comment “The ‘corporate capture’ of healthcare weakens government’s integrity” DAVID OLIVER “I have a problem with breast cancer screening“ HELEN SALISBURY PLUS Freedom of speech and assisted dying; recycling in hospitals

WOUNDED HEALER Clare Gerada Mandatory training needs a major review n a quiet Sunday afternoon, I decided and prescriptive, mandatory learning. Some could to update my compulsory online argue for merit in doing practical and non-clinical safeguarding training. Confronted by training online in one’s own time, although even photos of bruised children, tales of here learning is better done with room for discourse. Oabuse, and parental drug taking, I could Doctors are encouraged to reflect on their clinical bear no more. practice. Yet the current system leaves little time Who thought that such training should be done for true reflection, having become a largely solitary in sterile cyberspace, without discussion between activity more akin to rumination. peers? What with fire training, manual handling, Peer group learning (including supervision) allows and another dozen mandatory requirements, my doctors to explore the uncertainties of their work schedule is filled with having to “learn” what others and, importantly, the emotional impact of working decide is important for me to know to practise safely. so close to death, despair, and disability. It allows for The training is often described interchangeably cases to become real and for true learning to occur. as statutory and mandatory, yet these are different— Given the importance of some of the areas covered the former required by law, the latter determined by in the statutory and mandatory training and the the employer. scarcity of time for learning, it’s important to And it’s not clear who determines that the design a system that uses best evidence training is required—the Care Quality Commission, for learning. The lack of evidence for trusts, royal colleges, the GMC? For example, the the current approach leads me to CQC doesn’t have a list of mandatory training but suggest that the system of training does inspect against a set of subjects, and trusts requirements (including subjects, or practices can be marked down if not all staff content, duration, and format) needs a complete the training. fundamental review. Is it for revalidation? The GMC requires doctors to Clare Gerada is GP partner, Hurley Group, London judge for themselves how best to keep up to date, [email protected] whether evidence of training should be presented Cite this as: BMJ 2019;365:l1406 at appraisal, and how evidence of completion should be presented. The current suite of mandatory training has, in good faith, been deemed important by individuals Peer group or organisations. But it’s become at best a chore, an learning allows expensive tick box exercise. At worst, it contributes to high levels of mental distress in our profession. doctors to Delivery of much of the training also runs counter explore the to educational good practice. What’s apparent from uncertainties of educationists is that the best outcomes—behaviour their work and, change, educational impact, and improved patient importantly, care—are achieved through experiential, active learner, peer group learning. This is a long way from the emotional where we are now, with a focus on passive learners impact the bmj | 6 April 2019 21 PERSONAL VIEW We risk our careers if we discuss assisted dying with patients or colleagues Five anonymous palliative care doctors say that their professional association is stifling free speech and denying an informed debate e are five consultants; The assertion that between us we have 94 doctors in the years of consultant level UK might be experience in palliative called on to “kill” . We share patients is blatant concernsW about the way that our specialty’s scaremongering medical colleges represent assisted dying in the media, including in this journal. being asked to “kill” patients. In our view, those at the APM. We have no reason to The Royal College of Physicians (RCP), after these assertions are indefensible and morally suspect that our colleagues are any less a recent survey of its members and fellows, repugnant interpretations of a reasonable sympathetic, compassionate, or proficient, adopted a neutral position on assisted dying. attempt by the college to use neutrality to than we are. We, however, disagree that Since the survey was announced, there has facilitate discussion about the topic. assisted dying is inherently a bad thing. We been an outpouring of strong opinions from We are unaware of any evidence that other believe it is our professional responsibility the officers and members of the Association jurisdictions that have legalised forms of to have an open discussion on the subject. for Palliative Medicine (APM). Most criticised assisted dying have seen a loss of public faith It’s important to do this as many of the dying the RCP for not following the APM’s absolute in the medical profession. There is also no people for whom we care have expressed a opposition to a change in UK law to allow for evidence that assisted dying is inconsistent wish that assisted dying be an option they some forms of assisted dying. Fortunately, with modern evidence based medicine. Most could access. The BMJ restored some balance by publishing importantly, the assertion that doctors in the We would like to tackle the charge that articles from Canadian physicians who have UK might be called on to “kill” patients is legalising assisted dying would lead to experience of providing assisted dying. blatant scaremongering. doctors being asked—possibly even forced Critics suggest that by taking a neutral by unspecified insidious means—to “kill” stance the college is opening the door to an Not inherently a bad thing patients. We believe that our colleagues, irreversible breakdown of medical standards We would like to open another side to this for whom we have enormous respect, have and public trust; is a dereliction of thousands discussion. As consultants in palliative failed to read and understand the terms of of years of Hippocratic practices; and—worst medicine, we undoubtedly see the same recent attempts to bring assisted dying to of all—that it would lead directly to doctors spectrum of patients and their carers as the UK, and are confusing “assisted dying”

BMJ OPINION Richard Thorley Recycling in hospitals: The pollution of our oceans with plastics extensive, sterile procedures are performed, and the destruction of Earth’s forests to the volume of waste is even greater. couldn’t we do better? make paper based products have huge The packaging of medical supplies, implications for our planet and human just like the packaging of food and health. Recycling is no longer just an other commercial products, needs to be applaudable action; it is now expected slimmed down and, where possible, of us all. So why do we see so little of it in made of sustainable and recyclable hospitals? materials. But this won’t happen The healthcare environment has massive without incentives for manufacturers. potential to reduce waste and scale up When sourcing medical products, recycling. But while the rest of society has the environmental impact should be been relatively successful in trying to reduce considered alongside efficacy and cost. the amount of waste sent to landfill, there Typically, a ward treatment room will have has been little change to our practices separate bins for sharps, infectious waste, in hospitals. Recently, when I was in the clinical waste, and domestic items, but it’s process of inserting an intravenous cannula, rare to see a recycling bin too. Could we a patient commented on the amount of have them as well? Those materials that are packaging waste involved. When more already recyclable should be recycled; there

22 6 April 2019 | the bmj with “voluntary euthanasia.” An example is the ACUTE PERSPECTIVE David Oliver Falconer Commission which made it very clear that the act of dying would be at the competent patient’s repeated request, facilitated by a doctor writing It’s time to put a catch on the a prescription, for a lethal “draught” that would revolving door to the NHS lobby have to be taken by the conscious patient by his or her own hand. We challenge that this could be n January the chief digital officer tenders to be put out to “any qualified construed as “killing.” for NHS England, Juliet Bauer, provider”—to being chief executive We have tried in different ways to engender an left to take up a role at a Swedish of Care UK, “the largest provider of open and fair discussion about the subject with our digital start-up company. The private NHS services.” Mark Britnell specialist colleagues, in the hospices, hospitals, company, called Kry (Livi and Gary Belfield, who headed the and community settings in which we practise Iin the UK), has developed a video health department’s grandly named our craft. All of us have been stifled from talking consultation app and has partnered “world class commissioning,” moved about this topic. We believe that there are many general practices in England. to KPMG, which sells consultancy to more colleagues—especially trainees and early That same month the Financial the NHS. career consultants—who do not share the views Times reported that Bauer had written Monitor, the former regulator of of the officers of the APM, but we suspect they are a newspaper article extolling the foundation trusts, was headed by a inhibited from openly sharing their own views. virtues of Kry’s app without disclosing McKinsey consultant, David Bennett, that the company had already on one of the highest salaries in the No concession hired her (the piece was eventually NHS. His dual status as chair and chief Whenever a related situation arises—such as amended to clarify the matter). Meg executive of Monitor from March 2011 the RCP’s survey, or when a patient’s request for Hillier, chair of the Public Accounts to January 2014 was criticised by assisted dying is brought before British courts— Committee, described Bauer’s action the Public Accounts Committee, and the APM emails its members with the clear and in writing the article as “brazen” and he has since returned to consulting. unequivocal direction that they are to oppose “jaw-droppingly inappropriate.” Bauer Monitor employed more management these developments. There is no concession to was then “reminded” that she could consultants from the big firms than the possibility that other doctors practising high not lobby government agencies for six staff with frontline NHS experience, quality, ethical specialist palliative medicine may months after leaving NHS England. and it signed contracts with the big hold a different opinion—or simply want to hear The story is one of many illustrating four consultancies worth £32m. different views. the revolving door between the NHS The revolving door has been We hope readers understand why we decided and the private companies seeking to described as an element of the to write with anonymity, at least until there is a influence government policy or secure “corporate capture” of public climate of open and fair discussion where doctors its business. Employees, lobbyists, healthcare, a phenomenon that do not fear being criticised, ostracised, or—worst of and consultants secure advisory or weakens government’s integrity, all—having their careers threatened. We commend leadership roles in government bodies independence, and effectiveness. I’m the RCP’s move to bring more open discussion to and then move back to the private not suggesting we need to ban such the medical community, but hope that our specialty sector. Meanwhile, senior government moves. But we surely have to be far does not continue to deny its members that freedom. officials and former ministers take more transparent and shine some very Cite this as: BMJ 2019;365:l1494 their inside knowledge and contacts public light on this revolving door. to organisations and sectors that do David Oliver is a consultant in BMJ OPINION Richard Thorley regular business with government. geriatrics and acute general I’ll pick just a few examples. medicine, Berkshire are no excuses for filling landfills or incinerators Jim Easton moved from being davidoliver372@ when there is an alternative. Department of Health director for googlemail.com It’s not just clinical waste that can be recycled, improvement and efficiency—at a Cite this as: BMJ of course. In a variety of public places we expect to time when legislation forced NHS 2019;365:l1297 see recycling bins adjacent to conventional rubbish repositories. Yet, from what I’ve seen, many hospitals can’t even manage that. This needs to change; there’s no reason we shouldn’t have recycling facilities in all The former trusts hospital waiting rooms and corridors, just as we have regulator hired at the park or in shopping centres. For today’s generation of doctors, there cannot more big firm be more critical issues for the world’s health than consultants climate change and pollution. Recycling plays a part than staff in combating these challenges. It’s too late for us to with frontline set an example; households and businesses around NHS experience the country are already doing it. We need to catch up. Richard Thorley is a core medical trainee at the Royal Cornwall Hospital in Truro, UK

the bmj | 6 April 2019 23

PRIMARY COLOUR Helen Salisbury LATEST PODCASTS Should I champion mammograms?

ur practice has been said in a letter to the Times last week that invited by the local clinical “screening seems to be a zero sum game in commissioning group that for every breast cancer death avoided to take part in a quality there is one death from overtreatment of improvement scheme pseudocancers.” He went on to say that Oaimed at increasing the uptake of cancer it was time to de-implement screening. screening. We are offered support from He is not alone in this. In 2017 the Swiss Cancer Research UK to make an action Medical Board reviewed the available plan to improve rates of bowel, cervical, evidence and concluded that no new and breast cancer screening. We’re systematic mammography programmes incentivised with payments for engaging should be introduced in Switzerland. in the process and for any increase in the A Cochrane review in 2013 concluded Talk Evidence proportion of our patients screened. that, in every 2000 women invited The BMJ’s Helen Macdonald and Carl Heneghan, I wish I could say that my conversations for screening, one would avoid dying editor in chief of BMJ EBM, round up what’s about cancer screening all adhere to of breast cancer and 10 would have happening in the world of evidence based guidelines about how to share decisions unnecessary treatment. However, the medicine. This month they talk about statins, with patients. In reality, most of our conclusions of the Independent UK shoulder pain, and the drugs given to children exchanges are a very brief aside in a Panel on Breast Cancer Screening report and young people with gender dysphoria. On consultation about something else. If we published the same year were entirely this last subject, Carl Heneghan says, “there’s a do have time for more, the conversations different: one breast cancer death complete evidence void in this area. about bowel and cervical cancer screening prevented in every 235 patients screened. “It’s one of the poorest bodies of evidence are relatively straightforward—for me, So, what do I tell my patients? When I I've ever seen to inform decision making in a at least. I explore any reservations the share the ambiguity in the evidence, we field. There are no clinical trials, there are no patient has and try to explain the process will probably have a long conversation, randomised controlled trials, we only found two and the pros and cons. As the evidence of because I sincerely don’t know the answer studies that actually used case control methods. benefit is robust, I can advise my patients to the question, “Should I have my This approach to medicine, which says that we that any disadvantages of taking these mammogram?”—even for myself. can just use drugs because we think they’re a tests are very likely to be outweighed by If, after this initiative, breast cancer good idea or because patients want them, is the advantages of treating minor changes screening rates rise at our practice, can difficult for me to rationalise as appropriate.” and preventing cancer. I be sure that all patients have made But I have a problem with breast cancer a fully informed, shared decision? Or New power in medicine screening. The evidence for its benefit is there a risk that they will just have In this podcast we hear from Henry Timms, is very much less clear. There are well been advised by a trusted doctor to be coauthor of New Power, a book that explores known problems with lead time bias, screened? The fact that we’re being how, in our hyperconnected world, the way in overdiagnosis, and toxic treatments of offered a payment for this makes me which power is exercised is shifting. As Timms screen detected “cancers” that would very uncomfortable. says, “new power is made by the many, it’s never have been clinically relevant. Helen Salisbury is a GP in Oxford about what you upload rather than what people Michael Baum, an architect of [email protected] download, it’s a much more distributed type of the UK screening programme, Cite this as: BMJ 2019;365:l1409 power.” Now that people have more avenues of participation open to them and the expectation that they can join them, this will have big I sincerely don’t implications for medicine, says Timms. know the answer “These dynamics are especially relevant as to the question, we think about medicine because there’s almost nothing that people are more invested in than 'Should I have my their own health. How can we get that connected mammogram?' crowd serving not only individual interests—in even for myself terms of healthier, happier, fuller lives—but also social interests? How do we get that crowd to make us a more flourishing society?”

Catch up on all of The BMJ’s latest podcasts at bmj.com/podcasts

Edited by Kelly Brendel, assistant web editor, The BMJ

24 6 April 2019 | the bmj ANALYSIS Low risk pragmatic trials do not always require participants’ informed consent Regulations should remove unnecessary obstacles for studies assessing the comparative effectiveness of posing no or minimal risk to patients, say Rafael Dal-Ré and colleagues

eal world comparative effectiveness research is an important component of evidence-based medicine. Observational dataR can be collected in routine clinical practice but often have poor procedural quality and are prone to confounding, leading to overestimation of treatment effects.1 Randomised controlled trials (RCTs) are the gold standard for determining a causal effect of interventions, but the results may not be applicable to other settings.2 Two factors that prevent generalisability of RCT results are strict participant selection criteria and the informed consent process. Moreover, RCTs are susceptible LTH NHS TRUST / SPL / TRUST NHS LTH to the Hawthorne effect, whereby participants may change their professionals, and policy makers by recruitment, and follow-up. behaviour when they are aware of assessing interventions as prescribed, The critical point in low risk taking part in research managed, and used in normal clinical pragmatic trials is that randomisation Pragmatic RCTs aim to provide practice. This removes many of the of individual participants poses evidence of immediate relevance to features that can make RCTs artificial. no additional risk to them, as both the decisions of patients, healthcare Only two characteristics of pragmatic treatments would be considered RCTs interfere with the normal patient- appropriate with similar perceived KEY MESSAGES physician relationship: randomisation benefit:risk ratios. That the choice and the need to seek written informed will be made at random is the most Randomised controlled trials do not always • consent. When the perceived important thing that participants inform daily clinical practice because of limited benefit:risk comparative ratios of should know before consenting. generalisability two interventions are uncertain, To establish equipoise in the Low risk pragmatic randomised controlled • randomisation is the fairest way of perceived benefit:risk ratios at trials can assess comparative effectiveness of allocating treatment and is the best the design stage of the protocol, interventions with no or only minimal incremental way to handle unknown confounders. investigators should consider risk the efficacy and safety profiles Obtaining written informed consent for these • Low risk pragmatic RCTs and seek the views of patients. trials can hamper recruitment and reduce the Low risk pragmatic RCTs pose Contraindications and interactions generalisability of results no, or minimal, incremental risk that preclude patients from Council for International Organizations of Medical • compared with usual clinical care5 participating in the trial should be Sciences guidelines state that written informed and are typically head to head defined as exclusion criteria in the consent can be waived if the research would be impractical if consent was required, has important comparisons of medicines that are protocol. For patients who satisfy the social value, poses no more than minimal risk to routinely prescribed according to their criteria, as in normal routine, doctors participants, and is approved by a research ethics marketing authorisations. There are will discuss the advantages and committee several approaches to conducting low disadvantages of the medicines. EU clinical trial regulations should be revised risk pragmatic RCTs of medicines. After the patient consents to • 6 to allow the waiver or modification of informed Two of them—registry based trials treatment, randomisation takes consent in low risk pragmatic trials and using electronic health records— place and the patient is allocated to could facilitate implementation, receive one of the two treatments; the bmj | 6 April 2019 25 Examples of the challenges of pragmatic RCTs that required individual patient consent Consent related barriers to Trial Summary Sample size Recruitment trial participation Mosis et al11 Patients in a Dutch primary care electronic health record system were randomly 170 patients Of the eligible patients, only 20 were Doctors experienced patient allocated to receive diclofenac or celecoxib for osteoarthritis to compare identified randomly assigned to a drug. In 30 cases recruitment as a time consuming gastrointestinal tolerability. Both drugs were licensed, marketed, and reimbursed for the patient was not recruited because disruption of the normal work the treatment of osteoarthritis. All patients >18 years old who were diagnosed with the doctor was too busy to start the flow, especially because of the osteoarthritis, needed a non-steroidal anti-inflammatory drug for osteoarthritis, and recruitment procedure. Another 55 need to obtain informed consent were not treated in the past 3 months were eligible for the study patients received treatment in the practice but from a healthcare professional not involved in the trial van Staa et al7 Point-of-care trial in the UK including patients aged ≥40 years with a medical history 150 patients 31 patients were recruited for the eLung Information disclosure in of chronic obstructive pulmonary disease (COPD) who, in the opinion of their GP, had trial (two trials were included in the the trial was much more an acute exacerbation of COPD with an increase of non-purulent sputum volume, publication) detailed and onerous than who did not require immediate referral to specialist care for treatment of COPD that outside the trial. Consent exacerbation and consented to participation. Patients were randomly assigned to would be too difficult to obtain receive immediate (prophylactic), deferred, or non-use of antibiotics in a consultation the physician tells the patient The critical well against current standards for verbal consent or general notification, about specific adverse reactions or point is that shared decision making.13 although substantial minorities of up interactions to be avoided. At this randomisation The requirement for consent to 40%20 21 endorsed the alternative stage the patient should agree to be could also lead to the recruitment option over the standard written of individuals 14 treated with the medicine that has poses no of a selected group of patients. consent. been assigned. This does not interfere additional For example, recruiters may expect Current evidence around with the normal shared decision that a potential participant will modifications to the consent process risk to them making process between physicians say no, so they do not ask. Or they or format shows little or no effect on and patients. may not attempt to recruit potential recruitment compared with standard To ensure that the trial fully participants in whom the consent written consent.24 Electronic informed resembles routine care, the number process is more burdensome (such consent25 is starting to be used26 but of procedures, tests, and periodicity as those with low literacy or poor could lead to a non-representative of visits should be virtually the hearing). On the other hand, patients group of participants. Should we then same as in normal clinical practice, may consider the consent process consider including participants in low without extra baseline or outcome intrusive or suggestive of excessive risk pragmatic RCTs without seeking assessments. Participants should have risk and therefore decide not to informed consent? no more risks or burden than patients participate. Thus, the participants Clinical investigators agree that, in usual clinical practice. may inadvertently end up being when dealing with competent Although low risk pragmatic a selected subgroup of the target patients, all trials that randomise RCTs are close to the ideal design population. In the worst scenario, the individual participants should comply for primary care health research trial is terminated early.7 11 with the ethical principle of respect (and other settings), they can be for persons and allow patients to challenging to conduct. In addition Proposed solutions accept or reject participation (see to problems with recruiting clinicians Ethics box). But surveys conducted in the as investigators,7 9 the administrative Bioethicists and investigators US have shown that both the public27 ethics approval of the trial’s protocol,7 support alternatives to standard and patients28 who endorse written or and reporting of adverse events,7 10 written informed consent. These verbal consent in low risk pragmatic an important hurdle for recruitment include advance written consent RCTs change their minds if this would is related to the informed consent documented in the electronic health make the trial impractical. process (see table). record to be subsequently confirmed by the participant’s verbal consent Regulations Informed consent at the time of enrolment15 or verbal Canadian29 and US30 regulations Many clinical trial regulations require consent after the participant is briefly support modifying or waiving the need that any patient participating in a informed about the main features of for participants’ informed consent in pragmatic RCT must provide written the trial (notably, randomisation) in a human research with high social value informed consent. Obtaining this is clinical encounter.16 Another possible if specific requirements are fulfilled a disruption of the normal patient- approach is “general notification,” (table 2, see bmj.com). This is not true, physician encounter,11 as it entails whereby potential participants are however, for the EU regulations32 due the use of a participant’s information aware that healthcare and research are to be fully implemented in 2019 or sheet and a conversation about simultaneously provided and seeking those of Argentina,33 Australia,34 and the details of the trial. The consent informed consent for a specific trial is .35 These regulations are process, however, does not prevent a considered ethically unnecessary.17 18 hampering the conduct of important consistently poor understanding of In surveys on hypothetical low risk low risk pragmatic RCTs that could the information provided.12 Moreover, pragmatic RCTs, most of the public provide evidence for comparative these materials do not always perform preferred written informed consent to effectiveness (benefiting future

26 6 April 2019 | the bmj pragmatic RCTs in the Declaration of Helsinki. This would align the positions of the two most influential ethical guidelines for health related research in their approach.

Conclusions Over-regulation of research comparing alternative standard treatments presents a formidable challenge—by making that research harder to do, it will likely prolong clinical uncertainties.44 Evaluation of routinely used medicines in pragmatic RCTs 45 patients) and comparative efficiency 31 is a moral imperative, but Respect for persons and social benefit (benefiting public health budgets). unfortunately it occurs too little In its first guideline, the Council for International Organizations Many low risk pragmatic trials of Medical Sciences juxtaposes social value and respect for owing to several barriers, one of assessing comparative effectiveness persons (or autonomy), which is applied through seeking which is seeking the participant’s of commercially available medicines explicit informed consent from prospective participants written informed consent. could fulfil the three provisions or (legally) authorised third parties acting on their behalf, Professional and patients’ of the Council for International when appropriate. Social value is what justifies research and associations, research ethics Organizations of Medical Sciences needs to be supplemented with proper respect for persons. committees, regulators, and, (CIOMS) ethical guidelines: In healthcare research, respect for persons is accomplished in eventually, members of parliaments impracticality of the trial without two ways—by striving for the most effective treatment possible of interested jurisdictions, must work waiving consent, important social and by seeking informed consent when necessary. Recent towards issuing recommendations discussions on learning healthcare systems36 have brought value, and posing no more than and making legally possible what is this out clearly, noting that clinical practice is increasingly minimal risk. Firstly, trials with 37 ethically acceptable: modification or intertwined with research. In such a system, gathering expected small treatment effects or beneficial knowledge for society is seen as an intrinsic feature waiver of informed consent in certain small differences in treatment effect that both patients and healthcare professionals participate in.18 types of low risk pragmatic RCTs. sizes will need to recruit hundreds Low risk pragmatic RCTs are perhaps the best possible Rafael Dal-Ré, senior investigator, Health or thousands of participants; the example of what these systems aim for: to learn from ongoing Research Institute-Fundación Jiménez Díaz targeted recruitment could be at risk activities affecting real world patients under real world University Hospital, Madrid rafael.dalre@ without waiving informed consent. conditions, thereby gaining best evidence for treatment quironsalud.es choice and for directing care, and resources, to those who will Second, having head to head Cristina Avendaño-Solà, head, Clinical most likely benefit. Respect for persons is here shown in the valid comparisons of commonly Pharmacology Service, Puerta de Hierro continuing endeavour to improve the evidence base and reduce prescribed medicines is crucial to University Hospital, Madrid the risk of suboptimal treatment. The standard paradigm in making evidence informed and value Brigitte Bloechl-Daum, professor, Medical research ethics—where a sharp distinction is made between 38 University of Vienna for money decisions in the NHS. research and care—will only hamper important steps forward. Judgments about the social value of Anthonius de Boer, professor, Utrecht pragmatic RCTs should be supported must be as close to clinical practice Regulations University by patient involvement at the design as possible. In their trial protocols, are hampering Stefan Eriksson, associate professor, Uppsala 39 stage and review. investigators must show a high degree the conduct University Third, testing medicines according of trial pragmatism8—for example, Uwe Fuhr, professor, University of Cologne 41 of important Faculty of Medicine and University Hospital to their marketing authorisation and using the PRECIS-2 tool. . low risk without non-standard activities or Cologne Centre of Pharmacology data collection poses no more than Regulations—The EU (and other pragmatic Søren Holm, professor, University of minimal risk, with no incremental risk jurisdictions) should consider RCTs Manchester or burden than prescription in routine introducing some flexibility around Stefan K James, professor, Uppsala University care. the requirements of consent for low Robert J Mentz, investigator, Duke University The number of low risk pragmatic risk pragmatic RCTs. There is arguably Medical Centre and Clinical Research Institute, Durham, trials evaluating the comparative a moral need to make use of essential North Carolina effectiveness of medicines remains scientific information to inform Emilio Perucca professor, University of Pavia, very low,40 despite their high social clinical decision making. Italy value. The hurdles preventing such Frits R Rosendaal, professor, Leiden University studies must be overcome. Ethical guidelines—The World Medical Center, The Netherlands. Medical Association should debate Shaun Treweek, professor, University of Actions to improve the current situation and, hopefully, include provisions for Aberdeen Scientific methods—For a consent modification or waiver of informed waiver to be appropriate, the trial consent for research such as low risk Cite this as: BMJ 2019;364:l1092 the bmj | 6 April 2019 27 LETTERS Selected from rapid responses on bmj.com See www.bmj.com/rapid-responses

LETTERS Selected from rapid responses on bmj.com

SCREENING FOR ATRIAL FIBRILLATION additional monitoring was needed in One size does not fit all only eight of 1510 participants. We still don’t know whether screen The association between atrial detected atrial fibrillation carries the fibrillation and thromboembolism is same stroke risk as clinically detected, not as simple as portrayed (Head to or the burden of atrial fibrillation Head, 16 February). Stroke in chronic that should be found (and treated). atrial fibrillation is not Randomised controlled trials (RCTs) always thromboembolic, and are investigating this, but only in anticoagulation reduces but does not selected populations with existing eliminate stroke. implanted cardiac devices. No studies Reacting to atrial fibrillation have, to my knowledge, systematically can be fraught with error, bias, compared “total unknown atrial and confounding. That 90% of fibrillation” identified by handheld LETTER OF THE WEEK patients in the Strokestop screening ECG with long term implantable ECG study accepted anticoagulation devices. Could this be done in a Poor understanding of modern slavery is worrisome. This indicates that subgroup of the SAFER study? Such and colleagues describe modern slavery as a perhaps risk and benefit were The Wilson and Jungner WHO public health problem as well as a law enforcement issue oversimplified. screening criteria are often misused. and emphasise the missed opportunity for healthcare Anticoagulated patients continue The apparent fulfilment of these professionals to protect victims because of inadequate to have strokes due to poor control criteria is widely used to argue that training in, and awareness of, the signs, consequences, of atherosclerotic risk factors, atrial fibrillation screening should be and effective responses (Editorial, 9 March). This is unchecked obesity, hypoventilation, implemented. But these principles especially true for sexual exploitation. obstructive sleep apnoea, smoking, were intended only as a checklist to Data from the UK National Crime Agency show that sexual and lack of fitness. None of these justify the search for further RCT based exploitation was the second most common type of modern factors are offset by anticoagulation. evidence. This is where we stand now, slavery and human trafficking in 2017, accounting for 34% We must be cautious about waiting for the evidence. of all victims, and the most common type by far for female screening and presumably treating Meanwhile, we should continue victims at 66%. In in-depth interviews, Albanian female the majority. This is not informed searching for atrial fibrillation among survivors of sex slavery in England reported repeated choice. Cost utility is complex, and our patients—be it by conventional or problems accessing primary healthcare for themselves and patients should not be told one new methods. their children. The primary barriers were confusion around size fits all. Presuming that trials Trygve Berge, MD/PhD fellow, Gjettum, eligibility criteria and poor understanding of modern “strengthen the case” betrays Norway slavery in healthcare. confirmation bias before relevant Cite this as: BMJ 2019;364:l1416 A study of 98 female survivors of trafficking in England data are even available. Let’s see the TOO MUCH MEDICINE? found that 29% had one or more pregnancies while being data, consider their value, and then trafficked. Of these, 32% had been sexually abused, inform patients. The current minority Symptoms matter 89% had experienced a mental health disorder, and 43% of people who own a smart watch Godlee lists some efforts to tackle had at least one termination. Both victims and clinicians should use it to tell the time and too much medicine, as well as a reported difficulties accessing appropriate healthcare, with increase activity until we understand caution (Editor’s Choice, 2 March). I clinicians recognising their need for training. any atrial fibrillation better. am struck that the caution applies to A recent survey of 33 of the 34 UK medical schools found Robert J MacFadyen, professor of medicine a fundamentally different category of that only nine currently provide any teaching on modern and cardiologist, Hobart medical care. slavery and that the rest had little appetite to do so in the Cite this as: BMJ 2019;364:l1396 Routine monitoring in hospital, future—this is a serious gap. We can have little confidence statins for all patients over age 75, that the UK experience is not as parlous as that of the US, Wilson and Jungner would and whole genome sequencing for where 88% of female survivors reported being assessed healthy people all fall in the category not approve of screening by a clinician at least once while trafficked, but not a single of anticipatory medicine. These are one was identified as a victim. We used a handheld ECG monitor to efforts to detect and avoid events Patrick J Saunders, visiting professor of public health, Stoke on screen 65 year olds at increased stroke that might happen in the future. The Trent; Megan Harris, specialist registrar, Birmingham risk (CHA2DS2-VASc score ≥2 for men caution applies to a clinically evident Cite this as: BMJ 2019;365:l1449 or ≥3 for women) and found that only problem—urinary tract infection—an A study of survivors found that 0.9% had unknown atrial fibrillation. event that is happening now. Handheld ECG seems promising for The difference is symptoms. 29% of women had one or more screening, as 99.5% recorded ≥20 Symptoms matter. In symptom driven pregnancies while being trafficked scans over two weeks. The rate of medicine, patients are asking for our “incidentalomas” was negligible, and help; in anticipatory medicine, they

28 6 April 2019 | the bmj LETTERS Selected from rapid responses on bmj.com See www.bmj.com/rapid-responses

are being told they need our help. These positions offer not only Symptomatic people are more likely financial incentives but also tailored to have adverse outcomes (such as training opportunities and enhanced sepsis and death in the cohort with experiences such as dedicated urinary tract infection). Plus, the research time or even subspecialty presence of symptoms means there is exposure rarely afforded to those at room to get better. junior level.With more work flexibility, Symptoms make benefits more better pay, and better training possible and harms more acceptable. experiences, is it any wonder that more Of course, symptomatic patients can people are choosing to take up non- experience too much medicine, but training medical roles in the UK? they can also experience too little. Should we not be altering the That’s why caution is called for. approaches of specialty training itself registration and professional body The health H Gilbert Welch, general internist, to incorporate some of the tailored and recognises the complicated nature secretary Thetford, Vermont flexible approach that makes the non- of genetic disorders and their should at Cite this as: BMJ 2019;265:l1454 training medical roles so attractive? implications. least assign TRAINING BREAKS Daniel P Whitehouse, This stands in opposition to a any revenue specialty trainee year 1, Cambridge view that the UK population is best raised to Making specialty training Cite this as: BMJ 2019;365:l1477 served by treating genetic knowledge more attractive develop as a simple commodity (Editorial, services I am not surprised by the continued NHS GENOME SEQUENCING 2 March). If the health secretary is to for the downward trend in junior doctors pursue this policy, perhaps he should going directly into specialty training Genome commodification at least assign any revenue raised to unintended (Data Chart, 2 March). This creates in the NHS develop services for the unintended adverse more rota gaps, leading struggling The emergence of genetics nurses adverse consequences of his policy. consequences trusts to create lucrative trust grade and counsellors as a specific Adrian Sutton, director, Squiggle Foundation of his policy positions to meet service demand. practitioner group with its own Cite this as: BMJ 2019;365:l1475

such as candesartan. Before Kenneth Y-K Wong consultant cardiologist, Blackpool writing the prescription, I felt Suzanne Wong consultant physician obliged to advise the patient and geriatrician, Blackpool

that there was no evidence that Cite this as: BMJ 2019;365:l1456 candesartan would make them live longer, whereas ramipril Being over 75 isn’t would be expected to do so the end of life based on randomised controlled trials and a meta-analysis. What Working in geriatric medicine do you think the vast majority of 40 years ago, I was taught patients would say? about the problems of “Please give me the drug that overmedicating the frail elderly helps me live longer!” (Rammya Mathew, 2 March). Patient involvement in So, this is not a new problem; SUCCESSFUL OLD AGE the design of clinical trials is it is probably less so now. But, crucial to ensure that the key even then, we did not think Empowering patients to make informed choices outcome measures reflect what of being “over 75” as the last Mathew’s column on giving cough is mild, and patients put patients consider to be most few years, whatever the actual statins to patients over 75 was up with it having considered the important. When designing life expectancy. Approaching thought provoking, but we are benefits of the drug in prolonging a randomised controlled trial that age myself, I am hoping to concerned that readers may be life, reducing risk of readmission comparing outpatient based become at least as old as my tempted to withhold lifesaving to hospital, and improving heart acute heart failure management mother, now in her 90s. I don’t drugs from older patients failure symptoms. with standard inpatient care, want treatment decisions made without giving ample time and The challenge arises when I listened to my patients with for me on the basis of “being information to empower patients the cough is debilitating, heart failure who thought that all more comfortable in the last to make an informed choice keeping patients awake. Before cause mortality was a worthwhile few years.” I would rather linger (Rammya Mathew, 2 March). PARADIGM-HF showed that primary endpoint, and I included on; I shall have plenty of time to I (KW) have had numerous sacubitril/valsartan saves more other secondary endpoints that be dead, later. conversations with patients lives than ACE inhibitors, we are important to patients such Gerald T Freshwater, retired saying that ramipril gives them used to switch from ramipril to as admission to hospital within occupational health physician, Lerwick a cough. In many cases, the dry angiotensin receptor blockers 60 days. Cite this as: BMJ 2019;365:l1455

the bmj | 6 April 2019 29

Longer versions are on bmj.com. Submit obituaries with a contact telephone number to [email protected]

OBITUARIES Isidore Wolfe Crown Edward Milne Dunbar Hubert Sidney Sims Ryan General practitioner Consultant in infectious General practitioner (b 1923; q King’s College diseases Manchester (b 1920; q Barts London 1947; MRCS), (b 1947; q London 1972; 1953), died from died after a stroke on FRCP Lon), died suddenly bronchopneumonia after 19 December 2018 on 7 December 2018 a short illness on Isidore Wolfe Crown Edward Milne Dunbar 16 February 2019 established his own (“Ed”) became a Hubert Sidney Sims practice in Peckham consultant in infectious Ryan (“Hugh”) joined in south east London in January 1953. This diseases in 1980. He was one of the first to the Royal Air Force when the second world practice eventually became the Bellenden embrace the medical and social challenges war broke out. He became a navigator and Road Group Practice, and he continued to work of the HIV epidemic in the early 1980s and flight lieutenant, flew reconnaissance, and as senior partner in the same practice and in was responsible for laying the foundations for took part in a bomber raid over Germany. the same premises until his semi-retirement one of the most progressive HIV units in the After the war, he retrained to become doctor. at the end of 1997. The practice then moved north. Moreover, he set up dedicated dialysis He returned to Wales as a GP in Newport and into new purpose built premises, where a facilities for patients infected with bloodborne started his practice in St Julians. Hugh retired plaque outside the surgery remains until today, viruses, a hyperbaric oxygen service for severe at age 70. He was granted life membership bearing the name “Isidore Crown Medical anaerobic infections, and a high care unit within of the BMA and was a member for 55 years Centre.” The London Borough of Southwark the department. He led the Manchester regional and seven months. He enjoyed his family, awarded Crown the Honorary Liberty of infectious diseases unit from 1992 till 1997 and astronomy, physics, reading, and his large Camberwell for his services to his patients, in oversaw its move to its current location at North garden—but not gardening. He also enjoyed May 2000. He continued to work as a doctor Manchester General Hospital. His presence classical music, especially the violin, which part time, but discovered a new career as extended beyond Manchester, with periods he played well. He had an interest in Bible an author. Predeceased by his wife, Louise, working abroad in Bucharest, Kurdistan, study and had a deep Christian faith. He and a daughter, he leaves two sons, four , and south east Asia. Ed leaves his leaves his wife, Audrey; two children; and a grandchildren, and five great grandchildren. wife, Jacky; two sons; and three grandchildren. grandson. Barry Crown, Simon Crown E G L Wilkins, A Ustianowski, F J Vilar, A Bonington John Ryan Cite this as: BMJ 2019;364:l1157 Cite this as: BMJ 2019;364:l1154 Cite this as: BMJ 2019;364:l1153 David Hirschowitz James Arthur Nicholson David Frederick Harrison Orthopaedic surgeon Senior general surgical General practitioner (b 1943; q Cape Town registrar and honorary Sherburn-in-Elmet, University, 1961; FRCS), lecturer (b 1982; north Yorkshire (b 1935; died from cancer on q University College q Leeds 1958; MRCGP), 11 February 2019 London 2006; MRCS, died from thyroid cancer David Hirschowitz was PhD), died by suicide on on 17 July 2018 born in 22 October 2018 David Frederick and raised in South James Arthur Nicholson Harrison, an archetypal Africa and . At the time he (“Jimbob”) was originally from Stockton on family doctor, entered rural practice in 1960. graduated in 1967, David and his girlfriend, Tees. After qualifying he moved to Mersey At the forefront of innovation and progress, the Lynette, found the political and social Deanery to complete his surgical training practice embraced teaching and GP training, atmosphere intolerable and they moved to and made Liverpool his home. He completed moved into purpose built premises, and England in 1968. David began training as a a research fellowship and dedicated his established an effective and coherent primary general surgeon, and over a four year period short but exceptional research career to care team. David was honest and trustworthy, he rotated between various hospitals. He pancreatic cancer. After only three years and his standards of practice were rigorous and started to specialise in orthopaedics and in research, James was awarded the consistent. As an inspiring teacher he believed spent a year on a surgical research fellowship Hirschberg award for best paper in that guidance and example were the ways at the University of California in Los Angeles. pancreatic cancer basic science, the to promote excellence. He taught more than Back in England in 1977, David started as a Rodney Smith medal, and the European 35 registrars and many undergraduates. He consultant orthopaedic surgeon at hospitals Pancreatic Club gold medal. He published promoted the use of clinical photography and in St Albans and Hemel Hempstead. In 2009 several papers and abstracts, the last of computerisation. In 1995-97 he supervised the he was diagnosed with prostate cancer which was published the day after his death. extension of the practice into an adjacent listed and in 2018 with lymphoma. He remained James leaves his parents, Pam and Leslie; 17th century building. At school and university positive during bouts of chemotherapy and four siblings; and Andrew, his partner of 18 he played tennis and rugby. He was a keen radiotherapy. He leaves Lynette, his wife of 50 years. gardener and Francophile. He leaves his wife, years; two sons; and four grandchildren. Andrea R G Sheel, Amy J Thomas, on behalf of the Gillian; three children; and eight grandchildren. Ivan Hirschowitz surgical trainees of the Mersey Deanery Roger D Parkin, Jonathan K Bynoe Cite this as: BMJ 2019;364:l1155 Cite this as: BMJ 2019;364:l1139 Cite this as: BMJ 2019;364:l1160 the bmj | 6 April 2019 41

OBITUARIES John Beavis Trauma and orthopaedic surgeon who trained doctors in disaster zones

John Beavis (b 1940; q at the age of 53. Although he which aimed to train surgeons Beavis was an exceptional University College Hospital, returned to work at a hospital in in managing injuries in areas man, overflowing with London, 1967; FRCS, DMCC), Kent, he retired weeks later after affected by conflict or natural compassion, humour, and died from lung cancer (a non- experiencing severe chest pains. disaster. a never ending capacity smoker) after a relatively brief When a tsunami struck to engage with people final illness on 5 December 2018 Charity work southern Sri Lanka in 2004, Still youthful, bursting with Beavis provided emergency aid Surgeons who worked alongside John Beavis grew up in modest energy, and keen to relieve for desperate people who had Beavis in Gaza, recalled: “John circumstances and was able to suffering, Beavis answered an lost their livelihood and homes, Beavis was an exceptional man, benefit from the opportunities appeal for medics to volunteer funding the repair of fishing overflowing with compassion, provided by the Labour at hospitals in Bosnia, where boats and a ruined village school. humour, and a never ending government with the birth of the war was raging. In Sarajevo, he In 2003 Beavis set off for capacity to engage with people. NHS, free secondary education, taught orthopaedic surgeons north west Pakistan to train In Gaza, as everywhere else, he and social welfare. His success the latest techniques for treating local surgeons and nurses in became a much loved figure.” In made him determined to give some of the complex bomb managing extreme war injuries, collaboration with Medical Aid back to a society that had given injuries they faced. limb reconstruction, and burns for Palestinians, Beavis helped him so much. On one of his return flights treatment. Andy Ferguson, train large numbers of doctors From 1967 to 1973 Beavis from Bosnia he met businessman a doctor who knew Beavis in and nurses in Gaza and set up served in a Royal Marines Simon Oliver, then the chairman Pakistan, recalled: “One of my a unit at Al-Shifa, Gaza’s largest commando unit as a lieutenant of Dairy Crest Group. Oliver most vivid memories was of hospital, to treat complex limb medical officer, which offered to fund a charity so arriving with John in Abbottabad, injuries. inspired his interest in trauma, that Beavis’s work could be Pakistan, to deliver two days of A wicked mimic who was orthopaedics, and reconstructive expanded, both in Bosnia and primary trauma care training fond of practical jokes, Beavis surgery. He worked as a trauma elsewhere. This enabled Beavis workshops for local hospital enjoyed copying accents ranging and orthopaedic surgeon in the to found IDEALS (International doctors. from Indian to Irish to Geordie, NHS until he had a heart attack Disaster and Emergency Aid “Security tensions were high which provided a lighter note and coronary bypass surgery with Long Term Support), at the time. One by one his in often bleak situations. On fellow trainers pulled out, and one occasion, during their time John was left to run the whole in Gaza, Beavis convincingly course. He just laughed, stayed pretended to be English’s butler, up half the night preparing, then named “Beeves,” in the presence both entertained and educated of bemused local worthies. everyone for two days without missing a beat.” These courses Honours were so successful that more In the 2019 New Year’s honours than 2000 doctors in Pakistan for Beavis was appointed OBE received training in primary for his services to victims of war trauma care. and disaster. He was elected an In 2005, when an earthquake honourable citizen of Rochester, struck the area, Beavis in 1993 and was awarded the masterminded the delivery Bosnian medal of honour in of emergency food, medical 2001. In 2003 he was appointed equipment, fresh water, and Hunterian professor of the Royal tents. With funding from IDEALS, College of Surgeons for his war one devastated village, Bedadi, injuries work. He received the was dismantled and rebuilt Hugh O’Flaherty international by the villagers 50 miles away award in recognition of his on new land purchased by the humanitarian work in 2016. charity. John Beavis leaves his wife, For the next 10 years Beavis Kate Frankland, and three turned his energies to Gaza, children. which he visited more than 30 Rebecca Wallersteiner, London times. Terence English, a past [email protected]

SEAN SMITH/GURDIAN/EYEVINE SEAN president of the Royal College of Cite this as: BMJ 2019;364:l288

42 6 April 2019 | the bmj