Patient perspectives on adverse event investigations in health care.

BACKGROUND: Over the last decade attention has grown to give patients and next of kin (P/N) more substantial roles in adverse event investigations. Adverse event investigations occur after adverse events that resulted in death or severe injury. Few studies have focused on patient perspectives on their involvement in such investigations. The present study sets out to investigate how P/N and patient representatives (client councils and the Patient Federation Netherlands) view the involvement of P/N in adverse event investigations, particularly whether and why they want to involved, and how they want to shape their involvement. METHODS: The study features qualitative data on three levels: interviews with P/N (personal), focus groups with representatives of client councils (institutional), and an interview with the Patient Federation Netherlands (national). Researchers used inductive, thematic analysis and validated the results through data source triangulation. RESULTS: The initiative taken by the hospitals in this study provided P/N with the space to feel heard and a position as legitimate stakeholder. P/N appreciated the opportunity to choose whether and how they wanted to be involved in the investigation as stakeholders. P/N emphasized the need for hospitals to learn from the investigations, but for them the investigation was also part of a more encompassing relationship. P/N's views showed the inextricable link between the first conversation with the health care professional and the investigation, and the ongoing care after the investigation was finalized. Hence, an adverse event investigation is part of a broader experience when understood from a patient perspective. CONCLUSIONS: An adverse event investigation should be considered as part of an existing relationship between P/N and hospital that starts before the investigation and continues during follow up care. It is crucial for hospitals to take the initiative in the investigation and in the involvement of P/N. P/N motivations for involvement can be understood as driven by agency or communion. Agentic motivations include being an active participant by choice, while communion motivations include the need to be heard.

Case studies on the impact of ex-post legislative evaluations in Dutch healthcare: a within and cross-case analysis.

Globally, ex-post legislative evaluations are becoming increasingly important for understanding how laws function in practice and identifying their limitations and their effects upon stakeholders. This study delves into the impact of ex-post legislative evaluations within the Dutch healthcare system. Building upon insights from previous literature, we aim to refine existing ideas within the field through empirical data. Utilising the realist evaluation method, we examine three distinct case studies followed by a cross-case analysis. Our research underscores that the impact of these evaluations extends beyond policy and politics to the broader societal arena. Our findings also point towards opportunities for strengthening the impact of ex-post legislative evaluations within this broader societal arena. Specifically, we identify strategic phases within the evaluation process through which we aim to maximise impact. Finally, the study emphasises the importance of context awareness, the strategic utilisation of research quality as well as interactional factors for enhancing impact.

Involving Patients and/or Their Next of Kin in Serious Adverse Event Investigations: A Qualitative Study on Hospital Perspectives.

BACKGROUND: The involvement of patients or next of kin (P/N) after a serious adverse event (SAE) is evolving. Beyond providing mandatory information, there is growing recognition of the need to incorporate their interests. This study explores practical manifestations of P/N involvement and identifies significant considerations for hospitals. METHODS: The data collection involved various qualitative research methods: 7 focus groups with 56 professionals from 37 hospitals, an interview with 2 representatives from the Dutch Association of Hospitals, and an interactive reflection seminar with over 60 participants from 34 hospitals. Before the focus groups, a brief questionnaire was sent out to survey participants' practices regarding into SAE investigations. After the study, another questionnaire was distributed to gather suggestions for future improvements and to identify their lessons learned. Thematic analysis was applied to the gathered data to identify key themes. RESULTS: Hospitals are increasingly acknowledging the interests and perspectives of P/N, recognizing their potential contributions to organizational learning and improvement. P/N involvement following SAEs includes active participation in different stages of the investigation process, not just passive information dissemination. Important factors influencing involvement are the provision of (emotional) support, identification of needs, and transparency of the SAE investigation. CONCLUSIONS: This study enhances understanding of evolving practices surrounding P/N involvement in the context of SAEs in Dutch hospitals. The findings highlight the importance of promoting meaningful involvement, recognizing the significance of P/N experiences, and fostering a culture of transparency and collaboration. By examining the dynamics of involvement, this research aims to inform policy development and facilitate the implementation of patient-centered approaches to post-SAE care.

The Impact of Ex-Post Legislative Evaluations in Healthcare: A Mixed Methods Realist Evaluation Study Protocol for Conducting Case Studies.

Background: Recent studies on the impact of ex-post legislative evaluations show that there are different types of impact and different factors that can influence it. These include the context of a legislative evaluation, research quality, and interactions between researchers and other actors within the evaluation process. However, thorough empirical research in this area is lacking. This warrants empirical research into the factors that influence the impact of ex-post legislative evaluations, so these insights can be used to increase the likelihood of ex-post legislative evaluations having an impact. Methods and analysis: In this protocol, we report on the realist evaluation methodology that will be used to evaluate the impact of three ex-post legislative evaluations in the Dutch healthcare sector. The mixed methods realist evaluation approach will facilitate this theory-driven, qualitative research. The study will consist of the following three steps: (1) Initial programme theory development, (2) theory validation, and (3) theory refinement. Knowledge from two scoping reviews conducted previously, and two subsequent expert meetings will form the basis for developing the initial programme theory. During this study, three case studies will be conducted, in which three individual ex-post legislative evaluations will be examined. Specificmethods for data collection will include: documentary review, observation, structured questionnaires and focus group discussions with purposefully identified key stakeholders. Using the framework approach, the data will be analysed thematically in a within-case analysis followed by a cross-case analysis. Discussion: This protocol provides insight into how the study will be conducted. As this study uses multiple qualitative researchmethods to answer one question, this protocol supports refining data collection procedures. Careful consideration of the approach beforehand can minimise pitfalls, reduce publication bias and improve reproducibility. The protocol therefore specifies how the research question will be answered in detail, and this provides solid guidance for the research process.

Factors influencing the impact of ex-post legislative evaluations: a scoping review.

This article explores the factors that influence the impact of ex-post legislative evaluations and suggests that these factors can be divided into three main categories: context, research quality, and interaction. Contextual factors, including the evaluation's initiation, it's place in the legislative process, the varied functions given by stakeholders, and the level of political or social attention, are beyond researchers' control. However, researchers can influence research quality and interaction with stakeholders, such as the evaluations' commissioner, as well as the society at large, thereby increasing the likelihood of achieving impactful results. They should engage with the evaluation context to improve impact, but must also maintain independence while being influenced by the context. These findings are in line with the much broader literature on the impact of policy and programme evaluations which pays less attention to the policy instrument legislation. Therefore, both disciplines have an interest in a better exchange of knowledge.

The impact of ex-post legislative evaluations: a scoping review.

In various countries, laws are increasingly being evaluated by examining the effects in practice once a law enters into force. No systematic overview currently exists on the impact of these ex-post legislative evaluations. Therefore, this scoping review systematically examines the various types of impact of ex-post legislative evaluations. The studies we looked at demonstrate different types of impact that can be divided into the following seven categories: knowledge and understanding; confirmation of wellfunctioning legislation; legislative revision; influence on the legislative process; influence on the policy process; influence in the political sphere; and influence on society. The various types of impact are sometimes interrelated and can exist in various degrees. At the national and European levels, legislative revision and the tactical use of evaluation results in the political sphere, are the two most often mentioned categories. In contrast, the impact on society category is rarely mentioned.