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补充医学与安全性:系统评价设计与报告的系统性调查。

Complementary medicine and safety: a systematic investigation of design and reporting of systematic reviews.

机构信息

School of Life Sciences, University of Westminster, 115 New Cavendish Street, London W1W 6UW, UK.

出版信息

Complement Ther Med. 2012 Feb-Apr;20(1-2):73-82. doi: 10.1016/j.ctim.2011.10.002. Epub 2011 Nov 6.

Abstract

OBJECTIVES

The objective of this study was to examine the methods used in systematic reviews of safety across a range of complementary therapies to assess the variation in approach and the potential for developing guidance on conduct and reporting.

DESIGN

Systematic reviews focusing on safety were retrieved from NHS Evidence and searches of major databases. A pre-prepared template was used for data extraction. Information extracted included details of search strategies, sources, participants, interventions, reported adverse event/effect(s) and causality assessment. Data extraction was carried out by one researcher and a check for accuracy by a second researcher. Methods were assessed against criteria based on guidance provided by the Cochrane Adverse Effects Methods Group.

RESULTS

A total of 2563 citations were screened and 88 systematic reviews were selected for inclusion. The majority focused on the safety of herbs and nutritional supplements. Approximately half the reviews covered all aspects of safety; other reviews addressed specific adverse effects or interactions. Types of data included in the reviews did not always reflect the focus of the review. Search strategies, sources used, quality assessment and assessment of causality also varied.

CONCLUSIONS

Detailed examination and comparison of the methods has highlighted several areas in which there is potential for development of guidelines and consensus on standards. These include search strategies, sources of information, data extraction and assessment of causality. The value of systematic reviews in relation to large outcome studies requires further consideration.

摘要

目的

本研究旨在考察一系列补充疗法安全性系统评价中使用的方法,以评估方法的差异,并为其实施和报告提供指导。

设计

从 NHS 证据库和主要数据库中检索到关注安全性的系统评价。使用预先准备的模板进行数据提取。提取的信息包括搜索策略、来源、参与者、干预措施、报告的不良事件/效应和因果关系评估的详细信息。由一名研究人员进行数据提取,并由第二名研究人员进行准确性检查。方法根据 Cochrane 不良反应方法组提供的指南进行评估。

结果

共筛选出 2563 条引文,纳入了 88 篇系统评价。大多数研究集中在草药和营养补充剂的安全性上。约有一半的综述涵盖了安全性的所有方面;其他综述则针对特定的不良反应或相互作用。综述中包含的类型数据并不总是反映综述的重点。搜索策略、使用的来源、质量评估和因果关系评估也存在差异。

结论

对方法的详细检查和比较突出了在指南制定和标准共识方面有发展潜力的几个领域。这些领域包括搜索策略、信息来源、数据提取和因果关系评估。系统评价与大型结局研究的相关性需要进一步考虑。

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