Reed Shelby D, Friedman Joëlle Y, Gnanasakthy Ari, Schulman Kevin A
Center for Clinical and Genetic Economics, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC 17715, USA.
Int J Technol Assess Health Care. 2003 Spring;19(2):396-406. doi: 10.1017/s0266462303000357.
To develop and evaluate strategies for estimating hospitalization costs in multinational clinical trials.
Hospital cost estimates for eleven diagnoses were collected from twelve countries participating in a trial of therapies for congestive heart failure. Estimates were combined with U.S.-based diagnosis-related group weights to compute country-specific unit cost estimates for all reasons for hospitalization. Variations of hospital costing methods were developed. The unit cost method assigns a country-specific unit cost estimate to each hospitalization. The other methods adjust for length of stay using a daily cost (DC) estimate for each diagnosis, based on either the mean length of stay (DC-mean method) or the median length of stay (DC-median method) for each diagnosis in each country. Additional modifications were explored through adjustment of the distribution of daily costs incurred during a hospital stay.
The mean cost for all hospitalizations was dollars 10,242 (SD, 10,042) using the unit cost method, dollars 10,242 (SD, 12,760) using the standard DC-mean method, and dollars 13,967 (SD, 18,762) using the standard DC-median method. In comparisons of costs for all 5,486 hospitalizations incurred by a subset of 2,352 patients in the trial, the unit cost method provided 92% power to detect a dollars 1,000 cost difference. The standard DC-mean method provided 76% power, and the standard DC-median method provided 44% power.
Hospital costing methods that adjust for differences in length of stay require a significantly larger sample to attain comparable statistical power as methods that assign unadjusted unit cost estimates to hospitalization events.
制定并评估在跨国临床试验中估算住院费用的策略。
从参与一项充血性心力衰竭治疗试验的12个国家收集了11种诊断的住院费用估算数据。将这些估算数据与美国的诊断相关分组权重相结合,以计算所有住院原因的特定国家单位成本估算值。开发了住院成本计算方法的变体。单位成本法为每次住院分配一个特定国家的单位成本估算值。其他方法使用每个诊断的每日成本(DC)估算值来调整住院时间,该估算值基于每个国家每种诊断的平均住院时间(DC均值法)或中位数住院时间(DC中位数法)。通过调整住院期间发生的每日成本分布来探索其他修改方法。
使用单位成本法时,所有住院的平均成本为10242美元(标准差为10042美元);使用标准DC均值法时,为10242美元(标准差为12760美元);使用标准DC中位数法时,为13967美元(标准差为18762美元)。在该试验中2352名患者子集发生的所有5486次住院费用比较中,单位成本法有92%的把握检测到1000美元的成本差异。标准DC均值法有76%的把握,标准DC中位数法有44%的把握。
调整住院时间差异的住院成本计算方法需要显著更大的样本量才能获得与将未调整的单位成本估算值分配给住院事件的方法相当的统计效能。