To Expand the Evidence Base About Harms from Tests and Treatments

Area of Science:

• Clinical research
• Patient safety
• Health outcomes

Background:

• Limited evidence exists on the full spectrum of patient harms from medical tests and treatments.
• Comprehensive harm assessment is needed for informed clinical decision-making.

Purpose of the Study:

• To develop recommendations for researchers on comprehensively evaluating potential harms of healthcare interventions.
• To enable clinicians and patients to better utilize harm evidence in decision-making.

Main Methods:

• Proposing seven patient-relevant domains of harm: physical impairment, psychological distress, social disruption, disruption in healthcare connection, labeling, financial impact, and treatment burden.
• Highlighting the availability of diverse data and tools for assessing harms across these domains.
• Encouraging evaluation of harms in diverse sub-populations.

Main Results:

• A framework with seven comprehensive domains for evaluating patient harms from healthcare interventions.
• Identification of available data and tools for assessing these harms.
• Emphasis on the importance of considering demographic and clinical characteristics in harm assessment.

Conclusions:

• A structured approach to evaluating patient harms across seven domains can improve the comprehensiveness of research.
• Consideration of diverse populations and available tools can enhance harm assessment.
• Recommendations for regulators, funders, and editors to promote harm reporting are suggested.