Semi‐synthetic human insulin was delivered via a novel nebulizer to the respiratory tracts of six diabetic children. Blood glucose control obtained was at least as good as a control day when they received their usual dose of subcutaneous insulin.
Diet is one of the strongest modulators of the gut microbiome. However, the complexity of the interactions between diet and the microbial community emphasises the need for a robust study design and continued methodological development. This review aims to summarise considerations for conducting high‐quality diet–microbiome research, outline key challenges unique to the field, and provide advice for addressing these in a practical manner useful to dietitians, microbiologists, gastroenterologists and other diet–microbiome researchers. Searches of databases and references from relevant articles were conducted using the primary search terms ‘diet’, ‘diet intervention’, ‘dietary analysis’, ‘microbiome’ and ‘microbiota’, alone or in combination. Publications were considered relevant if they addressed methods for diet and/or microbiome research, or were a human study relevant to diet–microbiome interactions. Best‐practice design in diet–microbiome research requires appropriate consideration of the study population and careful choice of trial design and data collection methodology. Ongoing challenges include the collection of dietary data that accurately reflects intake at a timescale relevant to microbial community structure and metabolism, measurement of nutrients in foods pertinent to microbes, improving ability to measure and understand microbial metabolic and functional properties, adequately powering studies, and the considered analysis of multivariate compositional datasets. Collaboration across the disciplines of nutrition science and microbiology is crucial for high‐quality diet–microbiome research. Improvements in our understanding of the interaction between nutrient intake and microbial metabolism, as well as continued methodological innovation, will facilitate development of effective evidence‐based personalised dietary treatments.
Background and Aims: Endoscopic eradication therapy (EET) is the first line approach for treating Barrett's Esophagus (BE) related neoplasia globally. The British Society of Gastroenterology (BSG) recommend EET with combined endoscopic resection (ER) for visible dysplasia followed by endoscopic ablation in patients with both low and high grade dysplasia (LGD and HGD). The aim of this study is to perform a cost-effectiveness analysis for EET for treatment of all grades of dysplasia in BE patients. Methods: A Markov cohort model with a lifetime time horizon was used to undertake a cost effectiveness analysis. A hypothetical cohort of United Kingdom (UK) patients diagnosed with BE entered the model. Patients in the treatment arm with LGD and HGD received EET and patients with non-dysplastic BE (NDBE) received endoscopic surveillance only. In the comparator arm, patients with LGD, HGD and NDBE received endoscopic surveillance only. A UK National Health Service (NHS) perspective was adopted and the incremental cost effectiveness ratio (ICER) was calculated. Sensitivity analysis was conducted on key input parameters. Results: EET for patients with LGD and HGD arising in BE is cost-effective compared to endoscopic surveillance alone (lifetime ICER £3,006 per QALY gained). The results show that as the time horizon increases, the treatment becomes more cost-effective. The five year financial impact to the UK NHS of introducing EET is £7.1m. Conclusions: EET for patients with low and high grade BE dysplasia, following updated guidelines from the BSG has been shown to be cost-effective for patients with BE in the UK.
Objective: A randomised controlled trial (RCT) recruited women undergoing caesarean section (CS) in Poland. The aim of the trial was to assess the efficacy of a dialkylcarbamoyl chloride (DACC)-impregnated surgical dressing (bacterial-binding dressings) compared with standard of care (SoC) in preventing surgical site infection (SSI). The aim of the present analysis was to evaluate the cost-effectiveness of the bacterial-binding dressings in the context of the UK National Health Service (NHS). Method: The clinical trial randomised patients to a bacterial-binding dressing (n=272) or a standard surgical dressing (n=271). The study recorded the presence of SSI and associated resource use up to 14 days postoperatively. To generalise results to the NHS, UK unit costs were applied to resource use recorded in the trial. An alternative approach applied a single UK-specific episode cost per SSI. Results: There were 543 women recruited to the trial. SSI rates were 5/272 (1.8%) and 14/271 (5.2%) for bacterial-binding dressings and SoC, respectively (p=0.04). Patients in the bacterial-binding dressing group had six fewer outpatient visits and 33 fewer hospital bed-days. The mean length of SSI-attributable hospitalisation was 2.36 days. Applying UK unit costs at 2017 prices to resource use recorded in the trial, costs of SSI prophylaxis and treatment were £48.97 and £24.69 per patient in the SoC and bacterial-binding dressing groups respectively, a difference of £24.27 (49.6%) per patient. The alternative costing approach produced a cost saving of £119 (57.6%) per patient with the bacterial-binding dressing. Conclusion: Use of bacterial-binding dressings following CS has the potential to reduce the incidence of SSI and costs to the NHS.
Background. The SQ ® house dust mite (HDM) sublingual immunotherapy (SLIT)-tablet ACARIZAX ® , ALK-Abelló A/S, Hørsholm, Denmark) is an allergy immunotherapy tablet for people with allergic respiratory disease. This analysis aims to assess the cost-effectiveness of the SQ HDM SLIT-tablet from the perspective of three Eastern European countries: Czech Republic, Poland and Slovakia. Methods. A cost-utility model per country was developed, which compared the SQ HDM SLIT-tablet as add-on to pharmacotherapy with pharmacotherapy alone in patients with HDM allergic asthma (AA) over a five year time horizon. The effectiveness of the two interventions was based on the results from a large-scale randomised controlled trial. In the models, annual costs and quality-adjusted life year (QALY) scores from the trial were extrapolated over a five year period, and the incremental cost-effectiveness ratios (ICERs) were estimated. One-way deterministic sensitivity and scenario analyses were undertaken. Results. The SQ HDM SLIT-tablet is cost-effective in all three markets over the five year time horizon (ICERs of less than € 10,000 per additional QALY). Treatment with the SQ HDM SLIT-tablet improves patient outcomes, with QALY gains of 0.35, versus pharmacotherapy only. In all three countries, the SQ HDM SLIT-tablet also incurs increased costs compared to pharmacotherapy treatment only. The sensitivity analysis identified utility values from the clinical trial as the main driver of the model results. Conclusion. The SQ HDM SLIT-tablet is a cost-effective treatment option for people with HDM AA in three different health care settings in Eastern Europe.
Background: Treatment with a duodenal-jejunal bypass sleeve (DJBS) induces clinically significant weight loss, but little is known about the mechanisms of action of this device. Aim: The aim of this study was to characterize the mechanisms of action of the DJBS and determine the durability of weight loss and metabolic improvements. Materials and Methods: We studied a cohort of 19 subjects with severe obesity and type 2 diabetes (baseline body mass index: 43.7±5.3 kg/m2). Anthropometry, body composition, blood pressure, biochemical measures, and dietary intake were monitored for 48 weeks after DJBS implantation, and then for 1 year after device removal. Gastric emptying and triglyceride absorption were measured at baseline, 8 weeks after implant, and within 3 weeks of device explant. Visceral sensory function was assessed at baseline, 4 weeks after implant, and within 3 weeks after explant. Results: Significant weight loss (P<0.01) occurred following DJBS placement, with a mean weight reduction of 17.0±6.5% at 48 weeks. The symptom burden following a standardized nutrient challenge was increased after DJBS implantation (P<0.05), returning to baseline after DJBS removal. Neither gastric emptying nor triglyceride absorption changed with the device in situ. A significant reduction in energy intake was observed [baseline: 7703±2978 kJ (1841±712 kcal), 24 weeks: 4824±2259 kJ (1153±540 kcal), and 48 weeks: 4474±1468 kJ (1069±351 kcal)]. After 1 year, anthropometry remained significantly improved, but there was no durable impact on metabolic outcomes. Conclusions: DJBS treatment resulted in substantial weight loss. Weight loss is related to reduced caloric intake, which seems linked to an augmented upper gastrointestinal symptom response, but not altered fat absorption.
Results There were 28 instances of buried FREKA PEGs among 21 patients. Nowadays, our usual management is to deploy a new PEG in a separate site, then attempt endoscopic bumper removal using a wire-guided 15Fr dilatation balloon introduced via the cut stump of the buried PEG (balloon push technique). The balloon dilates the track and grips the internal surface of the bumper during forward traction.Conscious sedation was used in 21 instances and general anaesthesia in 7. It was possible to deploy a new PEG in 26 instances (93%) and to unbury the bumper endoscopically in 24 instances (86%). An external (push-pull) T snare technique was required twice.There were no immediate complications; all but one survived for at least 1 year and 11 patients (52%) remain alive after 1-130 months. Three required surgical removal ± deployment of a new PEG. A patient for whom the bumper stump was left alone and a new PEG deployed had recurrent infections at the stump site during his three remaining years. Conclusions Buried PEG bumpers can normally be managed safely endoscopically. If this fails, and the patient is expected to survive, surgery should be done to remove them. General anaesthesia was needed in around a quarter. Long term survival may be expected in some patients. Although buried bumpers could be avoided with meticulous daily care of these patients, when encountered appropriate intervention is necessary to deal with this uncommon complication associated with PEG tube feeding.
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