Obstetrics, Gynecology & Women's Health Institute and Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio; the Department of Obstetrics & Gynecology, Duke University, Durham, North Carolina; the Department of Reproductive Medicine, UC San Diego Health System, San Diego, California; RTI International, Research Triangle Park, North Carolina; the Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania; the Department of Obstetrics and Gynecology Women and Infants Hospital, Providence, Rhode Island; the Department of Obstetrics & Gynecology and Urology, Stritch School of Medicine, Loyola University Chicago, Chicago, Illinois; the Department of Obstetrics and Gynecology University of Utah, Salt Lake City, Utah; the Department of Obstetrics and Gynecology, University of Texas Southwestern, Dallas, Texas; the Division of Urology, University of Pennsylvania, Philadelphia, Pennsylvania; the Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama; Northwest Physician Group, Amarillo, Texas; and the Department of Medicine, University of Texas Health Science Center at Houston, Houston, Texas.
Obstet Gynecol. 2018 Aug;132(2):298-309. doi: 10.1097/AOG.0000000000002750.
To develop statistical models predicting recurrent pelvic organ prolapse, surgical complications, and change in health status 12 months after apical prolapse surgery.
Logistic regression models were developed using a combined cohort from three randomized trials and two prospective cohort studies from 1,301 participants enrolled in surgical studies conducted by the Pelvic Floor Disorders Network. Composite recurrent prolapse was defined as prolapse beyond the hymen; the presence of bothersome bulge symptoms; or prolapse reoperation or retreatment within 12 months after surgery. Complications were defined as any serious adverse event or Dindo grade III complication within 12 months of surgery. Significant change in health status was defined as a minimum important change of SF-6D utility score (±0.035 points) from baseline. Thirty-two candidate risk factors were considered for each model and model accuracy was measured using concordance indices. All indices were internally validated using 1,000 bootstrap resamples to correct for bias.
The models accurately predicted composite recurrent prolapse (concordance index=0.72, 95% CI 0.69-0.76), bothersome vaginal bulge (concordance index=0.73, 95% CI 0.68-0.77), prolapse beyond the hymen (concordance index=0.74, 95% CI 0.70-0.77), serious adverse event (concordance index=0.60, 95% CI 0.56-0.64), Dindo grade III or greater complication (concordance index=0.62, 95% CI 0.58-0.66), and health status improvement (concordance index=0.64, 95% CI 0.62-0.67) or worsening (concordance index=0.63, 95% CI 0.60-0.67). Calibration curves demonstrated all models were accurate through clinically useful predicted probabilities.
These prediction models are able to provide accurate and discriminating estimates of prolapse recurrence, complications, and health status 12 months after prolapse surgery.
开发预测 12 个月后盆底器官脱垂手术中复发性盆腔器官脱垂、手术并发症和健康状况变化的统计模型。
使用来自三个随机试验和两个前瞻性队列研究的合并队列，对来自盆底功能障碍网络外科研究的 1301 名参与者进行逻辑回归模型分析。复合复发脱垂定义为处女膜以外的脱垂；有明显膨出症状；或术后 12 个月内再次手术或再次治疗。并发症定义为术后 12 个月内任何严重不良事件或 Dindo 分级 III 并发症。健康状况的显著变化定义为 SF-6D 效用评分的最小重要变化（±0.035 分）。每个模型考虑了 32 个候选风险因素，并用一致性指数来衡量模型的准确性。所有指标均采用 1000 次 bootstrap 重采样进行内部验证，以纠正偏差。
该模型准确预测了复合复发脱垂（一致性指数=0.72，95%置信区间 0.69-0.76）、阴道膨出症状（一致性指数=0.73，95%置信区间 0.68-0.77）、处女膜外脱垂（一致性指数=0.74，95%置信区间 0.70-0.77）、严重不良事件（一致性指数=0.60，95%置信区间 0.56-0.64）、Dindo 分级 III 级或更高级别并发症（一致性指数=0.62，95%置信区间 0.58-0.66）以及健康状况改善（一致性指数=0.64，95%置信区间 0.62-0.67）或恶化（一致性指数=0.63，95%置信区间 0.60-0.67）。校准曲线表明，所有模型在临床有用的预测概率范围内都具有准确性。
这些预测模型能够准确、区分地预测脱垂手术后 12 个月的脱垂复发、并发症和健康状况。
