Costs and Complications of Radiotherapy Modalities

描述（由申请人提供）：本定量研究将比较用于早期浸润性乳腺癌和导管原位癌（DCIS）的两种放射治疗（RT）技术的成本和并发症。我们的目标是阐明风险，并发症发生率和成本的RT和后续并发症的全乳房RT相比，近距离放射治疗为基础的加速部分乳房RT，一种新形式的RT，可能与新的或增加的发病率的风险;缺乏长期的临床试验证据的有效性，并可能有一些优势，由于有限的后续行动，迄今为止没有证实。通过使用66岁以上诊断为乳腺癌并接受保乳手术和RT治疗的女性的医疗保险索赔数据，我们将评估这两种RT技术是否存在不同的并发症发生率和不同的成本负担。我们的具体目标是：1）识别和分类RT后一年内全乳房RT和基于近距离放射治疗的加速部分乳房RT的相关和可能相关并发症; 2）计算和比较RT模式的RT并发症的绝对数量和发生率，考虑患者和医疗保健系统因素; 3）评估和比较RT模式的成本，考虑患者和医疗保健系统因素。这是第一个已知的研究，以评估成本和并发症发生率的近距离治疗为基础的乳房RT相比，全乳房RT的人口水平。到目前为止，只有小的，选定的研究概述了并发症率的近距离放射治疗为基础的乳房RT。这样的小样本量可能会错过罕见的事件，并可能低估实际的并发症率。同样，成本的评估也只是基于医疗保险对治疗本身的预期补偿，而不是与治疗相关的后续问题，如意外的球囊导管的重新植入或重新植入，有问题的血清肿，脂肪坏死或感染。我们将评估治疗费用和治疗后一年内的并发症。我们的新方法将最大限度地减少RT类型的内分泌偏倚。这项研究将使我们能够确定和量化明确的健康权衡和成本影响的医疗保健系统的妇女接受RT后，保乳手术在人口为基础的水平。这对于这项新技术尤其重要，因为与标准治疗相比，该技术具有更高的前期成本，并且没有已知的额外治疗益处。

DESCRIPTION (provided by applicant): This quantitative study will compare the costs and complications of two radiotherapy (RT) techniques used for early invasive breast cancer and ductal carcinoma in situ (DCIS). Our goals are to elucidate the risks, complication rates, and costs of RT and subsequent complications for whole breast RT compared to brachytherapy-based accelerated partial breast RT, a newer form of RT that may be associated with new or increased risks of morbidity; that lacks long-term clinical trial evidence of effectiveness; and that may have some advantages not borne out due to limited follow-up thus far. By using Medicare claims data for women ages 66+ with a breast cancer diagnosis and treated with breast- conserving surgery and RT, we will evaluate whether there are different rates of complications and differential cost burdens of these two RT techniques. Our specific aims are to: 1) Identify and classify related and possibly-related complications of whole breast RT and brachytherapy-based accelerated partial breast RT within one year of RT; 2) Calculate and compare absolute numbers and rates of RT complications by RT modality, accounting for patient and healthcare system factors; and 3) Assess and compare the costs of the RT modalities, accounting for patient and healthcare system factors. This is the first known study to evaluate costs and complication rates of brachytherapy-based breast RT compared to whole breast RT on a population level. Thus far, only small, selected studies have outlined complication rates of brachytherapy-based breast RT. Such small sample sizes are likely to miss rarer events and could underestimate actual complication rates. Likewise, costs have only been evaluated on the basis of expected Medicare reimbursement for treatment itself, but not for subsequent problems associated with treatment, such as unexpected explantation or reimplantation of a balloon catheter, problematic seromas, fat necrosis, or infection. We will assess costs for treatment and complications within one year of treatment. Our novel methods will minimize endogeneity bias by RT type. This study will allow us to identify and quantify the explicit health trade-offs and cost impact to the healthcare system for women undergoing RT following breast- conserving surgery on a population-based level. This is particularly important for this new technology that has higher up-front costs with no known additional therapeutic benefit compared to the standard of care.