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Next-of-Kin Involvement in Regulatory Investigations of Adverse Events That Caused Patient Death

A Process Evaluation (Part II

The Inspectors' Perspective)

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

doi: 10.1097/PTS.0000000000000634
Original Article: PDF Only

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.

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

County Governor Oslo and Akershus, Oslo, Norway

Florence Nightingale Faculty of Nursing, Midwifery & Palliative Care, King's College London, London, United Kingdom.

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

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

The evaluation is 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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