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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)

Wiig, Siri PhD, MSc*; Haraldseid-Driftland, Cecilie PhD, RN*; Tvete Zachrisen, Rannveig MSc, RN*; Hannisdal, Einar PhD, MD; Schibevaag, Lene MSc*

doi: 10.1097/PTS.0000000000000630
Original Article: PDF Only

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.

From the *SHARE-Centre for Resilience in Healthcare, Faculty of Health Sciences, University of Stavanger, Stavanger

County Governor Oslo and Akershus, Oslo, Norway.

Correspondence: Cecilie Haraldseid-Driftland, PhD, RN, SHARE-Centre for Resilience in Healthcare, Faculty of Health Sciences, University of Stavanger, Kvitmyrveien 11, RO, 4027, Norway (e-mail:

E.H. is an employee at the County Governor involved in the study. The other authors disclose no conflict of interest.

The evaluation was funded by the Norwegian Board of Health Supervision.

This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

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