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INTRODUCTION: Antibiotic-associated diarrhea (AAD) is common and frequently more severe in hospitalized elderly adults. It can lead to increased use of healthcare resources. We estimated the cost-effectiveness of a fermented milk (FM) with probiotic in preventing AAD and in particular Clostridium difficile-associated diarrhea (CDAD).
METHODS: Clinical effectiveness data and cost information were incorporated in a model to estimate the cost impact of administering a FM containing the probiotic Lactobacillus paracasei ssp paracasei CNCM I-1518 in a hospital setting. Preventing AAD by the consumption of the probiotic was compared to no preventive strategy.
RESULTS: The probiotic intervention to prevent AAD generated estimated mean cost savings of £339 per hospitalized patient over the age of 65 years and treated with antibiotics, compared to no preventive probiotic. Estimated cost savings were sensitive to variation in the incidence of AAD, and to the proportion of patients who develop non-severe/severe AAD. However, probiotics remained cost saving in all sensitivity analyses.
CONCLUSION: Use of the fermented dairy drink containing the probiotic L. paracasei CNCM I-1518 to prevent AAD in older hospitalized patients treated with antibiotics could lead to substantial cost savings.
PURPOSE: This analysis compared the rate of deep wound infections in patients with open tibia fractures, treated with intramedullary nails, receiving additional locally-delivered antibiotics to those receiving standard care.
METHODS: Two systematic literature searches identified studies reporting infection rates in patients treated with intramedullary nails for tibia fractures receiving systemic antibiotics only (search one) and in patients receiving adjunctive locally-administered antibiotics peri-operatively at the tissue-implant interface (search two). After applying inclusion and exclusion criteria, 14 and seven papers from searches one and two, respectively, were included in meta-analyses.
RESULTS: The absolute rate of infection was lower for all Gustilo-Anderson grades of tibia fractures when local antibiotics were administered as adjunctive prophylactic therapy. For severe fractures, classified as GAIII fractures, patients receiving systemic antibiotics only had an infection rate of 14.4 % [95 % CI: 10.5 %, 18.5 %]; adding local antibiotics reduced the rate to 2.4 % [0.0 %, 9.4 %], with an odds ratio of 0.17. Risk of deep wound infections increased with severity of fracture, rising to over 31 % in GIIIB&C fractures for patients receiving systematic antibiotics only, but to below 9 % with additional local antibiotics.
CONCLUSION: The findings support consideration of augmenting the antibiotic prophylaxis regimen to include locally-delivered antibiotics. Patients with severe fractures will obtain greatest benefit from infections avoided. No trial directly compared the two treatments for open tibia fractures, limiting the ability to attribute the differences in observed infection rates directly to the treatments themselves. A large comparative study to improve the evidence on relative effect size is merited.
BACKGROUND: Macular oedema secondary to retinal vein occlusion (RVO) can cause vision loss due to blockage of the central retinal vein (CRVO) or a branch retinal vein (BRVO). This systematic review assessed the efficacies of widely used treatments for macular oedema secondary to RVO and the feasibility of conducting indirect comparisons between these therapies.
METHODS: A systematic review was undertaken in November 2010, including a literature search for trials in medical databases and relevant websites. Abstracts, conference presentations and unpublished studies were considered. Studies were data-extracted and quality assessed by two independent researchers. Outcome measures included the mean change in best corrected visual acuity (BCVA) from baseline in the study eye and/or number of patients gaining at least 10 letters from baseline to 6 months or the nearest equivalent time point.
RESULTS: Fourteen unique randomized controlled trials (RCTs) were identified. Ranibizumab 0.5 mg produced greater improvements in BCVA at 6 months than sham in BRVO (mean difference 11.0 letters, 95% confidence interval [CI] 7.83, 14.17) and CRVO (mean difference 14.10 letters, 95% CI 10.51, 17.69) in two double-blind sham-controlled RCTs. Pooled data from two double-blind, sham-controlled RCTs showed that improvements in BCVA were also significantly better for dexamethasone intravitreal (IVT) implant 0.7 mg compared with sham in patients with BRVO or CRVO (mean difference 2.5 letters, 95% CI 0.7, 4.3); the difference was significant for BRVO alone, but not CRVO alone. A significantly greater proportion of patients with BRVO gained =15 letters with laser therapy vs. no treatment at 36 months in a large prospective RCT (odds ratio 3.16, 95% CI 1.25, 8.00), whereas no difference was observed at 9 months in a smaller study. Three studies reported no benefit for laser therapy in CRVO. No indirect comparisons with ranibizumab were feasible due to differences in study design and baseline characteristics.
CONCLUSIONS: Data from RCTs for ranibizumab and dexamethasone IVT demonstrate that both new agents constitute significant improvements over the previously widely accepted standard of care (laser therapy) for the treatment of BRVO and CRVO. However, head-to-head studies are needed to assess the relative efficacies of licensed therapies for RVO.
OBJECTIVE: To determine the cost-effectiveness of home-based point-of-care self-monitoring compared to clinic-based care for patients managed on long-term warfarin medication. Current evidence is inconsistent; results should reduce uncertainty and inform service delivery.
METHODS: A Markov model compared self-testing and self-management, using point-of-care devices to usual care in patients with atrial fibrillation and mechanical heart valves. The primary clinical end-points were stroke and mortality avoided; costs and utilities were associated with these events. The costs of warfarin monitoring were included in the model.
RESULTS: Over 10 years, self-monitoring saved £1187 per person compared to usual care. Patients who self-monitored had notably fewer strokes and deaths. The results were sensitive to life-years gained and cost of the device. If the NHS purchased the device, financial break-even was achieved at the end of the second year; if the patient bought the device the NHS saved money every year. If 10% of the current 950,000 patients switched to point-of-care devices for 10 years, the NHS could save over £112million.
LIMITATIONS: Clinical studies had a relatively short duration and only data on composite end-points were reported.
CONCLUSIONS: With training, self-testing and self-management are safe, reliable, and cost-effective for a sizable proportion of patients receiving long-term warfarin. Compared to clinic-based services, self-monitoring offers the NHS the potential to make cost savings and release bed-days by reducing the number of strokes experienced by these high-risk patients.
OBJETIVO: Evaluar el coste-efectividad de dasatinib 100 mg/día frente a imatinib 600 mg/día, imatinib 800 mg/día y nilotinib 800 mg/día en pacientes con leucemia mieloide crónica (LMC) en fase crónica, resistentes al tratamiento previo con imatinib 400 mg/día desde la perspectiva del Servicio Nacional de Salud portugués.
MÉTODOS: Se desarrolló un modelo de Markov para el tratamiento de la LMC en Portugal. Se consideraron cuatro estados de salud: las tres fases de la LMC (crónica, acelerada y blástica) y el estado de muerte, con ciclos de transición mensuales. El modelo fue elaborado a partir de los datos de eficacia de los ensayos clínicos, el uso de recursos sanitarios según la opinión de los expertos consultados, datos de calidad de vida publicados en el Reino Unido y costes unitarios de las listas de precios oficiales de Portugal del año 2011. Se consideró un horizonte temporal que abarcaba toda la vida del paciente y se obtuvieron resultados determinísticos. También se realizó un análisis de sensibilidad determinístico para evaluar la consistencia de los resultados obtenidos.
RESULTADOS: Los resultados mostraron que los pacientes con LMC en fase crónica con resistencia a imatinib 400 mg/día ganaban en promedio 2,72 años de vida al ser tratados con dasatinib 100 mg/día en comparación con imatinib 600-800 mg/día, y ganaban una media de 0,53 años en comparación con nilotinib 800 mg/día. El coste incremental por año de vida ganado ajustado por calidad asciende a 37.583 € cuando comparamos dasatinib 100 mg/día con imatinib 600 mg/día, hasta 12.111 € en comparación con imatinib 800 mg/día, y 16.988 € en comparación con nilotinib, para un periodo de por vida.
CONCLUSIONES: Los resultados indican que dasatinib presenta unos resultados coste-efectividad razonables en pacientes con LMC resistentes a la dosis estándar de imatinib en comparación con dosis altas de imatinib y nilotinib en Portugal.
The objective of this review was to summarize the currently available data describing the sensitivity andspecificity of indicators of unconsciousness and death in the following stun-kill methods and speciescombinations: 1) penetrative captive bolt for bovine animals, 2) head-only electrical stunning for pigs, 3) head-only electrical stunning for sheep and goats, 4) electrical waterbath for poultry (chickens and turkeys), 5) carbondioxide at high concentration for pigs, 6) all authorized gas methods to slaughter chickens and turkeys (carbondioxide at high concentration, carbon dioxide in two phases, carbon dioxide associated with inert gases and inertgases alone), 7) slaughter without stunning for bovine animals, 8) slaughter without stunning for sheep andgoats, 9) slaughter without stunning for chickens and turkeys. The reference tests for unconsciousness and deathwere to have been measured using electroencephalography (EEG). The definition of unconsciousness and deathbased on EEG were not specified, and the definition used by authors was reported. The index tests of interestwere a variety of indicators requested by the funding agency such as no corneal reflex and immediate collapse.The index tests differed by stun-kill methods and species combination. A comprehensive search identified 22publications contained 24 species-stun/kill method combinations. No studies explicitly reported the sensitivityand specificity of the indicators in conscious and unconscious animals. Many studies reported the proportion ofstunned animals with indicators, rather than the proportion of unconscious or conscious animals at a set timepoint with the indicators. Such data could not be translated into sensitivity and specificity. Other studies reportedthe average time to occurrence of an indicator or average time to cessation of the indicators. Such data cannot betranslated into sensitivity and specificity estimates without knowledge of the joint distributions.
OBJECTIVE: To assess the likelihood of biased trials contained in 12 recently published meta-analyses.
DESIGN: A review of component randomised controlled trials of systematic reviews with 12 meta analyses.
DATA SOURCES: 12 recently published systematic reviews with 503 component randomised trials, which were published in the BMJ, Lancet, JAMA and The Annals of Internal Medicine up until May 2012.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Systematic reviews were eligible for inclusion if they included only randomised controlled trials (RCTs). We obtained the full text for the component RCTs of the 12 systematic reviews. We excluded RCTs which were not available in English from our review and analysis.
RESULTS: Five of the 12 meta-analyses exhibited heterogeneity (I2 >0.30) in age differences, when there should have been none, with two having significant or substantial heterogeneity (I2 > 0.50). In three meta-analyses we found that the age of intervention group was statistically significantly higher than in the control group. Two meta-analysis had a distribution of p-values that were inconsistent with chance. Meta-regression explained some of the observed heterogeneity in two meta-analyses as a consequence of poor allocation concealment.
CONCLUSIONS: The majority of a sample of recent meta-analyses showed that there were signs of imbalance and or heterogeneity in ages between treatment groups, when there should have been none. Systematic reviewers might consider using the techniques described here to assess the validity of their findings.
