H E Bolkenstein1, G A de Wit2,3, E C J Consten1, B J M Van de Wall4, I A M J Broeders1, W A Draaisma5. 1. Department of Surgery, Meander Medical Centre, Amersfoort, the Netherlands. 2. Julius Centre for Health Sciences and Primary Care, University Medical Centre Utrecht, Utrecht, the Netherlands. 3. Centre for Nutrition, Prevention and Healthcare, National Institute of Public Health and the Environment, Bilthoven, the Netherlands. 4. Department of Surgery, Diakonessenhuis, Utrecht, the Netherlands. 5. Department of Surgery, Jeroen Bosch Hospital, Den Bosch, the Netherlands.
Abstract
BACKGROUND: The results of the DIRECT trial, an RCT comparing conservative management with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints, showed that elective sigmoid resection leads to higher quality of life. The aim of this study is to determine the cost-effectiveness of surgical treatment at 1- and 5-year follow-up from a societal perspective. METHODS: Clinical effectiveness and resource use were derived from the DIRECT trial. The actual resource use and quality of life (EQ-5D-3L™ score) were documented prospectively per individual patient and analysed according to the intention-to-treat principle for up to 5 years after randomization. The main outcome was the incremental cost-effectiveness ratio (ICER), expressed as costs per quality-adjusted life-year (QALY). RESULTS: The study included 106 patients, of whom 50 were randomized to surgery and 56 to conservative treatment. At 1- and 5-year follow-up an incremental effect (QALY difference between groups) of 0·06 and 0·43 respectively was found, and an incremental cost (cost difference between groups) of €6957 and €2674 respectively, where surgery was more expensive than conservative treatment. This resulted in an ICER of €123 365 per additional QALY at 1-year follow-up, and €6275 at 5 years. At a threshold of €20 000 per QALY, operative treatment has 0 per cent probability of being cost-effective at 1-year follow-up, but a 95 per cent probability at 5 years. CONCLUSION: At 5-year follow-up, elective sigmoid resection in patients with recurring diverticulitis or persistent complaints was found to be cost-effective. Registration number: NTR1478 (www.trialregistrer.nl).
RCT Entities:
BACKGROUND: The results of the DIRECT trial, an RCT comparing conservative management with elective sigmoid resection in patients with recurrent diverticulitis or persistent complaints, showed that elective sigmoid resection leads to higher quality of life. The aim of this study is to determine the cost-effectiveness of surgical treatment at 1- and 5-year follow-up from a societal perspective. METHODS: Clinical effectiveness and resource use were derived from the DIRECT trial. The actual resource use and quality of life (EQ-5D-3L™ score) were documented prospectively per individual patient and analysed according to the intention-to-treat principle for up to 5 years after randomization. The main outcome was the incremental cost-effectiveness ratio (ICER), expressed as costs per quality-adjusted life-year (QALY). RESULTS: The study included 106 patients, of whom 50 were randomized to surgery and 56 to conservative treatment. At 1- and 5-year follow-up an incremental effect (QALY difference between groups) of 0·06 and 0·43 respectively was found, and an incremental cost (cost difference between groups) of €6957 and €2674 respectively, where surgery was more expensive than conservative treatment. This resulted in an ICER of €123 365 per additional QALY at 1-year follow-up, and €6275 at 5 years. At a threshold of €20 000 per QALY, operative treatment has 0 per cent probability of being cost-effective at 1-year follow-up, but a 95 per cent probability at 5 years. CONCLUSION: At 5-year follow-up, elective sigmoid resection in patients with recurring diverticulitis or persistent complaints was found to be cost-effective. Registration number: NTR1478 (www.trialregistrer.nl).
Authors: Johan Friso Lock; Christian Galata; Christoph Reißfelder; Jörg-Peter Ritz; Thomas Schiedeck; Christoph-Thomas Germer Journal: Dtsch Arztebl Int Date: 2020-08-31 Impact factor: 5.594
Authors: Emma C Gertsen; Alicia S Borggreve; Hylke J F Brenkman; Rob H A Verhoeven; Erik Vegt; Richard van Hillegersberg; Peter D Siersema; Jelle P Ruurda Journal: Ann Surg Oncol Date: 2020-09-08 Impact factor: 5.344