Development of a Patient-reported Outcome Instrument for Patients With Lumbar Degenerative Disease After Lumbar Fusion (DPROIPLDDALF)

The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness, and there is no scale for evaluating lumbar stiffness in China.Based on the Delphi method and the analytic hierarchy process, this study will improve and optimize the quality of life evaluation system for patients with severe degenerative lumbar disease, so as to obtain a concise, practical, and effective patient-reported outcome instrument.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Spine Degeneration

Detailed Description

Although lumbar fusion can improve function by correcting deformity,restoring spinal stability,and reducing pain, it also by intention leads to spinal stiffness which can impair function of daily activities.The commonly used scales (ODI+JOA-29+VAS) lack the assessment of lumbar stiffness.Lumbar Stiffness Disability Index (LSDI) has not been used widely, and there is no scale for evaluating lumbar stiffness in China.In addition, even if LSDI is modified, there is still an evaluation dilemma: after lumbar long-segment fixation, the pain and neurological function-related scale scores show that the quality of life is improved, while the lumbar stiffness-related scale scores show that the quality of life is reduced . So overall, is the patient's quality of life improved or decreased? Simply combining these two types of scales cannot explain clearly.

This study can be roughly divided into the following 5 main steps:

Step 1:Collect and sort out the dimensions and exhaustive items that affect the patients' quality of life by systematically reviewing the related literature and a qualitative interview study.

Step 2: Through a cross-sectional survey and experts' meetings, the items is initially optimized, and 35-45 items will be retained.

Step 3: Screen 20-25 excellent items by 2-3 rounds of Delphi method, then use the analytic hierarchy process to determine the weight of each item, so as to establish a initial PRO instrument.

Step 4: Verify the reliability and validity of the initial PRO instrument, and further optimize the initial PRO instrument in order to be used in clinical practice and research.

Step 5: Verify the responsiveness of the initial PRO instrument, calculate the ES, SRM, AUC and MICD values of the initial PRO instrument.

Finally, a novel, concise, practical, and effective PRO instrument for use in degenerative lumbar disease patients will be established.

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Weishi Li, PhD; Phone Number: 15611908864; Email: wslee@163.com
• Study Contact Backup: Name: Yu Jiang, PhD; Phone Number: 18501125711; Email: jiangyu@bjmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
      • Contact: Li Zhang, B.S; Phone Number: 18811778979; Email: 1835591174@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with lumbar degenerative diseases,planning or undergone their first lumbar fusion,are willing to participate in this research.They have no neurological diseases, severe cervical/thoracic spine disease or other diseases which seriously affect their quality of life, and haven't suffered lumbar trauma after lumbar fusion.

Description

Inclusion Criteria:

• Clinical diagnosis of Lumbar Spine Degeneration
• Plan for or have undergone lumbar fusion
• Be willing to participate in this research

Exclusion Criteria:

• Combined with neurological disease such as Motor neuron disease, Progressive muscular dystrophy, Peripheral neuropathy, Spinal cord disease, et al.
• Combined with severe cervical/thoracic spine disease or other diseases that seriously affect the quality of life
• Suffer lumbar spine trauma after lumbar fusion
• Preoperative cases exclude patients who plan for revision surgery
• Be unwilling to participate in this research

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Short-segment group; Lumbar degenerative diseases' patients,whose lumbar fixed segments less than 3 was divided into Short-segment group(200).
Long-segment group; Lumbar degenerative diseases' patients,whose lumbar fixed segments no less than 3 was divided into Long-segment group(200).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	In 7 days before lumbar fusion
The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	In 7 days before lumbar fusion
The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	In 7 days before lumbar fusion
The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	6 months after lumbar fusion
The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	6 months after lumbar fusion
The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	6 months after lumbar fusion
The Oswestry Disability Index (ODI)	Use the Oswestry Disability Index (ODI) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of ODI score is 0 and the maximum value is 50. Higher ODI scores mean a worse outcome.	12 months after lumbar fusion
The Japanese Orthopedic Association score(JOA-29)	Use the Japanese Orthopedic Association score(JOA-29) to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of JOA-29 score is 0 and the maximum value is 29. Higher JOA-29 scores mean a better outcome.	12 months after lumbar fusion
The novel PRO instrument	Use the novel PRO instrument to assess the quality of life of Patients with lumbar degenerative diseases before lumbar fusion.The minimum value of the novel PRO instrument score is 0 and the maximum value is 100. Higher the novel PRO instrument scores mean a worse outcome.	12 months after lumbar fusion

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Weishi Li, PhD, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 28, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 9, 2022
• Last Update Submitted That Met QC Criteria: February 7, 2022
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: quality of life; lumbar spine; patient reported outcome measures; questionnaire; lumbar fusion
• Other Study ID Numbers: LDDAFQ-PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: In order to protect the personal information of patients, there is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No