OpenSAFELY: impact of national guidance on switching anticoagulant therapy during COVID-19 pandemic.

BACKGROUND: Early in the COVID-19 pandemic, the National Health Service (NHS) recommended that appropriate patients anticoagulated with warfarin should be switched to direct-acting oral anticoagulants (DOACs), requiring less frequent blood testing. Subsequently, a national safety alert was issued regarding patients being inappropriately coprescribed two anticoagulants following a medication change and associated monitoring. OBJECTIVE: To describe which people were switched from warfarin to DOACs; identify potentially unsafe coprescribing of anticoagulants; and assess whether abnormal clotting results have become more frequent during the pandemic. METHODS: With the approval of NHS England, we conducted a cohort study using routine clinical data from 24 million NHS patients in England. RESULTS: 20 000 of 164 000 warfarin patients (12.2%) switched to DOACs between March and May 2020, most commonly to edoxaban and apixaban. Factors associated with switching included: older age, recent renal function test, higher number of recent INR tests recorded, atrial fibrillation diagnosis and care home residency. There was a sharp rise in coprescribing of warfarin and DOACs from typically 50-100 per month to 246 in April 2020, 0.06% of all people receiving a DOAC or warfarin. International normalised ratio (INR) testing fell by 14% to 506.8 patients tested per 1000 warfarin patients each month. We observed a very small increase in elevated INRs (n=470) during April compared with January (n=420). CONCLUSIONS: Increased switching of anticoagulants from warfarin to DOACs was observed at the outset of the COVID-19 pandemic in England following national guidance. There was a small but substantial number of people coprescribed warfarin and DOACs during this period. Despite a national safety alert on the issue, a widespread rise in elevated INR test results was not found. Primary care has responded rapidly to changes in patient care during the COVID-19 pandemic.

Viewpoint: digital paediatrics-so close yet so far away.

Technology is driving a revolution in healthcare, but paediatric services have not fully harnessed the potential. Digital health solutions yet to achieve their promise in paediatrics include electronic health records, decision support systems, telemedicine and remote consultations, despite the accelerated uptake during the COVID-19 pandemic. There are also significant potential benefits in digitally enabled research, including systems to identify and recruit participants online or through health records, tools to extract data points from routine data sets rather than new data collection, and remote approaches to outcome measurement. Children and their families are increasingly becoming digital health citizens, able to manage their own health and use of health services through mobile apps and wearables such as fitness trackers. Ironically, one barrier to the uptake of these technologies is that the fast pace of change in this area means the evidence base behind many of these tools remains underdeveloped. Clinicians are often sceptical of innovations which appear largely driven by enthusiasts rather than science. Rigorous studies are needed to demonstrate safety and effectiveness. Regulators need to be agile and responsive. Implementation needs adequate resource and time, and needs to minimise risks and address concerns, such as worries over losing human contact. Digital health care needs to be embedded in medical education and training so that clinicians are trained in the use of innovations and can understand how to embed within services. In this way, digital paediatrics can deliver benefits to the profession, to services and to our patients.

NICE rapid guidelines: exploring political influence on guidelines.

The National Institute for Health and Care Excellence (NICE) has been presented as politically independent, asserting it is free from industry influence and conflicts of interest so that its decisions may be led by evidence and science. We consider the ways in which soft political factors operate in guideline development processes at NICE such that guidelines are not truly led by science. We suggest that while NICE procedures explicitly incorporate scientific principles and mechanisms, including independent committees and quality assurance, these fail to operate as scientific practices because, for example, decisions may only be challenged through the courts, which regard NICE as a scientific authority. We then examine what the NICE rapid guideline procedure for COVID-19 reveals about the practical reality of claims about the scientific integrity of NICE guidelines. Changes to guideline development processes during the COVID-19 emergency demonstrated how easy it is to undermine the scientific integrity of NICE's decision-making. The cancellation of the guideline programme and the publication of a rapid guideline process specifically to address the COVID-19 pandemic removed scientific checks and balances, including independent committees, stakeholder consultation and quality assurance, demonstrating that the relationship between NICE and the UK government is more complex than a scientific principle truism. We suggest that NICE is not (and indeed cannot be) truly independent of government in practice, nor can it be truly led by science, in part because of its relationship to the state, which it is simultaneously constituted by and constitutive of.