Assessment of outcomes and cost-effectiveness in early orthodontic treatment

摘要 这是James Chen博士的K23指导研究职业发展奖申请，他是一名 加州大学旧金山分校的助理教授和正畸医生。陈博士正致力于建立他的研究， 为社会弱势儿童提供的拦截式正畸治疗和他的临床专业知识。本申请 旨在提供必要的指导，培训和研究支持陈博士需要成为一个 成功的独立调查员具体而言，该奖项旨在实现以下目标：（1） 成为以患者为基础的早期拦截正畸治疗研究的专家;（2）确定 基于可移动矫治器的治疗方案在治疗结果和儿童自我感知方面的等效性 （3）学习和应用先进的生物统计学方法， 研究;（4）学习和实施早期拦截正畸的成本效益分析模型 治疗方案;（5）发展和发展强大的独立临床研究事业;（6）成为 在美国获得正畸医疗保健。为了实现这些目标，陈博士将 需要支持来设计和实施研究。陈博士组建了一个多元化的指导团队 包括一个主要的导师，乔治泰勒博士，谁是预防和恢复系主任 科学和进行与糖尿病和牙周炎有关的公共卫生研究， 一位顾问：格雷格·黄博士，华盛顿大学正畸学主席，他是一位专家， 基于证据的正畸研究;詹姆斯卡恩博士，医学临床流行病学教授， 加州大学旧金山分校，谁是成本效益分析和医疗保健经济学专家;博士程静，助理 牙科学院教授，他是研究设计和生物统计分析方面的专家; 杰拉尔德纳尔逊，在加州大学旧金山分校正畸科代理主席，将担任临床顾问，因为 他在早期阻断正畸治疗方面的丰富知识和经验。 社会弱势儿童的口腔健康差异和获得正畸护理是一个主要问题， 美国的陈博士的研究将集中在批判性地分析一种新颖的可移动设备， 治疗方案旨在减少正畸需求，同时限制对低收入人群的经济影响 与现有的基于固定矫治器的治疗方案相比，这项研究的假设是， 基于使用可移动矫正器的治疗方案提供了相同的治疗结果， 比传统的固定设备协议更具成本效益。这项研究的关键将包括比较 治疗结果的差异（AIM 1），通过咬合指数评分（PAR指数和ICON指数）测量， 采用儿童知觉问卷（AIM 2）测量正畸治疗前后儿童自我知觉的差异 治疗，以及单独可摘矫治器组和 仅固定设备组。为了实现这三个目标，陈博士将尽早招募参与者 在La Clinica社区诊所和UCSF正畸住院医师诊所进行拦截性正畸治疗， 他将跟随他们完成他们的正畸治疗，然后进入完全永久 齿系这项研究将需要复杂的多元线性回归分析。这项研究将是 开发和启动大型干预试验的起点， 为社会弱势儿童提供固定器具治疗。在K23的最后 陈博士将准备并申请R34奖，以开发干预试验，然后进行 申请U 01临床试验奖。

Abstract This is an application for a K23 Mentored Research Career Development Award for Dr. James Chen, an Assistant Professor and Orthodontist at UCSF. Dr. Chen is working to establish his research on early interceptive orthodontic treatment for socially disadvantaged children and his clinical expertise. This application is designed to provide the necessary mentoring, training, and research support Dr. Chen needs to become a successful independent investigator. Specifically, this award sets out to accomplish the following goals: (1) become an expert in patient-based early interceptive orthodontic treatment research; (2) to determine the equivalence in treatment outcome and child self-perception between a removable-appliance-based protocol and a fixed-appliance-based protocol; (3) to learn and implement advanced biostatistical methods in clinical research; (4) to learn and implement cost-effectiveness analysis models on early interceptive orthodontic treatment protocols; (5) to develop and grow a strong independent clinical research career; (6) to be a leader in access to orthodontic health care in the United States. In order for Dr. Chen to achieve these goals he will need support to design and implement his study. Dr. Chen has assembled a diverse mentoring team comprised of a primary mentor, Dr. George Taylor, who is the Department Chair of Preventive and Restorative Sciences and conducts public-health-related research on diabetes and periodontitis, and three co-mentors with one consultant: Dr. Greg Huang, Chair of Orthodontics at the University of Washington, who is an expert on evidenced based orthodontic research; Dr. James Kahn, Professor of Clinical Epidemiology in Medicine at UCSF, who is an expert on cost-effectiveness analysis and health care economics; Dr. Jing Cheng, Associate Professor in the School of Dentistry, who is an expert on study design and biostatistical analysis; and Dr. Gerald Nelson, Acting Chair of Division of Orthodontics at UCSF, will serve as a clinical consultant because of his extensive knowledge and experience with early interceptive orthodontic treatment. Oral health disparities and access to orthodontic care for socially disadvantaged children is a major concern in the United States. Dr. Chen's research will focus on critically analyzing a novel removable appliance based treatment protocol aimed at reducing orthodontic need while limiting the financial impact on low-income families compared to the existing fixed appliance based treatment protocol. The hypothesis of this study is that a treatment protocol based on using removable appliances provides the same treatment outcome but better cost-effectiveness than a traditional fixed-appliance protocol. The crux of this study will include comparing the differences in treatment outcome (AIM 1), measured by occlusal index scores (PAR Index and ICON Index), the differences in child self-perception measured by Child Perception Questionnaire (AIM 2) after orthodontic treatment, and the difference in cost-effectiveness (AIM 3) between the removable appliance only group and the fixed appliances only group. For all three aims, Dr. Chen will recruit participants beginning early interceptive orthodontic treatment at La Clinica Community Clinic and UCSF Orthodontic Residency Clinic and he will follow them to completion of their orthodontic treatment and then progression into full permanent dentition. This study will require sophisticated multiple linear regression analyses. This research will be the starting point for developing and initiating a large intervention trial comparing removable based appliance therapy to fixed appliance based therapy for socially disadvantaged children. Towards the end of this K23 award Dr. Chen will prepare and apply for a R34 award to develop the intervention trial followed by an application for an U01 clinical trial award.