Interventions to improve spontaneous adverse drug reaction reporting by healthcare professionals and patients: systematic review and meta-analysis

The aim of this study was to evaluate the effectiveness of interventions used for improving ADR reporting by patients and healthcare professionals. A systematic review of literature was conducted by searching Medline, Embase and Cochrane Central Register of Controlled of Trials. Meta-analysis of randomized controlled trials (RCTs; <i>n</i> = 5) was conducted to estimate the pooled risk ratio for the effectiveness of interventions on ADR reporting rates. Data from observational studies were synthesized using narrative synthesis approach. A total of 28 studies were included. All except one study targeted healthcare professionals using educational, technological, policy, financial and/or mixed interventions. The results showed that financial and face-to-face educational interventions improved quality and quantity of ADR reporting when compared with interventions not involving face-to-face interactions. However, the quality of studies was generally low. Meta-analysis showed a statistically significant 3.5-fold overall increase in reporting of ADRs [RR 3.53; 95% CI (1.77,7.06)] in the intervention group compared to the control. There was a lack of consideration of theory and sustainability in the design of the interventions. There is a need to develop and test theory-based interventions and target patient reporting. More research needs to be conducted in the low- and middle-income countries.

本研究旨在评估用于提升患者与医疗卫生专业人士药品不良反应（Adverse Drug Reaction, ADR）报告率的干预措施有效性。本研究通过检索Medline、Embase及科克伦对照试验中心注册库（Cochrane Central Register of Controlled Trials）开展了系统性文献综述。针对5项随机对照试验（randomized controlled trials, RCTs；n=5）进行了荟萃分析，以估算干预措施对ADR报告率影响的合并风险比。观察性研究的数据采用叙述性综合法进行整合。最终共纳入28项研究，仅1项研究未以医疗卫生专业人士为干预对象，其采用的干预手段涵盖教育、技术、政策、财政及多模式干预。结果表明，相较于未涉及面对面互动的干预措施，财政支持与面对面教育类干预可提升ADR报告的质量与数量。不过，此类研究的整体质量普遍偏低。荟萃分析结果显示，干预组的ADR报告率较对照组整体提升3.5倍，且具有统计学显著性[相对风险比（Relative Risk, RR）=3.53；95%置信区间（Confidence Interval, CI）：1.77, 7.06]。现有干预措施的设计普遍未兼顾理论基础与可持续性。未来亟需开发并验证基于理论的干预措施，并将患者作为ADR报告的目标人群。同时，还需在低收入及中等收入国家开展更多相关研究。