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

患有难治性膀胱过度活动症的老年和体弱老年人的结局决定因素

• 批准号: 10912086
• 负责人: Anne M. Suskind
• 金额: $ 47.4万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10912086
• 关键词: Adult; Affect; Age; Aging; Anxiety; Behavioral; Calibration; Caring; Caucasians; Characteristics; Dangerousness; Data; Decision Making; Development; Diagnosis; Discrimination; Disease; Elderly; Ethnic Origin; Extravasation; Fee-for-Service Plans; Fracture; Frail Elderly; Health; Individual; Injections; Inpatients; Institutionalization; Knowledge; Measures; Medicare; Mental Depression; Minor; Mission; Not Hispanic or Latino; Operative Surgical Procedures; Outcome; Outpatients; Overactive Bladder; Patients; Peripheral; Persons; Pharmacotherapy; Physicians; Population; Procedures; Process; Provider; Public Health; Quality of life; Race; Refractory; Research; Selection for Treatments; Social isolation; Socioeconomic Factors; Socioeconomic Status; Specialist; Structure of tibial nerve; Surgeon; Syndrome; System; Testing; Treatment Efficacy; Treatment outcome; Underserved Population; Urine; Variant; Vulnerable Populations; Withholding Treatment; Work; age group; aged; beneficiary; botulinum neurotoxin injection; clinical decision-making; cohort; falls; frailty; health related quality of life; human old age (65+); implantable device; improved; improved outcome; indexing; ineffective therapies; innovation; medical specialties; middle age; neuroregulation; personalized decision; predictive tools; prevent; primary outcome; prognostic tool; risk minimization; side effect; socioeconomics; stressor

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.

项目摘要 我们对三线治疗结果的理解存在根本性的差距 [奥纳博林毒素A、外周胫神经刺激(PTNS)和骶神经调节]治疗难治性 老年和虚弱老年人的膀胱过度活动(OAB)，他们共同构成了大多数患者 患有这种病症的。尽管在年轻和中年健康的成年人中得到了很好的研究，但很少有 已知这些治疗在这些更脆弱的人群中的结果和并发症，可能 导致过度使用无效或危险的治疗方法，或未充分利用治疗方法 这可能会显著提高与健康相关的生活质量。我们的首要研究目标是改进 照顾所有正在接受OAB治疗的年长和虚弱的老年人。这项拟议研究的目的是 更好地了解与onabotulinumoxinA、PTNS和 老年和虚弱老年人的骶骨神经调节，并使用这些信息来创建个性化的 和可操作的预后工具。中心假设是，这些程序的使用可能是有偏见的。 针对较年轻的老年人(白人和较高的社会经济地位，通过大量演出) 专家)，与脆弱程度无关，但这种脆弱将与糟糕的结果高度相关， 并发症发生率增加。我们将利用100%的按服务收费的队列来检验这一假设 接受这些程序的联邦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 根据年龄和虚弱，以及(B)根据其他非临床因素：患者(种族/民族)、地区 (社会经济)和提供者(外科医生和体量)；(2)确定下游结果和利用 三线OAB治疗涵盖了高龄和虚弱的范围，最长可达术后2年； (3)开发和内部验证预后工具，以预测老年和虚弱老年人的成功结果 正在接受三线OAB治疗的成年人。这项研究具有创新性，因为它将测量和应用 脆弱的重要因素对100%正在接受按服务付费的医疗保险受益者的全国队列 On-abotulinumoxinA、PTNS和骶神经调节最终创建个体化预后工具 以改善这一研究不足的人群的结果。这项拟议的研究意义重大，因为有一项 严重缺乏关于难治性OAB在这一庞大而脆弱的人群中的结局的信息 很大程度上脱离了这种状况。开发一种个体化的预后工具来帮助这一决策 程序将有助于将可能不成功、不必要甚至有害的程序的风险降至最低， 同时促进在更有可能获得利益的个人中使用这种程序。