Next of Kin Involvement in Regulatory Investigations of Adverse Events That Caused Patient Death: A Process Evaluation (Part I - The Next of Kin's Perspective).

OBJECTIVE: The aim of the study was to explore experiences from the next of kin's perspective of a new involvement method in the regulatory investigation process of adverse events causing patient death. METHODS: The study design was a qualitative process evaluation of the new involvement method in two Norwegian counties. Next of kin who had lost a close family member in an adverse event were invited to a 2-hour face-to-face meeting with regulatory inspectors to shed light on the event from the next of kin's perspective. Data collection involved 18 interviews with 29 next of kin who had participated in the meeting and observations (20 hours) of meetings from 2017 to 2018. Data were analyzed using a thematic content analysis. RESULTS: Next of kin wanted to be involved and had in-depth knowledge about the adverse event and the healthcare system. Their involvement extended beyond sharing information, and some experienced it as having a therapeutic effect and contributing to transparency and trust building. The inspectors' professional, social, and human skills determined the experiences of the involvement and were key for next of kin's positive experiences. The meeting was emotionally challenging, and some next of kin found it difficult to understand the regulators' independent role and suggested improving information given to the next of kin before the meeting. CONCLUSIONS: Although the meeting was emotionally challenging, the next of kin had a positive experience of being involved in the investigation and believed that their information contributed to improving the investigation process.

Next-of-Kin Involvement in Regulatory Investigations of Adverse Events That Caused Patient Death: A Process Evaluation (Part II: The Inspectors' Perspective).

OBJECTIVE: The aim of the study was to explore regulatory inspectors' experiences with a new method for next-of-kin involvement in investigation of adverse events causing patient death. A resilient healthcare perspective is used as the theoretical foundation. METHODS: The study design was a qualitative process evaluation of the new involvement method in 2 Norwegian counties. Next of kin, who had lost a close family member in an adverse event, were invited to a 2-hour face-to-face meeting with the inspectors. Data collection involved 3 focus group interviews with regulatory inspectors and observation (20 hours) of the meetings (2017-2018). Data were analyzed by a thematic content analysis. RESULTS: Next-of-kin involvement informed the investigations by additional and new information about the adverse events and by different versions of the investigators' earlier obtained information, such as time sequences, what happened and how, and who were involved. Inspectors considered next of kin as a key source of information that contributed to improve the quality of the investigation. The downside was that the involvement method increased work load and could challenge the principle of equal treatment in regulatory practice. CONCLUSIONS: Involvement of next of kin in regulatory investigation of adverse events causing patient death contributes to a better understanding of work as done in clinical practice and contributes to strengthen the learning potential in resilience.