128 research outputs found
An Economic Evaluation of the A(H1N1) Flu Vaccine in Mexico
During 2009 Mexico experienced an A(H1N1) pandemic with a rapid increase in the number of observed cases. To reduce transmission, the Mexican Government purchased 30 million A(H1N1) vaccines that were under production. There was considerable uncertainty in whether this large expenditure represented value for money. The primary aim of this thesis is to estimate the cost-effectiveness (CE) of vaccination programmes using the information known at the time of the decision. This objective utilised an ordinary differential equations (ODE) approach calibrated via a Markov chain Monte Carlo (MCMC) algorithm. Additional objectives included: assessing whether the observed number of reported cases could also be replicated using discrete event simulation (DES) methodology and documenting the type and prevalence of models used to estimate the CE of an infectious disease vaccine intervention. There was inherent uncertainty regarding the anticipated CE of the vaccine at the time the decision to purchase was made, primarily as no definitive value for the reporting rate (RR), the number of cases that come to clinical attention could be estimated. Three RR values, for the 0-15-year-age group, were explored (0.75, 0.01 and 0.001) with RR in other age groups being estimated through the MCMC calibration. In two of the RRs (0.75 and 0.01), the vaccination programme was cost-effective, for the assumed threshold value for Mexico ($110,000 MXN per QALY gained). In contrast, when a low RR was assumed (0.001) the vaccine was dominated, being more expensive and producing less health due to the adverse events of the vaccine. These results were robust to most sensitivity analyses. When a pessimistic scenario was applied (low vaccine effectiveness, longer time required to apply the vaccines -an additional 55 days compared with the base case-, and vaccine arriving 31 days later) did the vaccine interventions become non-CE assuming an RR of 0.01. For the 0.001 RR scenario, when longer times of latent and infectious periods were assumed the vaccine became CE. As the Mexican Government anticipated an RR of approximately 0.09, it was concluded that the decision to purchase the vaccines would have been considered a cost-effective use of resources. The DES model was found to be an unsuitable approach to predict the pandemic as the calibration attempt was unsuccessful and running times were lengthy. There are clear advantages in using an ODE approach rather than a DES approach in a pandemic setting.
The analysis of the papers identified in the literature review has indicated most of the published literature are based on static approaches, although the use of dynamic
models has increased over time. Analyses indicated that the year of publication was a significant predictor for the use of dynamic models. The decision to construct a
dynamic, rather than a static model, however, was neither influenced by the GDP per capita of the effected country or the location of the lead author
Comparative effectiveness of heel-specific medical devices for the prevention of heel pressure ulcers: a systematic review
Background
Pressure ulcers (PUs) impact on patient's quality of life and are costly for healthcare providers. Heels are a particular concern due to specific risk factors. Relative effectiveness of medical devices, e.g., dressings, off-loading devices, heel cushioning devices, to reduce PU development is unknown.
Methods
Systematic review of the effectiveness of heel-specific medical devices for the prevention of heel PU (HPU)s. Database searches were performed from inception to June 2021 for RCTs. The primary outcome was incidence of new HPUs. Trials were assessed for risk of bias and data analysed with risk ratios, mean difference or hazard ratios as appropriate.
Results
Fifteen RCTs (4724 participants) were identified.
Dressings, as constant low pressure (CLP) devices vs standard care: eight trials (very low quality) showed no-significant difference in effectiveness (RR 0.31, 95%CI 0.10 to 1.01).
Off-loading devices vs standard care: three trials (low quality), showed significant reduction in development of Category≥1 HPUs (RR 0.20, 95%CI 0.05 to 0.80) two trials (medium quality), showed significant reduction in development of Category≥2 HPUs (RR 0.08, 95%CI 0.01 to 0.67).
Comparisons between off-loading devices: two trials (low quality) showed no clear difference in HPU incidence.
In a paediatric post-surgical population, one trial of off-loading device and one of a dressing (CLP device), both versus standard care, showed no clear difference in HPU incidence (RR 0.19 95%CI 0.02 to 1.55 and RR 0.89 95%CI 0.56 to 1.42 respectively).
Conclusions
Off-loading devices may reduce HPU incidence, from low-quality evidence. There is insufficient evidence to suggest that dressings reduce HPU incidence
Optimization of the physical-chemical treatment system for a carbonated water wastewater treatment plant
El presente trabajo permite resolver un grave problema económico-ambiental que afecta a la comunidad al tener unidades de tratamiento con bajo niveles de eficiencia y altos costos de operación por la adición en exceso de reactivos. Mediante la investigación aplicada y experimental, se realizó un diagnóstico para determinar los requerimientos de mantenimiento, la identificación de las concentraciones y el lugar exacto en donde se adicionan las soluciones que demanda el agua residual. Los resultados alcanzados en las pruebas establecen que la dosificación ideal de sulfato de aluminio fue de 250 ppm para la maximización de la eficiencia de remoción de la contaminación en la unidad de tratamiento en un valor mayor al 90%.This study makes it possible to resolve a serious environmental-economic problem that affects the community, caused by treatment plants with low levels of efficiency and high operating costs due to the excessive addition of reagents. After applied and experimental research, a diagnosis was made to determine the maintenance requirements, the identification of the concentrations and the exact point where solutions needed for wastewater treatment should be added. The results obtained establish that the ideal dosage of aluminum sulfate for maximizing the contaminant removal efficiency in the treatment plant at a value greater than 90% was 250 ppm
Comparing alternating pressure mattresses and high-specification foam mattresses to prevent pressure ulcers in high-risk patients: the PRESSURE 2 RCT
Background:
Pressure ulcers (PUs) are a burden to patients, carers and health-care providers. Specialist mattresses minimise the intensity and duration of pressure on vulnerable skin sites in at-risk patients.
Primary objective:
Time to developing a new PU of category ≥ 2 in patients using an alternating pressure mattress (APM) compared with a high-specification foam mattress (HSFM).
Design:
A multicentre, Phase III, open, prospective, planned as an adaptive double-triangular group sequential, parallel-group, randomised controlled trial with an a priori sample size of 2954 participants. Randomisation used minimisation (incorporating a random element).
Setting:
The trial was set in 42 secondary and community inpatient facilities in the UK.
Participants:
Adult inpatients with evidence of acute illness and at a high risk of PU development.
Interventions and follow-up:
APM or HSFM – the treatment phase lasted a maximum of 60 days; the final 30 days were post-treatment follow-up.
Main outcome measures:
Time to event.
Results:
From August 2013 to November 2016, 2029 participants were randomised to receive either APM (n = 1016) or HSFM (n = 1013). Primary end point – 30-day final follow-up: of the 2029 participants in the intention-to-treat population, 160 (7.9%) developed a new PU of category ≥ 2. There was insufficient evidence of a difference between groups for time to new PU of category ≥ 2 [Fine and Gray model HR 0.76, 95% confidence interval (CI) 0.56 to 1.04; exact p-value of 0.0890 and 2% absolute difference]. Treatment phase sensitivity analysis: 132 (6.5%) participants developed a new PU of category ≥ 2 between randomisation and end of treatment phase. There was a statistically significant difference in the treatment phase time-to-event sensitivity analysis (Fine and Gray model HR 0.66, 95% CI 0.46 to 0.93; p = 0.0176 and 2.6% absolute difference). Secondary end points – 30-day final follow-up: new PUs of category ≥ 1 developed in 350 (17.2%) participants, with no evidence of a difference between mattress groups in time to PU development, (Fine and Gray model HR 0.83, 95% CI 0.67 to 1.02; p-value = 0.0733 and absolute difference 3.1%). New PUs of category ≥ 3 developed in 32 (1.6%) participants with insufficient evidence of a difference between mattress groups in time to PU development (Fine and Gray model HR 0.81, 95% CI 0.40 to 1.62; p = 0.5530 and absolute difference 0.4%). Of the 145 pre-existing PUs of category 2, 89 (61.4%) healed – there was insufficient evidence of a difference in time to healing (Fine and Gray model HR 1.12, 95% CI 0.74 to 1.68; p = 0.6122 and absolute difference 2.9%). Health economics – the within-trial and long-term analysis showed APM to be cost-effective compared with HSFM; however, the difference in costs models are small and the quality-adjusted life-year gains are very small. There were no safety concerns. Blinded photography substudy – the reliability of central blinded review compared with clinical assessment for PUs of category ≥ 2 was ‘very good’ (kappa statistic 0.82, prevalence- and bias-adjusted kappa 0.82). Quality-of-life substudy – the Pressure Ulcer Quality of Life – Prevention (PU-QoL-P) instrument meets the established criteria for reliability, construct validity and responsiveness.
Limitations:
A lower than anticipated event rate.
Conclusions:
In acutely ill inpatients who are bedfast/chairfast and/or have a category 1 PU and/or localised skin pain, APMs confer a small treatment phase benefit that is diminished over time. Overall, the APM patient compliance, very low PU incidence rate observed and small differences between mattresses indicate the need for improved indicators for targeting of APMs and individualised decision-making. Decisions should take into account skin status, patient preferences (movement ability and rehabilitation needs) and the presence of factors that may be potentially modifiable through APM allocation, including being completely immobile, having nutritional deficits, lacking capacity and/or having altered skin/category 1 PU.
Future work:
Explore the relationship between mental capacity, levels of independent movement, repositioning and PU development. Explore ‘what works for whom and in what circumstances’.
Trial registration:
Current Controlled Trials ISRCTN01151335.
Funding:
This project was funded by the National Institute for Health Research Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 52. See the NIHR Journals Library website for further project information
The use of early decision modelling and value of information analysis in an adaptive trial design: results from the OPTIMA preliminary study
An adaptable implementation package targeting evidence-based indicators in primary care: a pragmatic cluster-randomised evaluation
Background
In primary care, multiple priorities and system pressures make closing the gap between evidence and practice challenging. Most implementation studies focus on single conditions, limiting generalisability. We compared an adaptable implementation package against an implementation control and assessed effects on adherence to four different evidence-based quality indicators.
Methods and findings
We undertook two parallel, pragmatic cluster-randomised trials using balanced incomplete block designs in general practices in West Yorkshire, England. We used ‘opt-out’ recruitment, and we randomly assigned practices that did not opt out to an implementation package targeting either diabetes control or risky prescribing (Trial 1); or blood pressure (BP) control or anticoagulation in atrial fibrillation (AF) (Trial 2). Within trials, each arm acted as the implementation control comparison for the other targeted indicator. For example, practices assigned to the diabetes control package acted as the comparison for practices assigned to the risky prescribing package. The implementation package embedded behaviour change techniques within audit and feedback, educational outreach, and computerised support, with content tailored to each indicator. Respective patient-level primary endpoints at 11 months comprised the following: achievement of all recommended levels of haemoglobin A1c (HbA1c), BP, and cholesterol; risky prescribing levels; achievement of recommended BP; and anticoagulation prescribing. Between February and March 2015, we recruited 144 general practices collectively serving over 1 million patients. We stratified computer-generated randomisation by area, list size, and pre-intervention outcome achievement. In April 2015, we randomised 80 practices to Trial 1 (40 per arm) and 64 to Trial 2 (32 per arm). Practices and trial personnel were not blind to allocation. Two practices were lost to follow-up but provided some outcome data. We analysed the intention-to-treat (ITT) population, adjusted for potential confounders at patient level (sex, age) and practice level (list size, locality, pre-intervention achievement against primary outcomes, total quality scores, and levels of patient co-morbidity), and analysed cost-effectiveness. The implementation package reduced risky prescribing (odds ratio [OR] 0.82; 97.5% confidence interval [CI] 0.67–0.99, p = 0.017) with an incremental cost-effectiveness ratio of £1,359 per quality-adjusted life year (QALY), but there was insufficient evidence of effect on other primary endpoints (diabetes control OR 1.03, 97.5% CI 0.89–1.18, p = 0.693; BP control OR 1.05, 97.5% CI 0.96–1.16, p = 0.215; anticoagulation prescribing OR 0.90, 97.5% CI 0.75–1.09, p = 0.214). No statistically significant effects were observed in any secondary outcome except for reduced co-prescription of aspirin and clopidogrel without gastro-protection in patients aged 65 and over (adjusted OR 0.62; 97.5% CI 0.39–0.99; p = 0.021). Main study limitations concern our inability to make any inferences about the relative effects of individual intervention components, given the multifaceted nature of the implementation package, and that the composite endpoint for diabetes control may have been too challenging to achieve.
Conclusions
In this study, we observed that a multifaceted implementation package was clinically and cost-effective for targeting prescribing behaviours within the control of clinicians but not for more complex behaviours that also required patient engagement.
Trial registration
The study is registered with the ISRCTN registry (ISRCTN91989345)
Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial
Comparison of ALitretinoin with PUVA as the first-line treatment in patients with severe chronic HAnd eczema (ALPHA):study protocol for a randomised controlled trial
Introduction Hand eczema (HE) is one of the most common skin disorders and an important cause for morbidity and occupational disability. The 1-year prevalence of HE is estimated to be up to 10% and it is estimated that 5%–7% of those develop severe chronic HE. However, current clinical evidence is not compelling enough to guide clinical practice. In a survey among 194 UK dermatologists the most frequent first choice approaches were psoralen combined with ultraviolet A (UVA) treatment (PUVA), oral steroids and alitretinoin (AL). When asked which strategy was most efficient for long-term outcome 20% of clinicians indicated they did not know; 43% of clinicians reported AL and 30% reported PUVA.
Methods and analysis ALPHA is a multicentre, open, prospective, two-arm parallel group, randomised controlled trial comparing PUVA and AL with a planned sample size re-estimation. Between 500 and 780 participants will be randomised on a 1:1 basis. The physician’s global assessment (PGA) will direct treatment after randomisation, non-responders will be treated according to usual clinical practice; providing valuable pilot data on second line therapeutic approaches to inform future trials.
Assessments will be conducted up to 52 weeks post randomisation. The primary outcome measure is the Hand Eczema Severity Index at 12 weeks. Secondary outcome measures include modified Total Lesion Symptom Score, PGA, time to relapse, patient reported outcome measures and DNA extraction and assessment of genetic variants. A substudy on molecular inflammatory mediators will provide information on subgroup specific treatment responses. Photographs will be taken and HE severity assessed by a central review panel
Protección humanitaria en la gestión integral del riesgo.
Este informe es el resultado del Curso de Especialización es el proceso en la elaboración, capacitación y entrega de las herramientas teóricas y prácticas donde se destacaron las diferentes acciones frente a las amenazas o desastres que se pueden presentar en El Salvador, debido a la alta vulnerabilidad del territorio por lo que es susceptible al impacto de los fenómenos naturales y antrópicos. Los mecanismos y procedimientos en la reducción, mitigación y prevención ante los desastres; permite salvaguardar la vida humana, el cuido del medio ambiente y garantizar los derechos humanos. Además, se formularon múltiples temáticas, consideraciones y apreciaciones que comprende 6 módulos; que introduce conceptos claves como también se conocieron los principios básicos de protección, para que se apliquen en los distintos eventos adversos, en las emergencias ocurridas, estos elementos deben incluirse en la formulación de planes de respuesta inmediata. Es por ello que la evaluación de daños es fundamental en la reducción de desastres.
Palabras claves: Riesgo ; Amenaza ; Vulnerabilidad ; Desastres ; Protección
Evaluación en época seca de ecosistemas acuáticos y terrestres: componentes de vegetación y faunación. Sector Centro Administrativo PNN El Tuparro (Cumaribo, Vichada)
La asignatura EcologÃa Regional Continental tiene como objetivo el análisis de los procesos ecológicos a escala de paisaje y bioma. A lo largo de su existencia dentro del programa curricular de BiologÃa de la Universidad Nacional de Colombia se han realizado distintos estudios ecológicos en distintas regiones del paÃs, ampliando cada vez más el conocimiento de los estudiantes que toman la asignatura y aportando al conocimiento de zonas poco estudiadas. Durante los últimos periodos, la fase de campo se ha realizado en zonas pertenecientes al Sistema de Parques Nacionales Naturales de Colombia. Es asà como se realizó un estudio preliminar durante el segundo semestre de 2010 en el PNN Cueva de Los Guacharos en el departamento del Huila, cumpliendo con el objetivo de una evaluación ecológica rápida a nivel de vegetación y limnologÃa de manera dirigida, además de proyectos de distintos temas sobre aspectos ecológicos de la región. Para este periodo, primer semestre de 2011, la fase de campo se desarrolló en el PNN El Tuparro, ubicado en el departamento del Vichada y se incluyó adicionalmente el componente de faunación. Esta zona del paÃs es poco conocida dado su difÃcil acceso, por lo que la información obtenida es de gran valor
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