Creating and administering video vignettes for a study examining the communication of diagnostic uncertainty: methodological insights to improve accessibility for researchers and participants.

BACKGROUND: Studying clinician-patient communication can be challenging, particularly when research seeks to explore cause-and-effect relationships. Video vignettes - hypothetical yet realistic scenarios - offer advantages to traditional observational approaches by enabling standardisation and manipulation of a clinician-patient encounter for assessment by participants. While published guidelines outline stages to create valid video vignette studies, constructing high quality vignettes which are accessible to a wide range of participants and feasible to produce within time and budget restraints remains challenging. Here, we outline our methods in creating valid video vignettes to study the communication of diagnostic uncertainty. We aim to provide practically useful recommendations for future researchers, and to prompt further reflection on accessibility issues in video vignette methodology. METHODS: We produced four video vignettes for use in an online study examining the communication of diagnostic uncertainty. We followed established guidelines for vignette production, with specific consideration of how these might be applied pragmatically to save time and resources. Scripts were pilot-tested with 15 laypeople, and videos with 14 laypeople; pilot-testing involved both quantitative and qualitative analysis. RESULTS AND DISCUSSION: We demonstrate the usefulness of existing guidelines, while also determining that vignette production need not necessarily be expensive or time-consuming to be valid. Our vignettes were filmed using an iPhone camera, and featured a physician rather than a professional actor; nonetheless, pilot-testing found them to be internally and externally valid for experimental use. We thus propose that if care is taken in initial script development and if pragmatic choices are made regarding filming techniques and pilot-testing, researchers can produce valid vignettes within reasonable time and budget restraints. We also suggest that existing research fails to critically examine the potential benefits and harms of online video vignette methodology, and propose that further research should consider how it can be adapted to be inclusive of those from underserved backgrounds. CONCLUSIONS: Researchers creating video vignette studies can adapt the video vignette development process to suit time and budget constraints, and to make best use of available technology. Online methods may be harnessed to increase participant accessibility, but future research should explore more inclusive vignette design.

What is in the toolkit (and what are the tools)? How to approach the study of doctor-patient communication.

Doctor-patient communication is important, but is challenging to study, in part because it is multifaceted. Communication can be considered in terms of both the aspects of the communication itself, and its measurable effects. These effects are themselves varied: they can be proximal or distal, and can focus on subjective measures (how patients feel about communication), or objective measures (exploring more concrete health outcomes or behaviours). The wide range of methodologies available has resulted in a heterogeneous literature which can be difficult to compare and analyse. Here, we provide a conceptual approach to studying doctor-patient communication, examining both variables which can controlled and different outcomes which can be measured. We present methodologies which can be used (questionnaires, semistructured interviews, vignette studies, simulated patient studies and observations of real interactions), with particular emphasis on their respective logistical advantages/disadvantages and scientific merits/limitations. To study doctor-patient communication more effectively, two or more different study designs could be used in combination. We have provided a concise and practically relevant review of the methodologies available to study doctor-patient communication to give researchers an objective view of the toolkit available to them: both to understand current research, and to conduct robust and relevant studies in the future.

The frontiers of medical negligence and diagnosis: an interview-based analysis.

While errors in medical diagnosis are common and often litigated, the different dimensions of diagnosis-formation, communication, recording-have received much less legal attention. When the process of diagnosis is differentiated in this way, new and contentious legal questions emerge that challenge the appropriateness of the Bolam/Bolitho standard. To explore these challenges, we interviewed 31 solicitors and barristers and asked them: (i) whether Montgomery should apply to information about alternative diagnoses; and (ii) whether the Bolam/Bolitho standard should be rejected in 'pure diagnosis' cases. Our qualitative analysis of the interviews sheds light not only on the two questions posed, but also on three cross-cutting themes. First, Bolam/Bolitho is criticised on two grounds that are often conflated: its paternalism for patients and its deference to medical professionals. Second, adopting different standards for different aspects of treatment and diagnosis may be justified in principle, but it can sometimes be difficult or not make sense in practice. Third, new conceptions of patients, doctors, and courts are being articulated in terms of rights or responsibilities over risks. In mapping these issues at the frontiers of medical negligence, this empirical study identifies potential pressure points for future legal developments.

Towards cataloguing and characterising advance care planning and end-of-life care resources.

BACKGROUND: Resources for healthcare professionals, patients and those important to them relating to planning and coordinating treatment and care at the end of life are abundant, and can be difficult to navigate. However, they have not been systematically collated or catalogued in terms of their purpose, scope or intended audience. AIM: To collate, categorise and characterise advance care planning and end-of-life treatment and care (EoLT + C) resources directed towards healthcare professionals, patients and their families. METHODS: Rapid review and thematic synthesis of resources available in the United Kingdom. Google searches and reviews of websites belonging to selected organisations that develop and publish materials relating to EoLT + C, and advance care planning were used. Materials were included if they were intended for those over 18 living in the UK and pertained to five domains of EoLT + C: identifying those approaching end of life; accessing EoLT + C services; conducting important conversations about EoLT + C and preferences; advance care planning, including recording of preferences and plans; and ensuring that plans and preferences are accessed and used by health and social care services. RESULTS: 246 resources directed at healthcare professionals, patients and their families were identified, collated, catalogued and made internationally available for clinicians, researchers, patients and the public. 61 were classified as interactive, providing decision support in EoLT + C that went beyond simply providing information. Of these, there was notable content overlap among tools for identifying patients in their last year of life. There was variation in the development of tools across all domains of end-of-life care by geography and patient group. Few interactive resources integrated seamlessly with a digital interface or healthcare provider workflows. Incentives for the adoption of best-practice appeared rare. CONCLUSIONS: We present a repeatable and scalable approach to the cataloguing and characterisation of palliative care resources. The identified resources will be of benefit not only to those in the UK but to those in other countries, developing or evaluating their own resources for aiding professionals and patients to plan and deliver excellent treatment and care at the end of life.

Implementation of ReSPECT in acute hospitals: A retrospective observational study.

AIMS: To evaluate, in UK acute hospitals, the early implementation of the Recommended Summary Plan for Emergency Care and Treatment (ReSPECT), which embeds cardiopulmonary resuscitation (CPR) recommendations within wider emergency treatment plans. To understand for whom and how the process was being used and the quality of form completion. METHODS: A retrospective observational study evaluating emergency care and treatment planning approaches used in acute UK hospitals (2015-2019), and in six English hospital trusts the extent of ReSPECT use, patient characteristics and completion quality in a sample 3000 patient case notes. RESULTS: The use of stand-alone Do Not Attempt Cardiopulmonary Resuscitation forms fell from 133/186 hospitals in 2015 to 64/186 in 2019 (a 38% absolute reduction). ReSPECT accounted for 52% (36/69) of changes. In the six sites, ReSPECT was used for approximately 20% of patients (range 6%-41%). They tended to be older, to have had an emergency medical admission, to have cognitive impairment and a lower predicted 10 year survival. Most (653/706 (92%)) included a 'not for attempted resuscitation' recommendation 551/706 (78%) had at least one other treatment recommendation. Capacity was not recorded on 13% (95/706) of forms; 11% (79/706) did not record patient/family involvement. CONCLUSIONS: ReSPECT use accounts for 52% of the change, observed between 2015 and 2019, from using standalone DNACPR forms to approaches embedding DNACPR decisions within in wider emergency care plans in NHS hospitals in the UK. Whilst recommendations include other emergencies most still tend to focus on recommendations relating to CPR. Completion of ReSPECT forms requires improvement. STUDY REGISTRATION: https://www.isrctn.com/ISRCTN11112933.

Differentiating Negligent Standards of Care in Diagnosis.

Diagnosis lies at the heart of the medical encounter, yet it has received much less attention than treatment. It is widely assumed that negligent diagnosis claims should be governed by the Bolam test, but we demonstrate that this is not always the case. First, we disaggregate the diagnostic process into three different acts: forming the diagnosis, communicating it to the patient, and recording it. Second, we consider alternatives to Bolam for defining negligence, including less deferential profession-led standards, patient-led standards, and even a reasonable person standard. Third, bringing together these distinctions-within the diagnostic process, and between standards of care-we reveal the unappreciated complexity of negligent diagnosis. Analysing the standard of care that might apply to the three different acts in the diagnostic process, we identify reasons to think that Montgomery should apply to the communication of a diagnosis. We also argue that even in areas where the law is well-established, such as the application of Bolam to the formation of a diagnosis, challenging questions arise that require further attention. Throughout, the framework and analysis that we develop have significant implications for a set of negligence cases, as well as for medical education, clinical guidelines, and patient care.

Montgomery's legal and practical impact: A systematic review at 6 years.

RATIONALE, AIMS AND OBJECTIVES: Six years ago, the Supreme Court judgement in Montgomery v Lanarkshire changed medical law. It introduced a new patient-based standard of care for the communication of treatment risks and alternatives, rejecting the doctor-based standard that had long governed all aspects of medical negligence. This is the first systematic review to analyse the literature on Montgomery. Our aim is to appraise and synthesize the literature on Montgomery's impact on medicine and the law and to identify areas for further academic enquiry and implications for professional guidance and training. METHODS: Searches were run in Medline, Embase, PsycINFO, Web of Science, Scopus, Westlaw UK, HeinOnline, and LexisNexis. Two reviewers screened papers. Extracted data was analysed and discussed by an interdisciplinary team. PRISMA guidelines were followed. RESULTS: Of the 1134 papers identified, 100 met the inclusion criteria. These papers revealed significant disagreement on four core sets of issues, focusing on Montgomery's impact on: (1) legal and professional duties; (2) medical practice; (3) the patient experience; and (4) litigation. The first set addresses whether the case actually changed doctors' legal and professional duties, the relationship between GMC guidance and medical law, and the boundaries of Montgomery. The second explores whether the decision has incentivized defensive medicine, its resource implications, and doctors' knowledge of it. The third concerns whether and how the decision has promoted patient autonomy and involvement in their own care. The fourth focuses on whether the case has caused an increase in litigation. CONCLUSIONS: Despite the abundance of legal and medical literature on Montgomery, many issues remain unresolved. Empirical research is required for many of the questions. Doctrinal analysis informed by medical knowledge is also required to assess whether Montgomery may have unrecognized ramifications-for example, whether it will require the disclosure of risks associated with diagnostic uncertainty, where doctors advise patients without performing procedures.

In defence of our model for just healthcare systems: why an explicit philosophy is needed in addition to the law, and how Scanlon helps derive just policies.

In a recent response to our paper on developing a philosophical framework to guide the design and delivery of a just health service, Sarela raises several objections. We feel that although Sarela makes points which are worthy of discussion, his critique does not undermine either the need for, or the worth of, our proposed model. First, the law does not negate the need for ethics in determining just healthcare policy. Reliance on legal processes can drive inappropriate focus on ensuring policies avoid judicial review, as opposed to ensuring they are truly just; the law affords protection against unjust policies but does not put a commitment to avoiding them at the heart of policy-making. We defend the need for Scanlonian supplementation by emphasising the practical value of adding a step based on reasonable rejection, particularly in ensuring that the views of vulnerable stakeholders are robustly considered. We discuss the similarities and differences between the work of Daniels and Sen in considering the relationship between health and opportunity, concluding that Sen's capability approach is both valuable and compatible with our proposed model. Finally, the practical use of our model requires consideration of what constitutes a reasonable person. Our model is explicitly intended to help develop a healthcare system which is just to all its users. With this in mind, we suggest that those involved in decision-making should meet Scanlon's definition of reasonable: they should be motivated to justify their actions to, and seek agreement with, others.

Assessing the quality of ReSPECT documentation using an accountability for reasonableness framework.

BACKGROUND: The Recommended Summary Plan for Emergency Care and Treatment (ReSPECT) form, which supports the ReSPECT process, is designed to prompt clinicians to discuss wider emergency treatment options with patients and to structure the documentation of decision-making for greater transparency. METHODS: Following an accountability for reasonableness framework (AFR), we analysed 141 completed ReSPECT forms (versions 1.0 and 2.0), collected from six National Health Service (NHS) hospitals in England during the early adoption of ReSPECT. Structured through an evaluation tool developed for this study, the analysis assessed the extent to which the records reflected consistency, transparency, and ethical justification of decision-making. RESULTS: Recommendations relating to CPR were consistently recorded on all forms and were contextualised within other treatment recommendations in most forms. The level of detail provided about treatment recommendations varied widely and reasons for treatment recommendations were rarely documented. Patient capacity, patient priorities and preferences, and the involvement of patients/relatives in ReSPECT conversations were recorded in some, but not all, forms. Clinicians almost never documented their weighing of potential burdens and benefits of treatments on the ReSPECT forms. CONCLUSION: In most ReSPECT forms, CPR recommendations were captured alongside other treatment recommendations. However, ReSPECT form design and associated training should be modified to address inconsistencies in form completion. These modifications should emphasise the recording of patient values and preferences, assessment of patient capacity, and clinical reasoning processes, thereby putting patient/family involvement at the core of good clinical practice. Version 3.0 of ReSPECT responds to these issues.

Doctors have an ethical obligation to ask patients about food insecurity: what is stopping us?

Inadequate diet is the leading risk factor for morbidity and mortality worldwide. However, approaches to identifying inadequate diets in clinical practice remain inconsistent, and dietary interventions (on both individual and public health policy levels) frequently focus on facilitating 'healthy choices', with limited emphasis on structural constraints. We examine the ethical implications of introducing a routine question in the medical history about ability to access food. Not collecting data on food security means that clinicians are unable to identify people who may benefit from support on an individual level, unable to consider relevant dietary risk factors for disease and disease progression and unable to monitor population trends and inequalities in dietary access in order to design effective policy interventions. We argue that the current lack of routine screening for food insecurity is inconsistent with our approach to other health behaviours (eg, smoking and alcohol use), as well as with doctors' frequent informal role as gatekeepers to the food aid system, and recent calls for governmental action on food insecurity and health inequalities from individual clinicians and professional bodies. Potential ethical barriers to asking patients about food security are addressed, including concerns about stigma, limiting autonomy, fair resource allocation, unclear professional remits and clinicians' ability to offer effective interventions. We suggest that there is an ethical imperative for doctors to ask patients about their ability to access healthy food. Gathering this data provides a valuable first step in re-framing the social determinants of health as modifiable risks, rather than inevitable inequities.

Sharing a written medical summary with patients on the post-admission ward round: A qualitative study of clinician and patient experience.

RATIONALE, AIMS AND OBJECTIVES: Sharing aspects of the traditional medical record with patients has been successful in primary and antenatal care, but has not been investigated in the UK inpatient setting. Our aim was to evaluate the impact on patient and clinician experience of providing patients with a written lay summary of their care-plan in the acute care setting. METHOD: We carried out a qualitative interview study on two acute medicine wards in an NHS University Teaching Hospital for a 4-week period in 2019. A summary record, designed in response to suggestions from doctors and patients from a previous study, was distributed to patients on the first ward round after admission. Eligible participants included all doctors and nurses working on and all patients and their families attending the acute medical units; patients were excluded if they lacked capacity to consent or were under 18. We interviewed 20 patients, 10 relatives, 10 doctors and 7 nurses. RESULTS: Patients felt that the summary improved their ability to remember details about their care so they could more accurately and easily update their relatives. They did not feel that the summary induced anxiety. Patient-doctor communication was improved: patients felt empowered to ask more questions and doctors felt that it solidified their plan and encouraged them to avoid medical jargon. Most patients felt the summary included the 'right' amount of information. Healthcare professionals were more concerned about the risk of breaching confidentiality than patients. Doctors felt that providing summaries was time-consuming; there were differing opinions about whether this was a worthwhile investment of time. Clinicians recognized that the traditional medical record has many roles. CONCLUSIONS: A summary record could empower patients and improve patient-doctor communication but would require additional clinician and administrative time.

Diagnostic uncertainty in primary care: what is known about its communication, and what are the associated ethical issues?

BACKGROUND: Diagnostic uncertainty (DU) in primary care is ubiquitous, yet no review has specifically examined its communication, or the associated ethical issues. OBJECTIVES: To identify what is known about the communication of DU in primary care and the associated ethical issues. METHODS: Systematic review, critical interpretive synthesis and ethical analysis of primary research published worldwide. Medline, Embase, Web of Science and SCOPUS were searched for papers from 1988 to 2020 relating to primary care AND diagnostic uncertainty AND [ethics OR behaviours OR communication]. Critical interpretive synthesis and ethical analysis were applied to data extracted. RESULTS: Sixteen papers met inclusion criteria. Although DU is inherent in primary care, its communication is often limited. Evidence on the effects of communicating DU to patients is mixed; research on patient perspectives of DU is lacking. The empirical literature is significantly limited by inconsistencies in how DU is defined and measured. No primary ethical analysis was identified; secondary analysis of the included papers identified ethical issues relating to maintaining patient autonomy in the face of clinical uncertainty, a gap in considering the direct effects of (not) communicating DU on patients, and considerations regarding over-investigation and justice. CONCLUSIONS: This review highlights significant gaps in the literature: there is a need for explicit ethical and patient-centred empirical analyses on the effects of communicating DU, and research directly examining patient preferences for this communication. Consensus on how DU should be defined, and greater research into tools for its measurement, would help to strengthen the empirical evidence base.

Development and evaluation of an illustrated paediatric leaflet 'Coming to Hospital: a guide to what goes on'.

Background: A paediatric information leaflet was produced to better prepare patients for time spent in hospital and to improve experience by informing them what to expect. Methods: The 'Coming to Hospital' leaflet was designed with input from paediatric research groups, and in collaboration with a children's author and publishing company. A questionnaire to evaluate the leaflet was developed; face validity was established in a pilot. The real-time patient experience of these leaflets was evaluated on paediatric wards in a university hospital. Results: The evaluation revealed that a significant majority of children 'really liked' the leaflet and found it helpful. 53 out of 72 of children reported that the leaflet made them feel 'happy' or 'calm', with no children responding that it made them feel 'very worried'. The leaflet was found to be informative, well presented and reassuring. Many parents stated that they wished they had received the leaflet prior to their child's first hospital visit. Suggestions for changes to the leaflet were minimal; it was considered to include all relevant information. Conclusion: A leaflet designed by clinical staff, patients and a publishing company was welcomed by paediatric patients and their parents. Patients reported it made them feel calmer. Such a leaflet should be available widely to improve children's experience of coming to hospital. Collaborations between clinicians, academics and publishing companies can produce positive results for the paediatric population.