Cost-effectiveness of sacral nerve stimulation and percutaneous tibial nerve stimulation for faecal incontinence

Background: Subcutaneous sacral nerve stimulation is recommended by NICE as a second line treatment for patients with faecal incontinence who failed conservative therapy. Sacral nerve stimulation is an invasive procedure associated with complications and reoperations. This study aimed to investigate whether delivering less invasive and less costly percutaneous tibial nerve stimulation prior to sacral nerve stimulation is cost-effective. Methods: A decision analytic model was developed to estimate the cost-effectiveness of percutaneous tibial nerve stimulation with subsequent subcutaneous sacral nerve stimulation versus subcutaneous sacral nerve stimulation alone. The model was populated with effectiveness data from systematic reviews and cost data from randomized studies comparing both procedures in an NHS setting. Results: Offering percutaneous tibial nerve stimulation prior to sacral nerve stimulation (compared to delivering sacral nerve stimulation straight away) was both more effective and less costly in all modeled scenarios. The estimated savings from offering percutaneous tibial nerve stimulation first were £662 - £5,697 per patient. The probability of this strategy being cost-effective was around 80% at £20,000 -£30,000 per QALY. Conclusion: Our analyses suggest that offering patients percutaneous tibial nerve stimulation prior to sacral nerve stimulation can be both cost effective and cost saving in the treatment of faecal incontinence

Developing core economic parameter sets for asthma studies: a realist review and an analytical framework

Objective To develop a standardised set of economic parameters (core economic parameter set) for economic evaluations in asthma studies. Design A systematic literature review and an analytical framework. Outcome measures Economic parameters used to evaluate costs and cost-effectiveness of healthcare interventions for people with asthma. Data sources PubMed, the Cochrane Database of Systematic Reviews, the National Health Service Economic Evaluation Database, the Database of Abstracts of Reviews of Effects and the Health Technology Aaaessment Library starting from 1990. Review methods Research methods were based on the realist review methodology and included a number of non-sequential, iterative and overlapping components, such as developing an analytical framework for the realist review; systematic literature review of economic parameters; identifying and categorising economic parameters; producing preliminary list of core economic parameters. Results Database searches found 2531 publications of which 224 were included in the systematic review. We identified 65 economic parameters that were categorised into 11 groups to enable the realist synthesis. Parameters related to secondary care, primary care, medication use, emergency care and work productivity comprised 84% of all economic parameters. An analytical framework was used to investigate the rationale behind the choices of economic parameters in these studies. The main framework domains included type of intervention, research population, study design, study setting and a stakeholder’s perspective. Conclusion Past research thus suggests that in asthma study parameters depicting the use of secondary care, primary care, medication, emergency care and work productivity can be considered as core economic parameters, since they apply to different types of studies. Parameters including diagnostics, healthcare delivery, school activity, informal care, medical devices and health utility apply to a particular type of study (or research question), and thus can be recommended as supplemental parameters

Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

Background: Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. Methods: We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. Findings: Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). Interpretation: We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial

Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial

BackgroundTranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding.MethodsWe did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124.FindingsBetween July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82–1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98).InterpretationWe found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial.</div