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: 10283351
• 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/10283351
• 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.

项目总结/摘要 这是一份K23奖的申请，申请人是Brett Einerson博士，他是一名母胎医学（MFM）医生， 犹他州大学。Einerson博士是一位有前途的胎盘植入谱（PAS）年轻研究者 research.他的长期职业目标是成为一名独立调查员和PAS的国家领导人 评估PAS治疗的研究，包括原位保守治疗（CM）。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] 发展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， 定性评估; 3]获得卫生经济学评估的高级技能; 4]发展和加强 研究领导和管理技能。为了实现这些目标，Einerson博士组建了一个指导小组， 团队由主要导师Robert银博士组成，他是MFM医生和PAS的国际领导者 研究，和两个共同导师：艾琳罗斯韦尔博士，NIH资助的科学家和专家在共同决策， 定性研究和研究伦理，以及理查德纳尔逊博士，联邦资助的健康经济学家。博士 Einerson还拥有四名在临床试验、CM和多中心研究领导方面具有专业知识的顾问。 PAS是一种非常病态和越来越常见的妊娠状况，通常会导致大量的 产科出血美国的标准治疗是子宫切除术，但这种治疗很复杂， 病态的，昂贵的。PAS治疗的一个有希望的替代方案是CM，这是一种将胎盘留在胎盘中的策略。 子宫不幸的是，没有足够的数据来比较这两种治疗方法的结果。 由于过去的研究受到非随机研究设计的限制， 做出治疗决定，并名义上考虑到治疗的经济障碍。一项大型临床试验 需要比较PAS治疗。Einerson博士的研究将提供必要的数据， 随机临床试验，并将提供证据基础，以加强共同决策， 治疗PAS。他将（目标1）评价将患者随机分配至CM进行PAS的可行性;（目标2） 确定考绩制度的信息需求、成果优先次序和共同的决策偏好;以及（目标 3)量化PAS治疗的成本。在目标1中，Einerson博士将设计和实施PAS的试点试验 患者随机接受CM或子宫切除术，以评估更大试验的可行性。在目标2中，Einerson博士将 与患者、临床医生和合作伙伴进行访谈，以评估他们的信息需求和价值。 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。 预期的结果将为一项比较子宫切除术与子宫切除术治疗PAS的大型临床试验奠定基础 并帮助建立必要的数据共享决策和价值为基础的护理在PAS。完成 这些目标和目的将使Einerson博士为成功过渡到独立的临床试验者做好准备。