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Background Critically ill patients in the intensive care unit (ICU) are at risk of clinically important gastrointestinal bleeding, and acid suppressants are frequently used prophylactically. However, stress ulcer prophylaxis may increase the risk of serious adverse events and, additionally, the quantity and quality of evidence supporting the use of stress ulcer prophylaxis is low. The aim of the SUP-ICU trial is to assess the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in adult patients in the ICU. We hypothesise that stress ulcer prophylaxis reduces the rate of gastrointestinal bleeding, but increases rates of nosocomial infections and myocardial ischaemia. The overall effect on mortality is unpredictable. Methods/design The SUP-ICU trial is an investigator-initiated, pragmatic, international, multicentre, randomised, blinded, parallel-group trial of stress ulcer prophylaxis with a proton pump inhibitor versus placebo (saline) in 3350 acutely ill ICU patients at risk of gastrointestinal bleeding. The primary outcome measure is 90-day mortality. Secondary outcomes include the proportion of patients with clinically important gastrointestinal bleeding, pneumonia, Clostridium difficile infection or myocardial ischaemia, days alive without life support in the 90-day period, serious adverse reactions, 1-year mortality, and health economic analyses. The sample size will enable us to detect a 20 % relative risk difference (5 % absolute risk difference) in 90-day mortality assuming a 25 % event rate with a risk of type I error of 5 % and power of 90 %. The trial will be externally monitored according to Good Clinical Practice standards. Interim analyses will be performed after 1650 and 2500 patients. Conclusion The SUP-ICU trial will provide high-quality data on the benefits and harms of stress ulcer prophylaxis with a proton pump inhibitor in critically ill adult patients admitted in the ICU. Trial registration ClinicalTrials.gov Identifier: NCT02467621 .

Proton pump inhibitors (PPIs) are effective in gastroesophageal reflux disease (GERD), but their cost effectiveness is unknown. This is usually determined by cost/quality-adjusted life year (QALY) gained, but whether PPI therapy improves QALYs has not been assessed in a randomized trial. The PPI acid suppression symptom (PASS) test is a five-item questionnaire that identifies patients with persistent acid-related symptoms. We evaluated whether a PASS test-based management strategy of changing GERD therapy to esomeprazole in those with continued symptoms on another PPI or H(2) receptor antagonist therapy would be cost effective. We expressed the data in terms of cost per quality-adjusted life months (QALM), as this was a 4-week trial. This is a multicenter, cluster-randomized, open-label study in primary care physician centers across Canada. Primary care physician centers were randomized to intervention or control arms. Patients on acid-suppressing medication were identified from primary care records and asked to complete the PASS test. PASS test failures at baseline assessment continued current therapy in control practices or switched to esomeprazole 20 or 40 mg daily (the dose was at the clinician's discretion) for 4 weeks in intervention practices. A planned secondary end point was QALM gain, measured using the validated Euroqol (EQ-5D) completed at baseline and 4 weeks. Medication use was also assessed by questionnaire. Canadian unit generic costs were applied to all GERD drugs, except to esomeprazole and lansoprazole, wherein proprietary costs were used (all costs in Canadian $). Data were analyzed using bootstrap sampling. A total of 1,564 patients were recruited from 134 intervention sites and 92 control sites. Data were evaluable for 808 intervention and 445 control patients. The mean (±standard deviation) QALM at 4 weeks in the intervention group was 0.885±0.164 compared with 0.814±0.179 in the control group, resulting in a mean 0.071 (95% CI=0.091-0.051) QALM gain (P<0.0001). Esomeprazole was cost effective for PASS test failures, with a mean cost of $763 (95% CI=456-1,414) per QALM gain. Esomeprazole was associated with a statistically significant gain in QALMs and was cost effective in primary care patients with persistent acid-related symptoms identified by the PASS test.

Abstract Objective To determine the impact of a community based Helicobacter pylori screening and eradication programme on the incidence of dyspepsia, resource use, and quality of life, including a cost consequences analysis. Design H pylori screening programme followed by randomised placebo controlled trial of eradication. Setting Seven general practices in southwest England. Participants 10 537 unselected people aged 20-59 years were screened for H pylori infection (13C urea breath test); 1558 of the 1636 participants who tested positive were randomised to H pylori eradication treatment or placebo, and 1539 (99%) were followed up for two years. Intervention Ranitidine bismuth citrate 400 mg and clarithromycin 500 mg twice daily for two weeks or placebo. Main outcome measures Primary care consultation rates for dyspepsia (defined as epigastric pain) two years after randomisation, with secondary outcomes of dyspepsia symptoms, resource use, NHS costs, and quality of life. Results In the eradication group, 35% fewer participants consulted for dyspepsia over two years compared with the placebo group (55/787 v 78/771; odds ratio 0.65, 95% confidence interval 0.46 to 0.94; P = 0.021; number needed to treat 30) and 29% fewer participants had regular symptoms (odds ratio 0.71, 0.56 to 0.90; P = 0.05). NHS costs were £84.70 (£74.90 to £93.91) greater per participant in the eradication group over two years, of which £83.40 ($146; €121) was the cost of eradication treatment. No difference in quality of life existed between the two groups. Conclusions Community screening and eradication of H pylori is feasible in the general population and led to significant reductions in the number of people who consulted for dyspepsia and had symptoms two years after treatment. These benefits have to be balanced against the costs of eradication treatment, so a targeted eradication strategy in dyspeptic patients may be preferable.

Background/Aims: Two studies have reported on the superiority of a proton pump inhibitor (PPI) compared with a histamine-2-receptor antagonist for the treatment of artificial ulcers after endoscopic submucosal dissection (ESD), but the optimal dose of PPI remains to be defined. The aim of this study was to evaluate the possibility of reducing the dose of PPI. The authors thus compared 30 mg (standard-dose) and 15 mg (half-dose) lansoprazole in terms of ulcer healing, prevention of bleeding and quality of life. Methods: 91 patients with gastric mucosal neoplasm were enrolled. All patients who underwent ESD were administered lansoprazole 30 mg daily during the first week, after which they were randomly assigned to either the standard-dose or half-dose group. Results: One patient in each group developed hematemesis. The stage of ulcers, ulcer reduction ratios and scores on the Gastrointestinal Symptom Rating Scale did not differ at 28 and 56 days. The costs of PPI for the half-dose group and standard-dose group were 7,326.5 and 11,698.4 JPY, respectively, i.e. a difference of 471.9 JPY. Conclusions: A reduced dose of PPI after 1 week of ESD was equivalent in treatment performance to the standard dose and cheaper.

Since 2001, one intravenous proton pump inhibitor (pantoprazole) has been available in the United States. A drug shortage bulletin was issued for this agent in 2003. To evaluate the patterns of use of intravenous proton pump inhibitors (IV PPIs) in routine clinical practice. Prospective evaluation of IV PPI use in two community-based teaching hospitals. A computerized pharmacy ordering system was used to identify all patients for whom an IV PPI was ordered. Trained investigators obtained clinical data from patient records and these data were mapped to establish clinical criteria for the use of IV PPIs. Intravenous PPIs were prescribed in 238 patients over a 30-day period and a total of 1,631 doses were prescribed. Primary care providers prescribed 46% of prescriptions. Fifty-six percent of patients who received IV PPIs had no acceptable indication for their use. Of the 126 (81%) patients who were started on PPIs for the first time during their hospital stay, 102 were discharged on a PPI. Intravenous PPIs are widely used for poor indications, which may contribute to the shortage of these agents.

BACKGROUND AND AIM To comprehensively assess the relative merits of medical and surgical therapy for gastro-oesophageal reflux disease (GORD), health economic aspects have to be incorporated. We have studied the direct and indirect costs of medical and surgical therapy within the framework of a prospective randomised multicentre trial. METHODS After initial treatment of reflux oesophagitis with omeprazole to control symptoms and to heal oesophagitis, 154 patients were randomised to continue treatment with omeprazole (20 or 40 mg daily) and 144 patients to have an open antireflux operation (ARS). In case of GORD relapse, patients allocated to omeprazole were offered ARS and those initially operated on had either a reoperation or were treated with omeprazole. The costs were assessed over five years from randomisation. RESULTS Differences in cumulative direct medical costs per patient between the two therapeutic strategies diminished with time. However, five year direct medical costs per patient when given omeprazole were still significantly lower than for those having ARS in Denmark, Norway, and Sweden (differences were DKK 8703 (US$1475), NOK 32 992 (US$ 5155), and SEK 13 036 (US$ 1946), respectively). However, in Finland the reverse was true (the difference in favour of ARS amounted to FMK 7354 (US$ 1599)). When indirect costs (loss of production due to GORD related sick leave) were also included, the cost of surgical treatment increased substantially and exceeded the cost of medical treatment in all countries. CONCLUSIONS The total costs of medical therapy for chronic GORD were lower than those of open ARS when prospectively assessed over a five year period, although significant differences in cost estimates were revealed between countries.

Helicobacter pylori (HP) eradication therapy is a useful treatment for idiopathic thrombocytopenic purpura (ITP). Some investigators have also reported the effects of proton pump inhibitor (PPI) monotherapy on ITP. We performed a randomized study of HP eradication therapy and PPI monotherapy on ITP. Four of nine patients achieved complete remission (CR), two of nine achieved partial remission (PR) in HP eradication therapy, three of eight achieved CR, and two of eight achieved PR in PPI monotherapy. No significant differences were observed in the CR + PR of these patients between HP eradication therapy and PPI monotherapy. As for cost comparisons, HP eradication therapy is cheaper than PPI monotherapy, but it is less effective.

IntroductionEconomic evaluations in healthcare can guide practice and inform policy. The objective of this paper is to present the protocol for a health economic evaluation comparing the cost-effectiveness of prophylactic treatment using pantoprazole 40 mg daily compared with no pantoprazole to prevent upper gastrointestinal (GI) bleed among invasively ventilated patients.Methods and analysisThis is an economic evaluation conducted alongside the Re-Evaluating the Inhibition of Stress Erosions (REVISE) trial (ClinicalTrials.gov NCT03374800). The primary outcome is the incremental cost per clinically important upper GI bleed prevented. The base-case analysis will focus on the entire international cohort of 4821 REVISE patients. The analysis will be conducted from a healthcare payer perspective over a time horizon of ICU admission to hospital discharge or death. To facilitate comparisons across countries given the international scope of the REVISE trial, costs will be presented in United States dollars. The study protocol was developed following the Professional Society for Health Economics and Outcomes Research guidelines.Ethics and disseminationThe trial was approved by each participating institution; this economic evaluation was approved by the Hamilton Integrated Research Ethics Board. Given widespread daily use of proton pump inhibitors for critically ill patients, the results of this economic evaluation will be of high relevance to patients, family members, physicians, pharmacists, policymakers and guideline developers. Integrated knowledge translation will involve periodic progress reports to collaborators. End-of-study knowledge translation will include rounds, videoconferences, abstracts and slide-decks for intensive care unit quality councils and healthcare organisations, and open-access publications. Patient and family partners will co-create lay language summaries for traditional and social media to help inform all interest groups.

In western European countries, most dyspeptic patients are initially managed by their general practitioners (GPs), who use a range of strategies to manage dyspepsia. We performed an economic analysis of a Helicobacter pylori test-and-treat strategy versus a prompt endoscopy approach in a primary care setting. Data were used from the Strategy: Endoscopy versus Serology (SENSE) study, performed in The Netherlands from 1998 to 2001. Patients were randomized to a prompt endoscopy (n = 105) or test-and-treat (n = 118) group. Follow-up lasted 1 year. Adverse events were not recorded in the SENSE study. Health care costs were based on the total amount of dyspepsia-related drugs used, the number of dyspepsia-related GP visits, the number of diagnostic tests, and the number of dyspepsia-related referrals to specialists. The use of medical resources was calculated as standardized costs for 1999, recorded as euros. (On December 31, 1999, 1.00 Euro = 1.00 US dollar.) Quality of life was measured at inclusion and 1 year later, using the RAND-36 questionnaire. To calculate quality-adjusted life-years (QALYs), we transformed the individual scores of the RAND-36 into 1 overall score, the Health Utilities Index Mark 2, which introduced a limitation to the study. An incremental cost-effectiveness ratio (ICER) was calculated. The 95% confidence limits were calculated using a parametric bootstrap method with angular transformation. All cost data were analyzed from a third-party payer perspective. The total costs per patient were 511 Euros, with 0.037 QALY gained per patient, in the test-and-treat group, and 748 Euros, with 0.032 QALY gained per patient, in the endoscopy group (between groups, P < 0.001 and P = NS, respectively). The point estimate of the ICER indicated that the test-and-treat strategy yielded cost savings and QALYs gained. Parametric bootstrap confidence limits indicated cost savings per QALY gained in 75.7% of the bootstrap simulations. This analysis of data from the SENSE1026 study suggests that the H pylori test-and-treat strategy was more cost-effective than prompt endoscopy in the initial management of dyspepsia in general practice, from the perspective of a third-party payer.

Although administration of stress ulcer prophylaxis (SUP) has been recommended for specific patients in the intensive care unit (ICU) setting, this practice has been extrapolated to care of non-ICU patients without evidence to support need or efficacy. To examine the practice of SUP in non-ICU patients in a university hospital setting, with specific attention to resource utilization. Retrospective chart review of adult non-ICU admissions to one family medicine and five general internal medicine teaching services over a consecutive 4-month period. Proportion of patients prescribed SUP was ascertained after exclusion of patients admitted on antisecretory therapy (AST) or prescribed AST for non-SUP indications. Annual cost estimates were calculated assuming full compliance. Of 1,769 patient admissions, 22% received SUP and 54% of these were discharged home on AST. None of these patients met evidence-based criteria for appropriate SUP. Inpatient SUP cost Dollars 11,024 over the 4 months of the study (Dollars 44,096 annually), and outpatient costs based on discharge prescriptions were Dollars 16,924 (Dollars 67,695 annually), yielding a total cost expenditure of Dollars 27,948 (Dollars 111,791 annually). SUP is overutilized in the non-ICU setting, and patients are often discharged unnecessarily on AST, resulting in significant cost expenditure. Interventions to ensure appropriate use of SUP should decrease resource expenditures without detrimental impact on quality of care.