一份教育手册作为风险最小化活动向医疗保健专业人员传达重要罕见不良事件的有效性。
The Effectiveness of an Educational Brochure as a Risk Minimization Activity to Communicate Important Rare Adverse Events to Health-Care Professionals.
作者信息
Bester Nicolette, Di Vito-Smith Michelle, McGarry Theresa, Riffkin Michael, Kaehler Stefan, Pilot Richard, Bwire Robert
机构信息
Specialised Therapeutics Australia, Melbourne, Australia.
Celgene Pty Ltd, Melbourne, Australia.
出版信息
Adv Ther. 2016 Feb;33(2):167-77. doi: 10.1007/s12325-016-0284-y. Epub 2016 Jan 23.
INTRODUCTION
Educational brochures are an important tool for communicating risk to health-care professionals. It is important to evaluate the impact of any risk minimization tool to understand the effectiveness of the strategy. The objective of this study was to assess the effectiveness (i.e., respondents' awareness and understanding of the communication) of a targeted educational brochure distributed to health-care professionals (HCPs) as a risk minimization strategy for the communication of new rare and important adverse events (AEs).
METHODS
A prospective, non-interventional, online survey was performed following distribution of a specifically designed brochure highlighting new and important adverse events to a targeted HCP population, consisting of known users of the target medicine, as represented by a commercial database. Predefined multiple-choice survey questions assessed overall HCP awareness of the brochure and understanding and retention of information in those HCPs who reported receiving the brochure.
RESULTS
The educational brochure was sent to a total of 565 HCPs; 121 (21.4%) responded to the survey. The majority of respondents (95.0%) had previously prescribed or dispensed the target medicine. In all, 88 (72.7%) respondents said they had received the educational brochure, of whom 95.5% stated they had at least scanned the main points. More participants who had received the brochure (86.4% to 96.6%) answered the five individual survey questions correctly compared with those who did not (51.5% to 97.0%); this was significant for four out of five questions (P ≤ 0.005). Significantly more HCPs who received the brochure achieved the predefined pass rate (at least four of five questions answered correctly) compared with HCPs who did not receive the brochure (93.2% vs 57.6%, respectively; P = 0.000003).
CONCLUSIONS
Distribution of targeted educational brochures may be an effective risk minimization strategy to raise HCP awareness of new rare and important AEs; educational brochures may also be an effective channel for sharing information on how these AEs can be best managed and on the importance and means of reporting AEs.
FUNDING
Celgene Pty Ltd, Melbourne, Australia.
引言
教育手册是向医疗保健专业人员传达风险的重要工具。评估任何风险最小化工具的影响对于了解该策略的有效性至关重要。本研究的目的是评估作为传达新的罕见且重要不良事件（AE）的风险最小化策略，分发给医疗保健专业人员（HCP）的针对性教育手册的有效性（即受访者对该沟通内容的知晓度和理解程度）。
方法
在向由商业数据库所代表的目标药物已知使用者这一目标HCP群体分发一份专门设计的突出新的重要不良事件的手册之后，进行了一项前瞻性、非干预性的在线调查。预定义的多项选择题调查问题评估了HCP对手册的总体知晓度以及那些报告收到手册的HCP对信息的理解和记忆情况。
结果
教育手册总共发送给了565名HCP；121名（21.4%）回复了调查。大多数受访者（95.0%）之前曾开具过或调配过目标药物。总共有88名（72.7%）受访者表示他们收到了教育手册，其中95.5%称他们至少浏览了要点。与未收到手册的受访者（51.5%至$97.0%$）相比，收到手册的更多参与者（86.4%至96.6%）正确回答了五个单独的调查问题；五个问题中有四个的这一差异具有统计学意义（P≤0.005）。与未收到手册的HCP相比，收到手册的HCP显著更多地达到了预定义的及格率（五个问题中至少答对四个）（分别为93.2%和57.6%；P = 0.000003）。
结论
分发针对性教育手册可能是提高HCP对新的罕见且重要AE知晓度的有效风险最小化策略；教育手册也可能是分享关于如何最佳管理这些AE以及报告AE的重要性和方式等信息的有效渠道。
资助
澳大利亚墨尔本的新基私人有限公司。
Zotero 插件