Desperately Seeking Intersectionality in Digital Health Disparity Research: Narrative Review to Inform a Richer Theorization of Multiple Disadvantage.

BACKGROUND: Digital consultations between patients and clinicians increased markedly during the COVID-19 pandemic, raising questions about equity. OBJECTIVE: This study aimed to review the literature on how multiple disadvantage-specifically, older age, lower socioeconomic status, and limited English proficiency-has been conceptualized, theorized, and studied empirically in relation to digital consultations. We focused mainly on video consultations as they have wider disparities than telephone consultations and relevant data on e-consultations are sparse. METHODS: Using keyword and snowball searching, we identified relevant papers published between 2012 and 2022 using Ovid MEDLINE, Web of Science, Google Scholar, and PubMed. The first search was completed in July 2022. Papers meeting the inclusion criteria were analyzed thematically and summarized, and their key findings were tabulated using the Grading of Recommendations Assessment, Development, and Evaluation Confidence in the Evidence from Reviews of Qualitative Research criteria. Explanations for digital disparities were critically examined, and a search was undertaken in October 2022 to identify theoretical lenses on multiple disadvantage. RESULTS: Of 663 articles from the initial search, 27 (4.1%) met our inclusion criteria. In total, 37% (10/27) were commentaries, and 63% (17/27) were peer-reviewed empirical studies (11/27, 41% quantitative; 5/27, 19% qualitative; 1/27, 4% mixed methods; 1/27, 4% systematic reviews; and 1/27, 4% narrative reviews). Empirical studies were mostly small, rapidly conducted, and briefly reported. Most studies (25/27, 93%) identified marked digital disparities but lacked a strong theoretical lens. Proposed solutions focused on identifying and removing barriers, but the authors generally overlooked the pervasive impact of multiple layers of disadvantage. The data set included no theoretically informed studies that examined how different dimensions of disadvantage combined to affect digital health disparities. In our subsequent search, we identified 3 theoretical approaches that might help account for these digital disparities. Fundamental cause theory by Link and Phelan addresses why the association between socioeconomic status and health is pervasive and persists over time. Digital capital theory by Ragnedda and Ruiu explains how people mobilize resources to participate in digitally mediated activities and services. Intersectionality theory by Crenshaw states that systems of oppression are inherently bound together, creating singular social experiences for people who bear the force of multiple adverse social structures. CONCLUSIONS: A limitation of our initial sample was the sparse and undertheorized nature of the primary literature. The lack of attention to how digital health disparities emerge and play out both within and across categories of disadvantage means that solutions proposed to date may be oversimplistic and insufficient. Theories of multiple disadvantage have bearing on digital health, and there may be others of relevance besides those discussed in this paper. We call for greater interdisciplinary dialogue between theoretical research on multiple disadvantage and empirical studies on digital health disparities.

Persistent symptoms after Covid-19: qualitative study of 114 "long Covid" patients and draft quality principles for services.

BACKGROUND: Approximately 10% of patients with Covid-19 experience symptoms beyond 3-4 weeks. Patients call this "long Covid". We sought to document such patients' lived experience, including accessing and receiving healthcare and ideas for improving services. METHODS: We held 55 individual interviews and 8 focus groups (n = 59) with people recruited from UK-based long Covid patient support groups, social media and snowballing. We restricted some focus groups to health professionals since they had already self-organised into online communities. Participants were invited to tell their stories and comment on others' stories. Data were audiotaped, transcribed, anonymised and coded using NVIVO. Analysis incorporated sociological theories of illness, healing, peer support, clinical relationships, access, and service redesign. RESULTS: Of 114 participants aged 27-73 years, 80 were female. Eighty-four were White British, 13 Asian, 8 White Other, 5 Black, and 4 mixed ethnicity. Thirty-two were doctors and 19 other health professionals. Thirty-one had attended hospital, of whom 8 had been admitted. Analysis revealed a confusing illness with many, varied and often relapsing-remitting symptoms and uncertain prognosis; a heavy sense of loss and stigma; difficulty accessing and navigating services; difficulty being taken seriously and achieving a diagnosis; disjointed and siloed care (including inability to access specialist services); variation in standards (e.g. inconsistent criteria for seeing, investigating and referring patients); variable quality of the therapeutic relationship (some participants felt well supported while others felt "fobbed off"); and possible critical events (e.g. deterioration after being unable to access services). Emotionally significant aspects of participants' experiences informed ideas for improving services. CONCLUSION: Suggested quality principles for a long Covid service include ensuring access to care, reducing burden of illness, taking clinical responsibility and providing continuity of care, multi-disciplinary rehabilitation, evidence-based investigation and management, and further development of the knowledge base and clinical services. TRIAL REGISTRATION: NCT04435041.

Developing user personas to capture intersecting dimensions of disadvantage in older patients who are marginalised: a qualitative study.

BACKGROUND: Remote and digital services must be equitable, but some patients have difficulty using these services. Designing measures to overcome digital disparities can be challenging for practices. Personas (fictional cases) are a potentially useful tool in this regard. AIM: To develop and test a set of personas to reflect the lived experiences and challenges that older people who are disadvantaged face when navigating remote and digital primary care services. DESIGN AND SETTING: Qualitative study of digital disparities in NHS community health services offering video appointments. METHOD: Following familiarisation visits and interviews with service providers, 17 older people with multiple markers of disadvantage (limited English, health conditions, and poverty) were recruited and interviewed using narrative prompts. Data were analysed using an intersectionality lens, underpinned by sociological theory. Combining data across all participant interviews, we produced personas and refined these following focus groups involving health professionals, patients, and advocates (n = 12). RESULTS: Digital services create significant challenges for older patients with limited economic, social, and linguistic resources and low digital, health, or system literacy. Four contrasting personas were produced, capturing the variety and complexity of how dimensions of disadvantage intersected and influenced identity and actions. The personas illustrate important themes including experience of racism and discrimination, disorientation, discontinuity, limited presence, weak relationships, loss of agency, and mistrust of services and providers. CONCLUSION: Personas can illuminate the multiple and intersecting dimensions of disadvantage in patient populations who are marginalised and may prove useful when designing or redesigning digital primary care services. Adopting an intersectional lens may help practices address digital disparities.

Training needs for staff providing remote services in general practice: a mixed-methods study.

BACKGROUND: Contemporary general practice includes many kinds of remote encounter. The rise in telephone, video and online modalities for triage and clinical care requires clinicians and support staff to be trained, both individually and as teams, but evidence-based competencies have not previously been produced for general practice. AIM: To identify training needs, core competencies, and learning methods for staff providing remote encounters. DESIGN AND SETTING: Mixed-methods study in UK general practice. METHOD: Data were collated from longitudinal ethnographic case studies of 12 general practices; a multi-stakeholder workshop; interviews with policymakers, training providers, and trainees; published research; and grey literature (such as training materials and surveys). Data were coded thematically and analysed using theories of individual and team learning. RESULTS: Learning to provide remote services occurred in the context of high workload, understaffing, and complex workflows. Low confidence and perceived unmet training needs were common. Training priorities for novice clinicians included basic technological skills, triage, ethics (for privacy and consent), and communication and clinical skills. Established clinicians' training priorities include advanced communication skills (for example, maintaining rapport and attentiveness), working within the limits of technologies, making complex judgements, coordinating multi-professional care in a distributed environment, and training others. Much existing training is didactic and technology focused. While basic knowledge was often gained using such methods, the ability and confidence to make complex judgements were usually acquired through experience, informal discussions, and on-the-job methods such as shadowing. Whole-team training was valued but rarely available. A draft set of competencies is offered based on the findings. CONCLUSION: The knowledge needed to deliver high-quality remote encounters to diverse patient groups is complex, collective, and organisationally embedded. The vital role of non-didactic training, for example, joint clinical sessions, case-based discussions, and in-person, whole-team, on-the-job training, needs to be recognised.

Safety implications of remote assessments for suspected COVID-19: qualitative study in UK primary care.

BACKGROUND: The introduction of remote triage and assessment early in the pandemic raised questions about patient safety. We sought to capture patients and clinicians' experiences of the management of suspected acute COVID-19 and generate wider lessons to inform safer care. SETTING AND SAMPLE: UK primary healthcare. A subset of relevant data was drawn from five linked in-pandemic qualitative studies. The data set, on a total of 87 participants recruited via social media, patient groups and snowballing, comprised free text excerpts from narrative interviews (10 survivors of acute COVID-19), online focus groups (20 patients and 30 clinicians), contributions to a Delphi panel (12 clinicians) and fieldnotes from an online workshop (15 patients, clinicians and stakeholders). METHODS: Data were uploaded onto NVivo. Coding was initially deductive and informed by WHO and Institute of Medicine frameworks of quality and safety. Further inductive analysis refined our theorisation using a wider range of theories-including those of risk, resilience, crisis management and social justice. RESULTS: In the early weeks of the pandemic, patient safety was compromised by the driving logic of 'stay home' and 'protect the NHS', in which both patients and clinicians were encouraged to act in a way that helped reduce pressure on an overloaded system facing a novel pathogen with insufficient staff, tools, processes and systems. Furthermore, patients and clinicians observed a shift to a more transactional approach characterised by overuse of algorithms and decision support tools, limited empathy and lack of holistic assessment. CONCLUSION: Lessons from the pandemic suggest three key strategies are needed to prevent avoidable deaths and inequalities in the next crisis: (1) strengthen system resilience (including improved resourcing and staffing; support of new tools and processes; and recognising primary care's role as the 'risk sink' of the healthcare system); (2) develop evidence-based triage and scoring systems; and (3) address social vulnerability.

Patient safety in remote primary care encounters: multimethod qualitative study combining Safety I and Safety II analysis.

BACKGROUND: Triage and clinical consultations increasingly occur remotely. We aimed to learn why safety incidents occur in remote encounters and how to prevent them. SETTING AND SAMPLE: UK primary care. 95 safety incidents (complaints, settled indemnity claims and reports) involving remote interactions. Separately, 12 general practices followed 2021-2023. METHODS: Multimethod qualitative study. We explored causes of real safety incidents retrospectively ('Safety I' analysis). In a prospective longitudinal study, we used interviews and ethnographic observation to produce individual, organisational and system-level explanations for why safety and near-miss incidents (rarely) occurred and why they did not occur more often ('Safety II' analysis). Data were analysed thematically. An interpretive synthesis of why safety incidents occur, and why they do not occur more often, was refined following member checking with safety experts and lived experience experts. RESULTS: Safety incidents were characterised by inappropriate modality, poor rapport building, inadequate information gathering, limited clinical assessment, inappropriate pathway (eg, wrong algorithm) and inadequate attention to social circumstances. These resulted in missed, inaccurate or delayed diagnoses, underestimation of severity or urgency, delayed referral, incorrect or delayed treatment, poor safety netting and inadequate follow-up. Patients with complex pre-existing conditions, cardiac or abdominal emergencies, vague or generalised symptoms, safeguarding issues, failure to respond to previous treatment or difficulty communicating seemed especially vulnerable. General practices were facing resource constraints, understaffing and high demand. Triage and care pathways were complex, hard to navigate and involved multiple staff. In this context, patient safety often depended on individual staff taking initiative, speaking up or personalising solutions. CONCLUSION: While safety incidents are extremely rare in remote primary care, deaths and serious harms have resulted. We offer suggestions for patient, staff and system-level mitigations.

'I can't cope with multiple inputs': a qualitative study of the lived experience of 'brain fog' after COVID-19.

OBJECTIVE: To explore the lived experience of 'brain fog'-the wide variety of neurocognitive symptoms that can follow COVID-19. DESIGN AND SETTING: A UK-wide longitudinal qualitative study comprising online focus groups with email follow-up. METHOD: 50 participants were recruited from a previous qualitative study of the lived experience of long COVID-19 (n=23) and online support groups for people with persistent neurocognitive symptoms following COVID-19 (n=27). In remotely held focus groups, participants were invited to describe their neurocognitive symptoms and comment on others' accounts. Individuals were followed up by email 4-6 months later. Data were audiotaped, transcribed, anonymised and coded in NVIVO. They were analysed by an interdisciplinary team with expertise in general practice, clinical neuroscience, the sociology of chronic illness and service delivery, and checked by people with lived experience of brain fog. RESULTS: Of the 50 participants, 42 were female and 32 white British. Most had never been hospitalised for COVID-19. Qualitative analysis revealed the following themes: mixed views on the appropriateness of the term 'brain fog'; rich descriptions of the experience of neurocognitive symptoms (especially executive function, attention, memory and language), accounts of how the illness fluctuated-and progressed over time; the profound psychosocial impact of the condition on relationships, personal and professional identity; self-perceptions of guilt, shame and stigma; strategies used for self-management; challenges accessing and navigating the healthcare system; and participants' search for physical mechanisms to explain their symptoms. CONCLUSION: These qualitative findings complement research into the epidemiology and mechanisms of neurocognitive symptoms after COVID-19. Services for such patients should include: an ongoing therapeutic relationship with a clinician who engages with their experience of neurocognitive symptoms in its personal, social and occupational context as well as specialist services that include provision for neurocognitive symptoms, are accessible, easily navigable, comprehensive and interdisciplinary.

Remote care in UK general practice: baseline data on 11 case studies.

Background: Accessing and receiving care remotely (by telephone, video or online) became the default option during the coronavirus disease 2019 (COVID-19) pandemic, but in-person care has unique benefits in some circumstances. We are studying UK general practices as they try to balance remote and in-person care, with recurrent waves of COVID-19 and various post-pandemic backlogs. Methods: Mixed-methods (mostly qualitative) case study across 11 general practices. Researchers-in-residence have built relationships with practices and become familiar with their contexts and activities; they are following their progress for two years via staff and patient interviews, documents and ethnography, and supporting improvement efforts through co-design. In this paper, we report baseline data. Results: Reflecting our maximum-variety sampling strategy, the 11 practices vary in size, setting, ethos, staffing, population demographics and digital maturity, but share common contextual features-notably system-level stressors such as high workload and staff shortages, and UK's technical and regulatory infrastructure. We have identified both commonalities and differences between practices in terms of how they: 1] manage the 'digital front door' (access and triage) and balance demand and capacity; 2] strive for high standards of quality and safety; 3] ensure digital inclusion and mitigate wider inequalities; 4] support and train their staff (clinical and non-clinical), students and trainees; 5] select, install, pilot and use technologies and the digital infrastructure which support them; and 6] involve patients in their improvement efforts. Conclusions: General practices' responses to pandemic-induced disruptive innovation appear unique and situated. We anticipate that by focusing on depth and detail, this longitudinal study will throw light on why a solution that works well in one practice does not work at all in another. As the study unfolds, we will explore how practices achieve timely diagnosis of urgent or serious illness and manage continuity of care, long-term conditions and complex needs.

We describe early results from the Remote by Default 2 study, which is following 11 UK general practices for two years as they introduce various kinds of remote appointment booking and clinical consultations. We have been using interviews and ethnography (watching real-world activities), and analysing documents (such as practice reports and websites) to prepare case studies of the 11 practices, which vary widely in size, ethos, geographical location, practice population and digital maturity. Our initial interviews identified the following cross-cutting themes, which showed both commonalities and differences across the 11 practices: - The 'digital front door' (patients gaining access using digital portals), which was used to a greater or lesser extent in all practices; some found these systems frustrating and inefficient.- Quality and safety. Staff were concerned about the risk of missing an important diagnosis when consulting remotely, and felt that digitisation could threaten continuity of care.- Digital inclusion. All practices were keen to ensure that patients who lacked digital devices or skills were not disadvantaged; this goal was achieved in different ways (and to different degrees) in different settings.- Staff support and training. Some practices are finding current workload unsustainable due to (among other things) rising patient demand, unfilled staff posts, a post-pandemic backlog of unmet need, and task-shifting from secondary care. Digitisation appears to have increased workload in most practices.- Technologies and infrastructure. The IT infrastructure in each practice had grown in a particular way over time, and was in this sense 'path-dependent' (hence, not easily changed). In conclusion, different practices are responding to the 'disruptive innovation' of digital technologies in very different ways, reflecting their different practice populations, settings and priorities. We plan to follow the above themes over time and explore additional themes including the experience and role of patients.

Protocol: Remote care as the 'new normal'? Multi-site case study in UK general practice.

Background: Following a pandemic-driven shift to remote service provision, UK general practices offer telephone, video or online consultation options alongside face-to-face. This study explores practices' varied experiences over time as they seek to establish remote forms of accessing and delivering care. Methods: This protocol is for a mixed-methods multi-site case study with co-design and national stakeholder engagement. 11 general practices were selected for diversity in geographical location, size, demographics, ethos, and digital maturity. Each practice has a researcher-in-residence whose role is to become familiar with its context and activity, follow it longitudinally for two years using interviews, public-domain documents and ethnography, and support improvement efforts. Research team members meet regularly to compare and contrast across cases. Practice staff are invited to join online learning events. Patient representatives work locally within their practice patient involvement groups as well as joining an online patient learning set or linking via a non-digital buddy system. NHS Research Ethics Approval has been granted. Governance includes a diverse independent advisory group with lay chair. We also have policy in-reach (national stakeholders sit on our advisory group) and outreach (research team members sit on national policy working groups). Results anticipated: We expect to produce rich narratives of contingent change over time, addressing cross-cutting themes including access, triage and capacity; digital and wider inequities; quality and safety of care (e.g. continuity, long-term condition management, timely diagnosis, complex needs); workforce and staff wellbeing (including non-clinical staff, students and trainees); technologies and digital infrastructure; patient perspectives; and sustainability (e.g. carbon footprint). Conclusion: By using case study methods focusing on depth and detail, we hope to explain why digital solutions that work well in one practice do not work at all in another. We plan to inform policy and service development through inter-sectoral network-building, stakeholder workshops and topic-focused policy briefings.

The pandemic required general practices to introduce remote (phone, video and email) consultations. That policy undoubtedly saved lives at the time but there are also clear benefits of face-to-face consultations in some circumstances, and the exact role of remote care still needs to be worked out. Despite best efforts, remote care tends to worsen health inequities (people who were poor or less well educated are less able to access and navigate the system and secure the type of appointment they need or prefer). Workstream 1: We will look at 11 GP surgeries across England, Scotland and Wales. We have selected a variety of sites: urban and rural, serving a range of different communities. Each surgery has a different approach to technology. A researcher from our team will work alongside surgery staff to learn what methods and technologies each practice uses to deliver care. They will gather information (mostly qualitative) about how different technological solutions are playing out over time. Workstream 2: Many people experience barriers to accessing care when it is done through technology. This could be because they lack understanding of how to do it, don't have the right equipment, can't afford data, or other reasons. We will ask patients about their experiences and work with them and staff to develop ideas about how to overcome barriers. Workstream 3: We will take what we have learnt in Workstreams 1 and 2 to make suggestions to inform national stakeholders and to influence policymakers. Patients and members of the public helped shape the research design. They continue to help guide our research by reading our reports, giving us their opinions and advising on how best to share our research so everyone can benefit from what we have learnt. Our governance panel is chaired by a member of the public.

Remote COVID-19 Assessment in Primary Care (RECAP) risk prediction tool: derivation and real-world validation studies.

BACKGROUND: Accurate assessment of COVID-19 severity in the community is essential for patient care and requires COVID-19-specific risk prediction scores adequately validated in a community setting. Following a qualitative phase to identify signs, symptoms, and risk factors, we aimed to develop and validate two COVID-19-specific risk prediction scores. Remote COVID-19 Assessment in Primary Care-General Practice score (RECAP-GP; without peripheral oxygen saturation [SpO2]) and RECAP-oxygen saturation score (RECAP-O2; with SpO2). METHODS: RECAP was a prospective cohort study that used multivariable logistic regression. Data on signs and symptoms (predictors) of disease were collected from community-based patients with suspected COVID-19 via primary care electronic health records and linked with secondary data on hospital admission (outcome) within 28 days of symptom onset. Data sources for RECAP-GP were Oxford-Royal College of General Practitioners Research and Surveillance Centre (RCGP-RSC) primary care practices (development set), northwest London primary care practices (validation set), and the NHS COVID-19 Clinical Assessment Service (CCAS; validation set). The data source for RECAP-O2 was the Doctaly Assist platform (development set and validation set in subsequent sample). The two probabilistic risk prediction models were built by backwards elimination using the development sets and validated by application to the validation datasets. Estimated sample size per model, including the development and validation sets was 2880 people. FINDINGS: Data were available from 8311 individuals. Observations, such as SpO2, were mostly missing in the northwest London, RCGP-RSC, and CCAS data; however, SpO2 was available for 1364 (70·0%) of 1948 patients who used Doctaly. In the final predictive models, RECAP-GP (n=1863) included sex (male and female), age (years), degree of breathlessness (three point scale), temperature symptoms (two point scale), and presence of hypertension (yes or no); the area under the curve was 0·80 (95% CI 0·76-0·85) and on validation the negative predictive value of a low risk designation was 99% (95% CI 98·1-99·2; 1435 of 1453). RECAP-O2 included age (years), degree of breathlessness (two point scale), fatigue (two point scale), and SpO2 at rest (as a percentage); the area under the curve was 0·84 (0·78-0·90) and on validation the negative predictive value of low risk designation was 99% (95% CI 98·9-99·7; 1176 of 1183). INTERPRETATION: Both RECAP models are valid tools to assess COVID-19 patients in the community. RECAP-GP can be used initially, without need for observations, to identify patients who require monitoring. If the patient is monitored and SpO2 is available, RECAP-O2 is useful to assess the need for treatment escalation. FUNDING: Community Jameel and the Imperial College President's Excellence Fund, the Economic and Social Research Council, UK Research and Innovation, and Health Data Research UK.

Developing services for long COVID: lessons from a study of wounded healers.

Persistent symptoms lasting longer than 3 weeks are thought to affect 10-20% of patients following SARS-CoV-2 infection. No formal guidelines exist in the UK for treating patients with long COVID and services are sporadic and variable, although additional funding is promised for their development.In this study, narrative interviews and focus groups are used to explore the lived experience of 43 healthcare professionals with long COVID. These individuals see the healthcare system from both professional and patient perspectives, thus represent an important wealth of expertise to inform service design.We present a set of co-designed quality standards, highlighting equity and ease of access, minimal patient care burden, clinical responsibility, a multidisciplinary and evidence-based approach, and patient involvement; and we apply these to propose a potential care pathway model that could be adapted and translated to improve care of patients long COVID.

Long Covid - The illness narratives.

Callard and Perego depict long Covid as the first illness to be defined by patients who came together on social media. Responding to their call to address why patients were so effective in making long Covid visible and igniting action to improve its care, we use narrative inquiry - a field of research that investigates the place and power of stories and storytelling. We analyse a large dataset of narrative interviews and focus groups with 114 people with long Covid (45 of whom were healthcare professionals) from the United Kingdom, drawing on socio-narratology (Frank), therapeutic emplotment (Mattingly) and polyphonia (Bakhtin). We describe how storytelling devices including chronology, metaphor, characterisation, suspense and imagination were used to create persuasive accounts of a strange and frightening new condition that was beset with setbacks and overlooked or dismissed by health professionals. The most unique feature of long Covid narratives (in most but not all cases) was the absence, for various pandemic-related reasons, of a professional witness to them. Instead of sharing their narratives in therapeutic dialogue with their own clinician, people struggled with a fragmented inner monologue before finding an empathetic audience and other resonant narratives in the online community. Individually, the stories seemed to make little sense. Collectively, they provided a rich description of the diverse manifestations of a grave new illness, a shared account of rejection by the healthcare system, and a powerful call for action to fix the broken story. Evolving from individual narrative postings to collective narrative drama, long Covid communities challenged the prevailing model of Covid-19 as a short-lived respiratory illness which invariably delivers a classic triad of symptoms; undertook and published peer-reviewed research to substantiate its diverse and protracted manifestations; and gained positions as experts by experience on guideline development groups and policy taskforces.

Planning and Evaluating Remote Consultation Services: A New Conceptual Framework Incorporating Complexity and Practical Ethics.

Establishing and running remote consultation services is challenging politically (interest groups may gain or lose), organizationally (remote consulting requires implementation work and new roles and workflows), economically (costs and benefits are unevenly distributed across the system), technically (excellent care needs dependable links and high-quality audio and images), relationally (interpersonal interactions are altered), and clinically (patients are unique, some examinations require contact, and clinicians have deeply-held habits, dispositions and norms). Many of these challenges have an under-examined ethical dimension. In this paper, we present a novel framework, Planning and Evaluating Remote Consultation Services (PERCS), built from a literature review and ongoing research. PERCS has 7 domains-the reason for consulting, the patient, the clinical relationship, the home and family, technologies, staff, the healthcare organization, and the wider system-and considers how these domains interact and evolve over time as a complex system. It focuses attention on the organization's digital maturity and digital inclusion efforts. We have found that both during and beyond the pandemic, policymakers envisaged an efficient, safe and accessible remote consultation service delivered through state-of-the art digital technologies and implemented via rational allocation criteria and quality standards. In contrast, our empirical data reveal that strategic decisions about establishing remote consultation services, allocation decisions for appointment type (phone, video, e-, face-to-face), and clinical decisions when consulting remotely are fraught with contradictions and tensions-for example, between demand management and patient choice-leading to both large- and small-scale ethical dilemmas for managers, support staff, and clinicians. These dilemmas cannot be resolved by standard operating procedures or algorithms. Rather, they must be managed by attending to here-and-now practicalities and emergent narratives, drawing on guiding principles applied with contextual judgement. We complement the PERCS framework with a set of principles for informing its application in practice, including education of professionals and patients.

An Early Warning Risk Prediction Tool (RECAP-V1) for Patients Diagnosed With COVID-19: Protocol for a Statistical Analysis Plan.

BACKGROUND: Since the start of the COVID-19 pandemic, efforts have been made to develop early warning risk scores to help clinicians decide which patient is likely to deteriorate and require hospitalization. The RECAP (Remote COVID-19 Assessment in Primary Care) study investigates the predictive risk of hospitalization, deterioration, and death of patients with confirmed COVID-19, based on a set of parameters chosen through a Delphi process performed by clinicians. We aim to use rich data collected remotely through the use of electronic data templates integrated in the electronic health systems of several general practices across the United Kingdom to construct accurate predictive models. The models will be based on preexisting conditions and monitoring data of a patient's clinical parameters (eg, blood oxygen saturation) to make reliable predictions as to the patient's risk of hospital admission, deterioration, and death. OBJECTIVE: This statistical analysis plan outlines the statistical methods to build the prediction model to be used in the prioritization of patients in the primary care setting. The statistical analysis plan for the RECAP study includes the development and validation of the RECAP-V1 prediction model as a primary outcome. This prediction model will be adapted as a three-category risk score split into red (high risk), amber (medium risk), and green (low risk) for any patient with suspected COVID-19. The model will predict the risk of deterioration and hospitalization. METHODS: After the data have been collected, we will assess the degree of missingness and use a combination of traditional data imputation using multiple imputation by chained equations, as well as more novel machine-learning approaches to impute the missing data for the final analysis. For predictive model development, we will use multiple logistic regression analyses to construct the model. We aim to recruit a minimum of 1317 patients for model development and validation. We will then externally validate the model on an independent dataset of 1400 patients. The model will also be applied for multiple different datasets to assess both its performance in different patient groups and its applicability for different methods of data collection. RESULTS: As of May 10, 2021, we have recruited 3732 patients. A further 2088 patients have been recruited through the National Health Service Clinical Assessment Service, and approximately 5000 patients have been recruited through the DoctalyHealth platform. CONCLUSIONS: The methodology for the development of the RECAP-V1 prediction model as well as the risk score will provide clinicians with a statistically robust tool to help prioritize COVID-19 patients. TRIAL REGISTRATION: ClinicalTrials.gov NCT04435041; https://clinicaltrials.gov/ct2/show/NCT04435041. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30083.

Predicting Risk of Hospital Admission in Patients With Suspected COVID-19 in a Community Setting: Protocol for Development and Validation of a Multivariate Risk Prediction Tool.

BACKGROUND: During the pandemic, remote consultations have become the norm for assessing patients with signs and symptoms of COVID-19 to decrease the risk of transmission. This has intensified the clinical uncertainty already experienced by primary care clinicians when assessing patients with suspected COVID-19 and has prompted the use of risk prediction scores, such as the National Early Warning Score (NEWS2), to assess severity and guide treatment. However, the risk prediction tools available have not been validated in a community setting and are not designed to capture the idiosyncrasies of COVID-19 infection. OBJECTIVE: The objective of this study is to produce a multivariate risk prediction tool, RECAP-V1 (Remote COVID-19 Assessment in Primary Care), to support primary care clinicians in the identification of those patients with COVID-19 that are at higher risk of deterioration and facilitate the early escalation of their treatment with the aim of improving patient outcomes. METHODS: The study follows a prospective cohort observational design, whereby patients presenting in primary care with signs and symptoms suggestive of COVID-19 will be followed and their data linked to hospital outcomes (hospital admission and death). Data collection will be carried out by primary care clinicians in four arms: North West London Clinical Commissioning Groups (NWL CCGs), Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), Covid Clinical Assessment Service (CCAS), and South East London CCGs (Doctaly platform). The study involves the use of an electronic template that incorporates a list of items (known as RECAP-V0) thought to be associated with disease outcome according to previous qualitative work. Data collected will be linked to patient outcomes in highly secure environments. We will then use multivariate logistic regression analyses for model development and validation. RESULTS: Recruitment of participants started in October 2020. Initially, only the NWL CCGs and RCGP RSC arms were active. As of March 24, 2021, we have recruited a combined sample of 3827 participants in these two arms. CCAS and Doctaly joined the study in February 2021, with CCAS starting the recruitment process on March 15, 2021. The first part of the analysis (RECAP-V1 model development) is planned to start in April 2021 using the first half of the NWL CCGs and RCGP RSC combined data set. Posteriorly, the model will be validated with the rest of the NWL CCGs and RCGP RSC data as well as the CCAS and Doctaly data sets. The study was approved by the Research Ethics Committee on May 27, 2020 (Integrated Research Application System number: 283024, Research Ethics Committee reference number: 20/NW/0266) and badged as National Institute of Health Research Urgent Public Health Study on October 14, 2020. CONCLUSIONS: We believe the validated RECAP-V1 early warning score will be a valuable tool for the assessment of severity in patients with suspected COVID-19 in the community, either in face-to-face or remote consultations, and will facilitate the timely escalation of treatment with the potential to improve patient outcomes. TRIAL REGISTRATION: ISRCTN registry ISRCTN13953727; https://www.isrctn.com/ISRCTN13953727. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/29072.

What items should be included in an early warning score for remote assessment of suspected COVID-19? qualitative and Delphi study.

BACKGROUND: To develop items for an early warning score (RECAP: REmote COVID-19 Assessment in Primary Care) for patients with suspected COVID-19 who need escalation to next level of care. METHODS: The study was based in UK primary healthcare. The mixed-methods design included rapid review, Delphi panel, interviews, focus groups and software development. Participants were 112 primary care clinicians and 50 patients recovered from COVID-19, recruited through social media, patient groups and snowballing. Using rapid literature review, we identified signs and symptoms which are commoner in severe COVID-19. Building a preliminary set of items from these, we ran four rounds of an online Delphi panel with 72 clinicians, the last incorporating fictional vignettes, collating data on R software. We refined the items iteratively in response to quantitative and qualitative feedback. Items in the penultimate round were checked against narrative interviews with 50 COVID-19 patients. We required, for each item, at least 80% clinician agreement on relevance, wording and cut-off values, and that the item addressed issues and concerns raised by patients. In focus groups, 40 clinicians suggested further refinements and discussed workability of the instrument in relation to local resources and care pathways. This informed design of an electronic template for primary care systems. RESULTS: The prevalidation RECAP-V0 comprises a red flag alert box and 10 assessment items: pulse, shortness of breath or respiratory rate, trajectory of breathlessness, pulse oximeter reading (with brief exercise test if appropriate) or symptoms suggestive of hypoxia, temperature or fever symptoms, duration of symptoms, muscle aches, new confusion, shielded list and known risk factors for poor outcome. It is not yet known how sensitive or specific it is. CONCLUSIONS: Items on RECAP-V0 align strongly with published evidence, clinical judgement and patient experience. The validation phase of this study is ongoing. TRIAL REGISTRATION NUMBER: NCT04435041.