CV4 Impact of Short Periods with Improved or Worsened INR Control on Life Expectancy and QALYs in Patients with Atrial Fibrillation

ObjectivesWarfarin-treated patients with poor international normalized ratio (INR) control, measured with time in therapeutic range (TTR) or the standard deviation of transformed INR (SDTINR), have an increased risk for clinical events. To what extent only a short period with an altered INR control may influence outcomes remains unknown. This study assessed the impact of transient periods of improved or worsened INR control on life expectancy and quality-adjusted life years (QALYs) among warfarin-treated patients with atrial fibrillation (AF) using both metrics.MethodsWarfarin-treated patients with AF, registered in the patient record system Journalia during years 1985-2000, were included. Information on all-cause mortality was collected from the Cause of Death Register. Scenarios where patients were assumed to have a transiently altered INR control during 30 days were modeled statistically using hazard functions, and the impact on remaining life expectancy and QALYs was assessed.ResultsWhen using SDTINR, a 70-year old man within the 2.5th worst INR control percentile was estimated to gain 10.8 days of life or 0.0168 QALYs from a 30-day improvement in INR control to that of an average 70-year old man. Correspondingly, 15.5 days of life or 0.0196 QALYs would be lost if a 70-year old man within the 2.5th best INR control percentile would have an average INR control during 30 days. The magnitudes were smaller when TTR was used to determine INR control.ConclusionsEven short periods of altered INR control is expected to have impact on life expectancy and QALYs among patients with AF

Health economic analysis of laparoscopic lavage versus Hartmann's procedure for diverticulitis in the randomized DILALA trial

BACKGROUND: Open surgery with resection and colostomy (Hartmann's procedure) has been the standard treatment for perforated diverticulitis with purulent peritonitis. In recent years laparoscopic lavage has emerged as an alternative, with potential benefits for patients with purulent peritonitis, Hinchey grade III. The aim of this study was to compare laparoscopic lavage and Hartmann's procedure with health economic evaluation within the framework of the DILALA (DIverticulitis – LAparoscopic LAvage versus resection (Hartmann's procedure) for acute diverticulitis with peritonitis) trial. METHODS: Clinical effectiveness and resource use were derived from the DILALA trial and unit costs from Swedish sources. Costs were analysed from the perspective of the healthcare sector. The study period was divided into short‐term analysis (base‐case A), within 12 months, and long‐term analysis (base‐case B), from inclusion in the trial throughout the patient's expected life. RESULTS: The study included 43 patients who underwent laparoscopic lavage and 40 who had Hartmann's procedure in Denmark and Sweden during 2010–2014. In base‐case A, the difference in mean cost per patient between laparoscopic lavage and Hartmann's procedure was €–8983 (95 per cent c.i. –16 232 to –1735). The mean(s.d.) costs per patient in base‐case B were €25 703(27 544) and €45 498(38 928) for laparoscopic lavage and Hartmann's procedure respectively, resulting in a difference of €–19 794 (95 per cent c.i. –34 657 to –4931). The results were robust as demonstrated in sensitivity analyses. CONCLUSION: The significant cost reduction in this study, together with results of safety and efficacy from RCTs, support the routine use of laparoscopic lavage as treatment for complicated diverticulitis with purulent peritonitis