Dto. de Medicina Preventiva y Salud Pública, Facultad de Medicina, University of Santiago de Compostela, c/ San Francisco s/n, 15786 Santiago de Compostela-A Coruña, Spain.
Drug Saf. 2013 May;36(5):317-28. doi: 10.1007/s40264-013-0058-2.
Underreporting is the major limitation of a voluntary adverse drug reaction (ADR) reporting system. Many studies have assessed the effectiveness of different interventions designed to reduce underreporting.
We aimed to conduct a critical review of papers that assessed the effectiveness of different strategies to increase ADR reporting, regardless of the health professionals or patients included.
Scientific papers were selected after a search of the MEDLINE-PubMed and EMBASE scientific databases up to 7 December 2010.
We included papers in English, French or Spanish that analysed an intervention aimed at increasing the number of reported ADRs, and quantify the results of the intervention in terms of number of reports.
The abstracts retrieved in both computerized searches were reviewed independently by two of the authors. Initially selected papers were thoroughly read to evaluate if they met inclusion and exclusion criteria. Data in finally selected papers were independently extracted by both authors and set in pre-designed tables. A third author took the final decision in case of disagreement. For each study, we analysed study design, type of intervention, assessment period, and results of the intervention.
Of the 4,221 papers located that fulfilled the search criteria, 43 met the selection criteria. With the exception of one study, the interventions assessed were deemed to be effective. The vast majority of papers displayed methodological and formal limitations that lowered the grade of evidence. Multiple interventions seem to have had more impact than did single interventions. There were very few cases in which interventions were designed on the basis of inappropriate attitudes and mistaken beliefs about ADRs.
In general, there is a need for studies of better methodological quality in this topic, so that more evidence of the effectiveness of the respective strategies can be collected for the purpose of improving ADR reporting by health professionals. It is probable that multiple interventions cause greater increases in the ADR reporting rates than single.
自愿药物不良反应（ADR）报告系统的主要局限性是漏报。许多研究评估了旨在减少漏报的不同干预措施的有效性。
我们旨在对评估增加 ADR 报告的不同策略的有效性的论文进行批判性回顾，无论纳入的是卫生专业人员还是患者。
在 2010 年 12 月 7 日之前，通过搜索 MEDLINE-PubMed 和 EMBASE 科学数据库选择了科学论文。
我们纳入了以增加报告的 ADR 数量为目标并以报告数量衡量干预效果的英语、法语或西班牙语论文。
对计算机搜索中检索到的摘要进行了由两位作者独立审查。最初选择的论文进行了仔细阅读，以评估其是否符合纳入和排除标准。最终选择的论文中的数据由两位作者独立提取并设置在预先设计的表格中。在有分歧的情况下，由第三位作者做出最终决定。对于每一项研究，我们分析了研究设计、干预类型、评估期和干预结果。
符合搜索标准的 4221 篇论文中，有 43 篇符合选择标准。除了一项研究外，评估的干预措施都被认为是有效的。绝大多数论文都存在方法和形式上的局限性，降低了证据的等级。与单个干预相比，多个干预措施似乎具有更大的影响。在极少数情况下，干预措施是基于对 ADR 的不当态度和错误信念设计的。
一般来说，需要在这一主题上进行更好的方法学质量的研究，以便为卫生专业人员收集更多关于各自策略有效性的证据，从而提高 ADR 报告率。与单个干预相比，多个干预措施可能会导致 ADR 报告率的更大提高。
