Long Term Oral Health Outcomes in the Chronic GVHD Consortium

慢性 GVHD 联盟的长期口腔健康结果

• 批准号: 10455702
• 负责人: Herve Y Sroussi
• 金额: $ 71.69万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10455702
• 关键词: Address; Affect; Allogenic; Biological Specimen Banks; Cells; Clinical; Clinical Data; Collaborations; Dana-Farber Cancer Institute; Data; Dental; Dental Care; Dental Hygiene; Dental caries; Dentists; Diagnosis; Disease; Effectiveness; Enrollment; Epidemiologist; Expert Opinion; Exposure to; Eye; Fluorides; Foundations; Fred Hutchinson Cancer Research Center; Funding; Future; Generations; Goals; Guidelines; Health; Health Services Accessibility; Health Status; Immune; Individual; Instruction; Intervention; Knowledge; Lesion; Level of Evidence; Lichen Planus; Liver; Lung; Malignant Neoplasms; Measures; Mediating; Mucous Membrane; Oral; Oral Examination; Oral cavity; Oral health; Organ; Outcome; Patient Outcomes Assessments; Patients; Personal Satisfaction; Pharmaceutical Preparations; Population; Prior Therapy; Prospective Studies; Prospective cohort; Protocols documentation; Quality of life; Recording of previous events; Research Personnel; Resources; Retrospective cohort; Risk; Risk Factors; Salivary; Site; Skin; Supplementation; Testing; Tooth Loss; Transplant Recipients; Transplantation; Treatment Effectiveness; Trismus; United States National Institutes of Health; Universities; Visit; Vulnerable Populations; Washington; Xerostomia; base; chronic graft versus host disease; cohort; cost; data repository; demographics; design; effectiveness outcome; evidence base; experience; health related quality of life; hematopoietic cell transplantation; improved; mouth squamous cell carcinoma; oral care; personalized management; population based; protective factors; recruit; secondary analysis; secondary endpoint; tool

Abstract: Nearly 50% of allogeneic hematopoietic cell transplantation recipients (AlloHCT) will develop chronic graft- versus-host disease (cGVHD). Oral involvement is seen in approximately 80% of patients with cGVHD. It presents as mucosal lesions mimicking lichen planus, hyposalivation, and trismus. Low-level evidence suggests that oral cGVHD is associated with increased risk for dental, periodontal, and mucosal diseases. The current oral health guidelines for cGVHD are largely based on expert opinion. Little evidence exists to guide treatment decisions or to personalize management plans. The short-term objective of this application is to address the important gaps of knowledge described above and generate a rationale for establishing an evidence-based approach in the management of patients with oral cGVHD. Our hypothesis is that exposure to oral cGVHD leads to increased tooth loss and that recalcitrant oral cGVHD decreases oral-health-related quality of life (OHRQL) (secondary endpoint), an effect which we hypothesize is mediated by mucosal sensitivity, reduced salivary flow, and trismus. We will utilize the on-going collaboration between the Fred Hutchinson Cancer Research Center (FHCRC) and the Dana-Farber Cancer Institute (DFCI), two key sites of the NIH-funded cGVHD Consortium and nest our studies in a large established population-based cohort. First, we will determine tooth loss rates and OHRQL in AlloHCT recipients and explore their association with oral cGVHD. Subjects in an established and representative cohort of the Chronic GVHD Consortium will be recruited in a retrospective cohort. They will undergo an oral examination by a calibrated examiner. Tooth loss will be evaluated by comparing current status to data collected at the pre-AlloHCT oral examination. OHRQL will be measured through a validated tool (OHIP14). Current and past oral cGVHD status (per NIH criteria) will be assessed through mucosal examination and through Consortium data. We will test for associations between exposure to cGVHD (number of visits with oral cGVHD), tooth loss, and OHRQL. Secondary analysis will assess other risk factors associated with tooth loss and lower OHRQL. Second, we will evaluate the association between recalcitrant oral cGVHD and OHRQL. Subjects with past (exposed) and current oral cGVHD will be enrolled in a prospective cohort and re-evaluated twice per year as in Aim#1. They will receive a comprehensive oral examination including mucosal and periodontal health, caries, and tooth loss. Patient reported outcomes will be measured with validated tools. Additionally, information will be collected from each subjects' primary dentist including number of visits, dental procedures, oral hygiene instructions, fluoride supplementation, and use of sialogogues/ salivary substitutes. We will explore associations between OHRQL and cGVHD, expecting the presence and intensity of oral cGVHD to be associated with lower OHRQL. Secondary analysis will assess additional mediating factors.

摘要： 近50%的异基因造血细胞移植受者将发展为慢性移植物- 抗宿主病(CGVHD)。约80%的cGVHD患者可见口腔受累。它 表现为类似扁平苔藓、唇裂和三叉神经的粘膜病变。低水平的证据表明 口服cGVHD与患牙科、牙周和粘膜疾病的风险增加有关。海流 慢性移植物抗宿主病的口腔健康指南主要基于专家的意见。几乎没有证据可以指导治疗 或制定个性化的管理计划。 此应用程序的短期目标是解决上述知识的重要差距 并为在口腔疾病患者的管理中建立基于证据的方法提供了理论基础 CGVHD。我们的假设是，接触cGVHD会导致牙齿脱落增加，顽固不化的口腔 慢性移植物抗宿主病降低了口腔健康相关的生活质量(OHRQL)(次要终点)，这是我们 假设是由粘膜敏感性、唾液流量减少和痉挛引起的。我们将利用正在进行的 弗雷德·哈钦森癌症研究中心(FHCRC)与Dana-Farber癌症的合作 研究所(DFCI)，NIH资助的cGVHD联盟的两个关键站点，并将我们的研究嵌套在一个 建立了以人口为基础的队列。 首先，我们将确定接受allHCT的患者的牙齿缺失率和OHRQL，并探讨它们与 口服cGVHD。慢性移植物抗宿主病联合会既定和有代表性的队列中的受试者将是 在追溯性队列中招募。他们将接受一名经过校准的主考员的口试。牙齿脱落 将通过将目前的状况与在Allen HCT前口腔检查中收集的数据进行比较来进行评估。OHRQL 将通过经过验证的工具(OHIP14)进行测量。目前和过去的口腔cGVHD状态(根据NIH标准) 将通过粘膜检查和联盟数据进行评估。我们将测试关联 暴露于cGVHD(因cGVHD就诊的次数)、牙齿脱落和OHRQL之间的关系。二次分析 将评估与牙齿脱落和OHRQL降低相关的其他风险因素。 其次，我们将评估顽固性口腔cGVHD与OHRQL的关系。与过去有关的主题 (暴露)和当前的口腔cGVHD将被纳入预期队列，并每年重新评估两次，如 目标#1.他们将接受全面的口腔检查，包括粘膜和牙周健康，龋齿， 还有牙齿脱落。患者报告的结果将使用经过验证的工具进行衡量。此外，信息将 从每个受试者的初级牙医那里收集，包括就诊次数、牙科手术、口腔卫生 使用说明书、补充氟化物和使用唾液/唾液替代品。我们将探索 OHRQL和cGVHD之间的关联，预计口服cGVHD的存在和强度将是 与较低的OHRQL有关。二次分析将评估其他中介因素。