Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, Pennsylvania 19104, USA.
Anesthesiology. 2010 Jun;112(6):1464-72. doi: 10.1097/ALN.0b013e3181de0e6d.
Pain intensity is commonly reported using a 0-10 Numeric Rating Scale in pain clinical trials. Analysis of the change on the Pain Intensity Numerical Rating Scale as a proportion has most consistently correlated with clinically important differences reported on the patient's global impression of change. The correlation of data from patients with breakthrough pain with a Pain Relief Scale and a different global outcome measures will extend our understanding of these measures.
Data were obtained from the open titration phase of a multiple crossover, randomized, double-blind clinical trial comparing oral transmucosal fentanyl citrate with immediate-release oral morphine sulfate for the treatment of cancer-related breakthrough pain. Raw and percentage changes in the pain intensity scores from 1,307 episodes of pain in 134 oral transmucosal fentanyl citrate-naïve patients were correlated with the clinically relevant secondary outcomes of Pain Relief Verbal Response Scale and the global medication performance scale. The changes in raw and percentage change were assessed over time and compared with the ordinal Pain Relief Verbal Response Scale and Global Medication Performance Scale.
The P value of the interaction between the raw pain intensity difference was significant (P = 0.034) for four 15-min time periods but not for the percentage pain intensity difference score (P = 0.26). We found similar results in comparison with the ordinal Pain Relief Verbal Response Scale (P = 0.0048 and P = 0.36 respectively) and global medication performance categories (P = 0.048 and P = 0.45, respectively).
The change in pain intensity in breakthrough pain was more consistent over time and when compared with both the Pain Relief Verbal Response Scale and the Global Medication Performance Scale when the percentage change is used rather than raw pain intensity difference.
在疼痛临床试验中，疼痛强度通常使用 0-10 数字评定量表来报告。分析疼痛强度数字评定量表的变化比例与患者对变化的总体印象报告的临床重要差异最一致相关。突破痛患者的数据与疼痛缓解量表和不同的总体结局测量的相关性将扩展我们对这些测量的理解。
数据来自一项多交叉、随机、双盲临床试验的开放滴定阶段，该试验比较了口腔黏膜芬太尼枸橼酸盐与即时释放口服硫酸吗啡治疗癌症相关突破痛。134 例口腔黏膜芬太尼枸橼酸盐初治患者的 1307 个疼痛发作的疼痛强度评分的原始和百分比变化与疼痛缓解口头反应量表和总体药物表现量表的临床相关次要结局相关。评估了随时间变化的原始和百分比变化，并与有序疼痛缓解口头反应量表和全球药物表现量表进行了比较。
在四个 15 分钟时间段内，原始疼痛强度差异的交互 P 值具有统计学意义（P = 0.034），但百分比疼痛强度差异评分的 P 值不具有统计学意义（P = 0.26）。我们在与有序疼痛缓解口头反应量表（P = 0.0048 和 P = 0.36）和全球药物表现类别（P = 0.048 和 P = 0.45）的比较中也得到了类似的结果。
在突破痛中，疼痛强度的变化在时间上更一致，与疼痛缓解口头反应量表和全球药物表现量表相比，当使用百分比变化而不是原始疼痛强度差异时，疼痛强度的变化更一致。
