1 Background

Patients and families affected by physical or psychological harm arising from their healthcare benefit from open and honest communication by healthcare staff about the events that have occurred [1-3]. Several health systems have adopted frameworks to encourage best practice, inclusive of transparent communication and apology every time an adverse event occurs. This is referred to as ‘incident disclosure’ or ‘open disclosure’ [4, 5]. In Australia, the Open Disclosure Standard was released in 2003. Following a review of the Standard in 2011, it was replaced by the Open Disclosure Framework endorsed nationally in 2012 [4]. Similarly, in the UK, the Being Open Framework was first released in 2002, and updated in 2012 [1].

Despite advancements in knowledge about the gains of open and honest communication and apology, and the adoption of incident disclosure frameworks and management policies, limited progress was demonstrated in the rate or quality of disclosure [3]. Fear of punitive action associated with legal implications of providing an apology and an absence of mandatory requirement for disclosure were cited as key barriers [1, 6]. With lack of disclosure or poor quality disclosures continuing to cause distress among patients and families affected by healthcare adverse events, consumer groups advocated for a statutory duty of candour (SDC) alongside disclosure frameworks to enhance their implementation and foster an open and honest culture [7]. The Duty requires each health service entity by law to provide the patient or their family or carer who experiences an adverse event with; a written account of the facts, an apology, a description of the health service's response to the event, and the steps taken to prevent reoccurrence. The threshold for an adverse event (events in which a patient is harmed by the healthcare they receive) to meet the SDC requirement varies between countries, but the focus is primarily on events that have caused patient harm [8, 9].

SDC or similar legislation and policies have been introduced in several countries over the past 10 years: England, Wales, Scotland, Ireland, Australia, Germany, Canada; yet its impacts in improving the management of adverse events for patients and families or the accountability of healthcare providers have not been evaluated until now [10]. The UK Department of Health and Social Care recently launched a review of the Duty of Candour to establish its compliance and enforcement in all health and social care providers that the Care Quality Commission (CQC) regulates. The review comes 10 years after the introduction of SDC in UK health settings [9]. Evidence gathering ceased in late May 2024 and a report of findings is forthcoming.

In Australia, SDC was introduced in one of the eight Australian states and territories rather than as a national requirement. As part of a wider culture of change in health services across the Australian state of Victoria, SDC and protections for adverse event reviews were recommended. The SDC was introduced by the Victorian Health Legislation Amendment (Quality and Safety) Act 2022 (the Act) to foster an open and honest culture by elevating existing obligations of open disclosure and apologies. In Victoria, SDC applies when moderate or severe harm occurs to patients. The Act introduced protections for adverse event reviews called serious adverse patient safety event (SAPSE) reviews, to encourage open and frank discussion between health services and consumers in such circumstances. Under the new legislation, if a patient experiences a SAPSE, the health service entity has a legal requirement to provide the patient or their family or carer with; a written account of the facts, an apology, a description of the health service's response to the event, and the steps being taken to prevent reoccurrence.

Independent evaluation of the implementation and impacts of SDC in all Victorian health settings is being conducted by academic researchers at the Australian Institute of Health Innovation supported by consumer advisors to the project. A three-phase research programme has been established that will evaluate SDC's impact within the 2 years since its implementation in Victorian health settings, with ethical approval granted, and data collection is set to begin in late 2024.

2 Methods

2.1 Research Design

A mixed-methods sequential design will be employed comprising of literature review, document analysis, survey and interview data from patients, families and health service staff. The overall completion of the project (Figure 1) is expected to take 2 years (2024–2026).

3 Expected Outcomes

In drawing upon existing tools for measurement, this research will also provide data that can be compared with findings from the UK Duty of candour review and the experiences of disclosure among patients in NSW. Our findings will provide a vital contribution to the sparse evidence base about the SDC and its application in healthcare settings internationally.

4 Patient and Public Involvement

The design and conduct of this research places patients and the public at the centre as essential collaborators. Three members of the public (JM, LW and KS) were involved in the design of the research proposal, reviewing and contributing to the ethics protocol, the protocol paper as authors and the protocol for the systematic review that has been developed as a basis for this research. These collaborators will continue to be involved in all aspects of the research as part of the project team. The active involvement of patients and the public as essential collaborators in this research ensures that the findings will have broader relevance, not only to academic research but also to patient-centred care. With public contributors playing a key role in the design of the research proposal, ethics protocol, and systematic review, the study is well-positioned to influence clinical practice and inform future research within the field. Their continued participation throughout the project will further enhance its real-world impact.

5 Ethics, Data Storage and Protection

The Human Research Ethics Committee at Macquarie University has approved this study (Project ID 520241807758893; Reference No: 18077). We will obtain implied consent from participants who complete the survey and written informed consent from those who complete interview research. We will ensure participants’ confidentiality and anonymity throughout the study, including during data gathering, management, analysis and reporting processes. All data from this study will be securely managed and protected, and only the researchers involved in the study can access them. We will store electronic data, such as audio recordings and survey responses, on the Macquarie University OneDrive, which is a secure, password-protected platform that requires two-factor authentication. Participant consent forms will be stored separately to their data. It is not anticipated that the data will be used for any other purpose, and a new ethics application will be made should there be a proposal to use the data for another purpose. The data will be destroyed per ethical requirements 7 years after the project's completion.

6 Projected Outputs and Dissemination Plans

In the absence of evaluative research about the impacts of SDC internationally, and in light of the unfolding UK review of SDC, dissemination of project outputs using broad and accessible approaches is vital. We anticipate producing outputs in formats suitable for academic, consumer, clinical and policy audiences relating to each of the three phases of the research. Beyond open access publication of findings in scientific journals and their presentation at scientific meetings, findings will be communicated via plain language summaries on the Macquarie University project page, infographics posted on social media to reach international stakeholders, and via a report to Safer Care Victoria that will be the basis for their communication of findings to policy and practice decision-makers. In presenting the work, we will target conferences and meetings that capture a cross-section of consumer, clinical and policy delegates internationally who share interests in healthcare quality enhancement.

7 Anticipated Strengths and Challenges

Being the first academic research project to evaluate the use and impacts of SDC internationally is a core strength of the work. The forthcoming evidence will provide new insight into how well SDC is understood by both patients and health professionals, but also how it is being applied in practice in Victorian health services. By analysing instances of SAPSE, coupled with literature review, survey and interview data, we will be able to provide a rich and expansive analysis of SDC in practice. With reference to other research conducted to date about open disclosure and experiences of healthcare adverse events, challenges in obtaining the sample required and ensuring that respondents have a shared understanding of what constitutes an adverse event, a requirement for disclosure and specifically for SDC will be ongoing. Working in partnership with Safer Care Victoria provides support for promoting and attracting participants to engage with the research. We will draw upon approaches we have previously used with patients and staff to clarify terms and concepts as we gather data. In speaking with people about adverse events occurring in healthcare, we will also need to support participants with difficult conversations and providing psychological support. Our experience as a team in researching this area equips our researchers with the skills and awareness to navigate these experiences appropriately. The research may be constrained by possible confounding changes in the health system during the periods of study on the incident analysis such as COVID-19, response rate and representativeness of samples in the Phase 3 survey, and by the limitations of the design in establishing effectiveness of SDC on patient, clinician and health system outcomes.

8 Discussion

Experiencing an adverse patient safety event can have life-long consequences for the patients, families and healthcare staff involved [1, 16]. Central to their recovery, and the ability of healthcare providers to learn and make improvements in care, is open and honest communication between these parties about what has occurred and a genuine apology [1, 2]. SDC is considered a critical tool to ensure healthcare providers take the appropriate action in the event of a SAPSE; it has been the subject of extensive campaigns and discussion internationally for more than 10 years [7]. Evaluating the understanding, use, and impact of SDC in this research is a crucial step in determining whether SDC is being implemented as intended and achieving the desired outcomes in managing adverse events. This new knowledge will inform healthcare providers, regulators and government agencies about gaps in knowledge or implementation, and of the target areas for action to ensure that SDC is effectively implemented in the interests of safe and high-quality patient care.

Author Contributions

Reema Harrison: conceptualisation, investigation, funding acquisition, writing–original draft, writing–review & editing, supervision, methodology. Corey Adams: conceptualisation, funding acquisition, investigation, writing–original draft, supervision, methodology, writing–review & editing. Nabila Binte Haque: investigation, formal analysis, writing–review & editing. Jennifer Morris: conceptualisation, methodology, writing–original draft. Liat Watson: conceptualisation, writing–original draft, methodology. Kristiina Siiankoski: Conceptualisation, Writing–original draft, Methodology. Ashfaq Chauhan: Conceptualisation, investigation, funding acquisition, writing–original draft, methodology, supervision. Thrivedi Sesha Sai Danthakani: writing–review & editing, formal analysis, investigation, methodology. Sarah Ameen: investigation, methodology, writing–review & editing. Peter Hibbert: methodology, investigation, conceptualisation, funding acquisition, writing–original draft, supervision. Elizabeth Manias: supervision, conceptualisation, investigation, funding acquisition, writing–original draft, methodology. Nicole Youngs: conceptualisation, investigation, funding acquisition, writing–original draft, methodology, supervision. Lanii Birks: conceptualisation, investigation, funding acquisition, writing–original draft, methodology, supervision. Ramesh Walpola: supervision, conceptualisation, investigation, funding acquisition, writing–original draft, methodology. Sarah Fischer: conceptualisation, investigation, writing–original draft, methodology. Jeffrey Braithwaite: conceptualisation, investigation, writing–original draft, methodology, supervision, funding acquisition.

Conflicts of Interest

Liat Watson, Kristiina Siiankoski, Nicole Youngs, Lanii Birks, and Sarah Fischer are employed by Safer Care Victoria who are the research funders. The other authors declare no conflicts of interest.