary cementless hip arthroplasty: prospective, randomised, double-blind and controlled study.

PubMed

Tavares Sánchez-Monge, F J; Aguado Maestro, I; Bañuelos Díaz, A; Martín Ferrero, M Á; García Alonso, M F

To evaluate the efficacy of topical tranexamic acid topical in cementless total hip arthroplasty from the point of view of bleeding, transfusion requirements and length of stay, and describe the complications of use compared to a control group. A prospective, randomised, double-blinded and controlled study including all patients undergoing cementless total hip arthroplasty in our centre between June 2014 and July 2015. Blood loss was estimated using the formula described by Nadler and Good. The final analysis included 119 patients. The decrease in haemoglobin after surgery was lower in the tranexamic acid group (3.28±1.13g/dL) than in the controls (4.03±1.27g/dL, P=.001) and estimated blood loss (1,216.75±410.46mL vs. 1,542.12±498.97mL, P<.001), the percentage of transfused patients (35.9% vs. 19.3%, P<.05) and the number of transfused red blood cell units per patient (0.37±0.77 vs. 0.98±1.77; P<.05). There were no differences between groups in the occurrence of complications or length of stay. The use of topical tranexamic acid in cementless total hip arthroplasty results in a decrease in bleeding and transfusion requirements without increasing the incidence of complications. Copyright © 2017 SECOT. Publicado por Elsevier España, S.L.U. All rights reserved.

Comparison between pathogen directed antibiotic treatment and empirical broad spectrum antibiotic treatment in patients with community acquired pneumonia: a prospective randomised study

PubMed Central

van der Eerden, M M; Vlaspolder, F; de Graaff, C S; Groot, T; Bronsveld, W; Jansen, H; Boersma, W

2005-01-01

Background: There is much controversy about the ideal approach to the management of community acquired pneumonia (CAP). Recommendations differ from a pathogen directed approach to an empirical strategy with broad spectrum antibiotics. Methods: In a prospective randomised open study performed between 1998 and 2000, a pathogen directed treatment (PDT) approach was compared with an empirical broad spectrum antibiotic treatment (EAT) strategy according to the ATS guidelines of 1993 in 262 hospitalised patients with CAP. Clinical efficacy was primarily determined by the length of hospital stay (LOS). Secondary outcome parameters for clinical efficacy were assessment of therapeutic failure on antibiotics, 30 day mortality, duration of antibiotic treatment, resolution of fever, side effects, and quality of life. Results: Three hundred and three patients were enrolled in the study; 41 were excluded, leaving 262 with results available for analysis. No significant differences were found between the two treatment groups in LOS, 30 day mortality, clinical failure, or resolution of fever. Side effects, although they did not have a significant influence on the outcome parameters, occurred more frequently in patients in the EAT group than in those in the PDT group (60% v 17%, 95% CI –0.5 to –0.3; p<0.001). Conclusions: An EAT strategy with broad spectrum antibiotics for the management of hospitalised patients with CAP has comparable clinical efficacy to a PDT approach. PMID:16061709

Effects of low and standard intra-abdominal pressure on systemic inflammation and immune response in laparoscopic adrenalectomy: A prospective randomised study.

PubMed

Schietroma, Mario; Pessia, Beatrice; Stifini, Derna; Lancione, Laura; Carlei, Francesco; Cecilia, Emanuela Marina; Amicucci, Gianfranco

2016-01-01

The advantages of laparoscopic adrenalectomy (LA) over open adrenalectomy are undeniable. Nevertheless, carbon dioxide (CO2) pneumoperitoneum may have an unfavourable effect on the local immune response. The aim of this study was to compare changes in the systemic inflammation and immune response in the early post-operative (p.o.) period after LA performed with standard and low-pressure CO2 pneumoperitoneum. We studied, in a prospective randomised study, 51 patients consecutively with documented adrenal lesion who had undergone a LA: 26 using standard-pressure (12-14 mmHg) and 25 using low-pressure (6-8 mmHg) pneumoperitoneum. White blood cells (WBC), peripheral lymphocyte subpopulation, human leucocyte antigen-DR (HLA-DR), neutrophil elastase, interleukin (IL)-6 and IL-1, and C-reactive protein (CRP) were investigated. Significantly higher concentrations of neutrophil elastase, IL-6 and IL-1 and CRP were detected p.o. in the standard-pressure group of patients in comparison with the low-pressure group (P < 0.05). A statistically significant change in HLA-DR expression was recorded p.o. at 24 h, as a reduction of this antigen expressed on the monocyte surface in patients from the standard group; no changes were noted in low-pressure group patients (P < 0.05). This study demonstrated that reducing the pressure of the pneumoperitoneum to 6-8 mmHg during LA reduced p.o. inflammatory response and averted p.o. immunosuppression.

Randomised clinical trial: enteral nutrition does not improve the long-term outcome of alcoholic cirrhotic patients with jaundice.

PubMed

Dupont, B; Dao, T; Joubert, C; Dupont-Lucas, C; Gloro, R; Nguyen-Khac, E; Beaujard, E; Mathurin, P; Vastel, E; Musikas, M; Ollivier, I; Piquet, M-A

2012-05-01

Malnutrition and jaundice are independent prognostic factors in cirrhosis. To assess the impact of enteral nutrition on the survival of alcoholic cirrhotic patients with jaundice but without acute alcoholic hepatitis. The study was a multicentre prospective randomised controlled trial comparing effects of enteral nutrition vs. a symptomatic support in patients with alcoholic cirrhosis and jaundice (bilirubin ≥51 µmol/L) but without severe acute alcoholic hepatitis. A total of 99 patients were randomised to receive either the conventional symptomatic treatment (55 patients) or the symptomatic support associated with 35 kcal/Kg/day of enteral nutrition during 4 weeks followed by an oral nutritional support during 2 months (44 patients). Randomisation was stratified on nutritional status. One-year survival curves were compared using the Kaplan-Meier method and Logrank test. Populations in both arms were similar. One-year survival was similar in the overall population (27/44 patients (61.4%) in the enteral nutrition arm vs. 36/55 (65.5%) in the control arm; Logrank P = 0.60) and in the subgroup suffering from malnutrition [18/29 patients (62.1%) in the enteral nutrition arm vs. 20/32 (62.5%) in the control arm; Logrank P = 0.99]. There was no statistical difference for bilirubin, prothrombin rate, Child-Pugh score, albumin or nutritional assessment. Complications during treatment (bleeding, encephalopathy, infection) occurred in 23% of patients in the enteral nutrition group (10/44) vs. 16% (9/55) of the control patients (P = 0.59). Enteral nutrition does not improve the survival and hepatic or nutritional parameters of cirrhotic patients with jaundice. © 2012 Blackwell Publishing Ltd.

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery

PubMed Central

Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-01-01

Introduction Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions—physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. Methods and analysis This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. Ethics and dissemination This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. Trial registration number NCT02921932 (ClinicalTrials.gov) PMID:28778994

Randomised trial of mitral valve repair with leaflet resection versus leaflet preservation on functional mitral stenosis (The CAMRA CardioLink-2 Trial).

PubMed

Chan, Vincent; Chu, Michael W A; Leong-Poi, Howard; Latter, David A; Hall, Judith; Thorpe, Kevin E; de Varennes, Benoit E; Quan, Adrian; Tsang, Wendy; Dhingra, Natasha; Yared, Kibar; Teoh, Hwee; Chu, F Victor; Chan, Kwan-Leung; Mesana, Thierry G; Connelly, Kim A; Ruel, Marc; Jüni, Peter; Mazer, C David; Verma, Subodh

2017-05-30

The gold-standard treatment of severe mitral regurgitation (MR) due to degenerative disease is valve repair, which is surgically performed with either a leaflet resection or leaflet preservation approach. Recent data suggest that functional mitral stenosis (MS) may occur following valve repair using a leaflet resection strategy, which adversely affects patient prognosis. A randomised comparison of these two approaches to mitral repair on functional MS has not been conducted. This is a prospective, multicentre randomised controlled trial designed to test the hypothesis that leaflet preservation leads to better preservation of mitral valve geometry, and therefore, will be superior to leaflet resection for the primary outcome of functional MS as assessed by 12-month mean mitral valve gradient at peak exercise. Eighty-eight patients with posterior leaflet prolapse will be randomised intraoperatively once deemed by the operating surgeon to feasibly undergo mitral repair using either a leaflet resection or leaflet preservation approach. Secondary end points include comparison of repair strategies with regard to mitral valve orifice area, leaflet coaptation height, 6 min walk test and a composite major adverse event end point consisting of recurrent MR ≥2+, death or hospital readmission for congestive heart failure within 12 months of surgery. Institutional ethics approval has been obtained from all enrolling sites. Overall, there remains clinical equipoise regarding the mitral valve repair strategy that is associated with the least likelihood of functional MS. This trial hopes to introduce high-quality evidence to help surgical decision making in this context. NCT02552771. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

PubMed

Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-08-04

Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Depression and prospection.

PubMed

Roepke, Ann Marie; Seligman, Martin E P

2016-03-01

Prospection, the mental representation of possible futures, is usually adaptive. When it goes awry, however, it disrupts emotion and motivation. A negative view of the future is typically seen as one symptom of depression, but we suggest that such negative prospection is the core causal element of depression. Here, we describe the empirical evidence supporting this framework, and we explore the implications for clinical interventions. We integrate several literatures: Using the database PsycInfo, we retrieved empirical studies with the keywords prospection, prediction, expectation, pessimism, mental simulation, future-thinking, future-directed thinking, foresight, and/or mental time travel, in conjunction with depression, depressed, or depressive. Three kinds of faulty prospection, taken together, could drive depression: Poor generation of possible futures, poor evaluation of possible futures, and negative beliefs about the future. Depressed mood and poor functioning, in turn, may maintain faulty prospection and feed a vicious cycle. Future-oriented treatment strategies drawn from cognitive-behavioural therapy help to fix poor prospection, and they deserve to be developed further. Prospection-based techniques may lead to transdiagnostic treatment strategies for depression and other disorders. © 2015 The British Psychological Society.

Prostate cancer mortality reduction by prostate-specific antigen-based screening adjusted for nonattendance and contamination in the European Randomised Study of Screening for Prostate Cancer (ERSPC).

PubMed

Roobol, Monique J; Kerkhof, Melissa; Schröder, Fritz H; Cuzick, Jack; Sasieni, Peter; Hakama, Matti; Stenman, Ulf Hakan; Ciatto, Stefano; Nelen, Vera; Kwiatkowski, Maciej; Lujan, Marcos; Lilja, Hans; Zappa, Marco; Denis, Louis; Recker, Franz; Berenguer, Antonio; Ruutu, Mirja; Kujala, Paula; Bangma, Chris H; Aus, Gunnar; Tammela, Teuvo L J; Villers, Arnauld; Rebillard, Xavier; Moss, Sue M; de Koning, Harry J; Hugosson, Jonas; Auvinen, Anssi

2009-10-01

Prostate-specific antigen (PSA) based screening for prostate cancer (PCa) has been shown to reduce prostate specific mortality by 20% in an intention to screen (ITS) analysis in a randomised trial (European Randomised Study of Screening for Prostate Cancer [ERSPC]). This effect may be diluted by nonattendance in men randomised to the screening arm and contamination in men randomised to the control arm. To assess the magnitude of the PCa-specific mortality reduction after adjustment for nonattendance and contamination. We analysed the occurrence of PCa deaths during an average follow-up of 9 yr in 162,243 men 55-69 yr of age randomised in seven participating centres of the ERSPC. Centres were also grouped according to the type of randomisation (ie, before or after informed written consent). Nonattendance was defined as nonattending the initial screening round in ERSPC. The estimate of contamination was based on PSA use in controls in ERSPC Rotterdam. Relative risks (RRs) with 95% confidence intervals (CIs) were compared between an ITS analysis and analyses adjusting for nonattendance and contamination using a statistical method developed for this purpose. In the ITS analysis, the RR of PCa death in men allocated to the intervention arm relative to the control arm was 0.80 (95% CI, 0.68-0.96). Adjustment for nonattendance resulted in a RR of 0.73 (95% CI, 0.58-0.93), and additional adjustment for contamination using two different estimates led to estimated reductions of 0.69 (95% CI, 0.51-0.92) to 0.71 (95% CI, 0.55-0.93), respectively. Contamination data were obtained through extrapolation of single-centre data. No heterogeneity was found between the groups of centres. PSA screening reduces the risk of dying of PCa by up to 31% in men actually screened. This benefit should be weighed against a degree of overdiagnosis and overtreatment inherent in PCa screening.

Randomised clinical simulation designed to evaluate the effect of telemedicine using Google Glass on cardiopulmonary resuscitation (CPR).

PubMed

Pérez Alonso, Nuria; Pardo Rios, Manuel; Juguera Rodriguez, Laura; Vera Catalan, Tomas; Segura Melgarejo, Francisca; Lopez Ayuso, Belen; Martí Nez Riquelme, Carolina; Lasheras Velasco, Joaquin

2017-11-01

Through a clinical simulation, this study aims to assess the effect of telematics support through Google Glass (GG) from an expert physician on performance of cardiopulmonary resuscitation (CPR) performed by a group of nurses, as compared with a control group of nurses receiving no assistance. This was a randomised study carried out at the Catholic University of Murcia (November 2014-February 2015). Nursing professionals from the Emergency Medical Services in Murcia (Spain) were asked to perform in a clinical simulation of cardiac arrest. Half of the nurses were randomly chosen to receive coaching from physicians through GG, while the other half did not receive any coaching (controls). The main outcome of the study expected was successful defibrillation, which restores sinus rhythm. Thirty-six nurses were enrolled in each study group. Statistically significant differences were found in the percentages of successful defibrillation (100% GG vs 78% control; p=0005) and CPR completion times: 213.91 s for GG and 250.31 s for control (average difference=36.39 s (95% CI 12.03 to 60.75), p=0.004). Telematics support by an expert through GG improves success rates and completion times while performing CPR in simulated clinical situations for nurses in simulated scenarios. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Proceedings of the Shuttle-based Cometary Science Workshop: a Forum for the Presentation and Discussion of Possible Shuttle-based Experiments and Observations of Comets and Cometary-like Materials

NASA Technical Reports Server (NTRS)

Gary, G. A. (Editor); Clifton, K. S. (Editor)

1976-01-01

The prospects of cometary research from the space shuttle are examined. Topics include: the shuttle as research environment; on-board experiments at zero-gravity and release of gas and dust to simulate cometary phenomena; and cometary observations from space.

Home-based care after a shortened hospital stay versus hospital-based care postpartum: an economic evaluation.

PubMed

Petrou, Stavros; Boulvain, Michel; Simon, Judit; Maricot, Patrice; Borst, François; Perneger, Thomas; Irion, Olivier

2004-08-01

To compare the cost effectiveness of early postnatal discharge and home midwifery support with a traditional postnatal hospital stay. Cost minimisation analysis within a pragmatic randomised controlled trial. The University Hospital of Geneva and its catchment area. Four hundred and fifty-nine deliveries of a single infant at term following an uncomplicated pregnancy. Prospective economic evaluation alongside a randomised controlled trial in which women were allocated to either early postnatal discharge combined with home midwifery support (n= 228) or a traditional postnatal hospital stay (n= 231). Costs (Swiss francs, 2000 prices) to the health service, social services, patients, carers and society accrued between delivery and 28 days postpartum. Clinical and psychosocial outcomes were similar in the two trial arms. Early postnatal discharge combined with home midwifery support resulted in a significant reduction in postnatal hospital care costs (bootstrap mean difference 1524 francs, 95% confidence interval [CI] 675 to 2403) and a significant increase in community care costs (bootstrap mean difference 295 francs, 95% CI 245 to 343). There were no significant differences in average hospital readmission, hospital outpatient care, direct non-medical and indirect costs between the two trial groups. Overall, early postnatal discharge combined with home midwifery support resulted in a significant cost saving of 1221 francs per mother-infant dyad (bootstrap mean difference 1209 francs, 95% CI 202 to 2155). This finding remained relatively robust following variations in the values of key economic parameters performed as part of a comprehensive sensitivity analysis. A policy of early postnatal discharge combined with home midwifery support exhibits weak economic dominance over traditional postnatal care, that is, it significantly reduces costs without compromising the health and wellbeing of the mother and infant.

Effect of lipid-based dry eye supplements on the tear film in wearers of eye cosmetics.

PubMed

Wang, Michael T M; Cho, Irene Sung Hee; Jung, Soo Hee; Craig, Jennifer P

2017-08-01

To compare the effects on tear film parameters and contamination in cosmetic eyeliner wearers, after single application of two lipid-based dry eye treatments: a lipid-containing lubricant eye drop and a phospholipid liposomal spray. Fifty participants were enrolled in a prospective, randomised, paired-eye, investigator-masked trial. Pencil eyeliner (Body Shop ® Crayon Eye Definer) was applied to the upper eyelid periocular skin of both eyes, anterior to the lash line. Baseline tear film quality was assessed fifteen minutes after eyeliner application. A lubricant drop (Systane ® Balance) was then applied to one eye (randomised), and liposomal spray (Tears Again ® ) to the contralateral eye. Tear film contamination, lipid layer grade, non-invasive tear film break-up time and tear evaporation rate were evaluated fifteen minutes post-treatment and compared to pre-treatment values. Pre-treatment measurements did not differ between eyes assigned to lubricant drop and liposomal spray. Tear film contamination was observed in a greater proportion of eyes following both treatments (both p<0.05), with no significant difference between treatments (p=0.41). Both treatments improved lipid layer thickness (both p≤0.01), but effected no significant change in non-invasive tear film break-up time or tear evaporation rate (all p>0.05). Changes in tear film parameters did not differ between treatments (all p>0.05). Both the lipid-containing lubricant eye drop and phospholipid liposomal spray result in clinically apparent tear film contamination in eyeliner cosmetic wearers. Although both treatments effected an increase in lipid layer thickness, neither displayed clinical efficacy in improving tear film stability. Copyright © 2017 British Contact Lens Association. Published by Elsevier Ltd. All rights reserved.

The challenge of recruiting people with schizophrenia to a health promotion trial

PubMed Central

Abbott, Margaret; Arthur, Antony; Walker, Liz; Doody, Gillian

2005-01-01

People with schizophrenia have an increased risk of coronary heart disease. This pilot study tested the feasibility of carrying out a randomised controlled trial to compare coronary heart disease prevention for this population through an enhanced occupational therapy support intervention versus a practice-based intervention. Difficulty in deciding whether to take part meant that 123 visits were made to 25 people with 12 ultimately providing informed consent. Participants' discussion at a subsequent focus group (n = 3) suggested a poor understanding of the study process. Distrust of randomisation suggests that randomised controlled trials may not be the best way to evaluate community-based interventions for people with schizophrenia. PMID:16105374

Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus

PubMed Central

2014-01-01

Background Diabetes mellitus may be present in patients with cystic fibrosis starting in the second decade of life. The prevalence increases rapidly with increasing age. As life-expectancy increases in cystic fibrosis, cystic fibrosis related diabetes will be diagnosed more frequently in the future. Up to date, no data are available to answer the question if cystic fibrosis related diabetes should always initially be treated by insulin therapy. Missing data regarding oral antidiabetic treatment of newly diagnosed cystic fibrosis related diabetes are an important reason to recommend insulin treatment. Several centres report the successful management of cystic fibrosis related diabetes using oral anti-diabetic drugs at least for some years. Oral therapies would be less invasive for a patient group which is highly traumatized by a very demanding therapy. Based on an initiative of the German Mukoviszidosis-Foundation, the present study tries to answer the question, whether oral therapy with repaglinide is as effective as insulin therapy in cystic fibrosis patients with early diagnosed diabetes mellitus. Methods/Design In all cystic fibrosis patients with an age of 10 years or older, an oral glucose tolerance test is recommended. The result of this test is classified according to the WHO cut off values. It is required to have two diabetes positive oral glucose tolerance tests for the diagnosis of diabetes mellitus. This study is a multi-national, multicentre, open labelled, randomized and prospective controlled parallel group’s trial, with 24 months treatment. The primary objective of this trial is to compare the glycaemic control of oral therapy with Repaglinide with insulin injections in patients with cystic fibrosis related diabetes after 2 years of treatment. The trial should include 74 subjects showing cystic fibrosis related diabetes newly diagnosed by oral glucose tolerance test during annual screening for cystic fibrosis related diabetes. Patients are randomised by central fax randomisation. Primary endpoint is mean HbA1c after 24 months of treatment. Secondary endpoints are change in FEV1% predicted and change in BMI-Z-score. Discussion There is only one prospective study comparing oral antidiabetic drugs to insulin in the treatment of CFRD without fasting hyperglycaemia. The results regarding BMI after 6 months and 12 months showed an improvement for the insulin treated patients and were inconsistent for those treated with repaglinide. HbA1c and lung function (FEV1%pred) were unchanged for either group. The authors compared the changes -12 months to baseline and baseline to +12 months separately for each group. Therefore a direct comparison of the effect of repaglinide versus insulin on BMI, HbA1c and FEV1%pred was not presented. According to our protocol, we will directly compare treatment effects (HbA1c, BMI, FEV1%pred) in between both groups. The actual Cochrane report regarding “Insulin and oral agents for managing CFRD” stated that further studies are needed to establish whether there is clear benefit for hypoglycemic agents. We expect that the results of our study will help to address this clinical need. Trial registration ClinicalTrials.gov Identifier: NCT00662714 PMID:24620855

Protocol for a systematic review of psychological interventions for cancer-related fatigue in post-treatment cancer survivors.

PubMed

Corbett, Teresa; Devane, Declan; Walsh, Jane C; Groarke, AnnMarie; McGuire, Brian E

2015-12-04

Fatigue is a common symptom in cancer patients that can persist beyond the curative treatment phase. Some evidence has been reported for interventions for fatigue during active treatment. However, to date, there is no systematic review on psychological interventions for fatigue after the completion of curative treatment for cancer. This is a protocol for a systematic review that aims to evaluate the effectiveness of psychological interventions for cancer-related fatigue in post-treatment cancer survivors. This systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) database. We will search the Cochrane Central Register of Controlled Trials (CENTRAL; The Cochrane Library), PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, and relevant sources of grey literature. Randomised controlled trials (RCTs) which have evaluated psychological interventions in adult cancer patients after the completion of treatment, with fatigue as an outcome measure, will be included. Two review authors will independently extract data from the selected studies and assess the methodological quality using the Cochrane Collaboration Risk of Bias Tool. Most existing evidence on cancer-related fatigue is from those in active cancer treatment. This systematic review and meta-analysis will build upon previous evaluations of psychological interventions in people during and after cancer treatment. With the growing need for stage-specific research in cancer, this review seeks to highlight a gap in current practice and to strengthen the evidence base of randomised controlled trials in the area. PROSPERO CRD42014015219.

The effectiveness of a preconditioning programme on preventing running-related injuries in novice runners: a randomised controlled trial.

PubMed

Bredeweg, Steef W; Zijlstra, Sjouke; Bessem, Bram; Buist, Ida

2012-09-01

There is no consensus on the aetiology and prevention of running-related injuries in runners. Preconditioning studies among different athlete populations show positive effects on the incidence of sports injuries. A 4-week preconditioning programme in novice runners will reduce the incidence of running-related injuries. Randomised controlled clinical trial; level of evidence, 1. Novice runners (N=432) prepared for a four-mile recreational running event. Participants were allocated to the 4-week preconditioning (PRECON) group (N=211) or the control group (N=221). The PRECON group started a 4-week training programme, prior to the running programme, with walking and hopping exercises. After the 4-week period both groups started a 9-week running programme. In both groups information was registered on running exposure and running-related injuries (RRIs) using an internet-based running log. Primary outcome measure was RRIs per 100 runners. An RRI was defined as any musculoskeletal complaint of the lower extremity or lower back causing restriction of running for at least a week. The incidence of RRIs was 15.2% in the PRECON group and 16.8% in the control group. The difference in RRIs between the groups was not significant (χ(2)=0.161, df=1, p=0.69). This prospective study demonstrated that a 4-week PRECON programme with walking and hopping exercises had no influence on the incidence of RRIs in novice runners.

Bridging the gap between the randomised clinical trial world and the real world by combination of population-based registry and electronic health record data: A case study in haemato-oncology.

PubMed

Kibbelaar, R E; Oortgiesen, B E; van der Wal-Oost, A M; Boslooper, K; Coebergh, J W; Veeger, N J G M; Joosten, P; Storm, H; van Roon, E N; Hoogendoorn, M

2017-11-01

Randomised clinical trials (RCTs) are considered the basis of evidence-based medicine. It is recognised more and more that application of RCT results in daily practice of clinical decision-making is limited because the RCT world does not correspond with the clinical real world. Recent strategies aiming at substitution of RCT databases by improved population-based registries (PBRs) or by improved electronic health record (EHR) systems to provide significant data for clinical science are discussed. A novel approach exemplified by the HemoBase haemato-oncology project is presented. In this approach, a PBR is combined with an advanced EHR, providing high-quality data for observational studies and support of best practice development. This PBR + EHR approach opens a perspective on randomised registry trials. Copyright © 2017 Elsevier Ltd. All rights reserved.

Safety and efficacy of vardenafil versus sertraline in the treatment of premature ejaculation: a randomised, prospective and crossover study.

PubMed

Mathers, M J; Klotz, T; Roth, S; Lümmen, G; Sommer, F

2009-06-01

We investigated safety and efficacy of vardenafil and sertraline in premature ejaculation (PE). Seventy-two men graded their primary PE on a scale of 0-8 (0 = almost never, 8 = almost always). Intravaginal ejaculatory latency time (IELT) was measured. Patients were included if they scored their PE as 4 or greater and their IELTs were less than 1.30 min. After 6 weeks of behavioural psychosexual therapy, 49 patients still had a PE of 4 or greater and an IELT less than 1.30 min and they were randomised: 6 weeks vardenafil (10 mg) or sertraline (50 mg). After a wash-out phase for 1 week, medication was changed in a cross-over design. Initially, all 72 men with PE received behavioural therapy. Twenty-three men were satisfied with treatment and excluded. The remaining 49 men graded their PE as 5.94 +/- 1.6 and IELT was 0.59 min and patients were randomised. Four men discontinued the study. Vardenafil improved PE grading: 2.7 +/- 2.1 (P < 0.01) and IELT increased to 5.01 +/- 3.69 (P < 0.001). PE grading improved 1.92 +/- 1.32, (P < 0.01) and IELT 3.12 +/- 1.89 (P < 0.001) with sertraline. It is concluded that vardenafil and sertraline are useful agents in the pharmacological treatment of PE.

A prospective randomised controlled trial of nutritional supplementation in malnourished elderly in the community: clinical and health economic outcomes.

PubMed

Edington, J; Barnes, R; Bryan, F; Dupree, E; Frost, G; Hickson, M; Lancaster, J; Mongia, S; Smith, J; Torrance, A; West, R; Pang, F; Coles, S J

2004-04-01

Malnutrition is common in sick elderly people on admission to hospital and in the community. We conducted a randomised controlled trial to determine if nutritional supplementation after discharge from hospital improved nutritional status and functional outcomes, or reduced health-care costs. Elderly malnourished subjects were randomised to 8 weeks of supplementation or no supplementation post discharge, and followed up for 24 weeks. Weight, body mass index, anthropometrics, handgrip strength, quality of life and requirements for health-care professionals' services and social services were measured throughout the study. Nutritional status improved significantly from baseline to week 24 in the intervention group (P<0.05), but not in the control group. There was no significant difference in nutritional status between groups at week 24. Handgrip strength improved significantly in the intervention group during supplementation, and was significantly different from that of the control group at week 8, but decreased thereafter. There was no significant difference in quality of life or health economic outcomes between groups at week 24. In already malnourished elderly subjects, it may be too late to expect to improve function or quality of life or to reduce health-care costs simply by providing nutritional supplements after hospitalisation. Prevention is key. All elderly patients should be nutritionally assessed as part of their routine care, and appropriate intervention initiated early.

Randomised trial of biofeedback training for encopresis.

PubMed Central

van der Plas, R N; Benninga, M A; Redekop, W K; Taminiau, J A; Büller, H A

1996-01-01

AIMS: To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. DESIGN: Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas, oral laxatives, and anorectal manometry. One group also received five biofeedback training sessions. MAIN OUTCOME MEASURES: Successful treatment was defined as less than two episodes of encopresis, regular bowel movements, and no laxatives. Psychosocial function after treatment was assessed using the Child Behaviour Checklist. RESULTS: Children given laxatives and biofeedback training had higher success rates than those who received laxatives alone (39% v 19%) at the end of the intervention period. At 12 and 18 months, however, approximately 50% of children in each group were successfully treated. Abnormal behaviour scores were initially observed in 35% of children. Most children had improved behaviour scores six months after treatment. Children with an initial abnormal behaviour score who were successfully treated had a significant improvement in their behavioural profiles. CONCLUSIONS: Biofeedback training had no additional effect on the success rate or behaviour scores. Psychosocial problems are present in a subgroup of children with encopresis. The relation between successful treatment and improvement in behavioural function supports the idea that encopresis has an aetiological role in the occurrence and maintenance of behavioural problems in children with encopresis. PMID:8957948

Metabolic manipulation in chronic heart failure: study protocol for a randomised controlled trial.

PubMed

Beadle, Roger M; Williams, Lynne K; Abozguia, Khaild; Patel, Kiran; Leon, Francisco Leyva; Yousef, Zaheer; Wagenmakers, Anton; Frenneaux, Michael P

2011-06-06

Heart failure is a major cause of morbidity and mortality in society. Current medical therapy centres on neurohormonal modulation with angiotensin converting enzyme inhibitors and β-blockers. There is growing evidence for the use of metabolic manipulating agents as adjunctive therapy in patients with heart failure. We aim to determine the effect of perhexiline on cardiac energetics and alterations in substrate utilisation in patients with non-ischaemic dilated cardiomyopathy. A multi-centre, prospective, randomised double-blind, placebo-controlled trial of 50 subjects with non-ischaemic dilated cardiomyopathy recruited from University Hospital Birmingham NHS Foundation Trust and Cardiff and Vale NHS Trust. Baseline investigations include magnetic resonance spectroscopy to assess cardiac energetic status, echocardiography to assess left ventricular function and assessment of symptomatic status. Subjects are then randomised to receive 200 mg perhexiline maleate or placebo daily for 4 weeks with serum drug level monitoring. All baseline investigations will be repeated at the end of the treatment period. A subgroup of patients will undergo invasive investigations with right and left heart catheterisation to calculate respiratory quotient, and mechanical efficiency. The primary endpoint is an improvement in the phosphocreatine to adenosine triphosphate ratio at 4 weeks. Secondary end points are: i) respiratory quotient; ii) mechanical efficiency; iii) change in left ventricular (LV) function. ClinicalTrials.gov: NCT00841139 ISRCTN: ISRCTN72887836.

Differences in health related quality of life in the randomised ARTSCAN study; accelerated vs. conventional radiotherapy for head and neck cancer. A five year follow up.

PubMed

Nyqvist, Johanna; Fransson, Per; Laurell, Göran; Hammerlid, Eva; Kjellén, Elisabeth; Franzén, Lars; Söderström, Karin; Wickart-Johansson, Gun; Friesland, Signe; Sjödin, Helena; Brun, Eva; Ask, Anders; Nilsson, Per; Ekberg, Lars; Björk-Eriksson, Thomas; Nyman, Jan; Lödén, Britta; Lewin, Freddi; Reizenstein, Johan; Lundin, Erik; Zackrisson, Björn

2016-02-01

Health related quality of life (HRQoL) was assessed in the randomised, prospective ARTSCAN study comparing conventional radiotherapy (CF) with accelerated radiotherapy (AF) for head and neck cancer. 750 patients with squamous cell carcinoma (of any grade and stage) in the oral cavity, oro-, or hypopharynx or larynx (except T1-2, N0 glottic carcinoma) without distant metastases were randomised to either conventional fractionation (2 Gy/day, 5 days/week in 49 days, total dose 68 Gy) or accelerated fractionation (1.1+2.0 Gy/day, 5 days/week in 35 days, total dose 68 Gy). HRQoL was assessed with EORTC QLQ-C30, QLQ-H&N35 and HADS at baseline, at end of radiotherapy (eRT) and at 3 and 6 months and 1, 2 and 5 years after start of treatment. The AF group reported HRQoL was significantly lower at eRT and at 3 months for most symptoms, scales and functions. Few significant differences were noted between the groups at 6 months and 5 years. Scores related to functional oral intake never reached baseline. In comparison to CF, AF has a stronger adverse effect on HRQoL in the acute phase. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Cost analysis of the Dutch obstetric system: low-risk nulliparous women preferring home or short-stay hospital birth--a prospective non-randomised controlled study.

PubMed

Hendrix, Marijke Jc; Evers, Silvia Maa; Basten, Marloes Cm; Nijhuis, Jan G; Severens, Johan L

2009-11-19

In the Netherlands, pregnant women without medical complications can decide where they want to give birth, at home or in a short-stay hospital setting with a midwife. However, a decrease in the home birth rate during the last decennium may have raised the societal costs of giving birth. The objective of this study is to compare the societal costs of home births with those of births in a short-stay hospital setting. This study is a cost analysis based on the findings of a multicenter prospective non-randomised study comparing two groups of nulliparous women with different preferences for where to give birth, at home or in a short-stay hospital setting. Data were collected using cost diaries, questionnaires and birth registration forms. Analysis of the data is divided into a base case analysis and a sensitivity analysis. In the group of home births, the total societal costs associated with giving birth at home were euro3,695 (per birth), compared with euro3,950 per birth in the group for short-stay hospital births. Statistically significant differences between both groups were found regarding the following cost categories 'Cost of contacts with health care professionals during delivery' (euro138.38 vs. euro87.94, -50 (2.5-97.5 percentile range (PR)-76;-25), p < 0.05), 'cost of maternity care at home' (euro1,551.69 vs. euro1,240.69, -311 (PR -485; -150), p < 0.05) and 'cost of hospitalisation mother' (euro707.77 vs. 959.06, 251 (PR 69;433), p < 0.05). The highest costs are for hospitalisation (41% of all costs). Because there is a relatively high amount of (partly) missing data, a sensitivity analysis was performed, in which all missing data were included in the analysis by means of general mean substitution. In the sensitivity analysis, the total costs associated with home birth are euro4,364 per birth, and euro4,541 per birth for short-stay hospital births. The total costs associated with pregnancy, delivery, and postpartum care are comparable for home birth and short-stay hospital birth. The most important differences in costs between the home birth group and the short-stay hospital birth group are associated with maternity care assistance, hospitalisation, and travelling costs.

Cost Analysis of the Dutch Obstetric System: low-risk nulliparous women preferring home or short-stay hospital birth - a prospective non-randomised controlled study

PubMed Central

2009-01-01

Background In the Netherlands, pregnant women without medical complications can decide where they want to give birth, at home or in a short-stay hospital setting with a midwife. However, a decrease in the home birth rate during the last decennium may have raised the societal costs of giving birth. The objective of this study is to compare the societal costs of home births with those of births in a short-stay hospital setting. Methods This study is a cost analysis based on the findings of a multicenter prospective non-randomised study comparing two groups of nulliparous women with different preferences for where to give birth, at home or in a short-stay hospital setting. Data were collected using cost diaries, questionnaires and birth registration forms. Analysis of the data is divided into a base case analysis and a sensitivity analysis. Results In the group of home births, the total societal costs associated with giving birth at home were €3,695 (per birth), compared with €3,950 per birth in the group for short-stay hospital births. Statistically significant differences between both groups were found regarding the following cost categories 'Cost of contacts with health care professionals during delivery' (€138.38 vs. €87.94, -50 (2.5-97.5 percentile range (PR)-76;-25), p < 0.05), 'cost of maternity care at home' (€1,551.69 vs. €1,240.69, -311 (PR -485; -150), p < 0.05) and 'cost of hospitalisation mother' (€707.77 vs. 959.06, 251 (PR 69;433), p < 0.05). The highest costs are for hospitalisation (41% of all costs). Because there is a relatively high amount of (partly) missing data, a sensitivity analysis was performed, in which all missing data were included in the analysis by means of general mean substitution. In the sensitivity analysis, the total costs associated with home birth are €4,364 per birth, and €4,541 per birth for short-stay hospital births. Conclusion The total costs associated with pregnancy, delivery, and postpartum care are comparable for home birth and short-stay hospital birth. The most important differences in costs between the home birth group and the short-stay hospital birth group are associated with maternity care assistance, hospitalisation, and travelling costs. PMID:19925673

A Pilot Randomised Controlled Trial of a School-Based Resilience Intervention to Prevent Depressive Symptoms for Young Adolescents with Autism Spectrum Disorder: A Mixed Methods Analysis

ERIC Educational Resources Information Center

Mackay, Bethany A.; Shochet, Ian M.; Orr, Jayne A.

2017-01-01

Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in…

Edoxaban versus enoxaparin-warfarin in patients undergoing cardioversion of atrial fibrillation (ENSURE-AF): a randomised, open-label, phase 3b trial.

PubMed

Goette, Andreas; Merino, Jose L; Ezekowitz, Michael D; Zamoryakhin, Dmitry; Melino, Michael; Jin, James; Mercuri, Michele F; Grosso, Michael A; Fernandez, Victor; Al-Saady, Naab; Pelekh, Natalya; Merkely, Bela; Zenin, Sergey; Kushnir, Mykola; Spinar, Jindrich; Batushkin, Valeriy; de Groot, Joris R; Lip, Gregory Y H

2016-10-22

Edoxaban, an oral factor Xa inhibitor, is non-inferior for prevention of stroke and systemic embolism in patients with atrial fibrillation and is associated with less bleeding than well controlled warfarin therapy. Few safety data about edoxaban in patients undergoing electrical cardioversion are available. We did a multicentre, prospective, randomised, open-label, blinded-endpoint evaluation trial in 19 countries with 239 sites comparing edoxaban 60 mg per day with enoxaparin-warfarin in patients undergoing electrical cardioversion of non-valvular atrial fibrillation. The dose of edoxaban was reduced to 30 mg per day if one or more factors (creatinine clearance 15-50 mL/min, low bodyweight [≤60 kg], or concomitant use of P-glycoprotein inhibitors) were present. Block randomisation (block size four)-stratified by cardioversion approach (transoesophageal echocardiography [TEE] or not), anticoagulant experience, selected edoxaban dose, and region-was done through a voice-web system. The primary efficacy endpoint was a composite of stroke, systemic embolic event, myocardial infarction, and cardiovascular mortality, analysed by intention to treat. The primary safety endpoint was major and clinically relevant non-major (CRNM) bleeding in patients who received at least one dose of study drug. Follow-up was 28 days on study drug after cardioversion plus 30 days to assess safety. This trial is registered with ClinicalTrials.gov, number NCT02072434. Between March 25, 2014, and Oct 28, 2015, 2199 patients were enrolled and randomly assigned to receive edoxaban (n=1095) or enoxaparin-warfarin (n=1104). The mean age was 64 years (SD 10·54) and mean CHA 2 DS 2 -VASc score was 2·6 (SD 1·4). Mean time in therapeutic range on warfarin was 70·8% (SD 27·4). The primary efficacy endpoint occurred in five (<1%) patients in the edoxaban group versus 11 (1%) in the enoxaparin-warfarin group (odds ratio [OR] 0·46, 95% CI 0·12-1·43). The primary safety endpoint occurred in 16 (1%) of 1067 patients given edoxaban versus 11 (1%) of 1082 patients given enoxaparin-warfarin (OR 1·48, 95% CI 0·64-3·55). The results were independent of the TEE-guided strategy and anticoagulation status. ENSURE-AF is the largest prospective randomised clinical trial of anticoagulation for cardioversion of patients with non-valvular atrial fibrillation. Rates of major and CRNM bleeding and thromboembolism were low in the two treatment groups. Daiichi Sankyo provided financial support for the study. Copyright © 2016 Elsevier Ltd. All rights reserved.

Quality assurance audit: a prospective non-randomised trial of chemotherapy and radiotherapy for osteolymphoma (TROG 99.04/ALLG LY02).

PubMed

Christie, D; Le, T; Watling, K; Cornes, D; O'Brien, P; Hitchins, R

2009-04-01

A quality assurance (QA) audit of the Trans Tasman Radiation Oncology Group and Australasian Lymphoma and Leukaemia Group trial (TROG 99.04/ALLG LY02) began after accrual of 25 patients. The trial is a prospective non-randomized study of standard treatment for osteolymphoma. Data relating to informed consent, eligibility, chemotherapy and radiotherapy were reviewed. The audit showed a relatively low level of major variations from the protocol, with an overall rate of 3.6%. As this trial has accrued slowly over a long period, the concept of QA has also developed. Amendments were made to the protocol accordingly. In the future, QA procedures should be predetermined, conducted rapidly in real time, and appropriately funded in order to be relevant to the ongoing conduct of the trial.

Design and application of nickel-titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial.

PubMed

Chen, Xiao; Liu, Peng; Zhu, Xiaofei; Cao, Liehu; Zhang, Chuncai; Su, Jiacan

2013-06-01

We carried out this study to test the efficacy of the olecranon memory connector (OMC) in olecranon fractures. We designed a prospective randomised controlled trial involving 40 cases of olecranon fractures. From May 2004 to December 2009, 40 patients with olecranon fractures were randomly assigned into two groups. Twenty patients were treated with OMC, while another 20 patients were fixed with locking plates in our hospital. The DASH score, MEP score, range of motion and radiographs were used to evaluate the postoperative elbow function and complications. For MEP score, OMC was better than the locking plate; for DASH score, complication rate, and range of elbow motion, the two methods presented no significant difference. The study showed that OMC could be an effective alternative to treat olecranon fractures.

Prevalence and reporting of recruitment, randomisation and treatment errors in clinical trials: A systematic review.

PubMed

Yelland, Lisa N; Kahan, Brennan C; Dent, Elsa; Lee, Katherine J; Voysey, Merryn; Forbes, Andrew B; Cook, Jonathan A

2018-06-01

Background/aims In clinical trials, it is not unusual for errors to occur during the process of recruiting, randomising and providing treatment to participants. For example, an ineligible participant may inadvertently be randomised, a participant may be randomised in the incorrect stratum, a participant may be randomised multiple times when only a single randomisation is permitted or the incorrect treatment may inadvertently be issued to a participant at randomisation. Such errors have the potential to introduce bias into treatment effect estimates and affect the validity of the trial, yet there is little motivation for researchers to report these errors and it is unclear how often they occur. The aim of this study is to assess the prevalence of recruitment, randomisation and treatment errors and review current approaches for reporting these errors in trials published in leading medical journals. Methods We conducted a systematic review of individually randomised, phase III, randomised controlled trials published in New England Journal of Medicine, Lancet, Journal of the American Medical Association, Annals of Internal Medicine and British Medical Journal from January to March 2015. The number and type of recruitment, randomisation and treatment errors that were reported and how they were handled were recorded. The corresponding authors were contacted for a random sample of trials included in the review and asked to provide details on unreported errors that occurred during their trial. Results We identified 241 potentially eligible articles, of which 82 met the inclusion criteria and were included in the review. These trials involved a median of 24 centres and 650 participants, and 87% involved two treatment arms. Recruitment, randomisation or treatment errors were reported in 32 in 82 trials (39%) that had a median of eight errors. The most commonly reported error was ineligible participants inadvertently being randomised. No mention of recruitment, randomisation or treatment errors was found in the remaining 50 of 82 trials (61%). Based on responses from 9 of the 15 corresponding authors who were contacted regarding recruitment, randomisation and treatment errors, between 1% and 100% of the errors that occurred in their trials were reported in the trial publications. Conclusion Recruitment, randomisation and treatment errors are common in individually randomised, phase III trials published in leading medical journals, but reporting practices are inadequate and reporting standards are needed. We recommend researchers report all such errors that occurred during the trial and describe how they were handled in trial publications to improve transparency in reporting of clinical trials.

Clinical results of computerized tomography-based simulation with laser patient marking.

PubMed

Ragan, D P; Forman, J D; He, T; Mesina, C F

1996-02-01

Accuracy of a patient treatment portal marking device and computerized tomography (CT) simulation have been clinically tested. A CT-based simulator has been assembled based on a commercial CT scanner. This includes visualization software and a computer-controlled laser drawing device. This laser drawing device is used to transfer the setup, central axis, and/or radiation portals from the CT simulator to the patient for appropriate patient skin marking. A protocol for clinical testing is reported. Twenty-five prospectively, sequentially accessioned patients have been analyzed. The simulation process can be completed in an average time of 62 min. Under many cases, the treatment portals can be designed and the patient marked in one session. Mechanical accuracy of the system was found to be within +/- 1mm. The portal projection accuracy in clinical cases is observed to be better than +/- 1.2 mm. Operating costs are equivalent to the conventional simulation process it replaces. Computed tomography simulation is a clinical accurate substitute for conventional simulation when used with an appropriate patient marking system and digitally reconstructed radiographs. Personnel time spent in CT simulation is equivalent to time in conventional simulation.

The effectiveness of crisis resource management and team debriefing in resuscitation education of nursing students: A randomised controlled trial.

PubMed

Coppens, Imgard; Verhaeghe, Sofie; Van Hecke, Ann; Beeckman, Dimitri

2018-01-01

The aim of this study was to investigate (i) whether integrating a course on crisis resource management principles and team debriefings in simulation training, increases self-efficacy, team efficacy and technical skills of nursing students in resuscitation settings and (ii) which phases contribute the most to these outcomes. Crisis resource management principles have been introduced in health care to optimise teamwork. Simulation training offers patient safe training opportunities. There is evidence that simulation training increases self-efficacy and team efficacy but the contribution of the different phases like crisis resource management principles, simulation training and debriefing on self-efficacy, team efficacy and technical skills is not clear. Randomised controlled trial in a convenience sample (n = 116) in Belgium. Data were collected between February 2015-April 2015. Participants in the intervention group (n = 60) completed a course on crisis resource management principles, followed by a simulation training session, a team debriefing and a second simulation training session. Participants in the control group (n = 56) only completed two simulation training sessions. The outcomes self-efficacy, team efficacy and technical skills were assessed after each simulation training. An ancillary analysis of the learning effect was conducted. The intervention group increased on self-efficacy (2.13%, p = .02) and team efficacy (9.92%, p < .001); the control group only increased significantly on team efficacy (4.5%, p = .001). The intervention group scored significantly higher on team efficacy (8.49%, p < .001) compared to the control group. Combining crisis resource management principles and team debriefings in simulation training increases self-efficacy and team efficacy. The debriefing phase contributes the most to these effects. By partnering with healthcare settings, it becomes possible to offer interdisciplinary simulation training that can increase patient safety. © 2017 John Wiley & Sons Ltd.

Feasibility of high-intensity interval training and moderate-intensity continuous training in adults with inactive or mildly active Crohn's disease: study protocol for a randomised controlled trial.

PubMed

Tew, Garry A; Carpenter, Roger; Seed, Michael; Anderson, Simon; Langmead, Louise; Fairhurst, Caroline; Bottoms, Lindsay

2017-01-01

Structured exercise training has been proposed as a useful adjunctive therapy for Crohn's disease by improving immune function and psychological health, reducing fatigue and promoting gains in muscle and bone strength. However, the evidence for exercise in Crohn's disease is sparse, with only a handful of small prospective trials [1, 2], with methodological limitations, including the use of non-randomised and non-controlled study designs and small sample sizes. Here, we describe the protocol for a study that aims to assess the feasibility and acceptability of two common types of exercise training-high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT)-in adults with inactive or mildly active Crohn's disease (CD). This is a randomised, controlled, assessor-blinded, feasibility trial with three parallel groups. Forty-five adults with inactive or mildly active Crohn's disease will be randomly assigned 1:1:1 to HIIT, MICT or usual care control. Participants in the HIIT and MICT groups will be invited to undertake three sessions of supervised exercise each week for 12 consecutive weeks. HIIT sessions will consist of ten 1-min intervals of cycling exercise at 90% of peak power output separated by 1 min of active recovery. MICT sessions will involve 30 min of continuous cycling at 35% of peak power output. Participants will be assessed before randomisation and 13 and 26 weeks after randomisation. Feasibility outcomes include rates of recruitment, retention and adherence. Interviews with participants will explore the acceptability of the exercise programmes and study procedures. Clinical/health outcomes include cardiorespiratory fitness, body mass index, resting blood pressure, markers of disease activity (faecal calprotectin and Crohn's Disease Activity Index) and activated T cell cytokine profiles. Study questionnaires include the Inflammatory Bowel Disease Quality of Life Questionnaire, EQ-5D-5L, IBD Fatigue Scale, Hospital and Anxiety Depression Scale, and International Physical Activity Questionnaire. This study will provide useful information on the feasibility and acceptability of supervised exercise training in adults with inactive and mildly active Crohn's disease and will inform the design of a subsequent, adequately powered, multi-centre trial. The trial is registered with the International Standard Randomised Controlled Trial Register (ISRCTN13021107). Date registration assigned was 02/12/2015.

Clinical- and cost-effectiveness of the STAR care pathway compared to usual care for patients with chronic pain after total knee replacement: study protocol for a UK randomised controlled trial.

PubMed

Wylde, Vikki; Bertram, Wendy; Beswick, Andrew D; Blom, Ashley W; Bruce, Julie; Burston, Amanda; Dennis, Jane; Garfield, Kirsty; Howells, Nicholas; Lane, Athene; McCabe, Candy; Moore, Andrew J; Noble, Sian; Peters, Tim J; Price, Andrew; Sanderson, Emily; Toms, Andrew D; Walsh, David A; White, Simon; Gooberman-Hill, Rachael

2018-02-21

Approximately 20% of patients experience chronic pain after total knee replacement. There is little evidence for effective interventions for the management of this pain, and current healthcare provision is patchy and inconsistent. Given the complexity of this condition, multimodal and individualised interventions matched to pain characteristics are needed. We have undertaken a comprehensive programme of work to develop a care pathway for patients with chronic pain after total knee replacement. This protocol describes the design of a randomised controlled trial to evaluate the clinical- and cost-effectiveness of a complex intervention care pathway compared with usual care. This is a pragmatic two-armed, open, multi-centred randomised controlled trial conducted within secondary care in the UK. Patients will be screened at 2 months after total knee replacement and 381 patients with chronic pain at 3 months postoperatively will be recruited. Recruitment processes will be optimised through qualitative research during a 6-month internal pilot phase. Patients are randomised using a 2:1 intervention:control allocation ratio. All participants receive usual care as provided by their hospital. The intervention comprises an assessment clinic appointment at 3 months postoperatively with an Extended Scope Practitioner and up to six telephone follow-up calls over 12 months. In the assessment clinic, a standardised protocol is followed to identify potential underlying causes for the chronic pain and enable appropriate onward referrals to existing services for targeted and individualised treatment. Outcomes are assessed by questionnaires at 6 and 12 months after randomisation. The co-primary outcomes are pain severity and pain interference assessed using the Brief Pain Inventory at 12 months after randomisation. Secondary outcomes relate to resource use, function, neuropathic pain, mental well-being, use of pain medications, satisfaction with pain relief, pain frequency, capability, health-related quality of life and bodily pain. After trial completion, up to 30 patients in the intervention group will be interviewed about their experiences of the care pathway. If shown to be clinically and cost-effective, this care pathway intervention could improve the management of chronic pain after total knee replacement. ISRCTN registry ( ISRCTN92545361 ), prospectively registered on 30 August 2016.

Pain Management after Laparoscopic Cholecystectomy-A Randomized Prospective Trial of Low Pressure and Standard Pressure Pneumoperitoneum

PubMed Central

Singla, Sanjeev; Mittal, Geeta; Raghav; Mittal, Rajinder K

2014-01-01

Background: Abdominal pain and shoulder tip pain after laparoscopic cholecystectomy are distressing for the patient. Various causes of this pain are peritoneal stretching and diaphragmatic irritation by high intra-abdominal pressure caused by pneumoperitoneum . We designed a study to compare the post operative pain after laparoscopic cholecystectomy at low pressure (7-8 mm of Hg) and standard pressure technique (12-14 mm of Hg). Aim : To compare the effect of low pressure and standard pressure pneumoperitoneum in post laparoscopic cholecystectomy pain . Further to study the safety of low pressure pneumoperitoneum in laparoscopic cholecystectomy. Settings and Design: A prospective randomised double blind study. Materials and Methods: A prospective randomised double blind study was done in 100 ASA grade I & II patients. They were divided into two groups -50 each. Group A patients underwent laparoscopic cholecystectomy with low pressure pneumoperitoneum (7-8 mm Hg) while group B underwent laparoscopic cholecystectomy with standard pressure pneumoperitoneum (12-13 mm Hg). Both the groups were compared for pain intensity, analgesic requirement and complications. Statistical Analysis: Demographic data and intraoperative complications were analysed using chi-square test. Frequency of pain, intensity of pain and analgesics consumption was compared by applying ANOVA test. Results: Post-operative pain score was significantly less in low pressure group as compared to standard pressure group. Number of patients requiring rescue analgesic doses was more in standard pressure group . This was statistically significant. Also total analgesic consumption was more in standard pressure group. There was no difference in intraoperative complications. Conclusion: This study demonstrates the use of simple expedient of reducing the pressure of pneumoperitoneum to 8 mm results in reduction in both intensity and frequency of post-operative pain and hence early recovery and better outcome.This study also shows that low pressure technique is safe with comparable rate of intraoperative complications. PMID:24701492

Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

PubMed

Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

2004-10-01

The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

Comparison of the Eder-Puestow and Celestin techniques for dilating benign oesophageal strictures.

PubMed

Hine, K R; Hawkey, C J; Atkinson, M; Holmes, G K

1984-10-01

The Celestin and Eder-Puestow methods of dilating benign oesophageal strictures have been compared prospectively in a randomised trial. One hundred and thirty three dilatations were performed on 72 patients. There was no significant difference between the two techniques with regard to the long term relief of symptoms. Celestin dilatation was quicker, less likely to cause pharyngeal trauma, and less damaging to guide wires. It could not be used, however, in those patients in whom only a short length of guide wire could be passed through the stricture.

Comparison of the Eder-Puestow and Celestin techniques for dilating benign oesophageal strictures.

PubMed Central

Hine, K R; Hawkey, C J; Atkinson, M; Holmes, G K

1984-01-01

The Celestin and Eder-Puestow methods of dilating benign oesophageal strictures have been compared prospectively in a randomised trial. One hundred and thirty three dilatations were performed on 72 patients. There was no significant difference between the two techniques with regard to the long term relief of symptoms. Celestin dilatation was quicker, less likely to cause pharyngeal trauma, and less damaging to guide wires. It could not be used, however, in those patients in whom only a short length of guide wire could be passed through the stricture. PMID:6479685

Representing the work of medical protocols for organizational simulation.

PubMed Central

Fridsma, D. B.

1998-01-01

Developing and implementing patient care protocols within a specific organizational setting requires knowledge of the protocol, the organization, and the way in which the organization does its work. Computer-based simulation tools have been used in many industries to provide managers with prospective insight into problems of work process and organization design mismatch. Many of these simulation tools are designed for well-understood routine work processes in which there are few contingent tasks. In this paper, we describe theoretic that make it possible to simulate medical protocols using an information-processing theory framework. These simulations will allow medical administrators to test different protocol and organizational designs before actually using them within a particular clinical setting. PMID:9929231

A prospective, randomised, controlled, multi-centre comparative effectiveness study of healing using dehydrated human amnion/chorion membrane allograft, bioengineered skin substitute or standard of care for treatment of chronic lower extremity diabetic ulcers.

PubMed

Zelen, Charles M; Gould, Lisa; Serena, Thomas E; Carter, Marissa J; Keller, Jennifer; Li, William W

2015-12-01

A prospective, randomised, controlled, parallel group, multi-centre clinical trial was conducted at three sites to compare the healing effectiveness of treatment of chronic lower extremity diabetic ulcers with either weekly applications of Apligraf(®) (Organogenesis, Inc., Canton, MA), EpiFix(®) (MiMedx Group, Inc., Marietta, GA), or standard wound care with collagen-alginate dressing. The primary study outcome was the percent change in complete wound healing after 4 and 6 weeks of treatment. Secondary outcomes included percent change in wound area per week, velocity of wound closure and a calculation of the amount and cost of Apligraf or EpiFix used. A total of 65 subjects entered the 2-week run-in period and 60 were randomised (20 per group). The proportion of patients in the EpiFix group achieving complete wound closure within 4 and 6 weeks was 85% and 95%, significantly higher (all adjusted P-values ≤ 0·003) than for patients receiving Apligraf (35% and 45%), or standard care (30% and 35%). After 1 week, wounds treated with EpiFix had reduced in area by 83·5% compared with 53·1% for wounds treated with Apligraf. Median time to healing was significantly faster (all adjusted P-values ≤0·001) with EpiFix (13 days) compared to Apligraf (49 days) or standard care (49 days). The mean number of grafts used and the graft cost per patient were lower in the EpiFix group campared to the Apligraf group, at 2·15 grafts at a cost of $1669 versus 6·2 grafts at a cost of $9216, respectively. The results of this study demonstrate the clinical and resource utilisation superiority of EpiFix compared to Apligraf or standard of care, for the treatment of diabetic ulcers of the lower extremities. © 2014 The Authors. International Wound Journal published by Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial.

PubMed

Cui, Ling; Shi, Yu; Zhang, G N

2016-12-15

Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery). This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean ± standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score. The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery. NCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

Supporting clinical rules engine in the adjustment of medication (SCREAM): protocol of a multicentre, prospective, randomised study.

PubMed

Mestres Gonzalvo, Carlota; de Wit, Hugo A J M; van Oijen, Brigit P C; Hurkens, Kim P G M; Janknegt, Rob; Schols, Jos M G A; Mulder, Wubbo J; Verhey, Frans R; Winkens, Bjorn; van der Kuy, Paul-Hugo M

2017-01-26

In the nursing home population, it is estimated that 1 in every 3 patients is polymedicated and given their considerable frailty, these patients are especially prone to adverse drug reactions. Clinical pharmacist-led medication reviews are considered successful interventions to improve medication safety in the inpatient setting. Due to the limited available evidence concerning the benefits of medication reviews performed in the nursing home setting, we propose a study aiming to demonstrate a positive effect that a clinical decision support system, as a health care intervention, may have on the target population. The primary objective of this study is to reduce the number of patients with at least one event when using the clinical decision support system compared to the regular care. These events consist of hospital referrals, delirium, falls, and/or deaths. This study is a multicentre, prospective, randomised study with a cluster group design. The randomisation will be per main nursing home physician and stratified per ward (somatic and psychogeriatric). In the intervention group the clinical decision support system will be used to screen medication list, laboratory values and medical history in order to obtain potential clinical relevant remarks. The remarks will be sent to the main physician and feedback will be provided whether the advice was followed or not. In the control group regular care will be applied. We strongly believe that by using a clinical decision support system, medication reviews are performed in a standardised way which leads to comparable results between patients. In addition, using a clinical decision support system eliminates the time factor to perform medication reviews as the major problems related to medication, laboratory values, indications and/or established patient characteristics will be directly available. In this way, and in order to make the medication review process complete, consultation within healthcare professionals and/or the patient itself will be time effective and the medication surveillance could be performed around the clock. The Netherlands National Trial Register NTR5165 . Registered 2nd April 2015.

A single-arm trial indirect comparison investigation: a proof-of-concept method to predict venous leg ulcer healing time for a new acellular synthetic matrix matched to standard care control.

PubMed

Shannon, Ronald; Nelson, Andrea

2017-08-01

To compare data on time to healing from two separate cohorts: one treated with a new acellular synthetic matrix plus standard care (SC) and one matched from four large UK pragmatic, randomised controlled trials [venous leg ulcer (VLU) evidence network]. We introduce a new proof-of-concept strategy to a VLU clinical evidence network, propensity score matching and sensitivity analysis to predict the feasibility of the new acellular synthetic matrix plus SC for success in future randomised, controlled clinical trials. Prospective data on chronic VLUs from a safety and effectiveness study on an acellular synthetic matrix conducted in one wound centre in the UK (17 patients) and three wound centres in Australia (36 patients) were compared retrospectively to propensity score-matched data from patients with comparable leg ulcer disease aetiology, age, baseline ulcer area, ulcer duration, multi-layer compression bandaging and majority of care completed in specialist wound centres (average of 1 visit per week), with the outcome measures at comparable follow-up periods from patients enrolled in four prospective, multicentre, pragmatic, randomised studies of venous ulcers in the UK (the comparison group; VLU evidence network). Analysis using Kaplan-Meier survival curves showed a mean healing time of 73·1 days for ASM plus SC (ASM) treated ulcers in comparison with 83·5 days for comparison group ulcers treated with SC alone (Log rank test, χ 2 5·779, P = 0·016) within 12 weeks. Sensitivity analysis indicates that an unobserved covariate would have to change the odds of healing for SC by a factor of 1·1 to impact the baseline results. Results from this study predict a significant effect on healing time when using a new ASM as an adjunct to SC in the treatment of non-healing venous ulcers in the UK, but results are sensitive to unobserved covariates that may be important in healing time comparison. © 2016 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

Better early functional outcome after short stem total hip arthroplasty? A prospective blinded randomised controlled multicentre trial comparing the Collum Femoris Preserving stem with a Zweymuller straight cementless stem total hip replacement for the treatment of primary osteoarthritis of the hip

PubMed Central

van Oldenrijk, Jakob; Scholtes, Vanessa A B; van Beers, Loes W A H; Geerdink, Carel H; Niers, Bob B A M; Runne, Wouter; Bhandari, Mohit; Poolman, Rudolf W

2017-01-01

Objectives Primary aim was to compare the functional results at 3 months and 2 years between short and conventional cementless stem total hip arthroplasty (THA). Secondary aim was to determine the feasibility of a double-blind implant-related trial. Design A prospective blinded randomised controlled multicentre trial in patients with osteoarthritis of the hip. All patients, research assistants, clinical assessors, investigators and data analysts were blinded to the type of prosthesis. Population: 150 patients between 18 and 70 years with osteoarthritis of the hip, 75 in the short stem and 75 in the conventional stem group. Mean age: 60 years (SD 7). Interventions: the Collum Femoris Preserving short stem versus the Zweymuller Alloclassic conventional stem. Main outcome measures The Dutch version of the Hip Disability and Osteoarthritis Outcome Score (HOOS). Secondary outcomes measures: Harris Hip Score, the Physical Component Scale of the SF12, the Timed Up and Go test, Pain and the EQ-5D. Feasibility outcomes: continued blinding, protocol adherence and follow-up success rate. Results No significant difference between the two groups. Mean HOOS total score in the short stem group increased 32.7 points from 36.6 (95% CI 32.9 to 40.2) preoperatively to 69.3 (95% CI 66.4 to 72.1) at 3 months follow-up. Mean HOOS total score in the conventional straight stem group increased 36.3 points from 37.1 (95% CI 33.9 to 40.3) preoperatively to 73.4 (95% CI 70.3 to 76.4) at 3 months follow-up. 91.2% of patients remained blinded at 2 years follow-up. Both protocol adherence and follow-up success rate were 98%. Conclusions Functional result at 3 months and 2 years after short stem THA is not superior to conventional cementless THA. There were more perioperative and postoperative complications in the short stem group. Direct comparison of two hip implants in a double-blinded randomised controlled trial is feasible. Trial registration number NTR1560. PMID:29042371

Placebo versus low-dose ketamine infusion in addition to remifentanil target-controlled infusion for conscious sedation during oocyte retrieval: A prospective, double-blinded, randomised controlled trial.

PubMed

Morue, Hélène I; Raj-Lawrence, Shalini; Saxena, Sarah; Delbaere, Anne; Engelman, Edgard; Barvais, Luc A

2018-04-30

Currently, there is no gold standard for monitored anaesthesia care during oocyte retrieval. In our institution, the standard is a conscious sedation technique using a target-controlled infusion (TCI) of remifentanil, titrated to maintain a visual analogue pain score less than 30 mm. This protocol is well accepted by patients but is associated with frequent episodes of respiratory depression. The main objective of this study was to evaluate whether the addition of a continuous intravenous infusion of ketamine could reduce these episodes. Controlled, randomised, prospective, double-blinded study. The current study was conducted in a tertiary-level hospital in Brussels (Belgium) from December 2013 to June 2014. Of the 132 women undergoing oocyte retrieval included, 121 completed the study. After randomisation, patients received either a ketamine infusion (40 μg kg min over 5 min followed by 2.5 μg kg min) or a 0.9% saline infusion in addition to the variable remifentanil TCI. The primary outcome was the number of respiratory depression episodes. Effect site target remifentanil concentrations, side effects, pain score, patient satisfaction and incidence of pregnancy were also recorded. No significant difference in the incidence of respiratory events was noted (pulse oximetry oxygen saturation < 95% was 49% in the ketamine group and 63% in the control group; P = 0.121). No patient required ventilatory support. In the ketamine group, visual analogue pain score and remifentanil concentrations were significantly reduced, but the latter remained above 2 ng ml. Postoperative nausea was less frequent in the ketamine group, 4 versus 15% (P = 0.038). The addition of ketamine did not influence length of stay nor patient satisfaction. The addition of low plasma levels of ketamine to a TCI remifentanil conscious sedation technique did not decrease the incidence nor the severity of respiratory depression. Continuous monitoring of capnography and oxygen saturation is always required. EUDRACT number 2013-003040-23.

Dietary sodium intake and overweight and obesity in children and adults: a protocol for a systematic review and meta-analysis.

PubMed

Grimes, Carley A; Bolhuis, Dieuwerke P; He, Feng J; Nowson, Caryl A

2016-01-18

Overweight and obesity in children and adults is a major public health concern. Emerging evidence suggests dietary sodium intake may be associated with obesity. This systematic review and meta-analysis will aim to (i) assess the relation between dietary sodium intake and measures of adiposity in children and adults and (ii) examine the relation between sodium intake and sugar-sweetened beverage (SSB) consumption, which is a known risk factor for obesity. An electronic search will be conducted using Medline Complete, CINAHL, Scopus, Embase and Cochrane central register of controlled trials (CENTRAL). The search strategy will identify published peer-reviewed articles that report on dietary sodium and either a marker of adiposity or SSB consumption. Only human studies (ages >1 year) in English will be included, and no limits will be placed on publication date. No restrictions will be placed on the method of sodium intake assessment. Cross-sectional, prospective studies, and randomised controlled trials with a duration of ≥ 3 months will be included. Studies with participants with renal disease, cancer, type 1 diabetes or heart failure or who are pregnant will be excluded. To assess the quality of studies, the Cochrane's Collaboration tool for assessing risk of bias in randomised trials will be used for randomised controlled trials (RCTs), and the modified Newcastle-Ottawa Scale will be used for cross-sectional and prospective studies. Meta-analysis will be used to assess the relation of sodium intake with two primary outcomes: (i) BMI and body weight in adults and BMI z-score in children and (ii) weight category (i.e. healthy weight vs. overweight/obese). For any outcomes in which meta-analysis is not possible, we will present data as a systematic review. Findings will be grouped and reported separately for children and adolescents (ages 1-17 years) and adults (ages >18 years). This review and meta-analysis will provide insight into the relation between dietary sodium intake and overweight and obesity. This information can be used to inform public health policies which target population sodium consumption. Prospero CRD42015016440.

Preventing musculoskeletal injuries among recreational adult volleyball players: design of a randomised prospective controlled trial.

PubMed

Gouttebarge, Vincent; Zwerver, Johannes; Verhagen, Evert

2017-08-02

Both acute and overuse injuries are common among recreational volleyball players, especially finger/wrist, ankle, shoulder and knee injuries. Consequently, an intervention ('VolleyVeilig') was developed to prevent or reduce the occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational volleyball players. This article describes the design of a study evaluating the effectiveness of the developed intervention on the one-season occurrence of finger/wrist, shoulder, knee and ankle injuries among recreational adult volleyball players. A randomized prospective controlled trial with a follow-up period of one volleyball season will be conducted. Participants will be healthy recreational adult volleyball players (18 years of age or older) practicing volleyball (training and/or match) at least twice a week. The intervention ('VolleyVeilig') consists of a warm-up program based on more than 50 distinct exercises (with different variations and levels). The effect of the intervention programme on the occurrence of injuries will be compared to volleyball as usual. Outcome measures will be incidence of acute injury (expressed as number of injuries per 1000 h of play) and prevalence of overuse injuries (expressed as percentage). This study will be one of the first randomized prospective controlled trials evaluating the effectiveness of an intervention on the occurrence of both acute and overuse injuries among recreational adult volleyball players. Outcome of this study could possibly lead to the nationwide implementation of the intervention in all volleyball clubs in The Netherlands, ultimately resulting in less injuries. Dutch Trial Registration NTR6202 , registered February 1st 2017. Version 3, February 2017.

Simulating the impact of case-mix adjusted hospice rates

PubMed Central

Mor, Vincent; Laliberte, Linda

1986-01-01

The Medicare hospice benefit prospectively reimburses hospices based on the inpatient status of the patient, whether or not the patient is at home, and whether the patient is receiving round-the-clock nursing. Using National Hospice Study data, two case-mix adjusters based on patient functioning and living arrangement were found to be significantly related to per diem cost. These were tested by simulating their impact on hospice revenues. Increasing per diem reimbursements 35 percent for nonambulatory patients living alone only increases hospice revenues by 4 percent; hospices with sicker patients benefit the most. PMID:10312012

High power laser therapy treatment compared to simple segmental physical rehabilitation in whiplash injuries (1° and 2° grade of the Quebec Task Force classification) involving muscles and ligaments

PubMed Central

Conforti, Maria; Fachinetti, Giorgio Paolo

2013-01-01

Summary Introduction: whiplash is a frequent post traumatic pathology caused by muscle, tendon and capsular elements over stretching. The authors conducted a short term prospective randomised study to test the effectiveness of a multi wave High Power Laser Therapy (HPLT) versus conventional simple segmental physical rehabilitation (PT) included in Italian tariff nomenclature performance physiotherapy Study Design: prospective randomised study (Level II). Material and methods: the authors identified 135 homogeneous patients with whiplash grade 1 – 2 of the Quebec Task Force classification (QTFC). INAIL, the Italian National Workers Insurance, based in Milan, was reliable source for identifying patients. All patients with whiplash injuries grade 1 or 2 QTFC, were eligible for the study, starting from April 28 2010 to September 30 2010. Patients referred to a Coordinator (C.M.) who applied the inclusion and exclusion criteria. Patients who agreed to participate were randomly assigned to one of the two treatment groups. Dates for initial treatment session were arranged, including cervical spine X-ray, and assessment. Each patient gave informed consent for participation and agreed to adopt only the study treatment for 6 weeks. Group A (84 patients) was treated with High Power Laser Therapy (HPLT), Group B (51 patients) received conventional simple segmental physical rehabilitation (PT). During the treatment period, no other electro-medical therapy, analgesics or anti-inflammatory drugs were allowed. All patients were assessed at baseline (T0) and at the end of the treatment period (T1) using a Visual Analogical Scale (VAS), (T2) the date of return to work was registered afterwards. Results: there was a reduction in VAS pain scores at T1. Group A (VAS = 20) Group B (VAS = 34,8) (p =0.0048). Laser treatment allowed quick recovery and return to work (T2). Group A after 48 days against 66 days of Group B (p=0.0005). Conclusions: results suggest that High Power Laser Therapy - is an effective treatment in patients with whiplash injury, compared to conventional simple segmental physical rehabilitation. PMID:23888293

High power laser therapy treatment compared to simple segmental physical rehabilitation in whiplash injuries (1° and 2° grade of the Quebec Task Force classification) involving muscles and ligaments.

PubMed

Conforti, Maria; Fachinetti, Giorgio Paolo

2013-04-01

whiplash is a frequent post traumatic pathology caused by muscle, tendon and capsular elements over stretching. The authors conducted a short term prospective randomised study to test the effectiveness of a multi wave High Power Laser Therapy (HPLT) versus conventional simple segmental physical rehabilitation (PT) included in Italian tariff nomenclature performance physiotherapy Study Design: prospective randomised study (Level II). the authors identified 135 homogeneous patients with whiplash grade 1 - 2 of the Quebec Task Force classification (QTFC). INAIL, the Italian National Workers Insurance, based in Milan, was reliable source for identifying patients. All patients with whiplash injuries grade 1 or 2 QTFC, were eligible for the study, starting from April 28 2010 to September 30 2010. Patients referred to a Coordinator (C.M.) who applied the inclusion and exclusion criteria. Patients who agreed to participate were randomly assigned to one of the two treatment groups. Dates for initial treatment session were arranged, including cervical spine X-ray, and assessment. Each patient gave informed consent for participation and agreed to adopt only the study treatment for 6 weeks. Group A (84 patients) was treated with High Power Laser Therapy (HPLT), Group B (51 patients) received conventional simple segmental physical rehabilitation (PT). During the treatment period, no other electro-medical therapy, analgesics or anti-inflammatory drugs were allowed. All patients were assessed at baseline (T0) and at the end of the treatment period (T1) using a Visual Analogical Scale (VAS), (T2) the date of return to work was registered afterwards. there was a reduction in VAS pain scores at T1. Group A (VAS = 20) Group B (VAS = 34,8) (p =0.0048). Laser treatment allowed quick recovery and return to work (T2). Group A after 48 days against 66 days of Group B (p=0.0005). results suggest that High Power Laser Therapy - is an effective treatment in patients with whiplash injury, compared to conventional simple segmental physical rehabilitation.

Effectiveness of electrocardiographic guidance in CVAD tip placement.

PubMed

Walker, Graham; Chan, Raymond J; Alexandrou, Evan; Webster, Joan; Rickard, Claire

International standard practice for the correct confirmation of the central venous access device is the chest X-ray. The intracavitary electrocardiogram-based insertion method is radiation-free, and allows real-time placement verification, providing immediate treatment and reduced requirement for post-procedural repositioning. Relevant databases were searched for prospective randomised controlled trials (RCTs) or quasi RCTs that compared the effectiveness of electrocardiogram-guided catheter tip positioning with placement using surface-anatomy-guided insertion plus chest X-ray confirmation. The primary outcome was accurate catheter tip placement. Secondary outcomes included complications, patient satisfaction and costs. Five studies involving 729 participants were included. Electrocardiogram-guided insertion was more accurate than surface anatomy guided insertion (odds ratio: 8.3; 95% confidence interval (CI) 1.38; 50.07; p=0.02). There was a lack of reporting on complications, patient satisfaction and costs. The evidence suggests that intracavitary electrocardiogram-based positioning is superior to surface-anatomy-guided positioning of central venous access devices, leading to significantly more successful placements. This technique could potentially remove the requirement for post-procedural chest X-ray, especially during peripherally inserted central catheter (PICC) line insertion.

Studies of a new multi-layer compression bandage for the treatment of venous ulceration.

PubMed

Scriven, J M; Bello, M; Taylor, L E; Wood, A J; London, N J

2000-03-01

This study aimed to develop an alternative graduated compression bandage for the treatment of venous leg ulcers. Alternative bandage components were identified and assessed for optimal performance as a graduated multi-layer compression bandage. Subsequently the physical characteristics and clinical efficacy of the optimal bandage combination was prospectively examined. Ten healthy limbs were used to develop the optimal combination and 20 limbs with venous ulceration to compare the physical properties of the two bandage types. Subsequently 42 consecutive ulcerated limbs were prospectively treated to examine the efficacy of the new bandage combination. The new combination produced graduated median (range) sub-bandage pressures (mmHg) as follows: ankle 59 (42-100), calf 36 (27-67) and knee 35 (16-67). Over a seven-day period this combination maintained a comparable level of compression with the Charing Cross system, and achieved an overall healing rate at one year of 88%. The described combination should be brought to the attention of healthcare professionals treating venous ulcers as a possible alternative to other forms of multi-layer graduated compression bandages pending prospective, randomised clinical trials.

Comprehensive geriatric care for patients with hip fractures: a prospective, randomised, controlled trial.

PubMed

Prestmo, Anders; Hagen, Gunhild; Sletvold, Olav; Helbostad, Jorunn L; Thingstad, Pernille; Taraldsen, Kristin; Lydersen, Stian; Halsteinli, Vidar; Saltnes, Turi; Lamb, Sarah E; Johnsen, Lars G; Saltvedt, Ingvild

2015-04-25

Most patients with hip fractures are characterised by older age (>70 years), frailty, and functional deterioration, and their long-term outcomes are poor with increased costs. We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care. We did a prospective, single-centre, randomised, parallel-group, controlled trial. Between April 18, 2008, and Dec 30, 2010, we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture, to either comprehensive geriatric care or orthopaedic care in the emergency department, to achieve the required sample of 400 patients. Randomisation was achieved via a web-based, computer-generated, block method with unknown block sizes. The primary outcome, analysed by intention to treat, was mobility measured with the Short Physical Performance Battery (SPPB) 4 months after surgery for the fracture. The type of treatment was not concealed from the patients or staff delivering the care, and assessors were only partly masked to the treatment during follow-up. This trial is registered with ClinicalTrials.gov, number NCT00667914. We assessed 1077 patients for eligibility, and excluded 680, mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years. Of the remaining patients, we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care. At 4 months, 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group; the main reason for dropout was death. Mean SPPB scores at 4 months were 5·12 (SE 0·20) for comprehensive geriatric care and 4·38 (SE 0·20) for orthopaedic care (between-group difference 0·74, 95% CI 0·18-1·30, p=0·010). Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months, compared with the usual orthopaedic care. The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care. Norwegian Research Council, Central Norway Regional Health Authority, St Olav Hospital Trust and Fund for Research and Innovation, Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology, the Department of Neuroscience at the Norwegian University of Science and Technology, Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology (SINTEF), and the Municipality of Trondheim. Copyright © 2015 Elsevier Ltd. All rights reserved.

Balanced: a randomised trial examining the efficacy of two self-monitoring methods for an app-based multi-behaviour intervention to improve physical activity, sitting and sleep in adults.

PubMed

Duncan, Mitch J; Vandelanotte, Corneel; Trost, Stewart G; Rebar, Amanda L; Rogers, Naomi; Burton, Nicola W; Murawski, Beatrice; Rayward, Anna; Fenton, Sasha; Brown, Wendy J

2016-07-30

Many adults are insufficiently physically active, have prolonged sedentary behaviour and report poor sleep. These behaviours can be improved by interventions that include education, goal setting, self-monitoring, and feedback strategies. Few interventions have explicitly targeted these behaviours simultaneously or examined the relative efficacy of different self-monitoring methods. This study aims to compare the efficacy of two self-monitoring methods in an app-based multi-behaviour intervention to improve objectively measured physical activity, sedentary, and sleep behaviours, in a 9 week 2-arm randomised trial. Participants will be adults (n = 64) who report being physically inactive, sitting >8 h/day and frequent insufficient sleep (≥14 days out of last 30). The "Balanced" intervention is delivered via a smartphone 'app', and includes education materials (guidelines, strategies to promote change in behaviour), goal setting, self-monitoring and feedback support. Participants will be randomly allocated to either a device-entered or user-entered self-monitoring method. The device-entered group will be provided with a activity tracker to self-monitor behaviours. The user-entered group will recall and manually record behaviours. Assessments will be conducted at 0, 3, 6, and 9 weeks. Physical activity, sedentary behaviour and sleep-wake behaviours will be measured using the wrist worn Geneactiv accelerometer. Linear mixed models will be used to examine differences between groups and over time using an alpha of 0.01. This study will evaluate an app-based multi-behavioural intervention to improve physical activity, sedentary behaviour and sleep; and the relative efficacy of two different approaches to self-monitoring these behaviours. Outcomes will provide information to inform future interventions and self-monitoring targeting these behaviours. ACTRN12615000182594 (Australian New Zealand Clinical Trials Registry. Registry URL: www.anzctr.org.au ; registered prospectively on 25 February 2015).

The use of a virtual reality surgical simulator for cataract surgical skill assessment with 6 months of intervening operating room experience.

PubMed

Sikder, Shameema; Luo, Jia; Banerjee, P Pat; Luciano, Cristian; Kania, Patrick; Song, Jonathan C; Kahtani, Eman S; Edward, Deepak P; Towerki, Abdul-Elah Al

2015-01-01

To evaluate a haptic-based simulator, MicroVisTouch™, as an assessment tool for capsulorhexis performance in cataract surgery. The study is a prospective, unmasked, nonrandomized dual academic institution study conducted at the Wilmer Eye Institute at Johns Hopkins Medical Center (Baltimore, MD, USA) and King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). This prospective study evaluated capsulorhexis simulator performance in 78 ophthalmology residents in the US and Saudi Arabia in the first round of testing and 40 residents in a second round for follow-up. Four variables (circularity, accuracy, fluency, and overall) were tested by the simulator and graded on a 0-100 scale. Circularity (42%), accuracy (55%), and fluency (3%) were compiled to give an overall score. Capsulorhexis performance was retested in the original cohort 6 months after baseline assessment. Average scores in all measured metrics demonstrated statistically significant improvement (except for circularity, which trended toward improvement) after baseline assessment. A reduction in standard deviation and improvement in process capability indices over the 6-month period was also observed. An interval objective improvement in capsulorhexis skill on a haptic-enabled cataract surgery simulator was associated with intervening operating room experience. Further work investigating the role of formalized simulator training programs requiring independent simulator use must be studied to determine its usefulness as an evaluation tool.

An extended PROSPECT: Advance in the leaf optical properties model separating total chlorophylls into chlorophyll a and b.

PubMed

Zhang, Yao; Huang, Jingfeng; Wang, Fumin; Blackburn, George Alan; Zhang, Hankui K; Wang, Xiuzhen; Wei, Chuanwen; Zhang, Kangyu; Wei, Chen

2017-07-25

The PROSPECT leaf optical model has, to date, well-separated the effects of total chlorophyll and carotenoids on leaf reflectance and transmittance in the 400-800 nm. Considering variations in chlorophyll a:b ratio with leaf age and physiological stress, a further separation of total plant-based chlorophylls into chlorophyll a and chlorophyll b is necessary for advanced monitoring of plant growth. In this study, we present an extended version of PROSPECT model (hereafter referred to as PROSPECT-MP) that can combine the effects of chlorophyll a, chlorophyll b and carotenoids on leaf directional hemispherical reflectance and transmittance (DHR and DHT) in the 400-800 nm. The LOPEX93 dataset was used to evaluate the capabilities of PROSPECT-MP for spectra modelling and pigment retrieval. The results show that PROSPECT-MP can both simultaneously retrieve leaf chlorophyll a and b, and also performs better than PROSPECT-5 in retrieving carotenoids concentrations. As for the simulation of DHR and DHT, the performances of PROSPECT-MP are similar to that of PROSPECT-5. This study demonstrates the potential of PROSPECT-MP for improving capabilities of remote sensing of leaf photosynthetic pigments (chlorophyll a, chlorophyll b and carotenoids) and for providing a framework for future refinements in the modelling of leaf optical properties.

Study protocol for a randomised controlled trial of invasive versus conservative management of primary spontaneous pneumothorax.

PubMed

Brown, Simon G A; Ball, Emma L; Perrin, Kyle; Read, Catherine A; Asha, Stephen E; Beasley, Richard; Egerton-Warburton, Diana; Jones, Peter G; Keijzers, Gerben; Kinnear, Frances B; Kwan, Ben C H; Lee, Y C Gary; Smith, Julian A; Summers, Quentin A; Simpson, Graham

2016-09-13

Current management of primary spontaneous pneumothorax (PSP) is variable, with little evidence from randomised controlled trials to guide treatment. Guidelines emphasise intervention in many patients, which involves chest drain insertion, hospital admission and occasionally surgery. However, there is evidence that conservative management may be effective and safe, and it may also reduce the risk of recurrence. Significant questions remain regarding the optimal initial approach to the management of PSP. This multicentre, prospective, randomised, open label, parallel group, non-inferiority study will randomise 342 participants with a first large PSP to conservative or interventional management. To maintain allocation concealment, randomisation will be performed in real time by computer and stratified by study site. Conservative management will involve a period of observation prior to discharge, with intervention for worsening symptoms or physiological instability. Interventional treatment will involve insertion of a small bore drain. If drainage continues after 1 hour, the patient will be admitted. If drainage stops, the drain will be clamped for 4 hours. The patient will be discharged if the lung remains inflated. Otherwise, the patient will be admitted. The primary end point is the proportion of participants with complete lung re-expansion by 8 weeks. Secondary end points are as follows: days in hospital, persistent air leak, predefined complications and adverse events, time to resolution of symptoms, and pneumothorax recurrence during a follow-up period of at least 1 year. The study has 95% power to detect an absolute non-inferiority margin of 9%, assuming 99% successful expansion at 8 weeks in the invasive treatment arm. The primary analysis will be by intention to treat. Local ethics approval has been obtained for all sites. Study findings will be disseminated by publication in a high-impact international journal and presentation at major international Emergency Medicine and Respiratory meetings. ACTRN12611000184976; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Comparing glycaemic benefits of Active Versus passive lifestyle Intervention in kidney Allograft Recipients (CAVIAR): study protocol for a randomised controlled trial.

PubMed

Wilcox, Joanne; Waite, Chantelle; Tomlinson, Lyndsey; Driscoll, Joanne; Karim, Asra; Day, Edward; Sharif, Adnan

2016-08-22

Lifestyle modification is widely recommended to kidney allograft recipients post transplantation due to the cardiometabolic risks associated with immunosuppression including new-onset diabetes, weight gain and cardiovascular events. However, we have no actual evidence that undertaking lifestyle modification protects from any adverse outcomes post transplantation. The aim of this study is to compare whether a more proactive versus passive interventional approach to modify lifestyle is associated with superior outcomes post kidney transplantation. We designed this prospective, single-centre, open-label, randomised controlled study to compare the efficacy of active versus passive lifestyle intervention for kidney allograft recipients early post transplantation. A total of 130 eligible patients, who are stable, nondiabetic and between 3 and 24 months post kidney transplantation, will be recruited. Randomisation is being undertaken by random block permutations into passive (n = 65, leaflet guidance only) versus active lifestyle modification (n = 65, supervised intervention) over a 6-month period. Supervised intervention is being facilitated by two dietitians during the 6-month intervention period to provide continuous lifestyle intervention guidance, support and encouragement. Both dietitians are accredited with behavioural intervention skills and will utilise motivational aids to support study recruits randomised to active intervention. The primary outcome is change in abnormal glucose metabolism parameters after 6 months of comparing active versus passive lifestyle intervention. Secondary outcomes include changes in a wide array of cardiometabolic parameters, kidney allograft function and patient-reported outcome measures. Long-term tracking of patients via data linkage to electronic patient records and national registries will facilitate long-term comparison of outcomes after active versus passive lifestyle intervention beyond the 6-month intervention period. This is the first randomised controlled study to investigate the benefits of active versus passive lifestyle intervention in kidney allograft recipients for the prevention of abnormal cardiometabolic outcomes. In addition, this is the first example of utilising behaviour therapy intervention post kidney transplantation to achieve clinically beneficial outcomes, which has potential implications on many spheres of post-transplant care. This study was registered with the Clinical Trials Registry on 27 August 2014 (ClinicalTrials.org Identifier: NCT02233491 ).

β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol

PubMed Central

Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

2016-01-01

Introduction A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. Methods and analyses This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. Ethics and dissemination The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. Trial registration number NCT02587351; Pre-results. PMID:27267111

β-Blockers for the prevention of acute exacerbations of chronic obstructive pulmonary disease (βLOCK COPD): a randomised controlled study protocol.

PubMed

Bhatt, Surya P; Connett, John E; Voelker, Helen; Lindberg, Sarah M; Westfall, Elizabeth; Wells, J Michael; Lazarus, Stephen C; Criner, Gerard J; Dransfield, Mark T

2016-06-07

A substantial majority of chronic obstructive pulmonary disease (COPD)-related morbidity, mortality and healthcare costs are due to acute exacerbations, but existing medications have only a modest effect on reducing their frequency, even when used in combination. Observational studies suggest β-blockers may reduce the risk of COPD exacerbations; thus, we will conduct a randomised, placebo-controlled trial to definitively assess the impact of metoprolol succinate on the rate of COPD exacerbations. This is a multicentre, placebo-controlled, double-blind, prospective randomised trial that will enrol 1028 patients with at least moderately severe COPD over a 3-year period. Participants with at least moderate COPD will be randomised in a 1:1 fashion to receive metoprolol or placebo; the cohort will be enriched for patients at high risk for exacerbations. Patients will be screened and then randomised over a 2-week period and will then undergo a dose titration period for the following 6 weeks. Thereafter, patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4-week washout period. The primary end point is time to first occurrence of an acute exacerbation during the treatment period. Secondary end points include rates and severity of COPD exacerbations; rate of major cardiovascular events; all-cause mortality; lung function (forced expiratory volume in 1 s (FEV1)); dyspnoea; quality of life; exercise capacity; markers of cardiac stretch (pro-NT brain natriuretic peptide) and systemic inflammation (high-sensitivity C reactive protein and fibrinogen). Analyses will be performed on an intent-to-treat basis. The study protocol has been approved by the Department of Defense Human Protection Research Office and will be approved by the institutional review board of all participating centres. Study findings will be disseminated through presentations at national and international conferences and publications in peer-reviewed journals. NCT02587351; Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Study protocol for a multi-institutional, randomised, double-blinded, placebo-controlled phase III trial investigating additive efficacy of duloxetine for neuropathic cancer pain refractory to opioids and gabapentinoids: the DIRECT study.

PubMed

Matsuoka, Hiromichi; Ishiki, Hiroto; Iwase, Satoru; Koyama, Atsuko; Kawaguchi, Takashi; Kizawa, Yoshiyuki; Morita, Tatsuya; Matsuda, Yoshinobu; Miyaji, Tempei; Ariyoshi, Keisuke; Yamaguchi, Takuhiro

2017-08-28

Management of patients with cancer suffering from neuropathic pain refractory to opioids and gabapentinoids remains an important challenge. Duloxetine is one of the choices after first-line treatment fails. The efficacy of duloxetine has been reported in patients with non-cancer disease and in chemotherapy-induced peripheral neuropathy, but no randomised clinical trials have examined its effects on neuropathic cancer pain refractory to first-line treatment. The objective of this study is to assess the analgesic efficacy of duloxetine in patients suffering from neuropathic cancer pain refractory to opioids and gabapentinoids. A multi-institutional, prospective, randomised, double-blind, placebo-controlled, two-parallel trial is planned. The inclusion criteria are adult patients with cancer suffering from neuropathic cancer pain refractory to opioids and gabapentinoids, patients with a Numerical Rating Scale (NRS) pain score of 4 or higher and patients with a total Hospital Anxiety and Depression Scale score of less than 20. Patients with chemotherapy-induced peripheral neuropathy are excluded. The study will take place at 14 sites across Japan. Participants will be randomised (1:1 allocation ratio) to a duloxetine intervention group or a placebo control group. Evaluations will be made at baseline (T0 randomisation), day 0 (T1), day 3 (T2) and day 10 (T3). The primary endpoint is defined as the difference in NRS score for pain intensity (average over the previous 24 hours) at T3 between the duloxetine and placebo groups. A sample size of 70 patients will be examined between July 2015 and March 2018. Ethics approval was obtained at all participating sites.The results of this study will be submitted for publication in international peer-reviewed journals and the key findings presented at international scientific conferences. UMIN000017647; Pre-results. 2.2, 26 April 2017. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The “Resus:Station”: The use of clinical simulations in a randomised crossover study to evaluate a novel resuscitation trolley☆

PubMed Central

Walker, Susanna T.; Brett, Stephen J.; McKay, Anthony; Aggarwal, Rajesh; Vincent, Charles

2012-01-01

Background and aim Inadequately designed equipment has been implicated in poor efficiency and critical incidents associated with resuscitation. A novel resuscitation trolley (Resus:Station) was designed and evaluated for impact on team efficiency, user opinion, and teamwork, compared with the standard trolley, in simulated cardiac arrest scenarios. Methods Fifteen experienced cardiac arrest teams were recruited (45 participants). Teams performed recorded resuscitation simulations using new and conventional trolleys, with order of use randomised. After each simulation, efficiency (“time to drugs”, un-locatable equipment, unnecessary drawer opening) and team performance (OSCAR) were assessed from the video recordings and participants were asked to complete questionnaires scoring various aspects of the trolley on a Likert scale. Results Time to locate the drugs was significantly faster (p = 0.001) when using the Resus:Station (mean 5.19 s (SD 3.34)) than when using the standard trolley (26.81 s (SD16.05)). There were no reports of missing equipment when using the Resus:Station. However, during four of the fifteen study sessions using the standard trolley participants were unable to find equipment, with an average of 6.75 unnecessary drawer openings per simulation. User feedback results clearly indicated a highly significant preference for the newly designed Resus:Station for all aspects. Teams performed equally well for all dimensions of team performance using both trolleys, despite it being their first exposure to the Resus:Station. Conclusion We conclude that in this simulated environment, the new design of trolley is safe to use, and has the potential to improve efficiency at a resuscitation attempt. PMID:22796405

An embedded checklist in the Anesthesia Information Management System improves pre-anaesthetic induction setup: a randomised controlled trial in a simulation setting.

PubMed

Wetmore, Douglas; Goldberg, Andrew; Gandhi, Nishant; Spivack, John; McCormick, Patrick; DeMaria, Samuel

2016-10-01

Anaesthesiologists work in a high stress, high consequence environment in which missed steps in preparation may lead to medical errors and potential patient harm. The pre-anaesthetic induction period has been identified as a time in which medical errors can occur. The Anesthesia Patient Safety Foundation has developed a Pre-Anesthetic Induction Patient Safety (PIPS) checklist. We conducted this study to test the effectiveness of this checklist, when embedded in our institutional Anesthesia Information Management System (AIMS), on resident performance in a simulated environment. Using a randomised, controlled, observer-blinded design, we compared performance of anaesthesiology residents in a simulated operating room under production pressure using a checklist in completing a thorough pre-anaesthetic induction evaluation and setup with that of residents with no checklist. The checklist was embedded in the simulated operating room's electronic medical record. Data for 38 anaesthesiology residents shows a statistically significant difference in performance in pre-anaesthetic setup and evaluation as scored by blinded raters (maximum score 22 points), with the checklist group performing better by 7.8 points (p<0.01). The effects of gender and year of residency on total score were not significant. Simulation duration (time to anaesthetic agent administration) was increased significantly by the use of the checklist. Required use of a pre-induction checklist improves anaesthesiology resident performance in a simulated environment. The PIPS checklist as an integrated part of a departmental AIMS warrant further investigation as a quality measure. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Effectiveness of a community-based intervention for people with schizophrenia and their caregivers in India (COPSI): a randomised controlled trial.

PubMed

Chatterjee, Sudipto; Naik, Smita; John, Sujit; Dabholkar, Hamid; Balaji, Madhumitha; Koschorke, Mirja; Varghese, Mathew; Thara, Rangaswamy; Weiss, Helen A; Williams, Paul; McCrone, Paul; Patel, Vikram; Thornicroft, Graham

2014-04-19

Observational evidence suggests that community-based services for people with schizophrenia can be successfully provided by community health workers, when supervised by specialists, in low-income and middle-income countries. We did the COmmunity care for People with Schizophrenia in India (COPSI) trial to compare the effectiveness of a collaborative community-based care intervention with standard facility-based care. We did a multicentre, parallel-group, randomised controlled trial at three sites in India between Jan 1, 2009 and Dec 31, 2010. Patients aged 16-60 years with a primary diagnosis of schizophrenia according to the tenth edition of the International Classification of Diseases, Diagnostic Criteria for Research (ICD-10-DCR) were randomly assigned (2:1), via a computer-generated randomisation list with block sizes of three, six, or nine, to receive either collaborative community-based care plus facility-based care or facility-based care alone. Randomisation was stratified by study site. Outcome assessors were masked to group allocation. The primary outcome was a change in symptoms and disabilities over 12 months, as measured by the positive and negative syndrome scale (PANSS) and the Indian disability evaluation and assessment scale (IDEAS). Analysis was by modified intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN 56877013. 187 participants were randomised to the collaborative community-based care plus facility-based care group and 95 were randomised to the facility-based care alone group; 253 (90%) participants completed follow-up to month 12. At 12 months, total PANSS and IDEAS scores were lower in patients in the intervention group than in those in the control group (PANSS adjusted mean difference -3.75, 95% CI -7.92 to 0.42; p=0.08; IDEAS -0.95, -1.68 to -0.23; p=0.01). However, no difference was shown in the proportion of participants who had a reduction of more than 20% in overall symptoms (PANSS 85 [51%] in the intervention group vs 44 [51%] in the control group; p=0.89; IDEAS 75 [48%] vs 28 [35%]). We noted a significant reduction in symptom and disability outcomes at the rural Tamil Nadu site (-9.29, -15.41 to -3.17; p=0.003). Two patients (one in each group) died by suicide during the study, and two patients died because of complications of a road traffic accident and pre-existing cardiac disease. 18 (73%) patients (17 in the intervention group) were admitted to hospital during the course of the trial, of whom seven were admitted because of physical health problems, such as acute gastritis and vomiting, road accident, high fever, or cardiovascular disease. The collaborative community-based care plus facility-based care intervention is modestly more effective than facility-based care, especially for reducing disability and symptoms of psychosis. Our results show that the study intervention is best implemented as an initial service in settings where services are scarce, for example in rural areas. Wellcome Trust. Copyright © 2014 Chatterjee et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd. All rights reserved.

Accelerating Dynamic Magnetic Resonance Imaging (MRI) for Lung Tumor Tracking Based on Low-Rank Decomposition in the Spatial–Temporal Domain: A Feasibility Study Based on Simulation and Preliminary Prospective Undersampled MRI

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

Sarma, Manoj; Department of Radiation Oncology, University of California, Los Angeles, California; Hu, Peng

Purpose: To evaluate a low-rank decomposition method to reconstruct down-sampled k-space data for the purpose of tumor tracking. Methods and Materials: Seven retrospective lung cancer patients were included in the simulation study. The fully-sampled k-space data were first generated from existing 2-dimensional dynamic MR images and then down-sampled by 5 × -20 × before reconstruction using a Cartesian undersampling mask. Two methods, a low-rank decomposition method using combined dynamic MR images (k-t SLR based on sparsity and low-rank penalties) and a total variation (TV) method using individual dynamic MR frames, were used to reconstruct images. The tumor trajectories were derived on the basis ofmore » autosegmentation of the resultant images. To further test its feasibility, k-t SLR was used to reconstruct prospective data of a healthy subject. An undersampled balanced steady-state free precession sequence with the same undersampling mask was used to acquire the imaging data. Results: In the simulation study, higher imaging fidelity and low noise levels were achieved with the k-t SLR compared with TV. At 10 × undersampling, the k-t SLR method resulted in an average normalized mean square error <0.05, as opposed to 0.23 by using the TV reconstruction on individual frames. Less than 6% showed tracking errors >1 mm with 10 × down-sampling using k-t SLR, as opposed to 17% using TV. In the prospective study, k-t SLR substantially reduced reconstruction artifacts and retained anatomic details. Conclusions: Magnetic resonance reconstruction using k-t SLR on highly undersampled dynamic MR imaging data results in high image quality useful for tumor tracking. The k-t SLR was superior to TV by better exploiting the intrinsic anatomic coherence of the same patient. The feasibility of k-t SLR was demonstrated by prospective imaging acquisition and reconstruction.« less

Impact of a web-based tool (WebCONSORT) to improve the reporting of randomised trials: results of a randomised controlled trial.

PubMed

Hopewell, Sally; Boutron, Isabelle; Altman, Douglas G; Barbour, Ginny; Moher, David; Montori, Victor; Schriger, David; Cook, Jonathan; Gerry, Stephen; Omar, Omar; Dutton, Peter; Roberts, Corran; Frangou, Eleni; Clifton, Lei; Chiocchia, Virginia; Rombach, Ines; Wartolowska, Karolina; Ravaud, Philippe

2016-11-28

The CONSORT Statement is an evidence-informed guideline for reporting randomised controlled trials. A number of extensions have been developed that specify additional information to report for more complex trials. The aim of this study was to evaluate the impact of using a simple web-based tool (WebCONSORT, which incorporates a number of different CONSORT extensions) on the completeness of reporting of randomised trials published in biomedical publications. We conducted a parallel group randomised trial. Journals which endorsed the CONSORT Statement (i.e. referred to it in the Instruction to Authors) but do not actively implement it (i.e. require authors to submit a completed CONSORT checklist) were invited to participate. Authors of randomised trials were requested by the editor to use the web-based tool at the manuscript revision stage. Authors registering to use the tool were randomised (centralised computer generated) to WebCONSORT or control. In the WebCONSORT group, they had access to a tool allowing them to combine the different CONSORT extensions relevant to their trial and generate a customised checklist and flow diagram that they must submit to the editor. In the control group, authors had only access to a CONSORT flow diagram generator. Authors, journal editors, and outcome assessors were blinded to the allocation. The primary outcome was the proportion of CONSORT items (main and extensions) reported in each article post revision. A total of 46 journals actively recruited authors into the trial (25 March 2013 to 22 September 2015); 324 author manuscripts were randomised (WebCONSORT n = 166; control n = 158), of which 197 were reports of randomised trials (n = 94; n = 103). Over a third (39%; n = 127) of registered manuscripts were excluded from the analysis, mainly because the reported study was not a randomised trial. Of those included in the analysis, the most common CONSORT extensions selected were non-pharmacologic (n = 43; n = 50), pragmatic (n = 20; n = 16) and cluster (n = 10; n = 9). In a quarter of manuscripts, authors either wrongly selected an extension or failed to select the right extension when registering their manuscript on the WebCONSORT study site. Overall, there was no important difference in the overall mean score between WebCONSORT (mean score 0.51) and control (0.47) in the proportion of CONSORT and CONSORT extension items reported pertaining to a given study (mean difference, 0.04; 95% CI -0.02 to 0.10). This study failed to show a beneficial effect of a customised web-based CONSORT checklist to help authors prepare more complete trial reports. However, the exclusion of a large number of inappropriately registered manuscripts meant we had less precision than anticipated to detect a difference. Better education is needed, earlier in the publication process, for both authors and journal editorial staff on when and how to implement CONSORT and, in particular, CONSORT-related extensions. ClinicalTrials.gov: NCT01891448 [registered 24 May 2013].

Evaluating an audit and feedback intervention for reducing antibiotic prescribing behaviour in general dental practice (the RAPiD trial): a partial factorial cluster randomised trial protocol.

PubMed

Prior, Maria; Elouafkaoui, Paula; Elders, Andrew; Young, Linda; Duncan, Eilidh M; Newlands, Rumana; Clarkson, Jan E; Ramsay, Craig R

2014-04-24

Antibiotic prescribing in dentistry accounts for 9% of total antibiotic prescriptions in Scottish primary care. The Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance in April 2008 (2nd edition, August 2011) for Drug Prescribing in Dentistry, which aims to assist dentists to make evidence-based antibiotic prescribing decisions. However, wide variation in prescribing persists and the overall use of antibiotics is increasing. RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland. Its aim is to compare the effectiveness of individualised audit and feedback (A&F) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing. The trial uses routinely collected electronic healthcare data in five aspects of its design in order to: identify the study population; apply eligibility criteria; carry out stratified randomisation; generate the trial intervention; analyse trial outcomes. Eligibility was determined on contract status and a minimum level of recent NHS treatment provision. All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group. Randomisation was stratified by single-handed/multi-handed practices. General dental practitioners (GDPs) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months. GDPs could not be blinded to their practice allocation. Intervention practices were further randomised using a factorial design to receive feedback with or without: a health board comparator; a supplementary text-based intervention; additional feedback at nine months. The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention. A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs. RAPiD will provide a robust evaluation of A&F in dentistry in Scotland. It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial. Current Controlled Trials ISRCTN49204710.

Evaluating an audit and feedback intervention for reducing antibiotic prescribing behaviour in general dental practice (the RAPiD trial): a partial factorial cluster randomised trial protocol

PubMed Central

2014-01-01

Background Antibiotic prescribing in dentistry accounts for 9% of total antibiotic prescriptions in Scottish primary care. The Scottish Dental Clinical Effectiveness Programme (SDCEP) published guidance in April 2008 (2nd edition, August 2011) for Drug Prescribing in Dentistry, which aims to assist dentists to make evidence-based antibiotic prescribing decisions. However, wide variation in prescribing persists and the overall use of antibiotics is increasing. Methods RAPiD is a 12-month partial factorial cluster randomised trial conducted in NHS General Dental Practices across Scotland. Its aim is to compare the effectiveness of individualised audit and feedback (A&F) strategies for the translation into practice of SDCEP recommendations on antibiotic prescribing. The trial uses routinely collected electronic healthcare data in five aspects of its design in order to: identify the study population; apply eligibility criteria; carry out stratified randomisation; generate the trial intervention; analyse trial outcomes. Eligibility was determined on contract status and a minimum level of recent NHS treatment provision. All eligible dental practices in Scotland were simultaneously randomised at baseline either to current audit practice or to an intervention group. Randomisation was stratified by single-handed/multi-handed practices. General dental practitioners (GDPs) working at intervention practices will receive individualised graphical representations of their antibiotic prescribing rate from the previous 14 months at baseline and an update at six months. GDPs could not be blinded to their practice allocation. Intervention practices were further randomised using a factorial design to receive feedback with or without: a health board comparator; a supplementary text-based intervention; additional feedback at nine months. The primary outcome is the total antibiotic prescribing rate per 100 courses of treatment over the year following delivery of the baseline intervention. A concurrent qualitative process evaluation will apply theory-based approaches using the Consolidated Framework for Implementation Research to explore the acceptability of the interventions and the Theoretical Domains Framework to identify barriers and enablers to evidence-based antibiotic prescribing behaviour by GDPs. Discussion RAPiD will provide a robust evaluation of A&F in dentistry in Scotland. It also demonstrates that linked administrative datasets have the potential to be used efficiently and effectively across all stages of an randomised controlled trial. Trial registration Current Controlled Trials ISRCTN49204710 PMID:24758164

Re-estimating sample size in cluster randomised trials with active recruitment within clusters.

PubMed

van Schie, S; Moerbeek, M

2014-08-30

Often only a limited number of clusters can be obtained in cluster randomised trials, although many potential participants can be recruited within each cluster. Thus, active recruitment is feasible within the clusters. To obtain an efficient sample size in a cluster randomised trial, the cluster level and individual level variance should be known before the study starts, but this is often not the case. We suggest using an internal pilot study design to address this problem of unknown variances. A pilot can be useful to re-estimate the variances and re-calculate the sample size during the trial. Using simulated data, it is shown that an initially low or high power can be adjusted using an internal pilot with the type I error rate remaining within an acceptable range. The intracluster correlation coefficient can be re-estimated with more precision, which has a positive effect on the sample size. We conclude that an internal pilot study design may be used if active recruitment is feasible within a limited number of clusters. Copyright © 2014 John Wiley & Sons, Ltd.

Axitinib with or without dose titration for first-line metastatic renal-cell carcinoma: a randomised double-blind phase 2 trial

PubMed Central

Rini, Brian I; Melichar, Bohuslav; Ueda, Takeshi; GrÜnwald, Viktor; Fishman, Mayer N; Arranz, José A; Bair, Angel H; Pithavala, Yazdi K; Andrews, Glen I; Pavlov, Dmitri; Kim, Sinil; Jonasch, Eric

2014-01-01

Summary Background Population pharmacokinetic data suggest axitinib plasma exposure correlates with efficacy in metastatic renal-cell carcinoma. Axitinib dose titration might optimise exposure and improve outcomes. We prospectively assessed the efficacy and safety of axitinib dose titration in previously untreated patients with metastatic renal-cell carcinoma. Methods In this randomised, double-blind, multicentre, phase 2 study, patients were enrolled from 49 hospitals and outpatient clinics in the Czech Republic, Germany, Japan, Russia, Spain, and USA. Patients with treatment-naive metastatic renal-cell carcinoma received axitinib 5 mg twice daily during a 4 week lead-in period. Those patients with blood pressure 150/90 mm Hg or lower, no grade 3 or 4 treatment-related toxic effects, no dose reductions, and no more than two antihypertensive drugs for 2 consecutive weeks were stratified by Eastern Cooperative Oncology Group performance status (0 vs 1), and then randomly assigned (1:1) to either masked titration with axitinib to total twice daily doses of 7 mg, and then 10 mg, if tolerated, or placebo titration. Patients who did not meet these criteria continued without titration. The primary objective was comparison of the proportion of patients achieving an objective response between randomised groups. Safety analyses were based on all patients who received at least one dose of axitinib. This ongoing trial is registered with ClinicalTrials.gov, number NCT00835978. Findings Between Sept 2, 2009, and Feb 28, 2011, we enrolled 213 patients, of whom 112 were randomly assigned to either the axitinib titration group (56 patients) or the placebo titration group (56 patients). 91 were not eligible for titration, and ten withdrew during the lead-in period. 30 patients (54%, 95% CI 40–67) in the axitinib titration group had an objective response, as did 19 patients (34%, 22–48]) in the placebo titration group (one-sided p=0·019). 54 (59%, 95% CI 49–70) of non-randomised patients achieved an objective response. Common grade 3 or worse, all-causality adverse events in treated patients were hypertension (ten [18%] of 56 in the axitinib titration group vs five [9%] of 56 in the placebo titration group vs 45 [49%] of 91 in the non-randomised group), diarrhoea (seven [13%] vs two [4%] vs eight [9%]), and decreased weight (four [7%] vs three [5%] vs six [7%]). One or more all-causality serious adverse events were reported in 15 (27%) patients in the axitinib titration group, 13 (23%) patients in the placebo titration group, and 35 (38%) non-randomised patients. The most common serious adverse events in all 213 patients were disease progression and dehydration (eight each [4%]), and diarrhoea, vomiting, pneumonia, and decreased appetite (four each [2%]). Interpretation The greater proportion of patients in the axitinib titration group achieving an objective response supports the concept of individual axitinib dose titration in selected patients with metastatic renal-cell carcinoma. Axitinib shows clinical activity with a manageable safety profile in treatment-naive patients with this disease. Funding Pfizer Inc. PMID:24140184

Procedural instruction in invasive bedside procedures: a systematic review and meta-analysis of effective teaching approaches.

PubMed

Huang, Grace C; McSparron, Jakob I; Balk, Ethan M; Richards, Jeremy B; Smith, C Christopher; Whelan, Julia S; Newman, Lori R; Smetana, Gerald W

2016-04-01

Optimal approaches to teaching bedside procedures are unknown. To identify effective instructional approaches in procedural training. We searched PubMed, EMBASE, Web of Science and Cochrane Library through December 2014. We included research articles that addressed procedural training among physicians or physician trainees for 12 bedside procedures. Two independent reviewers screened 9312 citations and identified 344 articles for full-text review. Two independent reviewers extracted data from full-text articles. We included measurements as classified by translational science outcomes T1 (testing settings), T2 (patient care practices) and T3 (patient/public health outcomes). Due to incomplete reporting, we post hoc classified study outcomes as 'negative' or 'positive' based on statistical significance. We performed meta-analyses of outcomes on the subset of studies sharing similar outcomes. We found 161 eligible studies (44 randomised controlled trials (RCTs), 34 non-RCTs and 83 uncontrolled trials). Simulation was the most frequently published educational mode (78%). Our post hoc classification showed that studies involving simulation, competency-based approaches and RCTs had higher frequencies of T2/T3 outcomes. Meta-analyses showed that simulation (risk ratio (RR) 1.54 vs 0.55 for studies with vs without simulation, p=0.013) and competency-based approaches (RR 3.17 vs 0.89, p<0.001) were effective forms of training. This systematic review of bedside procedural skills demonstrates that the current literature is heterogeneous and of varying quality and rigour. Evidence is strongest for the use of simulation and competency-based paradigms in teaching procedures, and these approaches should be the mainstay of programmes that train physicians to perform procedures. Further research should clarify differences among instructional methods (eg, forms of hands-on training) rather than among educational modes (eg, lecture vs simulation). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Simulation-based power calculations for planning a two-stage individual participant data meta-analysis.

PubMed

Ensor, Joie; Burke, Danielle L; Snell, Kym I E; Hemming, Karla; Riley, Richard D

2018-05-18

Researchers and funders should consider the statistical power of planned Individual Participant Data (IPD) meta-analysis projects, as they are often time-consuming and costly. We propose simulation-based power calculations utilising a two-stage framework, and illustrate the approach for a planned IPD meta-analysis of randomised trials with continuous outcomes where the aim is to identify treatment-covariate interactions. The simulation approach has four steps: (i) specify an underlying (data generating) statistical model for trials in the IPD meta-analysis; (ii) use readily available information (e.g. from publications) and prior knowledge (e.g. number of studies promising IPD) to specify model parameter values (e.g. control group mean, intervention effect, treatment-covariate interaction); (iii) simulate an IPD meta-analysis dataset of a particular size from the model, and apply a two-stage IPD meta-analysis to obtain the summary estimate of interest (e.g. interaction effect) and its associated p-value; (iv) repeat the previous step (e.g. thousands of times), then estimate the power to detect a genuine effect by the proportion of summary estimates with a significant p-value. In a planned IPD meta-analysis of lifestyle interventions to reduce weight gain in pregnancy, 14 trials (1183 patients) promised their IPD to examine a treatment-BMI interaction (i.e. whether baseline BMI modifies intervention effect on weight gain). Using our simulation-based approach, a two-stage IPD meta-analysis has < 60% power to detect a reduction of 1 kg weight gain for a 10-unit increase in BMI. Additional IPD from ten other published trials (containing 1761 patients) would improve power to over 80%, but only if a fixed-effect meta-analysis was appropriate. Pre-specified adjustment for prognostic factors would increase power further. Incorrect dichotomisation of BMI would reduce power by over 20%, similar to immediately throwing away IPD from ten trials. Simulation-based power calculations could inform the planning and funding of IPD projects, and should be used routinely.

Comparing motivational, self-regulatory and habitual processes in a computer-tailored physical activity intervention in hospital employees - protocol for the PATHS randomised controlled trial.

PubMed

Kwasnicka, Dominika; Vandelanotte, Corneel; Rebar, Amanda; Gardner, Benjamin; Short, Camille; Duncan, Mitch; Crook, Dawn; Hagger, Martin S

2017-05-26

Most people do not engage in sufficient physical activity to confer health benefits and to reduce risk of chronic disease. Healthcare professionals frequently provide guidance on physical activity, but often do not meet guideline levels of physical activity themselves. The main objective of this study is to develop and test the efficacy of a tailored intervention to increase healthcare professionals' physical activity participation and quality of life, and to reduce work-related stress and absenteeism. This is the first study to compare the additive effects of three forms of a tailored intervention using different techniques from behavioural theory, which differ according to their focus on motivational, self-regulatory and/or habitual processes. Healthcare professionals (N = 192) will be recruited from four hospitals in Perth, Western Australia, via email lists, leaflets, and posters to participate in the four group randomised controlled trial. Participants will be randomised to one of four conditions: (1) education only (non-tailored information only), (2) education plus intervention components to enhance motivation, (3) education plus components to enhance motivation and self-regulation, and (4) education plus components to enhance motivation, self-regulation and habit formation. All intervention groups will receive a computer-tailored intervention administered via a web-based platform and will receive supporting text-messages containing tailored information, prompts and feedback relevant to each condition. All outcomes will be assessed at baseline, and at 3-month follow-up. The primary outcome assessed in this study is physical activity measured using activity monitors. Secondary outcomes include: quality of life, stress, anxiety, sleep, and absenteeism. Website engagement, retention, preferences and intervention fidelity will also be evaluated as well as potential mediators and moderators of intervention effect. This is the first study to examine a tailored, technology-supported intervention aiming to increase physical activity in healthcare professionals. The study will evaluate whether including additional theory-based behaviour change techniques aimed at promoting motivation, self-regulation and habit will lead to increased physical activity participation relative to information alone. The online platform developed in this study has potential to deliver efficient, scalable and personally-relevant intervention that can be translated to other occupational settings. Australian New-Zealand Clinical Trial Registry: ACTRN12616000462482, submitted 29/03/2016, prospectively registered 8/04/2016.

Exercise combined with Acceptance and Commitment Therapy (ExACT) compared to a supervised exercise programme for adults with chronic pain: study protocol for a randomised controlled trial.

PubMed

Casey, Máire-Bríd; Smart, Keith; Segurado, Ricardo; Hearty, Conor; Gopal, Hari; Lowry, Damien; Flanagan, Dearbhail; McCracken, Lance; Doody, Catherine

2018-03-22

Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy, which may be beneficial for people with chronic pain. The approach aims to enhance daily functioning through increased psychological flexibility. Whilst the therapeutic model behind ACT appears well suited to chronic pain, there is a need for further research to test its effectiveness in clinical practice, particularly with regards to combining ACT with physical exercise. This prospective, two-armed, parallel-group, single-centre randomised controlled trial (RCT) will assess the effectiveness of a combined Exercise and ACT programme, in comparison to supervised exercise for chronic pain. One hundred and sixty patients, aged 18 years and over, who have been diagnosed with a chronic pain condition by a physician will be recruited to the trial. Participants will be individually randomised to one of two 8-week, group interventions. The combined group will take part in weekly psychology sessions based on the ACT approach, in addition to supervised exercise classes led by a physiotherapist. The control group will attend weekly supervised exercise classes but will not take part in an ACT programme. The primary outcome will be pain interference at 12-week follow-up, measured using the Brief Pain Inventory-Interference Scale. Secondary outcomes will include self-reported pain severity, self-perception of change, patient satisfaction, quality of life, depression, anxiety and healthcare utilisation. Treatment process measures will include self-efficacy, pain catastrophising, fear avoidance, pain acceptance and committed action. Physical activity will be measured using Fitbit Zip TM activity trackers. Both groups will be followed up post intervention and again after 12 weeks. Estimates of treatment effects at follow-up will be based on an intention-to-treat framework, implemented using a linear mixed-effects model. Individual and focus group qualitative interviews will be undertaken with a purposeful sample of participants to explore patient experiences of both treatments. To our knowledge, this will be the first RCT to examine whether combining exercise with ACT produces greater benefit for patients with chronic pain, compared to a standalone supervised exercise programme. www.ClinicalTrials.gov, ID: NCT03050528 . Registered on 13 February 2017.

The effects of a mindfulness-based lifestyle programme for adults with Parkinson's disease: protocol for a mixed methods, randomised two-group control study.

PubMed

Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

2013-10-10

Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11/2662-2011001553. This is the first research of its kind in Australia involving a comprehensive, lifestyle-based programme for people with PD and has the potential to involve a broader range of providers than standard care. The findings will be disseminated through peer reviewed journals, primary care conferences in Australia as well as abroad and through the Parkinson's community. Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820.

The effects of a mindfulness-based lifestyle programme for adults with Parkinson’s disease: protocol for a mixed methods, randomised two-group control study

PubMed Central

Advocat, Jenny; Russell, Grant; Enticott, Joanne; Hassed, Craig; Hester, Jennifer; Vandenberg, Brooke

2013-01-01

Introduction Parkinson's disease (PD) is the second most common neurodegenerative disorder in developed countries. There is an increasing interest in the use of mindfulness-related interventions in the management of patients with a chronic disease. In addition, interventions that promote personal control, stress-management and other lifestyle factors, such as diet and exercise, assist in reducing disability and improving quality of life in people with chronic illnesses. There has been little research in this area for people with PD. Methods A prospective mixed-method randomised clinical trial involving community living adults with PD aged <76 years and with moderate disease severity (Hoehn and Yahr stage 2) PD. Participants will be randomised into the ESSENCE 6-week programme or a matched wait list control group. ESSENCE is a multifaceted, healthy lifestyle and mindfulness programme designed to improve quality of life. We aim to determine whether participation in a mindfulness and lifestyle programme could improve PD-related function and explore self-management related experiences and changing attitudes towards self-management. The outcome measures will include 5 self-administered questionnaires: PD function and well-being questionnaire (PDQ39), Health Behaviours, Mental health, Multidimensional locus of control, and Freiburg mindfulness inventory. An embedded qualitative protocol will include in-depth interviews with 12 participants before and after participation in the 6-week programme and a researcher will observe the programme and take notes. Analysis Repeated measures of Analysis of Variance (ANOVA) will examine the outcome measures for any significant effects from the group allocation, age, sex, adherence score and attendance. Qualitative data will be analysed thematically. We will outline the benefits of, and barriers to, the uptake of the intervention. Ethics This protocol has received ethics approval from the Monash University Human Research Ethics Committee project number CF11/2662–2011001553. Dissemination This is the first research of its kind in Australia involving a comprehensive, lifestyle-based programme for people with PD and has the potential to involve a broader range of providers than standard care. The findings will be disseminated through peer reviewed journals, primary care conferences in Australia as well as abroad and through the Parkinson's community. Registration details Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000440820. PMID:24114370

The effects of immunotherapy with intravenous immunoglobulins versus no intervention, placebo, or usual care in patients with recurrent miscarriages: a protocol for a systematic review with meta-analyses, trial sequential analyses, and individual patient data meta-analyses of randomised clinical trials.

PubMed

Egerup, Pia; Lindschou, Jane; Gluud, Christian; Christiansen, Ole Bjarne

2014-08-15

Recurrent miscarriage is generally defined as three or more miscarriages before gestational week 20. Recurrent miscarriage affects 1% of all women and the condition can only be explained by parental chromosome abnormalities, uterine malformations, or endocrine or thrombophilic disturbances to a limited extent. Immunological disturbances are hypothesised to play an important role in recurrent miscarriage and, therefore, various types of immunologically-based therapies have been tested in recurrent miscarriage patients including intravenous immunoglobulins. So far, at least eight randomised placebo-controlled trials, with opposing results, investigating intravenous immunoglobulins with a total of 324 recurrent miscarriage patients have been published. We will include randomised clinical trials irrespective of publication date, publication type, publication language, and publication status investigating infusions with immunoglobulins in relation to pregnancy compared to placebo, no intervention, or treatment as usual for assessments of benefits and harms. The relevant published literature will be searched using the following databases: Cochrane Central Register of Controlled Trials, Medline, Embase, WHO International Clinical Trials Registry Platform, and Ovid Medline In-Process and Other Non-Indexed Citations databases. Two review authors will independently extract data and assess risk of bias. We will undertake meta-analyses according to the recommendations stated in the Cochrane Handbook for Systematic Reviews of Interventions. Further, we will conduct trial sequential analyses and individual patient data meta-analyses. A miscarriage results in great sorrow, loss of life quality, and personal concern. In particular, recurrent miscarriage is extremely stressful and burdensome. It is, therefore, very important to conduct research in this area. There is currently no evidence-based treatment for women with recurrent miscarriage which significantly improves their ability to give live birth. Therefore, a comprehensive up-to-date systematic review is needed. By using individual patient data, it will be possible to provide new knowledge about the benefits and harms of intravenous immunoglobulins and try to identify the subgroup in which the treatment will have the highest impact.This systematic review protocol was registered within the International Prospective Register of Systematic Reviews (PROSPERO) as number CRD42014007112.

Use of Low-Fidelity Simulation Laboratory Training for Teaching Radiology Residents CT-Guided Procedures.

PubMed

Picard, Melissa; Nelson, Rachel; Roebel, John; Collins, Heather; Anderson, M Bret

2016-11-01

To determine the benefit of the addition of low-fidelity simulation-based training to the standard didactic-based training in teaching radiology residents common CT-guided procedures. This was a prospective study involving 24 radiology residents across all years in a university program. All residents underwent standard didactic lecture followed by low-fidelity simulation-based training on three common CT-guided procedures: random liver biopsy, lung nodule biopsy, and drain placement. Baseline knowledge, confidence, and performance assessments were obtained after the didactic session and before the simulation training session. Approximately 2 months later, all residents participated in a simulation-based training session covering all three of these procedures. Knowledge, confidence, and performance data were obtained afterward. These assessments covered topics related to preprocedure workup, intraprocedure steps, and postprocedure management. Knowledge data were collected based on a 15-question assessment. Confidence data were obtained based on a 5-point Likert-like scale. Performance data were obtained based on successful completion of predefined critical steps. There was significant improvement in knowledge (P = .005), confidence (P < .008), and tested performance (P < .043) after the addition of simulation-based training to the standard didactic curriculum for all procedures. This study suggests that the addition of low-fidelity simulation-based training to a standard didactic-based curriculum is beneficial in improving resident knowledge, confidence, and tested performance of common CT-guided procedures. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Simultaneous mobile- and fixed-bearing total knee replacement in the same patients. A prospective comparison of mid-term outcomes using a similar design of prosthesis.

PubMed

Kim, Y-H; Kim, D-Y; Kim, J-S

2007-07-01

We conducted a randomised prospective study to evaluate the clinical and radiological results of a mobile- and fixed-bearing total knee replacement of similar design in 174 patients who had bilateral simultaneous knee replacement. The mean follow-up was for 5.6 years (5.2 to 6.1). The total knee score, pain score, functional score and range of movement were not statistically different (p > 0.05) between the two groups. Osteolysis was not seen in any knee in either group. Two knees (1%) in the mobile-bearing group required revision because of infection; none in the fixed-bearing group needed revision. Excellent results can be achieved with both mobile- and fixed-bearing prostheses of similar design at mid-term follow-up. We could demonstrate no significant clinical advantage for a mobile bearing.

Safety of 8-aminoquinolines given to people with G6PD deficiency: protocol for systematic review of prospective studies.

PubMed

Uthman, Olalekan A; Saunders, Rachel; Sinclair, David; Graves, Patricia; Gelband, Hellen; Clarke, Aileen; Garner, Paul

2014-05-14

A single dose or short course of primaquine given to people infected with malaria may reduce transmission of Plasmodium falciparum through its effects on gametocytes. Primaquine is also known to cause haemolysis in people with variants of glucose-6-phosphate dehydrogenase (G6PD) deficiency. The objective of this systematic review was to assess the risk of adverse effects in people with G6PD deficiency given primaquine or other 8-aminoquinoline (8AQ) as a single dose or short course (less than 7 days). We will search the following databases: Cochrane Infectious Diseases Group Specialized Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and LILACS. Prospective cohort studies, randomised and quasi-randomised trials that evaluated 8AQs for whatever reason in adults or children with a known G6PD deficiency will be included. Two authors will independently assess each study for eligibility, risk of bias and extract data. This systematic review will be published in a peer-reviewed journal. Brief reports of the review findings will be disseminated directly to the appropriate audiences and the WHO Technical Expert Group in Malaria Chemotherapy. As no primary data collection will be undertaken, no additional formal ethical assessment and informed consent are required. The protocol is registered with PROSPERO, registration number CRD42013006518. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Shoulder-arm morbidity in patients with sentinel node biopsy and complete axillary dissection--data from a prospective randomised trial.

PubMed

Helms, G; Kühn, T; Moser, L; Remmel, E; Kreienberg, R

2009-07-01

Axillary lymph node dissection (ALND) as part of surgical treatment in breast cancer has been the standard procedure for many decades. However, patients frequently develop shoulder-arm morbidity postoperatively. Recently, sentinel node (SN) biopsy has been established as a new standard of care for axillary staging in breast cancer. This study compares postoperative morbidity between ALND and SN biopsy. The results are compared with the existing literature. Between November 2000 and September 2002, 181 women with early stage breast cancer underwent primary surgery following preoperative randomisation into two groups, a "standard group" (SN biopsy was followed by ALND) and a study group (surgical procedure consisting of only SN biopsy when histologically metastasis-free SN was present). Follow-up data (362 sessions; 6 months to 3 years after primary surgery) were available from 150 patients. A summary morbidity score was calculated from four subjective (arm-strength, arm-mobility, arm swelling, pain) and four objective (arm-strength, arm-mobility, lymphedema, sensitivity) criteria. Fifty seven patients underwent SN biopsy only. Ninety three patients underwent ALND, 57 of which had lymph nodes free of metastasis and 36 had lymph nodes with metastasis and axillary clearing. Shoulder-arm morbidity was significantly different between the groups. Patients treated with SN biopsy only scored better on subjective and objective criteria. Postsurgical shoulder-arm morbidity is a major long-term problem in patients undergoing surgical treatment for breast cancer. This prospective study showed significantly less severe shoulder-arm morbidity following SN biopsy compared to patients undergoing ALND.

A comparison of the efficacy of intercostal nerve block and peritubal infiltration of ropivacaine for post-operative analgesia following percutaneous nephrolithotomy: A prospective randomised double-blind study.

PubMed

Jonnavithula, Nirmala; Chirra, Raveendra Reddy; Pasupuleti, Sai Lakshman; Devraj, Rahul; Sriramoju, Vidyasagar; Pisapati, Murthy Vln

2017-08-01

Intercostal nerve blockade (ICNB) and peritubal infiltration of the nephrostomy tract are well-established regional anaesthetic techniques for alleviating pain after percutaneous nephrolithotomy (PCNL). This prospective study compared the efficacy of ICNB and peritubal local anaesthetic infiltration of the nephrostomy tract in providing post-operative analgesia following PCNL. Sixty American Society of Anesthesiologist physical status 1 and II patients scheduled for PCNL requiring nephrostomy tube were randomised to receive either peritubal infiltration or ICNB. At the completion of the procedure, patients in Group P received peritubal infiltration and those in Group I received ICNB at 10, 11, 12 th spaces using fluoroscopy guidance. Postoperatively, patients were followed for 24 h for pain using Visual Analogue Scale (VAS) and Dynamic VAS. Rescue analgesia was inj. tramadol 1 mg/kg IV when pain score exceeded 4. Time to first rescue analgesia, number of doses and patient's satisfaction were noted in all patients. Pain scores were lower in the group I at all points of measurement than group P. The mean time to first demand for rescue analgesia was higher in Group I (13.22 ± 4.076 h vs 7.167 ± 3.92 h P - 0.001). The number of demands and the amount of analgesics consumed were less in Group I. ICNB provided superior analgesia as evidenced by longer time to first demand of analgesic, reduced number of demands and consumption of rescue analgesic. Peritubal infiltration, although less efficacious, may be a safe and simple alternative technique.

Abdominoplasty and seroma: a prospective randomised study comparing scalpel and handheld electrocautery dissection.

PubMed

Marsh, Dan J; Fox, Andreas; Grobbelaar, Adriaan O; Chana, Jagdeep S

2015-02-01

Seroma formation remains a significant problem in abdominoplasty procedures--the cause of which remains to be elucidated. It has been suggested that one of the causative factors for seroma formation is the use of handheld electrocautery as opposed to scalpel for abdominal flap dissection. Prospective trial in 102 consecutive abdominoplasty patients randomised to have abdominal flap dissection with either handheld electrocautery device on 'coagulation setting' or sharp dissection with scalpel and monopolar electrocautery forceps for haemostasis. In all other aspects the surgical technique was identical between the two groups. All drains were removed at 48 h, irrespective of drain volume. Primary outcome measure is postoperative seroma formation on clinical examination, secondary outcome measures are drain volume, weight of tissue removed, effect of liposuction and patient BMI. Both study groups were similar in demographics with no significant difference in weight of tissue excised, BMI, drain output or post operative complictions. There was no significant difference in seroma formation rates between the handheld electrocautery group (17.2%) and the sharp dissection group (20.1%). Overall, the seroma rate was 18.6%. Liposuction to the flanks at the time of abdominoplasty was found to significantly increase the incidence of seroma, compared to patients having abdominoplasty alone. Use of handheld electrocautery rather than scalpel for tissue dissection does not lead to increased seroma formation in abdominoplasty patients. Concomitant liposuction at the time of abdominoplasty increases the risk of seroma formation compared to patients having abdominoplasty alone. Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

Clinico-radiological Outcome Analysis of Parallel Plating with Perpendicular Plating in Distal Humeral Intra-articular Fractures: Prospective Randomised Study

PubMed Central

Shekhawat, Vishal; Banshiwal, Ramesh Chandra; Verma, Rajender Kumar

2017-01-01

Introduction The distal humeral fractures are common fractures of upper limb and are difficult to treat. These fractures, if left untreated or inadequately treated, leads to poor outcomes. Management of distal humeral fractures are pertained to many controversies and one among them is position of plates. Aim To compare the clinical and radiological outcomes in patients with intra-articular distal humerus fractures, treated using parallel and perpendicular double plating methods. Materials and Methods A total of 38 patients with distal humerus fractures, 20 in perpendicular plating group (group A) and 18 in parallel plating group (group B), were included in this prospective randomised study. At each follow up patients were evaluated clinically and radiologically for union and the outcomes were measured in terms of Mayo Elbow Performance Score (MEPS) consisting of pain intensity, range of motion, stability and function. MEP score greater than 90 is considered as excellent; Score 75 to 89 is good; Score 60 to 74 is fair and Score less than 60 is poor. Results In our study, 15 patients (75%) in group A, and 13 patients (72.22%) in group B achieved excellent results. Two patients (10%) in group A and 4 patients (22.22%) in group B attained good results. Complications developed in 2 patients in each groups. No significant differences were found between the clinical outcomes of the two plating methods. Conclusion Neither of the plating techniques are superior to the other, as inferred from the insignificant differences in bony union, elbow function and complications between the two plating techniques. PMID:28384948

Clinico-radiological Outcome Analysis of Parallel Plating with Perpendicular Plating in Distal Humeral Intra-articular Fractures: Prospective Randomised Study.

PubMed

Govindasamy, Ramachandran; Shekhawat, Vishal; Banshiwal, Ramesh Chandra; Verma, Rajender Kumar

2017-02-01

The distal humeral fractures are common fractures of upper limb and are difficult to treat. These fractures, if left untreated or inadequately treated, leads to poor outcomes. Management of distal humeral fractures are pertained to many controversies and one among them is position of plates. To compare the clinical and radiological outcomes in patients with intra-articular distal humerus fractures, treated using parallel and perpendicular double plating methods. A total of 38 patients with distal humerus fractures, 20 in perpendicular plating group (group A) and 18 in parallel plating group (group B), were included in this prospective randomised study. At each follow up patients were evaluated clinically and radiologically for union and the outcomes were measured in terms of Mayo Elbow Performance Score (MEPS) consisting of pain intensity, range of motion, stability and function. MEP score greater than 90 is considered as excellent; Score 75 to 89 is good; Score 60 to 74 is fair and Score less than 60 is poor. In our study, 15 patients (75%) in group A, and 13 patients (72.22%) in group B achieved excellent results. Two patients (10%) in group A and 4 patients (22.22%) in group B attained good results. Complications developed in 2 patients in each groups. No significant differences were found between the clinical outcomes of the two plating methods. Neither of the plating techniques are superior to the other, as inferred from the insignificant differences in bony union, elbow function and complications between the two plating techniques.

Early and late histamine release induced by albumin, hetastarch and polygeline: some unexpected findings.

PubMed

Celik, I; Duda, D; Stinner, B; Kimura, K; Gajek, H; Lorenz, W

2003-10-01

The perioperative use of colloidal plasma substitutes is still under discussion. We therefore conducted a prospective randomised study with three commonly used plasma substitutes to examine their histamine releasing effects in 21 volunteers. MATERIAL OR SUBJETS: 21 male volunteers were enrolled in this prospective, randomised, controlled clinical study. Endpoints were the incidence of early and late histamine release and the time course of the release kinetics. Normovolemic hemodilution technique was used with hydroxyethyl starch (n = 6), human albumin (n = 6) and polygeline (n = 9). Measurement and observation period was 240 min after the start of the plasma substitute infusion. Heart rate, blood pressure, SaO(2), clinical symptoms/signs and plasma histamine were measured during the observation period. The incidence of histamine release over the whole observation period in all three groups was 100%. Histamine release occurred frequently in all three groups until 30 min (50%-78%) and up to 240 min (late release reaction: 67%-83%) after the start of infusion. Surprisingly even hydroxyethyl starch, which is regarded as a generally safe and effective plasma substitute, caused high incidences of late histamine release (67%). Histamine release is a well known side effect of polygeline and - to a lesser extent - also of albumin, but was a novel finding for hydroxyethyl starch. We demonstrated for the first time histamine releasing effects of hydroxyethyl starch over a long period of time after administration. This perioperatively and for intensive care possibly relevant finding should make clinicians aware of late side effects not yet connected with the clinical use of these colloidal plasma substitutes.

Effect of levodopa in combination with physiotherapy on functional motor recovery after stroke: a prospective, randomised, double-blind study.

PubMed

Scheidtmann, K; Fries, W; Müller, F; Koenig, E

2001-09-08

Functional disability is generally caused by hemiplegia after stroke. Physiotherapy used to be the only way of improving motor function in such patients. However, administration of amphetamines in addition to exercise improves motor recovery in animals, probably by increasing the concentration of norepinephrine in the central nervous system. Our aim was to ascertain whether levodopa could enhance the efficacy of physiotherapy after hemiplegia. We did a prospective, randomised, placebo-controlled, double-blind study in which we enrolled 53 primary stroke patients. For the first 3 weeks patients received single doses of levodopa 100 mg or placebo daily in combination with physiotherapy. For the second 3 weeks patients had only physiotherapy. We quantitatively assessed motor function every week with Rivermead motor assessment (RMA). Six patients were excluded from analyses because of non-neurological complications. Motor recovery was significantly improved after 3 weeks of drug intervention in those on levodopa (RMA improved by 6.4 points) compared with placebo (4.1), and the result was independent of initial degree of impairment (p<0.004). The advantage of the levodopa group was maintained at study endpoint 3 weeks after levodopa was stopped. At the end of the study the total RMA score gain for the levodopa group was 8.2 points compared with 5.7 in the placebo group (p=0.020). A single dose of levodopa is well tolerated and, when given in combination with physiotherapy, enhances motor recovery in patients with hemiplegia. In view of its minimal side-effects, levodopa will be a possible add- on during stroke rehabilitation.

A prospective randomised trial comparing mesh types and fixation in totally extraperitoneal inguinal hernia repairs.

PubMed

Cristaudo, Adam; Nayak, Arun; Martin, Sarah; Adib, Reza; Martin, Ian

2015-05-01

The totally extraperitoneal (TEP) approach for surgical repair of inguinal hernias has emerged as a popular technique. We conducted a prospective randomised trial to compare patient comfort scores using different mesh types and fixation using this technique. Over a 14 month period, 146 patients underwent 232 TEP inguinal hernia repairs. We compared the comfort scores of patients who underwent these procedures using different types of mesh and fixation. A non-absorbable 15 × 10 cm anatomical mesh fixed with absorbable tacks (Control group) was compared with either a non-absorbable 15 × 10 cm folding slit mesh with absorbable tacks (Group 2), a partially-absorbable 15 × 10 cm mesh with absorbable tacks (Group 3) or a non-absorbable 15 × 10 cm anatomical mesh fixed with 2 ml fibrin sealant (Group 4). Outcomes were compared at 1, 2, 4 and 12 weeks using the Carolina Comfort Scale (CCS) scores. At 1, 2, 4 and 12 weeks, the median global CCS scores were low for all treatment groups. Statistically significant differences were seen only for median CCS scores and subscores with the use of partially-absorbable mesh with absorbable tacks (Group 3) at weeks 2 and 4. However, these were no longer significant at week 12. In this study, the TEP inguinal hernia repair with minimal fixation results in low CCS scores. There were no statistical differences in CCS scores when comparing types of mesh, configuration of the mesh or fixation methods. Copyright © 2015 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial.

PubMed

Hyland, Ela J; D'Cruz, Rachel; Harvey, John G; Moir, Jordyn; Parkinson, Christina; Holland, Andrew J A

2015-12-01

Burns remain extremely painful and distressing in young children. The consequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn dressing changes. A prospective, randomised controlled trial was conducted, comparing CLT versus standard care in relation to pain and anxiety scores of children undergoing their initial burn dressing change. Pain and anxiety were assessed by an independent observer and questionnaires completed by the child, parent/caregiver and nursing staff. 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group (p=0.03). Whilst pain was significantly better in the CLT group (p=0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial.

PubMed

Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Lam, Carly S Y; Dai, Shuan; Gao, Tina Y; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie; Wadham, Angela; Thompson, Benjamin

2016-10-18

Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at baseline, 3, 6, 12 and 24 weeks post randomisation. Treatment compliance and acceptability will also be assessed along with quality of life for adult participants. The BRAVO study is the first randomised controlled trial of a home-based videogame treatment for older children and adults with amblyopia. The results will indicate whether a binocular approach to amblyopia treatment conducted at home is effective for patients aged 7 years or older. This trial was registered in Australia and New Zealand Clinical Trials Registry ( ACTRN12613001004752 ) on 10 September 2013.

Is a controlled randomised trial the non-plus-ultra design? A contribution to discussion on comparative, controlled, non-randomised trials.

PubMed

Gaus, Wilhelm; Muche, Rainer

2013-05-01

Clinical studies provide formalised experience for evidence-based medicine (EBM). Many people consider a controlled randomised trial (CRT, identical to a randomised controlled trial RCT) to be the non-plus-ultra design. However, CRTs also have limitations. The problem is not randomisation itself but informed consent for randomisation and masking of therapies according to today's legal and ethical standards. We do not want to de-rate CRTs, but we would like to contribute to the discussion on clinical research methodology. Informed consent to a CRT and masking of therapies plainly select patients. The excellent internal validity of CRTs can be counterbalanced by poor external validity, because internal and external validity act as antagonists. In a CRT, patients may feel like guinea pigs, this can decrease compliance, cause protocol violations, reduce self-healing properties, suppress unspecific therapeutic effects and possibly even modify specific efficacy. A control group (comparative study) is most important for the degree of evidence achieved by a trial. Study control by detailed protocol and good clinical practice (controlled study) is second in importance and randomisation and masking is third (thus the sequence CRT instead of RCT). Controlled non-randomised trials are just as ambitious and detailed as CRTs. We recommend clinicians and biometricians to take high quality controlled non-randomised trials into consideration more often. They combine good internal and external validity, better suit daily medical practice, show better patient compliance and fewer protocol violations, deliver estimators unbiased by alienated patients, and perhaps provide a clearer explanation of the achieved success. Copyright © 2013 Elsevier Inc. All rights reserved.

Beyond total treatment effects in randomised controlled trials: Baseline measurement of intermediate outcomes needed to reduce confounding in mediation investigations.

PubMed

Landau, Sabine; Emsley, Richard; Dunn, Graham

2018-06-01

Random allocation avoids confounding bias when estimating the average treatment effect. For continuous outcomes measured at post-treatment as well as prior to randomisation (baseline), analyses based on (A) post-treatment outcome alone, (B) change scores over the treatment phase or (C) conditioning on baseline values (analysis of covariance) provide unbiased estimators of the average treatment effect. The decision to include baseline values of the clinical outcome in the analysis is based on precision arguments, with analysis of covariance known to be most precise. Investigators increasingly carry out explanatory analyses to decompose total treatment effects into components that are mediated by an intermediate continuous outcome and a non-mediated part. Traditional mediation analysis might be performed based on (A) post-treatment values of the intermediate and clinical outcomes alone, (B) respective change scores or (C) conditioning on baseline measures of both intermediate and clinical outcomes. Using causal diagrams and Monte Carlo simulation, we investigated the performance of the three competing mediation approaches. We considered a data generating model that included three possible confounding processes involving baseline variables: The first two processes modelled baseline measures of the clinical variable or the intermediate variable as common causes of post-treatment measures of these two variables. The third process allowed the two baseline variables themselves to be correlated due to past common causes. We compared the analysis models implied by the competing mediation approaches with this data generating model to hypothesise likely biases in estimators, and tested these in a simulation study. We applied the methods to a randomised trial of pragmatic rehabilitation in patients with chronic fatigue syndrome, which examined the role of limiting activities as a mediator. Estimates of causal mediation effects derived by approach (A) will be biased if one of the three processes involving baseline measures of intermediate or clinical outcomes is operating. Necessary assumptions for the change score approach (B) to provide unbiased estimates under either process include the independence of baseline measures and change scores of the intermediate variable. Finally, estimates provided by the analysis of covariance approach (C) were found to be unbiased under all the three processes considered here. When applied to the example, there was evidence of mediation under all methods but the estimate of the indirect effect depended on the approach used with the proportion mediated varying from 57% to 86%. Trialists planning mediation analyses should measure baseline values of putative mediators as well as of continuous clinical outcomes. An analysis of covariance approach is recommended to avoid potential biases due to confounding processes involving baseline measures of intermediate or clinical outcomes, and not simply for increased precision.

Implementing Randomised Control Trials in Open and Distance Learning: A Feasibility Study

ERIC Educational Resources Information Center

Herodotou, Christothea; Heiser, Sarah; Rienties, Bart

2017-01-01

Randomised control trials (RCTs) are an evidence-based research approach which has not yet been adopted and widely used in open and distance education to inform educational policy and practice. Despite the challenges entailed in their application, RCTs hold the power to robustly evaluate the effects of educational interventions in distance…

A prospective randomised trial comparing the novel ridaforolimus-eluting BioNIR stent to the zotarolimus-eluting Resolute stent: six-month angiographic and one-year clinical results of the NIREUS trial.

PubMed

Paradies, Valeria; Ben-Yehuda, Ori; Jonas, Michael; Banai, Shmuel; Iñiguez, Andres; Perlman, Gidon Y; Kandzari, David E; Stone, Gregg W; Smits, Pieter C

2018-05-20

The aim of this study was to evaluate the efficacy and safety of the BioNIR stent compared with the Resolute Integrity stent for the treatment of coronary artery disease. This first-in-human, multicentre, single-blind randomised non-inferiority trial was performed in Europe and Israel. Patients with stable coronary artery disease or acute coronary syndromes were randomly assigned to treatment with BioNIR or Resolute Integrity stents in a 2:1 fashion. The primary endpoint was angiographic in-stent late lumen loss (LLL) at six months. Three hundred and two patients were randomised, of whom 261 (86.0%) underwent six-month angiographic follow-up. The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of in-stent LLL at six months (0.04±0.30 mm vs. 0.03±0.31 mm, respectively, pnoninferiority<0.0001). At 12-month follow-up, target lesion failure occurred in 3.4% in the BioNIR group and 5.9% in the Resolute Integrity group (p=0.22). Rates of MACE were similar between the BioNIR and Resolute Integrity groups (4.3% vs. 5.9%, respectively, p=0.45). The BioNIR stent was non-inferior to the Resolute Integrity stent for the primary endpoint of angiographic in-stent LLL at six months. Clinical outcomes at one year were comparable between the two groups.

Endovenous laser ablation of the great saphenous vein using a bare fibre versus a tulip fibre: a randomised clinical trial.

PubMed

Vuylsteke, M E; Thomis, S; Mahieu, P; Mordon, S; Fourneau, I

2012-12-01

This clinical trial aimed to evaluate the clinical results of the use of a tulip fibre versus the use of a bare fibre for endovenous laser ablation. In a multicentre prospective randomised trial 174 patients were randomised for the treatment of great saphenous vein reflux. A duplex scan was scheduled 1 month, 6 months and 1 year postoperatively. Ecchymosis was measured on the 5th postoperative day. In addition, pain, analgesics requirement, postoperative quality of life (CIVIQ 2) and patient satisfaction rate were noted. Patients treated with a tulip fibre had significantly less postoperative ecchymosis (0.04 vs. 0.21; p < 0.001) and pain (5th day) (1.00 vs. 2.00; p < 0.001) and had a better postoperative quality of life (27 vs. 32; p = 0.023). There was no difference in analgesic intake (p = 0.11) and patient satisfaction rate (p = 0.564). The total occlusion rate at 1 year was 97.02% and there was no significant difference between the two groups (p = 0.309). Using a tulip fibre for EVLA of the great saphenous vein results, when compared with the use of a bare fibre, in equal occlusion rates at 1 year but causes less postoperative ecchymosis and pain and in a better postoperative quality of life. Copyright © 2012 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Multicolour versus monocolour inking specimens after pancreaticoduodenectomy for periampullary cancer: A single centre prospective randomised clinical trial.

PubMed

Casadei, Riccardo; Ricci, Claudio; Taffurelli, Giovanni; Pacilio, Carlo Alberto; Santini, Donatella; Di Marco, Mariacristina; Minni, Francesco

2018-03-01

R status represents an important prognostic factors in periampullary cancers. Thus, it is useful to verify if it can be influenced by different techniques of margination. Single-centre, randomised clinical trial of patients affected by periampullary cancer who underwent pancreaticoduodenectomies which included two different types of margination: arm A (multicolour inking) and arm B (monocolour inking). The primary endpoint was the overall R1 resection rate and its difference between the two arms. The secondary endpoints were the R1 resection rate in each margin and its difference between the two arms, and the impact of margin status on survival. Fifty patients were randomised, 41 analysed: 22 in arm A, 19 arm B. The overall R1 status was 61%, without significant differences between the two arms. The margin most commonly involved was the superior mesenteric artery (SMA) (36.6%). A trend in favour of arm B was shown for the superior mesenteric artery margin (arm A = 22.7% versus arm B = 52.6%; P = 0.060). The anterior surface (P = 0.015), SMA (P = 0.047) and pancreatic remnant (P = 0.018) margins significantly influenced disease-free survival. The R status was not influenced by different techniques of margination using a standardised pathological protocol. The SMA margin seemed to be the most important margin for evaluating both R status and disease-free survival. Copyright © 2018. Published by Elsevier Ltd.

Randomised trial of amnioinfusion during labour with meconium stained amniotic fluid.

PubMed

Rathor, Asmita Muthal; Singh, Ruchira; Ramji, S; Tripathi, Reva

2002-01-01

To assess the effect of amnioinfusion during labour with meconium stained amniotic fluid on caesarean section rate and perinatal outcome. Prospective randomised controlled study. A tertiary care teaching hospital in India. Women in labour at term with meconium stained amniotic fluid. Two hundred women in labour with > or = 37 weeks gestation, single cephalic presentation with moderate or thick meconium were randomised to control and amnioinfusion groups at a 1:1 ratio. Amnioinfusion was performed using 500 mL of normal saline over a period of 30 minutes in a study group. The control group received routine care. Both groups had intermittent auscultation of fetal heart rate during labour. The primary outcome measure was caesarean section rate. Secondary outcome measures were meconium aspiration syndrome, 1 minute and 5 minute apgar < 7, hypoxic ischaemic encephalopathy, neonatal intensive care unit admission, meconium at the level of vocal cords. The caesarean section rate in the amnioinfusion group was less than the control group (RR 0.47; 95% CI 0.24-0.93). Amnioinfusion was associated with a significant decrease in the incidence of meconium at the vocal cords (P = 0.001); improvement in 1 minute apgar scores (P < 0.05), respiratory distress (P = 0.002) and fewer admissions to nursery compared with the controls. This sample size was inadequate to study the impact on meconium aspiration syndrome. Amnioinfusion in an under resourced labour ward decreases caesarean section rates and fetal morbidity.

A meta-analysis of randomised controlled trials on preoperative oral carbohydrate treatment in elective surgery.

PubMed

Awad, Sherif; Varadhan, Krishna K; Ljungqvist, Olle; Lobo, Dileep N

2013-02-01

Whilst preoperative carbohydrate treatment (PCT) results in beneficial physiological effects, the effects on postoperative clinical outcomes remain unclear and were studied in this meta-analysis. Prospective studies that randomised adult non-diabetic patients to either PCT (≥50 g oral carbohydrates 2-4 h pre-anaesthesia) or control (fasted/placebo) were included. The primary outcome was length of hospital stay. Secondary outcomes included development of postoperative insulin resistance, complications, nausea and vomiting. Methodological quality was assessed using GRADEpro® software. Twenty-one randomised studies of 1685 patients (733 PCT: 952 control) were included. No overall difference in length of stay was noted for analysis of all studies or subgroups of patients undergoing surgery with an expected hospital stay ≤2 days or orthopaedic procedures. However, patients undergoing major abdominal surgery following PCT had reduced length of stay [mean difference, 95% confidence interval: -1.08 (-1.87 to -0.29); I² = 60%, p = 0.007]. PCT reduced postoperative insulin resistance with no effects on in-hospital complications over control (risk ratio, 95% confidence interval, 0.88 (0.50-1.53), I² = 41%; p = 0.640). There was significant heterogeneity amongst studies and, therefore, quality of evidence was low to moderate. PCT may be associated with reduced length of stay in patients undergoing major abdominal surgery, however, the included studies were of low to moderate quality. Copyright © 2012 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

A randomised controlled trial of the effect of biphasic or monophasic waveform on the incidence and severity of cutaneous burns following external direct current cardioversion.

PubMed

Ambler, Jonathan J S; Deakin, Charles D

2006-12-01

Cutaneous burns are a common cause of morbidity following direct current (DC) cardioversion. We designed a prospective randomised double-blinded controlled study to determine the effect of biphasic or monophasic waveform on the pain and inflammation occurring after elective cardioversion. One hundred and thirty nine patients undergoing elective DC cardioversion were randomised to receive monophasic (HP Codemaster XL; 100, 200, 300, 360, and 360 J) or biphasic (Welch Allyn-MRL PIC defibrillator; 70, 100, 150, 200, and 300 J) waveforms. Two hours after DC cardioversion, skin temperature, erythema index and sensory threshold to light and sharp touch was measured at the centre and edge of paddle sites. Visual analogue pain score (VAS) was recorded at 2 and 24 h. There was significantly less pain following biphasic cardioversion as assessed by VAS at both 2 h (p < 0.001; 95% confidence intervals of difference of medians (CI) 0.2-0.8 cm) and 24 h (p = 0.004; 95% CI 0.0-0.4 cm). There was significantly less erythema in patients receiving biphasic cardioversion at the edge of the sternal site (p = 0.046; 95% CI 0.41-4.5). There was no difference in any other variable at any site between biphasic and monophasic cardioversion. The use of a biphasic waveform for DC cardioversion reduces the inflammation and pain of burns as measured by erythema index and visual analogue scale.

No effect of the infiltration of local anaesthetic for total hip arthroplasty using an anterior approach: a randomised placebo controlled trial.

PubMed

den Hartog, Y M; Mathijssen, N M C; van Dasselaar, N T; Langendijk, P N J; Vehmeijer, S B W

2015-06-01

Only limited data are available regarding the infiltration of local anaesthetic for total hip arthroplasty (THA), and no studies were performed for THA using the anterior approach. In this prospective, randomised placebo-controlled study we investigated the effect of both standard and reverse infiltration of local anaesthetic in combination with the anterior approach for THA. The primary endpoint was the mean numeric rating score for pain four hours post-operatively. In addition, we recorded the length of hospital stay, the operating time, the destination of the patient at discharge, the use of pain medication, the occurrence of side effects and pain scores at various times post-operatively. Between November 2012 and January 2014, 75 patients were included in the study. They were randomised into three groups: standard infiltration of local anaesthetic, reversed infiltration of local anaesthetic, and placebo. There was no difference in mean numeric rating score for pain four hours post-operatively (p = 0.87). There were significantly more side effects at one and eight hours post-operatively in the placebo group (p = 0.02; p = 0.03), but this did not influence the mobilisation of the patients. There were no differences in all other outcomes between the groups. We found no clinically relevant effect when the infiltration of local anaesthetic with ropivacaine and epinephrine was used in a multimodal pain protocol for THA using the anterior approach. ©2015 The British Editorial Society of Bone & Joint Surgery.

Cost-effective recruitment methods for a large randomised trial in people with diabetes: A Study of Cardiovascular Events iN Diabetes (ASCEND).

PubMed

Aung, Theingi; Haynes, Richard; Barton, Jill; Cox, Jolyon; Murawska, Aleksandra; Murphy, Kevin; Lay, Michael; Armitage, Jane; Bowman, Louise

2016-06-13

Clinical trials require cost-effective methods for identifying, randomising, and following large numbers of people in order to generate reliable evidence. ASCEND (A Study of Cardiovascular Events iN Diabetes) is a randomised '2 × 2 factorial design' study of aspirin and omega-3 fatty acid supplements for the primary prevention of cardiovascular events in people with diabetes; this study used central disease registers and a mail-based approach to identify, randomise, and follow 15,000 people. In collaboration with UK consultants and general practitioners (GPs), researchers identified potentially eligible people with diabetes from centrally held registers (e.g. for retinopathy screening) and GP-held disease registers. Permission was obtained under section 251 of the National Health Service Act 2006 (previously section 60 of the NHS act 2001) to allow invitation letters to be generated centrally in the name of the holder of the register. In addition, with the collaboration of the National Institutes for Health Research (NIHR) Diabetes and Primary Care Research Networks (DRN and PCRN), general practices sent pre-assembled invitation packs to people with a diagnosis of diabetes. Invitation packs included a cover letter, screening questionnaire (with consent form), information leaflet, and a Freepost envelope. Eligible patients entered a 2-month, pre-randomisation, run-in phase on placebo tablets and were only randomised if they completed a randomisation form and remained willing and eligible at the end of the run-in. Follow-up is ongoing, using mail-based approaches that are being supplemented by central registry data. Information on approximately 600,000 people listed on 58 centrally held diabetes registers was obtained, and 300,188 potentially eligible patients were invited to join the study. In addition, 785 GP practices mailed invitations to 120,875 patients. A further 2,340 potential study participants were identified via other routes. In total, 423,403 people with diabetes were invited to take part; 26,462 entered the 2-month, pre-randomisation, run-in phase; and 15,480 were randomised. If sufficient numbers of potentially eligible patients can be identified centrally and the trial treatments do not require participants to attend clinics, the recruitment and follow-up of patients by mail is feasible and cost-effective. Wider use of these methods could allow more, large, randomised trials to be undertaken successfully and cost-effectively. Current Controlled Trials, ISRCTN60635500 , registered on 14 July 2005.

A prospective, randomised trial of prophylactic antibiotics versus bag extraction in the prophylaxis of wound infection in laparoscopic cholecystectomy.

PubMed

Harling, R; Moorjani, N; Perry, C; MacGowan, A P; Thompson, M H

2000-11-01

Septic complications are rare following laparoscopic cholecystectomy if prophylactic antibiotics are given, as demonstrated in previous studies. Antibiotic treatment may be unnecessary and, therefore, undesirable, so we compared two forms of prophylaxis: a cephalosporin antibiotic and bag extraction of the dissected gallbladder. A total of 76 patients undergoing laparoscopic cholecystectomy were randomised to either receive an antibiotic or to have their gallbladder removed from the abdomen in a plastic bag. Complicated cases were excluded. There was a total of 6 wound infections (7.9%), 3 in each of the study groups. All these were associated with skin commensals. There were no other septic complications. Bacteriological studies grouped the organisms isolated from the bile and the wound as potential pathogens and likely commensals. A total of 10 potential pathogens were isolated, 9 of which were found in the group receiving antibiotics. We conclude that septic sequelae of uncomplicated laparoscopic cholecystectomy are uncommon, but clearly not entirely prevented by antibiotic or mechanical prophylaxis. Prophylactic antibiotics may not be required in uncomplicated laparoscopic cholecystectomy. Further study is warranted.

You can't pay me to quit: the failure of financial incentives for smoking cessation in head and neck cancer patients.

PubMed

Ghosh, A; Philiponis, G; Bewley, A; Ransom, E R; Mirza, N

2016-03-01

A prospective randomised study was conducted at a tertiary care hospital to evaluate the effects of financial incentives for smoking cessation targeted at a high-risk population. Patients with a past history of head and neck cancer were voluntarily enrolled over a two-year period. They were randomised to a cash incentives or no incentive group. Subjects were offered enrolment in smoking cessation courses. Smoking by-product levels were assessed at 30 days, 3 months and 6 months. Subjects in the incentive group received $150 if smoking cessation was confirmed. Over 2 years, 114 patients with an established diagnosis of head and neck cancer were offered enrolment. Twenty-four enrolled and 14 attended the smoking cessation classes. Only two successfully quit smoking at six months. Both these patients were in the financially incentivised group and received $150 at each test visit. Providing a financial incentive for smoking cessation to a population already carrying a diagnosis of head and neck cancer in order to promote a positive behaviour change was unsuccessful.

Neck dissection with harmonic scalpel and electrocautery? A randomised study.

PubMed

Verma, Roshan K; Mathiazhagan, Arulalan; Panda, Naresh K

2017-10-01

Is the use of harmonic scalpel for neck dissection useful? Literature search did not show a single, prospective, randomised control trial. We intended to study the role of harmonic scalpel in neck dissection and compare it with conventional electrocautery technique for oral cavity carcinoma. 40 patients undergoing selective neck dissection for primary oral cavity malignancy were enrolled in this study. The harmonic scalpel (HS) group consisted of 20 patients, and the electrocautery technique (ET) group comprised of 20 patients. The following variables were examined: intraoperative blood loss, operative time, number of ligatures used, postoperative drain, and postoperative hospital stay. Intraoperative blood loss was found to be significantly reduced in harmonic scalpel group as compared to electrocautery group. However, we found no difference in other parameters like operative time, postop drain, postoperative hospital stay and number of ligatures used between both groups. Harmonic scalpel for neck dissection is associated with significantly lesser intraoperative blood loss as compared to electrocautery. There is no effect on operative time and postoperative hospital stay in both groups. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Improvement in bronchial hyper-responsiveness in patients with moderate asthma after treatment with a hypnotic technique: a randomised controlled trial.

PubMed Central

Ewer, T C; Stewart, D E

1986-01-01

A prospective, randomised, single blind, and controlled trial of a hypnotic technique was undertaken in 39 adults with mild to moderate asthma graded for low and high susceptibility to hypnosis. After a six week course of hypnotherapy 12 patients with a high susceptibility score showed a 74.9% improvement (p less than 0.01) in the degree of bronchial hyper-responsiveness to a standardised methacholine challenge test. Daily home recordings of symptoms improved by 41% (p less than 0.01), peak expiratory flow rates improved by 5.5% (p less than 0.01), and use of bronchodilators decreased by 26.2% (p less than 0.05). The improvement in bronchial hyper-reactivity occurred without a change in subjective appreciation of the degree of bronchoconstriction. A control group 17 patients and 10 patients undergoing treatment with low susceptibility to hypnosis had no change in either bronchial hyper-responsiveness or any of the symptoms recorded at home. This study shows the efficacy of a hypnotic technique in adult asthmatics who are moderately to highly susceptible to hypnosis. PMID:3094804

The Value of Audio Devices in the Endoscopy Room (VADER) study: a randomised controlled trial.

PubMed

Ardalan, Zaid Sm; Vasudevan, Abhinav; Hew, Simon; Schulberg, Julien; Lontos, Steve

2015-12-14

To evaluate the effect of Star Wars music (SWM) compared with endoscopist-selected popular music (PM) on quality outcomes in colonoscopy. A single-centre, prospective, randomised controlled trial conducted in an endoscopy suite within a quaternary-centre gastroenterology unit, Melbourne, Australia. The primary outcome measures were procedure time, polyp detection rate (PDR) and adenoma detection rate (ADR). The secondary outcome measure was adenomas per colonoscopy (APC). 103 colonoscopies were analysed: 58 in the SWM group and 45 in the PM group. Bowel preparation was assessed as good or excellent in 57% of the SWM group compared with 69% of the PM group (P < 0.01). The PDR was significantly higher in the SWM group than in the PM group (60% v 35%; P = 0.006). Similarly, the ADR was significantly higher in the SWM group than in the PM group (48% v 27%; P = 0.01). The APC in the SWM group was 84% compared with 35% in the PM group (P = 0.01). SWM compared with PM improves key quality outcomes in colonoscopy, despite poorer bowel preparation.

Effect of tube drainage compared with conventional suturing on postoperative discomfort after extraction of impacted mandibular third molars.

PubMed

Koyuncu, B Ö; Zeytinoğlu, M; Tetik, A; Gomel, M M

2015-01-01

The aim of this prospective randomised study was to assess the effects of tube drainage on postoperative discomfort after the extraction of impacted mandibular third molars. We studied 40 patients (11 men and 29 women) 18 years or older (mean (SD) 21 (3), range 18-29) who required extraction of mandibular third molars. We used a randomised crossover design by which if a drain was inserted on one side, then the other side was managed without a drain on a later occasion. Pain, swelling, and mouth opening were evaluated after 48 h and 7 days postoperatively in both groups. Facial swelling (p=0.001), pain p=0.001), and trismus (p=0.001) were significantly less common in the drained group compared with those not drained. We conclude that the use a tube drain is of benefit in minimising postoperative swelling, pain, and trismus after extraction of mandibular third molars. Copyright © 2014 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Acute effects of traditional Thai massage on cortisol levels, arterial blood pressure and stress perception in academic stress condition: A single blind randomised controlled trial.

PubMed

Bennett, Surussawadi; Bennett, Michael John; Chatchawan, Uraiwon; Jenjaiwit, Patcharaporn; Pantumethakul, Rungthip; Kunhasura, Soontorn; Eungpinichpong, Wichai

2016-04-01

Traditional Thai massage (TTM) has been applied widely to promote relaxation. However, there is little evidence to support its efficacy on academic stress. A randomised controlled trial was performed to examine the acute effects of TTM on cortisol level, blood pressure, heart rate and stress perception in academic stress. This prospective trial included 36 physiotherapy students with a self perceived stress score of between 3 and 5. They were randomly allocated into the TTM (18 people) group or the control group (18 people). Saliva cortisol level, blood pressure, heart rate and stress perception rating were measured before and after the intervention. Both groups showed a significant reduction in cortisol level and heart rate when compared with baseline (p < 0.001). There were no significant differences in cortisol level between the two groups. The results suggest the need for further study into other possible physiological effects on stress of TTM. Copyright © 2015 Elsevier Ltd. All rights reserved.

Impact of online education on intern behaviour around joint commission national patient safety goals: a randomised trial.

PubMed

Shaw, Tim J; Pernar, Luise I; Peyre, Sarah E; Helfrick, John F; Vogelgesang, Kaitlin R; Graydon-Baker, Erin; Chretien, Yves; Brown, Elizabeth J; Nicholson, James C; Heit, Jeremy J; Co, John Patrick T; Gandhi, Tejal

2012-10-01

To compare the effectiveness of two types of online learning methodologies for improving the patient-safety behaviours mandated in the Joint Commission National Patient Safety Goals (NPSG). This randomised controlled trial was conducted in 2010 at Massachusetts General Hospital and Brigham and Women's Hospital (BWH) in Boston USA. Incoming interns were randomised to either receive an online Spaced Education (SE) programme consisting of cases and questions that reinforce over time, or a programme consisting of an online slide show followed by a quiz (SQ). The outcome measures included NPSG-knowledge improvement, NPSG-compliant behaviours in a simulation scenario, self-reported confidence in safety and quality, programme acceptability and programme relevance. Both online learning programmes improved knowledge retention. On four out of seven survey items measuring satisfaction and self-reported confidence, the proportion of SE interns responding positively was significantly higher (p<0.05) than the fraction of SQ interns. SE interns demonstrated a mean 4.79 (36.6%) NPSG-compliant behaviours (out of 13 total), while SQ interns completed a mean 4.17 (32.0%) (p=0.09). Among those in surgical fields, SE interns demonstrated a mean 5.67 (43.6%) NPSG-compliant behaviours, while SQ interns completed a mean 2.33 (17.9%) (p=0.015). Focus group data indicates that SE was more contextually relevant than SQ, and significantly more engaging. While both online methodologies improved knowledge surrounding the NPSG, SE was more contextually relevant to trainees and was engaging. SE impacted more significantly on both self-reported confidence and the behaviour of surgical residents in a simulated scenario.

Burden of tuberculosis in intensive care units in Cape Town, South Africa, and assessment of the accuracy and effect on patient outcomes of the Xpert MTB/RIF test on tracheal aspirate samples for diagnosis of pulmonary tuberculosis: a prospective burden of disease study with a nested randomised controlled trial.

PubMed

Calligaro, Gregory L; Theron, Grant; Khalfey, Hoosain; Peter, Jonathan; Meldau, Richard; Matinyenya, Brian; Davids, Malika; Smith, Liezel; Pooran, Anil; Lesosky, Maia; Esmail, Aliasgar; Miller, Malcolm G; Piercy, Jenna; Michell, Lancelot; Dawson, Rodney; Raine, Richard I; Joubert, Ivan; Dheda, Keertan

2015-08-01

There are few prospective data about the incidence and mortality associated with pulmonary tuberculosis in intensive care units (ICUs), and none on the accuracy and clinical effect of the Xpert-MTB/RIF assay in this setting. We aimed to measure the frequency of culture-positive tuberculosis in ICUs in Cape Town, South Africa and to assess the performance and effect on patient outcomes of Xpert MTB/RIF versus smear microscopy for diagnosis of tuberculosis. We did a prospective burden of disease study with a randomised controlled substudy at the ICUs of four hospitals in Cape Town. Mechanically ventilated adults (≥18 years) with suspected pulmonary tuberculosis admitted between Aug 1, 2010, and July 31, 2013 (irrespective of the reason for admission), were prospectively investigated by culture, and by Xpert-MTB/RIF testing or smear microscopy, of tracheal aspirate samples. In the substudy, patients were randomly assigned (1:1), via a computer-generated allocation list, to smear microscopy or Xpert MTB/RIF. Participants, caregivers, and outcome assessors were not masked to group assignment. Only the laboratory staff were blinded to the clinical details of the participants. In November, 2012, Xpert MTB/RIF was adopted as the initial diagnostic test for respiratory samples in Western Cape province. Thereafter, patients received Xpert MTB/MIF and culture as standard of care. For the whole study cohort, the primary outcome was the frequency of bacteriologically confirmed tuberculosis. The primary endpoint of the randomised substudy was the proportion of culture-positive patients on treatment at 48 h after enrolment. The randomised substudy is registered with ClinicalTrials.gov, number NCT01530568. We investigated 341 patients for suspected pulmonary tuberculosis out of a total of 2309 ICU admissions. 46 (15%) of 317 patients included in the final analysis had a positive test for tuberculosis (Xpert MTB/RIF or culture). Culture-positive patients who failed to initiate treatment (adjusted HR 4·49, 95% CI 1·45-13·89) or who received inotropes (4·33, 1·49-12·60) were more likely to die. However, tuberculosis status was not associated with 28-day or 90-day mortality. In the substudy, we randomly assigned 115 patients to smear microscopy and 111 to Xpert MTB/RIF. Smear microscopy detected six (43%) of 14 culture-positive patients, and Xpert MTB/RIF detected 11 (100%) of 11 culture-positive patients (p=0·002). The proportion of culture-positive patients on treatment at 48 h was higher in the Xpert MTB/RIF group than in the smear microscopy group (11 [92%] of 12 vs nine [53%] of 17; p=0·043), although use of Xpert MTB/RIF had no effect on mortality or other patient outcomes. Tuberculosis is fairly common in ICUs in high-burden settings, and clinicians should screen and test patients for tuberculosis with Xpert MTB/RIF where available. This test improves diagnostic yield and rates of treatment initiation, and reduces unnecessary treatment, but might not increase the total number of patients on treatment when empirical treatment is widely used. A suspected diagnosis of pulmonary tuberculosis should not exclude patients from ICU care in resource-limited settings because mortality is unaffected by the presence of this disease. European and Developing Countries Clinical Trials Partnership, South African Medical Research Council, and the Discovery Foundation. Copyright © 2015 Elsevier Ltd. All rights reserved.

Designing a SCADA system simulator for fast breeder reactor

NASA Astrophysics Data System (ADS)

Nugraha, E.; Abdullah, A. G.; Hakim, D. L.

2016-04-01

SCADA (Supervisory Control and Data Acquisition) system simulator is a Human Machine Interface-based software that is able to visualize the process of a plant. This study describes the results of the process of designing a SCADA system simulator that aims to facilitate the operator in monitoring, controlling, handling the alarm, accessing historical data and historical trend in Nuclear Power Plant (NPP) type Fast Breeder Reactor (FBR). This research used simulation to simulate NPP type FBR Kalpakkam in India. This simulator was developed using Wonderware Intouch software 10 and is equipped with main menu, plant overview, area graphics, control display, set point display, alarm system, real-time trending, historical trending and security system. This simulator can properly simulate the principle of energy flow and energy conversion process on NPP type FBR. This SCADA system simulator can be used as training media for NPP type FBR prospective operators.

3D printing of intracranial aneurysm based on intracranial digital subtraction angiography and its clinical application.

PubMed

Wang, Jian-Li; Yuan, Zi-Gang; Qian, Guo-Liang; Bao, Wu-Qiao; Jin, Guo-Liang

2018-06-01

The study aimed to develop simulation models including intracranial aneurysmal and parent vessel geometries, as well as vascular branches, through 3D printing technology. The simulation models focused on the benefits of aneurysmal treatments and clinical education. This prospective study included 13 consecutive patients who suffered from intracranial aneurysms confirmed by digital subtraction angiography (DSA) in the Neurosurgery Department of Shaoxing People's Hospital. The original 3D-DSA image data were extracted through the picture archiving and communication system and imported into Mimics. After reconstructing and transforming to Binary STL format, the simulation models of the hollow vascular tree were printed using 3D devices. The intracranial aneurysm 3D printing simulation model was developed based on DSA to assist neurosurgeons in aneurysmal treatments and residency training. Seven neurosurgical residents and 15 standardization training residents received their simulation model training and gave high assessments for the educational course with the follow-up qualitative questionnaire. 3D printed simulation models based on DSA can perfectly reveal target aneurysms and help neurosurgeons select therapeutic strategies precisely. As an educational tool, the 3D aneurysm vascular simulation model is useful for training residents.

Computer-based teaching is as good as face to face lecture-based teaching of evidence based medicine: a randomised controlled trial

PubMed Central

2007-01-01

Background At postgraduate level evidence based medicine (EBM) is currently taught through tutor based lectures. Computer based sessions fit around doctors' workloads, and standardise the quality of educational provision. There have been no randomized controlled trials comparing computer based sessions with traditional lectures at postgraduate level within medicine. Methods This was a randomised controlled trial involving six postgraduate education centres in the West Midlands, U.K. Fifty five newly qualified foundation year one doctors (U.S internship equivalent) were randomised to either computer based sessions or an equivalent lecture in EBM and systematic reviews. The change from pre to post-intervention score was measured using a validated questionnaire assessing knowledge (primary outcome) and attitudes (secondary outcome). Results Both groups were similar at baseline. Participants' improvement in knowledge in the computer based group was equivalent to the lecture based group (gain in score: 2.1 [S.D = 2.0] versus 1.9 [S.D = 2.4]; ANCOVA p = 0.078). Attitudinal gains were similar in both groups. Conclusion On the basis of our findings we feel computer based teaching and learning is as effective as typical lecture based teaching sessions for educating postgraduates in EBM and systematic reviews. PMID:17659076

Exploring prospective secondary science teachers' understandings of scientific inquiry and Mendelian genetics concepts using computer simulation

NASA Astrophysics Data System (ADS)

Cakir, Mustafa

The primary objective of this case study was to examine prospective secondary science teachers' developing understanding of scientific inquiry and Mendelian genetics. A computer simulation of basic Mendelian inheritance processes (Catlab) was used in combination with small-group discussions and other instructional scaffolds to enhance prospective science teachers' understandings. The theoretical background for this research is derived from a social constructivist perspective. Structuring scientific inquiry as investigation to develop explanations presents meaningful context for the enhancement of inquiry abilities and understanding of the science content. The context of the study was a teaching and learning course focused on inquiry and technology. Twelve prospective science teachers participated in this study. Multiple data sources included pre- and post-module questionnaires of participants' view of scientific inquiry, pre-posttests of understandings of Mendelian concepts, inquiry project reports, class presentations, process videotapes of participants interacting with the simulation, and semi-structured interviews. Seven selected prospective science teachers participated in in-depth interviews. Findings suggest that while studying important concepts in science, carefully designed inquiry experiences can help prospective science teachers to develop an understanding about the types of questions scientists in that field ask, the methodological and epistemological issues that constrain their pursuit of answers to those questions, and the ways in which they construct and share their explanations. Key findings included prospective teachers' initial limited abilities to create evidence-based arguments, their hesitancy to include inquiry in their future teaching, and the impact of collaboration on thinking. Prior to this experience the prospective teachers held uninformed views of scientific inquiry. After the module, participants demonstrated extended expertise in their understandings of following aspects of scientific inquiry: (a) the iterative nature of scientific inquiry; (b) the tentativeness of specific knowledge claims; (c) the degree to which scientists rely on empirical data, as well as broader conceptual and metaphysical commitments, to assess models and to direct future inquiries; (d) the need for conceptual consistency; (e) multiple methods of investigations and multiple interpretations of data; and (f) social and cultural aspects of scientific inquiry. This research provided evidence that hypothesis testing can support the integrated acquisition of conceptual and procedural knowledge in science. Participants' conceptual elaborations of Mendelian inheritance were enhanced. There were qualitative changes in the nature of the participants' explanations. Moreover, the average percentage of correct responses improved from 39% on the pretest to 67% on the posttest. Findings also suggest those prospective science teachers' experiences as learners of science in their methods course served as a powerful tool for thinking about the role of inquiry in teaching and learning science. They had mixed views about enacting inquiry in their teaching in the future. All of them stated some kind of general willingness to do so; yet, they also mentioned some reservations and practical considerations about inquiry-based teaching.

TOPS: Trial Of Prevention Strategies for low back pain in patients recently recovered from low back pain—study rationale and protocol

PubMed Central

Lin, Chung-Wei C; Hancock, Mark J; Latimer, Jane; Buchbinder, Rachelle; Grotle, Margreth; van Tulder, Maurits; New, Charles H; Wisby-Roth, Trish; Maher, Chris G

2016-01-01

Introduction Low back pain (LBP) is the health condition that carries the greatest disability burden worldwide; however, there is only modest support for interventions to prevent LBP. The aim of this trial is to establish the effectiveness and cost-effectiveness of group-based exercise and educational classes compared with a minimal intervention control in preventing recurrence of LBP in people who have recently recovered from an episode of LBP. Methods and analysis TOPS will be a pragmatic comparative effectiveness randomised clinical trial with a parallel economic evaluation combining three separate cohorts (TOPS Workers, TOPS Primary Care, TOPS Defence) with the same methodology. 1482 participants who have recently recovered from LBP will be randomised to either a comprehensive exercise and education programme or a minimal intervention control. Participants will be followed up for a minimum of 1 year. The primary outcome will be days till recurrence of LBP. Effectiveness will be assessed using survival analysis. Cost-effectiveness will be assessed from the societal perspective. Ethics and dissemination This trial has been approved by the University of Sydney Human Research Ethics Committee (HREC) (ref: 2015/728) and prospectively registered with the Australian and New Zealand Clinical Trials Registry (ref: 12615000939594). We will also obtain ethics approval from the Australian Defence Force HREC. The results of this study will be submitted for publication in a prominent journal and widely publicised in the general media. Trial registration number Australian and New Zealand Clinical Trial Registry (ANZCTR) 12615000939594. PMID:27217287

Prophylactic antibiotics after acute stroke for reducing pneumonia in patients with dysphagia (STROKE-INF): a prospective, cluster-randomised, open-label, masked endpoint, controlled clinical trial.

PubMed

Kalra, Lalit; Irshad, Saddif; Hodsoll, John; Simpson, Matthew; Gulliford, Martin; Smithard, David; Patel, Anita; Rebollo-Mesa, Irene

2015-11-07

Post-stroke pneumonia is associated with increased mortality and poor functional outcomes. This study assessed the effectiveness of antibiotic prophylaxis for reducing pneumonia in patients with dysphagia after acute stroke. We did a prospective, multicentre, cluster-randomised, open-label controlled trial with masked endpoint assessment of patients older than 18 years with dysphagia after new stroke recruited from 48 stroke units in the UK, accredited and included in the UK National Stroke Audit. We excluded patients with contraindications to antibiotics, pre-existing dysphagia, or known infections, or who were not expected to survive beyond 14 days. We randomly assigned the units (1:1) by computer to give either prophylactic antibiotics for 7 days plus standard stroke unit care or standard stroke unit care only to patients clustered in the units within 48 h of stroke onset. We did the randomisation with minimisation to stratify for number of admissions and access to specialist care. Patient and staff who did the assessments and analyses were masked to stroke unit allocation. The primary outcome was post-stroke pneumonia in the first 14 days, assessed with both a criteria-based, hierarchical algorithm and by physician diagnosis in the intention-to-treat population. Safety was also analysed by intention to treat. This trial is closed to new participants and is registered with isrctn.com, number ISRCTN37118456. Between April 21, 2008, and May 17, 2014, we randomly assigned 48 stroke units (and 1224 patients clustered within the units) to the two treatment groups: 24 to antibiotics and 24 to standard care alone (control). 11 units and seven patients withdrew after randomisation before 14 days, leaving 1217 patients in 37 units for the intention-to-treat analysis (615 patients in the antibiotics group, 602 in control). Prophylactic antibiotics did not affect the incidence of algorithm-defined post-stroke pneumonia (71 [13%] of 564 patients in antibiotics group vs 52 [10%] of 524 in control group; marginal adjusted odds ratio [OR] 1·21 [95% CI 0·71-2·08], p=0·489, intraclass correlation coefficient [ICC] 0·06 [95% CI 0·02-0·17]. Algorithm-defined post-stroke pneumonia could not be established in 129 (10%) patients because of missing data. Additionally, we noted no differences in physician-diagnosed post-stroke pneumonia between groups (101 [16%] of 615 patients vs 91 [15%] of 602, adjusted OR 1·01 [95% CI 0·61-1·68], p=0·957, ICC 0·08 [95% CI 0·03-0·21]). The most common adverse events were infections unrelated to post-stroke pneumonia (mainly urinary tract infections), which were less frequent in the antibiotics group (22 [4%] of 615 vs 45 [7%] of 602; OR 0·55 [0·32-0·92], p=0·02). Diarrhoea positive for Clostridium difficile occurred in two patients (<1%) in the antibiotics group and four (<1%) in the control group, and meticillin-resistant Staphylococcus aureus colonisation occurred in 11 patients (2%) in the antibiotics group and 14 (2%) in the control group. Antibiotic prophylaxis cannot be recommended for prevention of post-stroke pneumonia in patients with dysphagia after stroke managed in stroke units. UK National Institute for Health Research. Copyright © 2015 Elsevier Ltd. All rights reserved.

Effect of peer support on prevention of postnatal depression among high risk women: multisite randomised controlled trial.

PubMed

Dennis, C-L; Hodnett, E; Kenton, L; Weston, J; Zupancic, J; Stewart, D E; Kiss, A

2009-01-15

To evaluate the effectiveness of telephone based peer support in the prevention of postnatal depression. Multisite randomised controlled trial. Seven health regions across Ontario, Canada. 701 women in the first two weeks postpartum identified as high risk for postnatal depression with the Edinburgh postnatal depression scale and randomised with an internet based randomisation service. Proactive individualised telephone based peer (mother to mother) support, initiated within 48-72 hours of randomisation, provided by a volunteer recruited from the community who had previously experienced and recovered from self reported postnatal depression and attended a four hour training session. Edinburgh postnatal depression scale, structured clinical interview-depression, state-trait anxiety inventory, UCLA loneliness scale, and use of health services. After web based screening of 21 470 women, 701 (72%) eligible mothers were recruited. A blinded research nurse followed up more than 85% by telephone, including 613 at 12 weeks and 600 at 24 weeks postpartum. At 12 weeks, 14% (40/297) of women in the intervention group and 25% (78/315) in the control group had an Edinburgh postnatal depression scale score >12 (chi(2)=12.5, P<0.001; number need to treat 8.8, 95% confidence interval 5.9 to 19.6; relative risk reduction 0.46, 95% confidence interval 0.24 to 0.62). There was a positive trend in favour of the intervention group for maternal anxiety but not loneliness or use of health services. For ethical reasons, participants identified with clinical depression at 12 weeks were referred for treatment, resulting in no differences between groups at 24 weeks. Of the 221 women in the intervention group who received and evaluated their experience of peer support, over 80% were satisfied and would recommend this support to a friend. Telephone based peer support can be effective in preventing postnatal depression among women at high risk. ISRCTN 68337727.

Design research of nanopositioner based on SPM and its simulation of FEM

NASA Astrophysics Data System (ADS)

Zhang, Zhenyu; Li, Hongqi; Zhou, Hongxiu; Li, Linan; Liu, Xiangjun

2006-01-01

A novel nanopositioning stage was designed according to the scanning property of SPM with flexure hinge as kinematic structure and piezoelectric ceramic as actuator. Kinetic precision and X directional area of nanopositioner are 1.55nm and 26.4 micron, respectively, which is demonstrated by kinetic analysis and finite element method FEM simulation. Designed nanopositioner based on SPM moves at 3 dimensions with nanometer scale and its motion of X, Y, and Z directions is decoupled and isotropic. Furthermore, frame of nanopositioner is simple and manufacturing is convenient, which will have broad prospect in the field of nanopositioning and nanotracing.

Peyton's 4-Steps-Approach in comparison: Medium-term effects on learning external chest compression – a pilot study

PubMed Central

Münster, Tobias; Stosch, Christoph; Hindrichs, Nina; Franklin, Jeremy; Matthes, Jan

2016-01-01

Introduction: The external chest compression is a very important skill required to maintain a minimum of circulation during cardiac arrest until further medical procedures can be taken. Peyton’s 4-Steps-Approach is one method of skill training, the four steps being: Demonstration, Deconstruction, Comprehension and Execution. Based on CPR skill training, this method is widely, allegedly predominantly used, although there are insufficient studies on Peyton’s 4-Steps-Approach for skill training in CPR in comparison with other methods of skill training. In our study, we compared the medium- term effects on learning external chest compression with a CPR training device in three different groups: PEY (Peyton’s 4-Steps-Approach), PMOD (Peyton’s 4-Steps-Approach without Step 3) and STDM, the standard model, according to the widely spread method “see one, do one” (this is equal to Peyton’s step 1 and 3). Material and Methods: This prospective and randomised pilot study took place during the summer semester of 2009 at the SkillsLab and Simulation Centre of the University of Cologne (Kölner interprofessionelles Skills Lab und Simulationszentrum - KISS). The subjects were medical students (2nd and 3rd semester). They volunteered for the study and were randomised in three parallel groups, each receiving one of the teaching methods mentioned above. One week and 5/6 months after the intervention, an objective, structured single assessment was taken. Compression rate, compression depth, correct compressions, and the sum of correct checklist items were recorded. Additionally, we compared cumulative percentages between the groups based on the correct implementation of the resuscitation guidelines during that time. Results: The examined sample consisted of 134 subjects (68% female; age 22±4; PEY: n=62; PMOD: n=31; STDM: n=41). There was no difference between the groups concerning age, gender, pre-existing experience in CPR or time of last CPR course. The only significant difference between the groups was the mean compression rate (bpm): Group 1 (PEY) with 99±17 bpm, Group 2 (PMOD) with 101±16 bpm and Group 3 (STDM) with 90±16 bpm (p=0,007 for Group 3 vs. Group 1 and Group 3 vs. Group 2, Mann-Whitney- U-Test). We observed no significant differences between the groups after the second assessment. Conclusion: Our study showed that there are no essential differences in external chest compression during CPR performed by medical students dependent on the teaching method (Peyton vs. “Non-Peyton”) implemented with regard to the medium-term effects. The absence of benefits could possibly be due to the simplicity of external chest compression. PMID:27579360

GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

PubMed Central

2014-01-01

Background Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT. Methods/design A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation. Discussion This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD. Trial registration German Clinical Trial Registration (DRKS): DRKS00005025 PMID:24476555

The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: statistical and health economic analysis plan for the trials and for the individual patient data meta-analysis.

PubMed

Graham, Catriona; Lewis, Steff; Forbes, John; Mead, Gillian; Hackett, Maree L; Hankey, Graeme J; Gommans, John; Nguyen, Huy Thang; Lundström, Erik; Isaksson, Eva; Näsman, Per; Rudberg, Ann-Sofie; Dennis, Martin

2017-12-28

Small trials have suggested that fluoxetine may improve neurological recovery from stroke. FOCUS, AFFINITY and EFFECTS are a family of investigator-led, multicentre, parallel group, randomised, placebo-controlled trials which aim to determine whether the routine administration of fluoxetine (20 mg daily) for six months after an acute stroke improves patients' functional outcome. The core protocol for the three trials has been published (Mead et al., Trials 20:369, 2015). The trials include patients aged 18 years and older with a clinical diagnosis of stroke and persisting focal neurological deficits at randomisation 2-15 days after stroke onset. Patients are randomised centrally via each trials' web-based randomisation system using a common minimisation algorithm. Patients are allocated fluoxetine 20 mg once daily or matching placebo capsules for six months. The primary outcome measure is the modified Rankin scale (mRS) at six months. Secondary outcomes include: living circumstances; the Stroke Impact Scale; EuroQol (EQ5D-5 L); the vitality subscale of the 36-Item Short Form Health Survey (SF36); diagnosis of depression; adherence to medication; serious adverse events including death and recurrent stroke; and resource use at six and 12 months and the mRS at 12 months. Minor variations have been tailored to the national setting in the UK (FOCUS), Australia, New Zealand and Vietnam (AFFINITY) and Sweden (EFFECTS). Each trial is run and funded independently and will report its own results. A prospectively planned individual patient data meta-analysis of all three trials will provide the most precise estimate of the overall effect and establish whether any effects differ between trials or subgroups. This statistical analysis plan describes the core analyses for all three trials and that for the individual patient data meta-analysis. Recruitment and follow-up in the FOCUS trial is expected to be completed by the end of 2018. AFFINITY and EFFECTS are likely to complete follow-up in 2020. FOCUS: ISRCTN , ISRCTN83290762 . Registered on 23 May 2012. EudraCT, 2011-005616-29. Registered on 3 February 2012. Australian New Zealand Clinical Trials Registry, ACTRN12611000774921 . Registered on 22 July 2011. ISRCTN , ISRCTN13020412 . Registered on 19 December 2014. Clinicaltrials.gov, NCT02683213 . Registered on 2 February 2016. EudraCT, 2011-006130-16 . Registered on 8 August 2014.

Cost-effectiveness of simulation-based team training in obstetric emergencies (TOSTI study).

PubMed

van de Ven, J; van Baaren, G J; Fransen, A F; van Runnard Heimel, P J; Mol, B W; Oei, S G

2017-09-01

Team training is frequently applied in obstetrics. We aimed to evaluate the cost-effectiveness of obstetric multi-professional team training in a medical simulation centre. We performed a model-based cost-effectiveness analysis to evaluate four strategies for obstetric team training from a hospital perspective (no training, training without on-site repetition and training with 6 month or 3-6-9 month repetition). Data were retrieved from the TOSTI study, a randomised controlled trial evaluating team training in a medical simulation centre. We calculated the incremental cost-effectiveness ratio (ICER), which represent the costs to prevent the adverse outcome, here (1) the composite outcome of obstetric complications and (2) specifically neonatal trauma due to shoulder dystocia. Mean costs of a one-day multi-professional team training in a medical simulation centre were €25,546 to train all personnel of one hospital. A single training in a medical simulation centre was less effective and more costly compared to strategies that included repetition training. Compared to no training, the ICERs to prevent a composite outcome of obstetric complications were €3432 for a single repetition training course on-site six months after the initial training and €5115 for a three monthly repetition training course on-site after the initial training during one year. When we considered neonatal trauma due to shoulder dystocia, a three monthly repetition training course on-site after the initial training had an ICER of €22,878. Multi-professional team training in a medical simulation centre is cost-effective in a scenario where repetition training sessions are performed on-site. Copyright © 2017 Elsevier B.V. All rights reserved.

Long-term complete remission with belinostat in a patient with chemotherapy refractory peripheral T-cell lymphoma.

PubMed

Reimer, Peter; Chawla, Shanta

2013-09-10

Peripheral T/NK-cell lymphomas (PTCL) are rare malignancies with a poor prognosis. Due to the lack of randomised studies, standard therapy has not been established. First-line treatment with anthracycline-based polychemotherapy followed by consolidation with high-dose therapy and autologous stem cell transplant in responding patients has demonstrated good feasibility with low toxicity in prospective studies and is widely used in eligible patients. In relapsed and refractory patients, who are not candidates for transplant approaches, therapeutic options are limited and are usually palliative. Several new agents are currently under investigation to improve the outcome of PTCL in the first line and salvage settings. Belinostat, a histone deacetylase (HDAC) inhibitor, has demonstrated broad antineoplastic activity in preclinical studies, and promising results in advanced relapsed/refractory lymphomas.Here, we report the case of a 73 year old patient with heavily pre-treated refractory PTCL in complete remission with belinostat for 39 months.