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: 10221670
• 负责人: Herve Y Sroussi
• 金额: $ 72.16万
• 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/10221670
• 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.

抽象的： 近 50% 的异基因造血细胞移植受者 (AlloHCT) 会出现慢性移植- 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、唾液分泌不足和牙关紧闭的粘膜病变。低水平证据表明 口腔 cGVHD 与牙齿、牙周和粘膜疾病的风险增加有关。目前的 cGVHD 口腔健康指南主要基于专家意见。几乎没有证据可以指导治疗 决策或个性化管理计划。 该应用程序的短期目标是解决上述知识的重要差距 并为建立口腔疾病患者管理的循证方法提供理论依据 移植物抗宿主病（GVHD）。我们的假设是，暴露于口腔 cGVHD 会导致牙齿脱落增加，而顽固的​​口腔 cGVHD 会降低口腔健康相关的生活质量 (OHRQL)（次要终点），我们认为这种影响 假设是由粘膜敏感性、唾液流量减少和牙关紧闭介导的。我们将利用正在进行的 Fred Hutchinson 癌症研究中心 (FHCRC) 与丹纳法伯癌症中心之间的合作 研究所 (DFCI)，NIH 资助的 cGVHD 联盟的两个关键站点，并将我们的研究集中在一个大型研究中心 建立了基于人群的队列。 首先，我们将确定 AlloHCT 接受者的牙齿缺失率和 OHRQL，并探讨它们与 口服cGVHD。慢性 GVHD 联盟已建立的代表性队列中的受试者将 在回顾性队列中招募。他们将接受经过校准的考官的口试。牙齿缺失 将通过将当前状态与 AlloHCT 前口腔检查中收集的数据进行比较来进行评估。 OHHRQL 将通过经过验证的工具（OHIP14）进行测量。当前和过去的口服 cGVHD 状态（根据 NIH 标准） 将通过粘膜检查和联盟数据进行评估。我们将测试关联性 暴露于 cGVHD（口服 cGVHD 的就诊次数）、牙齿脱落和 OHRQL 之间的关系。二次分析 将评估与牙齿缺失和较低 OHRQL 相关的其他风险因素。 其次，我们将评估顽固性口服 cGVHD 与 OHRQL 之间的关联。过去的主题 （暴露的）和当前口服 cGVHD 将被纳入前瞻性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、 和牙齿脱落。患者报告的结果将使用经过验证的工具进行测量。此外，信息将 从每个受试者的主牙医处收集，包括就诊次数、牙科手术、口腔卫生 说明、氟化物补充以及唾液酸/唾液替代品的使用。我们将探索 OHRQL 和 cGVHD 之间的关联，预计口服 cGVHD 的存在和强度 与较低的 OHRQL 相关。二次分析将评估其他中介因素。