跳至主要内容
临床试验/NCT05070078
NCT05070078招募中不适用

The Single Assessment Numeric Evaluation (SANE): Is a Reliable Metric to Measure Clinically Significant Improvements After Lumbar Discectomy

Windsor-Essex Compassionate Care Community1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
Correlation of SANE score

研究概览

简要总结

In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity.

The Single Assessment Numeric Evaluation (SANE) is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36).

详细描述

Background/Rational: In the last several decades, many Patient Reported Outcomes Measures (PROMs) have been developed to provide assessment of patient health across multiple domains, as they relate to various spine conditions. When considered in concert, these instruments quantify and stratify an individual's health state before and after surgery and can be utilized to perform research as well as inform clinical practice. However, many of the available PROM surveys have many questions and require substantial time to complete and/or assess one focal domain of health requiring multiple tools to achieve an overall assessment of well-being. Thus, concerns have arisen regarding patient survey fatigue and data integrity. Ideally, a PROM would provide sufficient information to define health status longitudinally, while requiring the least amount of time and effort to complete. The current approach to PROMs in spine surgery research has been mostly to require an assessment of pain, disease specific disability and general health, requiring answers for up to of 40 unique questions, despite efforts to shorten the questionnaires in other neurosurgery and orthopedics disciplines.

The Single Assessment Numeric Evaluation (SANE) score is one such example of a limited question survey that aims to assess multiple domains. The SANE is a single-question outcome measure that asks patients to rate their function, as it pertains to the area being treated, on a scale of 0 to 100. The SANE score has excellent acceptance in some orthopedic surgery research, where it has been shown responsiveness similar to more comprehensive legacy measures. The SANE thus eliminates survey fatigue and has been validated across a spectrum of orthopedic subspecialties. To our knowledge, however, the SANE has never been studied in a patient population undergoing any type of spinal surgery. Thus, we set out to compare the SANE score in patients undergoing lumbar discectomy to currently utilized PROM scores, including the Oswestry Disability Index (ODI), Zurich Claudication Scale (ZCS), and short form-36 (SF-36).

Design: Survey research design, prospective outcomes measure validation study.

Objectives: We hypothesized that the SANE score would correlate strongly and demonstrate similar magnitudes of longitudinal responsiveness with the more lengthy and burdensome legacy PROMs used in spine surgery research today.

Primary Objective: To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient over 18 years of age undergoing a lumbar discectomy.

排除标准

  • Previous history of lumbar surgery.
  • Pediatric age group.
  • Patients with a postoperative follow-up time of less than 1 year.
  • Unstable patients in need of fixation.
  • Patients with cauda equina syndrome.
  • Non-compliant patients.

结局指标

主要结局

Correlation of SANE score

时间窗: November 2022

To correlate and confirm that SANE score to the more lengthy and burdensome legacy PROMs used in spine surgery research today. Spearman's correlation and linear regression will be performed for each time point, and for the change from preoperative to final follow up to validate the SANE as compared to the other PROMs.

次要结局

未报告次要终点

研究者

发起方
Windsor-Essex Compassionate Care Community
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Soliman

Neurosurgeon, Principal Investigator

Windsor-Essex Compassionate Care Community

研究点 (1)

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