Aronson Jeffrey K
University of Oxford, Centre for Evidence Based Medicine, Nuffield Department of Primary Care Health Sciences, New Radcliffe House, Radcliffe Observatory Quarter, Woodstock Road, Oxford OX2 6GG, UK.
Expert Rev Clin Pharmacol. 2015;8(4):399-409. doi: 10.1586/17512433.2015.1049598. Epub 2015 May 27.
Anecdotal reports contribute 30% of the literature on adverse drug reactions and interactions. However, the quality of such reports has not been uniformly high. Standardized reporting of clinical studies is of increasing interest, including the CARE guidelines on reporting anecdotal cases in general. Although there are guidelines on evaluating and managing drug-drug interactions, there are none recommending methods for reporting suspected drug interactions. Here, based on published guidelines for reporting suspected adverse drug reactions, I propose a checklist for reporting details of suspected drug interactions, the REporting Anecdotal Drug Interactions (READI) checklist, hoping to stimulate discussion and improve reporting of suspected drug interactions. The checklist includes items relating, among others, to the patient affected, the drugs involved, and the outcome.
轶事性报告占药物不良反应和相互作用文献的30%。然而,此类报告的质量并非一直都很高。临床研究的标准化报告越来越受到关注,包括一般轶事性病例报告的CARE指南。尽管有评估和管理药物相互作用的指南,但没有推荐报告疑似药物相互作用的方法。在此,基于已发表的疑似药物不良反应报告指南,我提出了一份报告疑似药物相互作用细节的清单,即报告轶事性药物相互作用(READI)清单,希望能引发讨论并改善疑似药物相互作用的报告。该清单包括与受影响患者、所涉药物及结果等相关的项目。