Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.
Effectiveness of the Med Safety mobile application in improving adverse drug reaction reporting by healthcare professionals in Uganda: a protocol for a pragmatic cluster-randomised controlled trial.
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DOI：
10.1136/bmjopen-2022-061725
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发表时间：
2022-07-01
期刊：
影响因子：
2.9
通讯作者：
Pirmohamed, Munir
中科院分区：
文献类型：
--
作者：
Kiguba, Ronald;Mwebaza, Norah;Ssenyonga, Ronald;Ndagije, Helen Byomire;Nambasa, Victoria;Katureebe, Cordelia;Katumba, Kenneth;Tregunno, Phil;Harrison, Kendal;Karamagi, Charles;Scott, Kathryn A.;Pirmohamed, Munir
抗逆转录病毒联合疗法（cART）大大降低了艾滋病毒死亡率。然而，长期cART增加了药物不良反应（adr）的风险，这可能导致艾滋病毒感染者（PLHIV）更高的发病率、死亡率和医疗费用。药物警戒——监测药物的影响——对于了解现实世界的药物安全至关重要。在乌干达，药物警戒系统是最近才建立起来的，cART的不良反应报告率非常低。因此，目前在我国人口中用于治疗艾滋病毒和结核病的药物的安全性知之甚少。Med Safety移动应用程序是通过欧盟的创新药物倡议网络识别药物不良反应项目开发的，以促进数字药物警戒。这个移动应用程序已经被乌干达国家药物管理局批准用于adr报告。然而，目前尚不清楚Med Safety采用的障碍和促进因素，以及它在提高药物警戒方面的有效性。一项实用的集群随机对照试验将在191个干预点和191个比较cART点实施30个月，以评估Med安全性。使用密封信封软件生成的随机序列，我们将382个预先筛选的cART位点随机分配到干预组和比较组。每个cART站点都是一个集群，由医疗保健专业人员和接受基于曲地韦的cART和/或异烟肼预防治疗的艾滋病毒感染者组成。在干预组登记的医疗保健专业人员将接受使用手机、纸质和网络报告的培训，而在比较组登记的医疗保健专业人员将只接受纸质和网络报告的培训。由Makerere大学生物医学科学研究与伦理委员会（SBS-REC-720）给予伦理批准，并获得乌干达国家科学技术委员会（HS1366ES）的行政许可。研究结果将与医疗保健专业人员、政策制定者、公众和学术界分享。PACTR202009822379650。
Combination antiretroviral therapy (cART) has massively reduced HIV mortality. However, long-term cART increases the risk of adverse drug reactions (ADRs), which can lead to higher morbidity, mortality and healthcare costs for people living with HIV (PLHIV). Pharmacovigilance—monitoring the effects of medicines—is essential for understanding real-world drug safety. In Uganda, pharmacovigilance systems have only recently been developed, and rates of ADR reporting for cART are very low. Thus, the safety profile of medicines currently used to treat HIV and tuberculosis in our population is poorly understood. The Med Safety mobile application has been developed through the European Union’s Innovative Medicines Initiative WEB-Recognising Adverse Drug Reactions project to promote digital pharmacovigilance. This mobile application has been approved for ADR-reporting by Uganda’s National Drug Authority. However, the barriers and facilitators to Med Safety uptake, and its effectiveness in improving pharmacovigilance, are as yet unknown. A pragmatic cluster-randomised controlled trial will be implemented over 30 months at 191 intervention and 191 comparison cART sites to evaluate Med Safety. Using a randomisation sequence generated by the sealed envelope software, we shall randomly assign the 382 prescreened cART sites to the intervention and comparison arms. Each cART site is a cluster that consists of healthcare professionals and PLHIV receiving dolutegravir-based cART and/or isoniazid preventive therapy. Healthcare professionals enrolled in the intervention arm will be trained in the use of mobile-based, paper-based and web-based reporting, while those in the comparison arm will be trained in paper-based and web-based reporting only. Ethical approval was given by the School of Biomedical Sciences Research and Ethics Committee at Makerere University (SBS-REC-720), and administrative clearance was obtained from Uganda National Council for Science and Technology (HS1366ES). Study results will be shared with healthcare professionals, policymakers, the public and academia. PACTR202009822379650.
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