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Tool to assess causality of direct and indirect adverse events associated with therapeutic interventions
Liliane Zorzela1, Silvano Mior2, Heather Boon3
1a Department of Pediatrics, University of Alberta , Edmonton , Alberta , Canada.
Objective:
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).
Methods:
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.
Results:
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).
Conclusion:
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.
Insights
A new tool was developed to assess direct and indirect adverse events from therapies, including drugs, devices, and professional practices. This method aids in understanding harm and preventing future occurrences.
Area of Science:
- Pharmacovigilance and patient safety research.
- Development and validation of clinical assessment tools.
Background:
- Assessing causality of adverse events is crucial for understanding harm and preventing recurrence.
- Existing causality scales (WHO-UMC, Naranjo, Horn) have limitations, particularly in assessing indirect harm and provider-related factors.
Purpose of the Study:
- To develop and test a novel tool for assessing the causality of direct and indirect adverse events associated with therapeutic interventions.
- To incorporate assessment of harm caused by diagnostic/treatment delays and the healthcare provider's role.
Main Methods:
- Adapted existing causality scales (WHO-UMC, Naranjo, Horn) into a new algorithm and table.
- Incorporated novel assessment of indirect harm and provider-related factors (practice).
- Tested the tool on eight serious adverse events reported from complementary therapy use, with two independent assessors per case.
Main Results:
- The developed tool was applied to eight serious adverse events.
- Two assessors independently evaluated each event using the tool.
- High inter-rater reliability was achieved, with agreement on seven of eight cases (weighted kappa = 0.75).
Conclusions:
- A validated tool for assessing the causality of adverse events, including direct and indirect harms, has been developed.
- The tool offers a novel approach to evaluating harms related to products, devices, or practices.
- Further research is recommended to evaluate the tool's efficacy across diverse settings and interventions.