Synthesis of qualitative research studies regarding the factors surrounding UK critical care trial infrastructure

© 2019 Author(s). Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJConducting clinical trials in critical care is integral to improving patient care. Unique practical and ethical considerations exist in this patient population that make patient recruitment challenging, including narrow recruitment timeframes and obtaining patient consent often in time-critical situations. Units currently vary significantly in their ability to recruit according to infrastructure and level of research activity. Aim : To identify variability in the research infrastructure of UK intensive care units (ICUs) and their ability to conduct research and recruit patients into clinical trials. Design: We evaluated factors related to intensive care patient enrolment into clinical trials in the UK. This consisted of a qualitative synthesis carried out with two datasets of in-depth interviews (distinct participants across the two datasets) conducted with 27 intensive care consultants (n=9), research nurses (n=17) and trial coordinators (n=1) from 27 units across the UK. Primary and secondary analysis of two datasets (one dataset had been analysed previously) was undertaken in the thematic analysis. Findings: The synthesis yielded an overarching core theme of Normalising Research, characterised by motivations for promoting research and fostering research-active cultures within resource constraints, with six themes under this to explain the factors influencing critical care research capacity: Organisational, Human, Study, Practical resources, Clinician, and Patient/family factors. There was a strong sense of integrating research in routine clinical practice, and recommendations are outlined. Conclusions: The central and transferable tenet of Normalising Research advocates the importance of developing a culture where research is inclusive alongside clinical practice in routine patient care and is requisite for all healthcare individuals from organisational to direct patient contact level.Peer reviewedFinal Published versio

Health Risks and Emerging Trends with the Use of Electronic Cigarettes

Cigarette smoking is associated with many health risks and complications. Despite smokers\u27 strong desire to quit, most battle with nicotine withdrawal and relapse. Because electronic cigarettes (e-cigarettes) do not contain tobacco, some believe them to be safer than traditional cigarettes and have used them as a replacement or adjunct nicotine source to prevent withdrawal symptoms. Electronic cigarettes are designed to mimic traditional cigarettes and expel a vapor composed of nicotine, water, glycerol, propylene glycol and other flavorings. Many e-cigarette companies use appealing platforms, which promise smoking cessation and harm reduction, to attract consumers; however, several studies have found e-cigarettes actually contain ingredients that are harmful to one\u27s health. Studies have demonstrated that the use of e-cigarettes can be toxic to patients\u27 health if patients do not research the products they intend to purchase. The flavoring of e-cigarettes may be a major contributor to e-cigarette cytotoxicity. If flavoring and other cytotoxic contents of e-cigarettes can be eliminated, e-cigarettes may be useful in smoking reduction and cessation. Many clinicians today support traditional forms of nicotine replacement therapy for smoking cessation rather than e-cigarettes. Due to the lack of regulation and studies by the U.S. Food and Drug Administration, e-cigarettes may not be as safe as users may perceive and should not be a preferred product for smoking cessation therapy until they are further studied and regulated

Relevancia de la auditoria interna en la gestión de medianas y grandes empresas del sector construcción en el Perú, período 2017-2018

La finalidad de la tesis es de ofrecer aportes significativos respecto a los alcances que tiene la auditoría interna en la gestión de las empresas del sector construcción a nivel de Lima Metropolitana, por lo que se utilizó la metodología de la investigación científica, herramienta que sirvió para desarrollar aspectos importantes del trabajo, en todos sus capítulos. La investigación realizó la recopilación de información acerca de diferentes expertos con respecto al desarrollo de las variables: auditoría interna y gestión empresarial; en cuanto al estudio de campo se utilizó la técnica de la encuesta y como herramienta el cuestionario, la misma que estuvo conformada por 14 preguntas que fueron respondidas por Auditores, quienes dieron sus diferentes puntos de vista sobre esta problemática, para luego ser llevadas a gráficos estadísticos, así como sus respectivas interpretaciones; desde luego, las hipótesis planteadas fueron contrastadas para luego llegar a las conclusiones y recomendaciones de la investigación. En la parte final de la tesis concluye con los aportes que se dan como resultado de la investigación, los mismos que se alcanzaron a totalidad, facilitando las recomendaciones, las cuales se consideran como viables y practicables; también se añade la amplia bibliografía, así como los anexos correspondientes.Tesi

Functional Activation of Newborn Neurons Following Alcohol-Induced Reactive Neurogenesis

Abstinence after alcohol dependence leads to structural and functional recovery in many regions of the brain, especially the hippocampus. Significant increases in neural stem cell (NSC) proliferation and subsequent “reactive neurogenesis” coincides with structural recovery in hippocampal dentate gyrus (DG). However, whether these reactively born neurons are integrated appropriately into neural circuits remains unknown. Therefore, adult male rats were exposed to a binge model of alcohol dependence. On day 7 of abstinence, the peak of reactive NSC proliferation, rats were injected with bromodeoxyuridine (BrdU) to label dividing cells. After six weeks, rats underwent Morris Water Maze (MWM) training then were sacrificed ninety minutes after the final training session. Using fluorescent immunohistochemistry for c-Fos (neuronal activation), BrdU, and Neuronal Nuclei (NeuN), we investigated whether neurons born during reactive neurogenesis were incorporated into a newly learned MWM neuronal ensemble. Prior alcohol exposure increased the number of BrdU+ cells and newborn neurons (BrdU+/NeuN+ cells) in the DG versus controls. However, prior ethanol exposure had no significant impact on MWM-induced c-Fos expression. Despite increased BrdU+ neurons, no difference in the number of activated newborn neurons (BrdU+/c-Fos+/NeuN+) was observed. These data suggest that neurons born during alcohol-induced reactive neurogenesis are functionally integrated into hippocampal circuitry

Hypercapnic Acidosis Reduces Oxidative Reactions in Endotoxin-Induced Lung Injury

Hypercapnic acidosis frequently occurs when patients with acute lung injury are initially ventilated with low tidal volume protective strategies. Hypercapnic acidosis per se, in the absence of any change in tidal volume or airway pressure, is protective when instituted before the onset of injury. However, the mechanisms by which hypercapnic acidosis confers this protection are incompletely understood, in particular, the effects on pulmonary oxidative reactions, which are potent mediators of tissue damage, have not been previously examined in vivo

Unfitness to Plead. Volume 1: Report.

This has been produced along with Volume 2: Draft Legislation as a combined document Presented to Parliament pursuant to section 3(2) of the Law Commissions Act 1965 Ordered by the House of Commons to be printed on 12 January 201

Noninterventional statistical comparison of BTS and CHEST guidelines for size and severity in primary pneumothorax.

Hilar rather than apical interpleural distance more accurately predicts need for intercostal chest drain insertion http://ow.ly/JvKFYThe study was funded by the East Anglian Thoracic Society. M.Z. Nikolić is a Wellcome Trust PhD Programme for Clinicians Fellow at the University of Cambridge. S.J. Marciniak is a Medical Research Council Senior Clinical Fellow. J. Wason is funded by the Cambridge Biomedical Research Centre. Funding information for this article has been deposited with FundRef.This is the final version of the article. It first appeared from the European Respiratory Society via http://dx.doi.org/10.1183/09031936.0011861

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

INTRODUCTION: Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes. METHODS AND ANALYSIS: The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.The trial will be delivered by a multidisciplinary research team through a series of five work packages.The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers. ETHICS AND DISSEMINATION: The study has been approved by the London-Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants. TRIAL REGISTRATION NUMBER: ISRCTN13296529

Shaping care home COVID-19 testing policy: a protocol for a pragmatic cluster randomised controlled trial of asymptomatic testing compared with standard care in care home staff (VIVALDI-CT)

INTRODUCTION: Care home residents have experienced significant morbidity, mortality and disruption following outbreaks of SARS-CoV-2. Regular SARS-CoV-2 testing of care home staff was introduced to reduce transmission of infection, but it is unclear whether this remains beneficial. This trial aims to investigate whether use of regular asymptomatic staff testing, alongside funding to reimburse sick pay for those who test positive and meet costs of employing agency staff, is a feasible and effective strategy to reduce COVID-19 impact in care homes. METHODS AND ANALYSIS: The VIVALDI-Clinical Trial is a multicentre, open-label, cluster randomised controlled, phase III/IV superiority trial in up to 280 residential and/or nursing homes in England providing care to adults aged >65 years. All regular and agency staff will be enrolled, excepting those who opt out. Homes will be randomised to the intervention arm (twice weekly asymptomatic staff testing for SARS-CoV-2) or the control arm (current national testing guidance). Staff who test positive for SARS-CoV-2 will self-isolate and receive sick pay. Care providers will be reimbursed for costs associated with employing temporary staff to backfill for absence arising directly from the trial.The trial will be delivered by a multidisciplinary research team through a series of five work packages.The primary outcome is the incidence of COVID-19-related hospital admissions in residents. Secondary outcomes include the number and duration of outbreaks and home closures. Health economic and modelling analyses will investigate the cost-effectiveness and cost consequences of the testing intervention. A process evaluation using qualitative interviews will be conducted to understand intervention roll out and identify areas for optimisation to inform future intervention scale-up, should the testing approach prove effective and cost-effective. Stakeholder engagement will be undertaken to enable the sector to plan for results and their implications and to coproduce recommendations on the use of testing for policy-makers. ETHICS AND DISSEMINATION: The study has been approved by the London-Bromley Research Ethics Committee (reference number 22/LO/0846) and the Health Research Authority (22/CAG/0165). The results of the trial will be disseminated regardless of the direction of effect. The publication of the results will comply with a trial-specific publication policy and will include submission to open access journals. A lay summary of the results will also be produced to disseminate the results to participants. TRIAL REGISTRATION NUMBER: ISRCTN13296529