Real-world effectiveness of preventive pharmacological therapy for patients with kidney stones

肾结石患者预防性药物治疗的真实有效性

基本信息

批准号：
10584488
负责人：
John Malcolm Hollingsworth
金额：
$ 59.02万
依托单位：
UNIVERSITY OF MICHIGAN AT ANN ARBOR
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-04-01 至 2025-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10584488
关键词：
Accident and Emergency department Acute Adult Adverse event Affect Age Alkalies Allopurinol American Caring Chemistry Chronic Kidney Failure Citrates Clinical Clinical Data Clinical Management Clinical Practice Guideline Collection Data Data Sources Development Effectiveness Elderly Emergency department visit Event Excision Expenditure Facilities and Administrative Costs Flank Pain Funding Agency Future Guidelines Health Care Costs Health Personnel Health Promotion Healthcare Healthcare Systems Hospitalization Hour Image Intervention Kidney Calculi Link Longterm Follow-up Measures Medicare Medicare claim Observational Study Operative Surgical Procedures Outcome Pain Patient risk Patients Pharmaceutical Preparations Pharmaceutical Services Practice Guidelines Prevention Preventive Procedures Productivity Professional Organizations Provider Randomized, Controlled Trials Recommendation Recurrence Reporting Research Resources Running Sample Size Savings Source Specific qualifier value System Techniques Thiazide Diuretics United States Agency for Healthcare Research and Quality Urine Veterans Health Administration Work beneficiary clinically relevant comorbidity comparative effectiveness cost data warehouse demographics econometrics economic implication evidence base experience innovation inpatient service medication compliance outpatient programs patient subsets patient tolerability payment pharmacologic prevent relapse patients surgical service systematic review thiazide treatment as usual

项目摘要

PROJECT SUMMARY Kidney stones affect one in 11 Americans. With related expenditures of $4.5 billion annually, they also pose a tremendous resource burden. In addition, they are not a one-off event with 50% of patients developing a recurrence within five years of their first stone. Thus, interventions that reduce recurrent stones may promote health and have positive economic implications. The use of thiazide diuretics, alkali citrate treatment, or allopurinol—referred to as preventive pharmacological therapy (PPT)—may represent one such intervention. Yet, while current guidelines recommend PPT, it is infrequently used. A recent systematic review funded by the Agency for Healthcare Research & Quality highlighted three gaps in the evidence base for PPT, tempering enthusiasm for it. First, findings from prior studies were driven mainly by intermediate outcomes, but what matters to patients and providers is whether an intervention will prevent future pain episodes that require an emergency department (ED) visit, hospitalization, or surgery. Second, prior studies reported few data on treatment tolerability. Third, the impact that PPT has on future costs in stone formers is largely unknown. If this therapy yields a substantial savings to the healthcare system over the long run, acceptance of it may increase. An obstacle to filling these three gaps has been the availability of data sources with the necessary sample size, clinical granularity, and long-term follow-up for examining the real-world effectiveness of PPT. To overcome this obstacle, we propose a study using innovative linkages of administrative and clinical data. Our proposal has three Specific Aims. Aim 1: To evaluate the impact that PPT has on clinical outcomes. Using the Veterans Health Administration Corporate Data Warehouse and Medicare claims linked with urine chemistry data from Litholink Corporation, we will identify adults with kidney stones, distinguishing patients prescribed thiazides, citrates, or allopurinol from those receiving usual care. We will evaluate ED visit, hospitalization, and surgery rates in these two groups. Aim 2: To examine patient tolerability for PPT. As an assessment of tolerability, we will then measure medication adherence and adverse event rates among patients prescribed thiazides, citrates, or allopurinol. We will examine differences in tolerability across patient subgroups. Aim 3: To determine the healthcare costs associated with PPT use. Finally, we will assess longitudinal payments for patients with kidney stones. We will determine whether variability in these payments exists between patients prescribed PPT versus those receiving usual care. Findings from our study serve to inform the optimal management of kidney stones. To this end, patients will ultimately benefit most from our research.

项目概要每 11 名美国人中就有 1 人患有肾结石，每年相关支出达 45 亿美元，这也构成了肾结石的负担。此外，它们并不是一次性事件，50% 的发展中患者都患有这种疾病。因此，减少结石复发的干预措施可能会促进结石复发。使用噻嗪类利尿剂、碱柠檬酸盐治疗或具有积极的经济影响。别嘌呤醇——称为预防性药物治疗（PPT）——可能代表这样的干预措施之一。然而，虽然当前的指南推荐使用 PPT，但它很少被使用。最近由美国资助的系统审查。医疗保健研究与质量机构强调了 PPT 证据基础中的三个差距，缓和首先，之前的研究结果主要是由中间结果驱动的，但是是什么？对于患者和医疗服务提供者来说，重要的是干预措施是否能够预防未来需要治疗的疼痛发作。其次，之前的研究报告的数据很少。第三，PPT 对石材成型机未来成本的影响在很大程度上是未知的。从长远来看，治疗可以为医疗保健系统带来大量节省，对其的接受度可能会增加。填补这三个空白的一个障碍是具有必要样本量的数据源的可用性，临床粒度和长期随访，以检查 PPT 在现实世界中的有效性。针对这一障碍，我们提出了一项利用管理和临床数据的创新联系的研究。具有三个具体目标 1：评估 PPT 对临床结果的影响。退伍军人健康管理局企业数据仓库和与尿液化学相关的医疗保险索赔根据 Litholink Corporation 的数据，我们将识别患有肾结石的成年人，区分处方患者我们将评估接受常规护理的患者的噻嗪类药物、柠檬酸盐或别嘌呤醇。目标 2：检查患者对 PPT 的耐受性。耐受性，然后我们将测量处方患者的药物依从性和不良事件发生率我们将检查不同患者亚组的耐受性差异。目标 3：为了确定与 PPT 使用相关的医疗费用，我们将评估纵向付款。对于肾结石患者，我们将确定这些付款之间是否存在差异。接受 PPT 治疗的患者与接受常规护理的患者相比，我们的研究结果有助于提供最佳的选择。为此，患者最终将从我们的研究中受益最多。

项目成果

期刊论文数量（14）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Opioid-Free Discharge is Not Associated With Increased Unplanned Healthcare Encounters After Ureteroscopy: Results From a Statewide Quality Improvement Collaborative.

DOI：
10.1016/j.urology.2021.07.037
发表时间：
2021-12
期刊：
Urology
影响因子：
2.1
作者：
Hawken SR;Hiller SC;Daignault-Newton S;Ghani KR;Hollingsworth JM;Conrado B;Maitland C;Wenzler DL;Ludlow JK;Ambani SN;Brummett CM;Dauw CA;Michigan Urological Surgery Improvement Collaborative
通讯作者：
Michigan Urological Surgery Improvement Collaborative

Comparison of Empiric Preventative Pharmacologic Therapies on Stone Recurrence Among Patients with Kidney Stone Disease.

DOI：
10.1016/j.urology.2022.04.031
发表时间：
2022-08
期刊：
UROLOGY
影响因子：
2.1
作者：
Hsi, Ryan S.;Yan, Phyllis L.;Crivelli, Joseph J.;Goldfarb, David S.;Shahinian, Vahakn;Hollingsworth, John M.
通讯作者：
Hollingsworth, John M.

Ureteroscopy in Patients Taking Anticoagulant or Antiplatelet Therapy: Practice Patterns and Outcomes in a Surgical Collaborative.

DOI：
10.1097/ju.0000000000001416
发表时间：
2021-03
期刊：
The Journal of urology
影响因子：
0
作者：
Hiller SC;Qi J;Leavitt D;Frontera JR;Jafri SM;Hollingsworth JM;Dauw CA;Ghani KR
通讯作者：
Ghani KR

Comparison of Class-Specific Side Effects Across Preventative Pharmacologic Therapies for Kidney Stone Disease.

肾结石疾病预防性药物治疗的特定类别副作用的比较。

DOI：
10.1097/upj.0000000000000470
发表时间：
2024
期刊：
Urology practice
影响因子：
0.8
作者：
Hsi,RyanS;Crivelli,JosephJ;Yan,PhyllisL;Shahinian,Vahakn;Hollingsworth,JohnM
通讯作者：
Hollingsworth,JohnM

Associations Between Provider Specialty and Use of Follow-up Testing Among Patients on Preventive Pharmacological Therapy for Urinary Stone Disease.

提供者专业与尿路结石预防性药物治疗患者随访测试使用之间的关联。

DOI：
10.1097/upj.0000000000000414
发表时间：
2023
期刊：
Urology practice
影响因子：
0.8
作者：
Crivelli,JosephJ;Yan,PhyllisL;Shahinian,Vahakn;Hsi,RyanS;Hollingsworth,JohnM
通讯作者：
Hollingsworth,JohnM