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Assessing the Ethical Integrity of Quality Improvement Studies [AEGIS]: a mixed methods study
Matthew J Leach1,2, Vanesa Bochkezanian2, Alexa McArthur2
1Faculty of Health and Community Services, TAFE SA, Adelaide, SA, Australia.
JBI Evidence Implementation
|December 23, 2025
Summary
This study developed the Assessment of the Ethical Integrity of QI Studies (AEGIS) tool to evaluate ethical standards in quality improvement initiatives. The AEGIS tool demonstrates good reliability and utility for assessing ethical conduct in healthcare.
Area of Science:
- Healthcare Ethics
- Quality Improvement Research
- Research Methodology
Background:
- Quality improvement (QI) initiatives are crucial for enhancing healthcare quality.
- However, the ethical integrity of QI initiatives often lacks sufficient attention and evaluation.
- A standardized tool is needed to assess the ethical dimensions of QI studies.
Purpose of the Study:
- To develop and psychometrically evaluate the Assessment of the Ethical Integrity of QI Studies (AEGIS) tool.
- To operationalize key criteria for assessing the ethical integrity of quality improvement research.
- To provide a reliable instrument for ethical review of QI projects.
Main Methods:
- A four-phase sequential mixed methods design was employed.
- Phase I & II: Systematic mapping study to identify and map preliminary criteria against international ethical guidelines.
- Phase III: e-Delphi study for consensus on AEGIS criteria.
- Phase IV: Psychometric evaluation of the AEGIS tool's utility and reliability.
Main Results:
- Phase I identified 23 preliminary criteria, mapped against 18 ethical guidelines.
- The e-Delphi study achieved consensus on 18 transformed AEGIS criteria (>70% agreement).
- Psychometric evaluation showed good internal consistency (α=0.734), moderate interrater reliability (κ=0.481), and good utility.
Conclusions:
- The 18-item AEGIS tool possesses excellent face and content validity.
- The AEGIS tool demonstrates good internal consistency, utility, and broad international relevance.
- AEGIS is a valuable instrument for enhancing the ethical conduct and integrity of QI projects.
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