Testing minimal clinically important difference: consensus or conundrum?
Testing minimal clinically important difference: consensus or conundrum?
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DOI：
10.1016/j.spinee.2009.10.015
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发表时间：
2010-04-01
期刊：
影响因子：
4.5
通讯作者：
Mayer, Tom G.
中科院分区：
文献类型：
--
作者：
Gatchel, Robert J.;Mayer, Tom G.
背景背景：已使用各种方法来尝试阐明计算最小临床重要差异（MCID）的标准方法。基于共识的决定（临床试验方法、测量和疼痛评估倡议 [IMMPACT] 小组）建议将基线减少 30%，作为定义自我报告背痛测量的 MCID 的方法。此外，在使用基于锚的方法进行 MCID 时，需要解决重要的心理测量问题，即使用相同结构的独立测量作为外部标准，而不是简单地使用另一种自我报告测量。目的：目的是使用自我报告背痛测量和客观社会经济结果来测试最近发布的关于 MCID 指南的有效性。研究设计/设置：这是一项前瞻性研究，评估慢性致残职业性脊柱患者常用脊柱疼痛评估测量的变化分数患者样本：该研究由完成功能恢复计划的 CDOSD 患者连续队列 (N=1,180) 组成。 结果测量：自我报告测量，包括治疗前后获得的 Oswestry 残疾指数 (ODI) 以及简表 36 (SF-36) 的身体成分总结 (PCS) 和精神成分总结 (MCS)。与治疗 1 年后获得的客观社会经济相关结果（即工作状态和额外的医疗保健利用）进行比较，这是评估 MCID 的外部标准。 方法：针对每项测量分别计算治疗前至治疗后的改善，并根据相对于基线的分数变化将受试者分为两组：改善 30% 或以上与小于 30%。治疗后一年的客观社会经济结果被用作与 CDOSD 人群相关的独立外部标准。该人群通常被认为是脊柱护理中成本最高、问题最多的群体。 结果：ODI 和 SF-36 MCS 与用作外部标准的任何客观 1 年结果均无关。相对于评分相对于基线变化小于 30% 的患者而言，康复后医疗保健利用率的降低（基于向新提供者寻求医疗保健的患者的百分比）与 SF-36 PCS 30% 或更大的改善微弱相关（17.0% 与 21.1%）。 ODI 和重返工作岗位也是如此。结论：当在 CDOSD 队列中使用客观和独立的标准（社会经济结果）时，ODI 和 SF-36 的 30% 改善可能不是有效的 MCID 指数。这重复了一个独立研究小组使用基于分布的 MCID 方法得出的类似结论。 MCID 概念的有效性取决于使用客观外部标准的未来研究。此外，仍然存在一个问题：MCID 中的“重要”一词是否可以明确且可操作地定义为可靠的结构。 (C) 2010 Elsevier Inc. 保留所有权利。
BACKGROUND CONTEXT: Various methodologies have been used in attempting to elucidate a standard method for calculating minimal clinically important difference (MCID). A consensus-based decision (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [IMMPACT] group) suggested a 30% reduction from baseline as a means to define the MCID of self-report back pain measures. Additionally, important psychometric issues need to be addressed regarding use of an independent measure of the same construct as an external criterion, instead of simply using another self-report measure, when using an anchor-based approach to MCID.PURPOSE: The purpose was to test the validity of recently published guidelines regarding MCID using self-report back pain measures and objective socioeconomic outcomes.STUDY DESIGN/SETTING: This is a prospective study assessing change scores on commonly used spinal pain assessment measures in patients with chronic disabling occupational spinal disorders (CDOSDs) treated in a regional referral rehabilitation center performing interdisciplinary functional restoration.PATIENT SAMPLE: The study consisted of consecutive cohort of patients (N=1,180) with CDOSDs completing a functional restoration program.OUTCOMES MEASURES: Self-report measures including the Oswestry Disability Index (ODI) and the physical component summary (PCS) and mental component summary (MCS) of the Short Form-36 (SF-36) obtained before and after treatment, were compared with objective socioeconomically relevant outcomes obtained 1 year after treatment (ie, work status and additional health-care utilization), that were the external criteria for evaluating MCID.METHODS: Pre- to posttreatment improvement was calculated separately for each measure, and subjects were divided into two groups based on the change in scores relative to baseline: 30% or greater versus less than 30% improvement. One-year posttreatment objective socioeconomic outcomes were used as independent external criteria relevant to the CDOSD population. This population is often studied as the most costly and problematic cohort in spine care.RESULTS: The ODI and SF-36 MCS were not associated with any of the objective 1-year outcomes used as external criteria. Reduced post-rehabilitation health-care utilization (based on the percentage of patients pursuing health care from a new provider) was weakly associated with 30% or greater improvement on the SF-36 PCS, relative to patients whose scores changed by less than 30% relative to baseline (17.0% vs. 21.1%). The same was true for the ODI and return-to-work.CONCLUSIONS: When objective and independent criteria are used (socioeconomic outcomes) in a CDOSD cohort, the 30% improvement in the ODI and SF-36 may not be a valid MCID index. This replicates similar conclusions made by an independent research group using a distribution-based approach to MCID. The validity of the MCID concept rests on future research using objective external criteria. Moreover, there remains a question whether the term "important" in MCID can be unequivocally and operationally defined as a reliable construct. (C) 2010 Elsevier Inc. All rights reserved.