Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, The Netherlands.
Crit Care. 2010;14(3):R97. doi: 10.1186/cc9032. Epub 2010 May 27.
Results of the first randomized trial comparing on-demand versus planned-relaparotomy strategy in patients with severe peritonitis (RELAP trial) indicated no clear differences in primary outcomes. We now report the full economic evaluation for this trial, including detailed methods, nonmedical costs, further differentiated cost calculations, and robustness of different assumptions in sensitivity analyses.
An economic evaluation was conducted from a societal perspective alongside a randomized controlled trial in 229 patients with severe secondary peritonitis and an acute physiology and chronic health evaluation (APACHE)-II score >or=11 from two academic and five regional teaching hospitals in the Netherlands. After the index laparotomy, patients were randomly allocated to an on-demand or a planned-relaparotomy strategy. Primary resource-utilization data were used to estimate mean total costs per patient during the index admission and after discharge until 1 year after the index operation. Overall differences in costs between the on-demand relaparotomy strategy and the planned strategy, as well as relative differences across several clinical subgroups, were evaluated.
Costs were substantially lower in the on-demand group (mean, 65,768 euro versus 83,450 euro per patient in the planned group; mean absolute difference, 17,682 euro; 95% CI, 5,062 euro to e29,004 euro). Relative differences in mean total costs per patient (approximately 21%) were robust to various alternative assumptions. Planned relaparotomy consistently generated more costs across the whole range of different courses of disease (quick recovery and few resources used on one end of the spectrum; slow recovery and many resources used on the other end). This difference in costs between the two surgical strategies also did not vary significantly across several clinical subgroups.
The reduction in societal costs renders the on-demand strategy a more-efficient relaparotomy strategy in patients with severe peritonitis. These differences were found across the full range of healthcare resources as well as across patients with different courses of disease.
ISRCTN51729393.
首次比较按需与计划性剖腹再探查策略治疗严重腹膜炎患者的随机试验（RELAP 试验）结果表明，主要结局无明显差异。我们现报告该试验的完整经济学评价，包括详细方法、非医疗费用、进一步差异化成本计算以及敏感性分析中不同假设的稳健性。
在荷兰的两家学术医院和五家区域教学医院，对 229 例患有严重继发性腹膜炎和急性生理学和慢性健康评估（APACHE）-II 评分>11 分的患者进行了一项随机对照试验，同时进行了一项经济学评价。在首次剖腹手术后，患者被随机分配至按需剖腹再探查策略组或计划性剖腹再探查策略组。使用主要资源利用数据来估计每位患者在首次住院期间和出院后至首次手术 1 年期间的平均总费用。评估了按需剖腹再探查策略与计划性剖腹再探查策略之间的总体费用差异，以及在多个临床亚组之间的相对差异。
按需组的费用明显更低（平均每位患者分别为 65768 欧元和 83450 欧元；平均绝对差异为 17682 欧元；95%CI 为 5062 欧元至 29004 欧元）。在各种替代假设下，患者的总费用差异具有稳健性（约为 21%）。在疾病的整个病程中，计划性剖腹再探查策略始终产生更多的费用（一端是快速康复和较少的资源使用，另一端是缓慢康复和大量资源使用）。这两种手术策略之间的成本差异在几个临床亚组中也没有显著差异。
在严重腹膜炎患者中，与计划性剖腹再探查策略相比，按需策略降低了社会成本，提高了效率。这些差异在整个医疗资源范围内以及不同病程的患者中均存在。
ISRCTN51729393。
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