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Studies of harm. Clinical applications.
Susana M Fernandes1, Domingos Vaz, Laura Santos
1Centro de Estudos de Medicina Baseada na Evidência Faculdade de Medicina de Lisboa, Lisboa, Portugal.
Summary
Assessing drug-induced harm is crucial. This review focuses on observational study designs, like case-control and cohort studies, for evaluating iatrogenic events when experimental methods are not feasible.
Area of Science:
- Pharmacovigilance
- Clinical Epidemiology
- Drug Safety
Background:
- Clinicians must evaluate both therapeutic efficacy and potential harm of foreign substances.
- The increasing availability of drugs leads to a rise in iatrogenic events, termed 'iatroepidemic'.
- Experimental studies for harm assessment present ethical and financial challenges.
Purpose of the Study:
- To review study designs for determining the harm caused by therapeutic interventions.
- To complement previous discussions on evaluating therapeutic benefit.
Main Methods:
- Focus on observational data for harm assessment.
- Review of case-control study designs.
- Review of cohort study designs.
Main Results:
- Observational data provide essential evidence for harm assessment.
- Case-control and cohort studies are primary methods for evaluating iatrogenic events.
- These designs mitigate ethical and financial concerns associated with experimental studies.
Conclusions:
- Observational studies are vital for understanding drug-induced harm.
- Appropriate study design is critical for accurate assessment of iatrogenic events.
- This review provides a foundation for selecting suitable methodologies to determine therapeutic harm.