Personalized Medicine, Disruptive Innovation, and "Trailblazer" Guidelines: Case Study and Theorization of an Unsuccessful Change Effort.

Policy Points For complex reasons, the promise of "precision medicine" based on molecular pathways remains unrealized for many conditions. Clinical practice guidelines (theoretically, at least) can act as "trailblazers" to introduce tests and treatments that reflect precision medicine discoveries. We describe a detailed case study from the United Kingdom in which such an attempt was (so far) unsuccessful and show how this case provides generalizable lessons. Policymakers should be wary of using clinical practice guidelines as the sole, or even the primary, lever for introducing precision medicine. CONTEXT: Precision medicine, which addresses underlying molecular mechanisms of disease, depends on new technologies that measure specific biomarkers, leading (it is anticipated) to more accurate diagnosis, patient stratification, and tailored treatment. These technologies can be disruptive-that is, they make possible, and often require, radical changes to clinical practice and service organization-thereby improving quality, safety, or efficiency of care. Clinical practice guidelines may act as "trailblazers," introducing and legitimizing novel technologies and practices. METHODS: We describe a case study of an attempt by academic researchers to radically change asthma management in the United Kingdom using a precision medicine biomarker (fractional exhaled nitric oxide, FeNO), measured using a portable breath device. We collected a wide-ranging data set that included more than 100 documents, 61 interviews, and 150 hours of ethnographic observation, and we analyzed it using technology-enhanced strong structuration theory (TESST). FINDINGS: Our study describes a so-far unsuccessful attempt by academic respiratory medicine researchers to pave the way for a precision medicine approach to asthma using a government-endorsed national guideline. These researchers considered asthma management, especially in primary care, to be characterized by overdiagnosis and poor tailoring of treatment; engaged a national guideline development body in an effort to fix this problem; and ensured that the guideline required primary care clinicians to use FeNO technology for diagnosis and monitoring. However, clinicians working outside the tertiary referral centers did not accept, or agree to enact, the vision of precision medicine inscribed in the guideline-for multiple professional, operational, and economic reasons. CONCLUSIONS: "Trailblazer" guidelines, in which new technologies are recommended, may succeed as catalysts of change only in a limited way for interested individuals and groups. In the absence of a wider program of professionally led and adequately resourced change efforts, such guidelines will lack meaning, legitimacy, and authority among intended users and may be strongly resisted.

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.

Changing media depictions of remote consulting in COVID-19: analysis of UK newspapers.

BACKGROUND: Remote consulting was introduced quickly into UK general practice in March 2020 as an emergency response to COVID-19. In July 2020, 'remote-first' became long-term government policy. AIM: To explore how this change was portrayed in national newspapers and how depictions changed over time. DESIGN AND SETTING: Thematic analysis of newspaper articles referring to remote GP consultations from two time periods: 2 March-31 May 2020 (period 1) and 30 July-12 August 2020 (period 2). METHOD: Articles were identified through, and extracted from, LexisNexis Academic UK. A coding system of themes and narrative devices was developed and applied to the data. The analysis was developed iteratively, amending the coding structure as new data were added. RESULTS: Remote consulting was widely covered in newspapers. Articles in period 1 depicted it positively, equating digital change with progress and linking novel technological solutions with improved efficiency and safety (for example, infection control) in a service that was overdue for modernisation. Articles in period 2 questioned the persistence of a remote-first service now that the pandemic was waning, emphasising, for example, missed diagnoses, challenges to the therapeutic relationship, and digital inequalities. CONCLUSION: As the first wave of the pandemic came and went, media depictions of remote consulting evolved from an 'efficiency and safety' narrative to a 'risks, inequalities, and lack of choice' narrative. To restore public trust in general practice, public communication should emphasise the wide menu of consulting options now available to patients and measures being taken to assure safety and avoid inequity.

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.

Achieving Spread, Scale Up and Sustainability of Video Consulting Services During the COVID-19 Pandemic? Findings From a Comparative Case Study of Policy Implementation in England, Wales, Scotland and Northern Ireland.

Requirements for physical distancing as a result of COVID-19 and the need to reduce the risk of infection prompted policy supporting rapid roll out of video consulting across the four nations of the UK-England, Northern Ireland, Scotland and Wales. Drawing on three studies of the accelerated implementation and uptake of video consulting across the four nations, we present a comparative and interpretive policy analysis of the spread and scale-up of video consulting during the pandemic. Data include interviews with 59 national level stakeholders, 55 health and social care staff and 30 patients, 20 national documents, responses to a UK-wide survey of NHS staff and analysis of routine activity data. Sampling ensured variations in geography, clinical context and adoption progress across the combined dataset. Comparative analysis was guided by theory on policy implementation and crisis management. The pandemic provided a "burning platform" prompting UK-wide policy supporting the use of video consulting in health care as a critical means of managing the risk of infection and a standard mode of provision. This policy push facilitated interest in video consulting across the UK. There was, however, marked variation in how this was put into practice across the four nations. Pre-existing infrastructure, policies and incentives for video consulting in Scotland, combined with a collaborative system-level approach, a program dedicated to developing video-based services and resourcing and supporting staff to deliver them enabled widespread buy-in and rapid spread. In England, Wales and Northern Ireland, pre-existing support for digital health (e.g., hardware, incentives) and virtual care, combined with reduced regulation and "light touch" procurement managed to override some (but by no means all) cultural barriers and professional resistance to implementing digital change. In Northern Ireland and Wales, limited infrastructure muted spread. In all three countries, significant effort at system level to develop, review and run video consulting programs enabled a substantial number of providers to change their practice, albeit variably across settings. Across all four nations ongoing uncertainty, potential restructuring and tightening of regulations, along with difficulties inherent in addressing inequalities in digital access, raise questions about the longer-term sustainability of changes to-date.