Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS)

用于个性化护理和治疗的腰椎管狭窄预后亚组（前景）

• 批准号: 10091730
• 负责人: Sean Daniel Rundell
• 金额: $ 61.11万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-30 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10091730
• 关键词: Adult; Advisory Committees; Age; Anatomy; Anxiety; Back; Back Pain; Caring; Characteristics; Chronic; Chronic low back pain; Clinic; Clinical; Clinical Trials; Clinical Trials Design; Cohort Studies; Computerized Medical Record; Data; Decision Making; Degenerative Disorder; Degenerative polyarthritis; Diabetes Mellitus; Effectiveness; Elderly; Enrollment; Future; Goals; Health; Health Policy; Healthcare; Heterogeneity; Image; Individual; Intervention; Interview; Lead; Level of Evidence; Low Back Pain; Lower Extremity; Malignant neoplasm of lung; Measures; Medicine; Mental Depression; Modeling; Modification; Neurologic Symptoms; Operative Surgical Procedures; Outcome; Pain; Pain Research; Participant; Pathway interactions; Patient Care; Patients; Performance; Pharmaceutical Preparations; Phenotype; Physical Function; Population; Prevalence; Prognostic Factor; Psychological Factors; Questionnaires; Reporting; Research; Research Design; Research Personnel; Resources; Risk; Self Management; Spinal Stenosis; Stenosis; Stroke; Structure; Subgroup; Symptoms; Telephone; Telephone Interviews; Testing; United States; United States National Institutes of Health; Validation; Vertebral column; Visit; Walking; Work; aged; base; clinical application; clinical decision-making; clinical phenotype; comorbidity; design; disability; expectation; functional outcomes; improved; improved outcome; indexing; individualized medicine; older patient; optimal treatments; outcome forecast; pain symptom; patient oriented; personalized care; personalized medicine; predictive modeling; primary care setting; prognostic; prospective; public health relevance; recruit; sound; treatment comparison; trial design

Project Summary/Abstract The overall objective of this project is to develop and evaluate a clinically useful predictive model of long-term function in older patients initiating non-surgical care for symptomatic lumbar spinal stenosis. Lumbar spinal stenosis is a common cause of low back pain and its associated disability among older adults, but there is little data on prognosis to guide clinical trial design and clinical decision making. Using a prospective, inception cohort study design, we will identify prognostic trajectories that can be easily applied clinically and describe each group's phenotype using baseline variables. We will then develop and estimate the performance of a model to predict patients' 12-month physical function. We will enroll adults aged 50 years and older initiating non-surgical care for symptomatic lumbar spinal stenosis. Participants will be recruited from The Duke Spine Clinic and UW Medicine spine clinics. Baseline characteristics and candidate predictor variables, selected a priori, will be measured after the index visit using patient-reported information from telephone interviews and electronic medical record data. Back-related outcomes will be measured using a phone interview at 3, 6, and 12 months after the initial visit. Healthcare and medication use during the six months after the new visit will be measured using the electronic medical record and patient questionnaires. This design will provide the highest level of evidence to date for the prognosis of patients with symptomatic lumbar spinal stenosis not receiving surgery. A parsimonious, accurate, and clinically useful prognostic model can be used to guide participant selection for future clinical trials, as an adjustment or modification variable in studies comparing different treatments, and can lead to new tailored treatment approaches for individuals with symptomatic lumbar spinal stenosis. Ultimately, this line of research has substantial potential to improve the effectiveness and value of care for patients with symptomatic lumbar spinal stenosis. Tailored treatment pathways for older adults with symptomatic lumbar spinal stenosis in non-surgical settings are currently non-existent, but they have shown great promise in other back pain populations, such as non-specific back pain in primary care settings.

项目摘要/摘要 本项目的总体目标是开发和评估一个临床上有用的预测模型。 开始非手术治疗症状性腰椎管狭窄症的老年患者的功能。腰椎 狭窄是老年人下腰痛及其相关残疾的常见原因，但很少有 用于指导临床试验设计和临床决策的预后数据。使用前瞻性的、开始的 队列研究设计，我们将确定易于临床应用的预后轨迹，并描述 使用基线变量计算每组的表型。然后，我们将开发和评估 预测患者12个月身体功能的模型。我们将招收50岁及以上的成年人印心。 症状性腰椎管狭窄症的非手术治疗。参与者将从杜克·斯皮恩大学招募 诊所和威斯康星大学医学脊柱诊所。基线特征和候选预测变量，选定一个 在指数访问之后，将使用来自电话采访的患者报告的信息和 电子病历数据。与背部相关的结果将通过电话采访在3、6和 在第一次访问12个月后。新就诊后六个月内的医疗保健和用药情况将是 使用电子病历和患者问卷进行测量。这种设计将提供最高的 迄今为止关于症状性腰椎管狭窄症患者预后的证据水平 做手术。一种简明、准确和临床有用的预后模型可以用来指导参与者 未来临床试验的选择，作为比较不同研究中的调整或修改变量 治疗，并可为有症状的腰椎患者带来新的量身定制的治疗方法 狭窄。归根结底，这一研究路线有很大的潜力来提高 护理症状性腰椎管狭窄症患者。为老年患者量身定做的治疗路径 非手术状态下的症状性腰椎管狭窄症目前并不存在，但他们已经表明 在其他背痛人群中很有希望，例如初级保健环境中的非特异性背痛。