The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study
Abstract Background 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...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2022-07-01
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| Series: | BMC Musculoskeletal Disorders |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12891-022-05598-x |
| _version_ | 1818192639303876608 |
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| author | Sean D. Rundell Ayumi Saito Eric N. Meier Stephanie T. Danyluk Jeffrey G. Jarvik Kelley Seebeck Janna L. Friedly Patrick J. Heagerty Sandra K. Johnston Monica Smersh Maggie E. Horn Pradeep Suri Amy M. Cizik Adam P. Goode |
| author_facet | Sean D. Rundell Ayumi Saito Eric N. Meier Stephanie T. Danyluk Jeffrey G. Jarvik Kelley Seebeck Janna L. Friedly Patrick J. Heagerty Sandra K. Johnston Monica Smersh Maggie E. Horn Pradeep Suri Amy M. Cizik Adam P. Goode |
| author_sort | Sean D. Rundell |
| collection | DOAJ |
| description | Abstract Background 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. Methods 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. Discussion 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. |
| first_indexed | 2024-12-12T00:33:42Z |
| format | Article |
| id | doaj.art-da15a7eaa7444035a61902f77c77a914 |
| institution | Directory Open Access Journal |
| issn | 1471-2474 |
| language | English |
| last_indexed | 2024-12-12T00:33:42Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Musculoskeletal Disorders |
| spelling | doaj.art-da15a7eaa7444035a61902f77c77a9142022-12-22T00:44:25ZengBMCBMC Musculoskeletal Disorders1471-24742022-07-0123111110.1186/s12891-022-05598-xThe Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort studySean D. Rundell0Ayumi Saito1Eric N. Meier2Stephanie T. Danyluk3Jeffrey G. Jarvik4Kelley Seebeck5Janna L. Friedly6Patrick J. Heagerty7Sandra K. Johnston8Monica Smersh9Maggie E. Horn10Pradeep Suri11Amy M. Cizik12Adam P. Goode13Department of Rehabilitation Medicine, University of WashingtonDepartment of Rehabilitation Medicine, University of WashingtonClinical Learning, Evidence, and Research Center, University of WashingtonDepartment of Orthopaedic Surgery, Duke UniversityDepartment of Health Systems and Population Health, University of WashingtonDepartment of Orthopaedic Surgery, Duke UniversityDepartment of Rehabilitation Medicine, University of WashingtonClinical Learning, Evidence, and Research Center, University of WashingtonClinical Learning, Evidence, and Research Center, University of WashingtonDepartment of Rehabilitation Medicine, University of WashingtonDepartment of Orthopaedic Surgery, Duke UniversityDepartment of Rehabilitation Medicine, University of WashingtonDepartment of Orthopaedics, University of UtahDepartment of Orthopaedic Surgery, Duke UniversityAbstract Background 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. Methods 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. Discussion 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.https://doi.org/10.1186/s12891-022-05598-xLumbar spinal stenosisSpine painCohort studyPrognostic model |
| spellingShingle | Sean D. Rundell Ayumi Saito Eric N. Meier Stephanie T. Danyluk Jeffrey G. Jarvik Kelley Seebeck Janna L. Friedly Patrick J. Heagerty Sandra K. Johnston Monica Smersh Maggie E. Horn Pradeep Suri Amy M. Cizik Adam P. Goode The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study BMC Musculoskeletal Disorders Lumbar spinal stenosis Spine pain Cohort study Prognostic model |
| title | The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study |
| title_full | The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study |
| title_fullStr | The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study |
| title_full_unstemmed | The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study |
| title_short | The Lumbar Stenosis Prognostic Subgroups for Personalizing Care and Treatment (PROSPECTS) study: protocol for an inception cohort study |
| title_sort | lumbar stenosis prognostic subgroups for personalizing care and treatment prospects study protocol for an inception cohort study |
| topic | Lumbar spinal stenosis Spine pain Cohort study Prognostic model |
| url | https://doi.org/10.1186/s12891-022-05598-x |
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