Implantable cardioverter defibrillators for the treatment of arrhythmias and cardiac resynchronisation therapy for the treatment of heart failure: systematic review and economic evaluation

Background This assessment updates and expands on two previous technology assessments that evaluated implantable cardioverter defibrillators (ICDs) for arrhythmias and cardiac resynchronisation therapy (CRT) for heart failure (HF). Objectives To assess the clinical effectiveness and cost-effectiveness of ICDs in addition to optimal pharmacological therapy (OPT) for people at increased risk of sudden cardiac death (SCD) as a result of ventricular arrhythmias despite receiving OPT; to assess CRT with or without a defibrillator (CRT-D or CRT-P) in addition to OPT for people with HF as a result of left ventricular systolic dysfunction (LVSD) and cardiac dyssynchrony despite receiving OPT; and to assess CRT-D in addition to OPT for people with both conditions. Data sources Electronic resources including MEDLINE, EMBASE and The Cochrane Library were searched from inception to November 2012. Additional studies were sought from reference lists, clinical experts and manufacturers’ submissions to the National Institute for Health and Care Excellence. Review methods Inclusion criteria were applied by two reviewers independently. Data extraction and quality assessment were undertaken by one reviewer and checked by a second. Data were synthesised through narrative review and meta-analyses. For the three populations above, randomised controlled trials (RCTs) comparing (1) ICD with standard therapy, (2) CRT-P or CRT-D with each other or with OPT and (3) CRT-D with OPT, CRT-P or ICD were eligible. Outcomes included mortality, adverse events and quality of life. A previously developed Markov model was adapted to estimate the cost-effectiveness of OPT, ICDs, CRT-P and CRT-D in the three populations by simulating disease progression calculated at 4-weekly cycles over a lifetime horizon. Results A total of 4556 references were identified, of which 26 RCTs were included in the review: 13 compared ICD with medical therapy, four compared CRT-P/CRT-D with OPT and nine compared CRT-D with ICD. ICDs reduced all-cause mortality in people at increased risk of SCD, defined in trials as those with previous ventricular arrhythmias/cardiac arrest, myocardial infarction (MI) > 3 weeks previously, non-ischaemic cardiomyopathy (depending on data included) or ischaemic/non-ischaemic HF and left ventricular ejection fraction ≤ 35%. There was no benefit in people scheduled for coronary artery bypass graft. A reduction in SCD but not all-cause mortality was found in people with recent MI. Incremental cost-effectiveness ratios (ICERs) ranged from £14,231 per quality-adjusted life-year (QALY) to £29,756 per QALY for the scenarios modelled. CRT-P and CRT-D reduced mortality and HF hospitalisations, and improved other outcomes, in people with HF as a result of LVSD and cardiac dyssynchrony when compared with OPT. The rate of SCD was lower with CRT-D than with CRT-P but other outcomes were similar. CRT-P and CRT-D compared with OPT produced ICERs of £27,584 per QALY and £27,899 per QALY respectively. The ICER for CRT-D compared with CRT-P was £28,420 per QALY. In people with both conditions, CRT-D reduced the risk of all-cause mortality and HF hospitalisation, and improved other outcomes, compared with ICDs. Complications were more common with CRT-D. Initial management with OPT alone was most cost-effective (ICER £2824 per QALY compared with ICD) when health-related quality of life was kept constant over time. Costs and QALYs for CRT-D and CRT-P were similar. The ICER for CRT-D compared with ICD was £27,195 per QALY and that for CRT-D compared with OPT was £35,193 per QALY. Limitations Limitations of the model include the structural assumptions made about disease progression and treatment provision, the extrapolation of trial survival estimates over time and the assumptions made around parameter values when evidence was not available for specific patient groups. Conclusions In people at risk of SCD as a result of ventricular arrhythmias and in those with HF as a result of LVSD and cardiac dyssynchrony, the interventions modelled produced ICERs of < £30,000 per QALY gained. In people with both conditions, the ICER for CRT-D compared with ICD, but not CRT-D compared with OPT, was < £30,000 per QALY, and the costs and QALYs for CRT-D and CRT-P were similar. A RCT comparing CRT-D and CRT-P in people with HF as a result of LVSD and cardiac dyssynchrony is required, for both those with and those without an ICD indication. A RCT is also needed into the benefits of ICD in non-ischaemic cardiomyopathy in the absence of dyssynchrony. Study registration This study is registered as PROSPERO number CRD42012002062. Funding The National Institute for Health Research Health Technology Assessment programme

Mechanical versus manual chest compressions in the treatment of in-hospital cardiac arrest patients in a non-shockable rhythm : a randomised controlled feasibility trial (COMPRESS-RCT)

Background Mechanical chest compression devices consistently deliver high-quality chest compressions. Small very low-quality studies suggest mechanical devices may be effective as an alternative to manual chest compressions in the treatment of adult in-hospital cardiac arrest patients. The aim of this feasibility trial is to assess the feasibility of conducting an effectiveness trial in this patient population. Methods COMPRESS-RCT is a multi-centre parallel group feasibility randomised controlled trial, designed to assess the feasibility of undertaking an effectiveness to compare the effect of mechanical chest compressions with manual chest compressions on 30-day survival following in-hospital cardiac arrest. Over approximately two years, 330 adult patients who sustain an in-hospital cardiac arrest and are in a non-shockable rhythm will be randomised in a 3:1 ratio to receive ongoing treatment with a mechanical chest compression device (LUCAS 2/3, Jolife AB/Stryker, Lund, Sweden) or continued manual chest compressions. It is intended that recruitment will occur on a 24/7 basis by the clinical cardiac arrest team. The primary study outcome is the proportion of eligible participants randomised in the study during site operational recruitment hours. Participants will be enrolled using a model of deferred consent, with consent for follow-up sought from patients or their consultee in those that survive the cardiac arrest event. The trial will have an embedded qualitative study, in which we will conduct semi-structured interviews with hospital staff to explore facilitators and barriers to study recruitment. Discussion The findings of COMPRESS-RCT will provide important information about the deliverability of an effectiveness trial to evaluate the effect on 30-day mortality of routine use of mechanical chest compression devices in adult in-hospital cardiac arrest patients

Monsters: interdisciplinary explorations in monstrosity

There is a continued fascination with all things monster. This is partly due to the popular reception of Mary Shelley’s Monster, termed a “new species” by its overreaching but admiringly determined maker Victor Frankenstein in the eponymous novel first published in 1818. The enduring impact of Shelley’s novel, which spans a plethora of subjects and genres in imagery and themes, raises questions of origin and identity, death, birth and family relationships as well as the contradictory qualities of the monster. Monsters serve as metaphors for anxieties of aberration and innovation. Stephen Asma (2009) notes that monsters represent evil or moral transgression and each epoch, to speak with Michel Foucault, evidences a “particular type of monster” (2003, 66). Academic debates tend to explore how social and cultural threats come to be embodied in the figure of a monster and their actions literalize our deepest fears. Monsters in contemporary culture, however, have become are more humane than ever before. Monsters are strong, resilient, creative and sly creatures. Through their playful and invigorating energy they can be seen to disrupt and unsettle. They still cater to the appetite for horror, but they also encourage us to feel empathy. The encounter with a monster can enable us to stop, wonder and change our attitudes towards technology and our body and each other. This commentary article considers the use of the concepts of ‘monsters’ or ‘monstrosity’ in literature, contemporary research, culture and teaching contexts at the intersection of the Humanities and the Social Sciences

Review of methods used by chiropractors to determine the site for applying manipulation

Background: With the development of increasing evidence for the use of manipulation in the management of musculoskeletal conditions, there is growing interest in identifying the appropriate indications for care. Recently, attempts have been made to develop clinical prediction rules, however the validity of these clinical prediction rules remains unclear and their impact on care delivery has yet to be established. The current study was designed to evaluate the literature on the validity and reliability of the more common methods used by doctors of chiropractic to inform the choice of the site at which to apply spinal manipulation. Methods: Structured searches were conducted in Medline, PubMed, CINAHL and ICL, supported by hand searches of archives, to identify studies of the diagnostic reliability and validity of common methods used to identify the site of treatment application. To be included, studies were to present original data from studies of human subjects and be designed to address the region or location of care delivery. Only English language manuscripts from peer-reviewed journals were included. The quality of evidence was ranked using QUADAS for validity and QAREL for reliability, as appropriate. Data were extracted and synthesized, and were evaluated in terms of strength of evidence and the degree to which the evidence was favourable for clinical use of the method under investigation. Results: A total of 2594 titles were screened from which 201 articles met all inclusion criteria. The spectrum of manuscript quality was quite broad, as was the degree to which the evidence favoured clinical application of the diagnostic methods reviewed. The most convincing favourable evidence was for methods which confirmed or provoked pain at a specific spinal segmental level or region. There was also high quality evidence supporting the use, with limitations, of static and motion palpation, and measures of leg length inequality. Evidence of mixed quality supported the use, with limitations, of postural evaluation. The evidence was unclear on the applicability of measures of stiffness and the use of spinal x-rays. The evidence was of mixed quality, but unfavourable for the use of manual muscle testing, skin conductance, surface electromyography and skin temperature measurement. Conclusions: A considerable range of methods is in use for determining where in the spine to administer spinal manipulation. The currently published evidence falls across a spectrum ranging from strongly favourable to strongly unfavourable in regard to using these methods. In general, the stronger and more favourable evidence is for those procedures which take a direct measure of the presumptive site of care– methods involving pain provocation upon palpation or localized tissue examination. Procedures which involve some indirect assessment for identifying the manipulable lesion of the spine–such as skin conductance or thermography–tend not to be supported by the available evidence.https://doi.org/10.1186/2045-709X-21-3

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Book synopsis: William Blake, poet and artist, is a figure often understood to have 'created his own system'. Combining close readings and detailed analysis of a range of Blake's work, from lyrical songs to later myth, from writing to visual art, this collection of thirty-eight lively and authoritative essays examines what Blake had in common with his contemporaries, the writers who influenced him, and those he influenced in turn. Chapters from an international team of leading scholars also attend to his wider contexts: material, formal, cultural, and historical, to enrich our understanding of, and engagement with, Blake's work. Accessibly written, incisive, and informed by original research, William Blake in Context enables readers to appreciate Blake anew, from both within and outside of his own idiom

Capacitação de técnicos/auxiliares de enfermagem: repercussão nos registros de enfermagem relacionados ao atendimento pré-hospitalar móvel Capacitación de técnicos y auxiliares de enfermería en la atención pre-hospitalaria móvil: repercusiones en los registros de enfermería Training of nursing technicians/assistants in mobile pre-hospital healthcare: results from nursing records

OBJETIVO: Avaliar o impacto de um curso de capacitação na melhoria dos registros realizados por técnicos/auxiliares de enfermagem no atendimento pré-hospitalar a crianças menores de cinco anos com dificuldade respiratória. MÉTODOS: Estudo prospectivo exploratório, realizado no Serviço de Atendimento Móvel de Urgências - Recife. Foram incluídas as fichas de atendimentos realizados por Unidades de Suporte Básico a crianças menores de cinco anos com quadro de dificuldade respiratória, totalizando 148 ocorrências em 2006, antes do curso de capacitação e 113 em 2007/2008 após a capacitação de técnicos/auxiliares de enfermagem. RESULTADOS: Observou-se mudança significativa na qualidade da informação registrada, passando os sinais de gravidade respiratória a serem avaliados com maior freqüência, como o uso da musculatura acessória, batimento de asa de nariz, agitação, retração xifóide e sibilos expiratórios (p<0,01). CONCLUSÃO: O curso de capacitação implementado proporcionou melhor comunicação com a central médica de regulação no repasse objetivo dos sinais de dificuldade respiratória, favorecendo a adoção de condutas apropriadas.<br>OBJETIVO: Evaluar el impacto de un curso de capacitación para la mejoría de los registros realizados por técnicos/auxiliares de enfermería en la atención pre hospitalaria a niños menores de cinco años con dificultad respiratoria. MÉTODOS: Se trata de un estudio prospectivo exploratorio, realizado en el Servicio de Atención Móvil de Urgencias - Recife. Fueron incluídas las fichas de atención realizadas por Unidades de Soporte Básico a niños menores de cinco años con cuadro de dificuldad respiratoria, con un total de 148 ocurrencias en el 2006, antes del curso de capacitación y 113 en 2007/2008 después de la capacitación de técnicos/auxiliares de enfermería. RESULTADOS: Se observó un cambio significativo en la calidad de la información registrada, pasando las señales de gravedad respiratoria a ser evaluados con mayor frecuencia, como el uso de la musculatura accesoria, aleteo nasal, agitación, retracción xifoide y sibilancias expiratorias (p<0,01). CONCLUSIÓN: El curso de capacitación implementado proporcionó mejor comunicación con la central médica de regulación en el repaso objetivo de las señales de dificultad respiratoria, favoreciendo la adopción de conductas apropiadas.<br>OBJECTIVE: To evaluate the impact of a program for capacitation of associate degree nurses and licensed practical nurses in improving the documentation of respiratory care for children less than 5 years old in pre-hospital mobile units. METHODS: A quasi-experimental, prospective, and comparative one-group before and after design was used to conduct the study. The study was conducted in the Pre-Hospital Mobile Units of Recife. The sample consisted of 148 children's records in 2006 before the initiation of the program of capacitation and 113 children's records in 2007 and 2008 after the implementation of the program. RESULTS: There was a statistical significant change after the implementation of the program regarding to quality documentation and the frequency of respiratory system assessment, such as the use of the accessory respiratory muscle, nose flaring, agitation, xiphoid process retraction, and wheezes (p < .01). CONCLUSIONS: The implementation of the program of capacitation of associate degree nurses and licensed practical nurses improved communication, nursing care, documentation, and respiratory assessment of children in pre-hospital mobile units