针灸临床试验的注册质量评估。

Registration quality assessment of acupuncture clinical trials.

机构信息

Evidence-Based Medicine Center, Institute of Integrated Traditional Chinese and Western Medicine, School of Basic Medical Sciences, Lanzhou University, Lanzhou, Gansu, China.

出版信息

PLoS One. 2013;8(3):e59506. doi: 10.1371/journal.pone.0059506. Epub 2013 Mar 28.

DOI:10.1371/journal.pone.0059506

PMID:23555686

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3610907/

Abstract

BACKGROUND

Registration can help with transparency of acupuncture clinical trials (ACTs) by making protocol information and results available to the public. Recently, the number of registered ACTs has increased greatly, but only a few researchers have focused on the quality of ACTs registration. This review provides the first assessment of the registration quality of ACTs and the baseline information for future development.

METHODS

All records of ACTs registered in the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) were collected. Data was extracted and input to Excel spreadsheets. The current 20 items of the WHO Trial Registration Data Set (TRDS) and the special prepared items for acupuncture intervention details were used to assess the registration quality of ACTs.

RESULTS

A total of 740 records, found in 11 registries, were examined. The number of registered ACTs increased rapidly and involved a number of different diseases. The completeness of 20 items was not too poor due to 16 of them had a higher reported percentage (>85%). The completeness of the 20 items was different among registries. For example, the average registration percentage of 20 items in Clinicaltrials.gov, ChiCTR, ISRCTN and ANZCTR were 89.6%, 92.2%, 82.4% and 91.6% respectively. Detailed information regarding acupuncture intervention was seriously insufficient. Among the 740 registration records, 89.2% lacked information on the style of acupuncture, 80.8% did not contain details regarding the needles used, 53.5% lacked information on the treatment regimen and 76.2% did not give details of other interventions administered with acupuncture.

CONCLUSIONS

The overall registration quality of ACTs is not high enough due to the serious lack of information on the specifics of acupuncture intervention. It is vital that a number of special items be set regarding acupuncture in order to develop a suitable system for the registration of ACTs.

摘要

背景

注册可以通过向公众提供方案信息和结果来提高针灸临床试验（ACTs）的透明度。最近，注册的 ACT 数量大大增加，但只有少数研究人员关注 ACT 注册的质量。本综述首次评估了 ACTs 的注册质量，并为未来的发展提供了基线信息。

方法

收集了世界卫生组织（WHO）国际临床试验注册平台（ICTRP）中所有 ACTs 的记录。提取数据并输入 Excel 电子表格。使用当前的 WHO 试验注册数据集（TRDS）的 20 项和专门为针灸干预细节准备的特殊项目来评估 ACTs 的注册质量。

结果

共检查了 11 个注册中心的 740 个记录。注册的 ACT 数量迅速增加，涉及许多不同的疾病。由于其中 16 项报告的比例较高（>85%），20 项的完整性不是太差。各注册中心的 20 项完整性不同。例如，Clinicaltrials.gov、ChiCTR、ISRCTN 和 ANZCTR 的 20 项注册平均百分比分别为 89.6%、92.2%、82.4%和 91.6%。关于针灸干预的详细信息严重不足。在 740 个注册记录中，89.2%缺乏针灸方式的信息，80.8%未包含有关使用的针的详细信息，53.5%缺乏治疗方案的信息，76.2%未提供与针灸一起进行的其他干预措施的详细信息。