Feedback for patients reporting adverse drug reactions; satisfaction and expectations

<b><i>Objective:</i></b> Due to the rising number of patient reports in pharmacovigilance, the manner in which feedback is provided to patients is an element to be considered. The objective is to explore the satisfaction of patients towards personalized and general feedback in response to their reported adverse drug reactions (ADRs). <b><i>Methods:</i></b> Patients who reported an ADR to the Dutch Pharmacovigilance Centre for the first time in the period between October 2012 and April 2013 were included. Reporters received personalized feedback or a general acknowledgement letter. Satisfaction towards the received feedback, expressed on a 5-point Likert scale (1 very good to 5 very poor), was studied using a web-based questionnaire. Data were analyzed using Pearson Chi-square test and linear regression analysis. Statistical significance was based on p &lt; 0.05. <b><i>Results:</i></b> A total of 471 patient-reporters were contacted with a total response of 52.5%. Respondents of both groups were satisfied with the received feedback, average score 2 (good). Respondents of the personalized feedback-group were however more satisfied score 2.0 versus 2.5 (p &lt; 0.001) and considered the feedback more clear and useful compared with respondents of the acknowledgement letter-group, respectively score 1.6 versus 1.7 (p = 0.01) and score 2.1 versus 2.5 (p &lt; 0.001). <b><i>Conclusion:</i></b> Patients reporting ADRs are satisfied with feedback received from the pharmacovigilance centre, whether this is a personalized feedback or a general acknowledgment letter. They find it clear, useful and it meets their expectation. Although differences were found between the two types of feedback, these differences did not indicate dissatisfaction towards the received feedback.

**<i>研究目的</i>**：鉴于药物警戒（pharmacovigilance）领域患者上报病例数持续攀升，向患者反馈的方式已成为一项需考量的重要环节。本研究旨在探究患者对针对其上报的药品不良反应（adverse drug reactions, ADRs）所提供的个性化反馈与通用反馈的满意度情况。
**<i>研究方法</i>**：纳入2012年10月至2013年4月期间首次向荷兰药物警戒中心上报药品不良反应的患者作为研究对象。上报者被分配至两组，分别接收个性化反馈或通用确认函。通过网络问卷收集受试者对所接收反馈的满意度数据，满意度采用5级李克特量表（5-point Likert scale）进行评价，其中1分代表“非常好”，5分代表“非常差”。采用皮尔逊卡方检验（Pearson Chi-square test）与线性回归分析（linear regression analysis）对数据进行统计学分析，以p<0.05作为具有统计学显著性的判定标准。
**<i>研究结果</i>**：本研究共联系了471名患者上报者，总应答率为52.5%。两组受试者均对所接收的反馈表示满意，整体平均得分为2分（对应“良好”等级）。其中，个性化反馈组受试者的满意度更高，平均得分为2.0分，而通用确认函组得分为2.5分（p<0.001）；同时，个性化反馈组受试者认为反馈的清晰度与实用性均更优，清晰度评分分别为1.6分与1.7分（p=0.01），实用性评分分别为2.1分与2.5分（p<0.001）。
**<i>研究结论</i>**：向药物警戒中心上报药品不良反应的患者，无论接收的是个性化反馈还是通用确认函，均对所获得的反馈表示满意。受试者均认为反馈清晰易懂、具备实用性，且符合其预期。尽管两种反馈方式的评价存在统计学差异，但该差异并不代表受试者对所接收的反馈存在不满情绪。