Zorzela Liliane, Mior Silvano, Boon Heather, Gross Anita, Yager Jeromy, Carter Rose, Vohra Sunita
a Department of Pediatrics, University of Alberta , Edmonton , Alberta , Canada.
b Canadian Memorial Chiropractic College , Toronto , Ontario , Canada.
Curr Med Res Opin. 2018 Mar;34(3):407-414. doi: 10.1080/03007995.2017.1383891. Epub 2017 Oct 24.
To develop and test a tool to assess the causality of direct and indirect adverse events associated with therapeutic interventions. The intervention was one or more drugs and/or natural health products, a device, or practice (professional delivering the intervention).
Through the assessment of causality of adverse events, we can learn about factors contributing to the harm and consider what modification may prevent its reoccurrence. Existing scales (WHO-UMC, Naranjo and Horn) were adapted to develop a tool (algorithm and table) to evaluate cases of serious harmful events reported through a national surveillance study. We also incorporated a novel approach that assesses indirect harm (caused by the delay in diagnosis/treatment) and the health provider delivering the intervention (practice). The tool was tested, revised and then implemented to assess all reported cases of serious events resulting from use of complementary therapies. The use of complementary therapies was the trigger to report the event. Each case was evaluated by two assessors, out of a panel of five, representing different health care professionals.
The tool was used in assessment of eight serious adverse events. Each event was independently evaluated by two assessors. The algorithm facilitated assessment of a serious direct or indirect harm. Assessors agreed in the final score on seven of eight cases (weighted kappa coefficient of 0.75).
A tool to support the assessment of causality of adverse events was developed and tested. We propose a novel method to assess direct and indirect harms related to product(s), device(s), practice or a combination of the previous. Further research will probably help evaluate this approach across different settings and interventions.
开发并测试一种工具，以评估与治疗干预相关的直接和间接不良事件的因果关系。干预措施为一种或多种药物和/或天然健康产品、一种器械或做法（实施干预的专业人员）。
通过评估不良事件的因果关系，我们可以了解造成伤害的因素，并考虑进行何种改进以防止其再次发生。对现有量表（世界卫生组织药物不良反应因果关系评估量表、纳兰霍量表和霍恩量表）进行调整，以开发一种工具（算法和表格），用于评估通过一项全国性监测研究报告的严重有害事件案例。我们还纳入了一种新颖的方法，该方法可评估间接伤害（由诊断/治疗延迟导致）以及实施干预的医疗服务提供者（做法）。对该工具进行测试、修订，然后用于评估所有报告的因使用补充疗法导致的严重事件案例。使用补充疗法是报告该事件的触发因素。每个案例由五人专家小组中的两名评估人员进行评估，这两名评估人员代表不同的医疗保健专业人员。
该工具用于评估八起严重不良事件。每起事件均由两名评估人员独立评估。该算法有助于对严重的直接或间接伤害进行评估。在八起案例中的七起案例中，评估人员在最终得分上达成了一致（加权卡帕系数为0.75）。
开发并测试了一种支持评估不良事件因果关系的工具。我们提出了一种新颖的方法来评估与产品、器械、做法或上述各项组合相关的直接和间接伤害。进一步的研究可能有助于在不同环境和干预措施中评估这种方法。
