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：急性脱髓鞘视神经炎(ON)的治疗证据之间存在很大差距。 和医生的临床实践。这项拟议的研究试图通过设计干预措施来缩小这一差距 促进循证、个性化的治疗决策。会导致永久性失明，但瓦里亚- 视力预后中存在视功能障碍。视神经炎治疗试验(ONTT)显示，对于平均患者- 静脉注射皮质类固醇不能改善视力，但可能加速恢复。这位谦虚的保证人- 年龄皮质类固醇的好处伴随着潜在的危害：药物副作用，以及不便和 住院或门诊输液的费用。此外，ONTT缺乏现代神经轴突结构- 缺乏实际结果和足够有力的前瞻性研究。尽管预后各不相同， 治疗的好处/风险不大，对皮质类固醇对结构结果的影响了解有限， 供应商对几乎所有患者都进行强化皮质类固醇治疗--采用“一刀切”的方法 去接受治疗。利用多变量风险分层分析和模拟分析对ONTT数据进行个性化 神经轴突的结构结果具有很大的潜力来指导个人的治疗决定。这一战略将-- 通过检查多个临床因素的复杂方式，指出了亚组分析的弱点 塑造个人从治疗中获得的总体风险/收益。然而，光靠信息是不足以改变的。 决策行为。对治疗的看法是决策的重要决定因素 哈沃。该建议的目标是设计一种具有个性化风险/收益的决策支持干预 由医生的治疗认知提供的信息，以促进更细微的、基于证据的 关于治疗决定的。这一目标将通过三个具体目标来实现。(1)确立关键待遇-- 以理论为基础的混合方法对医生决策的认知。 (2)在个体层面上建立皮质类固醇的风险/收益模型。(3)使用AIMS的结果 1和2开发和试点决策支持干预措施的可用性、可行性和可接受性。德博士 洛特在神经眼科和卫生服务研究方面拥有独特的背景。她会患上ADI- 在多变量风险分层分析、模拟分析、混合方法、临床试验和 设计决策支持系统，成为独立资助的调查员，致力于开发 优化循证护理的策略。这项建议充分利用了这所大学的独特优势 密歇根大学：神经学和眼科卫生服务研究项目和卫生研究所 护理政策和创新--美国最大的学术卫生服务研究中心之一。Dr。 德洛特将得到一个杰出的多学科指导团队的支持：凯文·科伯博士，他是 神经健康服务研究，保罗·李博士，T3眼部护理转化研究的专家，和Dr。 决策心理学家和决策辅助开发的领导者Brian Zikmund-Fisher说。