盲法与非盲法 POP-Q 检查的结局评估。

Outcome assessment with blinded versus unblinded POP-Q exams.

机构信息

Section of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Washington Hospital Center, George Washington University, Washington, DC, USA.

出版信息

Am J Obstet Gynecol. 2011 Nov;205(5):489.e1-4. doi: 10.1016/j.ajog.2011.07.007. Epub 2011 Jul 20.

DOI:10.1016/j.ajog.2011.07.007

PMID:21907962

Abstract

OBJECTIVE

To determine whether blinded and unblinded Pelvic Organ Prolapse Quantification (POP-Q) examinations differ in a randomized trial.

STUDY DESIGN

Blinded POP-Q examinations performed at 3 months and 1 year were compared with unblinded examinations performed by the surgeon in a randomized trial of vaginal mesh for pelvic organ prolapse.

RESULTS

Sixty-five patients were included in the study. Correlations between the blinded and unblinded POP-Q points and stages varied from low to moderate (rho = 0.29-0.78). At 3 months, the blinded overall prolapse recurrence rate was 45.3% compared with 39.1% based on unblinded staging (P = .34). At 1 year, the blinded overall recurrence rate was significantly higher than the unblinded recurrence rate: 68.3% vs 53.3% (P = .004). The 1-year blinded anterior wall recurrence rate was also higher than the recurrence based on unblinded staging: 56.7% vs 43.3% (P = .021).

CONCLUSION

Use of unblinded POP-Q staging resulted in underestimation of 1-year overall recurrence after prolapse repair.

摘要

目的

在一项随机试验中，确定盲法和非盲法盆腔器官脱垂定量（POP-Q）检查是否存在差异。

研究设计

在一项阴道网片治疗盆腔器官脱垂的随机试验中，对盲法 POP-Q 检查（在 3 个月和 1 年进行）与由外科医生进行的非盲法检查进行了比较。

结果

本研究纳入了 65 例患者。盲法和非盲法 POP-Q 点和分期之间的相关性从低到中度不等（rho = 0.29-0.78）。3 个月时，盲法整体脱垂复发率为 45.3%，而非盲法分期为 39.1%（P =.34）。1 年时，盲法整体复发率明显高于非盲法复发率：68.3%比 53.3%（P =.004）。1 年时盲法前壁复发率也高于非盲法分期的复发率：56.7%比 43.3%（P =.021）。