Stewart Samuel Alan, Clive Amelia O, Maskell Nick A, Penz Erika
Dalhousie University, Halifax, NS, Canada.
Respiratory Research Unit, North Bristol NHS Trust, Bristol, United Kingdom.
PLoS One. 2018 Feb 5;13(2):e0190257. doi: 10.1371/journal.pone.0190257. eCollection 2018.
The SMART trial is a UK-based, multicentre RCT comparing prophylactic radiotherapy and symptom-based (deferred) radiotherapy in 203 patients with Malignant Pleural Mesothelioma who had undergone large bore pleural interventions. Using costs and quality of life data collected alongside the clinical trial, we will estimate the cost-effectiveness of prophylactic radiotherapy compared to deferred radiotherapy over a 1-year period.
Healthcare utilization and costs were captured during the trial. Utility weights produced by the EQ-5D questionnaire were used to determine quality-adjusted life-years (QALY) gained. The incremental cost-effectiveness ratio was calculated over the one-year trial period.
Costs were similar in the immediate and deferred radiotherapy groups: £5480.40 (SD = £7040; n = 102) and £5461.40 (SD = £7770; n = 101) respectively. There was also no difference in QALY: 0.498 (95% CI: [0.45, 0.547]) in the prophylactic radiotherapy group versus 0.525 (95% CI: [0.471, 0.580]) in the deferred group. At a willingness to pay threshold of £30,000/QALY there was only a 24% chance that prophylactic radiotherapy was cost-effective compared to deferred radiotherapy.
There was no significant effect of prophylactic radiotherapy on quality of life in the intervention group, nor was there any discernable decrease in healthcare costs. There is little evidence to suggest that prophylactic radiotherapy is a cost-effective intervention in this population.
ISRCTN72767336 with ISRCTN.
SMART试验是一项在英国开展的多中心随机对照试验，比较了203例接受大口径胸膜干预的恶性胸膜间皮瘤患者接受预防性放疗和基于症状（延迟）放疗的效果。利用在临床试验过程中收集的成本和生活质量数据，我们将估计预防性放疗与延迟放疗相比在1年期间的成本效益。
在试验期间记录医疗保健利用情况和成本。使用EQ-5D问卷产生的效用权重来确定获得的质量调整生命年（QALY）。在为期一年的试验期内计算增量成本效益比。
立即放疗组和延迟放疗组的成本相似：分别为5480.40英镑（标准差=7040英镑；n=102）和5461.40英镑（标准差=7770英镑；n=101）。QALY也没有差异：预防性放疗组为0.498（95%置信区间：[0.45，0.547]），延迟放疗组为0.525（95%置信区间：[0.471，0.580]）。在支付意愿阈值为30000英镑/QALY的情况下，与延迟放疗相比，预防性放疗具有成本效益的可能性仅为24%。
预防性放疗对干预组的生活质量没有显著影响，医疗保健成本也没有明显降低。几乎没有证据表明预防性放疗对该人群是一种具有成本效益的干预措施。
ISRCTN72767336，ISRCTN编号。
