de Vries Esther, Denig Petra, Monster Taco B M, Mol Peter G M
Department Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.
Medicines Evaluation Board, Utrecht, the Netherlands.
Pharmacoepidemiol Drug Saf. 2025 Mar;34(3):e70135. doi: 10.1002/pds.70135.
Direct Healthcare Professional Communications (DHPCs) are an important risk minimisation measure. Their effect has been shown to be variable and has been measured using different outcomes and study populations. Depending on the content of the message, the optimal outcome to measure a direct effect of the DHPC can differ. This systematic review investigates whether the effects of DHPCs differ according to the use of proximal outcomes and the inclusion of the targeted population.
EMBASE and MEDLINE were searched for European DHPC effectiveness studies performed up to April 6, 2022, evaluating the impact of DHPCs issued from 2008. Outcomes and their impact were extracted, together with a classification of the message. The outcomes were categorised as knowledge/awareness, self-reported behaviour (prescribing/monitoring), prescribing of medication (including dosage changes), monitoring, or adverse events/other health outcomes, including hospitalisation. The outcomes closest to the message of the DHPC were defined as proximal. Outcomes were coded 1 when effective and 0 if not. If multiple outcomes were reported in a study, a composite outcome was created ranging from 0 to 1. Chi-square or Fisher exact tests were performed.
From 7063 (scientific) publications identified in our literature search, 60 publications evaluating 31 different DHPCs were selected for our review. As publications could study multiple messages with an outcome, from the 60 scientific publications, 103 outcomes were generated for the messages, of which 30 had a high impact on the composite outcome, with the proportion of analyses with a significant association between 0.75 and 1. When taking the target population into account, some messages were studied in more than one population, resulting in 115 outcomes, of which 33 had a high impact, that is, a composite outcome between 0.75 and 1.
Neither the use of proximal outcomes nor the restriction of the analysis to the targeted population significantly influenced the impact observed of the DHPC. These results stress the need for improving drug safety communication.
直接医疗专业人员沟通（DHPCs）是一项重要的风险最小化措施。其效果已显示出具有变异性，并且已使用不同的结果和研究人群进行衡量。根据信息内容，用于衡量DHPC直接效果的最佳结果可能会有所不同。本系统评价调查了DHPCs的效果是否因使用近端结果和纳入目标人群而有所不同。
检索EMBASE和MEDLINE数据库，查找截至2022年4月6日进行的欧洲DHPC有效性研究，评估2008年以来发布的DHPCs的影响。提取结果及其影响，以及信息分类。结果分为知识/意识、自我报告行为（处方/监测）、药物处方（包括剂量变化）、监测或不良事件/其他健康结果，包括住院。最接近DHPC信息的结果被定义为近端结果。结果有效时编码为1，无效时编码为0。如果一项研究报告了多个结果，则创建一个从0到1的综合结果。进行卡方检验或Fisher精确检验。
在我们的文献检索中识别出的7063篇（科学）出版物中，选择了60篇评估31种不同DHPCs的出版物进行综述。由于出版物可以研究多个带有结果的信息，从60篇科学出版物中，为这些信息生成了103个结果，其中30个对综合结果有高影响，具有显著关联的分析比例在0.75至1之间。考虑到目标人群时，一些信息在多个群体中进行了研究，产生了115个结果，其中33个有高影响，即综合结果在0.75至1之间。
使用近端结果或仅对目标人群进行分析，均未显著影响观察到的DHPC的影响。这些结果强调了改善药物安全沟通的必要性。
