Epidemiology & Risk Management, OXON Epidemiology, Madrid, Spain.
Worldwide Patient Safety, Bristol-Myers Squibb, Uxbridge, UK.
Pharmacoepidemiol Drug Saf. 2020 Jun;29(6):664-674. doi: 10.1002/pds.5012. Epub 2020 May 12.
Patient alert cards (PACs) for abatacept (ORENCIA) inform patients and healthcare professionals (HCPs) about the risk of infections and allergic reactions. The study evaluates the effectiveness of the PACs in rheumatoid arthritis patients and HCPs, using process indicators (awareness, receipt, utility, knowledge, behaviour) and outcomes.
Surveys of patients and HCPs in five European countries. A retrospective chart review permitted linking clinical and safety outcomes with survey responses.
Data on 190 patients and 79 HCPs (50 physicians and 29 nurses) were analysed. Sixty percent of patients were aware of the PAC, of whom 95% had received it. Knowledge of risk of infection was higher among patients who had received the PAC vs those who had not (64% vs 46%; P = .013). Infections leading to hospitalisation increased with decreasing patient survey global scores: scores of ≥67%, 34%-67% and ≤ 33% were associated with hospitalisation rates of 2.5%, 5.2% and 8.4%, respectively (P = .4). Among HCPs 90% were aware and 68% had accessed the PAC. More nurses than physicians were aware (93% vs 88%), had accessed (78% vs 74%), read (90% vs 59%), distributed (81% vs 66%) and explained the content (94% vs 43%) of the PAC. Knowledge of risk of infection was higher among HCPs who had (91%) vs those who had not (73%) accessed the PAC (P = .053).
PACs were effective in improving knowledge of key safety messages in patients and HCPs. This novel study design bridges the gap of linking process indicators with outcomes in the same patients, thereby strengthening the clinical relevance of patient surveys.
阿巴西普(ORENCIA)的患者警示卡(PAC)向患者和医疗保健专业人员(HCP)告知感染和过敏反应的风险。本研究使用过程指标(意识、接受、效用、知识、行为)和结果评估 PAC 在类风湿关节炎患者和 HCP 中的效果。
在五个欧洲国家对患者和 HCP 进行调查。回顾性病历审查允许将临床和安全结果与调查结果联系起来。
分析了 190 名患者和 79 名 HCP(50 名医生和 29 名护士)的数据。60%的患者知道 PAC,其中 95%的人收到了 PAC。与未收到 PAC 的患者相比,收到 PAC 的患者对感染风险的认识更高(64%对 46%;P = 0.013)。随着患者调查全球评分的降低,导致住院的感染增加:评分≥67%、34%-67%和≤33%分别与住院率 2.5%、5.2%和 8.4%相关(P = 0.4)。在 HCP 中,90%的人知道并访问了 PAC。与医生相比,更多的护士知道(93%对 88%)、访问(78%对 74%)、阅读(90%对 59%)、分发(81%对 66%)和解释 PAC 的内容(94%对 43%)。与未访问 PAC 的 HCP 相比,访问 PAC 的 HCP 对感染风险的认识更高(91%对 73%)(P = 0.053)。
PAC 有效提高了患者和 HCP 对关键安全信息的认识。这种新颖的研究设计弥合了在同一患者中连接过程指标与结果的差距,从而加强了患者调查的临床相关性。