Enhancing Meaningfulness and Usefulness of Pediatric and Caregiver PROMIS Measures Across Illness Groups

增强儿科和护理人员 PROMIS 措施在不同疾病组中的意义和实用性

• 批准号: 9077747
• 负责人: MICHAEL D KAPPELMAN
• 金额: $ 55.4万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至 2017-07-10
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9077747
• 关键词: Address; Adolescent; Adoption; Age; Algorithms; Anxiety; Caregivers; Caring; Characteristics; Child; Childhood; Classification; Clinical; Clinical Trials; Cohort Studies; Complex; Computerized Medical Record; Data; Data Collection; Decision Making; Development; Diagnosis; Disease; Educational workshop; Emotional; Ensure; Fatigue; Future; Goals; Guidelines; Health; Individual; Inflammatory Bowel Diseases; Judgment; Life; Malignant Neoplasms; Measurement; Measures; Medical; Medical History; Mental Depression; Mental Health; Methods; Modeling; Outcome; Outpatients; Pain interference; Parents; Patient Outcomes Assessments; Patients; Physical Function; Physicians; Physiological; Population; Positioning Attribute; Procedures; Provider; Psychosocial Factor; Qualitative Methods; Quality of life; Questionnaires; Registries; Reporting; Research; Research Personnel; Rheumatism; Sampling; Severities; Specific qualifier value; Subgroup; Symptoms; System; Time; Toxic effect; Validation; abstracting; base; clinical care; clinical decision-making; clinical phenotype; clinical practice; data management; design; end of life; experience; functional status; improved; intervention effect; pediatric patients; physical conditioning; response; social; tool; willingness

Project 2 Abstract/Summary An ill child's individual disease experience cannot be predicted by physiologic parameters alone, but rather results from a complex interaction between physiologic and psychosocial factors. Children and adolescents with identical diseases have unique outcomes and symptoms. Improving the health outcome of every child thus necessitates attending to all aspects of their disease experience-physiologic, emotional, and social. PROMIS measures represent a robust set of questionnaires for capturing the patient's experience. However, before using them in clinical trials or introducing them into clinical care, information about their clinical meaningfulness must be obtained. The current project represents part 2 of a larger research initiative aimed at validating PROMIS Pediatric measures and assessing clinical meaningfulness. Project 1 will generate robust clinical and PRO data on children with rheumatic disease, cancer and IBD, through a longitudinal cohort study of over 1500 patients ages 8-20 years. The overall goal of the current project is to utilize the information from project 1 to build the necessary components for a clinician dashboard that can be used in clinical practice. We will explore the needs of our stakeholders and utilize advanced analytic approaches to enhance clinical meaning for the PROMIS Pediatric measures by exploiting the robust clinical phenotyping that the longitudinal cohort study provides. The three specific aims are to 1) Generate patient profiles that allow for the prediction of important clinical outcomes using the PROMIS measures. This will be achieved by using latent profile analysis instead of standard regression and modeling approaches, which allow for presentation of individual patient results in the context of the entire population. 2) Calculate minimally important differences (MID) for the PROMIS measures, so that changes in patient scores can be clinically interpreted. And 3) Determine cut- points using standard setting methods in workshops with key stakeholders including adolescents, parents, and clinicians in each disease group. This project leverages existing registries for identification of subjects and for data collection and data management. It addresses PROMIS measures across three disease groups, and engages diverse stakeholders- patients, parents and providers, for the qualitative methods. The validation and ascertainment of clinical meaning of the PROMIS measures will position future investigators to utilize these measures in their clinical trials to better evaluate the effect of interventions on the child's disease experience. Additionally, through this project we will develop the necessary components for practical clinical tools that integrate PROMIS measures with interpretative guidelines for use in the clinical setting. The next steps will be to implement the tools in clinical practice, and to conduct a wide-scale assessment of the impact of these tools on clinical decision-making and patient outcomes.

项目2摘要/摘要 病童的个体疾病经历不能仅通过生理参数来预测，而是 由生理和社会心理因素之间的复杂相互作用产生的结果。儿童和青少年 相同的疾病具有独特的结果和症状。改善每个孩子的健康结果 因此，需要参与其疾病经验 - 生理学，情感和社交的各个方面。 Promis措施代表了一组强大的问卷，用于捕获患者的经历。然而， 在临床试验中使用它们或将其引入临床护理之前，有关其临床的信息 必须获得有意义的。当前的项目代表了针对大型研究计划的第2部分 验证Promis小儿措施并评估临床意义。项目1将产生强大的 通过纵向队列研究 超过1500名8-20岁的患者。当前项目的总体目标是利用来自 项目1用于为临床实践中使用的临床医生仪表板构建必要的组件。我们 将探索利益相关者的需求，并利用先进的分析方法来增强临床 通过利用纵向的稳健临床表型来实现Promis小儿测量的含义 队列研究提供。三个具体目的是1）产生允许预测的患者概况 使用Promis措施的重要临床结果。这将通过使用潜在资料分析来实现 而不是标准回归和建模方法，这允许呈现个别患者 导致整个人群的背景。 2）计算最小重要的差异（中间） Promis措施，以便可以在临床上解释患者评分的变化。 3）确定切割 - 使用与关键利益相关者在内的研讨会中使用标准设置方法的点，包括青少年，父母和 每个疾病组的临床医生。该项目利用现有的注册表来识别主题和 数据收集和数据管理。它涉及三个疾病组的Promis措施，以及 与各种利益相关者 - 患者，父母和提供者一起使用定性方法。验证和 确定Promis措施的临床含义将使未来的研究人员使用这些措施 他们的临床试验中的措施可以更好地评估干预措施对儿童疾病经历的影响。 此外，通过这个项目，我们将开发用于实用临床工具的必要组件 将Promis措施与解释性指南相结合，以在临床环境中使用。下一步将是 在临床实践中实施工具，并对这些工具的影响进行大规模评估 关于临床决策和患者结果。