Development of a PROMIS measure for adult dental patients

14年前，创建了PROMIS，即患者报告结果测量信息系统 作为最先进的患者报告结局（PRO）指标系统。它承诺高效，可靠， 有效评估患者如何看待他们的健康;然而，没有专门针对口腔健康的措施， available.这种情况阻碍了牙科中的可靠PRO测量，也阻碍了PROMIS捕获 健康更全面。我们建议为成年人发展一套四款的口腔健康仪器， PROMIS方法，基于最近确定的口腔健康相关生活质量的维度， OHRQoL（口腔功能、口腔疼痛、口腔外观、心理社会影响）。这些尺寸 代表了患者感知口腔疾病影响的主要领域。超过53例患者报告 成年患者的口腔健康工具将合并为一个标准化的，灵活的和精确的度量标准， 对口腔健康和牙科环境的影响。四个分数的轮廓，基于四个 将形成患者报告的口腔健康度量并表征患者在空间中的站立 患者报告的口腔健康的四个“坐标”-每个维度一个。本提案的目标是 (i)探索现有仪器如何覆盖四种患者报告的口腔健康状况 口腔功能，口面疼痛，口面外观和心理社会影响，（ii）制定四个 初步试题库，每个维度一个，（iii）开发四个最终试题库，每个维度一个， 以及（iv）根据试题库开发四个固定长度的工具，每个维度一个。 现有的OHRQoL和2，115名牙科患者的其他患者报告的口腔健康数据将用于次要研究。 数据分析，以探索患者报告的四个口腔健康维度的严重程度谱， 现有的调查表项目涵盖这一范围。来自53个已确定的自我报告的问卷项目 将通过系统搜索新的调查表/项目来补充这些工具。所有确定的项目将 采用混合方法，通过焦点小组和认知访谈进行综合， 有代表性的患者群体。我们的流程将遵循PROMIS定性项目审查方法，以识别， 评估和修改项目，以创建四个初步的题库。接下来，在2,000名牙科患者的新样本中， 涵盖了功能，疼痛，美学和更广泛的心理社会问题的整个范围， 口腔疾病，先前生成的四个初步项目库将进行调查和校准，使用 运用项目反应理论分析，得出四个最终的试题库。将从每一个衍生出一个固定长度的工具 试题库，并对其心理测量学特性进行评价。 这个项目将介绍PROMIS方法的一个重要的病人群体，成年牙科病人。四 表征口腔功能、口面部疼痛、口面部外观和心理社会影响的评分将 成为从成年患者的角度评估口腔状况和治疗效果的标准工具。

Fourteen years ago, PROMIS, the Patient Reported Outcome Measurement Information System, was created as the most advanced system of patient-reported outcome (PRO) measures. It promises efficient, reliable, and valid assessments of how patients perceive their health; however, no measures specific to oral health are available. This situation impedes solid PRO measurement in dentistry and also prevents PROMIS from capturing health more comprehensively. We propose to develop for adults a set of four oral health instruments using PROMIS methodology, based on the recently determined dimensions of oral health-related quality of life, OHRQoL (Oral Function, Orofacial Pain, Orofacial Appearance, Psychosocial Impact). These dimensions represent the main areas where patients perceive the impact of oral disorders. More than 53 patient-reported oral health instruments for adult patients would merge into a standardized, flexible and precise metric to measure oral health impact across oral conditions and dental settings. A profile of four scores, based on the four dimensions, would form the patient-reported oral health metric and characterize a patient’s standing in the space of patient-reported oral health with four “coordinates” – one for each dimension. The goals of this proposal are (i) to explore how well available instruments cover the spectrum of the four patient-reported oral health dimensions Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact, (ii) to develop four preliminary item banks, one for each dimension, (iii) to develop four final item banks, one for each dimension, and (iv) to develop four fixed-length instruments based on the item banks, one for each dimension. Existing OHRQoL and other patient-reported oral health data from 2,115 dental patients will be used in secondary data analyses to explore the severity spectrum of the four patient-reported oral health dimensions and how well available questionnaire items cover this spectrum. Questionnaire items from 53 already identified self-report instruments will be supplemented by a systematic search for new questionnaires/items. All identified items will undergo a mixed-methods approach to be synthesized through focus groups and cognitive interviews with representative patient groups. Our process will follow the PROMIS Qualitative Item Review method to identify, evaluate, and revise items to create four preliminary item banks. Next, in a new sample of 2,000 dental patients covering the entire spectrum of functional, painful, aesthetical, and broader psychosocial problems related to oral disorders, the previously generated four preliminary item banks will be investigated and calibrated using item response theory analyses to derive four final item banks. A fixed-length instrument will be derived from each item bank, and its psychometric properties will be evaluated. This project will introduce PROMIS methodology to an important patient population, adult dental patients. Four scores characterizing Oral Function, Orofacial Pain, Orofacial Appearance, and Psychosocial Impact would become the standard tool for assessing oral conditions and treatment effects from the adult patient’s perspective.