面对随机对照试验（RCTs）报告质量过低的种种确凿证据和严重后果，许多医学杂志及编辑小组现已接受并支持一份包含有22个条目的清单和一个流程图的CONSORT声明（试验报告统一标准）。由于CONSORT的主旨是提高干预措施疗效的报告质量，故其中只有一个条目是具体针对安全性的。大量证据表明，报告RCT中的危害的相关数据的报告质量有待提高。2003年5月，CONSORT小组成员，包括杂志编辑和科学家，齐聚加拿大魁北克省Mentoebello探讨了这一问题，并形成以下文件：标准CONSORT清单附带报告危害相关问题的10个新推荐意见，并附上说明及恰当报告的实例。我们希望该声明连同其它CONSORT相关材料（www.consort-statement.org）将有助于作者提高RCT报告中与危害相关数据的报告质量。高质量报告有助于读者批判性评价和诠释试验结果。各杂志可通过修改稿约来向作者传达这一文件以支持这一目标。
Objectives We tended to evaluate the effectiveness of prophylactic antibiotics for preventing meningitis in patients with BSF. Method We searched the Cochrane Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 3, 2005), MEDLINE (1966 to September 2005), EMBASE (1974 to June 2005), and LILACS (1982 to September 2005). We also performed an electronic search of meeting proceedings from the American Association of Neurological Surgeons (1997 to September 2005) and handsearched the abstracts of meeting proceedings of the European Association of Neurosurgical Societies (1995, 1999 and 2003). Randomized controlled trials (RCTs) comparing any antibiotic versus placebo or no intervention were identified. We also identified non-RCTs to perform a separate meta-analysis to compare results. At least two authors independently appraised the quality and extracted the data of each trial. Meta-analysis was conducted using RevMan 4.2 software. Results Five RCTs and 17 non-RCTs comparing different types of antibiotic prophylaxis with placebo or no intervention in patients with BSF were identified. Most trials presented insufficient methodological detail. All studies included meningitis in their primary outcome. Overall, we evaluated 208 participants from the four RCTs that were considered suitable for inclusion in the meta-analysis. There were no significant differences between antibiotic prophylaxis groups and control groups in terms of reduction of the frequency of meningitis, all-cause mortality, meningitis-related mortality, and need for surgical correction in patients with CSF leakage. We performed a subgroup analysis to evaluate the primary outcome in patients with and without CSF leakage. We also completed a meta-analysis of all the identified controlled non-RCTs (enrolling a total of 2 168 patients), producing results consistent with the randomised data. Conclusions Currently available evidence from RCTs does not support prophylactic antibiotic use in patients with BSF, whether there is evidence of CSF leakage or not. Until more research is completed, the effectiveness of antibiotics in patients with BSF cannot be determined because studies published to date are flawed by biases. Large, appropriately designed RCTs are needed.