Determinants of outcomes for older and frail older adults with refractory overactive bladder

项目摘要 我们对三线治疗相关结果的理解存在根本性差距 [肉毒杆菌毒素A、周围胫神经刺激（PTNS）和骶神经调节]治疗难治性 老年人和体弱老年人中的膀胱过度活动症（OAB），他们共同构成了大多数患者 患有这种疾病。尽管在年轻和中年健康成年人中进行了充分的研究， 了解这些治疗在这些更脆弱人群中的结果和并发症， 导致过度使用无效或危险的治疗，或治疗利用不足 可以显著改善健康相关的生活质量。我们的首要研究目标是提高 护理所有接受OAB治疗的年老体弱的老年人。这项拟议研究的目的是 更好地了解与onabotulinumtoxinA、PTNS和 骶神经调节在老年人和体弱的老年人，并利用这些信息来创建一个个性化的 和可操作的预测工具。中心假设是，这些程序的使用可能是有偏见的 针对年轻人（白色种族和较高的社会经济地位， 专家），无论虚弱程度如何，但虚弱将与不良结局高度相关， 并发症的发生率增加。我们将通过利用100%的按服务收费的队列来测试这一假设 接受这些程序的医疗保险受益人和基于索赔的脆弱指数（CFI）作为衡量标准， 通过以下三个目的：（1）了解侵入性OAB治疗的利用（a）根据 （B）根据其他非临床因素：患者（人种/种族）、地区 （社会经济学）和提供者（外科医生和数量）;（2）确定下游结果和 在手术后2年内，针对高龄和虚弱人群的三线OAB治疗; (3)开发和内部验证一种预测工具，以预测老年人和体弱老年人的成功结局 接受三线OAB治疗的成年人。这项研究是创新的，因为它将衡量和应用 对于一个100%的按服务收费的医疗保险受益人的国家队列来说， onabotulinumtoxinA，PTNS和骶神经调节，最终创建一个个性化的预后工具 来改善这个未充分研究的人群的结果。这项研究之所以重要，是因为 严重缺乏关于难治性OAB在这一庞大且易受影响的人群中结局的信息， 从这个条件来看，开发个性化的预后工具，以帮助做出这一决策 过程将有助于尽量减少可能不成功、不必要甚至有害的程序的风险， 同时在更有可能受益的个人中推广使用这种程序。

PROJECT ABSTRACT There is a fundamental gap in our understanding of outcomes related to third-line treatments [onabotulinumtoxinA, peripheral tibial nerve stimulation (PTNS), and sacral neuromodulation] for refractory overactive bladder (OAB) in older and frail older adults, who collectively comprise the majority of patients suffering from this condition. Despite being well-studied in young and middle-aged healthy adults, little is known about outcomes and complications of these treatments in these more vulnerable populations, potentially resulting in overutilization of treatments that are ineffective or dangerous, or in underutilization of treatments that may significantly improve health related quality of life. Our overarching research objective is to improve care for all older and frail older adults undergoing treatment for OAB. The objective of this proposed study is to better understand the utilization, outcomes and complications associated with onabotulinumtoxinA, PTNS, and sacral neuromodulation in older and frail older adults, and to use this information to create an individualized and actionable prognostic tool. The central hypothesis is that utilization of these procedures may be biased towards younger aged individuals (of white race and higher socioeconomic status, performed by high volume specialists), regardless of level of frailty, but that frailty will be highly correlated with poor outcomes and increased rates of complications. We will test this hypothesis by leveraging a 100% cohort of fee-for-service Medicare beneficiaries undergoing these procedures and the claims based frailty index (CFI), as the measure of frailty, by the following three aims: (1) to understand the utilization of invasive OAB treatments (a) according to age and frailty, and (b) according to other non-clinical factors: patient (race/ethnicity), regional (socioeconomic) and provider (surgeon and volume); (2) to determine downstream outcomes and utilization of third-line OAB treatments across the spectrum of advancing age and frailty up to 2 years after the procedure; (3) to develop and internally validate a prognostic tool to predict successful outcomes for older and frail older adults undergoing third-line OAB treatments. This study is innovative because it will measure and apply the important factor of frailty to a national cohort of 100% of fee-for-service Medicare beneficiaries undergoing onabotulinumtoxinA, PTNS, and sacral neuromodulation to ultimately create an individualized prognostic tool to improve outcomes in this understudied population. The proposed research is significant because there is a critical lack of information about outcomes for refractory OAB in this large and vulnerable population who suffer greatly from this condition. Development of an individualized prognostic tool to aid in this decision-making process will serve to minimize the risks of potentially unsuccessful, unnecessary and even harmful procedures, while promoting the use of such procedures among individuals who are more likely to receive benefit.