Patient Safety at Risk from Staff Shortages

this week MISSING TESTS page 44 • BIRTHING PARTNERS page 47 • NHS NET ZERO EMISSIONS page 49 DAN KITWOOD/GETTYIMAGESDAN Patient safety at risk from staff shortages

NHS trusts in England have reported and infrastructure, including the Queen Jonathan Ashworth, the various risks to the safety of patients linked Elizabeth Hospital King’s Lynn. It reported shadow health secretary, to staffi ng shortages, lack of funding, “a direct risk to life and safety of patients, said the risks were particularly or problems with buildings and failing visitors, and staff ” from the potential failure worrying for the NHS given the approaching winter and the equipment, shows an analysis of risk of a structurally defi cient roof. ongoing pandemic registers carried out by the Labour Party. Rob Harwood, BMA Consultants Labour says the documents show the NHS Committee chair, said, “This worrying entered the pandemic with major problems analysis illustrates the very real impact that and that urgent action is now needed for it understaffi ng and inadequate funding has to cope with a second wave of covid-19 on on the safety of our hospitals. It has never top of the usual winter pressures. been more essential that the NHS gets Jonathan Ashworth, shadow health everything it needs as the already exhausted secretary, said, “In a normal winter these and traumatised workforce look ahead to a risks would be worrying. In the coming winter where we face both a second wave of winter they take on a whole new meaning.” covid-19 and a massive backlog of care.” Labour analysed 114 risk registers, The analysis came as an NHS Providers LATEST ONLINE compiled after the onset of the pandemic, survey of 140 NHS trust leaders found that from non-specialist acute care NHS trusts in 99% were concerned about staff burnout, Confusion England and found over half reported risks while 94% were concerned about the eff ects continues over described as “signifi cant” or “extreme.” of winter pressures. Over half (56%) were Trump’s illness and treatment Ninety fi ve trusts (83%) reported a worried they did not receive the necessary workforce risk, including insuffi cient staff . support to deliver a sustainable service. Antibiotics are as For example, University Hospitals of Derby A Department of Health and Social Care good as surgery for appendicitis, and Burton warned it did not have enough spokesperson said, “On top of the record study reports clinical oncologists. And 75 trusts reported a investment already in place, the government fi nancial risk, including Liverpool Women’s, provided £31.9bn extra in July, with £3bn Anti-TNF drug adalimumab to which warned it was not fi nancially specifi cally to support the NHS during the be trialled for sustainable beyond this fi nancial year. winter and to update A&E facilities.” covid-19 patients The analysis also found that 69% of Jacqui Wise , London in the community trusts (77) reported risks linked to capital Cite this as: BMJ 2020;371:m3885 the bmj | 10 October 2020 43 SEVEN DAYS IN Only half of 16 000 patients missed from England’s covid fi gures have been traced Details of nearly 16 000 cases of covid-19 were not transferred to England’s NHS Test and Trace service and were missed from offi cial fi gures because of an updating error. The health and social care secretary, Matt Hancock, told MPs on Monday 5 October that the error was discovered on the Friday and 6500 hours of extra contact tracing had been carried out since. As he spoke only half (51%) of the contacts had been reached. In response, the shadow health secretary, Jonathan Ashworth, said, “Thousands of people are blissfully unaware they have been exposed to covid, potentially spreading this deadly virus at a time when hospital admissions are rising and we are in the second wave. This is not just a shambles, it is so much worse.” The missed cases were added to the weekend’s daily fi gures, meaning that 22 961 cases were reported on Sunday and 12 872 on Saturday. Reports indicated the problem may have been caused by the row limit on Microsoft ’s Excel soft ware, which caused numbers sent from one laboratory to be missed off . Hancock would not confi rm the cause but he told the House of Commons he had already decided in July to replace the system at fault.

ALEX LENTATI/LNP/SHUTTERSTOCK Elisabeth Mahase , The BMJ Cite this as: BMJ 2020;371:m3891

Covid-19 not only reinforces inequitable 176 UK hospitals. Many clinical the Bill and Melinda Gates GPs need extra support power structures but undermines care guidelines that have Foundation and the World for second wave an effective covid-19 response— recommended the combination Health Organization. The move General practices will struggle to ultimately costing lives.” for patients admitted with covid- came after WHO approved the cope with a second wave of covid- 19 should now be updated, first rapid point-of-care test 19 without urgent measures Politicians must be honest researchers wrote in the Lancet . for emergency use, from SD to support them, the BMA about NHS delivery Biosensor, on 22 September. warned. In a report published NHS leaders called for an honest Testing Several other tests that do not on 30 September its General assessment of what the service Test staff weekly to keep require laboratory processing are Practitioners Committee called for can deliver as it grapples with a NHS running, say MPs being assessed, including one occupational health services to “triple whammy” of rising covid- The government should ensure from US company Abbott, which be made available to all practice 19 infections, a major backlog that all NHS staff are routinely is in the final stages of approval. staff, alongside free supplies of of treatment, tested for covid-19 this winter to personal protective equipment, and reduced enable services to continue, MPs GMC cases suspension of routine capacity owing to urged. In its inquiry report the Consultant is re-registered inspections by the Care Quality infection control Health and Social Care Committee after “deep remorse” Commission, and suspension measures. A said urgent action was needed to Pandeshwar Gururaj, a of the Quality and Outcomes report by the NHS tackle a treatment backlog and an consultant anaesthetist who Framework, as part of efforts to Confederation said the service unknown level of demand for all was suspended from the reduce bureaucracy. was at “a critical crossroads” as health services. The MPs said that medical register for 12 months winter approached. Niall Dickson they had accepted advice from for adding his name to theatre Men dominate decision (above), the confederation’s scientists about a “significant sheets at the private Albyn making groups outgoing chief executive, said risk that not testing NHS staff Hospital in Aberdeen when An analysis of 115 covid-19 that, while the NHS had made routinely could lead to higher he was not present, has been decision making task forces “fantastic strides” towards levels of nosocomial infections in allowed back on the register from 87 countries published in resuming routine services, any second spike.” after telling a tribunal of his BMJ Global Health found that covid’s impact on capacity was “deep shame and remorse.” A men predominated in over 85% “likely to go on for several years.” Poorer countries to get medical practitioners tribunal of these groups, while women 120 million rapid tests heard he had repaid the predominated in just 11.5%, Antiviral combination does Low and middle income money he was paid, worked with gender parity in 3.5%. not help severe illness countries were promised as a volunteer at a British “Men dominating leadership The drug combination lopinavir- 120 million covid-19 Red Cross store, and positions in global health has ritonavir is not an effective diagnostic tests, which undertaken educational long been the default mode of treatment for patients admitted can provide results in courses. Insight into governing,” excluding those to hospital with covid-19, showed 15-30 minutes, his behaviour was “who offer unique perspectives, results from the Randomised by a group of “substantial and expertise and lived realities,” Evaluation of COVid-19 thERapY organisations comprehensive,” the authors concluded. “This (RECOVERY) trial, under way at including it said.

44 10 October 2020 | the bmj SIXTY SECONDS MEDICINE ON . . . VITAMIN D Maternity care New royal college Communication campaign guidance aims to aims to tackle disparities improve communication THE SUNSHINE ONE? The Royal College of Obstetrics with pregnant women Indeed, as we enter the season of mists and and Gynaecology and the mellow fruitfulness, thoughts have been campaigning group Five X More turning to the sunshine vitamin and its potential role in beating covid-19. published guidance to help improve communication between CAN YOU SHED MORE LIGHT ON THAT? healthcare professionals and England’s health secretary, Matt Hancock, pregnant women to try to drive put his foot in it when he told MPs last week down maternal health disparities that he had ordered a trial to see if vitamin D in the UK. The five actions include reduced the incidence or eff ects of covid-19 listening to women’s concerns, the Democratic Republic of the and that “the results were that it does not anxieties, and responses to Congo. WHO stated, “The betrayal MENTAL appear to have any impact.” It turns out that pain and removing barriers to of people in the communities we there have been no government trials. communication by using lay serve is reprehensible. We do not HEALTH DID THAT RAYS SOME QUESTIONS? terms and translation services tolerate such behaviour in any of Hancock appears to have been confused. when needed. The campaign our staff, contractors or partners. A survey of 512 Rupa Huq, a Labour backbencher, put also recommends providing clear Anyone identified as being British adults him right when she said that he had been information about the choices involved will be held to account waiting for mental referring to a review of evidence published in available and championing and face serious consequences, health treatment, June by NICE. “The word ‘trial’ implies fresh evidence, not reheated left overs,” she said. changes in obstetrics units. including immediate dismissal.” conducted Nobel prize Research ethics over 10 days in IS NICE ANY MORE ILLUMINATING? September, found Its summary, which looked at emerging Scientists behind HCV Pandemic may have led to evidence, concluded that there was discovery are recognised substandard research currently no evidence to support vitamin D This year’s A rush to publish during the that 38% supplements reducing the risk or severity of Nobel pandemic has created a flood of contacted covid-19. The Scientifi c Advisory Commission prize for potentially substandard research, emergency or on Nutrition also studied whether physiology with a string of papers retracted crisis services and supplementation could reduce the risk of or medicine and a surge in submissions to acute respiratory tract infections other than was awarded preprint servers where fewer 11% ended up covid but concluded the jury was still out. to Harvey J quality checks are made, said WHAT ELSE CLOUDS THE DEBATE? Alter of the US National Institutes Katrina Bramstedt, adjunct in A&E [Royal College of Adrian Martineau has updated his 2017 of Health, Michael Houghton of professor at Bond University meta-an alysis of vitamin D’s eff ects on Psychiatrists ] BMJ Rockefeller University in New in Queensland and secretary respiratory tract infections, which is on a York, and Charles M Rice of general at the Luxembourg preprint server and not yet peer reviewed. University of Alberta in Canada, Agency for Research Integrity. He told The BMJ, “The antiviral and anti- whose discoveries led to the Writing in the Journal of Medical inflammatory actions of vitamin D make it an identification of the hepatitis C Ethics , she called for a tighter interesting candidate for prevention of viral virus. The discovery of the submission process and for respiratory infections. Our updated meta- hepatitis A and B viruses had ethics and integrity training to be analysis shows modest protective eff ects been critical steps, but most compulsory for all researchers. overall. Clinical trials of vitamin D to reduce bloodborne hepatitis cases risk or severity of covid-19 are needed.” remained unexplained. HCV Cite this as: BMJ 2020;371:m3874 AREN’T WE ALL SUPPOSED TO BE revealed the cause of those cases CORRECTION TAKING VITAMIN D ANYWAY? and enabled new medicines that We are . In 2016 Public Health England have saved millions of lives. In our coverage of the BMA annual representative meeting advised children and adults to Ebola response in the 26 September issue we consider taking 10 μg of vitamin D a described the proposer of the day in autumn and winter to protect Claims of sexual abuse in motion calling for a public inquiry bone and muscle health. Scotland’s DRC are investigated into the handling of the covid-19 government has similar advice for times The World Health Organization pandemic as “GP Steven Miller.” when “0-15 minutes of unprotected has initiated a review of reports The proposer was in fact Stephen Scottish sun exposure” is not possible. of alleged sexual exploitation Millar, a retired consultant and abuse of some agency staff anaesthetist. We apologise for Zosia Kmietowicz, The BMJ during the Ebola response in these errors. Cite this as: BMJ 2020; 371: m3872

the bmj | 10 October 2020 45 “One stop shop” diagnostic services in community are needed to clear backlog

radical overhaul of diagnostic will require major investment in facilities, The pandemic has brought services is needed in England equipment, and workforce, he said, and will into sharper focus the need to provide quick access to be necessary to tackle both the year-on-year to overhaul our diagnostic scans and tests during and rise in demand and the backlog of patients services Mike Richards Aafter the covid-19 pandemic, a now waiting for investigations as a result of report commissioned by the NHS concludes. the pandemic. should be expanded by 100% over the next Community diagnostic hubs for cancer, Figures show that by early June this year fi ve years, which should include access to a cardiac, respiratory, and other conditions around 580 000 patients were waiting more minimum of two scanners for every hospital should be set up as “one stop shops” away than six weeks for a diagnostic test, up from emergency department to keep covid-19 from acute hospitals and kept as free from 30 000 in February. Changes already in place positive and negative patients apart. All covid-19 as possible, said Mike Richards, because of the initial NHS response to covid- tests should be done on the day of request the NHS’s fi rst cancer tsar and former 19, including the use of virtual consultations to reduce hospital stays, and availability of chief inspector of hospitals for the Care and community phlebotomy, should be covid-19 virus testing for patients and NHS Quality Commission. expanded to keep visits to acute hospitals to a staff was “likely to be critical” in carrying out Emergency and elective testing should minimum, he recommended. the recommendations, he said. also be kept separate to prevent hold-ups for Computed tomography scanning capacity The proposed expansion will require 2000 patients, he said in a review of diagnostic radiologists and 4000 radiographers, as services as part of the NHS plan in 2019. well as extra echocardiographers, clinical In the recommendations presented to NHS BY EARLY June around scientists, and genomic scientists. board members on 1 October Richards said Richards said the recommendations would covid-19 had exacerbated existing problems 580 000 patients make services more accessible, improve and amplifi ed the need for investment to were waiting more than six weeks outcomes, and make diagnostics more improve diagnostic services. for a diagnostic test, up from effi cient. “The pandemic has brought into The fi ve year programme of expansion, sharper focus the need to overhaul the way which should start as soon as possible, 30 000 in February our diagnostic services are delivered,” he said.

Pause in breast cancer screening is NHS leaders say chance to re-evaluate, says critic hospital funding Figures showing that a screening programmes are pledge is inadequate million women missed at a very early stage, and so mammograms after any impact on patients who The government’s plan to build or refurbish programmes were paused were due to be screened is 40 hospitals in England will fall short of in March have reignited the extremely low.” what is required without substantial extra debate about whether the In a BMJ Opinion post, investment, healthcare leaders have warned. screening does more harm women coming forward with Susan Bewley, emeritus On 30 September the prime minister than good. concerns about symptoms professor of women’s announced a £3.7bn allocation for 40 The Breast Cancer Now will place huge pressure on health at King’s College hospitals to be built by 2030, under the charity estimates that an overstretched workforce. London and a longstanding government’s health infrastructure plan. around 986 000 women Delyth Morgan, the critic of breast screening, But only £1.6bn of this is new money. The have missed mammograms charity’s chief executive, described the suspension as rest has already been announced, including since they were ended as said, “We understand the “unexpected good news.” £850m last year to upgrade outdated part of covid-19 prevention programme was paused She added that it was “a facilities and equipment at 20 hospitals. measures. Each year more out of necessity, but we golden opportunity to pause, The money will fund six hospital building than two million women are must now press ‘play.’ reconsider criticisms of the projects between now and 2025 and a further normally screened in the UK. Governments and the NHS screening programme, and 21 schemes for 34 newbuilds between 2025 Although screening is must set out how the infl ux evaluate whether to modify and 2030. Areas will be invited to bid for a resuming, appointments in demand for imaging and a programme that does not further eight developments. are signifi cantly reduced, diagnostics will be met.” impress clinically or cost However, NHS leaders said substantially the charity said. It said that An NHS England eff ectively.” more funding and a long term capital covid measures, the backlog, spokesperson said, “Most Shaun Griffin, London strategy would be needed to achieve such and the increased number of cancers detected through Cite this as: BMJ 2020;371:m3810 ambitions. Saffron Cordery, deputy chief

46 10 October 2020 | the bmj Partners’ access to scans and birth is a postcode lottery, data show

EXCLUSIVE restrictions in the event of local Trusts must respond better to the needs lockdowns or a second peak in cases. of pregnant women and their partners, On 8 September NHS England researchers have said, after fi nding that published joint guidance with the Royal they have been slow to lift bans imposed College of Midwives and the Royal College on attending scans and births, creating a of Obstetrics and Gynaecology to help postcode lottery in access. trusts reintroduce access for partners. It Most trusts in England banned partners also wrote to trusts asking them to relax attending antenatal scans during the fi rst visiting restrictions. An NHS spokesperson Miriam Deakin, director of policy and peak of covid-19 in March and most still said, “Our advice is clear that wherever strategy at NHS Providers, said trust leaders had restrictions in place in August, show possible mums should be able to be would welcome the plans but added, “We need fi ndings from freedom of information accompanied by their partners for scans, to see a multi-year capital settlement in the requests from public health academics antenatal visits, and for childbirth.” spending review to support this change in how at the University of Cambridge. But Walsh, calling for a more nuanced diagnostic services are delivered.” the extent of these restrictions varied approach from trusts, said the new advice Martin Marshall, chair of the Royal College considerably (see box). would alleviate some of the problems, but of General Practitioners, said, “We’d like to see Sebastian Walsh, academic public they could resurface in a second wave. an investment in community diagnostics and health specialty registrar, who helped “A signifi cant number of trusts have said the commissioning of a signifi cant expansion collect and analyse the data, said, “We that, even in light of the NHS guidance, of diagnostic services based within the expected to fi nd that there had been if there’s a second major peak we will do community, with rapid access for GPs and their severe restrictions overall. But underneath the same again. It looks like there is some teams, and appropriate investment in order to that there was a lot of discrepancy, partly work still to do to persuade trusts.” deliver this—as well as detailed plans as to how during the peak but also in the way that Lucy Watson, chair of the Patients these hubs will work in practice.” trusts have gone about trying to reverse Association, said, “All maternity services Emma Wilkinson, Sheffield them. It has created a postcode lottery.” should be ensuring women can be Cite this as: BMJ 2020;371:m3855 The academics sent FOI requests to supported by their partners.” every NHS maternity service in England Gareth Iacobucci, The BMJ on 24 August, asking for details of Cite this as: BMJ 2020;371:m3876 executive of NHS Providers, welcomed the restrictions on partner attendance through focus on the “urgent problem” of replacing and the maternity pathway during the fi rst refurbishing old buildings but added, “Building peak of covid-19. They also asked whether an average mid-sized hospital costs around restrictions were still in place. £500m, so this is just an initial down payment. All the trusts that responded (81 of “If the government wants these hospitals 127 (63%)) reported implementing built in the time it is specifying, trusts will need restrictions, and most still had restrictions the rest of the capital as soon as possible.” in place at the end of August. A quarter

Sally Warren, director of policy at the of trusts also said they would reimpose SORTLAND/GETTYIMAGES MORTEN FALCH King’s Fund, said, “The piecemeal nature of government announcements of new spending TRUSTS’ RESTRICTIONS ON ACCESS TO MATERNITY SERVICES makes it difficult to tell exactly how much • Nine in 10 trusts (73 of the 81 that responded) prohibited partners attending the money is available and how much of it is on top 12 week antenatal scans during the first peak of the virus, and 71 (88%) had the of or included in existing budgets. same policy in place for attending the 20 week scan “The NHS desperately needs a multi-year • At the end of August only 20 trusts (25%) said they had lifted restrictions for 12 capital funding settlement to make long term week scans, and 31 (38%) had done so for 20 week scans plans to improve buildings and facilities.” • Most trusts (77 or 95%) restricted partner attendance at non-routine services, such as She added that the government should assessment for reduced fetal movements, during the first peak also focus on increasing staff numbers and • All trusts allowed partners to attend the birth, but 70 (86%) applied some supporting services outside hospitals. restrictions, such as banning attendance during induction of labour England’s health and social care secretary, • Sixteen trusts (20%) stopped offering women the choice of a home birth during the Matt Hancock, said that further funding first peak, and 39 (48%) restricted partner attendance at the home birth commitments would be set out after the review • Eighty trusts (99%) restricted partner attendance in some way at postnatal services, of capital funding, which would provide a with 40 (49%) barring partners from attending altogether • Thirty five trusts indicated they had not yet started to reverse their policies, “multi-year settlement.” (43%) and 17 (24%) said they would reinstate restrictions in their original form in the event Gareth Iacobucci, The BMJ of local lockdowns or a significant second peak of the virus Cite this as: BMJ 2020;371:m3879 the bmj | 10 October 2020 47 BRIEFING

Which emerging rapid covid-19 tests is the UK pinning its hopes on?

Rapid diagnostic testing is integral to the government’s Moonshot plan to carry out up to 10 million tests a day by early next year. Jacqui Wise looks at the options being developed and trialled

swab or saliva samples. A preprint logistical problems with the current found a diagnostic sensitivity of 99.1% testing system instead. and a diagnostic speciﬁ city of 99.6%. T here are few published data on The LamPORE test was hailed by rapid tests. The Royal Statistical England’s health and social care Society, which set up a working secretary, Matt Hancock, as giving group in response to this lack, is also results in just 90 minutes. “That was concerned that they are not being held misleading,” says Jon Deeks, professor to a common statistical standard in the of biostatistics at the University of UK, US, or EU. Birmingham, “as it actually takes “There is a massive opportunity for

ADRIAN WROTH about 6.5 hours to go from sample companies to get very rich selling poor The LamPORE test was developed by Oxford Nanopore to result. Its benefi ts will be in tests,” warns Deeks. “Our regulations [supplementing PCR test] capacity, not don’t protect us. You don’t need to have There is a he UK’s testing system in being point-of-care.” a good test to be able to sell it.” massive is under immense strain The machines, which are being opportunity partly owing to a lack piloted in several laboratories, are due WHO standard for companies of laboratory capacity to be rolled out nationwide soon. Last month the World Health to get very T for the gold standard Organization approved two “lateral polymerase chain reaction (PCR) test. Saliva versus swabs fl ow” antigen tests, which display rich selling The government wants mass testing What is potentially faster is using a result like a pregnancy test, are poor tests to “support economic activity and a saliva rather than nasal swabs. A portable, and deliver a result in Jon Deeks return to normal life” under its £100bn saliva test also has the advantage of 15-30 minutes. Made by the South Operation Moonshot programme, being easier to use at home and more Korean company SD Biosensor and according to documents seen by acceptable for repeat testing. the US company Abbott, they are The BMJ . They say that “alongside The government is evaluating the fi rst rapid tests to meet WHO’s increased PCR capacity, we are also several options. One, from a company specifi cations. An independent seeking to validate, buy, trial and scale called Optigene, is being piloted in evaluation of the SD Biosensor test a number of new technologies.” Southampton, with a community found it had a clinical specifi city of One of the new technologies being pilot due to start in Salford. It has also 99.3% and a clinical sensitivity of heavily promoted by the government been reported that ministers are in 76.6%. There is as yet no independent is the NudgeBox machine, developed talks with Halo, a UK fi rm that has evaluation of the Abbott test. by DnaNudge. This is basically a developed a saliva based quantitative Deeks called these tests—which laboratory in a box that uses reverse (RT-qPCR) test, potentially combining can be done without a laboratory, transcription (RT) PCR technology. A the benefi ts of PCR testing with easier running water, or electricity—a “game nose swab is inserted into a handheld use and a faster result. The company changer” for low and middle income reader, and a result is provided in says the test is 100% specifi c and countries. Higher income countries are less than 90 minutes. A paper in results can be sent to a phone app in as also interested: Germany has ordered Lancet Microbe found the test to have little as seven hours. The University of 20 million tests, while France and an overall sensitivity of 94% and a Exeter has agreed a deal to use the test. Switzerland also intend to buy. It is not specifi city of 100%. Other saliva based tests are also clear whether the UK will follow suit. The government has bought 5000 being investigated, but Deeks thinks But a study has shown them to be kits, which have been trialled in this is a bit of a distraction. “The UK about 20% less sensitive than PCR, eight London hospitals. It has also seems transfi xed by getting a point-of- Deeks said. “They miss lower viral purchased 450 000 LamPORE tests care antigen saliva test, which is giving loads. This means they may miss developed by Oxford Nanopore. These, us an extra technical challenge,” he people at an early stage of infection which come in a laboratory version says. He thinks it may be better to focus and give a false negative. This could and a portable version, can process eff ort and resources on overcoming the give people false confi dence, which would be a problem if they stopped social distancing,” he said. HALO says its saliva test is 100% specific and results can be Jacqui Wise, freelance journalist, London sent directly to a phone app in as little as seven hours Cite this as: BMJ 2020;371:m3868

48 10 October 2020 | the bmj NHS aims to be world’s first “net zero” health service by 2040

The NHS in England has committed The report says the NHS, as the UK’s There are which represents organisations that itself to becoming “net zero” for largest employer and responsible for both moral deliver NHS services, said trusts were greenhouse gas emissions for the care around 4% of the nation’s greenhouse and practical already taking greater strides to help it provides within three decades. gas emissions, has a major part to play reasons create sustainable change but that The health service has direct in the country reaching its climate goal for health they needed more support as they control over emissions produced by of becoming “net zero” by 2050. responded to a second wave of covid- professionals its services, buildings, and vehicles, To achieve its target the NHS will 19, traditional winter pressures, and a and it will take until 2028 to 2032 to need to fi nd new ways to reduce to be at the backlog of elective care. reduce these by 80% and until 2040 journeys to hospitals by delivering forefront of “The spending review is an to eliminate them, says a report it care at or closer to people’s homes and climate action opportunity for the government to commissioned. of greening its vehicles, including road Renee Salas show their commitment in supporting It will take until 2045 to reach “net testing a zero emissions emergency trusts to deliver on the ambition set zero” for all the emissions over which ambulance by 2022, the report says. out in the report through a multiyear the NHS has infl uence, such as those It will also need to build hospitals and capital spending regime,” she said. relating to its supply chain and to other buildings as net zero emitters, travel by patients and staff . reduce waste of consumable products, Responsbility and opportunity with use of low carbon alternatives, In an analysis published by The BMJ , Feasible targets and train staff in energy conservation. Renee Salas from the Harvard Global The 2040 and 2045 targets are Stevens said, “2020 has been Health Institute and colleagues “feasible,” says the report. It sets out dominated by covid-19 and is the most argue that healthcare leaders the conclusions of an expert panel pressing health emergency facing and organisations have both a chaired by Nick Watts from Lancet us. But undoubtedly climate change responsibility and an opportunity to Countdown, a collaboration of experts poses the most profound long term chart a path to net zero emissions. who work to ensure that health is threat to the health of the nation. It “There are both moral and practical at the centre of how governments is not enough for the NHS to treat the reasons for health professionals to be understand and respond to climate problems caused by air pollution and at the forefront of climate action,” they change. The panel was tasked by NHS climate change, from asthma to heart write. “Healthcare must lead from the chief executive Simon Stevens attacks and strokes. We need to play front, which entails urgently getting in January to determine how and when our part in tackling them at source.” our own house in order.” it would be possible for the NHS to Miriam Deakin, director of policy Recovery from the pandemic and reach “net zero.” and strategy at NHS Providers, its associated economic downturn “provides the opportunity to reimagine and transform healthcare,” they add. Major CH N O SF CO CFCs PFCs HFCs Fiona Godlee, editor in chief of The emissions 4 2 6 2 BMJ and a member of the net zero NHS advisory group, said, “We know doctors are increasingly concerned by Direct Indirect the threat that climate change poses to Travel human health and about the impact Outside NHS’s scope their practice has on the environment. “NHS England’s unprecedented Fossil fuels Medical Energy commitment to ending its contribution devices Well to tank to the climate emergency sends a vital Patient Medicines signal of the need for us all to do things Business travel Freight and Public transport transport visitor very diff erently in future if we are to Food and NHS facilities JUH\ƠHHWHWF journeys avert global catastrophe.” catering Business Nicky Philpott, director of the UK Anaesthetics Health Alliance on Climate Change, Electricity services Commissioned health added, “As the NHS moves into its 1+6ƠHHWDQG Construction services outside NHS eighth decade it continues to evolve to Waste Water ICT leased vehicles the challenges it faces. This requires Metered dose Manufacturing 6WDƷ all health professionals to do things inhalers Products, chemicals, gases commuting diff erently, and together they will rise to this challenge, advocating, NHS carbon NHS carbon educating, and leading the way.” footprint footprint plus Ingrid Torjesen, London Cite this as: BMJ 2020;371:m3856 the bmj | 10 October 2020 49 THE BIG PICTURE Covid-19 heroes—putting faces to the statistics Mary Black sees all of humanity in the people celebrated in an exhibition of healthworkers’ portraits

I count things for a living—trend lines go up, go down, and I check that the story of those lines makes sense. I look for patterns: what are we missing here? What needs to happen next? Where is this going? Lately I’ve found myself checking for the meaning behind each covid-19 data point: is that really a case, or a death, or correctly tagged as a healthcare worker? As a public health doctor I look after populations of people, not individuals, yet the stories I tell are ultimately about people—large numbers of people. The pandemic unfolds before me in waves, logarithms, totals. I may wield my tools of statistics, data capture, automation, and linkage expertly, but I know I can capture only the rough outlines of what is happening. Sometimes late at night I look at a number and think of what lies behind it, the individual lives and stories, the families. Healthcare Heroes is a collaboration between Google Arts & Culture and the national charity Paintings in Hospitals. This online portrait exhibition curated by Thomas Croft depicts the stories of our health and care workers, peeling off the plastic layers of personal protective equipment to wordlessly interrogate covid-19. A patchwork quilt of images, the fi rst impression is of a sea of NHS blue, then the eye catches the other colours, the reds, greens, yellows, the varied skin tones. Look further and note the indentations on skin left by masks and visors, the weariness around the eyes, the humour and sprightliness. Each portrait is unique, as the sitters tell their own stories in a dialogue between paint and experience. Here, I see people—their emotion, exhaustion, and their sacrifi ce—not just data points. It reminds me why I do my job. What is a hero anyway? These are ordinary people, adorned in plastic, sweltering under it, going back again the next day, and the next: the very healthcare workers that I as a public health doctor do my incomplete best to protect. These are my colleagues, faces that would reassure me if I too end up in intensive care, struggling to breathe. In them I see my scared self in the early days of the HIV pandemic, wondering if I might get infected. I see my niece, a trainee surgeon who is now working on a covid-19 ward. I see those of you who are reading this and who will in a few hours or days go back to work on the front line. As Marion Lynch, nurse leader and fellow trustee at Paintings in Hospitals, says, “We are humans. We need connection with other people. Art acts as an anchor to our humanity.” This is a warm and human exhibition, and it dignifi es the sitters. It gives me hope that, in this pandemic, art will help us to share stories, and heal. Visit artsandculture.google.com/project/healthcare-heroes Mary E Black , clinical director and director of health protection, Public Health Scotland, and trustee of the national charity Paintings in Hospitals

50 10 October 2020 | the bmj the bmj | 10 October 2020 51 EDITORIAL Covid-19: a fork in the road for general practice We must choose a personal not an impersonal future

ovid-19 has produced satisfaction.11 GPs fi nd remote the biggest change in consulting easier with patients they the organisation of UK know, and continuity of care would general practice for be improved by electronic messages C 200 years. As in many and phone calls being answered by the countries, face-to-face consultations patient’s own GP whenever possible. have fallen to about 10% of their previous level and most contacts are Longer consultations now provided remotely using symptom Fewer face-to-face contacts may make checkers, electronic messaging, and 15 minute consultations possible. phone or video consultations. Several Longer consultations are both more of these changes may be permanent, patient centred and less stressful with fewer face-to-face consultations for clinicians, and the UK is an in future. Opportunity and danger are international outlier in its reliance on two aspects of change: both now apply short consultations. 12 Fewer physical to general practice. Continuity of and fewer admissions to hospital, examinations and non-verbal cues GPs currently have quieter waiting care by doctors especially for older people.3 4 Two probably mean reduced quality of rooms, fewer locums, and reduced is associated recent systematic reviews, one of them care and research is urgently needed regulatory burdens. However, normal with reduced focused on primary care, showed to identify what can and cannot be workload is returning, and while mortality that continuity of care by doctors is remotely handled safely. Can trusted remote consulting makes access associated with reduced mortality. 5 6 relationships be built this way, for much easier for some patients, Patients also greatly value empathy example? Some patients already feel general practice may become shown by GPs which is associated disempowered by losing their ability to less personal. Worryingly, remote with signifi cantly greater patient make appointments. consultations may increase overall satisfaction and enablement,7 fewer Demand can be modifi ed to free-up GP workload and exclude patients metabolic complications, reduced time for longer consultations. Some without internet access.1 patient anxiety,8 and reduced all-cause practices report annual face-to-face mortality in people with diabetes. 9 consultation rates as low as two per Continuity GPs can be proud of what they can patient using personal lists and 15 This colossal change in organisation achieve, but empathy cannot be minute consultations.13 This approach occurred just when research on provided by symptom checkers and might become more widespread the doctor-patient relationship electronic messaging. if alternatives to face-to-face had reached new heights. Patient With fewer face-to-face consultations allowed GPs to use their enablement (empowering people to consultations, what can be done time more effi ciently. Policy makers undertake self-care) is signifi cantly to ensure that the benefi ts of high should be encouraged by the evidence related to patients “knowing the GP quality consultations and continuity showing how much healthcare costs well” and to longer consultations.2 of care can be realised while avoiding can be reduced with better continuity Numerous observational studies general practice becoming an of GP care. 14 show that continuity of care is impersonal call centre? A key question for all countries signifi cantly associated with higher The fi rst priority is to reverse the is which changes to keep or discard patient satisfaction, better adherence decline in continuity of care, which after the pandemic. In the UK, general to medical advice, better adherence to was evident well before the pandemic. practice faces a choice between a prescribed medication, better take-up If continuity continues to fall, personal or an impersonal future. The of personal preventive medicine, patient safety will be undermined, pandemic could be a spur for self- fewer emergency department visits, organisational ineffi ciency will grow, governing practices to win effi ciencies and collusion of anonymity (when by using alternatives to face-to- Denis Pereira Gray, professor emeritus, University of Exeter no one in a practice takes personal face consultations when possible, George Freeman, emeritus professor of general practice , Department of responsibility for a patient) will providing 15 minute consultations in Primary Care and Public Health, Imperial College London become widespread. the clinic, and maximising continuity Catherine Johns, interim chair of the patient participation group, St Personal lists where GPs of care in both. Leonard’s Practice, St Leonards, Exeter have responsibility for defi ned Cite this as: BMJ 2020;370:m3709 Martin Roland, emeritus professor of health services research, lists of patients are associated Find the full version with references at University of Cambridge [email protected] with signifi cantly better patient http://dx.doi.org/10.1136/bmj.m3709

52 10 October 2020 | the bmj EDITORIAL Confusion around heated tobacco products Tobacco manufacturer exploits FDA’s ambiguous ruling

he emergence of new Concerns about Phillip Morris’s IQOS consumer tobacco and research13 14 and failure to make data nicotine products, notably from its longer term studies public15 16 electronic cigarettes and are amplifi ed by the industry’s history heated tobacco products,1 of research manipulation and hiding T 13 17 has produced controversy and the harms of smoking. Smokers confusion. This is partly because the looking to reduce harm rather than two products are often confl ated, not quit should see heated tobacco least by Philip Morris International, products as a last resort. the world’s largest tobacco company.2 For regulators, the risk-benefi t With global sales of cigarettes calculation is more complex. Even the declining, the company’s future now introduction of products genuinely depends on IQOS, its fl agship heated less risky than cigarettes may lead to tobacco product.2 3 population level harm if taken up by E-cigarettes heat nicotine large numbers of people who would containing liquids to produce an never have smoked cigarettes. Here, inhalable aerosol. They can help the FDA’s decision is most surprising smokers quit4 and, while not safe, are because it is required to determine that currently considered a less harmful even its exposure modifi cation order alternative to smoking.4 5 By contrast, will benefi t population health.6 9 IQOS, which heats small cigarette-like There is little role for heated tobacco products That is highly contestable given tobacco sticks, has not been shown to little role for at either individual or population level. the absence of evidence on quitting, enable quitting or to be signifi cantly heated tobacco For individual smokers, decisions the evidence on harm, and because 1 lower risk than smoking. products at about new products are reasonably uptake among young, non-smokers Confusion has now been individual or straightforward—if the product helps seems inevitable given Phillip Morris’s escalated by the US Food and Drug them quit or is genuinely less harmful documented marketing.2 18 Regulators population Administration’s recent decision than smoking, it can reduce health must also recognise focusing on heated about the status of IQOS under its level risks. With no evidence that IQOS tobacco products may distract them “modifi ed risk tobacco product” helps quitting, smokers wishing to from the evidence based measures criteria.6 The poorly titled criteria quit should stick with evidence based known to reduce tobacco use at scale.20 actually comprise two diff erent smoking cessation interventions. standards—risk modifi cation and IQOS exposes users to lower Last word exposure modifi cation. The FDA levels of some harmful substances For once we should perhaps leave the denied risk modifi cation status for than cigarette smoke but this does last word with Phillip Morris, which IQOS, clearly stating that Phillip Morris not result in reduced disease risk discreetly (page 17, FDA application “has not demonstrated that [IQOS] compared with cigarette smoking.19 summary) acknowledges: “It has not will signifi cantly reduce harm and For example, independent analyses of been demonstrated that switching to the risk of tobacco-related disease.”6 Phillip Morris’s clinical data show that the iQOS system reduces the risk of Instead the FDA granted only its lower switching from cigarettes to IQOS does developing tobacco-related diseases exposure modifi cation status.6 not lead to signifi cant improvements compared to smoking cigarettes.”21 Phillip Morris nevertheless in pulmonary infl ammation and Until that changes, heated tobacco misrepresented the decision as a function or in biomarkers predictive of products have no public health “milestone for public health.”7 The major illness.10 11 role. Governments should resist company immediately launched a Anna B Gilmore, Yet in granting the exposure pressure to open their markets to global public relations campaign professor modifi cation order, the FDA is these products and, where already abcg20@bath. using the decision to push other required to consider it “reasonably present, should regulate both the ac.uk governments to open their markets to likely” that future studies will show heating device and the tobacco Sophie Braznell , or relax rules regulating IQOS.7 8 reductions in mortality and morbidity sticks as tobacco products, in line PhD student, 6 9 Tobacco Control compared with ongoing smoking. with World Health Organization’s 22 Minefield Research Group, This is arguably possible but caution recommendations. How do consumers and regulators Department for is needed. Some potentially harmful Cite this as: BMJ 2020;370:m3528 attempt to make sense of this Health, University substances are higher in IQOS Find the full version with references at minefi eld? The short answer is there is of Bath aerosol than in cigarette smoke.6 12 http://dx.doi.org/10.1136/bmj.m3528 the bmj | 10 October 2020 53 ESSAY Understanding the US failure on coronavirus The world has been staggered by America’s disjointed response to covid-19, resulting in by far the world’s highest case and death count. The die was cast by two policy decisions taken by the Trump administration, writes Drew Altman

n 9 August, the US passed the fi ve million mark in cases in the US after deploying strict public health measures, the infection of covid-19, representing slightly more than a quarter of rate was low enough that the governor, whose daily press conferences all global cases. That day, more than half the states in the had become national television events, announced he was ready to US qualifi ed as coronavirus hot spots. open schools. O The same day in South Dakota, the small town of And so goes the American response to covid-19: a patchwork of Sturgis with a population of less than 7000 prepared to welcome responses by state and local governments, divided sharply along 250 000 bikers to its annual biker rally. With no social distancing or partisan lines. face masks required by that mostly conservative rural state, it would Our lamentable performance is not the product of a famously be the largest known public gathering in the world in the middle of fragmented, market driven healthcare system. The US medical system the pandemic. has in many ways performed well and even valiantly, increasing At the same time, 40 million Californians were living with their capacity when needed, and saving lives when possible. Uninsured governor’s mandatory mask order imposed when the state’s decision to people and working people are faced with much higher out-of-pocket open up its economy led to a resurgence in covid-19 infections. costs and surprise costs than they are in other countries, but our In Georgia, the Republican governor and the Democratic mayor of deaths per case of covid-19 compare favourably with other developed Atlanta continued to spar over the mayor’s desire to take more stringent nations that have signifi cant numbers of cases. We celebrate our heroic measures to protect public health than the governor, a Trump loyalist, frontline workers with cheers and applause just as other countries do. wanted to allow. Similar tensions between Democratic mayors and pro- No, the disappointing US response to covid-19 has been because of Trump Republican governors were playing out in Texas and Florida, a failure of policy and leadership, not healthcare, and largely owing to two large states where cases of the virus were increasing. two fateful policy decisions. In New York, where the state had come through the worst epidemic The federal government as back-up BIOGRAPHY After fi rst casting himself as a wartime president, in April Trump made Drew Altman is president and a fundamental policy shift that has shaped the US response to the chief executive of the Henry J pandemic ever since. He announced that states would have primary Kaiser Family Foundation (KFF). responsibility for containing the virus, with the federal government in a He is an innovator in the world “back-up” role. of foundations and non-profit A state role in public health is traditional in the US, and any organisations and a leading expert national plan would allow for customisation to refl ect regional and on national health policy who state circumstances. Delegating primary responsibility to states in a publishes and speaks widely on president of the Robert Wood crisis is unprecedented. It was, as far as I know, the fi rst time a sitting health issues. Johnson Foundation, and served in He founded the present day the Carter administration. He is a US president has sought to decentralise authority and responsibility KFF in the early 1990s. He is member of the National Academy during a national crisis. also founding publisher of KFF’s of Medicine and the Council on The motivation for the policy shift was never clearly articulated. Kaiser Health News , the largest Foreign Relations and serves on While consistent with conservative principles to let state and local health newsroom in the US, numerous advisory committees. governments customise solutions to local circumstances, it may also distributing coverage of health Drew Altman earned his PhD in have been an eff ort, however futile in retrospect, to offl oad political issues through major news outlets political science at Massachusetts accountability for a growing pandemic with the presidential election across the country. Institute of Technology and looming. He was commissioner of the completed his post-doctoral work As a former state commissioner of human services experienced Department of Human Services for at Harvard University before moving in the vagaries of state government, I felt at the time that the the state of New Jersey, director on to public service. He holds of health and human services at an honorary doctorate from the consequences were predictable. On 5 April, I tweeted: “This is the the Pew Charitable Trusts, vice Morehouse School of Medicine. result when you leave it to states to decide what to do on their own with the federal government as ‘back-up.’ Pacesetters, a muddled

54 10 October 2020 | the bmj The coronavirus is not or will not be a mjor problem in the US The worst is behind us The worst is yet to come 100

Percentage 60

0 Total Democrats Independents Republicans Democrats twice as likely as Republicans to say worst of coronavirus is yet to come. Source: KFF health tracking poll (conducted 14-19 July 2020) STEPHEN MATUREN/GETTYIMAGES STEPHEN

The American people split strikingly along partisan willingness to prevent the spread of the virus substantially collapsed lines in their response to covid-19, as if the country across red America. has both red and blue pandemics The partisan divide can be seen on almost every dimension of the epidemic. Democrats are about twice as likely as Republicans to say middle, and laggards, often in the South. The consequences this time the worst is still yet to come on the pandemic in the US (fi gure, above), may be tragic.” and a wide gulf has opened between Democrats and Republicans in the In practice the ramifi cations were even more complex, with states, debate around opening schools. counties, and cities all fi lling the vacuum created by the lack of an Strikingly, in a late August poll CBS and YouGov found that 90% overall national response. of Democrats said the number of coronavirus deaths in the US was The US has 3141 counties. Some are rural with no health unacceptable. But a majority (57%) of Republicans said it was departments; others are as large as states and have health directors acceptable, in part because they believe the death count has been with strong independent authority to implement public health exaggerated. It is an open question whether attitudes and behaviour measures, such as stay-at-home orders. Three hundred cities in the will change as the virus spreads through red and rural America. US have populations of 100 000 or more. In some jurisdictions, county and city authorities overlap. A city may deliver health services Not too late and a county may control public health. A school system may Other reasons account for the poor performance in the US. The historic operate independently of both. Virtually every combination exists neglect and underfunding of our state and local public health system across the country. have also contributed to the weak US response. And our country’s In the absence of a centralised federal response, this fragmentation public health system also operates independently of our healthcare resulted in extreme variation in our national response to covid-19 by system, which does not help. and within states. For example, at the time of writing, 33 states had Overall, however, the US response to the pandemic has much more instituted mandatory mask orders, while other states imposed softer to do with fundamental policy decisions made—and not made—in the orders or none at all. This variation had signifi cant public health White House than the nature of our much debated health system. consequences. Some states opened up their economies earlier than The distribution of a vaccine in the US may well be built on a others—and, in general, the states that opened up their economies similar state by state architecture, allowing for customisation but also earlier suff ered larger outbreaks. substantial variation in performance, depending on the degree of This led directly to the second fateful policy decision shaping the US oversight exercised by federal public health agencies. response: the Trump administration’s decision to push for an opening The decentralised structure of the US response could have worked up of the economy before the virus was contained—and the fracturing more eff ectively had the role of the federal government as “back-up” of the country along partisan lines in response. been buttressed by a national plan overlaying state responses and more generous federal support for testing, contact tracing, personal A starkly partisan pandemic response protective equipment, school reopening, and other elements of the Initially, the White House sought to impose so called “gating criteria” response that require a national policy and resources targeted to state to be met by states before they opened up. These guidelines could have and local conditions. imposed greater discipline on the fragmented response of state and The US coronavirus failure was not inevitable and does not have to be local government. But the criteria were abandoned with the president permanent. But it is historically aberrant for our federal government pushing initially for opening up as early as Easter, then moving that to follow and not lead in a national crisis, and equally unusual for timetable back in the face of pandemic reality. our country to divide rather than unify in a time of crisis. This too is The response has been the defi ning and most troubling the product of the policy decisions that have been made and can be characteristic of the American response to the pandemic: the states altered or unmade by the current or a future administration. and the American people split strikingly along partisan lines in their Drew Altman, president and chief executive, Henry J Kaiser Family Foundation, response to covid-19, as if the country has both red [Republican] and San Francisco, California [email protected] blue [Democratic] pandemics. When that happened, the public’s Cite this as: BMJ 2020;370:m3417 the bmj | 10 October 2020 55 DIABETES DIY artificial pancreases and the dilemma of unregulated devices Patient developed automated insulin delivery systems are increasingly popular with patients with diabetes— but the lack of regulation and practice guidance present a challenge for clinicians. Jo Best reports

ometime before the fi rst There is no glucose measurements change, Outside regulation commercial automated way for users artifi cial pancreas systems can help insulin delivery system to report reduce the amount of time users DIY systems require users to became accessible any adverse spend outside of their ideal blood acquire some skills. OpenAPS S in the UK last year, incidents glucose range. provides the necessary software and technologically minded patients The fi rst commercial hybrid closed documentation to guide users through with diabetes began creating loop system only became broadly the set-up process, and there are active their own “artifi cial pancreases.” accessible in the UK in 2019. Rather and enthusiastic support groups With the number of people using than wait for companies to deliver for would-be users, but the work such DIY technology seemingly artifi cial pancreases, some began of putting the system together and growing, managing patients using working on creating their own maintaining it, as well as weighing the unregulated medical devices is systems, writing and using software risks, ultimately rests with the user. becoming a challenge for clinicians. that could combine readily available Because the systems are not made While continuous glucose pumps and CGMs into hybrid closed commercially, they are not approved monitors (CGMs) and insulin pumps loop systems. The fi rst DIY system, by healthcare regulators and the have been available commercially in OpenAPS, launched in 2015; two Medicines and Healthcare Products the UK for some years, the evolution further artifi cial pancreas designs, Regulatory Agency has produced of these and other technologies to AndroidAPS and Loop, followed no guidance on their use. Without manage diabetes has been slow—and shortly after. regulation or a central manufacturer, the results far from user friendly Without a commercial sponsor there is no way for users to report any considering the pace of change to track take-up of the technology, adverse incidents as would be the in consumer technology, such as user numbers for DIY systems are case for other medical hardware. The smartphones and wearable devices hard to confi rm, but Dana Lewis— US Food and Drug Administration with Bluetooth connectivity that can who has type 1 diabetes and is published an advisory warning be used for health monitoring. one of the creators of OpenAPS— in 2019 after one user needed A hybrid closed loop system, also believes several thousand medical attention when incorrect known as an artifi cial pancreas, people are now using the system CGM readings caused their artifi cial brings together a CGM, an insulin worldwide. A UK Facebook group pancreas to deliver excess insulin. pump, and controller software. dedicated to supporting “looping” The software underpinning the The software is usually run on a has over 20 000 members. three main DIY systems is available smartphone or other device, and Anecdotally, endocrinologists under an open source licence, allows communication between the report the numbers of DIY system meaning it can be freely reviewed pump and CGM, so the pump can users they see in clinic have been and reused by anyone and its safety automatically deliver the user’s basal growing, usually among patients protocols are transparent. There insulin dose according to the CGM’s who are already adept at managing are also technical and procedural measurements. By raising or lowering their condition and have good backstops to make sure users the basal insulin dose as the user’s glycaemic control. are aware of any changes to the

56 10 October 2020 | the bmj ARTIFICIAL PANCREASES IN NUMBERS 400 000 people with type 1 diabetes in the UK 2000-10 000 DIY artificial pancreas users worldwide (estimated)

1 in 5 CCGs will fund closed loop systems

250 000 users of the commercial Medtronic Minimed 670G closed loop system worldwide

18% expected growth in the artificial pancreas market 2020-2025 PATRICK HERZOG/GETTYIMAGES PATRICK software and can update their Clinicians and consider whether extra safety principles of good medical practice,” systems accordingly. should measures are needed. she says. “They have to have But—because systems like respect the As well as acknowledging their monitoring in place, they have to have OpenAPS sit outside traditional patient’s right own level of understanding of the clear clinical records, and usually regulatory, testing, and medicolegal to use a DIY technology, clinicians will need to there has to be some sort of evidence frameworks—clinicians may feel closed loop factor in their patient’s capabilities about the safety and eff ectiveness for uncomfortable discussing their use when discussing DIY systems. “A whatever they want to use that it isn’t with patients, despite the benefi ts and continue person has autonomy in deciding licensed for.” users may report. to offer care how they would like to pursue the and support management of their diabetes, and Liability unlikely Practice guidance our role as care professionals is to support them in that journey,” says Quigley says one of the big sticking There’s little specifi c guidance from Sufyan Hussain, consultant physician points is that there isn’t offi cial data. clinical bodies to help inform medical in diabetes at Guy’s and St Thomas’ Most research into DIY systems practice. A position statement from NHS Foundation Trust. to date is observational or patient patient group Diabetes UK, however, Hussain says that conversations reported, meaning it is likely to advises clinicians not to advocate around DIY systems should be include motivated and enthusiastic DIY systems or initiate conversations guided by the patient’s familiarity users who are willing to share their about them, and, if a patient brings and confi dence with their use. “It data, and so exposes such research up the subject, to warn them of the boils down to the person who’s using to accusations of bias. The situation, risks. Clinicians should respect the it—if they’ve done their homework however, is changing: randomised patient’s right to use a DIY closed loop in terms of understanding what’s controlled trials into DIY artifi cial and continue to off er them care and required. Then our role is to support pancreases are currently ongoing, support in managing their diabetes, them and try and help them to get the and the Association of British they say. best outcomes.” Clinical Diabetologists is running an The GMC highlights its prescribing Muireann Quigley, professor of audit to assess the safety and effi cacy and managing medicines and devices law, medicine, and technology at of such systems. guidance as relevant to DIY systems. the University of Birmingham, says, Studies have found improvements Under the guidance, doctors can “It isn’t the case that clinicians in blood glucose levels among DIY discuss DIY systems, but if they are precluded from prescribing artifi cial pancreas users. A study suggest or recommend them they must unlicensed medicines or unlicensed published in Diabetes, Obesity, and ensure monitoring is available. If they medical devices, it’s just that they Metabolism last year, for example, become aware that a patient is using have to think very carefully about it. reviewed the glycaemic control of 80 an unlicensed device, they should There’s a requirement that things are people using OpenAPS, and found take that into account when deciding to the overall benefi t of the patient.” a 9.3% increase in the time users their management plan, explain “They have to make sure whatever spent in range. While acknowledging any interactions, document fully, they do is in line with the wider that the cohort may not refl ect the the bmj | 10 October 2020 57 PATIENT PERSPECTIVE: “DIABETES IS A MENTAL BURDEN—MY DIY DEVICE FREES ME FROM SOME OF THAT” I’ve lived with type 1 diabetes for This is the neglected impact of type Two key points are flagged with over 25 years—and for over 25 years 1 diabetes: the mental burden of patient built systems: safety and I’ve been frustrated with the lack of having to constantly check, action, acceptance. Insulin is a dangerous technology to help me manage it. and worry. The value of an artificial drug: misusing my insulin pump Type 1 diabetes is a data intensive pancreas system is that it can take or making poor, rushed decisions condition and this lack of access some of this burden and automate based on my CGM readings is and progress means that I have to some of the more mundane dangerous—but all within the rely on one of the most unreliable discussions; using the data I collect accepted regulatory frameworks. processors of this data: me. and add it can automatically adjust My artificial pancreas system is The introduction of some my basal insulin. In doing so it is not much better than I am at taking technology—CGMs that provide impacted by my irrational decisions the information it has and making They enable patients real time blood glucose readings, and distraction by my child. controlled actions that are to feel empowered and insulin pumps that allow finer While these patient developed constantly monitored and when control of insulin delivery—while systems sit outside medical needed alerting me. and it has a vibrant and passionate welcome, can actually add to the regulatory frameworks, they have As for acceptance, there is no community that continues stress of managing the condition allowed patients to achieve two one model that fits all for the development and provides support. by providing more decisions to things: to better use the data we management of such conditions. Compare this to commercially make and possible actions to already have and to feel empowered. The open source community offered systems that are perform every day. In 2016 I worked on a mobile app, does not seek acceptance of unaffordable to me or the healthcare Clinicians provide direction HAPP, that implemented an open such devices and for them to fit system, and with limited support on how to manage diabetes and loop solution that crunched my data within the traditional regulatory provided by appointment only. monitor its long term effect—but and gave me feedback every 15 frameworks, but acknowledgement Commercial solutions have their what about these multiple daily minutes through my smartwatch. that they are helping with the daily place and may offer solutions to decisions that have to be made? I was amazed how much mental management of their condition, those less technologically confident. “Am I going to regret having a second space this freed up for me and also be it through more advanced I have my yearly check up with my coffee this morning and should I by the improvements to my blood technology that isn’t commercially clinician and leave the continuous take insulin for it if I know I’m about glucose levels. Was this because of available or more engaged patients monitoring burden to the app. This to go for a walk, and I also had a the technology, or from me taking who feel empowered. leaves me to check in as needed and carbohydrate heavy breakfast. Hang more of an interest in my condition? The use of such open source focus on more important things— on, I need to get my child ready; I’ll Honestly, I would say both: my data solutions is a personal preference; like enjoying life. have that coffee and worry about was working for me and providing the reasons I use them are that it is Tim Omer this later.” feedback and I felt empowered. more within my reach financially, www.hypodiabetic.co.uk diabetic population at large, the Commercial options interested in hybrid closed loops but study’s authors say, “OpenAPS shows would rather not use a DIY system. similar results to more rigorously “When someone comes back into That doesn’t necessarily spell the end developed and tested artifi cial your clinic with the best control of the DIY trend, however. pancreas technology in a highly they’ve ever achieved in their lifetime, Only one in fi ve clinical selective, motivated, and technology reporting the best quality of life commissioning groups (CCGs) are adept population of people with type they’re ever had in their time with thought to fund commercial closed 1 diabetes.” diabetes, taking it off them is just not loop systems for those meeting No cases involving harm caused an option for me,” says Emma Wilmot, the appropriate National Institute by DIY closed loops or analogous consultant diabetologist at Derby for Health and Care Excellence technology have come before the Teaching Hospitals. criteria. Those who can’t get funding courts, so clinicians concerned about “It’s often the improvement in from their CCG can opt to pay for negligence and liability for such quality of life that people most talk a commercial system themselves, systems should follow the same about when they talk about closing but the costs (£2000 to £3000 for established practice for other medical the loop. Then they’ll say, ‘Also, by the set-up and £100 or more a month for devices. way, my haemoglobin A 1c is great and maintenance) may be prohibitive. In “It’s unlikely clinicians are going my doctor is happy too,’” says Lewis. contrast, the hardware components to be liable for any harm, as long as “Diabetes is a hard disease because of an OpenAPS system can cost from the conversation is conducted in the it impacts on so much more than just £120, while the software is free. As same way it would be about any other blood sugar levels. Closed looping, in well as being put off by cost, some medical technology or device—which addition to helping with blood sugar may prefer to start or continue using means they make sure the patient levels, tackles a lot of quality of life DIY systems for the functionality and is aware of any risks to do with the matters.” (See Patient Perspective, customisability they off er. Jo Best , doctor and technology,” Quigley says. This means above.) journalist, London “Type 1 diabetes has always been the doctor must know a bit about the With commercial systems starting to in some ways DIY,” says Hussain. jo.best@ technology, ensure they understand make their way on to the market, there journalist.com “You have to adapt what’s been given that information, and document it in will soon be more alternatives for Cite this as: BMJ to you and what you’ve been advised the notes. both clinicians and patients who are 2020;371:m3801 to do around your life.”

58 10 October 2020 | the bmj