Association of Maternal Diabetes With Autism in Offspring.
Association of Maternal Diabetes With Autism in Offspring.
复制标题
DOI：
10.1001/jama.2016.20122
复制
发表时间：
2017
期刊：
影响因子：
--
通讯作者：
A. Xiang
中科院分区：
文献类型：
--
作者：
A. Xiang
补片加固几乎总是用于切口疝的选择性修补，以最大限度地降低复发风险，1以及小的脐疝和上腹疝修补术。2专家一致推荐使用补片的依据是来自专业疝中心的随机试验（具有较高的内部效度）和来自报告“真实世界”的全国性临床前瞻性数据库的证据。具有高外部效度的结果。临床复发的再手术低估了临床复发3 - 4倍，这一事实使得补片加固的优势更大。此外，腹腔镜或开放性修复术的早期手术并发症风险约为10%（5%严重），3进一步强调需要补片加固以限制后期再次手术复发的风险。然而，正如我们的研究所示，使用网状钢筋并非没有风险。我们发现5年后5%的患者发生补片相关并发症。使用基于登记的数据有几个局限性，如未测量的混杂和选择偏倚。然而，Cherla博士和他的同事说我们没有调整风险因素是不正确的。对疝尺寸和初次与复发修补进行调整，以分析补片的使用以及倾向评分调整。由于使用了模糊的并发症定义和非盲评估，研究结局可能存在偏倚。我们同意非盲评分不是最佳的。然而，在本研究中，非盲评估实际上是不可能的，因为仅为了确定手术类型，就必须非盲地进入首次切口疝手术。当对并发症的相关性存在疑问时，2名研究者达成共识。Cherla及其同事认为，几种疝相关并发症的复合结局上级我们的2种单独结局，即复发和补片相关并发症。使用复合结果将使长期结果更难以解释。如Cherla及其同事所述，单独评估了2个结局指标，结果未合并。任何一种结局的发生均导致该患者的随访结束。因此，没有患者重叠。然而，由于伤口感染是复发的风险因素，进一步随访可能显示发生补片相关并发症的患者复发率增加。使用异物补片材料修补切口疝时，利大于弊。然而，值得注意的是，与其他医疗器械类似，补片在推荐常规使用前不接受临床质量监测。包含详细术中信息的临床数据库可能有助于疝手术的质量评估。例如，数据库可能拥有前瞻性术中信息，包括长期随访，并具有足够的患者数量和统计功效来跟踪结局指标，例如不同类型补片的补片相关并发症或再手术率。
In Reply Mesh reinforcement is almost always used in elective repair of an incisional hernia to minimize the risk of recurrence,1 as well as in repair of small umbilical and epigastric hernias.2 The expert consensus recommendation for the use of mesh was based on evidence from randomized trials from specialized hernia centers with high internal validity and from clinical nationwide prospective databases reporting “realworld” outcomes with high external validity. The fact that reoperation for clinical recurrence underestimates clinical recurrence by a factor of 3 to 4 makes the advantages of mesh reinforcement even larger. Additionally, laparoscopic or open repair carries a risk of approximately 10% for early surgical complications (5% severe),3 further emphasizing the need for mesh reinforcement to limit the risk of a later reoperation for recurrence. However, as shown in our study, the use of mesh reinforcement is not risk free. We found mesh-related complications in 5% of patients after 5 years. There are several limitations of using registry-based data, such as unmeasured confounding and selection bias. However, Dr Cherla and colleagues are not correct to state that we did not adjust for risk factors. Adjustment for hernia size and primary vs recurrent repair were performed for analyses on the use of mesh, as well as propensity score adjustment. The study outcomes may have been biased by use of ambiguous definitions of complications and unblinded assessment. We agree that nonblinded scoring is not optimal. However, in this study, nonblinded assessment was not practically possible because nonblinded access to the index incisional hernia operation was necessary simply to identify the type of operation. When doubt existed about the relatedness of complications, consensus was obtained between 2 investigators. Cherla and colleagues suggest that a composite outcome of several hernia-related complications would be superior to our 2 separate outcomes, recurrence and mesh-related complications. Using a composite outcome would make longterm results more difficult to interpret. The 2 outcome measures were assessed separately and results were not pooled, as indicated by Cherla and colleagues. Occurrence of either outcome led to ending the follow-up for that patient. Therefore, there was no overlap of patients. However, because wound infection is a risk factor for recurrence, further follow-up might show an increased recurrence rate in patients who had a meshrelated complication. The benefits outweigh the disadvantages when repairing incisional hernias with a foreign-body mesh material. However, it is remarkable that meshes, similar to other medical devices, are not subject to clinical quality monitoring before routine use is recommended. Clinical databases containing detailed intraoperative information may contribute to quality assessment in hernia surgery. For instance, databases may possess prospective intraoperative information, include longterm follow-up, and have sufficient numbers of patients and statistical power to track outcome measures such as meshrelated complications or reoperation rates for different types of mesh.