Lafay Pillet M C, Huchon C, Santulli P, Borghese B, Chapron C, Fauconnier A
Université Paris Descartes, Sorbonne Paris Cité, Faculté de Médecine, Assistance Publique - Hôpitaux de Paris (APHP), Groupe Hospitalier Universitaire (CHU) Cochin, Department of Gynaecology II and Reproductive Medicine Paris, Paris, France INSERM, Unité de Recherche U953, Paris, France
Service de Gynécologie Obstétrique, CHI Poissy Saint-Germain en Laye, Poissy, Université Versailles- Saint Quentin en Yvelines, Versailles, France EA 7285 Risques cliniques et sécurité en santé des femmes, Université Versailles-Saint-Quentin en Yvelines, Versailles, France.
Hum Reprod. 2014 Aug;29(8):1666-76. doi: 10.1093/humrep/deu128. Epub 2014 Jun 4.
Is it possible to detect associated deep infiltrating endometriosis (DIE) before surgery for patients operated on for endometriomas using a preoperative clinical symptoms questionnaire?
A diagnostic score of DIE associated with endometriomas using four clinical symptoms defined a high-risk group where the probability of DIE was 88% and a low-risk group with a 10% probability of DIE.
Many clinical symptoms are already known to be associated with DIE but they have not yet been used to build a clinical prediction model.
STUDY DESIGN, SIZE, DURATION: We built a diagnostic score of DIE based on a case control study of 326 consecutive patients operated on for an endometrioma between January 2005 and October 2011: 164 had associated DIE (DIE+) and 162 had no DIE (DIE-). We derived the score on a training sample obtained from a random selection of 2/3 of the population (211 patients, 101 DIE+, 110 DIE-), and validated the results on the remaining third (115 patients, 63 DIE+, 52 DIE-). The gold standard for the diagnosis of DIE was based on surgical exploration and histological diagnosis.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants were consecutive patients aged 18-42 years who underwent surgery for an endometrioma with histological confirmation and complete treatment of their endometriotic lesions: data for these women were extracted from a prospective database including a standardized preoperative questionnaire. On the training dataset, variables associated with DIE in a univariate analysis were introduced in a multiple logistic regression and selected by a backward stepwise procedure and a Jackknife procedure. A diagnostic score of DIE was built with the scaled/rounded coefficients of the multiple regression. Two cut-off values delimitated a high and a low risk group, and their diagnostic accuracy was tested on the validation dataset.
Four variables were independently associated with DIE: visual analogue scale of gastro-intestinal symptoms ≥5 or of deep dyspareunia >5 (adjusted diagnostic odds ratio (aDOR) = 6.0, 95% confidence interval (CI) [2.9-12.1]), duration of pain greater than 24 months (aDOR = 3.8, 95% CI [1.9-7.7]), severe dysmenorrhoea (defined as the prescription of the oral contraceptive pill for the treatment of a primary dysmenorrhoea or the worsening of a secondary dysmenorrhoea) (aDOR = 3.8, 95% CI [1.9-7.6]) and primary or secondary infertility (aDOR = 2.5, 95% CI [1.2-4.9]). The sum of these variables weighted by their rounded/scaled coefficients constituted the score ranging from 0 to 53. A score <13 defined a low-risk group where the probability of DIE was 10% (95% CI [7-15] with a sensitivity of 95% (95% CI [89-98]) and a negative likelihood ratio of 0.1 (95% CI [0.0-0.3]). A score ≥35 defined a high-risk group where the probability of DIE was 88% (95% CI [83-92%]), with a specificity of 94% (95% CI [87-97]), and a positive likelihood ratio of 8.1 (95% CI [3.9-17.0]). The performance of the score was confirmed on the validation dataset with 11% of DIE+ patients having a score <13 (sensibility: 95%) and 90% of DIE+ patients having a score ≥35 (specificity: 94%).
LIMITATION, REASONS FOR CAUTION: This study was performed in a department specialized in DIE management. Score accuracy could be different in less specialized centres.
This score could have a major clinical impact on the time of diagnosis, the management of DIE and could reduce the cost of investigations by helping to identify high-risk patients, while preserving the quality of care.
STUDY FUNDING/COMPETING INTERESTS: The authors have no competing interests to declare. No grant supported the study.
对于因卵巢子宫内膜异位囊肿接受手术的患者,术前使用临床症状问卷能否检测出相关的深部浸润性子宫内膜异位症(DIE)?
使用四种临床症状对与卵巢子宫内膜异位囊肿相关的DIE进行诊断评分,确定了一个高风险组,其中DIE的概率为88%,以及一个低风险组,DIE的概率为10%。
已知许多临床症状与DIE相关,但尚未用于建立临床预测模型。
研究设计、规模、持续时间:我们基于2005年1月至2011年10月间连续326例因卵巢子宫内膜异位囊肿接受手术的患者进行病例对照研究,构建了DIE诊断评分:164例伴有相关DIE(DIE+),162例无DIE(DIE-)。我们从随机选择的2/3人群(211例患者,101例DIE+,110例DIE-)中获得的训练样本得出评分,并在其余1/3人群(115例患者,63例DIE+,52例DIE-)中验证结果。DIE诊断的金标准基于手术探查和组织学诊断。
参与者/材料、设置、方法:参与者为年龄在18 - 42岁之间、因卵巢子宫内膜异位囊肿接受手术且组织学确诊并对其子宫内膜异位病变进行彻底治疗的连续患者:这些女性的数据从包含标准化术前问卷的前瞻性数据库中提取。在训练数据集上,单变量分析中与DIE相关的变量被纳入多元逻辑回归,并通过向后逐步法和刀切法进行选择。用多元回归的缩放/四舍五入系数构建DIE诊断评分。两个临界值界定了高风险组和低风险组,并在验证数据集上测试了它们的诊断准确性。
四个变量与DIE独立相关:胃肠道症状视觉模拟评分≥5或深部性交困难评分>5(调整后的诊断比值比(aDOR)= 6.0,95%置信区间(CI)[2.9 - 12.1])、疼痛持续时间大于24个月(aDOR = 3.8,95% CI [1.9 - 7.7])、严重痛经(定义为因原发性痛经开具口服避孕药或继发性痛经加重)(aDOR = 3.8,95% CI [1.9 - 7.6])以及原发性或继发性不孕(aDOR = 2.5,95% CI [1.2 - 4.9])。这些变量与其四舍五入/缩放系数加权后的总和构成了范围从0到53的评分。评分<13定义为低风险组,其中DIE的概率为10%(95% CI [7 - 15]),敏感性为95%(95% CI [89 - 98]),阴性似然比为0.1(95% CI [0.0 - 0.3])。评分≥35定义为高风险组,其中DIE的概率为88%(95% CI [83 - 92%]),特异性为94%(95% CI [87 - 97]),阳性似然比为8.1(95% CI [3.9 - 17.0])。评分的性能在验证数据集上得到证实,11%的DIE+患者评分<13(敏感性:95%),90%的DIE+患者评分≥35(特异性:94%)。
局限性、谨慎理由:本研究在一个专门管理DIE的科室进行。在专业性较低的中心,评分准确性可能不同。
该评分可能对诊断时间、DIE的管理产生重大临床影响,并通过帮助识别高风险患者降低检查成本,同时保持医疗质量。
研究资金/利益冲突:作者声明无利益冲突。本研究无资助支持。