Defining the clinically important difference in pain outcome measures
Defining the clinically important difference in pain outcome measures
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DOI：
10.1016/s0304-3959(00)00339-0
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发表时间：
2000-12-01
期刊：
影响因子：
7.4
通讯作者：
Strom, BL
中科院分区：
文献类型：
--
作者：
Farrar, JT;Portenoy, RK;Strom, BL
本研究的目的是确定代表患者临床重要差异的标准疼痛量表的变化水平。镇痛药研究的数据往往难以解释，因为结果的临床重要性并不明显。组间的差异，概括为平均值随时间的变化，很难应用于临床护理。基线评分差异很大，组平均差异可以反映少数患者的大变化，许多患者的小变化，或这些结果的任何组合。确定临床上疼痛有重要改善的患者比例，将提供具有直接临床意义的更可解释的结果。然而，确定临床上重要的结果需要关于随时间变化程度的信息，这些信息在临床上是重要的。重新分析口服经黏膜枸橼酸芬太尼（OTFC）治疗癌症相关突破性疼痛的多交叉随机临床试验滴定阶段的数据，以检查疼痛缓解和未缓解的治疗发作之间疼痛评分的差异。评估的量表为绝对疼痛强度差（PID， 0-10量表），疼痛强度差百分比（PID%， 0-100%量表），疼痛缓解（PR, 0（无），1（轻微），2（中度），3（大量），4（完全）），疼痛强度差（SPID超过60分钟），最大总疼痛缓解百分比（超过60分钟的最大TOTPAR百分比）和整体用药表现（0（差），1（一般），2（好），3（非常好），4（优秀））。充分缓解的定义是患者决定不使用另一剂量的阿片类药物作为救援，除了研究药物，治疗每次疼痛发作。130名OTFC新手患者提供了1268次突破性疼痛发作的数据。转换成百分比变化的量表在预测足够的缓解方面产生了最好的准确性，具有平衡的敏感性和特异性。最大TOTPAR %和PID%的最佳截断点均为33%。绝对量表的最佳分界点为绝对疼痛强度差2分，疼痛缓解2分（中度），SPID 2分。整体用药表现2（良好）也具有优异值。本研究提出了几种疼痛量表变化的数据衍生截止点，每一个都反映了使用OTFC治疗突破性癌症疼痛发作的患者的临床重要改善。需要在其他患者群体和不同的疼痛综合征中进行确认。在未来的疼痛治疗临床试验中，使用一致的临床重要分界点作为主要结局，将增强其有效性、可比性和临床适用性。(C) 2000国际疼痛研究协会。Elsevier Science B.V.版权所有。
The purpose of this study was to determine the levels of change on standard pain scales that represent clinically important differences to patients. Data from analgesic studies are often difficult to interpret because the clinical importance of the results is not obvious. Differences between groups, as summarized by a change in mean values over time, can be difficult to apply to clinical care. Baseline scores vary widely and group mean differences could reflect large changes in a few patients, small changes in many patients, or any combination of these outcomes. Determination of the proportion of patients who have a clinically important improvement in their pain would provide a more interpretable result with direct clinical implications. However, determining a clinically important outcome requires information about the degree of change over time that is clinically important. Data from the titration phase of a multiple cross-over randomized clinical trial of oral transmucosal fentanyl citrate (OTFC) for the treatment of cancer-related breakthrough pain were re-analyzed to examine the differences in pain scores between treatment episodes that did and did not yield adequate pain relief. The scales evaluated were absolute pain intensity difference (PID, 0-10 scale), percentage pain intensity difference (PID%, 0-100% scale), pain relief (PR, 0 (none), 1 (slight), 2 (moderate), 3 (lots), 4 (complete)), sum of the pain intensity difference (SPID over 60 min), percentage of maximum total pain relief (% Max TOTPAR over 60 min), and global medication performance (0 (poor), 1 (fair), 2 (good), 3 (very good), 4 (excellent)). Adequate relief was defined by the patient's decision not to use another dose of opioid medication as a rescue, in addition to the study medication, to treat each painful episode. One hundred thirty OTFC naive patients contributed data on 1268 episodes of breakthrough pain. The scales that were converted to a percentage change yielded the best accuracy in predicting adequate relief, with balanced sensitivity and specificity. The best cut-off point for both the % Max TOTPAR and the PID% was 33%. The best cut-off points for the absolute scales were absolute pain intensity difference of 2, pain relief of 2 (moderate), and SPID of 2. The global medication performance of 2 (good) had excellent values as well. This study presents data-derived cut-off points for the changes in several pain scales, each reflecting the clinically important improvement for patients treating breakthrough cancer pain episodes with OTFC. Confirmation in other patient populations and different pain syndromes will be needed. The use of consistent clinically important cut-off points as the primary outcome in future pain therapy clinical trials will enhance their validity, comparability, and clinical applicability. (C) 2000 International Association for the Study of Pain. Published by Elsevier Science B.V. All rights reserved.