Optimizing Treatment Decisions for Acute Demyelinating Optic Neuritis

优化急性脱髓鞘性视神经炎的治疗决策

• 批准号: 10004625
• 负责人: Lindsey Blake De Lott
• 金额: $ 20.76万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10004625
• 关键词: Acute; Address; Adherence; Adopted; Adrenal Cortex Hormones; Adverse event; Behavior; Belief; Benefits and Risks; Big Data; Blindness; Caring; Clinical; Clinical Trials Design; Complex; Country; Coupled; Data; Databases; Decision Aid; Decision Making; Decision Support Systems; Development; Disease; Evidence based practice; Evidence based treatment; Eye; Eye diseases; Foundations; Funding; Goals; Health Policy; Health Services Research; Hospital Costs; Hospitalization; Individual; Infusion procedures; Injury; Institutes; Intervention; Intravenous; Mentorship; Methodology; Methods; Michigan; Mission; Modeling; Modernization; Neurologic; Neurology; Ophthalmology; Optic Neuritis; Optical Coherence Tomography; Outcome; Outpatients; Patient Care; Patient Rights; Patients; Perception; Pharmaceutical Preparations; Physician' s Role; Physicians; Prospective Studies; Provider; Psychologist; Randomized Clinical Trials; Recovery; Registries; Research; Research Personnel; Right to Treatments; Risk; Shapes; Structure; Subgroup; Techniques; Testing; Thick; Training; Translational Research; Treatment Efficacy; United States National Institutes of Health; Universities; Variant; Vision; Visual; Work; base; care providers; career; career development; clinical practice; design; disability; evidence base; functional outcomes; individual patient; innovation; multidisciplinary; outcome forecast; personalized medicine; programs; response; retinal nerve fiber layer; side effect; simulation; social norm; theories; therapy design; tool; treatment effect; treatment optimization; treatment risk; treatment trial; usability; young adult

ABSTRACT: A wide gap exists between the evidence for acute demyelinating optic neuritis (ON) treatment and physicians’ clinical practice. The proposed research seeks to narrow this gap by designing an intervention to promote evidence-based, personalized treatment decisions. ON can cause permanent vision loss, but varia- tion exists in the visual prognosis. The Optic Neuritis Treatment Trial (ONTT) showed that, for the average pa- tient, intravenous corticosteroids did not improve visual outcomes, but may hasten recovery. This modest aver- age corticosteroids benefit comes with potential harms: medication side effects, and the inconvenience and cost of hospital admissions or outpatient infusions. Furthermore, the ONTT lacks modern neuro-axonal struc- tural outcomes and adequately powered prospective studies are lacking. Despite the variability in prognosis, modest benefits/risks of treatment, and limited understanding of corticosteroids effects on structural outcomes, providers treat nearly all patients with intensive corticosteroid therapy--adopting a “one-size-fits-all” approach to treatment. Personalizing ONTT data using multivariable risk stratified analyses and simulation analyses of neuroaxonal structural outcomes has great potential to inform individual treatment decisions. This strategy cir- cumvents the weaknesses of subgroup analyses, by examining the complex ways that multiple clinical factors shape an individual’s overall risks/benefits from treatment. However, information alone is not enough to change decision-making behavior. Perceptions about the treatment are important determinants of decision making be- havior. The objective of this proposal is to design a decision support intervention with personalized risk/benefit information that is informed by physician’s treatment perceptions to promote more nuanced, evidence-based ON treatment decisions. This objective will be addressed through 3 specific aims. (1) Establish the key treat- ment perceptions underlying physician’s ON decision making using a theory-based, mixed methods approach. (2) Develop models of the risks/benefits of corticosteroids at the individual level. (3) Use the results from Aims 1 and 2 to develop and pilot the usability, feasibility and acceptability of a decision support intervention. Dr. De Lott has a unique background in neuro-ophthalmology and health services research. She will develop addi- tional expertise in multivariable risk stratified analyses, simulation analyses, mixed methods, clinical trials, and design of decision support systems to become an independently-funded investigator committed to developing strategies to optimize evidence-based care. This proposal capitalizes on the unique strengths of the University of Michigan: Neurology and Ophthalmology Health Services Research Programs and the Institute for Health Care Policy and Innovation-among the largest academic health services research centers in the country. Dr. De Lott will be supported by an outstanding multi-disciplinary mentorship team: Dr. Kevin Kerber, a leader in neurological health services research, Dr. Paul Lee, an expert in T3 translational research for eye care, and Dr. Brian Zikmund-Fisher, a decisional psychologist and leader in decision aid development.

摘要：急性脱髓鞘神经（ON）治疗的证据之间存在很大的差距 和医生的临床实践。拟议的研究试图通过设计干预来缩小这一差距 促进基于证据的个性化治疗决策。在上可能会导致永久视力丧失，但变量 - 视觉预后存在。视神经炎治疗试验（ONTT）表明，对于平均PA- Tient，静脉注射皮质类固醇不能改善视觉结果，但可能会恢复。这个谦虚的平均 年龄皮质类固醇的好处带有潜在危害：药物副作用，不便和 住院费用或门诊输注的成本。此外，ONTT缺乏现代的神经轴结构 - 缺乏刺激性的结果和足够的前瞻性研究。尽管提示有可变性，但 适度的治疗益处/风险，对皮质类固醇对结构结果的影响有限， 提供者几乎对所有强化皮质类固醇疗法的患者进行治疗 - 采用“一定大小的”方法 治疗。使用多变量风险分层分析和模拟分析来个性化ONTT数据 神经乳突结构结果具有巨大的潜力，可以为个人治疗决定提供信息。这种策略cir- 通过检查多个临床因素的复杂方式，堆积亚组分析的弱点 塑造个人的总体风险/益处。但是，仅信息不足以改变 决策行为。对治疗的看法是决策的重要决定者 - Havior。该建议的目的是设计具有个性化风险/利益的决策支持干预措施 物理学的治疗看法所告知的信息，以促进更细微的循证 关于治疗决策。该目标将通过3个具体目标来解决。 （1）建立关键待遇 - 采用基于理论的混合方法方法来制定实物制定的基础知识。 （2）开发单个水平上皮质类固醇的风险/益处的模型。 （3）使用目标的结果 1和2开发和试行决策支持干预的可用性，可行性和可接受性。 de博士 洛特（Lott）在神经跨科学和卫生服务研究方面具有独特的背景。她会发展 - 多变量风险分层分析，模拟分析，混合方法，临床试验和 决策支持系统的设计，成为致力于开发的独立资助的调查员 优化循证护理的策略。该提议利用了大学的独特优势 密歇根州：神经病学和眼科健康服务研究计划和卫生研究所 护理政策和创新 - 该国最大的学术卫生服务研究中心。博士 德洛特（De Lott）将得到一个杰出的多学科心态团队的支持： 神经健康服务研究研究，T3翻译研究专家Paul Lee博士和博士 Brian Zikmund-Fisher是决策援助开发的决策心理学家和领导者。