当前位置: X-MOL 学术Fertil. Steril. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosis
Fertility and Sterility ( IF 6.7 ) Pub Date : 2021-02-01 , DOI: 10.1016/j.fertnstert.2020.07.013
Robin M Pokrzywinski 1 , Ahmed M Soliman 2 , Michael C Snabes 2 , Jun Chen 1 , Hugh S Taylor 3 , Karin S Coyne 1
Affiliation  

OBJECTIVE To evaluate the utility, responsiveness, and thresholds for clinically meaningful change of a numerical rating scale for worst pain associated with dysmenorrhea (NRS-DYS) and nonmenstrual pelvic pain (NRS-NMPP) in women with moderate to severe endometriosis-associated pain. DESIGN Analysis of data from two phase III randomized clinical trials (EM-I [NCT01620528] and EM-II [NCT01931670]). SETTING Not applicable. PATIENT(S) Premenopausal women ages 18-49 years with moderate to severe endometriosis-associated pain. INTERVENTION(S) Participants in both trials were randomized 3:2:2 to receive placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily for 6 months. MAIN OUTCOME MEASURE(S) NRS-DYS and NRS-NMPP. RESULT(S) EM-I enrolled 871 women and EM-II enrolled 815 women. For patients with a global impression of improvement at month 3, the least-squares mean change between baseline and month 3 was -3.6 (EM-I and EM-II) for NRS-DYS and -1.9 (EM-I) and -2.0 (EM-II) for NRS-NMPP. Standard errors of measurement were 2.99 (EM-I) and 2.86 (EM-II) for NRS-DYS and 1.74 (EM-I) and 1.71 (EM-II) for NRS-NMPP. Baseline half standard deviations were 0.78 (EM-I) and 0.85 (EM-II) for NRS-DYS and 0.92 (EM-I) and 0.96 (EM-II) for NRS-NMPP. Based on these results, clinically meaningful changes were defined as a reduction of 4 points for NRS-DYS and 2 points for NRS-NMPP. CONCLUSION(S) This study demonstrated the utility and responsiveness of separate numerical rating scales to assess worst pain for dysmenorrhea and NMPP in women with moderate to severe endometriosis-associated pain and identified initial thresholds for clinically meaningful change.

中文翻译:

中度至重度子宫内膜异位症女性痛经和非经期骨盆疼痛的最严重疼痛数值评定量表的反应性和临床意义变化的阈值

目的 评估在患有中度至重度子宫内膜异位症相关疼痛的女性中,与痛经相关的最严重疼痛 (NRS-DYS) 和非经期盆腔疼痛 (NRS-NMPP) 的数值评定量表具有临床意义变化的效用、反应性和阈值。设计 对两项 III 期随机临床试验(EM-I [NCT01620528] 和 EM-II [NCT01931670])的数据进行分析。设置 不适用。患者 18-49 岁的绝经前妇女,患有中度至重度子宫内膜异位症相关疼痛。干预措施 两项试验的参与者按 3:2:2 随机分配接受安慰剂、elagolix 150 mg 每天一次或 elagolix 200 mg 每天两次,共 6 个月。主要结果测量 NRS-DYS 和 NRS-NMPP。结果 EM-I 招募了 871 名女性,EM-II 招募了 815 名女性。对于在第 3 个月总体上有改善印象的患者,NRS-DYS 的基线和第 3 个月之间的最小二乘平均变化为 -3.6(EM-I 和 EM-II)以及 -1.9(EM-I)和 -2.0 (EM-II) 用于 NRS-NMPP。NRS-DYS 的测量标准误差为 2.99 (EM-I) 和 2.86 (EM-II),NRS-NMPP 的标准误差为 1.74 (EM-I) 和 1.71 (EM-II)。NRS-DYS 的基线半标准偏差为 0.78 (EM-I) 和 0.85 (EM-II),NRS-NMPP 的基线半标准偏差为 0.92 (EM-I) 和 0.96 (EM-II)。根据这些结果,有临床意义的变化被定义为 NRS-DYS 降低 4 分,NRS-NMPP 降低 2 分。
更新日期:2021-02-01
down
wechat
bug