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临床试验/NCT02257554
NCT02257554进行中(未招募)不适用

Comparing Patients' and Surgeons' Expectations of Lumbar Spine Surgery

Hospital for Special Surgery, New York1 个研究点 分布在 1 个国家目标入组 437 人开始时间: 2014年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
437
试验地点
1
主要终点
Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.

研究概览

简要总结

The goals of this study are to assess concordance between the patient-surgeon pair regarding expectations of lumbar spine surgery.

详细描述

Low back pain is a prevalent medical condition afflicting primarily older adults but affecting all age groups and due to acute and non-acute diagnoses. Multiple possible conservative therapies exist; however, their major drawback is that the time required to advance therapy is often prolonged and accompanied by persistent disability and psychological suffering. Thus, some patients seek surgery after exhausting other therapies and some patients seek surgery earlier in their course. For both groups, decisions to undergo surgery are based on personal circumstances, perspectives, and expectations of outcome. Prior studies have shown that patients typically have high expectations of orthopedic surgery. Although high aspirations can be motivating, they also may predispose to poor outcomes if they are unrealistic and cause patients to become discouraged with recuperation time and ignore recommended lifestyle changes that avert progression of disease. Expectations that are too low, conversely, also may predispose to poor outcomes if patients lack motivation to participate in rehabilitation and to follow postop precautions. In order to achieve maximum benefit from surgery, patients and surgeons need to share an understanding of what is possible, probable, and realistic, and to join together and work toward the same goals. The primary objective of this proposed cross-sectional study is to assess the concordance between patients and their surgeons regarding expectations of lumbar spine surgery. Patients scheduled for lumbar surgery will be dichotomized according to whether they have acute versus non-acute conditions. Several days before surgery patients will complete the validated Lumbar Spine Surgery Expectations Survey measuring their physical and psychological expectations. Also before surgery their surgeons will complete the surgeon's version of the same survey for each patient. The main outcome will be a comparison of the concordance within each patient-surgeon pair according to acute versus non-acute groups based on the concordance correlation coefficient. Multivariate regression analysis based on the GEE method will be used to assess covariates.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • Patients will be eligible if they are ≥ 18 years old, speak English, and are scheduled for non-trauma-related lumbar spine surgery.

排除标准

  • Patients will be excluded if they have cognitive deficits and cannot provide informed consent.

结局指标

主要结局

Comparison of Lumbar Spine Surgery Expectations Survey scores for patients and their surgeons.

时间窗: participants will be surveyed before surgery, an expected average of 5 days

comparison of patients and surgeons responses

次要结局

未报告次要终点

研究者

发起方
Hospital for Special Surgery, New York
申办方类型
Other
责任方
Sponsor

研究点 (1)

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