The Spinal Research Foundation, Reston, VA 20190, USA.
Spine J. 2010 Apr;10(4):291-6. doi: 10.1016/j.spinee.2009.12.027. Epub 2010 Feb 19.
BACKGROUND CONTEXT: Outcomes of spinal treatments are evaluated by clinical relevance: the proportion of patients who reach a minimum clinically important outcome change. Outcomes are evaluated through multiple measurements, and the inconsistency of outcome change across measurements is not known. PURPOSE: The primary purpose of this study was to illustrate outcome inconsistencies after spinal surgery. Secondary goals of this study were to develop an index of overall change that incorporates outcome inconsistencies, to relate the index of overall change to patients' global assessment and satisfaction with treatment, to relate the index of global change to an intuitively understandable outcome: the level of tolerable pain. STUDY DESIGN: This study is a review of prospectively collected patient-reported outcomes data. PATIENT SAMPLE: Four hundred sixty patients from a large multicenter database were chosen. Those patients were included in the sample because they had undergone lumbar surgery and had baseline and 1-year follow-up scores. Baseline and 1-year follow-up scores for Oswestry Disability Index (ODI), physical component summary (PCS) of the Medical Outcome Study Short Form-36 (SF-36), numerical back and leg pain scales, and 1-year scores for satisfaction with results were included in the study. OUTCOME MEASURES: The outcome measures of the study were preoperative and 1-year postoperative scores for ODI, PCS, back pain scale, leg pain scale, health transition item of the SF-36, and satisfaction with results scales. METHODS: Oswestry Disability Index, SF-36, and pain scales were administered before and 1 year after spinal surgery. Satisfaction with results questionnaires were administered 1 year after surgery. The following threshold values were previously established and were used to evaluate outcome changes: minimum clinically important difference (MCID), substantial clinical benefit (SCB), and standard error of the mean. The following proportions of patients were determined according to outcome changes: "deteriorated," "no change," "below MCID," "above MCID," and "above SCB." The consistency of outcome change was determined amongst the four outcome measures. An index of overall change was developed and related to patients' answers to the health transition item of the SF-36 and to the satisfaction with results scale. The overall change index was also compared with the tolerable pain level. RESULTS: Only 40.5% of patients report consistent outcome changes on all four measures. The overall change index was significantly correlated to the global change and satisfaction scale (rho=.67, p less than .001). The overall change index was clearly associated with the tolerable pain level. CONCLUSIONS: Efforts should be made to take into account the inconsistency of outcomes and to make clinical relevance more readily understandable by patients and clinicians.
背景:通过临床相关性来评估脊柱治疗的结果:达到最小临床重要性结果变化的患者比例。结果通过多种测量方法进行评估,并且测量之间的结果变化不一致。
目的:本研究的主要目的是说明脊柱手术后的结果不一致。本研究的次要目标是开发一个综合结果不一致的整体变化指数,将整体变化指数与患者对治疗的整体评估和满意度相关,将整体变化指数与一个直观易懂的结果:可耐受疼痛水平相关。
研究设计:这是一项前瞻性收集患者报告结果数据的回顾性研究。
患者样本:从一个大型多中心数据库中选择了 460 名患者。这些患者被纳入样本是因为他们接受了腰椎手术,并且有基线和 1 年随访评分。本研究纳入了 Oswestry 残疾指数(ODI)、医疗结果研究简明健康调查问卷 36 项(SF-36)的物理成分综合评分(PCS)、数字腰背腿痛量表以及 1 年治疗结果满意度的基线和 1 年随访评分。
结果测量:本研究的结果测量指标是 ODI、PCS、腰背疼痛量表、腿痛量表、SF-36 的健康转移项目以及治疗结果满意度量表的术前和 1 年术后评分。
方法:在脊柱手术后 1 年前和 1 年后,进行 Oswestry 残疾指数、SF-36 和疼痛量表的评估。术后 1 年进行治疗结果满意度问卷的评估。先前已建立了以下阈值值来评估结果变化:最小临床重要差异(MCID)、明显临床获益(SCB)和均数的标准误差。根据结果变化确定了以下患者比例:“恶化”、“无变化”、“低于 MCID”、“高于 MCID”和“高于 SCB”。确定了四项结果测量之间的结果变化一致性。开发了一个整体变化指数,并将其与患者对 SF-36 的健康转移项目的回答以及对治疗结果满意度量表的回答相关联。整体变化指数也与可耐受疼痛水平进行了比较。
结果:只有 40.5%的患者在所有四项测量中报告结果一致。整体变化指数与整体变化和满意度量表显著相关(rho=.67,p 小于.001)。整体变化指数与可耐受疼痛水平明显相关。
结论:应该努力考虑结果的不一致性,并使患者和临床医生更容易理解临床相关性。
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