Shielding from covid-19 should be stratified by risk
BMJ 2020; 369 doi: https://doi.org/10.1136/bmj.m2063 (Published 28 May 2020) Cite this as: BMJ 2020;369:m2063Read our latest coverage of the coronavirus pandemic
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Dear Editor,
The benefits of selecting patients to be shielded only by their clinical risk seem clear – reducing the physical, mental and financial burden on members of the population at lower risk of critical care and death. However, this would also by necessity ensure that these burdens of shielding fall even more disproportionately on those considered at higher risk of SARS-CoV-2.
The risks of death from SARS-CoV-2 is already higher for those of minority ethnic backgrounds, those suffering from deprivation, and the elderly(1). Increasing the impact on them of shielding measures - by making it more difficult for them to be part of the workforce, engage in their local communities and in wider society - poses a huge risk of entrenching and worsening already harmful inequalities. This is a risk not only in the short term but it is feasible that a prolonged period where shielded persons are unable to advance their careers, make and maintain friendships and engage in community activities may impact the rest of their lives and livelihoods.
Whilst the aim of minimising the risks of shielding by restricting it to only those at higher clinical risk of SARS-CoV-19 is laudable, great care should be taken over the design and implementation of such a system. Consideration should be made at the outset to committing resources to mitigate inequalities produced not only immediately but over the longer term.
References:
1. Williamson E, Walker AJ, Bhaskaran KJ, et al. OpenSAFELY: factors associated with covid-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. medRxiv 2020.05.06.20092999. [Preprint.] doi:10.1101/2020.05.06.20092999
Competing interests: No competing interests
Dear Editor,
The concept of stratified shielding from covid-19 is interesting, but complex and potentially unethical to implement in practice.
As described by Davey Smith and Spiegelhalter risk of covid-19 mortality can be described as a two-step process. 1) the risk of getting infected, 2) the risk of dying once infected.
In theory, it would be relatively straight forward to derive a risk prediction tool to identify 'segments' of our society most at risk of dying once infected with covid-19. Other risk prediction tools have successfully been implemented in UK clinical practice. For example, tools to identify individuals eligible for preventative cardiovascular treatments.
The question is whether it would be feasible and ethical to implement risk prediction tools in the context of covid-19?
First, it is likely that the risk prediction tool would identify many people at high risk unable to shield for a long period of time due to work and family commitments. Will it be ethical to offer a risk score to someone who is unable to modify their risk?
Second, we should consider the ethical implication of shielding/isolation for an extended period of time.
Finally, the question is whether shielding is effective when the prevalence of COVID-19 in the local community is high. Up to now we have failed to shield some of the people who needed it the most i.e. people living in care homes.
The idea of stratified shielding looks compelling on paper, but perhaps the authors may reconsider the proposal if it turns out that they are in the high risk group - eligible for shielding?
Competing interests: No competing interests
Dear Editor
Davey Smith and Spiegelhalter [1] hold that ‘Lockdown is damaging people’s lives and that stratified shielding could help us get out’. The case they make advocates a policy of risk stratification across the population with the most vulnerable being encouraged to curtail social interactions, while those at lower risk of adverse events, young people, be allowed more freedoms and a return to a way of life somewhat approaching normality.
In reality, the lockdown has not been a total blanket ban on social and setting based interaction with up to 40% of the working age population in the UK, defined as essential workers, interacting freely, with schools remaining open for their children. Reflecting on this it should not be such a leap of faith, or increased risk, if we start reopening society, along the lines of Sweden [2] and South Korea [3].
The societal and economic impact, of the ‘Lockdown’, not only on our personal lives but also on the health of the global economy has been profound, with businesses, both large and small, going into receivership and bankruptcy with workers furloughed in order to protect jobs. This period of economic stasis has been heavily supported by the UK government with the historically largest economic package put in place to reduce hardship. [4] Despite this, the very agencies there to help individuals and employers--the banks, benefits agencies and local government--have been completely overwhelmed, resulting in a sector of the population left financially stranded, resorting to ‘soup kitchens’, food handouts and homelessness. [5]
The Office of Budget Responsibility, estimates that the economic impact of the current lockdown to the UK’s economy will see an increase in public sector borrowing, this year, of £218 billion and a net debt, by the middle of this decade, of around £260 billion, 10% of GDP, if it remains in place for 3 months. [6] These findings are echoed by the Centre for Economics and Business Research who have estimated the lockdown costs to the UK economy of some £2.4 billion per day, an average household income losing £515 per month, with public debt rising to wartime levels. [7]
At the London School of Economics and Political Science, researchers have used the Imperial Model to calculate the net lives saved by the current lockdown in the UK. [8] They made the assumption that the lockdown would not only save lives from COVID-19 infections but also from deaths averted. They also factored in the possibility that the lockdown itself is detrimental to human welfare and wellbeing, resulting in deaths from not seeking, or being provided with, vital health services, changes in therapy, or the consequences of enforced confinement on mental health and wellbeing leading to depression, suicides, domestic violence, substance misuse, etc., the ramifications of which can last long after isolation ends. In addition, the researchers made the assumption that there would be a 50% overlap with expected all-cause mortality. Using this methodology they estimate around 159,000 deaths would be prevented with a fiscal gain to the UK’s GDP of 3%, or £60 billion, with, on average, each life saved surviving for a further 5 years.
NICE methodology has led the world in evaluating the cost effectiveness of new health interventions, compared to standard care, with health gains measured in Quality-Adjusted Life Years, QALYS and the additional costs expressed in monetary terms. [9] Decisions about funding a therapy are based on the value of this calculated Incremental Cost Effectiveness Ratio, or ICER for short. It must be noted that NICE uses the lens of direct healthcare costs, from the perspective of the payer and not the net cost to society, nevertheless, for many conditions the full societal burden may well lead to a lower ICER than their willingness to pay threshold, around £20,000 to £30,000, with those who benefit from treatment often returning to full economic activity. Even in very special circumstances, such as with rare conditions, or end of life, NICE are unwilling to sanction interventions above £50,000/OALY. [9]
Using the ICER methodology of NICE and the net cost of the lockdown of £200 billion, less the fiscal benefits of saved lives, each of the prevented deaths will have cost the UK around £251,000.
While direct comparisons between the NICE threshold of willingness to pay and the cost benefit analysis calculated here for the lockdown, are not wholly justified, it does throw into stark relief the level of debt we are currently prepared to accept and our attitudes to the value of life in more normal, circumspect times. This sum of £251,000 per life year may, in QALY terms, be far more costly since we know that COVID-19 has a profound effect on people’s health in the short to medium term and some elderly may never recover to return to their former independent lives.
If we accept that 80% of COVID-19 infections are mild, or asymptomatic and that most deaths occur in the vulnerable groups we already identify and vaccinate against Influenza, then we should be able to develop a policy, coming out of lockdown, that recognises this segregation of risk, as Davey Smith and Spiegelhalter [1] suggest and not impose economically damaging, unsustainable, confinement on the population as a whole. We should also recognise that individuals have separate physical, social and psychological needs; while the physically vulnerable need to be isolated, other groups with mental health problems, or chaotic social lives, need to socialise, moving forward a balance needs to be struck.
Political decisions were made assuming lockdown was the only way forward in tackling this pandemic. South Korea, Sweden and other places have demonstrated that this may not necessarily be the case and the cost effectiveness argument does not support its continuation. The current strategy of societal lockdown cannot continue indefinitely and the longer it continues the more damage we do to individuals who will never suffer adverse effects from COVID-19 infection, while placing an ever increasing economic burden on this and future generations.
References
1. Davey Smith G, Spiegelhalter D. Shielding from covid-19 should be stratified by risk. BMJ 2020;369:m2063 doi: 10.1136/bmj.m2063
2. Coronavirus: Has Sweden got its science right? BBC News 2020 April 25. https://www.bbc.co.uk/news/world-europe-52395866
3. Coronavirus: What can the world learn from South Korea? BBC News 2020 March 26. https://www.bbc.co.uk/programmes/w3csythk
4. Department for Business, Energy and Industrial Strategy, Ministry of Housing, Communities & Local Government, and HM Revenue & Customs. 3rd April 2020 https://www.gov.uk/government/collections/financial-support-for-business...
5. Coronavirus: The newly jobless struggle to claim benefits. BBC 2020 March 25. https://www.bbc.co.uk/news/uk-52028644
6. Office of Budget Responsibility. The OBR’s Coronavirus Analysis. 2020 April 14. https://cdn.obr.uk/The_OBRs_coronavirus_analysis.pdf
7. Centre for Economics and Business Research. Estimates of daily economic impact of the UK’s lockdown by sector. 2020 April 6. https://cebr.com/reports/as-the-uk-remains-in-lockdown-government-may-ne...
8. Dolan P, Jenkins P. Estimating the monetary value of the deaths prevented from the UK Covid-19 lockdown when it was decided upon – and the value of “flattening the curve”. The London School of Economics and Political Science. 2020 April 18. http://www.lse.ac.uk/PBS/assets/documents/Estimating-the-monetary-value-...
9. National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. 2013 April 4. https://www.nice.org.uk/process/pmg9/chapter/the-appraisal-of-the-eviden...
Competing interests: No competing interests
COVID-19 Pandemic and stratified shielding: Some more matters for the works
The ‘COVID-19 Pandemic’ is, indeed, a ‘COVID Phenomenon’ as it continues to impact on ‘Virtually Every ASPECT of Human Existential and Developmental Domains’ [1]! It is not only an ‘Unprecedented Ravaging and Devastating Scourge’, it has, in fact, continued to be the basis for ‘New Normals’ impacting on our ‘Common Humanity’. Much as there are ‘Immense Devastations’ [2-4] wreaked by the ‘Pandemic’, there are also ‘Increasing Benefits’ [5,6] from its existence in the ‘Annals of our Humanity’! The spectrum of ‘COVID-19 Pandemic Negatives’ and ‘COVID-19 Pandemic Positives’ has been the subject of previous ‘Communications’ [2-6] and will not be exposed further in the current piece!! It is, however, expedient to reiterate the fact that the ‘Unprecedented 21st Century Pandemic’ has excited the emergence of an ‘Avalanche of COVID-19 Research Data/ Information’ but the hurried approach to the ‘Pandemic Research’ has resulted in a ‘Huge Body of Questionable and Poor Quality Data’ now largely regarded as ‘Waste in COVID-19 Research’ [7-10]!!
A ‘New Normal’ occasioned by the ‘COVID-19 Pandemic’ is ‘LOCKDOWN’ which is part of the ‘Non-Pharmaceutical Interventions (NPIs)’! The NPIs are the ‘Pandemic Interventions that Work’!! The ‘Interventional Lockdown’ in the ‘COVID-19 Pandemic Era’ includes, among others: Country Lockdown, Business Shutdown, Economic Shutdown, Public Worship Prohibition, Travel Lockdown, Schools Shutdown, World Sports Championships/ Tournaments Shutdown etc! While the ‘Interventional Lockdowns’ are effective in contributing to slowing and reducing the spread of the ‘Pandemic’, they are also known to result in increasing ‘Economic Burden’ and ‘Untoward Human Survival Difficulties’. It has, in fact, been suggested that ‘Interventional Lockdowns’ should be short-lived because of the ‘Untold Negative Effects’ of the ‘COVID-19 Pandemic’ [11]! In an attempt to minimize the ‘Economic Burden’ of the ‘Interventional Lockdown’, several ‘Programmatic interventional Lockdown Models’ have been proposed [12-16]!! Different perspectives of ‘Stratified Shielding’ by ‘Identified Risks/ Vulnerability’ are disposed. Those in the Population, ‘Stratified’ as ‘Most Vulnerable’, are offered greater ‘Protection against the Pandemic’ by ‘Shielding’ as an Intervention. Therefore, people are only ‘Shielded by Lockdown’ according to the identified recognized ‘COVID-19 Pandemic Risks’ [2,3]!!! The ‘Risk Factors’ disposed include, among others: Age, Sex, Immune Status etc, and it is, in fact, proposed that ‘Shielding through Lockdown’ can be ended with reasonable level of ‘Herd Immunity’ [3]!! There is ‘More Work in the Works’ concerning the role of ‘Antibodies and Immunity’ in the ‘COVID-19 Pandemic’. Are the detected ‘SARS-CoV-2 Antibodies’ proven to be ‘Neutralizing Antibodies’ and do they, in fact, confer ‘Protection or Immunity’? [17] Are the ‘Monoclonal Antibodies (mAbs)’ also ‘Neutralizing Antibodies (Abs)’ and do they target the ‘Receptor Binding Domain (RBD)-epitope’ and block the ‘ACE2 Site’: the ‘Neutralization Mechanism’ [17]? The ‘Shield Immunity’ has also been explored as an ‘Interactional Intervention’ in the ‘Global Fight’ against the ‘COVID-19 Pandemic’ as ‘Recovered Patients’ are deployed in ‘Interactions’ involving ‘Essential Goods and Services’ [14]!! The ‘Differential Levels and Neutralizing Potency’ of ‘Convalescent Serum Antibodies’ among ‘Recovered Patients’ is also an ‘Issue in Contention’ [17]!! The relationship between the ‘Identified Antibodies’, ‘Different Targetted RBD-epitopes’ and ‘Disease Manifestations Variability’ are also ‘Issues in the Works’!! The ‘Issues’ of ‘Cross-Neutralization’, ‘Somatic Hypermutation (SHM)’, ‘Clonal Expansion’ etc related to ‘Disease Severity’ remain ‘More Work in the Works’ [17]!!
Further still, other ‘Communications’ have explored the role of ‘Risks Scores’ for the ‘Stratified Shielding Intervention’ for managing the ‘Interventional Lockdown’ in checking the spread of ‘COVID-19 Pandemic’ while assuring that the ‘Economic-Survival Burden’ is minimized and differentially distributed within the Population [15,16,18]! The ‘OpenSAFELY’ uses ‘Risks Score’ based on Prescription Drugs Use (Evidence of Comorbidities), Postcode (Evidence of Socioeconomic Status and Urbanicity), Ethnicity, Cardiometabolic Problems, Obesity, Local SARS-CoV-2 Epidemiology etc! This ‘Risks Score’ is dichotomized into ‘Updatable Chance of getting Infected Score’ and ‘Risk of Dying if Infected Score’ which can be used for ‘Stratifying’ and, therefore, ‘Shielding’ the Populace to inform the ‘Differential Exit from a Lockdown’ [18]!! The ‘Differential Predisposition or Susceptibility’ to the ‘COVID-19 Pandemic’ is not a ‘Concluded Matter’ or ‘Taken as Given’ with the increasing ‘Pandemic Information’ increasingly transmuting and unearthed by the day re: the ‘Variables’ subsumed into the ‘Risks Score Computation’!! For ‘Age’ as a Case-in-Point, the ‘Elderly’ are generally regarded to be more ‘At Risk’ for ‘More Severe Disease’ when ‘Infected’ and, hence, should be ‘More Shielded’! More recent ‘COVID-19 Pandemic Information’ suggests ‘Very Severe Kawasaki-like Disease’ in ‘Children’: ‘Paediatric Inflammatory Multi-System Syndrome (PIMS)’ or ‘Multi-System Inflammatory Syndrome (MIS)’!! There is also the ‘Cytokines Storm’ in ‘Previously Healthy Young Adults’ infected with SARS-CoV-2 with ‘More Severe Disease’!! Therefore, ‘Age’ is not a ‘Simple Binary Classifier’ for the ‘Risk Factors’ to undergird ‘Disease Severity’ and the ‘Stratified Shielding Intervention’ with ‘Interventional Lockdown’ in the ‘COVID-19 Pandemic Mitigation Measures’!!! The role of ‘Sex’ is ‘Information in a flux’ and may not be exposed further but certainly also requires ‘More Work in the Works’!!!!
The use of ‘Postcode’ as a ‘Proxy for Socioeconomic Status’ is interesting and requires some critiquing! This assumes proper ‘Planning and Development’ of Cities/ Towns and also the location of Citizens predictably by ‘Socioeconomic Standing’ and this may not be exactly true for all Cities globally!! How effectively 'Socioeconomic Status’ correlates with ‘Economic Endowment’ and/ or ‘Educational Attainment’ is another basis for critiquing the ‘Postcode-influenced Risks Score’ for the ‘Interventional Stratified Shielding’ in the ‘Lockdown’ to slow the spread of the ‘COVID-19 Pandemic’. Citizens are placed in ‘Categories 1 to 5’ and ‘Individuals’ can opt for ‘Shift’ in ‘Risk Categories’ according to ‘Risk Appetite’ [19]! This introduces ‘Subjectivity’ and may affect the ‘Scores Sensitivity’! The ‘Acceptability’ of the ‘Stratified Shielding’ by the Public is yet another ‘Issue’ re: ‘Stratified Shielding’ as a ‘Public Health Intervention’ against the ‘COVID-19 Pandemic’ [20]!!
The ‘Interventional Lockdown’, part of the NPIs, is effective against the ‘COVID-19 Pandemic’ but comes with ‘Huge Economic Burden and other Negative Consequences’! There are ‘Communications’ criticizing ‘Interventional Precocity’ in ‘Easing the Lockdown’ [21,22]!! The proposed ‘Stratified Shielding’ as an ‘Interventional Lockdown’ needs critical scrutiny as a ‘Public Health Strategy’ against the ‘Pandemic’ using ‘Risk-related Differential Protection’ needing to address ‘Some More Matters for the Works’!!!
REFERENCES
1. Eregie C. O. COVID Phenomenon: An innovative conceptual coinage in human development and sustainable development in the 21st Century. https://www.bmj.com/content/368/bmj.m1199/rr-17 of 9th April 2020
2. Godlee F. COVID-19: Weathering the storm. BMJ 2020; 368:m1199 of 26th March 2020
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6. Eregie C.O. COVID-19 Pandemic: The daunting challenges of assuring sustainable benefits from weathering the storm. https://www.bmj.com/content/368/bmj.m1199/rr-14 of 8th April 2020
7. Yan W. Coronavirus tests science’s need for speed limits. New York Times 2020 Apr 14. https://www.nytimes.com/2020/04/14/science/coronavirus-disinformation.html
8. Clinical Trials.gov. History of changes for study. NCT04280705, 1 May 2020. https://clinicaltrials.gov/ct2/history/NCT04280705?A=10&B=15&C=Side-by-S....
9. Glasziou PP, Sanders S, Hoffmann T. Waste in covid-19 research. BMJ 2020; 369:m1847
10. Eregie CO. COVID-19 Pandemic: The multifaceted picture of compromised COVID-19 research and the ‘COVID Phenomenon’. https://www.bmj.com/content/369/bmj.m1847/rr-12 of 10th June 2020
11. Ioannidis JPA. Coronavirus disease 2019: The harms of exaggerated information and non-evidence-based measures. Eur J Clin Invest 2020; 50:e13222
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13. McKeigue PM, Colhoun HM. Evaluation of ‘stratify and shield’ as a policy option for ending the COVID-19 lockdown in the UK. medRxiv 2020.0425.20079913 (Preprint) doi:10.1101/2020.04.25.20079913
14. Weitz JS, Beckett SJ, Coenen AR et al. Intervention serology and interaction substitution: modeling the role of ‘shield immunity’ in reducing covid-19 pandemic spread. medRxiv 2020.04.01.20049767 (Preprint) doi:10.1101/2020.04.01.20049767
15. Acemoglu D, Chernozhukov V, Werning I et al. A multi-risk SIR model with optimally targeted lockdown. National Bureau of Economic Research working paper. 2020. https://www.nber.org/papers/w27102
16. Smith GD, Spiegelhalter D. Shielding from covid-19 should be stratified by risk. BMJ 2020; 369:m2063
17. Brouwer PJM, Caniels TG, Straten K et al. Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability. https://science.sciencemag.org/content/2020/06/15/science.abc5902
18. Williamson E, Walker AJ, Bhaskaran KJ et al. OpenSAFELY: factors associated with covid-19-related hospital death in the linked electronic health records of 17 million adult NHS patients. medRxiv 2020.05.06.20092999. (Preprint) doi:10.1101/2020.05.06.20092999
19. Dasvison C, Frankel S, Smith GD. The limits of lifestyle: re-assessing ‘fatalism’ in the popular culture of illness prevention. Soc Sci Med 1992; 34:675-85
20. Rose G. The strategy of preventive medicine. Oxford Medical Publications. 1993
21. Godlee F. Covid-19: It’s too soon to lift lockdown. BMJ 2020; 369:m2202
22. Eregie CO. COVID-19 Pandemic Interventions: Lockdown is not lockout; avoid interventional precocity with easing lockdowns. https://www.bmj.com/content/369/bmj.m2202/rr-4 of 14th June 2020
Professor Charles Osayande Eregie,
MBBS, FWACP, FMCPaed, FRCPCH (UK), Cert. ORT (Oxford), MSc (Religious Education),
Professor of Child Health and Neonatology, University of Benin, Benin City, Nigeria.
Consultant Paediatrician and Neonatologist, University of Benin Teaching Hospital, Benin City, Nigeria.
UNICEF-Trained BFHI Master Trainer,
ICDC-Trained in Code Implementation,
*Technical Expert/ Consultant on the FMOH-UNICEF-NAFDAC Code Implementation Project in Nigeria.
*No Competing Interests.
Competing interests: No competing interests