Roche Nicolas, Campbell Jonathan D, Krishnan Jerry A, Brusselle Guy, Chisholm Alison, Bjermer Leif, Thomas Mike, van Ganse Eric, van den Berge Maarten, Christoff George, Quint Jennifer, Papadopoulos Nikolaos G, Price David
1Pneumologie, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75014 Paris, France.
2Center for Pharmaceutical Outcomes Reasearch, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Anschutz Medical Campus, Aurora, CO USA.
Clin Transl Allergy. 2019 Mar 27;9:20. doi: 10.1186/s13601-019-0255-x. eCollection 2019.
A Task Force was commissioned jointly by the European Academy of Allergy and Clinical Immunology (EAACI) and the Respiratory Effectiveness Group (REG) to develop a quality assessment tool for real-life observational research to identify high-quality real-life asthma studies that could be considered within future guideline development.
The resulting REal Life EVidence AssessmeNt Tool (RELEVANT) was achieved through an extensive analysis of existing initiatives in this area. The first version was piloted among 9 raters across 6 articles; the revised, interim, version underwent extensive testing by 22 reviewers from the EAACI membership and REG collaborator group, leading to further revisions and tool finalisation. RELEVANT was validated through an analysis of real-life effectiveness studies identified via systematic review of Medline and Embase databases and relating to topics for which real-life studies may offer valuable evidence complementary to that from randomised controlled trials. The topics were selected through a vote among Task Force members and related to the influence of adherence, smoking, inhaler device and particle size on asthma treatment effectiveness.
Although highlighting a general lack of high-quality real-life effectiveness observational research on these clinically important topics, the analysis provided insights into how identified observational studies might inform asthma guidelines developers and clinicians. Overall, RELEVANT appeared reliable and easy to use by expert reviewers.
Using such quality appraisal tools is mandatory to assess whether specific observational real-life effectiveness studies can be used to inform guideline development and/or decision-making in clinical practice.
欧洲变态反应与临床免疫学会（EAACI）和呼吸有效性小组（REG）联合委托一个特别工作组开发一种用于现实生活观察性研究的质量评估工具，以识别高质量的现实生活哮喘研究，这些研究可在未来指南制定过程中加以考虑。
通过对该领域现有举措的广泛分析，形成了现实生活证据评估工具（RELEVANT）。第一个版本在9名评估人员对6篇文章的评估中进行了试点；修订后的临时版本由EAACI成员和REG合作团队的22名评审员进行了广泛测试，从而进行了进一步修订并最终确定了该工具。通过对通过系统检索Medline和Embase数据库确定的现实生活有效性研究进行分析，并涉及现实生活研究可能提供与随机对照试验证据互补的有价值证据的主题，对RELEVANT进行了验证。这些主题是通过特别工作组成员投票选出的，与依从性、吸烟、吸入装置和颗粒大小对哮喘治疗效果的影响有关。
尽管该分析突出表明在这些临床上重要的主题方面普遍缺乏高质量的现实生活有效性观察性研究，但它为已识别的观察性研究如何为哮喘指南制定者和临床医生提供信息提供了见解。总体而言，RELEVANT似乎可靠且便于专家评审员使用。
必须使用此类质量评估工具来评估特定的现实生活有效性观察性研究是否可用于为指南制定和/或临床实践中的决策提供信息。
