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.

Mediators of change in healthcare organisations subject to external assessment: a systematic review with narrative synthesis.

OBJECTIVES: External inspections are widely used to improve the quality of care. The effects of inspections remain unclear and little is known about how they may work. We conducted a narrative synthesis of research literature to identify mediators of change in healthcare organisations subject to external inspections. METHODS: We performed a literature search (1980-January 2020) to identify empirical studies addressing change in healthcare organisations subject to external inspection. Guided by the Consolidated Framework for Implementation Research, we performed a narrative synthesis to identify mediators of change. RESULTS: We included 95 studies. Accreditation was the most frequent type of inspection (n=68), followed by statutory inspections (n=19), and external peer review (n=9). Our findings suggest that the regulatory context in which the inspections take place affect how they are acted on by those being inspected. The way inspections are conducted seem to be critical for how the inspection findings are perceived and followed up. Inspections can engage and involve staff, facilitate leader engagement, improve communication and enable the creation of new networks for reflection on clinical practice. Inspections can contribute to creating an awareness of the inspected organisation's current practice and performance gaps, and a commitment to change. Moreover, they can contribute to facilitating the planning and implementation of change, as well as self-evaluation and the use of data to evaluate performance. CONCLUSIONS: External inspections can affect different mediators of organisational change. The way and to what extent they do depend on a range of factors related to the outer setting, the way inspections are conducted and how they are perceived and acted on by the inspected organisation. To improve the quality of care, the organisational change processes need to involve and impact the way care is delivered to the patients.

A risk analysis of cancer care in Norway: the top 16 patient safety hazards.

BACKGROUND: Cancer care processes represents a number of potential threats to patient safety. A national risk analysis of Norwegian cancer care, entailing diagnosis, treatment, follow-up, palliative care, and terminal care, was conducted. METHODS: Literature review and a retrospective analysis of hazards in different national databases were combined with interviews with key health personnel in an attempt to identify 50 possible hazards. A project team from the Norwegian Board of Health Supervision (NBHS) and 23 other persons participated in the workshop in 2009. RESULTS: In a stepwise, consensus-driven process, the 23 participants discussed the 50 possible hazards and then selected the 16 that they considered most important-clustered into three groups: diagnosis and primary treatment, interactions, and complications. The NBHS distributed the risk analysis report to a variety of stakeholders and asked Norway's hospital trusts to address the hazards. The report generally met a positive reception, albeit with local and interdisciplinary differences in the extent of the perceived applicability of the respective hazards. Two follow-up studies in 2012 and 2013 showed that the hospital trusts lacked the implementation capacity to identify operational solutions to reduce the hazards. At the largest hospital trust in Norway-Oslo University Hospital-the Department of Oncology retested the national risk analysis in in 2011. Four groups, representing different parts of the patient care process. selected 9 of the 16 national hazards and identified 4 new ones. The department has established goals and appropriate activities for 3 of the hazards. CONCLUSIONS: The Ministry of Health and Care determined that hospital trusts must increase their implementation capacity regarding operational solutions to reduce the hazards.

Cisplatin and etoposide regimen is superior to cyclophosphamide, epirubicin, and vincristine regimen in small-cell lung cancer: results from a randomized phase III trial with 5 years' follow-up.

PURPOSE: To investigate whether chemotherapy with etoposide and cisplatin (EP) is superior to cyclophosphamide, epirubicin, and vincristine (CEV) in small-cell lung cancer (SCLC). PATIENTS AND METHODS: A total of 436 eligible patients were randomized to chemotherapy with EP (n = 218) or CEV (n = 218). Patients were stratified according to extent of disease (limited disease [LD], n = 214; extensive disease [ED], n = 222). The EP group received five courses of etoposide 100 mg/m(2) intravenously (IV) and cisplatin 75 mg/m(2) IV on day 1, followed by oral etoposide 200 mg/m(2) daily on days 2 to 4. The CEV group received five courses of epirubicin 50 mg/m(2), cyclophosphamide 1,000 mg/m(2), and vincristine 2 mg, all IV on day 1. In addition, LD patients received thoracic radiotherapy concurrent with chemotherapy cycle 3, and those achieving complete remission during the treatment period received prophylactic cranial irradiation. RESULTS: The treatment groups were well balanced with regard to age, sex, and prognostic factors such as weight loss, and performance status. The 2- and 5-year survival rates in the EP arm (14% and 5%, P =.0004) were significantly higher compared with those in the CEV arm (6% and 2%). Among LD patients, median survival time was 14.5 months versus 9.7 months in the EP and CEV arms, respectively (P =.001). The 2- and 5-year survival rates of 25% and 10% in the EP arm compared with 8% and 3% in the CEV arm (P =.0001). For ED patients, there was no significant survival difference between the treatment arms. Quality-of-life assessments revealed no major differences between the randomized groups. CONCLUSION: EP is superior to CEV in LD-SCLC patients. In ED-SCLC patients, the benefits of EP and CEV chemotherapy seem equivalent, with similar survival time and quality of life.