提高实效性临床试验报告的质量——《CONSORT声明》的扩展

近年来实效性临床试验受到更多重视,尤其在传统医学临床评价研究领域。为了提高实效性临床试验报告的质量,CONSORT声明组和医疗保健体系中的实效性随机对照临床试验(pragmatic randomized controlled trials in health care systems,PRACTIHC)小组对《CONSORT声明》进行了修改,以帮助读者评估试验质量和结果的可靠性。实效性试验报告指南,作为《CONSORT声明》的一个特殊扩展,能在报告、评价和应用实效性试验方面帮助编辑、系统评价者、试验设计者和决策者评估实效性试验报告中的信息,判定其结论是否适用,以及干预措施是否可行、可否被接受。2005年1月和2008年3月,在加拿大多伦多分别举行了为期两天的会议来探讨提高随机对照试验对卫生保健决策贡献的方法,焦点集中于实效性试验。2005年会,后扩展版草案修订清单发送至编写组成员,经过几次修订,编写组起草了一份摘要草案。在2008年讨论并修改了这一草案。这份草案发给CONSORT声明组以供修改并发表。这份声明的扩展版提出了对8个条目的补充。及时向国内读者和临床试验研究人员介绍该指南有重要的现实意义和学术价值。北京中医药大学循证医学中心刘建平教授等在短时间内翻译了该指南。本刊希望通过介绍中文版"提高实效性临床试验报告的质量——《CONSORT声明》的扩展"以提高国内实效性临床试验报告的质量,相信也有助于改进试验设计的方法学质量。

A nested case-control study of maternal-neonatal transmission of hepatitis B virus in a Chinese population

AIM:To examine the determinants of maternal-neonatal transmission of hepatitis B virus(HBV) METHODS:A nested case-control study was conducted in Changsha,Hunan,People's Republic of China from January 1,2005 to September 31,2006 To avoid potential maternal blood contamination,we collected vein blood of newborns immediately after birth and before initial hepatitis B vaccination to determine the HBV infection status of the newborn For each HBsAg-positive infant,one HBsAg-negative infant born to an HBsAg-positive mother was matched by hospital at birth(same),gender(same),and date of birth(within 1 mo) A faceto-face interview was conducted to collect clinical and epidemiological data Conditional logistic regression analysis was used to estimate the independent effects of various determinants on maternal-neonatal transmission of HBV RESULTS:A total of 141 HBsAg-positive infants and 141 individually matched HBsAg-negative infants were included in the final analysis Maternal first-degree family history of HBV infection,intrahepatic cholestasis,and premature rupture of membranes were risk factors for perinatal transmission of HBV,whereas systematic treatment and HBV immunoglobulin injections for mothers with HBV infection were protective factors for maternal-neonatal transmission of HBV,after adjustment for potential confounding factors CONCLUSION:For HBsAg-positive mothers,systematic treatment,HBV immunoglobulin administration,and controlling intrahepatic cholestasis and pregnancy complications may reduce the incidence of perinatal transmission of HBV.

Emerging neuromodulatory molecules for the treatment of neurogenic erectile dysfunction caused by cavernous nerve injury

Advances in the neurobiology of growth factors, neural development, and prevention of cell death have resulted in a heightened clinical interest for the development of protective and regenerative neuromodulatory strategies for the cavernous nerves （CNs）, as therapies for prostate cancer and other pelvic malignancies often result in neuronal damage and debilitating loss of sexual function. Nitric oxide released from the axonal end plates of these nerves within the corpora cavernosa causes relaxation of smooth muscle, initiating the haemodynamic changes of penile erection as well as contributing to maintained tumescence; the loss of CN function is primarily responsible for the development of erectile dysfunction （ED） after pelvic surgery and serves as the primary target for potential neuroprotective or regenerative strategies. Evidence from pre-clinical studies for select neuromodulatory approaches is reviewed, including neurotrophins, glial cell line-derived neurotrophic factors （GDNF）, bone morphogenic proteins, immunophilin ligands, erythropoetin （EPO）, and stem cells.

Brainstem auditory evoked potentials in patients with delayed encephalopathy after acute carbon monoxide poisoning

Objective:To evaluate the changes of brainstem auditory evoked potential (BAEP) in patients with delayed encephalopathy after acute carbon monoxide poisoning. Methods: BAEPs were performed in 32 controls and 40 patients. Wave Ⅰ , Ⅱ , Ⅲ ,Ⅳ, Ⅴ latencies and Ⅰ-Ⅲ , Ⅲ-Ⅴ , Ⅰ-Ⅴ interpeak latencies were measured, respectively. Results: Abnormalities of BAEPs in 13 patients (13/40, 32 ％). Among the13 abnormal BAEPs, 3 displayed prolongation of latency to waves in one side, no potential in another side; 5 displayed a similar abnormality which was bilateral prolongation of latency to waves ;and another 5 displayed unilateral latency delay. Compared wave Ⅰ , Ⅱ , Ⅲ , Ⅳ, Ⅴ latencies and Ⅰ-Ⅲ , Ⅲ-Ⅴ , Ⅰ-Ⅴ interpeak latencies in the patients and the controls, there were no significant differences (P＞0.05). Conclusion: BAEPs can be used for evaluating the diagnostic and prognostic values in the cases of delayed encephalopathy after acute carbon monoxide poisoning.

知证卫生决策工具之五--使用证据拟订解决问题的方案

决策者及其决策支持者可能会面临以下三种情况中的一种或多种,均需要他们评估拟订方案的成本和效果。这三种情况如下:①当做出决策后,决策者及其决策支持者需考虑如何使该方案的获益最大化、危害最小化、资金使用最优化。如果方案可能需要的成本及产生的效果都存在很大不确定性时,还需制定监测和评估计划;②决策过程中,决策者及其决策支持者需要对提交上来的方案进行评估;③决策尚未做出前,决策者及其决策支持者需开展确定方案、分析方案不同的成本和效果、寻找实施方案的最佳时机。上述情况下,研究证据,特别是有关利弊评估及成本分析方面的证据可帮助决策者及其决策支持者了解方案的可行性。本文将列出以下6个问题供那些为解决最优问题和评估项目成本和效果而需要理清政策和项目方案的人参考:①是否已有一套解决问题的合理方案?②哪些获益对受方案影响者重要;每种方案将会产生哪些获益?③哪些方案会严重影响受方案影响者;各种方案将产生哪些危害?④每种方案的当地成本是多少;是否有各种方案成本效果研究的当地证据?⑤执行任何一项"拿来方案"时应做出哪些相应的调整,其是否会改变方案的获益、危害和成本?⑥哪些利益相关者的哪些意见和经验可能影响方案的可接受性以及方案获益、危害和成本?

知证卫生决策工具之七--查找系统评价

系统评价越来越成为决策的重要信息来源,尤其对评价方案效果更重要。相对于单个研究,系统评价对评价方案效果有很多优势,也被视为找准问题和为备选方案提供补充意见的重要信息来源。系统评价可从比较的角度看问题,也可描述一个方案可能产生的危害。系统评价有助于理解对同一问题个人或群体怎样实施、为什么要这样实施及利益相关者对此方案的看法和经验。但大量限制因素妨碍了系统评价在决策方面更广泛的应用。这些限制因素包括对系统评价价值缺乏认识和当试图检索系统评价时决策者使用的检索词与这些系统评价原作者标注的检索词不匹配。决策者检索的信息类型与系统评价原作者未明确标注该信息类型间不匹配成为突出问题。本文我们将提出三个问题用于指导全面查找系统评价,特别是对备选方案效果评价的系统评价。这些问题包括:①是否真正需要系统评价?②可以通过哪些数据库和检索策略找到相关的系统评价?③若无相关系统评价可获得哪些替代信息?

改进实效型试验的报告质量：CONSORT声明的扩充（2）

实效型试验旨在为临床实践决策提供依据，但报告得不好会降低其实用性。CONSORT和Practihc小组描述了对CONSORT指南的修改，帮助读者评估研究结果的适用性。