DataSheet3_Engaging Patients via Online Healthcare Fora: Three Pharmacovigilance Use Cases.docx

Increasingly, patient-generated safety insights are shared online, via general social media platforms or dedicated healthcare fora which give patients the opportunity to discuss their disease and treatment options. We evaluated three areas of potential interest for the use of social media in pharmacovigilance. To evaluate how social media may complement existing safety signal detection capabilities, we identified two use cases (drug/adverse event [AE] pairs) and then evaluated the frequency of AE discussions across a range of social media channels. Changes in frequency over time were noted in social media, then compared to frequency changes in Food and Drug Administration Adverse Event Reporting System (FAERS) data over the same time period using a traditional disproportionality method. Although both data sources showed increasing frequencies of AE discussions over time, the increase in frequency was greater in the FAERS data as compared to social media. To demonstrate the robustness of medical/AE insights of linked posts we manually reviewed 2,817 threads containing 21,313 individual posts from 3,601 unique authors. Posts from the same authors were linked together. We used a quality scoring algorithm to determine the groups of linked posts with the highest quality and manually evaluated the top 16 groups of posts. Most linked posts (12/16; 75%) contained all seven relevant medical insights assessed compared to only one (of 1,672) individual post. To test the capability of actively engage patients via social media to obtain follow-up AE information we identified and sent consents for follow-up to 39 individuals (through a third party). We sent target follow-up questions (identified by pharmacovigilance experts as critical for causality assessment) to those who consented. The number of people consenting to follow-up was low (20%), but receipt of follow-up was high (75%). We observed completeness of responses (37 out of 37 questions answered) and short average time required to receive the follow-up (1.8 days). Our findings indicate a limited use of social media data for safety signal detection. However, our research highlights two areas of potential value to pharmacovigilance: obtaining more complete medical/AE insights via longitudinal post linking and actively obtaining rapid follow-up information on AEs.

患者自发产生的安全相关见解正日益通过通用社交媒体平台或专业医疗论坛在线分享——这类平台为患者提供了讨论自身疾病与治疗方案的契机。本研究针对药物警戒领域中社交媒体应用的三大潜在方向展开评估。为评估社交媒体如何补充现有安全信号检测能力，本研究确定了两类应用场景（药物/不良事件 (Adverse Event, AE) 配对），随后对多类社交媒体渠道中的不良事件讨论频次进行了统计分析。研究记录了社交媒体上讨论频次随时间的变化趋势，并采用传统非均衡性分析方法，将其与同期美国食品药品监督管理局不良事件报告系统 (Food and Drug Administration Adverse Event Reporting System, FAERS) 中的频次变化进行对比。尽管两类数据源的不良事件讨论频次均随时间呈上升趋势，但FAERS数据中的增幅显著高于社交媒体渠道。为验证关联帖子中医疗/不良事件见解的可靠性，本研究人工审阅了来自3601位独立作者的2817个讨论串，总计21313条独立帖子。研究将同一作者发布的帖子进行关联整合，采用质量评分算法筛选出质量最高的关联帖子群组，并对排名前16的群组进行了人工评估。经评估，16个群组中12个（占比75%）的关联帖子涵盖了全部7项相关医疗见解，而1672条独立帖子中仅有1条做到了这一点。为验证通过社交媒体主动触达患者以获取不良事件随访信息的可行性，本研究通过第三方机构联系了39名受试者并发送了随访知情同意书。向同意参与随访的受试者发送了由药物警戒专家认定的、对因果关系评估至关重要的针对性随访问题。同意参与随访的受试者占比偏低（20%），但在同意者中完成随访问卷回收的比例高达75%。研究观察到随访问卷的作答完整性极佳（37道问题全部完成作答），且平均回收时长极短（仅1.8天）。本研究结果显示，社交媒体数据在安全信号检测中的应用价值较为有限。但本研究同时揭示了两大对药物警戒具有潜在价值的方向：一是通过纵向关联帖子获取更完整的医疗/不良事件见解，二是主动快速收集不良事件的随访信息。