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1.
Europace ; 23(23 Suppl 4): iv33-iv44, 2021 06 23.
Artículo en Inglés | MEDLINE | ID: mdl-34160600

RESUMEN

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems.


Asunto(s)
Desfibriladores Implantables , Infecciones Relacionadas con Prótesis , Antibacterianos/uso terapéutico , Análisis Costo-Beneficio , Desfibriladores Implantables/efectos adversos , Electrónica , Humanos , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/prevención & control
2.
Europace ; 20(12): 1974-1980, 2018 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-29672690

RESUMEN

Aims: This study assessed the contemporary occurrence of cardiac device infections (CDIs) following implantation in French hospitals and estimated associated costs. Methods and Results: A retrospective analysis was conducted on the French National Hospital Database (PMSI). Patients with a record of de novo cardiac implantable electronic device (CIED) implantation or replacement interventions in France in 2012 were identified and followed until the end of 2015. Cardiac device infections (CDIs) were identified based on coding using the French classification for procedures [Classification Commune des Actes Médicaux (CCAM)] and International Classification of Diseases (ICD-10). Associated costs were estimated based on direct costs from the perspective of the French social security system. In total 78 267 CIED patients (72% de novo implants) were identified (15% defibrillators; 84% pacemakers). The 36-month infection rate associated with de novo defibrillator-only implants, as well as for cardiac resynchronisation therapy - defibrillators (CRT-Ds) was 1.6%. The CDI risk was 2.9% and 3.9% for replacement ICDs and CRT-Ds. Infection rates were lower for de novo single-chamber pacemaker (SCP)/dual-chamber pacemaker (DCP) (0.5%) and cardiac resynchronisation therapy - pacemaker (CRT-P) implants (1.0%), while for replacement procedures the risk increased to 1.4% (SCP/DCP) and 1.3% (CRT-P). Mean infection-related costs over 24 months were €20 623 and €23 234 for CDIs associated with replacement and de novo procedures, and overall costs were not significantly different between pacemaker and defibrillator patients. Conclusion: Cardiac device infections in France are associated with substantial costs, when considering inpatient hospitalizations. Strategies to minimize the rate of CIED infection should be a priority for health care providers and payers.


Asunto(s)
Estimulación Cardíaca Artificial/efectos adversos , Desfibriladores Implantables/efectos adversos , Cardioversión Eléctrica/efectos adversos , Cardioversión Eléctrica/instrumentación , Marcapaso Artificial/efectos adversos , Infecciones Relacionadas con Prótesis/epidemiología , Anciano , Anciano de 80 o más Años , Estimulación Cardíaca Artificial/economía , Bases de Datos Factuales , Desfibriladores Implantables/economía , Remoción de Dispositivos/economía , Cardioversión Eléctrica/economía , Femenino , Francia/epidemiología , Costos de Hospital , Hospitalización/economía , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Marcapaso Artificial/economía , Infecciones Relacionadas con Prótesis/diagnóstico , Infecciones Relacionadas con Prótesis/economía , Infecciones Relacionadas con Prótesis/terapia , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
3.
Pharmacoecon Open ; 8(3): 417-429, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38244143

RESUMEN

BACKGROUND AND AIMS: Symptom control for atrial fibrillation can be achieved by catheter ablation or drug therapy. We assessed the cost effectiveness of a novel streamlined atrial fibrillation cryoballoon ablation protocol (AVATAR) compared with optimised antiarrhythmic drug (AAD) therapy and a conventional catheter ablation protocol, from a UK National Health Service (NHS) perspective. METHODS: Data from the AVATAR study were assessed to determine the cost effectiveness of the three protocols in a two-step process. In the first stage, statistical analysis of clinical efficacy outcomes was conducted considering either a three-way comparison (AVATAR vs. conventional ablation vs. optimised AAD therapies) or a two-way comparison (pooled ablation protocol data vs. optimised AAD therapies). In the second stage, models assessed the cost effectiveness of the protocols. Costs and some of the clinical inputs in the models were derived from within-trial cost analysis and published literature. The remaining inputs were derived from clinical experts. RESULTS: No significant differences between the ablation protocols were found for any of the clinical outcomes used in the model. Results of a within-trial cost analysis show that AVATAR is cost-saving (£1279 per patient) compared with the conventional ablation protocol. When compared with optimised AAD therapies, AVATAR (pooled conventional and AVATAR ablation protocols efficacy) was found to be more costly while offering improved clinical benefits. Over a lifetime time horizon, the incremental cost-effectiveness ratio of AVATAR was estimated as £21,046 per quality-adjusted life-year gained (95% credible interval £7086-£71,718). CONCLUSIONS: The AVATAR streamlined protocol is likely to be a cost-effective option versus both conventional ablation and optimised AAD therapy in the UK NHS healthcare setting.

4.
BMJ Open ; 14(4): e081637, 2024 Apr 05.
Artículo en Inglés | MEDLINE | ID: mdl-38580355

RESUMEN

INTRODUCTION: An association between deep sedation and adverse short-term outcomes has been demonstrated although this evidence has been inconsistent. The A2B (alpha-2 agonists for sedation in critical care) sedation trial is designed to determine whether the alpha-2 agonists clonidine and dexmedetomidine, compared with usual care, are clinically and cost-effective. The A2B intervention is a complex intervention conducted in 39 intensive care units (ICUs) in the UK. Multicentre organisational factors, variable cultures, perceptions and practices and the involvement of multiple members of the healthcare team add to the complexity of the A2B trial. From our pretrial contextual exploration it was apparent that routine practices such as type and frequency of pain, agitation and delirium assessment, as well as the common sedative agents used, varied widely across the UK. Anticipated challenges in implementing A2B focused on the impact of usual practice, perceptions of risk, ICU culture, structure and the presence of equipoise. Given this complexity, a process evaluation has been embedded in the A2B trial to uncover factors that could impact successful delivery and explore their impact on intervention delivery and interpretation of outcomes. METHODS AND ANALYSIS: This is a mixed-methods process evaluation guided by the A2B intervention logic model. It includes two phases of data collection conducted during and at the end of trial. Data will be collected using a combination of questionnaires, stakeholder interviews and routinely collected trial data. A framework approach will be used to analyse qualitative data with synthesis of data within and across the phases. The nature of the relationship between delivery of the A2B intervention and the trial primary and secondary outcomes will be explored. ETHICS AND DISSEMINATION: All elements of the A2B trial, including the process evaluation, are approved by Scotland A Research Ethics Committee (Ref. 18/SS/0085). Dissemination will be via publications, presentations and media engagement. TRIAL REGISTRATION NUMBER: NCT03653832.


Asunto(s)
Agonistas de Receptores Adrenérgicos alfa 2 , Enfermedad Crítica , Humanos , Enfermedad Crítica/terapia , Agonistas de Receptores Adrenérgicos alfa 2/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Unidades de Cuidados Intensivos , Cuidados Críticos/métodos , Ensayos Clínicos Controlados Aleatorios como Asunto
5.
Mediators Inflamm ; 2013: 496031, 2013.
Artículo en Inglés | MEDLINE | ID: mdl-24089588

RESUMEN

BACKGROUND: The receptor for advanced glycation end products (RAGE) is an inflammation-perpetuating receptor, and soluble RAGE (sRAGE) is a marker of cellular RAGE expression. This study investigated whether raised plasma levels prior to surgery of sRAGE or S100A8/A9 (a RAGE ligand) were associated with longer duration of hospital care in patients undergoing cardiac surgery necessitating cardiopulmonary bypass. METHODS: Patients (n = 130) undergoing elective cardiac surgery were enrolled prospectively. Plasma sRAGE and S100A8/A9 concentrations were measured before and 2 h after surgery. RESULTS: Preoperative plasma sRAGE increased significantly (P < 0.0001) from 1.06 ng/mL (IQR, 0.72-1.76) to 1.93 ng/mL (IQR, 1.14-2.63) 2 h postoperatively. Plasma S100A8/9 was also significantly (P < 0.0001) higher 2 h postoperatively (2.37 µ g/mL, IQR, 1.81-3.05) compared to pre-operative levels (0.41 µ g/mL, IQR, 0.2-0.65). Preoperative sRAGE, but not S100A8/A9, was positively and significantly correlated with duration of critical illness (r = 0.3, P = 0.0007) and length of hospital stay (LOS; r = 0.31, P < 0.0005). Multivariate binary logistic regression showed preoperative sRAGE to be, statistically, an independent predictor of greater than median duration of critical illness (odds ratio 16.6, P = 0.014) and to be, statistically, the strongest independent predictor of hospital LOS. CONCLUSION: Higher preoperative plasma sRAGE levels were associated with prolonged duration of care in adults undergoing cardiac surgery requiring cardiopulmonary bypass.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Regulación de la Expresión Génica , Cardiopatías/sangre , Receptores Inmunológicos/sangre , Anciano , Biomarcadores/metabolismo , Puente Cardiopulmonar , Femenino , Cardiopatías/cirugía , Humanos , Tiempo de Internación , Ligandos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Oportunidad Relativa , Periodo Preoperatorio , Estudios Prospectivos , Receptor para Productos Finales de Glicación Avanzada , Riesgo , Factores de Tiempo , Resultado del Tratamiento
6.
BMJ Open ; 13(12): e078645, 2023 12 10.
Artículo en Inglés | MEDLINE | ID: mdl-38072483

RESUMEN

INTRODUCTION: Almost all patients receiving mechanical ventilation (MV) in intensive care units (ICUs) require analgesia and sedation. The most widely used sedative drug is propofol, but there is uncertainty whether alpha2-agonists are superior. The alpha 2 agonists for sedation to produce better outcomes from critical illness (A2B) trial aims to determine whether clonidine or dexmedetomidine (or both) are clinically and cost-effective in MV ICU patients compared with usual care. METHODS AND ANALYSIS: Adult ICU patients within 48 hours of starting MV, expected to require at least 24 hours further MV, are randomised in an open-label three arm trial to receive propofol (usual care) or clonidine or dexmedetomidine as primary sedative, plus analgesia according to local practice. Exclusions include patients with primary brain injury; postcardiac arrest; other neurological conditions; or bradycardia. Unless clinically contraindicated, sedation is titrated using weight-based dosing guidance to achieve a Richmond-Agitation-Sedation score of -2 or greater as early as considered safe by clinicians. The primary outcome is time to successful extubation. Secondary ICU outcomes include delirium and coma incidence/duration, sedation quality, predefined adverse events, mortality and ICU length of stay. Post-ICU outcomes include mortality, anxiety and depression, post-traumatic stress, cognitive function and health-related quality of life at 6-month follow-up. A process evaluation and health economic evaluation are embedded in the trial.The analytic framework uses a hierarchical approach to maximise efficiency and control type I error. Stage 1 tests whether each alpha2-agonist is superior to propofol. If either/both interventions are superior, stages 2 and 3 testing explores which alpha2-agonist is more effective. To detect a mean difference of 2 days in MV duration, we aim to recruit 1437 patients (479 per group) in 40-50 UK ICUs. ETHICS AND DISSEMINATION: The Scotland A REC approved the trial (18/SS/0085). We use a surrogate decision-maker or deferred consent model consistent with UK law. Dissemination will be via publications, presentations and updated guidelines. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov NCT03653832.


Asunto(s)
Dexmedetomidina , Propofol , Adulto , Humanos , Propofol/uso terapéutico , Dexmedetomidina/uso terapéutico , Análisis Costo-Beneficio , Clonidina/uso terapéutico , Enfermedad Crítica/terapia , Calidad de Vida , Agonistas de Receptores Adrenérgicos alfa 2/uso terapéutico , Hipnóticos y Sedantes/uso terapéutico , Dolor/inducido químicamente , Unidades de Cuidados Intensivos , Reino Unido , Respiración Artificial , Ensayos Clínicos Controlados Aleatorios como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Fase III como Asunto
7.
J Clin Med ; 11(14)2022 Jul 06.
Artículo en Inglés | MEDLINE | ID: mdl-35887701

RESUMEN

Muscle wasting is implicated in the pathogenesis of intensive care unit acquired weakness (ICU-AW), affecting 40% of patients and causing long-term physical disability. A repetitive vascular occlusion stimulus (RVOS) limits muscle atrophy in healthy and orthopaedic subjects, thus, we explored its application to ICU patients. Adult multi-organ failure patients received standard care +/- twice daily RVOS {4 cycles of 5 min tourniquet inflation to 50 mmHg supra-systolic blood pressure, and 5 min complete deflation} for 10 days. Serious adverse events (SAEs), tolerability, feasibility, acceptability, and exploratory outcomes of the rectus femoris cross-sectional area (RFCSA), echogenicity, clinical outcomes, and blood biomarkers were assessed. Only 12 of the intended 32 participants were recruited. RVOS sessions (76.1%) were delivered to five participants and two could not tolerate it. No SAEs occurred; 75% of participants and 82% of clinical staff strongly agreed or agreed that RVOS is an acceptable treatment. RFCSA fell significantly and echogenicity increased in controls (n = 5) and intervention subjects (n = 4). The intervention group was associated with less frequent acute kidney injury (AKI), a greater decrease in the total sequential organ failure assessment score (SOFA) score, and increased insulin-like growth factor-1 (IGF-1), and reduced syndecan-1, interleukin-4 (IL-4) and Tumor necrosis factor receptor type II (TNF-RII) levels. RVOS application appears safe and acceptable, but protocol modifications are required to improve tolerability and recruitment. There were signals of possible clinical benefit relating to RVOS application.

8.
Adv Drug Deliv Rev ; 177: 113949, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34461199

RESUMEN

UV-vis spectrometry is widely used in the pharmaceutical sciences for compound quantification, alone or in conjunction with separation techniques, due to most drug entities possessing a chromophore absorbing light in the range 190-800 nm. UV dissolution imaging, the scope of this review, generates spatially and temporally resolved absorbance maps by exploiting the UV absorbance of the analyte. This review aims to give an introduction to UV dissolution imaging and its use in the determination of intrinsic dissolution rates and drug release from whole dosage forms. Applications of UV imaging to non-oral formulations have started to emerge and are reviewed together with the possibility of utilizing UV imaging for physical chemical characterisation of drug substances. The benefits of imaging drug diffusion and transport processes are also discussed.


Asunto(s)
Liberación de Fármacos , Rayos Ultravioleta , Formas de Dosificación , Sistemas de Liberación de Medicamentos , Preparaciones Farmacéuticas/administración & dosificación , Preparaciones Farmacéuticas/química
10.
Pharmaceutics ; 12(12)2020 Nov 28.
Artículo en Inglés | MEDLINE | ID: mdl-33260657

RESUMEN

Hydrophilic matrix systems can be found in a wide range of extended release pharmaceutical formulations. The main principle of these systems is that upon contact with water, the hydrophilic component swells to form a hydrated gel layer which controls drug release. The following work demonstrates an explorative study into the use of dissolution imaging and focus variation microscopy with hydrophilic polymers. This study investigated the surface properties of xanthan gum (XG), polyethylene oxide (PEO), and hypromellose (hydroxypropyl methylcellulose, HPMC) compacts with each of these three hydrophilic polymers from one of each classification of natural, semi-synthetic, or synthetic polymer using a focus variation instrument. The auto correlation length (Sal) showed all surface profiles from the compacts displayed a value below 0.1 mm, indicating that only high frequency components (i.e., roughness) were considered and that the analysis had been successful. The developed interfacial area ratio (Sdr) displayed values below 5% in line with ISO guidelines for all the polymers studied with their texture aspect ratio values (Str) > 0.5, indicating uniformity of the surfaces of the produced compacts. Of the various parameters studied, areal material ratio (Smr2) predicted XG to wet and hydrate quicker than PEO, with PEO also wetting and hydrating quicker than the HPMC. The dissolution imaging and initial swelling studies proved to concur with the findings from the areal material ratio (Smr2) parameter, suggesting porosity was not an indicator for the ease with which water ingress occurs. This study suggests the Smr2 surface parameter to potentially predict wetting and initial hydration of hydrophilic polymers, however care should be taken as this study consists of a selected number of hydrophilic polymers.

11.
BMJ ; 368: m540, 2020 Mar 11.
Artículo en Inglés | MEDLINE | ID: mdl-32161042

RESUMEN

OBJECTIVE: To identify, appraise, and synthesise the best available evidence on the efficacy of perioperative interventions to reduce postoperative pulmonary complications (PPCs) in adult patients undergoing non-cardiac surgery. DESIGN: Systematic review and meta-analysis of randomised controlled trials. DATA SOURCES: Medline, Embase, CINHAL, and CENTRAL from January 1990 to December 2017. ELIGIBILITY CRITERIA: Randomised controlled trials investigating short term, protocolised medical interventions conducted before, during, or after non-cardiac surgery were included. Trials with clinical diagnostic criteria for PPC outcomes were included. Studies of surgical technique or physiological or biochemical outcomes were excluded. DATA EXTRACTION AND SYNTHESIS: Reviewers independently identified studies, extracted data, and assessed the quality of evidence. Meta-analyses were conducted to calculate risk ratios with 95% confidence intervals. Quality of evidence was summarised in accordance with GRADE methods. The primary outcome was the incidence of PPCs. Secondary outcomes were respiratory infection, atelectasis, length of hospital stay, and mortality. Trial sequential analysis was used to investigate the reliability and conclusiveness of available evidence. Adverse effects of interventions were not measured or compared. RESULTS: 117 trials enrolled 21 940 participants, investigating 11 categories of intervention. 95 randomised controlled trials enrolling 18 062 participants were included in meta-analysis; 22 trials were excluded from meta-analysis because the interventions were not sufficiently similar to be pooled. No high quality evidence was found for interventions to reduce the primary outcome (incidence of PPCs). Seven interventions had low or moderate quality evidence with confidence intervals indicating a probable reduction in PPCs: enhanced recovery pathways (risk ratio 0.35, 95% confidence interval 0.21 to 0.58), prophylactic mucolytics (0.40, 0.23 to 0.67), postoperative continuous positive airway pressure ventilation (0.49, 0.24 to 0.99), lung protective intraoperative ventilation (0.52, 0.30 to 0.88), prophylactic respiratory physiotherapy (0.55, 0.32 to 0.93), epidural analgesia (0.77, 0.65 to 0.92), and goal directed haemodynamic therapy (0.87, 0.77 to 0.98). Moderate quality evidence showed no benefit for incentive spirometry in preventing PPCs. Trial sequential analysis adjustment confidently supported a relative risk reduction of 25% in PPCs for prophylactic respiratory physiotherapy, epidural analgesia, enhanced recovery pathways, and goal directed haemodynamic therapies. Insufficient data were available to support or refute equivalent relative risk reductions for other interventions. CONCLUSIONS: Predominantly low quality evidence favours multiple perioperative PPC reduction strategies. Clinicians may choose to reassess their perioperative care pathways, but the results indicate that new trials with a low risk of bias are needed to obtain conclusive evidence of efficacy for many of these interventions. STUDY REGISTRATION: Prospero CRD42016035662.


Asunto(s)
Vías Clínicas , Complicaciones Posoperatorias/prevención & control , Enfermedades Respiratorias/prevención & control , Analgesia Epidural , Expectorantes/uso terapéutico , Fluidoterapia , Hemodinámica , Humanos , Cuidados Intraoperatorios , Modalidades de Fisioterapia , Terapia Respiratoria , Vasoconstrictores/uso terapéutico
12.
Crit Care ; 13(3): 221, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-19519946

RESUMEN

Nitric oxide (NO) is an endogenous mediator of vascular tone and host defence. Inhaled nitric oxide (iNO) results in preferential pulmonary vasodilatation and lowers pulmonary vascular resistance. The route of administration delivers NO selectively to ventilated lung units so that its effect augments that of hypoxic pulmonary vasoconstriction and improves oxygenation. This 'Bench-to-bedside' review focuses on the mechanisms of action of iNO and its clinical applications, with emphasis on acute lung injury and the acute respiratory distress syndrome. Developments in our understanding of the cellular and molecular actions of NO may help to explain the hitherto disappointing results of randomised controlled trials of iNO.


Asunto(s)
Broncodilatadores/uso terapéutico , Óxido Nítrico/uso terapéutico , Síndrome de Dificultad Respiratoria/tratamiento farmacológico , Administración por Inhalación , Adulto , Anemia de Células Falciformes/tratamiento farmacológico , Broncodilatadores/administración & dosificación , Broncodilatadores/farmacología , Humanos , Hipertensión Pulmonar/tratamiento farmacológico , Óxido Nítrico/administración & dosificación , Óxido Nítrico/farmacología , Disfunción Ventricular Derecha/tratamiento farmacológico
13.
Biomark Med ; 13(3): 205-218, 2019 02.
Artículo en Inglés | MEDLINE | ID: mdl-30810341

RESUMEN

AIM: We investigated whether plasma levels of the inflammation marker S100A8/A9, could predict acute kidney injury (AKI) onset in patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB). PATIENTS & METHODS: Plasma levels of S100A8/A9 and other neutrophil cytosolic proteins were measured in 39 patients pre- and immediately post-CPB. RESULTS: All markers increased significantly post-CPB with S100A8/A9, S100A12 and myeloperoxidase levels significantly higher in patients who developed AKI within 7 days. S100A8/A9 had good prognostic utility for AKI, with an area under the receiver operating characteristic curve of 0.81 (95% CI: 0.676-0.949) and a cut-off value of 10.6 µg/ml (85.7% sensitivity and 75% specificity) irrespective of age. CONCLUSION: Plasma S100A8/A9 levels immediately after cardiac surgery, can predict onset of AKI, irrespective of age.


Asunto(s)
Lesión Renal Aguda/diagnóstico , Biomarcadores/sangre , Calgranulina A/sangre , Calgranulina B/sangre , Procedimientos Quirúrgicos Cardíacos/efectos adversos , Puente Cardiopulmonar/efectos adversos , Lesión Renal Aguda/sangre , Lesión Renal Aguda/etiología , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Pronóstico , Curva ROC
14.
Trials ; 20(1): 456, 2019 Jul 24.
Artículo en Inglés | MEDLINE | ID: mdl-31340849

RESUMEN

BACKGROUND: Forty per cent of critically ill patients are affected by intensive care unit-acquired weakness (ICU-AW), to which skeletal muscle wasting makes a substantial contribution. This can impair outcomes in hospital, and can cause long-term physical disability after hospital discharge. No effective mitigating strategies have yet been identified. Application of a repetitive vascular occlusion stimulus (RVOS) a limb pressure cuff inducing brief repeated cycles of ischaemia and reperfusion, can limit disuse muscle atrophy in both healthy controls and bed-bound patients recovering from knee surgery. We wish to determine whether RVOS might be effective in mitigating against muscle wasting in the ICU. Given that RVOS can also improve vascular function in healthy controls, we also wish to assess such effects in the critically ill. We here describe a pilot study to assess whether RVOS application is safe, tolerable, feasible and acceptable for ICU patients. METHODS: This is a randomised interventional feasibility trial. Thirty-two ventilated adult ICU patients with multiorgan failure will be recruited within 48 h of admission and randomised to either the intervention arm or the control arm. Intervention participants will receive RVOS twice daily (except only once on day 1) for up to 10 days or until ICU discharge. Serious adverse events and tolerability (pain score) will be recorded; feasibility of trial procedures will be assessed against pre-specified criteria and acceptability by semi-structured interview. Together with vascular function, muscle mass and quality will be assessed using ultrasound and measures of physical function at baseline, on days 6 and 11 of study enrolment, and at ICU and hospital discharge. Blood and urine biomarkers of muscle metabolism, vascular function, inflammation and DNA damage/repair mechanism will also be analysed. The Health questionnaire will be completed 3 months after hospital discharge. DISCUSSION: If this study demonstrates feasibility, the derived data will be used to inform the design (and sample size) of an appropriately-powered prospective trial to clarify whether RVOS can help preserve muscle mass/improve vascular function in critically ill patients. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN44340629. Registered on 26 October 2017.


Asunto(s)
Debilidad Muscular/prevención & control , Músculo Esquelético/irrigación sanguínea , Atrofia Muscular/prevención & control , Oclusión Terapéutica/métodos , Enfermedad Crítica , Inglaterra , Estudios de Factibilidad , Humanos , Estudios Multicéntricos como Asunto , Debilidad Muscular/diagnóstico , Debilidad Muscular/fisiopatología , Atrofia Muscular/diagnóstico , Atrofia Muscular/fisiopatología , Proyectos Piloto , Ensayos Clínicos Controlados Aleatorios como Asunto , Flujo Sanguíneo Regional , Oclusión Terapéutica/efectos adversos , Factores de Tiempo , Resultado del Tratamiento
15.
J Nurs Educ ; 47(10): 448-57, 2008 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18856099

RESUMEN

Despite the American Association of Colleges of Nursing's adoption of the Doctor of Nursing Practice (DNP) degree as the appropriate level of education for advanced practice, a number of controversies have persisted, including questions of timing, academic support, grandfathering, diffusion of nursing research, and economics. This article discusses the path to the professional doctorate in optometry, osteopathy, public health, pharmacy, physical therapy, audiology, chiropractic, and naturopathy. It reveals similar struggles to professionalism and the consensus drawn from doctoral development in these fields. It concludes with lessons for a path forward for the DNP.


Asunto(s)
Habilitación Profesional/historia , Educación de Postgrado en Enfermería , Empleos en Salud/normas , Enfermeras Practicantes/normas , Práctica Profesional/normas , Empleos en Salud/historia , Historia del Siglo XIX , Historia del Siglo XX , Humanos , Enfermeras Practicantes/educación , Práctica Profesional/historia , Estados Unidos
16.
J Med Econ ; 21(3): 294-300, 2018 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-29171319

RESUMEN

AIMS: Infection is a major complication of cardiovascular implantable electronic device (CIED) therapy that usually requires device extraction and is associated with increased morbidity and mortality. The TYRX Antibacterial Envelope is a polypropylene mesh that stabilizes the CIED and elutes minocycline and rifampin to reduce the risk of post-operative infection. METHODS: A decision tree was developed to assess the cost-effectiveness of TYRX vs standard of care (SOC) following implantation of four CIED device types. The model was parameterized for a UK National Health Service perspective. Probabilities were derived from the literature. Resource use included drug acquisition and administration, hospitalization, adverse events, device extraction, and replacement. Incremental cost-effectiveness ratios (ICERs) were calculated from costs and quality-adjusted life-years (QALYs). RESULTS: Over a 12-month time horizon, TYRX was less costly and more effective than SOC when utilized in patients with an ICD or CRT-D. TYRX was associated with ICERs of £46,548 and £21,768 per QALY gained in patients with an IPG or CRT-P, respectively. TYRX was cost-effective at a £30,000 threshold at baseline probabilities of infection exceeding 1.65% (CRT-D), 1.95% (CRT-P), 1.87% (IPG), and 1.38% (ICD). LIMITATIONS AND CONCLUSIONS: Device-specific infection rates for high-risk patients were not available in the literature and not used in this analysis, potentially under-estimating the impact of TYRX in certain devices. Nevertheless, TYRX is associated with a reduction in post-operative infection risk relative to SOC, resulting in reduced healthcare resource utilization at an initial cost. The ICERs are below the accepted willingness-to-pay thresholds used by UK decision-makers. TYRX, therefore, represents a cost-effective prevention option for CIED patients at high-risk of post-operative infection.


Asunto(s)
Antibacterianos/administración & dosificación , Antibacterianos/economía , Insuficiencia Cardíaca/cirugía , Control de Infecciones/métodos , Prótesis e Implantes/microbiología , Mallas Quirúrgicas/economía , Análisis Costo-Beneficio , Humanos , Mortalidad/tendencias , Calidad de Vida , Reino Unido
17.
J Am Heart Assoc ; 6(8)2017 Jul 27.
Artículo en Inglés | MEDLINE | ID: mdl-28751544

RESUMEN

BACKGROUND: This study sought to assess payer costs following cryoballoon or radiofrequency current (RFC) catheter ablation of paroxysmal atrial fibrillation in the randomized FIRE AND ICE trial. METHODS AND RESULTS: A trial period analysis of healthcare costs evaluated the impact of ablation modality (cryoballoon versus RFC) on differences in resource use and associated payer costs. Analyses were based on repeat interventions, rehospitalizations, and cardioversions during the trial, with unit costs based on 3 national healthcare systems (Germany [€], the United Kingdom [£], and the United States [$]). Total payer costs were calculated by applying standard unit costs to hospital stays, using International Classification of Diseases, 10th Revision diagnoses and procedure codes that were mapped to country-specific diagnosis-related groups. Patients (N=750) randomized 1:1 to cryoballoon (n=374) or RFC (n=376) ablation were followed for a mean of 1.5 years. Resource use was lower in the cryoballoon than the RFC group (205 hospitalizations and/or interventions in 122 patients versus 268 events in 154 patients). The cost differences per patient in mean total payer costs during follow-up were €640, £364, and $925 in favor of cryoballoon ablation (P=0.012, 0.013, and 0.016, respectively). This resulted in trial period total cost savings of €245 000, £140 000, and $355 000. CONCLUSIONS: When compared with RFC ablation, cryoballoon ablation was associated with a reduction in resource use and payer costs. In all 3 national healthcare systems analyzed, this reduction resulted in substantial trial period cost savings, primarily attributable to fewer repeat ablations and a reduction in cardiovascular rehospitalizations with cryoballoon ablation. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Identifier: NCT01490814.


Asunto(s)
Fibrilación Atrial/economía , Fibrilación Atrial/cirugía , Cateterismo Cardíaco/economía , Ablación por Catéter/economía , Criocirugía/economía , Costos de Hospital , Fibrilación Atrial/diagnóstico , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Catéteres Cardíacos/economía , Ablación por Catéter/efectos adversos , Ahorro de Costo , Análisis Costo-Beneficio , Criocirugía/efectos adversos , Criocirugía/instrumentación , Cardioversión Eléctrica/economía , Europa (Continente) , Humanos , Tiempo de Internación/economía , Readmisión del Paciente/economía , Retratamiento/economía , Medicina Estatal/economía , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
19.
Health Psychol Open ; 3(1): 2055102915622928, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-28070383

RESUMEN

This study investigated how intensivists make decisions regarding withholding and withdrawing treatment for patients at the end of their lives. This involved completing in-depth interviews from two sites of the South of England, United Kingdom by twelve intensivists. The data collected by these intensivists were analysed using thematic analysis. This resulted in the identification of three themes: intensivists' role, treatment effectiveness, and patients' best interest. Transcending these were two overarching themes relating to the balance between quantity and quality of life, and the intensivists' sense of responsibility versus burden. The results are considered in terms of making sense of death and the role of beliefs in the decision-making process.

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