The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study

BMC Musculoskeletal Disorders - Tập 23 - Trang 1-11 - 2022
Sean D. Rundell1,2,3, Ayumi Saito1,4, Eric N. Meier3,5, Stephanie T. Danyluk6, Jeffrey G. Jarvik2,3,7,8, Kelley Seebeck6, Janna L. Friedly1,3, Patrick J. Heagerty3,5, Sandra K. Johnston3,7, Monica Smersh1, Maggie E. Horn6,9, Pradeep Suri1,3,10,11, Amy M. Cizik12, Adam P. Goode6,9,13
1Department of Rehabilitation Medicine, University of Washington, Seattle USA
2Department of Health Systems and Population Health, University of Washington, Seattle, USA
3Clinical Learning, Evidence, and Research Center, University of Washington, Seattle, USA
4Department of Epidemiology, University of Washington, Seattle, USA
5Department of Biostatistics, University of Washington, Seattle, USA
6Department of Orthopaedic Surgery, Duke University, Durham, USA
7Department of Radiology, University of Washington, Seattle, USA
8Department of Neurological Surgery, University of Washington, Seattle, USA
9Department of Population Health Sciences, Duke University, Durham, USA
10Division of Rehabilitation Care Services, Veteran Affairs Puget Sound Health Care System, Seattle, USA
11Seattle Epidemiologic Research and Information Center, Veteran Affairs Puget Sound Health Care System,, Seattle, USA
12Department of Orthopaedics, University of Utah, Salt Lake City, USA
13Duke Clinical Research Institute, Duke University, Durham, USA

Tóm tắt

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.

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BMC Musculoskeletal Disorders

Tập 23

1-11

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