tailieunhanh - báo cáo khoa học:" Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale: analyses of two placebo-controlled, randomized trials | Gerlinger et al. Health and Quality of Life Outcomes 2010 8 138 http content 8 1 138 HEALTH AND QUALITY of life outcomes RESEARCH Open Access Defining a minimal clinically important difference for endometriosis-associated pelvic pain measured on a visual analog scale analyses of two placebo-controlled randomized trials c hrictcir h rtdrlinc idr 1 llril o riLi hijr2 i- .i ictm 5nn3 Actio f c dlic ic4 Hdnv riitv5 hrictian Qdit 75 Cl uistopn Genu Iger Ulrike Jtiiuiiidciiei iiiuiHas raustiiiann Antje Colligs Heinz sci III litz Christian Seitz Abstract Background When comparing active treatments a non-inferiority or one-sided equivalence study design is often used. This design requires the definition of a non-inferiority margin the threshold value of clinical relevance. In recent studies a non-inferiority margin of 15 mm has been used for the change in endometriosis-associated pelvic pain EAPP on a visual analog scale VAS . However this value was derived from other chronic painful conditions and its validation in EAPP was lacking. Methods Data were analyzed from two placebo-controlled studies of active treatments in endometriosis including 281 patients with laparoscopically-confirmed endometriosis and moderate-to-severe EAPP. Patients recorded EAPP on a VAS at baseline and the end of treatment. Patients also assessed their satisfaction with treatment on a modified Clinical Global Impression scale. Changes in VAS score were compared with patients selfassessments to derive an empirically validated non-inferiority margin. This anchor-based value was compared to a non-inferiority margin derived using the conventional half standard deviation rule for minimal clinically important difference MCID in patient-reported outcomes. Results Anchor-based and distribution-based MCIDs mm mm respectively. Conclusions An empirically validated non-inferiority margin of 10 mm for EAPP measured on a VAS is appropriate to compare treatments in endometriosis. .