Salimi Negar, Aleksejūnienė Jolanta, Yen Edwin H K, Loo Angelina Y C
From the *University of British Columbia; †Department of Oral Health Sciences, Faculty of Dentistry, University of British Columbia; and ‡British Columbia's Children's Hospital Cleft and Craniofacial Team, Vancouver, Canada.
Ann Plast Surg. 2017 Jan;78(1):91-102. doi: 10.1097/SAP.0000000000000819.
(1) Assess the level of available evidence regarding fistula occurrence in cleft lip and palate patients, (2) identify main research areas in the original studies, (3) evaluate the quality of original studies, and (4) summarize the evidence.
Two independent researchers searched the Cochrane Database of Systematic Reviews, Medline, Web of Knowledge, Web of Science and EMBASE, the Grey literature, and the reference lists of main references. The level of evidence was assessed based on study design and according to the Hierarchy of Evidence. The quality assessment was done using the adapted Consolidated Standards of Reporting Trials and Strengthening the Reporting of Observational Studies in Epidemiology checklists and a validity scoring system. Main findings were summarized, and fistula rates were compared between early and more recent articles, also between high-quality and low-quality studies.
The systematic search and relevance assessment identified a total of 127 sources of evidence. The overall level of evidence was weak because it was dominated by small studies (<30 subjects), retrospective cohort studies, and case series. Main research areas were either: (1) focused on surgeries or (2) focused on risk determinants associated with fistula occurrence. Recent reports were of higher quality than the older ones, but the overall quality in the majority of reports was low. Knowledge synthesis demonstrated a wide range of rates for primary fistula (0-78%). No significant difference was found in the fistula rates of older studies compared with more recent studies or among different quality studies. Multiple risk determinants were studied and age at surgery, surgeon's experience, type and severity of cleft were the most frequently examined risk determinants. However, findings concerning different risk determinants and fistula occurrence were not consistent.
The research mainly focused on surgeries and fistula-related risk determinants. The available evidence was low level and of poor quality. No consistent pattern between fistula occurrence and any of the risk determinants could be detected. Reported fistula rates did not differ significantly when comparing older studies with more recent studies or when high-quality studies were compared with low-quality studies.
（1）评估唇腭裂患者瘘管发生情况的现有证据水平；（2）确定原始研究中的主要研究领域；（3）评估原始研究的质量；（4）总结证据。
两名独立研究人员检索了Cochrane系统评价数据库、Medline、Web of Knowledge、Web of Science和EMBASE、灰色文献以及主要参考文献的参考文献列表。根据研究设计并依据证据等级对证据水平进行评估。使用改编后的《报告试验的统一标准》和《加强流行病学观察性研究报告》清单以及有效性评分系统进行质量评估。总结主要研究结果，并比较早期和近期文章之间以及高质量和低质量研究之间的瘘管发生率。
系统检索和相关性评估共确定了127个证据来源。总体证据水平较弱，因为其主要由小型研究（<30名受试者）、回顾性队列研究和病例系列组成。主要研究领域要么是：（1）专注于手术，要么是（2）专注于与瘘管发生相关的风险决定因素。近期报告的质量高于旧报告，但大多数报告的总体质量较低。知识综合显示原发性瘘管的发生率范围很广（0-78%）。与近期研究相比，旧研究的瘘管发生率或不同质量研究之间未发现显著差异。研究了多个风险决定因素，手术年龄、外科医生经验、腭裂类型和严重程度是最常检查的风险决定因素。然而，关于不同风险决定因素与瘘管发生的研究结果并不一致。
该研究主要集中在手术和与瘘管相关的风险决定因素上。现有证据水平较低且质量较差。未发现瘘管发生与任何风险决定因素之间存在一致模式。比较旧研究与近期研究或高质量研究与低质量研究时，报告的瘘管发生率无显著差异。
