背景:程序的标准化可以改善结果。虽然系统评价总结了剖宫产(CD)的循证步骤(EBS),他们的捆绑实施尚未得到调查。
目的:在实施前后的试验中,我们试图确定是否捆绑了CD的EBS,与外科医生的偏好相比,改善结果。
方法:符合StaRI(报告实施研究标准),在4所教学医院进行了多中心实施前后试验.实施前阶段包括根据医生的偏好进行3个月的CD;教育干预(例如,说教,徽章卡,海报,视频)发生在第四个月。实施后期间的CD采用了捆绑的EBS。对两组进行了预先计划的10%随机审核,评估了EBS的依从性和摄取。主要结局是复合孕产妇发病率(CMM),其中包括估计的失血量>1000毫升,输血,子宫内膜炎,产后发烧,伤口并发症,脓毒症,血栓形成,入住ICU,子宫切除术,或死亡。次要结局是复合新生儿发病率(CNM),其一些组成部分是5-minApgar评分<7,正压吸氧,低血糖,或者败血症.先验贝叶斯样本量计算表明,每组需要700CD才能证明CMM相对减少20%(从15%到12%),确定性为75%。使用具有中性先验的贝叶斯逻辑回归来计算具有95%可信间隔(CrI)的调整后相对风险(aRR)的净改善可能性。
结果:共检查了1,425个连续CD(实施前721个,实施后704个)。经审核的数据表明,实施前期间的基准EBS利用率为79%;在实施CD的EBS捆绑后,经审核的依从性为89%,占EBS的10.0%。在四个方面,实施前和实施后的母亲特征显着不同:种族/民族,高血压疾病,以及4个中心对队列的相对贡献和分娩时的胎龄,但CD的适应症及其持续时间是否<与>60分钟没有。实施前和实施后的CMM比率分别为26%和22%,分别(ARR,0.88;95%CrI,0.73-1.04),坐标测量机减少的贝叶斯概率为94%。CNM发生在实施前的37%和实施后的41%(aRR,1.12;95%CrI0.98-1.39),CNM恶化的贝叶斯概率为95%。当CMM被早产(<37周)和足月(>37周)CD分开时,产妇结局的改善持续;当CNM按胎龄亚组进行隔离时,新生儿结局恶化的可能性也持续存在.
结论:剖宫产的循证捆绑步骤的标准化导致复合产妇结局的适度降低;然而,观察到新生儿复合发病率的矛盾增加.尽管基于证据的个体步骤可能是有价值的,在等待额外的干预试验时,目前不建议将这些步骤正式捆绑在一起.
BACKGROUND: Standardization of procedures improves outcomes. Though systematic reviews have summarized the evidence-based steps (EBS) of cesarean delivery (CD), their bundled implementation has not been investigated.
OBJECTIVE: In this pre- and post-implementation
trial, we sought to ascertain if bundled EBS of CD, compared to surgeon\'s preference, improves outcomes.
METHODS: A StaRI (Standards for Reporting Implementation Studies) compliant, multi-center pre- and post-implementation
trial at 4 teaching hospitals was conducted. The pre-implementation period consisted of CD done based on the physicians\' preferences for 3 months; educational intervention (e.g., didactics, badge cards, posters, video) occurred at the 4th month. CDs in post-implementation period employed the bundled EBS. A pre-planned 10% randomized audit of both groups assessed adherence and uptake of EBS. The primary outcome was a composite maternal morbidity (CMM), which included estimated blood loss > 1,000 mL, blood transfusion, endometritis, post-partum fever, wound complications, sepsis, thrombosis, ICU admission, hysterectomy, or death. The secondary outcome was a composite neonatal morbidity (CNM) and some of its components were 5-min Apgar score < 7, positive pressure oxygen use, hypoglycemia, or sepsis. A priori Bayesian sample size calculation indicated 700 CD in each group was needed to demonstrate 20% relative reduction (from 15% to 12%) of CMM with 75% certainty. Bayesian logistic regression with neutral priors was used to calculate likelihood of net-improvement in adjusted relative risk (aRR) with 95% credible intervals (CrI).
RESULTS: A total of 1,425 consecutive CD (721 in pre- and 704 in post-implementation group) were examined. Audited data indicated that the baseline EBS utilization rate during the pre-implementation period was 79%; after the implementation bundled EBS of CD the audited adherence was 89%-an uptake of 10.0% of the EBS. In four aspects, the maternal characteristics differed significantly in the pre- and post-implementation periods: race/ethnicity, hypertensive disorder, and the relative contribution of the 4 centers to the cohorts and the gestational age at delivery, but the indications for CD and whether its duration was < versus > 60 min did not. The rates of CMM in the pre- and post-implementation groups were 26% and 22%, respectively (aRR, 0.88; 95% CrI, 0.73-1.04), with a 94 % Bayesian probability of a reduction in CMM. The CNM occurred in 37% of the pre- and in 41% of the post-implementation group (aRR, 1.12; 95% CrI 0.98-1.39), with a 95% Bayesian probability of worsening in CNM. When CMM were segregated by preterm (<37 wks) and term (> 37 weeks) CD, the improvement in maternal outcomes persisted; when CNM were segregated by gestational age subgroupsthe potential for worsening neonatal outcomes persisted as well.
CONCLUSIONS: Standardization of the evidence-based bundled steps of cesarean delivery resulted in a modest reduction of the composite maternal outcome; however, a paradoxical increase in neonatal composite morbidity was noted. Although individual evidence-based steps may be of value, while awaiting additional intervention trials a formal bundling of such steps is currently not recommended.