Research, Development, Quality Assurance, m&i Hospital Group Enzensberg, Hopfen am See, Germany.
Department of Orthopaedics and Trauma Surgery, Fachklinik Herzogenaurach, Germany.
Z Orthop Unfall. 2022 Apr;160(2):213-221. doi: 10.1055/a-1304-3677. Epub 2021 Jan 18.
Pain intensity is frequently measured on the 11-point numerical pain rating scale (NRS-PI), ranging from 0 (no pain) to 10 points (worst imaginable pain). However, it is difficult to interpret the clinical importance of changes from baseline to endpoint on this instrument.
To estimate the minimal detectable change (MDC) and the minimal clinically important difference (MCID) for average pain intensity in patients with specific back pain.
Data on 1232 subjects with specific back pain from a German hospital were included in this study. A score combining the patient's (PGIC) and the physician's global impression of change (CGIC) over the in-patient length of stay was used as an external criterion. A priori, we considered the score value "slightly improved" as the MCID. MDC was calculated using the standard error of measurement (SEM) and the standard deviation (SD) of the sample. MCID was estimated by the mean value of PI-NRS change in patients who self-assess as "slightly improved", and by sensitivity/specificity analyses, computed by the receiver operating characteristic method (ROC).
MDC was 1.77. The MCS and ROC methods consistently showed an MCID of 2 for the total sample. Both methods showed the dependence of the MCID on the initial pain: 1 for mild to moderate pain at baseline (1 - 4 NRS points), 2 for moderate to severe pain (5 - 7) and 3 - 4 for very severe to extreme pain (8 - 10). For patients with lumbosacral intervertebral disc disorders and patients in the acute phase (duration of pain < 6 weeks), the ROC method resulted in a higher limit than the MCS method.
In order to facilitate the interpretation of changes and to take into account the patient's perspective, the global assessment of the success of treatment should be used as an anchor criterion. In addition to dealing with pain measurement, function-related and psychosocial aspects of pain symptoms should be kept in mind.
疼痛强度通常使用 11 点数字疼痛评分量表（NRS-PI）进行测量，范围从 0（无痛）到 10 分（可想象的最严重疼痛）。然而，在该工具上从基线到终点的变化的临床重要性很难解释。
估计特定腰痛患者平均疼痛强度的最小可检测变化（MDC）和最小临床重要差异（MCID）。
本研究纳入了来自德国医院的 1232 名特定腰痛患者的数据。使用住院期间患者（PGIC）和医生整体印象变化（CGIC）评分相结合作为外部标准。我们预先将“略有改善”的评分值视为 MCID。MDC 通过测量的标准误差（SEM）和样本的标准差（SD）计算得出。通过自我评估为“略有改善”的患者的 PI-NRS 变化值，以及通过敏感性/特异性分析，通过接收者操作特征方法（ROC）计算得出 MCID。
MDC 为 1.77。MCS 和 ROC 方法一致显示总样本的 MCID 为 2。两种方法均显示 MCID 依赖于基线疼痛：轻度至中度疼痛（1-4 NRS 点）时为 1，中度至重度疼痛（5-7）时为 2，重度至极度疼痛（8-10）时为 3-4。对于腰椎间盘疾病患者和急性疼痛患者（疼痛持续时间<6 周），ROC 方法的上限高于 MCS 方法。
为了便于解释变化并考虑患者的观点，应将治疗成功的整体评估作为锚定标准。除了处理疼痛测量外，还应牢记与疼痛症状相关的功能和心理社会方面。
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