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Abstract
Introduction Communication failings may compromise the diagnostic process and pose a risk to quality of care and patient safety. With a focus on emergency care settings, this project aims to examine the critical role and impact of communication in the diagnostic process, including in diagnosis-related health and research policy, and diagnostic patient–clinician interactions in emergency departments (EDs).
Methods and analysis This project uses a qualitatively driven multimethod design integrating findings from two research studies to gain a comprehensive understanding of the impact of context and communication on diagnostic excellence from diverse perspectives. Study 1 will map the diagnostic policy and practice landscape in Australia, New Zealand and the USA through qualitative expert interviews and policy analysis. Study 2 will investigate the communication of uncertainty in diagnostic interactions through a qualitative ethnography of two metropolitan Australian ED sites incorporating observations, field notes, video-recorded interactions, semistructured interviews and written medical documentation, including linguistic analysis of recorded diagnostic interactions and written documentation. This study will also feature a description of clinician, patient and carer perspectives on, and involvement in, interpersonal diagnostic interactions and will provide crucial new insights into the impact of communicating diagnostic uncertainty for these groups. Project-spanning patient and stakeholder involvement strategies will build research capacity among healthcare consumers via educational workshops, engage with community stakeholders in analysis and build consensus among stakeholders.
Ethics and dissemination The project has received ethical approvals from the Human Research Ethics Committee at ACT Health, Northern Sydney Local Health District and the Australian National University. Findings will be disseminated to academic peers, clinicians and healthcare consumers, health policy-makers and the general public, using local and international academic and consumer channels (journals, evidence briefs and conferences) and outreach activities (workshops and seminars).
- ACCIDENT & EMERGENCY MEDICINE
- QUALITATIVE RESEARCH
- Health Services
- Social Interaction
- Health policy
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STRENGTHS AND LIMITATIONS OF THIS STUDY
Adopting a multimethod design, triangulating analysts and findings from two main qualitative studies, allows us to gain a rigorous and holistic understanding of the importance and impact of context and communication on diagnostic excellence, from multiple analytical perspectives.
This study addresses a critical gap by including patients and carers in the analysis of communication around diagnostic uncertainty in the emergency departments (EDs). Its strength lies in its focus on capturing communication in a naturalistic setting, analysing a rich corpus of patient journeys in conjunction with contextualised information and including community-based researchers from conceptualisation to dissemination.
The qualitative nature of the analysis, inclusion of policy documents from only three countries, inclusion of patient journeys from only two EDs and the exclusion of high acuity presentations—while necessary for ethical and practical reasons—limits the generalisability of findings to a broader range of policy contexts and emergency care settings. Future research should explore these factors in greater depth across diverse populations of varying acuity and healthcare systems to enhance the generalisability of findings.
Introduction
Most of us will be affected by a medical misdiagnosis at least once in our lifetime.1 Diagnostic errors including incorrect, missed or delayed diagnosis have been described as the most deadly medical error, leading to up to 371 000 annual deaths in the USA.2 For US emergency departments (EDs), a potential 7.4 million diagnostic errors have been estimated to result in up to 250 000 deaths.3 In Australia, an estimated 140 000 patients are exposed to diagnostic errors annually, leading to 21 000 cases of serious harm and up to 2000–4000 deaths.4
By definition, diagnostic error occurs when there is a ‘failure to (1) establish an accurate and timely explanation of the patient’s health problem(s) or (2) communicate that explanation to the patient’ (emphasis added).1 The US-based ECRI (formerly Emergency Care Research Institute) has listed diagnostic errors and related concepts of delayed diagnosis and cognitive bias among the top 10 patient safety concerns multiple times since 2019.5–7 In 2024, the WHO’s patient safety day is running under the banner of ‘Improving diagnosis for patient safety’.8
As research in the field of diagnosis has matured over the past decade, the narrative has shifted from a focus on diagnostic error to diagnostic excellence. Diagnostic excellence has been defined as ‘an optimal process to attain an accurate and precise explanation about a patient’s condition’.9 It is a process informed by considerations and appropriate actions regarding safety and quality of care, and the impact of time, cost, communication10 and patient understanding on health outcomes.
In Australia, misdiagnosis is a leading cause of malpractice claims and sentinel events, featuring in 17%–36.5% of cases.11–13 A quarter of diagnosis-related claims at one Australian medical indemnity insurer were linked to poor communication, mirroring international findings.13 Four out of five diagnostic errors are considered to be preventable,4 yet communication practices and their impact on diagnosis have not yet been systematically investigated10 and the meaningful research partnerships with patients and healthcare consumers required to address misdiagnosis remain elusive.1 14–16 Miscommunication, especially concerning diagnostic uncertainty, can jeopardise diagnostic safety. Patients might be unduly reassured if they mistakenly interpret a tentative diagnosis as definitive, are led to believe such or might remain unaware of any uncertainty if their doctor does not explicitly communicate it.10
To date, efforts to improve diagnostic excellence have largely focused on clinicians’ cognitive errors17–19 and/or health system faults20–22 and have been based almost exclusively in health service research.23–25 Instead of analysing actual patient–clinician interactions, scholars focused on surveys, interviews, medical records and incident reports.23 24 26 Thus, recognition and research about the impact of communication on (mis)diagnosis which analyses interpersonal communication during diagnostic interactions are only beginning to emerge.27–33
Diagnosis in EDs
EDs are high-pressure environments where clinicians and patients often meet without prior contact or an established history or relationship. Effective communication practices are thus critical34–36 in ensuring positive patient experiences, and the delivery of safe, high-quality healthcare, especially in diagnosis. Most patient complaints in Australian EDs relate to diagnosis and poor communication.37 Up to two-thirds of diagnostic errors in EDs leading to malpractice claims involve poor communication between clinicians and patients or in handovers.22
Over the past decade, numerous reports1 38 39 on improving diagnostic quality and safety have reiterated the importance of engaging patients and their caregivers in the diagnostic process. This is especially crucial in the emergency medicine context where patients often present with complex problems, in a state of heightened vulnerability and where they are often accompanied by carers. Carers, including family members, friends and formal carers, provide a range of valuable supports to patients during what can be a vulnerable time. Carers often play an influential role in deciding to seek care in the ED.40 They provide emotional support to patients by keeping them company and helping pass the time.41 They are also involved in clinical interactions, providing information about patients’ usual health, symptoms and medical history, identifying concerns and advocating for care.40 42–44 Carers also facilitate patient–clinician communication when it may be challenging or compromised, such as with children or patients with cognitive impairment or limited English proficiency.1 Doctors and nurses report that carer involvement in clinical interactions can help determine medical urgency and support clinical decision-making in the diagnostic process.45 46 Doctors also frequently call on carers as a resource to support follow-up care post discharge.44 This evidence suggests that carer involvement in interactions in emergency care can be particularly valuable to clinicians, as they are working in an environment where they have no prior relationship with patients, experience high levels of uncertainty and are under pressure to assess, treat and move patients through the ED efficiently.
With increasing need for health services, patients with complex needs and multiple comorbidities, and limited resources, pressure on Australian EDs is unlikely to abate. It is therefore urgent to conduct detailed empirical analysis of diagnostic interactions in EDs, and how such conversations are influenced by the specific institutional context in which they occur. Ethnographic and discourse analysis of ED policy and recorded ED interactions, and sustained engagement with consumers and stakeholders, is required to develop a foundational understanding of communication during diagnosis and its influence on diagnostic excellence.
Communicating diagnosis and uncertainty in EDs
Poor communication can lead to misdiagnosis,1 20 47 with communication of diagnostic uncertainty being a significant contributor.10 Diagnostic uncertainty,48 defined as a clinician’s perceived ‘inability to provide an accurate explanation of the patient’s health problem’, can delay diagnosis when clinicians fail to clearly communicate uncertainty or its implications for care to patients or other clinicians. While uncertainty is universal in medicine, clinicians in EDs experience more diagnostic uncertainty and higher rates of misdiagnosis compared with other health settings.4 20 49 50
A patient-centred definition of expressions of uncertainty refers to ‘any statement made by a provider that either directly or indirectly indicates uncertainty to a patient’.51 Including levels of directness in the definition highlights the importance of effective communication in which senders (clinicians) and receivers (patients) share an understanding of the message being communicated. Shared understanding, and in fact shared expectations (eg, what is involved in diagnosis in EDs), cannot be taken for granted.15 52 53
This study will focus on communication of certainty and uncertainty in interpersonal diagnostic interactions. We adopted the term interpersonal from the linguistic field interpersonal pragmatics where interpersonal refers to the ‘relational aspect of interactions between people’ (ie, patients, carers and clinicians), and how their relative roles, dynamics and expectations affect the language they use in interactions.54 Diagnostic interactions are interpersonal interactional events55 56 between clinicians and patients, and among clinicians during the diagnostic process (not restricted to talk about diagnostic testing or imaging). Health communication studies with linguistic underpinnings can reveal how broader social and local institutional context shapes expectations and language use between patients and clinicians when exchanging information and building relationships in clinical encounters.54 56 57 As in other social interactions, patients’ and clinicians’ knowledge, expectations and communication behaviour about clinical interactions are shaped over time by life and professional experiences. In diagnostic interactions in emergency settings, patients and clinicians often have mismatched expectations.53 Patients may expect a concrete diagnosis,58 59 whereas clinicians expect a level of uncertainty, and thus often seek to exclude the worst-case scenario and might view definite diagnosis of ‘every problem patients have’60 as unfeasible in the ED.4 34 53
Clinicians might express their diagnostic uncertainty explicitly (‘I don’t know’) or implicitly by using hedges (‘It might be broken’).25 28 Hedges mitigate the seriousness or certainty of what is being said and can be realised by a large number of lexicalised items and grammatical constructions, such as epistemic/evidential verbs (‘It looks like it’s broken’), modal verbs/adverbs/nouns (‘The assumption is that it could possibly be broken’), adverbs/adjectives (‘Your X-ray was reportedly normal’), hypothetical stance (‘If the x-ray shows nothing’) or shields/introductory phrases (‘My guess is it’s broken’).25 28 32 61–63 Overall, the impact of uncertainty on patients’ experiences including satisfaction, trust and perceived clinician competence is inconclusive with positive and negative patient reactions reported.28 However, communication and context (eg, attending to patients emotions, prior relationships, shared vs mismatched expectations and institutional practices) are important factors shaping patients’ reactions.28 64 65 If and how uncertainty is communicated is a critical factor for safe and high-quality diagnostic interactions between patients and clinicians. Yet, to date, it remains largely unknown exactly how clinician express uncertainty, and how different strategies to communicate certainty and uncertainty might be linked to institutional context and contribute to diagnostic excellence.24 Moreover, research focusing on the impact of communicating diagnostic uncertainty on patients and carers is in its infancy.24 66–69 This project will deliver insights into patient and carer expectations about, and preferences for, communication about diagnostic uncertainty in emergency care, and how patients and carers perceive, respond to and influence such communication.
Consumer involvement in diagnostic communication research
Healthcare consumers can be defined as people, and their family or carers, who have, who are currently or who could potentially use health services.70 Globally, the benefits of consumer engagement and the coproduction of healthcare services have become widely acknowledged71–73 including in research related to diagnostic excellence1 74–76 and health communication.77 Consumers’ crucial contributions in research conceptualisation and conduct can inform current evidence-based findings, facilitate patient-driven change in healthcare delivery, and improve patient outcomes.71 78 79 Yet, consumer involvement in research on the diagnostic process or diagnostic communication is still in a nascent stage,14 often tokenistic80 and affected by lack of recognition of consumers’ vital roles, limited funding, and/or limited research engagement capacity and skills among consumers and researchers alike.
This project will extend how healthcare consumers and stakeholders are engaged in diagnostic research, to ensure their voices are heard and translated into relevant policy and practice changes. Building research capacity among healthcare consumers, and employing meaningful engagement strategies, will improve the breadth, depth and dissemination of findings.
Aims
This project seeks to examine the crucial role of communication in the diagnostic process, seeking to identify the previously unexplored impact of communicating (un-)certainty on diagnosis. Collaborating with national and international experts in emergency medicine, health policy and health consumer advocacy, this project will use this new understanding to inform national policy changes, and enhance communicative and organisational practices, thus improving diagnostic communication and health services efficiency in EDs and other health settings. Specifically, the project’s three aims are as follows:
Map the international context of diagnosis-related policies and practice in health and ED settings.
Describe the communication of certainty and uncertainty in interpersonal diagnostic interactions in the ED, including clinician, patient and carer perspectives on, and involvement in, such communication.
Engage consumers and stakeholders to address uncertainty in diagnostic interactions.
Methods
Project design
We will use a qualitatively driven multimethod design81 that integrates findings from two research studies to gain a comprehensive understanding of the context and impact of communication and diagnostic excellence from diverse perspectives. This project started collecting data on 19 October 2022 (study 1) and completion is anticipated for mid 2027. Study 1 will map the diagnostic policy and practice landscape in Australia, New Zealand and the USA. Study 2 will investigate the communication of uncertainty in diagnostic interactions in two Australian ED settings. Project-spanning patient and stakeholder involvement strategies will build research capacity among healthcare consumers and engage with community stakeholders to address diagnostic uncertainty.
Integrating these two studies allows us to overcome and explain the well-documented discrepancies82 between what people are ‘told’ to do (as documented in policy and sociocultural organisational practices), what people think they do (as expressed in expert focus groups, interviews) and what they actually do (as observed in observations, interactions and written clinical documentation).
Study 1: diagnosis-related policy development—Quo vadis?
Aim: map the international context of diagnosis-related policies and practice in health and ED settings.
We will analyse diagnosis-related healthcare and research policy documents from Australia, New Zealand and the USA, in combination with key issues identified in interviews with international experts well versed with issue of diagnostic excellence in research/policy, emergency medicine and health consumer advocacy. Combined analysis of these data will allow us to (1) examine and compare developments in diagnosis-related policy across countries and (2) draw on expert insights to inform global development of policy related to diagnostic excellence.
Content analysis of policy documents and clinical guidelines
We will source relevant publicly available policy and guidelines related to (1) healthcare (eg, diagnostic guidelines, practice standards, safety and performance measures) and/or (2) research (eg, funding policy, strategic research plans) from organisational websites and libraries of Australian, New Zealand and US national health quality organisations, emergency medicine colleges and policy and funding agencies. We will gather, extract and systematically analyse documents83 84 using principles of qualitative content analysis85 to identify, map and compare national and international policy on diagnostic safety and excellence, or lack thereof.
Semistructured in-depth expert interviews
Expert86 participants across Australia, New Zealand and the USA will participate in audio-recorded interviews via videoconferencing for 30–45 min about strategies to embed diagnostic excellence in national policy, how diagnostic work is experienced and how relevant policy is applied in practice (see online supplemental appendix for interview guides).
Supplemental material
Recruitment and consent
Participants will be identified through their leadership roles in relevant organisations (eg, US Society to Improve Diagnosis in Medicine) and on advice from the project’s advisory board. MRD will contact them via email with an invitation letter, answer any questions and obtain informed written consent. Guided by the concept of information power,87 we anticipate 30 total participants (n=~10 key experts per country, equally distributed across 3 expert groups versed in diagnostic excellence (research/policy, emergency medicine and health consumer advocacy)).
Analysis
To ensure trustworthiness,88 interviewees will receive interview transcripts to check for accuracy or to make changes. In addition, multiple analysts will be involved in the qualitative, inductive thematic analysis89 of transcripts, which will progress through multiple coding iterations to develop a framework to be applied in NVivo qualitative data analysis software (QSR International V.12/14). We will triangulate findings from interviews with those from the document analysis to identify perspectives and policy gaps related to diagnostic excellence and determine where policy and practice do not (yet) align.
Study 2—investigating the communication of certainty and uncertainty in diagnostic interactions
Aim: describe the communication of certainty and uncertainty in interpersonal diagnostic interactions in the ED, including clinician, patient and carer perspectives on, and involvement in, such communication.
Setting and participants
This study will combine a qualitative ethnography of two Australian ED sites, with linguistic analysis of recorded diagnostic interactions and hospital records. Because local organisational culture and practices can impact health communication even within the same healthcare specialty, two ED sites were selected based on size, to access different workplace profiles. Both EDs are located in metropolitan teaching hospitals; site 1 with ~90 000 presentations in 2021/202290 will be compared with site 2 with ~43 000 presentations.90 Sites cannot be identified in line with ethics approvals.
Participants will be consenting patients (and their carers) receiving care, and clinicians providing care at the ED study sites. Eligible patients will be adults (18 years+) in Australasian Triage Scale categories 3/4/5 (potentially life threatening, potentially serious, less urgent; requiring assessment and treatment to start within 30, 60 or 120 min)91 with sufficient English proficiency (self-identified), and without history of verbal or physical aggression, mental health problems or poor cognition (eg, known dementia, under the influence of drugs or alcohol).
Recruitment and consent
All participants will be asked to provide written informed consent. Study posters will be displayed in staff break rooms, key ED staff areas and patient waiting rooms. Patients (and if present their carers) will be recruited and consented first. Clinicians will be recruited and consented based on whether they will be caring for consented patients.
A pragmatic convenience sample (ie, first eligible patients to say yes) of moderate to low-acuity patients with commonly uncertain presentations (eg, abdominal pain, headache and dizziness) will be recruited. Lead researchers (MRD, LJC) will alternately approach eligible patients and introduce the project via a short invitation infographic summarising the study codeveloped with consumer input. We will provide patients who express interest in participation with information and consent forms, and answer any questions, before obtaining their written consent.
Clinicians will be briefed multiple times via emailed invitations and briefing presentations during regular staff meetings, to ensure ED staff are aware of the project and to provide opportunities to ask questions. On data collection days, MRD and LJC will remind clinicians on shift about the project during morning handovers, answer any remaining questions and gain their in-principle consent (ie, agreement to participate should they care for a consenting patient). Clinicians will only be asked to sign consent forms if they are directly involved in patient care (including discussions about the patient away from the patient).
We will be keeping a recruitment log of all participants approached for consent, recording basic demographics and asking all potential participants to voluntarily provide their reason for agreeing or declining to participate.
Qualitative ethnography
Data will be collected through observations, field notes, video-recorded interactions, audio-recorded interviews and written medical documentation.
Observations, recorded interactions, field notes
At least two researchers will follow a total of 24 ED (12 from each site) patient journeys (after triage until admission/discharge) observing and video-recording patients (and if present, their carers) during all their interactions with their treating clinicians (doctors and nurses), and with their carers. Lead researchers will take detailed interactional field notes, with one shadowing the patient (LJC) and the other observing the main treating clinician (MRD) and video recording their interactions with other clinicians (eg, formal handovers, informal chats about the consenting patient).
Interviews
Lead researchers (MRD, LJC) will conduct context and debrief interviews for both patients (and carers if present) and their main treating doctor at different times in relation to the recorded ED presentation (see online supplemental appendix for interview guides). Patient and carer context interviews will ideally take place before care contact with ED clinicians. These interviews will focus on previous experience in EDs, expectations for the current visit and perspectives on (communication of) diagnostic uncertainty. Context interviews with the main treating doctor will be conducted in the weeks following the recorded presentation, to explore their general approach to diagnosis in the ED, perspectives on communication of/organisational culture related to diagnostic uncertainty and (diagnostic) patient safety mechanisms (incident reporting, complaints and malpractice cases). Doctors will only be interviewed once, although they might care for more than one participating patient. Additional context interviews will be conducted with ED medical and nursing management. There will be two types of debrief interviews: (1) ED debrief—following patient discharge or admission, patients, carers and main treating doctor will be briefly interviewed to determine patients’ reported understanding of diagnosis and doctors’ confidence in diagnosis and (2) follow-up debrief (patients only)—at ~28 days and ~3 months after their ED visit patients will be asked whether their diagnosis changed, they represented to hospital or sought clinical care for the same health issues that brought them to ED.
Written clinical documentation
Patients and clinicians will be asked to provide consent for researchers to access their written clinical documentation (eg, clinical progress notes and discharge summaries). Disparities exist between what people say verbally, versus what they record in written notes. The modality alone might change the way content is presented (including expressions of uncertainty). By linking expression of diagnostic uncertainty features in verbal interactions and associated medical records, this project will trace how verbally expressed uncertainty might be documented, changed or omitted in written form or vice versa. This can give us an indication about the differences in strategies to communicate uncertainty in verbal and written modalities. Medical documentation will also enable us to collect and trace presenting symptoms, ED discharge diagnoses and admitting diagnoses, and to connect these with expressions of diagnostic uncertainty.
Analysis
Data will be deidentified during transcription. Interview analysis will follow the same steps as outlined for study 1, with additional triangulation from recorded interactions and field notes. The research team, including community-based researchers and emergency medicine clinicians, will discuss preliminary interpretations of observed practices and underlying workplace cultures with participants, to clarify or expand understanding, and enable member checking85 to ensure analytical rigour.
Linguistic discourse analysis
The transcripts of video-recorded naturally occurring interactions (patient–clinician (carer, if present), clinician–clinician and patient–carer) and extracts of written hospital documentation (clinical progress notes and discharge summaries) will be compiled into a large corpus.
To identify how certainty and uncertainty are communicated, and how this might impact on diagnostic interactions, we will use linguistic discourse analysis57 92 93 and apply previous pragmatics discipline knowledge32 54 61–63 on lexical items and discourse features that express (un-)certainty. Analysis of interactions and written documentation will be further aided by detailed field notes and transcripts of ED debrief interviews, to assess how effectively clinicians convey a (working) diagnosis within the particular clinical context. The detailed linguistics analysis will follow a stepwise approach: (1) build a corpus of diagnostic interactions and written documents, (2) identify expressions of (un-)certainty in each interaction and document, (3) identify patterns in expressions of (un-)certainty across the corpus and (4) conduct comparative analysis of patterns: (a) across spoken and written modalities, (b) in relation to the clinician’s confidence in the diagnosis (from debriefs) and (c) in relation to the patient’s understanding of the diagnosis (from debriefs).
This new knowledge and linguistic understanding will be used to develop a framework for diagnostic communication describing the diagnostic landscape of communicative strategies and their impact in diagnostic interactions. As part of the project knowledge translation strategies, this framework will include practical guides to inform clinician communication training and support patients in health interactions.
Patient and public involvement
Across studies 1 and 2, we will extend how healthcare consumers and stakeholders are engaged in diagnostic communication research. Patient advocates and healthcare consumers from the consumer reference group at the ANU Institute for Communication in Health Care provided input into the study design and ethical considerations. Dedicated community-based researchers will collaborate in analysis, interpretation and dissemination of project findings.
Collaborating with healthcare consumers and stakeholders to include multiple perspectives will strengthen our understanding of diagnostic communication and provide pathways to translate findings into policy and practice,94 leading to greater community benefits. This project will adopt project-spanning engagement strategies79 to upskill healthcare consumers’ research capacity, and work closely with stakeholders to address critical concerns in diagnostic communication.
Alongside studies 1 and 2, this project will collaborate with a local health consumer advocacy group to develop and deliver educational webinars to build healthcare consumer research capacity in Australia. These workshops will train healthcare consumers in academic research concepts from design and conduct to dissemination, providing them with the necessary tools to meaningfully engage in research. Further, the project team includes community-based researchers who will be mentored and, according to their preferences, collaborate on any aspect of the project to integrate the patient voice in addressing uncertainty in diagnostic communication.
Additional opportunities to collaborate with stakeholders to address uncertainty in diagnostic interactions include expert consultations, a series of professional workshops and public events/seminars on ‘Communication for Diagnosis’, and a project-closing national symposium to share research findings with academics, healthcare consumers, emergency medicine and health policy-makers and the general public.
Expected outcomes and significance
Translating project findings will address key issues in diagnostic communication and provide tools and new knowledge to inform healthcare policy and practice.
Study 1 will map and compare the current diagnosis-related health and research policy landscape across three countries. This will (1) situate each country in the wider international context and (2) identify opportunities to improve policy and guidelines to support diagnostic excellence, including through improved communication. Study 1 will also produce a diagnosis policy roadmap, tracing barriers and facilitators to embed diagnostic excellence in policy.
Study 2 will be the first study to examine the communication of uncertainty in interpersonal diagnostic interactions by analysing ethnographic data and naturally occurring interactions in the ED. This study prioritises a descriptive analysis of communication patterns surrounding diagnostic (un-)certainty. We will not assess the impact of (un-)certainty expressions on diagnostic outcomes or errors, but rather focus on identifying strengths and challenges in diagnostic interactions across various modalities within the ED context.
Given that diagnostic errors are said to be the deadliest medical errors,2 appropriate recommendations for professional training and support materials for patient and carer communication strategies will be summarised in a research-informed communication framework coproduced by multidisciplinary stakeholders. The framework will highlight the importance of communication in the diagnostic process, outline the spoken and written discourse features used to communicate diagnosis and express certainty and uncertainty in the ED and offer practical guidance to clinicians and patients to improve diagnostic interactions.
Ethics and dissemination
Ethics approval for study 1 was granted by the Australian National University Human Research Ethics Committee (2022/589). Ethical approval for study 2 across two ED sites was granted from the ACT Health Human Research Ethics Committee (2022.ETH.00174) and the Northern Sydney Local Health District Research Office (2023/STE04395) including site-specific assessment.
All participants will be audio/video recorded in interviews and/or interactions and will be required to provide informed written consent before the start of data collection or recording. All data will be stored electronically on a password-protected cloud-based drive with servers based in Australia only accessible to the core researchers (MRD and LJC). Deidentification will vary according to study. Participants in the expert interviews (study 1) will be able to choose the level of attribution between (1) full name, role and organisation, (2) gendered pseudonym and generic role/organisation or (3) generic role only. For study 2, all data will be deidentified (eg, location, participant names) and all participants will be assigned a unique study code to protect their privacy and confidentiality. In a master ID code sheet, researchers will record the patient’s medical record number, date of birth, study site, date of presentation, unique study identifier and if shared contact details. These data will allow matching of written clinical documentation of the ED presentation for later analysis, as well as contacting patients for follow-up interviews. This master sheet will only be accessible to the core research team and will be stored electronically, separately from all other demographic information.
According to the Australian Code for the Responsible Conduct of Research,95 the clinical ED interactional data to be collected are unique data that are not easy to replicate. With participant consent, the deidentified transcripts will be archived in a suitable research or language data repository to allow future research with relevant project and ethical approvals.
This project brings together academic researchers supported by an advisory board of clinicians, researchers, healthcare consumers and senior policy-makers from Australian health agencies including national and international representatives from the Society to Improve Diagnosis in Medicine, Health Consumers NSW and Australasian emergency medicine and nursing colleges. The multidisciplinary board will provide strategic advice on emergent findings and guide and collaborate in communicating findings to key stakeholders to facilitate policy and practice change.
Findings from this project will be disseminated to academic peers, clinicians and community experts, health policy-makers and the general public through strategically publishing and presenting findings using local and international scholarly channels and outreach activities. For example, publishing via academic peer-reviewed literature (open access), conference presentations, evidence briefs, media and popular science communication channels, and health consumer and industry/clinical publications. Policy and communication frameworks will also be disseminated through clinical practice-oriented educational workshops for clinicians and patients, and translational and implementation channels via key stakeholders to inform development or review of policy.
Ethics statements
Patient consent for publication
Acknowledgments
The research team would like to thank the Consumer Reference Group at the ANU Institute for Communication in Health Care for their valuable input into study design and ethical considerations.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
X @DrMaryDahm, @Laura_Chien
Contributors MRD initiated the project and led the development of the Australian Research Council (ARC) grant proposal and is the chief investigator. The study concept and design were further refined by LJC. MRD and LJC will conduct data collection facilitated by SS and LL. Analysis will be performed by MRD and LJC with critical input from JM, SS, LL and CC. MRD prepared the first draft of the manuscript. All authors have reviewed and provided input. MRD is the guarantor.
Funding MRD: This work is supported by the Australian Research Council, Discovery Early Career Researcher Award grant number (DE220100785) and Society to Improve Diagnosis in Medicine (SIDM) Diagnostic Excellence Fellowship. LJC: This work is supported by the ANU College of Arts and Social Sciences Kathleen Woodroofe PhD Scholarship in the Humanities/Social Sciences.
Competing interests JM is a member of the Council of Education of the Australasian College for Emergency Medicine.
Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.