Bjöholt Ingela, Janson Martin, Jönsson Bengt, Haglind Eva
Institute of Surgical Sciences, Sahlgrenska University Hospital, Göteborg, Sweden.
Int J Technol Assess Health Care. 2006 Winter;22(1):130-5. doi: 10.1017/s0266462306050926.
The objective is to describe the principles for the design of the economic evaluation of COLOR II, a randomized, multi-country study comparing laparoscopic and open surgery for rectal cancer.
By using the experiences gained in a recent economic evaluation in colon cancer, where the same surgical techniques were compared, we could improve the method for identifying and measuring resource use items and also accommodate the use of data from the global study population.
In the design of the study, the uncertainty in the resource-use variables was reduced by considering (i) what aspects drive each variable, (ii) what resource use is related to the intervention, (iii) how data from different countries affects the variable.
The aim was to refine the data collection so that the economic research question could be answered in the best possible way, given the circumstances in the clinical study. Thus, (i) some variables were treated as stochastic variables and others as deterministic variables, (ii) aggregate key cost-driving resource items were developed that corresponded to clinical events, and (iii) a surrogate variable was selected, instead of the "obvious variable", to reduce the impact of confounding factors for one particular resource unit.
目的是描述COLOR II经济评估的设计原则，COLOR II是一项比较腹腔镜手术和开放手术治疗直肠癌的随机、多国研究。
通过利用近期结肠癌经济评估中获得的经验（该评估比较了相同的手术技术），我们能够改进识别和测量资源使用项目的方法，并纳入来自全球研究人群的数据。
在研究设计中，通过考虑以下方面减少了资源使用变量的不确定性：（i）驱动每个变量的因素，（ii）与干预相关的资源使用，（iii）来自不同国家的数据如何影响该变量。
目的是优化数据收集，以便在临床研究的情况下以尽可能好的方式回答经济研究问题。因此，（i）一些变量被视为随机变量，另一些被视为确定性变量，（ii）开发了与临床事件相对应的汇总关键成本驱动资源项目，（iii）选择了一个替代变量而非“明显变量”，以减少一个特定资源单位的混杂因素影响。
