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开发一种将 Neck Disability Index (NDI)转化为颈椎疾病成本效用分析中效用评分的模型。

The development of a model for translation of the Neck Disability Index to utility scores for cost-utility analysis in cervical disorders.

机构信息

Department of Orthopaedic Surgery, University of California, San Francisco, 500 Parnassus Ave., MU320W, San Francisco, CA 94143, USA.

出版信息

Spine J. 2012 Jan;12(1):55-62. doi: 10.1016/j.spinee.2011.12.002. Epub 2011 Dec 29.

Abstract

BACKGROUND CONTEXT

The Neck Disability Index (NDI) is a commonly used disease-specific instrument for cervical spine disorders with good responsiveness and psychometric properties compared with general health status measures. However, NDI scores are unitless and do not have an intrinsic value that is comparable to other health status measures, and these scores have limited value in cost-utility analysis. The translation of disease-specific measures to Short Form-6 Dimensions (SF-6D) utility scores may be useful in cost-utility analysis.

PURPOSE

The purpose of this study is to present a model for translating the NDI to SF-6D utility scores, permitting the use of NDI scores in the cost-utility analysis of cervical disorders.

STUDY DESIGN/SETTING: A secondary analysis of a multicenter prospective clinical trial of the Synthes ProDisc-C (Synthes, West Chester, PA, USA) was performed.

PATIENT SAMPLE

Patients included were randomized to receive either a total disc arthroplasty or anterior cervical discectomy and fusion for treatment of symptomatic cervical disc disease involving one vertebral level between C3 and C7. All subjects completed NDI and 36-Item Short Form Health Survey (SF-36) self-assessments at preoperative and postoperative follow-ups of 6 weeks, 3, 6, 12, 18, and 24 months.

OUTCOME MEASURES

The NDI is a validated and widely used self-reported questionnaire designed to assess patient-determined disability resulting from neck pain, including pain level and effects on activities of daily living. The SF-6D is a preference-based health state classification system derived from six health dimensions of the SF-36 self-reported questionnaire, including the domains of physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.

METHODS

The collected data points were divided into two cohorts: one for model formation and one for the assessment of model validity. SF-36 scores were converted to SF-6D utilities via three previously published methods. Correlation analyses and linear regression modeling between SF-6D and NDI created the models for translating scores. For validation, Spearman and Pearson correlations were calculated between the observed and predicted SF-6D utilities, and prediction errors were calculated.

RESULTS

Four hundred thirty patients with 2,137 time points were used for creation and validation of the model. Pearson and Spearman correlation coefficients between the NDI and the SF-6D derived from each conversion method were found to be between -0.8255 and -0.8504 (p<.01). R(2) values ranged from 0.68 to 0.71 and root mean squared error (RMSE) from 0.092 to 0.084. Correlations between estimated and observed SF-6D scores ranged from 0.8325 to 0.8372 (p<.01). The mean prediction error was less than 0.006, with standard deviation (SD) between 0.082 and 0.093.

DISCUSSION

Correlations between NDI and SF-6D utility scores are strong and statistically significant. The model has a large R(2) and small RMSE. The prediction models produce a small mean prediction error, but the SD of the prediction errors is large. High correlations between NDI and SF-6D permit these models to be used to calculate overall utilities, changes in utilities, and quality-adjusted life-years for large data samples. However, the relatively large observed prediction error SDs may limit the accuracy of translation of individual data points or small sample sizes.

摘要

背景

颈残指数量表(NDI)是一种常用于颈椎疾病的特定疾病的工具,与一般健康状况衡量标准相比,它具有良好的反应性和心理测量学特性。然而,NDI 评分是无量纲的,没有与其他健康状况衡量标准可比的内在价值,在成本效益分析中这些评分的价值有限。将特定疾病的衡量标准转换为简短形式 6 维度(SF-6D)效用评分可能在成本效益分析中有用。

目的

本研究旨在提出一种将 NDI 转换为 SF-6D 效用评分的模型,允许在颈椎疾病的成本效益分析中使用 NDI 评分。

研究设计/设置:对 Synthes ProDisc-C(Synthes,西彻斯特,宾夕法尼亚州,美国)的多中心前瞻性临床试验进行二次分析。

患者样本

纳入的患者随机接受全椎间盘置换术或前路颈椎间盘切除术和融合术治疗涉及 C3 至 C7 之间一个椎骨水平的有症状的颈椎间盘疾病。所有患者在术前和术后 6 周、3 个月、6 个月、12 个月、18 个月和 24 个月的随访中均完成了 NDI 和 36 项简明健康调查(SF-36)自我评估。

结果测量

NDI 是一种经过验证和广泛使用的自我报告问卷,用于评估颈部疼痛导致的患者确定的残疾,包括疼痛水平和对日常生活活动的影响。SF-6D 是一种基于 SF-36 自我报告问卷的六个健康维度的偏好健康状况分类系统,包括身体功能、角色限制、社会功能、身体疼痛、心理健康和活力。

方法

收集的数据点分为两个队列:一个用于模型形成,另一个用于模型有效性评估。通过三种先前发表的方法将 SF-36 评分转换为 SF-6D 效用。SF-6D 与 NDI 之间的相关性分析和线性回归建模创建了转换评分的模型。为了验证,计算了观察到的和预测的 SF-6D 效用之间的 Spearman 和 Pearson 相关性,以及预测误差。

结果

使用 430 名患者的 2137 个时间点创建和验证模型。发现从每种转换方法得出的 NDI 和 SF-6D 的 Pearson 和 Spearman 相关系数在-0.8255 至-0.8504 之间(p<.01)。R(2)值范围为 0.68 至 0.71,均方根误差(RMSE)为 0.092 至 0.084。估计和观察到的 SF-6D 评分之间的相关性在 0.8325 至 0.8372 之间(p<.01)。平均预测误差小于 0.006,标准偏差(SD)在 0.082 到 0.093 之间。

讨论

NDI 和 SF-6D 效用评分之间的相关性很强且具有统计学意义。该模型具有较大的 R(2)和较小的 RMSE。预测模型产生较小的平均预测误差,但预测误差的 SD 较大。NDI 和 SF-6D 之间的高相关性允许使用这些模型计算大型数据样本的总体效用、效用变化和质量调整生命年。然而,观察到的预测误差 SD 较大可能会限制个别数据点或小样本量的翻译准确性。

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