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.

项目摘要肾结石影响了11个美国人中的一个。每年相关支出为45亿美元，他们也构成巨大的资源伯恩。此外，它们不是一次性事件，有50％的患者发展在他们的第一块石头五年内复发。那就是减少复发石的干预措施可能会促进健康并具有积极的经济影响。噻嗪类利尿剂的使用，柠檬酸碱处理或阿哌他醇（作为预防性药物疗法（PPT））可能代表这样一种干预措施。但是，尽管当前的指南建议PPT，但很少使用它。最近的系统评价由医疗保健研究和质量机构在PPT的证据基础中突出了三个差距对此的热情。首先，先前研究的发现主要是由中间结果驱动的，但是什么对患者和提供者的重要事项是干预是否会防止未来的疼痛发作急诊科（ED）访问，住院或手术。第二，先前的研究报告了很少的数据治疗耐受性。第三，PPT对石材形成者未来成本的影响在很大程度上是未知的。如果这个从长远来看，治疗可以为医疗体系节省大量节省，接受该系统可能会增加。填补这三个空白的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，用于检查PPT的现实有效性。克服我们提出了使用行政和临床数据的创新联系的研究。我们的建议具有三个具体目标。目标1：评估PPT对临床结果的影响。使用退伍军人卫生管理局公司数据仓库和与尿液化学相关的Medicare索赔 Litholink Corporation的数据，我们将确定具有肾结石的成年人，并区分处方的患者噻嗪类，柠檬酸盐或别嘌醇来自接受常规护理的人。我们将评估Ed访问，住院和这两组的手术率。目标2：检查患者对PPT的耐受性。作为评估耐受性，我们将测量处方的患者中的药物依从性和不良事件发生率噻嗪类，柠檬酸盐或别嘌醇。我们将检查患者亚组的耐受性差异。目标3：确定与PPT使用相关的医疗费用。最后，我们将评估纵向付款适用于肾结石的患者。我们将确定这些付款的可变性是否存在患者开处方PPT与接受常规护理的患者相比。我们研究的发现有助于最佳肾结石的管理。为此，患者最终将从我们的研究中受益最大。

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

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 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.

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

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