论文部分内容阅读
背景与目的 对卫生保健干预措施进行决策权衡需要有不良和有益的可靠证据,然而绝大多数系统评价针对的是研究方法非常成熟的随机对照试验及其有效性评价,系统地评价不良反应的方法尚未完善,对研究者而言,能作为相关指南的资源很少。为此,作者在文中报告了对不良反应进行系统评价的新近体会,同时提出进一步实践和研究的建议。方法 描述并比较3个包含不良反应评价的药物干预的系统评价的方法学,重点评价其研究问题、研究设计和质量评价。结果 1个研究关注于如何根据提供的特殊不良反应数据建立卫生经济学模式,而其它两个研究涉及更广泛的问题。尽管每个评价对纳入标准的定义不同,但它们均纳入了随机和观察性数据。对研究质量的评价采用了标准方法。由于研究设计不良、报告不充分和现有研究工具有限,在运用纳入标准和评估研究质量时,研究者遇到了各种问题。最终发现, 3个评价都做了大量的工作,但对卫生保健决策者有用的资料不多。研究者确认,改善的关键在于如何提出系统评价的问题和发展不良反应研究的质量评价方法学。结论 若不良反应的系统评价只专注于一个中心问题,那么它会提供与临床决策更相关的资料,也有利于明确纳入系统评价研究的类型。系统评价中不良反应的质量评估的方法学需要进一步完善。
Background and Objectives The decision-making trade-offs for health care interventions require unscrupulous and helpful credible evidence. However, the vast majority of systematic reviews are aimed at well-developed randomized controlled trials and their effectiveness assessments, and systematic approaches to evaluate adverse reactions. Not yet perfect, for researchers, there are few resources that can serve as guidance. To this end, the author reported in his paper a recent experience in the systematic evaluation of adverse reactions and proposed further practice and research. Methods To describe and compare the methodologies of three systematic reviews of drug interventions that include adverse reactions assessment, with a focus on evaluating their research issues, research design, and quality assessment. Results One study focused on how to establish a model of health economics based on the specific adverse reaction data provided, while the other two studies involved broader issues. Although each evaluation defined different inclusion criteria, they included random and observational data. The standard method was used to evaluate the quality of the study. Due to poor research design, inadequate reporting, and limited research tools available, researchers have encountered various problems in applying inclusion criteria and assessing research quality. In the end, it was found that all three evaluations did a lot of work, but little information was available to health care decision makers. Researchers have confirmed that the key to improvement lies in how to put forward the questions of systematic evaluation and the methodology of quality assessment of adverse reaction research. Conclusion If systematic reviews of adverse reactions focus on only one central issue, then it will provide more relevant information for clinical decision-making, and it will also facilitate the explicit inclusion of systematic review studies. The methodological assessment of adverse reactions in systematic reviews needs further refinement.