Assessing the Ethical Integrity of Quality Improvement Studies [AEGIS]: a mixed methods study

INTRODUCTION: Although health care agencies are encouraged to use quality improvement (QI) initiatives to improve quality of care, the ethical integrity of such initiatives has received little attention. OBJECTIVE: This project aimed to develop and evaluate key criteria to operationalize the Assessment of the Ethical Integrity of QI Studies (AEGIS). METHODS: The study used a four-phase sequential mixed methods design, comprising (i) a systematic mapping study to identify [Phase I] and map [Phase II] preliminary criteria against international ethical guidelines; (ii) an e-Delphi study to reach consensus on the transformed AEGIS criteria [Phase III]; and (iii) a psychometric evaluation to assess the utility and reliability of the AEGIS criteria [Phase IV]. RESULTS: Phase I identified 23 preliminary AEGIS criteria, which were mapped against 18 ethical guidelines/statements [Phase II]. No statements were mapped to the five levels of ethical review; 0%-61.5% were mapped to four criteria for ethical review exemption; 15.4%-30.8% were mapped to seven triggers for ethical review; and 69.2%-100% were mapped to seven ethical principles. Preliminary criteria were transformed into 18 criteria, with a Delphi panel reaching > 70% consensus on all criteria [Phase III]. A panel of international experts tested the AEGIS tool against five randomly selected publications of QI activities [Phase IV], demonstrating that the tool had good internal consistency (α = 0.734), moderate interrater reliability (κ = 0.481), and good utility. CONCLUSIONS: The 18-item AEGIS tool demonstrated excellent face and content validity, good internal consistency and utility, moderate interrater reliability, and broad application and international relevance. Thus, the AEGIS tool represents an important step toward improving the ethical conduct and integrity of QI projects. SPANISH ABSTRACT: http://links.lww.com/IJEBH/A451.