Sherman E J, Pfister D G, Ruchlin H S, Rubin D M, Radzyner M H, Kelleher G H, Slovin S F, Kelly W K, Scher H I
Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center, 1275 York Avenue, New York, NY 10021, USA.
Cancer. 2001 Feb 15;91(4):841-53.
There are limited data available regarding the cost of care in patients with androgen independent prostate carcinoma (AIPC), and there are no data on the impact of direct nonmedical and indirect costs (DNM/IC). This lack of data, along with the feasibility of collecting DNM/IC, was examined in patients with AIPC who took part in a randomized trial using a newly developed questionnaire, the Collection of Indirect and Nonmedical Direct Costs (COIN) form.
Patients with AIPC were randomized to one of three treatment arms: 1) strontium only (strontium 4 Mci in Week 1 and Week 12) (STRONT); 2) vinblastine 4 mg/m(2) per week for 3 weeks then 1 week off and estramustine, 10 mg/kg per day (CHEMO); or 3) a combination of treatments outlined in the arms for CHEMO and STRONT (CHEMO/STRONT). Direct medical costs were collected through the hospital billing system. DNM/IC data were obtained prospectively using the COIN form. Cost data were analyzed for a period of 6 months.
Twenty-nine patients were randomized, after which the protocol was closed because of poor accrual. The median survival of the patients was 22.3 months. The mean and median total costs for the 20 of 29 patients with complete cost information were $12,647 and $11,257 over 6 months, respectively. DNM/IC represented 11% of the total cost (range, from < 1% to 42%); in 20% of participating individuals, these costs accounted for 35-42% of total costs. Failure to collect complete cost information was due to early death, administrative difficulties, and loss to follow-up.
In this pilot project, the collection of these cost data using the COIN form was feasible and practical and was limited primarily by logistic, not form specific, issues. DNM/IC were found to be a significant proportion of total costs (up to 42%) in selected patients, and this information proved to be a useful addition to the cost analysis. Approximately 98 patients would be required to detect a 20% difference in total costs between arms in a properly powered, randomized trial. Considering the potentially significant impact on total costs, DNM/IC data should be included in future cost-analysis studies of patients with AIPC and other diseases.
关于雄激素非依赖性前列腺癌(AIPC)患者的护理成本,现有数据有限,且尚无关于直接非医疗成本和间接成本(DNM/IC)影响的数据。使用新开发的问卷“间接和非医疗直接成本收集(COIN)表”,对参与一项随机试验的AIPC患者进行研究,以探讨数据缺失情况以及收集DNM/IC的可行性。
将AIPC患者随机分为三个治疗组之一:1)仅使用锶(第1周和第12周给予4毫居里锶)(STRONT);2)长春碱4毫克/平方米,每周一次,共3周,然后休息1周,同时给予雌莫司汀,每天10毫克/千克(CHEMO);或3)CHEMO组和STRONT组治疗方案的联合(CHEMO/STRONT)。通过医院计费系统收集直接医疗成本。使用COIN表前瞻性获取DNM/IC数据。对6个月期间的成本数据进行分析。
29例患者被随机分组,之后由于入组情况不佳,试验方案终止。患者的中位生存期为22.3个月。29例中有20例具有完整成本信息的患者,6个月期间的平均总成本和中位总成本分别为12,647美元和11,257美元。DNM/IC占总成本的11%(范围为<1%至42%);在20%的参与个体中,这些成本占总成本的35 - 42%。未能收集到完整成本信息的原因是早期死亡、管理困难和失访。
在这个试点项目中,使用COIN表收集这些成本数据是可行且实用的,主要受限因素是后勤方面而非表格本身的问题。在部分患者中,DNM/IC占总成本的比例相当大(高达42%),并且这一信息被证明是成本分析的有益补充。在一项样本量充足的随机试验中,大约需要98例患者才能检测出各治疗组之间总成本有20%的差异。考虑到对总成本可能产生的重大影响,DNM/IC数据应纳入未来AIPC患者及其他疾病患者的成本分析研究中。