SUMMARY
BackgroundThe long-term effects of participation in trials has not been reported. A randomized-controlled trial (the ONE study) reported on the management of gastro-oesophageal reflux disease with esomeprazole in primary care, testing on-demand treatment vs. treatment courses.
SUMMARY
Background:A prospective, open, randomized multicentre study with parallel group design was conducted in 155 general practice clinics, and included 1357 endoscopically uninvestigated patients with symptoms suggestive of gastro-oesophageal reflux disease. Aim: To assess the differences in direct medical costs between a patient-controlled on-demand treatment strategy with esomeprazole, 20 mg daily, and general practitioner-controlled intermittent treatment strategies with esomeprazole, 40 mg daily, for either 2 or 4 weeks. Secondary objectives were to measure other costs, total costs, patient satisfaction and time to first relapse. Methods: The primary cost analysis was carried out as a cost minimization analysis, comparing the direct medical costs in patients allocated to on-demand treatment
The cost-effectiveness of smoking cessation interventions is well documented. However, most studies are based on randomized controlled trials (RCTs) and provide little information on the differences between subgroups. This study assessed the relative cost-effectiveness of smoking cessation interventions offered to various subgroups of smokers, based on real-life data. Regression analyses provided information on the factors determining abstinence and costs and led to the formation of relevant subgroups of smokers. Probabilistic Markov modeling was then used to estimate the relative cost-effectiveness of smoking cessation interventions for the entire database population and for the subgroups compared to a no-intervention case. The ICER for the base case population was estimated at 1,358 euro. This is consistent with results from the existing literature. Group simulations showed lower ICERs for men, hospitals, and light smokers and falling ICERs with increasing age. Despite differences in the cost-effectiveness ratios between subgroups our results do not justify any kind of subgroup differentiation in a smoking prevention policy.
Although we did not find any statistical significant differences in health care costs, we did observe a higher consumption of prescribed medication and lower costs of work hours lost if both patient and GPs participated in a former clinical trial. The results may be limited due to a lower number of patients included than expected.
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