An instrument for assessing the quality of informed consent documents for elective procedures: development and...

Area of Science:

• Medical quality improvement
• Patient safety research
• Health informatics

Background:

• Informed consent is crucial for elective procedures.
• Existing tools for assessing informed consent document quality are limited.
• A standardized, nationally applicable tool is needed to evaluate informed consent quality.

Purpose of the Study:

• To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.
• To establish a minimum standard for informed consent documents.
• To enable healthcare providers to evaluate and improve informed consent quality.

Main Methods:

• A mixed qualitative-quantitative approach was employed.
• Stakeholder input (patients, caregivers, physicians, experts) was gathered through seven meetings.
• An abstraction tool was iteratively developed and refined in three phases, including testing on documents from multiple hospitals.

Main Results:

• 53 elements of informed consent quality were identified; 15 were prioritized for the tool.
• The final tool included 8 feasible-to-measure items.
• Two trained raters achieved high item-level agreement (92%-100%) after iterative development and training.

Conclusions:

• Key quality elements for informed consent documents were identified and operationalized.
• A reliable abstraction tool was developed to assess informed consent quality.
• This tool provides a foundation for hospitals to evaluate and enhance their informed consent processes.