Propert K J, Litwin M S, Wang Y, Alexander R B, Calhoun E, Nickel J C, O'Leary M P, Pontari M, McNaughton-Collins M
Department of Biostatistics and Epidemiology, University of Pennsylvania School of Medicine, Philadelphia, PA 19104-6021, USA.
Qual Life Res. 2006 Mar;15(2):299-305. doi: 10.1007/s11136-005-1317-1.
The NIH-Chronic Prostatitis Symptom Index (NIH-CPSI) was developed to assess symptoms and quality of life in men with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We assessed the responsiveness of the NIH-CPSI to change over time and defined thresholds for changes perceptible to patients.
We studied 174 men with CP/CPPS who participated in a placebo-controlled randomized clinical trial. Changes from baseline to six weeks in the NIH-CPSI total score and pain, urinary, and quality of life subscores were compared to a global response assessment (GRA). Effect sizes and Guyatt statistics were calculated to evaluate responsiveness; 95% confidence intervals were produced using bootstrapping.
All scores decreased over time with the largest decrease in subjects who reported on the GRA that they were markedly improved. The NIH-CPSI total, pain, and quality of life scores were highly responsive in the improved groups; the urinary score showed minimal responsiveness. There was no evidence of responsiveness among those subjects who worsened on the trial. ROC curves identified a 6-point decline in the NIH-CPSI total score as the optimal threshold to predict treatment response.
The NIH-CPSI total score and pain and quality of life subscores are responsive to change over time.
美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）旨在评估慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）男性患者的症状及生活质量。我们评估了NIH-CPSI随时间变化的反应性，并确定了患者可察觉的变化阈值。
我们研究了174名参与安慰剂对照随机临床试验的CP/CPPS男性患者。将NIH-CPSI总分以及疼痛、排尿和生活质量子分数从基线到六周的变化与整体反应评估（GRA）进行比较。计算效应量和盖亚特统计量以评估反应性；使用自抽样法生成95%置信区间。
所有分数均随时间下降，在GRA中报告明显改善的受试者下降幅度最大。在改善组中，NIH-CPSI总分、疼痛和生活质量分数反应性高；排尿分数反应性最小。在试验中病情恶化的受试者中没有反应性的证据。ROC曲线确定NIH-CPSI总分下降6分为预测治疗反应的最佳阈值。
NIH-CPSI总分以及疼痛和生活质量子分数随时间变化有反应性。
