LAUSR

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.