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10.1136/bmjopen-2024-085335
bmjopen-2024-085335
Protocol
Health Services Research
1704
1506
Addressing diagnostic uncertainty and excellence in emergency care—from multicountry policy analysis to communication practice in Australian emergency departments: a multimethod study protocol
DrMaryDahm
http://orcid.org/0000-0001-8067-4600
Dahm Maria R 1Maria.Dahm@anu.edu.au

https://twitter.com/Laura_Chien
http://orcid.org/0000-0003-2211-0844
Chien Laura J 1laura.chien@anu.edu.au

Morris Jen 1jen.morris@safercare.vic.gov.au

Lutze Lucy 2Lucy.Lutze@health.nsw.gov.au

Scanlan Sam 3Samuel.Scanlan@act.gov.au

Crock Carmel 4carmel.crock@eyeandear.org.au

1 Institute for Communication in Health Care, Australian National University, Canberra, Australian Capital Territory, Australia
2 Hornsby and Ku-ring-gai Hospital, Hornsby, New South Wales, Australia
3 Canberra Health Services, Canberra, Australian Capital Territory, Australia
4 The Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia
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.

JM is a member of the Council of Education of the Australasian College for Emergency Medicine.

DrMaria RDahm; Maria.Dahm@anu.edu.au
2024
13 9 2024
14 9 e08533512 2 2024
30 8 2024
Copyright © Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
2024
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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
http://dx.doi.org/10.13039/100027162 Society to Improve Diagnosis in Medicine Diagnostic Excellence Fellowship http://dx.doi.org/10.13039/501100000995 Australian National University ANU CASS Kathleen Woodroofe PhD Scholarship http://dx.doi.org/10.13039/501100000923 Australian Research Council DE220100785
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pmcSTRENGTHS 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 2019.57 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.1113 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.11416 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 errors1719 and/or health system faults2022 and have been based almost exclusively in health service research.2325 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.2733

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 critical3436 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.404244 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’).2528 32 6163 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.246669 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 acknowledged7173 including in research related to diagnostic excellence17476 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).

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 knowledge3254 6163 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.

supplementary material

10.1136/bmjopen-2024-085335 online supplemental file 1

Acknowledgements

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.

Review Process File
13 09 2024

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.

Prepublication history and additional supplemental material for this paper are available online. To view these files, please visit the journal online (https://doi.org/10.1136/bmjopen-2024-085335).

Provenance and peer review: Not commissioned; externally peer reviewed.

Patient consent for publication: Not applicable.

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.
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References

1 National Academies of Science Engineering & Medicine (NASEM) Improving diagnosis in health care Washington DC NASEM 2015
2 Newman-Toker DE Nassery N Schaffer AC et al Burden of serious harms from diagnostic error in the USA BMJ Qual Saf 2024 33 109 20 10.1136/bmjqs-2021-014130
3 Newman-Toker DE Peterson SM Badihian S et al Diagnostic errors in the emergency department: a systematic review Rockville (MD) Agency for Healthcare Research and Quality (US) 2022
4 Scott IA Crock C Diagnostic error: incidence, impacts, causes and preventive strategies Med J Aust 2020 213 302 5 10.5694/mja2.50771 32951211
5 ECRI Top 10 patient safety concerns 2020 ECRI 2020 Available https://www.ecri.org/landing-top-10-patient-safety-concerns-2020
6 ECRI Top 10 patient safety concerns 2022 ECRI 2022 Available https://home.ecri.org/blogs/ecri-thought-leadership-resources/top-10-patient-safety-concerns-2022
7 ECRI Top 10 patient safety concerns 2024 ECRI 2024 Available https://home.ecri.org/blogs/ecri-thought-leadership-resources/top-10-patient-safety-concerns-2024
8 WHO World patient safety day, 17 september 2024: “Improving diagnosis for patient safety 2024 Available https://www.who.int/news-room/events/detail/2024/09/17/default-calendar/world-patient-safety-day-17-september-2024-improving-diagnosis-for-patient-safety
9 Yang D Fineberg HV Cosby K Diagnostic Excellence JAMA 2021 326 1905 6 10.1001/jama.2021.19493 34709367
10 Dahm MR Crock C Understanding and Communicating Uncertainty in Achieving Diagnostic Excellence JAMA 2022 327 1127 8 10.1001/jama.2022.2141 35238876
11 Victorian Managed Insurance Authority Preventing patient harm in emergency and urgent care settings 2022 Available https://www.vmia.vic.gov.au/risk-advisory/harm-prevention/emergency-department
12 Avant Diagnosis-related claims 2019 Available https://avant.org.au/Resources/Public/Diagnosis-related-claims
13 Moran K Jammal W Avant research reveals factors underlying diagnostic error claims 2018 Available www.avant.org.au/diagnostic-error-claims/
14 Dahm MR Williams M Crock C “More than words” - Interpersonal communication, cognitive bias and diagnostic errors Pat Educ Couns 2022 105 252 6 10.1016/j.pec.2021.05.012
15 Berwick DM Diagnostic Excellence Through the Lens of Patient-Centeredness JAMA 2021 326 2127 8 10.1001/jama.2021.19513 34792525
16 Graedon T Graedon J Let patients help with diagnosis Diagnosis (Berl) 2014 1 49 51 10.1515/dx-2013-0006 29539987
17 Trowbridge RL Twelve tips for teaching avoidance of diagnostic errors Med Teach 2008 30 496 500 10.1080/01421590801965137 18576188
18 Croskerry P The importance of cognitive errors in diagnosis and strategies to minimize them Acad Med 2003 78 775 80 10.1097/00001888-200308000-00003 12915363
19 Graber ML Kissam S Payne VL et al Cognitive interventions to reduce diagnostic error: a narrative review BMJ Qual Saf 2012 21 535 57 10.1136/bmjqs-2011-000149
20 Graber ML Franklin N Gordon R Diagnostic error in internal medicine Arch Intern Med 2005 165 1493 9 10.1001/archinte.165.13.1493 16009864
21 Kachalia A Gandhi TK Puopolo AL et al Missed and delayed diagnoses in the emergency department: a study of closed malpractice claims from 4 liability insurers Ann Emerg Med 2007 49 196 205 10.1016/j.annemergmed.2006.06.035 16997424
22 Lemoine N Dajer A Konwinski J et al Understanding diagnostic safety in emergency medicine: A case-by-case review of closed ED malpractice claims J Healthc Risk Manag 2018 38 48 53 10.1002/jhrm.21321 29752833
23 Hussain F Cooper A Carson-Stevens A et al Diagnostic error in the emergency department: learning from national patient safety incident report analysis BMC Emerg Med 2019 19 77 10.1186/s12873-019-0289-3 31801474
24 Bhise V Meyer AND Menon S et al Patient perspectives on how physicians communicate diagnostic uncertainty: An experimental vignette study Int J Qual Health Care 2018 30 2 8 10.1093/intqhc/mzx170 29329438
25 Gordon GH Joos SK Byrne J Physician expressions of uncertainty during patient encounters Patient Educ Couns 2000 40 59 65 10.1016/s0738-3991(99)00069-5 10705065
26 Hanauer DA Liu Y Mei Q et al Hedging their mets: the use of uncertainty terms in clinical documents and its potential implications when sharing the documents with patients AMIA Annu Symp Proc 2012 2012 321 30 23304302
27 Dahm MR Crock C Diagnostic statements: a linguistic analysis of how clinicians communicate diagnosis Diagnosis (Berl) 2022 9 316 22 10.1515/dx-2021-0086 34954929
28 Dahm MR Cattanach W Williams M et al Communication of Diagnostic Uncertainty in Primary Care and Its Impact on Patient Experience: an Integrative Systematic Review J GEN INTERN MED 2023 38 738 54 10.1007/s11606-022-07768-y 36127538
29 Doty AM Rising KL Hsiao T et al “Unfortunately, I don’t have an answer for you”: How resident physicians communicate diagnostic uncertainty to patients during emergency department discharge Patient Educ Couns 2022 105 2053 7 10.1016/j.pec.2021.12.002 35168855
30 Heritage J McArthur A The diagnostic moment: A study in US primary care Soc Sci Med 2019 228 262 71 10.1016/j.socscimed.2019.03.022 30946982
31 White SJ Stubbe M Patient Responses to Diagnosis in Surgeon-Patient Consultations Health Commun 2023 38 608 17 10.1080/10410236.2021.1965278 34496683
32 Dahm MR Crock C The pragmatics of diagnostic uncertainty: a closer look at hedges and shared understanding in diagnostic statements Bigi S Rossi MG A Pragmatic Agenda for Healthcare: Fostering inclusion and active participation through shared understanding Amsterdam/Philadelphia John Benjamins 2023 330 58
33 Khazen M Sullivan EE Ramos J et al Anatomy of diagnosis in a clinical encounter: how clinicians discuss uncertainty with patients BMC Prim Care 2022 23 153 10.1186/s12875-022-01767-y 35715733
34 Slade D Manidis M McGregor J et al Communicating in hospital emergency departments Berlin Springer 2015
35 Mahajan P Mollen C Alpern ER et al An Operational Framework to Study Diagnostic Errors in Emergency Departments: Findings From A Consensus Panel J Patient Saf 2021 17 570 5 10.1097/PTS.0000000000000624 31790012
36 Manojlovich M Bettencourt AP Mangus CW et al Refining a Framework to Enhance Communication in the Emergency Department During the Diagnostic Process: An eDelphi Approach Jt Comm J Qual Patient Saf 2024 50 348 56 10.1016/j.jcjq.2024.01.013 38423950
37 NSW Health Care Complaints Commission Annual report 2018-19 2019 Available www.hccc.nsw.gov.au/Publications/Annual-Reports
38 Khan S Cholankeril R Sloane J et al Current state of diagnostic safety: implications for research, practice, and policy: ahrq Agency for Healthcare Research and Quality 2024 Available https://web.archive.org/web/20240809035859/https://www.ahrq.gov/diagnostic-safety/resources/issue-briefs/dxsafety-current-state.html Accessed 20-Aug-2024
39 National Quality Forum (NQF) Improving diagnostic quality and safety final report 2017 Available https://www.qualityforum.org/Publications/2017/09/Improving_Diagnostic_Quality_and_Safety_Final_Report.aspx
40 Fry M Elliott R Murphy S et al The role and contribution of family carers accompanying community-living older people with cognitive impairment to the emergency department: An interview study J Clin Nurs 2022 31 975 84 10.1111/jocn.15954 34254383
41 Bull C Latimer S Crilly J et al ‘I knew I’d be taken care of’: Exploring patient experiences in the Emergency Department J Adv Nurs 2022 78 3330 44 10.1111/jan.15317 35719017
42 Cooper S Stevenson F Communicating decisions about care with patients and companions in emergency department consultations Health Expect 2022 25 1766 75 10.1111/hex.13519 35715945
43 Peguero-Rodriguez G Polomeno V Backman C et al The Experience of Families Accompanying a Senior to the Emergency Department: A Scoping Review J Emerg Nurs 2023 49 611 30 10.1016/j.jen.2023.03.005 37178091
44 Rance S Westlake D Brant H et al Admission Decision-Making in Hospital Emergency Departments: The Role of the Accompanying Person Glob Qual Nurs Res 2020 7 10.1177/2333393620930024
45 Fry M Gallagher R Chenoweth L et al Nurses’ experiences and expectations of family and carers of older patients in the emergency department Int Emerg Nurs 2014 22 31 6 10.1016/j.ienj.2013.03.007 23660385
46 Østervang C Lassen AT Øelund K et al Health professionals’ perspectives of patients’ and family members’ needs in emergency departments and patient pathway improvement: a qualitative study in Denmark BMJ Open 2022 12 e057937 10.1136/bmjopen-2021-057937
47 Singh H Giardina TD Meyer AND et al Types and origins of diagnostic errors in primary care settings JAMA Intern Med 2013 173 418 25 10.1001/jamainternmed.2013.2777 23440149
48 Bhise V Rajan SS Sittig DF et al Defining and Measuring Diagnostic Uncertainty in Medicine: A Systematic Review J Gen Intern Med 2018 33 103 15 10.1007/s11606-017-4164-1 28936618
49 Meyer AND Giardina TD Khawaja L et al Patient and clinician experiences of uncertainty in the diagnostic process: Current understanding and future directions Pat Educ Couns 2021 104 2606 15 10.1016/j.pec.2021.07.028
50 Rising KL Papanagnou D McCarthy D et al Emergency Medicine Resident Perceptions About the Need for Increased Training in Communicating Diagnostic Uncertainty Cureus 2018 10 e2088 10.7759/cureus.2088 29564193
51 Blanch DC Hall JA Roter DL et al Is it good to express uncertainty to a patient? Correlates and consequences for medical students in a standardized patient visit Patient Educ Couns 2009 76 300 6 10.1016/j.pec.2009.06.002 19604663
52 Lindley SW Gillies EM Hassell LA Communicating diagnostic uncertainty in surgical pathology reports: disparities between sender and receiver Pathol Res Pract 2014 210 628 33 10.1016/j.prp.2014.04.006 24939143
53 Than MP Flaws DF Communicating diagnostic uncertainties to patients: the problems of explaining unclear diagnosis and risk Evid Based Med 2009 14 66 7 10.1136/ebm.14.3.66 19483015
54 Locher MA Graham SL Interpersonal Pragmatics Berlin Mouton 2010
55 Heritage J Maynard DW Communication in Medical Care Cambridge Cambridge University Press 2006
56 Undeland M Malterud K Diagnostic interaction: the patient as a source of knowledge? Scand J Prim Health Care 2008 26 222 7 10.1080/02813430802325086 18803068
57 Roberts C Sarangi S Theme-oriented discourse analysis of medical encounters Med Educ 2005 39 632 40 10.1111/j.1365-2929.2005.02171.x 15910440
58 Gerolamo AM Jutel A Kovalsky D et al Patient-Identified Needs Related to Seeking a Diagnosis in the Emergency Department Ann Emerg Med 2018 72 282 8 10.1016/j.annemergmed.2018.02.021 29764689
59 Rising KL Hudgins A Reigle M et al “I’m Just a Patient”: Fear and Uncertainty as Drivers of Emergency Department Use in Patients With Chronic Disease Ann Emerg Med 2016 68 536 43 10.1016/j.annemergmed.2016.03.053 27156123
60 Schiff GD Kim S Abrams R et al Diagnosing diagnosis errors: lessons from a multi-institutional collaborative project Henriksen K Battles JB Marks ES Advances in patient safety: from research to implementation 2005 255 78
61 Caffi C Mitigation Amsterdam Elsevier 2007
62 Prince EF Frader J Bosk C On hedging in physician-physician discourse Ling Prof 1982 8 83 97
63 Kaltenböck G Mihatsch W Schneider S New Approaches to Hedging Bingley Emerald 2010
64 Ghosh AK Understanding medical uncertainty: a primer for physicians J Assoc Physicians India 2004 52 739 42 15839454
65 McGovern R Harmon D Patient response to physician expressions of uncertainty: a systematic review Ir J Med Sci 2017 186 1061 5 10.1007/s11845-017-1592-1 28271278
66 Bontempo AC Patient attitudes toward clinicians’ communication of diagnostic uncertainty and its impact on patient trust SSM - Qual Res Health 2023 3 100214 10.1016/j.ssmqr.2022.100214
67 Cox CL Miller BM Kuhn I et al Diagnostic uncertainty in primary care: what is known about its communication, and what are the associated ethical issues? Fam Pract 2021 38 654 68 10.1093/fampra/cmab023 33907806
68 Cox C Hatfield T Fritz Z How and why do doctors communicate diagnostic uncertainty: An experimental vignette study Health Expect 2024 27 e13957 10.1111/hex.13957 38828702
69 Dukhanin V McDonald KM Gonzalez N et al Patient Reasoning: Patients’ and Care Partners’ Perceptions of Diagnostic Accuracy in Emergency Care Med Decis Making 2024 44 102 11 10.1177/0272989X231207829 37965762
70 National Health and Medical Research Council & Consumers Health Forum of Australia Statement on consumer and community involvement in health and medical research 2016 Available https://www.nhmrc.gov.au/about-us/publications/statement-consumer-and-community-involvement-health-and-medical-research
71 Elwyn G Nelson E Hager A et al Coproduction: when users define quality BMJ Qual Saf 2020 29 711 6 10.1136/bmjqs-2019-009830
72 World Health Organisation (WHO), World Alliance for Patient Safety. Research Priority Setting Working Group World alliance for patient safety - summary of the evidence on patient safety: implications for research geneva, switzerland 2008 Available http://apps.who.int/iris/handle/10665/43874
73 National Patient Safety Foundation’s Lucian Leape Institute Safety Is Personal: Partnering with Patients and Families for the Safest Care Boston, MA National Patient Safety Foundation 2014 Available http://www.npsf.org/about-us/lucian-leape-institute-at-npsf/lli-reports-and-statements/safety-is-personal-partnering-with-patients-and-families-for-the-safest-care/
74 Zwaan L Smith KM Giardina TD et al Patient generated research priorities to improve diagnostic safety: A systematic prioritization exercise Pat Educ Couns 2023 110 107650 10.1016/j.pec.2023.107650
75 Giardina TD Haskell H Menon S et al Learning From Patients’ Experiences Related To Diagnostic Errors Is Essential For Progress In Patient Safety Health Aff (Millwood) 2018 37 1821 7 10.1377/hlthaff.2018.0698 30395513
76 McDonald KM Bryce CL Graber ML The patient is in: patient involvement strategies for diagnostic error mitigation BMJ Qual Saf 2013 22 ii33 9 10.1136/bmjqs-2012-001623
77 Epstein RM Making communication research matter: What do patients notice, what do patients want, and what do patients need? Patient Educ Couns 2006 60 272 8 10.1016/j.pec.2005.11.003 16426796
78 Liang L Cako A Urquhart R et al Patient engagement in hospital health service planning and improvement: a scoping review BMJ Open 2018 8 e018263 10.1136/bmjopen-2017-018263
79 Dahm MR Brown A Martin D et al Interaction and innovation: practical strategies for inclusive consumer-driven research in health services BMJ Open 2019 9 e031555 10.1136/bmjopen-2019-031555
80 Xiao Y Miller K Werner N et al Co-Design with Patients for Improving Patient Safety: Strategies, Barriers and pitfalls Proc Hum Factors Ergon Soc Annu Meet 2023 67 633 8 10.1177/21695067231192416 38213999
81 Hesse-Biber SN Johnson RB The Oxford Handbook of Multimethod and Mixed Methods Research Inquiry Oxford OUP 2015
82 Mays N Pope C Qualitative research: Observational methods in health care settings BMJ 1995 311 182 4 10.1136/bmj.311.6998.182 7613435
83 Bowen GA Document Analysis as a Qualitative Research Method Qual Res J 2009 9 27 40 10.3316/QRJ0902027
84 Dalglish SL Khalid H McMahon SA Document analysis in health policy research: the READ approach Health Policy Plan 2021 35 1424 31 10.1093/heapol/czaa064 33175972
85 Hsieh H-F Shannon SE Three approaches to qualitative content analysis Qual Health Res 2005 15 1277 88 10.1177/1049732305276687 16204405
86 Meuser M Nagel U The expert interview and changes in knowledge production Bogner A Littig B Menz W Interviewing experts London: Palgrave Macmillan UK 2009 17 42
87 Malterud K Siersma VD Guassora AD Sample Size in Qualitative Interview Studies: Guided by Information Power Qual Health Res 2016 26 1753 60 10.1177/1049732315617444 26613970
88 Patton MQ Qualitative Research & Evaluation Methods: Integrating Theory and Practice Thousand Oaks, CA, USA Sage Publications Inc 2015
89 Braun V Clarke V Using thematic analysis in psychology Qual Res Psychol 2006 3 77 101 10.1191/1478088706qp063oa
90 Australian Institute for Health and Welfare MyHospitals - emergency department care 2023 n.d. Available https://www.aihw.gov.au/reports-data/myhospitals/sectors/emergency-department-care
91 Australian Commission on Safety and Quality in Health Care Emergency Triage Education Kit 2nd edn Sydney ACSQHC 2024 Available https://www.safetyandquality.gov.au/publications-and-resources/resource-library/emergency-triage-education-kit-etek-second-edition
92 Harvey K Adolphs S Discourse and healthcare The Routledge handbook of discourse analysis 2013 Routledge n.d. 496 507
93 Brookes G Harvey K Adolphs S Discourse and health(care) Handford M Gee JP The Routledge Handbook of Discourse Analysis 2nd edn London: Routledge 2023 553 67
94 Harrison JD Auerbach AD Anderson W et al Patient stakeholder engagement in research: A narrative review to describe foundational principles and best practice activities Health Expect 2019 22 307 16 10.1111/hex.12873 30761699
95 National Health and Medical Research Council Australian code for the responsible conduct of research 2018 Available https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018
