Conservative management as an alternative to hysterectomy for placenta accreta spectrum.

保守治疗作为植入性胎盘谱子宫切除术的替代方案。

• 批准号: 10468186
• 负责人: Brett David Einerson
• 金额: $ 17.17万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-12 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468186
• 关键词: Address; Award; Benefits and Risks; Caring; Clinical; Clinical Treatment; Clinical Trials; Clinical Trials Design; Cohort Studies; Complex; Control Groups; Counseling; Data; Decision Aid; Decision Making; Discipline of obstetrics; Disease; Economic Burden; Economics; Enrollment; Foundations; Funding; Future; Goals; Health; Healthcare Systems; Hemorrhage; Hysterectomy; In Situ; Incidence; Infertility; International; Interview; Knowledge; Leadership; Left; Maternal-fetal medicine; Mentored Patient-Oriented Research Career Development Award; Mentors; Monitor; Morbidity - disease rate; Neonatal; Operative Surgical Procedures; Outcome; Patient Care; Patient Outcomes Assessments; Patients; Physicians; Placenta; Placenta Accreta; Positioning Attribute; Pregnancy; Principal Investigator; Process; Qualitative Methods; Qualitative Research; Quality of life; Randomized; Randomized Clinical Trials; Repeat Surgery; Research; Research Design; Research Ethics; Research Personnel; Risk; Safety; Scientist; Silver; Structure; Therapeutic; Time; Treatment Step; United States National Institutes of Health; Universities; Utah; Uterus; Woman; Work; alternative treatment; barrier to care; base; career; career development; cost; cost effective; cost effective treatment; design; economic evaluation; evidence base; follow-up; health economics; improved; mortality; novel; patient oriented; pilot trial; preference; pregnancy disorder; premature; severe maternal morbidity; shared decision making; skills; standard care; treatment comparison; trial comparing; trophoblast

PROJECT SUMMARY/ABSTRACT This is an application for a K23 award for Dr. Brett Einerson, a Maternal-Fetal Medicine (MFM) physician at the University of Utah. Dr. Einerson is a promising young investigator in placenta accreta spectrum (PAS) research. His long-term career goal is to become an independent investigator and national leader of PAS studies that evaluate treatments for PAS, including in situ conservative management (CM). This K23 award will provide Dr. Einerson with the protected time and mentored support to accomplish the following career goals: 1] develop expertise in clinical trial design and management; 2] acquire proficiency in interview study design and qualitative assessment; 3] obtain advanced skills in health economic evaluation; and 4] develop and strengthen research leadership and management skills. To achieve these goals, Dr. Einerson assembled a mentoring team comprising a primary mentor, Dr. Robert Silver, a MFM physician and international leader in PAS research, and two co-mentors: Dr. Erin Rothwell, a NIH-funded scientist and expert in shared decision-making, qualitative research, and research ethics, and Dr. Richard Nelson, a federally-funded health economist. Dr. Einerson also has four advisors with expertise in clinical trials, CM, and multicenter research leadership. PAS is an extremely morbid and increasingly common pregnancy condition that often results in massive obstetric hemorrhage. The standard treatment in the US is hysterectomy, but this treatment is complex, morbid, and costly. A promising alternative for PAS treatment is CM, a strategy in which the placenta is left in the uterus. Unfortunately, there are insufficient data available to compare outcomes of these two treatments because past studies are limited by non-randomized study designs, minimal inclusion of patient values in making treatment decisions, and nominal consideration of economic barriers to care. A large clinical trial comparing PAS treatments is needed. Dr. Einerson's research will provide essential data to prepare for a randomized clinical trial and will provide the evidence base for enhanced shared decision-making regarding treatments for PAS. He will (Aim 1) evaluate the feasibility of randomizing patients to CM for PAS; (Aim 2) identify the information needs, outcome priorities, and shared decision-making preferences for PAS; and (Aim 3) quantify the cost of PAS treatments. In Aim 1, Dr. Einerson will design and implement a pilot trial of PAS patients randomized to CM or hysterectomy to evaluate feasibility of a larger trial. In Aim 2, Dr. Einerson will conduct interviews with patients, clinicians, and partners to assess the information needs and values of those who are part of making treatment decisions for PAS. In Aim 3, Dr. Einerson will compare the cost of PAS treatments using advanced economic analytics. The expected outcome will lay the groundwork for a large clinical trial of CM versus hysterectomy for PAS and help to establish the data necessary for shared decision-making and value-based care in PAS. Completing these goals and aims will prepare Dr. Einerson for a successful transition into an independent clinical trialist.

项目概要/摘要 这是 Brett Einerson 博士的 K23 奖项申请，他是一名母胎医学 (MFM) 医生 犹他大学。 Einerson 博士是侵入性胎盘谱 (PAS) 领域一位有前途的年轻研究者 研究。他的长期职业目标是成为一名独立调查员和伊党国家领导人 评估 PAS 治疗方法的研究，包括原位保守治疗 (CM)。这个K23奖将 为 Einerson 博士提供受保护的时间和指导支持，以实现以下职业目标：1] 培养临床试验设计和管理方面的专业知识； 2] 熟练掌握访谈研究设计和 定性评估； 3]获得卫生经济评估的高级技能； 4] 发展和加强 研究领导和管理技能。为了实现这些目标，艾纳森博士组建了一个指导团队 团队由主要导师 Robert Silver 博士组成，他是 MFM 医生和 PAS 领域的国际领导者 研究和两位共同导师：Erin Rothwell 博士，美国国立卫生研究院资助的科学家和共同决策专家， 定性研究和研究伦理，以及联邦政府资助的健康经济学家理查德·尼尔森博士。博士。 Einerson 还拥有四名顾问，他们在临床试验、CM 和多中心研究领导方面拥有专业知识。 PAS 是一种极其病态且日益常见的妊娠病症，通常会导致大量妊娠 产科出血。美国的标准治疗方法是子宫切除术，但这种治疗方法很复杂， 病态的，而且代价高昂。 PAS 治疗的一个有前途的替代方案是 CM，这是一种将胎盘留在体内的策略。 子宫。不幸的是，没有足够的数据来比较这两种治疗的结果 由于过去的研究受到非随机研究设计的限制，因此在研究中极少包含患者价值观 做出治疗决定，并名义上考虑护理的经济障碍。大型临床试验 需要比较 PAS 治疗方法。艾纳森博士的研究将为 随机临床试验将为加强共同决策提供证据基础 PAS 的治疗。他将（目标 1）评估将患者随机分配至 CM 进行 PAS 的可行性； （目标2） 确定考绩制度的信息需求、成果优先事项和共同决策偏好；和（目标 3）量化PAS治疗的成本。在目标 1 中，Einerson 博士将设计并实施 PAS 试点试验 患者随机接受 CM 或子宫切除术，以评估更大规模试验的可行性。在目标 2 中，艾纳森博士将 与患者、临床医生和合作伙伴进行访谈，评估他们的信息需求和价值观 他们是 PAS 治疗决策的一部分。在目标 3 中，Einerson 博士将比较 PAS 的成本 使用先进的经济分析进行治疗。 预期结果将为 CM 与子宫切除术治疗 PAS 的大型临床试验奠定基础 帮助建立 PAS 中共享决策和基于价值的护理所需的数据。正在完成 这些目标将为 Einerson 博士成功转型为独立临床试验师做好准备。