The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study.
The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study.
复制标题
DOI：
10.1186/s12891-022-05598-x
复制
发表时间：
2022-07-21
影响因子：
2.3
通讯作者：
中科院分区：
文献类型：
--
作者：
腰椎管狭窄症（LSS）是一种常见的退行性疾病，导致老年人背部和背部相关的腿部疼痛。大多数有症状的LSS患者在手术咨询前最初接受非手术治疗。然而，寻求非手术治疗的患者的预后数据稀缺。该项目的总体目标是开发和评估一个临床有用的模型，以预测开始非手术治疗症状性LSS患者的长期身体功能。这是一项针对50岁及以上成人的初始队列研究方案，这些成人在二级护理环境中开始对症状性LSS进行非手术治疗。我们计划在两个研究中心招募多达625名患者。我们排除了既往接受过腰椎手术或计划接受腰椎手术的患者。我们还排除了有背痛症状或行走受限的严重医疗状况的患者。我们每周从电子健康记录中自动提取数据，以识别潜在的参与者。然后，我们在新的访视后21天内通过电子邮件和电话联系患者，以确定合格性，获得同意并招募参与者。我们通过电话访谈、网络调查和电子健康记录查询来收集数据。参与者被跟踪12个月，在基线，3，6和12个月完成调查。主要结局指标是8项PROMIS身体功能（PF）简表。我们将使用PROMIS PF评分在基线和3，6和12个月时使用基于组的轨迹建模来识别不同的表型。我们将开发和评估多变量预后模型的性能，以使用最小绝对收缩和选择算子预测12个月的身体功能，并将性能与其他机器学习方法进行比较。将使用k折交叉验证进行内部验证。这项研究将是最大的一个队列的个人与症状LSS开始新的事件的非手术治疗。该项目的成功完成将产生一个交叉验证的LSS预后模型，可用于定制患者护理和临床试验的治疗方法。在线版本包含补充材料，可通过10.1186/s12891-022-05598-x获得。
Lumbar spinal stenosis (LSS) is a common degenerative condition that contributes to back and back-related leg pain in older adults. Most patients with symptomatic LSS initially receive non-operative care before surgical consultation. However, there is a scarcity of data regarding prognosis for patients seeking non-surgical care. The overall goal of this project is to develop and evaluate a clinically useful model to predict long-term physical function of patients initiating non-surgical care for symptomatic LSS. This is a protocol for an inception cohort study of adults 50 years and older who are initiating non-surgical care for symptomatic LSS in a secondary care setting. We plan to recruit up to 625 patients at two study sites. We exclude patients with prior lumbar spine surgeries or those who are planning on lumbar spine surgery. We also exclude patients with serious medical conditions that have back pain as a symptom or limit walking. We are using weekly, automated data pulls from the electronic health records to identify potential participants. We then contact patients by email and telephone within 21 days of a new visit to determine eligibility, obtain consent, and enroll participants. We collect data using telephone interviews, web-based surveys, and queries of electronic health records. Participants are followed for 12 months, with surveys completed at baseline, 3, 6, and 12 months. The primary outcome measure is the 8-item PROMIS Physical Function (PF) Short Form. We will identify distinct phenotypes using PROMIS PF scores at baseline and 3, 6, and 12 months using group-based trajectory modeling. We will develop and evaluate the performance of a multivariable prognostic model to predict 12-month physical function using the least absolute shrinkage and selection operator and will compare performance to other machine learning methods. Internal validation will be conducted using k-folds cross-validation. This study will be one of the largest cohorts of individuals with symptomatic LSS initiating new episodes of non-surgical care. The successful completion of this project will produce a cross-validated prognostic model for LSS that can be used to tailor treatment approaches for patient care and clinical trials. The online version contains supplementary material available at 10.1186/s12891-022-05598-x.
登录
查看更多内容
影响因子：
3
作者：
Atlas, SJ;Deyo, RA;Singer, DE
通讯作者：
Singer, DE
影响因子：
4.5
作者：
Cleland, Joshua A.;Whitman, Julie M.;Childs, John D.
通讯作者：
Childs, John D.
影响因子：
120.7
作者：
Deyo, Richard A.;Mirza, Sohail K.;Martin, Brook I.;Kreuter, William;Goodman, David C.;Jarvik, Jeffrey G.
通讯作者：
Jarvik, Jeffrey G.
影响因子：
3
作者：
Hébert JJ;Abraham E;Wedderkopp N;Bigney E;Richardson E;Darling M;Hall H;Fisher CG;Rampersaud YR;Thomas KC;Jacobs WB;Johnson M;Paquet J;Attabib N;Jarzem P;Wai EK;Rasoulinejad P;Ahn H;Nataraj A;Stratton A;Manson N
通讯作者：
Manson N
影响因子：
7.2
作者：
Groll, DL;To, T;Wright, JG
通讯作者：
Wright, JG