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: 10266796
• 负责人: Sean Daniel Rundell
• 金额: $ 50.25万
• 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/10266796
• 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; Prognosis; 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; pain symptom; patient oriented; personalized care; personalized medicine; predictive modeling; primary care setting; prognostic; prognostic model; 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.

项目总结/摘要 该项目的总体目标是开发和评估一个临床上有用的长期预测模型。 在开始非手术治疗症状性腰椎管狭窄症的老年患者中的功能。腰椎管 狭窄是老年人腰痛及其相关残疾的常见原因， 预后数据，以指导临床试验设计和临床决策。使用一个前瞻性的， 队列研究设计，我们将确定预后轨迹，可以很容易地应用于临床，并描述 每个组的表型使用基线变量。然后，我们将开发和评估一个 模型来预测患者12个月的身体功能。我们将招募50岁及以上的成年人， 腰椎管狭窄症的治疗方法参与者将从The杜克脊柱招募 诊所和UW医学脊柱诊所。基线特征和候选预测变量，选择a 将在索引访视后使用电话访谈中患者报告的信息进行测量， 电子病历数据。背部相关的结果将在3、6和12小时通过电话采访进行测量。 首次访视后12个月。新访视后6个月内的医疗保健和药物使用将 使用电子病历和患者问卷进行测量。该设计将提供最高的 迄今为止，没有接受治疗的症状性腰椎管狭窄症患者预后的证据水平 手术一个简洁、准确和临床有用的预后模型可用于指导参与者 未来临床试验的选择，作为比较不同药物的研究中的调整或修改变量 治疗，并可能导致新的定制治疗方法的个人症状腰椎 狭窄最终，这一研究方向具有提高有效性和价值的巨大潜力， 腰椎管狭窄症的治疗方法为老年人量身定制的治疗途径 非手术治疗的症状性腰椎管狭窄症目前尚不存在，但他们已经表明， 在其他背痛人群中有很大的希望，例如在初级保健环境中的非特异性背痛。