wounded healer clare gerada - the bmj 2020. 2. 7. · medicine a less risky profession we must...

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I recently had the good fortune to be invited to talk alongside firefighters, air ambulance crew, and other emergency personnel about how professionals risk their lives in the service of others. Doctors, in contrast, do not (often)

risk their physical wellbeing to keep us safe—indeed, the actual practice of medicine has become less dangerous. Doctors work in safer physical spaces, for shorter hours, and with better technology for more routine tasks. But, as I argued, doctors do risk their psychological lives, increasingly so—owing to shame, perfectionism, and isolation.

Shame is a powerful, primitive, and silent emotion, differing from guilt in its relation to our identity. The medical profession is often exposed to shaming experiences, exemplified by a culture of “name, shame, and blame,” for failing to meet NHS targets or for becoming unwell, especially mentally unwell. In today’s medical environment the impact of errors, and the fear of committing them, may be the most pressing source of shame, while the impact of complaints leaves doctors feeling humiliated and at risk of depression or suicide.

Perfectionism, which doctors demand of themselves, becomes impossible in the real world of medical care. It’s one of the most pervasive of all personality traits in doctors, and levels have risen in society in recent decades. A large study of medical students over the past 27 years found that levels of self-oriented, socially prescribed, and professionally determined perfectionism had all increased. Given that perfectionism is a core vulnerability for mental health disorders, its rise among doctors could explain why medicine is becoming a riskier profession.

A lack of connectedness, which is becoming endemic in the practice of medicine, adds to the risk factor for doctors. The structures in medicine where doctors can come together to train, work, play, and reflect have been reduced, removed completely, or moved to the sterile virtual world, threatening our

ability to build the connections we need to work and to process our struggles.

Although I’ve painted a largely negative picture, I believe that the tide is turning. We’re seeing some progress in decreasing isolation in medicine. Money has been provided to recreate lost rest spaces (“doctors’ messes”) in every hospital. The NHS long term plan acknowledges the importance of people— all staff who work in the service—and, for the first time, we have an NHS people’s lead.

But there’s some way to go. If we’re to make medicine a less risky profession we must support all staff in how to deal with significant events. We must bring in a no-blame, learning, fair culture. We must tackle perfectionism and have a realistic discussion with our patients and the public about the power of medicine, as well as teaching our doctors that perfectionists don’t necessarily deliver better care.Clare Gerada is GP partner, Hurley Group, London [email protected] this as: BMJ 2020;368:m393

the bmj | 8 February 2020 189

We’re seeing progress in decreasing isolation in medicine

WOUNDED HEALER Clare Gerada

Shame and perfectionism among doctors

“Should we turn people so symbolically into institutionalised patients?” DAVID OLIVER “Sitting at reception for a bit may stop you asking daft questions” HELEN SALISBURY PLUS Don’t devalue my experience as a story; knowledge as the antidote to fear

190 8 February 2020 | the bmj

I’ve been thinking about the phrase “patient story.” On the surface it seems harmless enough—patients are often invited, in healthcare and research, to share their “story” or their

“journey”—but some comments have made me wonder about the word and its use in this context.

My fellow Canadian patient advocate Annette McKinnon said “characterising patient and caregiver interactions with healthcare as ‘stories’ is so frustrating. The experiences we describe are based on fact and we communicate them because we want to protect others from having similar encounters.”

While “story” is defined in many ways, including an account of incidents or events; a statement regarding the facts pertinent to a situation; or an anecdote (especially an amusing one)—in healthcare it may suggest other meanings such as a fictional narrative; the plot of a narrative or dramatic work; a widely circulated rumour; or a lie or falsehood. In healthcare, it can feel

like the word “story” devalues a person’s experience, as if it is not evidence based.

When I work with organisations that include patients, I encourage them to move beyond having a patient present to “tell their story.” Patients are more than their stories and I’ve written previously about how I prefer to be seen as an entire person, not just the story of me in the healthcare system.

Integral part of my lifeWhen I’m asked to talk about “My patient life,” I purposely strike through the word “patient” on my slides because being a patient is my life. My “patient story” is an integral part of my life—how do I parse that out? Why do we “limit” a person to a slice of their life when it’s intertwined into the fabric of their identity, their role(s), and more?

I realise that my preference to move away from story is just that—my preference. Others might appreciate using the terms “story” or “journey,” for the same reasons that I wish to move away from them. I live with a chronic incurable disease but for others with

conditions that are acute or curable, maybe recognising this experience as a small part of their lives at a particular point in time is better described as “story.” I recognise that this may be part of an effort to compartmentalise their experiences instead of allowing them to define a person.

In order to recognise others’ preferences, I’m going to make an effort to consider terms like “patient experience” or “patient perspective,” or, as another Canadian patient advocate, Julie Drury, said, “fact sharing, knowledge transfer, lived experience.”

Words matter, and for me there is a need to move beyond stories. It seems that we view stories in healthcare as having a neat beginning and end. We would be better to recognise that patients’ experiences and lives are moving all the time, dynamic and

Epidemics have mythological potential. Behind the media storm over the emergence of a new coronavirus lie the shadows of medieval plagues. Reality, of course, is different. Although there is still uncertainty, science is chipping away. One thing is clear: knowledge is the antidote to fear. Research is

as critical as first line response.I have been working with the Nuffield

Council on Bioethics on a project on the ethics of research in global health emergencies. The final report has just been published. It involved colleagues from across the world and has also been a personal revelation.

I first got some idea of the personal impact of global health emergencies in Senegal, sitting in a bland hotel garden in Dakar, a stone’s throw from the sea. We were talking to survivors of Ebola, people from across the region whose lives had been irrevocably changed on contracting the disease.

Yusuf Kabba is the president of the Sierra Leone Association of Ebola Survivors. He

watched five members of his family die from the disease before he too felt the tell-tale fever and chills. The ambulance—which felt like his hearse—took him to a makeshift assessment centre. There were armed guards and the health staff were sealed inside personal protective equipment. None of them would meet his eye. For hours he lay in the heat, awaiting his diagnosis. Around him, terrified people were crying out for water. Amazingly, he pulled through. But on leaving the centre he could not return to his village; he would be shunned. He returned to the Ebola treatment centre as a volunteer. Drawing on bitter personal experience, he started to help others who were sick and terrified.

Weighed against the scale of global human need, Yusuf’s is one small story. But as our report makes clear, small stories can be rich. Naively, I had assumed that at the centre of

Coronavirus: knowledge is the antidote to fearIntellectual and economic value must not flow back to the West. This neo-colonial ghost has to be laid to rest

BMJ OPINION Julian Sheather

PERSONAL VIEW Dawn P Richards

Don’t call my experience a “patient story”The phrase when used in healthcare research can devalue a person’s reality, as if it were not evidence based


changing. These experiences deserve to inform systems and system change, and be learnt from rather than being viewed as static “one time only events.” Let’s represent that better in the terms we use when we engage patients.

Goodbye, “patient story”; I’ll be using “patient experience” and “patient perspective” from now on, ensuring that I introduce these terms to others and, when I work with patients, being certain that their whole perspectives are seen, heard, and, most importantly, appreciated.Dawn P Richards, founder , Five02 Labs [email protected] this as: BMJ 2020;368:m414

our project would be the tension between the urgency of a global health emergency and the time consuming strictures of ethical research. Yes, it’s in the mix, but overwhelmingly the messages we heard were about global justice, fairness, and respect. Response cannot be something done to a community; it must be cooperative. Value—intellectual, economic—must not flow out of affected communities and back to the West. This neo-colonial ghost has to be laid to rest. Expecting people to volunteer as research participants where their basic needs are not met is a moral outrage.

The outbreak of a serious infectious disease is not just a biomedical event. It affects people and communities. It provokes passions. It drives people apart; it brings strangers together. It is a human event. And for me the overriding message is that responders who ignore these dimensions of a global health emergency imperil their response.Julian Sheather, ethics manager, BMA

The effect is to leave patients with exposed flesh and a feeling of extreme vulnerability

BMJ OPINION Julian Sheather

ACUTE PERSPECTIVE David Oliver

There’s no dignity in hospital gowns

I’ve often wondered why we put so many patients into gowns within minutes of their arrival at hospital. Sometimes referred to as “dignity gowns,” such dignity as they afford is

only in comparison to being stark naked. They don’t come in a wide range of sizes,

and they’re open along the back. The effect is to leave patients with exposed flesh, with underwear or buttocks intermittently displayed and a feeling of extreme vulnerability, not to mention being cold if they have no other layers to wear.

We should bear in mind that patients in hospital—even those attending for planned investigations or procedures—are often anxious and in an unfamiliar, depersonalising environment. Such fear is multiplied in emergency admissions or for those with dementia, delirium, or sensory impairment. Such patients are also often in public areas with many other patients and visitors of both sexes, and they may have to walk to toilets or get on a trolley or chair to be wheeled down corridors.

There are legitimate reasons for gown use—for example, in critical care or surgery or for some procedures, where easy access to the whole body is vital. But that’s not the case for most patients for most of their stay. Yet still we use gowns or we keep people in them well beyond that immediate need.

In 2010 the fashion designer Ben de Lisi worked with the Design Council to develop a better design, with side fastenings. But it was not introduced throughout the NHS. More recently, units at some trusts (for example, the radiology department at Leicester teaching hospitals) have used gowns designed for more dignity and comfort. But walk into many places

around the country, and you’ll still see the “old draughty” in widespread use.

If you’ve ever been on a tour of a historical prison you’ll have seen descriptions of the arrival process—people being forced into standard prison clothing, symbolising the transition from citizen to inmate. Surely, we shouldn’t be turning people so symbolically into institutionalised patients. Even if it’s just hospital issue pyjamas, we surely want patients recovering from acute illness or surgery to spend more time in day clothes and shoes to help them regain their independence, as emphasised in the “End PJ Paralysis” campaign.

Last year the Lancet published a paper on the impact of wearing gowns, surveying 928 adult patients. More than half (58%) reported wearing the gown despite feeling uncertain that it was a medical necessity. Gown design was considered inadequate, with 61% reporting they struggled to put it on or required assistance and 67% reporting that it didn’t fit. Most worryingly, 72% felt exposed, 60% felt self-conscious, and 57% felt uncomfortable wearing one.

Perhaps a starting point would be to use the gowns only in those immediate contexts where they’re required and, even then, to encourage people to wear a dressing gown over them or pyjama bottoms under them. Wherever possible, let’s encourage people to be in their day clothes or their own nightwear. And yes, a better gown design

would help. Most of all, we should be asking why people are wearing them

at all.David Oliver, consultant in geriatrics and acute general medicine, Berkshire [email protected] Twitter @mancunianmedicCite this as: BMJ 2020;368:m413

We would be better to recognise that patients’ experiences and lives are dynamic and changing all the time


This week I took a turn at our front desk while the reception team had a long overdue meeting. I wasn’t very good at it, and at the

end of my short shift I had to leave a list of things I’d not been able to sort out. My main learning was the extent of my ignorance about the practical complexities of being a GP receptionist. One of my colleagues asked whether it was good use of a doctor’s time, which was a fair question, so I’ve been thinking about why the answer is probably yes.

We ask our medical students to spend a session at the front desk during their attachment with us, but many doctors have done nothing similar since qualifying. When primary care is overstretched and the receptionist is the frequent bearer of bad news, in the shape of another visit request or urgent task when you’re already drowning in work, it’s easy for relationships to deteriorate. “Why can’t X just do Y?” is often our complaint—where X is a group of staff and Y is a seemingly simple task that would make our life much easier.

One way of approaching this is simply to ask that question, in the spirit of genuine inquiry rather than an accusatory tone. Another is to sit at reception for a bit and see the reality of the job, which may stop you asking daft questions. You might even end up contributing useful suggestions to help the efficiency of your practice.

My stint at the desk was also time well spent as a concrete (albeit small) expression of how highly we value our reception team and trust them to come up with ideas. We won’t necessarily do it the same way for their next meeting—we may borrow a receptionist from a neighbouring practice (who will certainly do a better job than I did)—but we have established that it’s important for them to get together as a team.

Adopting another’s perspective can be useful in many spheres: at a recent mock exam the “patient” was played by a junior student who sat in the patient’s chair and was quizzed by a succession of senior students. He was grateful for the experience, which he said taught him a lot about how it feels to be a patient and how to listen and ask questions when taking a medical history.

The growing literary genre of “autopathography,” described by Aronson in 2000, includes doctors reflecting on the insights into their profession gained from becoming patients and sitting in the other seat. Without being ill ourselves, most of us could improve our clinical practice by reading about these experiences or by viewing patients’ accounts online—for example, on healthtalk.org. We may also become better colleagues and managers

by occasionally swapping seats with the people we work with.

Helen Salisbury, GP, Oxford [email protected]

Twitter @HelenRSalisburyCite this as: BMJ 2020;368:m330

Listen and subscribe to The BMJ podcast on Apple Podcasts, Spotify, and other major podcast apps

Edited by Kelly Brendel, deputy digital content editor, The BMJ

Precocious pubertyPrecocious puberty—that is, starting before the age of 8 in girls and 9 in boys—seems to be on the rise. As Stephen Bradley, a GP, and Neil Lawrence, a paediatric trainee, explain in this podcast, while precocious puberty in girls is commonly idiopathic, in boys it is more likely to be a red flag for pathology. They discuss how GPs should respond to these cases, with Bradley outlining how this should be a patient centred process with families, particularly with idiopathic cases:

“The core conundrum in idiopathic precocious puberty is usually whether treatment is warranted. One of the most important things I’ve learnt is that one can’t assume that the treatment will be beneficial. So it’s really vital to explore with the patients—the children themselves and their parents—what they want to get out of treatment and what treatment can do for them.”

QI and improvement are not synonymsMary Dixon-Woods, director of the THIS Institute, recently wrote an essay for The BMJ in which she argued that "quality improvement" isn’t necessarily the best way to improve healthcare. In this podcast she joins us to elaborate on her points and to argue why just focusing on quality improvement in healthcare can limit people’s perspective:

“QI you can view as being this well defined set of techniques that you can be taught how to do, but not everything that you want to improve is tractable to QI. An example could be something as simple as looking after your staff better. I wouldn't call knowing people’s names a QI technique, but we know that it actually makes a huge difference to people’s experiences at work, as does making sure you greet people in the morning. All these things are improvement efforts, but they’re not QI."

PRIMARY COLOUR Helen Salisbury

Sitting in someone else’s chairLATEST PODCASTS

Adopting another’s perspective can be useful in many spheres


Safety concerns

The phase III randomised controlled trials recruited children in two age groups (6-12 weeks and 5-17 months). Vaccine efficacy was highest (36%) in the cohort of 5-17 month olds who received a booster dose, so the 5-17 month age group with a booster dose was selected for the pilot study.

The final phase III report, however, noted that, in the 5-17 month age group, significantly more children who received the malaria vaccine had meningitis than those in the control group (who received the rabies vaccine): 21 of 5948 in the RTS,S groups (with and without booster), and 1 of 2974 in the control group.5 The difference was observed both before the time of the booster vaccine (16 of 5948 versus 1 of 2974, relative risk (RR) 8.0, 95% confidence interval 1.1 to 60.3) and after the time of the booster vaccine (5 of 5400 versus 0 of 2702).

Subsequent analyses of the 5-17 month population found that the RTS,S groups also had more cases of cerebral malaria: 43 of 5948 cases compared with 10 of 2974 cases among controls (RR 2.15 (1.08 to 4.27)).11 This calculation was based on a clinical algorithm. A later review by two independent external experts reduced the total number of possible cerebral malaria cases from 53 to 37,12 resulting in a new RR estimate of 0.93 (0.37 to 2.32) in the first 20 months of follow-up and 3.75 (0.86 to 16.39) after the booster dose.12

The published data also showed a trend towards a higher rate of death among patients hospitalised with severe malaria in those who received the vaccine (21 of 648) than in controls (6 of 388) (RR 2.10 (0.85 to 5.15)).5 13

Finally, we analysed the data released by GlaxoSmithKline14 and found that female children who received the vaccine had significantly higher all cause mortality than controls in both age groups, the RR being 2.00 (1.18 to 3.39) in the 5-17 month age group, which is the focus of the pilot implementation study.15 In its position paper, WHO emphasised that mortality was similar for male and female children in the control

KEY MESSAGES

• Phase III trials of the RTS,S malaria vaccine identified higher risks of meningitis and cerebral malaria and doubled female mortality

• These safety concerns are now being investigated in pilot implementation studies with 720 000 participating children in Ghana, Kenya, and Malawi, planned to last 4-5 years

• WHO intends to decide on extending the vaccine to other African countries after only 24 months using the prevention of “severe malaria” as a surrogate marker for overall mortality

• Severe malaria is not a good marker for all cause mortality• An early decision after 24 months might be biased in favour of the vaccine

based on data from the phase III trials

ANALYSIS

Malaria vaccine in Africa: can safety be guaranteed after only 24 months? WHO will decide whether to roll out the malaria vaccine in Africa after only 24 months of the pilot study. Peter Aaby and colleagues voice concerns about making a premature decision

World malaria day on 23 April 2019 saw the start of the first routine malaria vaccine programme in Africa—a pilot study in Malawi. Ghana and Kenya have now followed. The RTS,S/AS01 malaria vaccine has been under development by GlaxoSmithKline for 30 years and is the first malaria vaccine to

receive regulatory approval for human use. The pilot study aims to enrol 720 000 children in vaccination and control clusters over a two year period; it is planned to last about 50 months.

Media and leading medical journals have celebrated the news,1‑4 emphasising the potential to dramatically reduce child mortality. In the words of Tedros Adhanom Ghebreyesus, director general of the World Health Organization, “It has the potential to save tens of thousands of children’s lives.”1 3

Why then are pilot studies needed before rolling out the vaccine for all children? One reason is that achieving an efficacy of 36% in the phase III trials required a booster dose at 20 months after the primary series of three doses given at 5‑17 months of age.5 Giving a booster dose after 2 years of age is a challenge because the current vaccination programme is focused on vaccine delivery in infancy, so the pilot study is partly to examine whether boosters are logistically feasible. Furthermore, the European Medicines Agency (EMA) requested the pilot study to confirm or refute important safety concerns around meningitis, cerebral malaria, and sex specific, all cause mortality identified in the phase III trials.6 7

WHO advisory bodies and the EMA have said that these safety concerns might have arisen by chance. But we should be particularly careful about introducing new vaccines amid unresolved safety concerns, especially given recent use of a dengue vaccine in the Philippines that led to increased morbidity and mortality from dengue8 9 as well as a resurgence of measles and polio secondary to a fall in public confidence in vaccination programmes.10 Making a premature decision on a malaria vaccine that is ultimately found to have detrimental effects would be disastrous for the credibility of vaccination programmes (and all types of vaccines).

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and vaccine arms.11 But female recipients of the vaccine in the 5-17 month age group had 33% (2% to 74%) significantly higher mortality than the male recipients.15 Notably, the excess mortality among recipients of the vaccine increased after the booster dose (table 1). This trend was particularly marked for female children (RR 3.40 (1.01 to 11.42)) after the booster dose (table 1).

WHO and GlaxoSmithKline have interpreted this sex difference in mortality as a possible chance finding or due to unnatural low mortality in the female control group.11 16 But the statistical likelihood that particularly low mortality among female controls would have happened in both age groups must be slim.15 Some researchers have proposed that the higher mortality in vaccinated female children was due to the rabies vaccine having beneficial non-specific effects leading to unnaturally low mortality in the female 5-17 month control group.16 17 But this would not explain the higher mortality among female recipients of the malaria vaccine in the 6-12 week age group (table 1), in which the controls received meningococcal serogroup C conjugate vaccine.5

Table 1 | Mortality risk ratios for RTS,S recipients and controls by sex and length of follow-up. Data from 11 sites in seven countries in Africa.14

Period of follow-up by sex and age group

% deaths (deaths/n)RTS,S vaccinated (with and without booster) Controls

Risk ratio (RTS,S/controls) (95% CI)

Male, 0-20 months: 5-17 months 0.9% (27/2981) 1.3% (19/1471) 0.70 (0.39 to 1.26) 6-12 weeks 1.8% (40/2234) 1.9% (21/1079) 0.92 (0.55 to 1.55) All 0.82 (0.55 to 1.20)*Male, 21 months to study end: 5-17 months 0.6% (18/2954) 0.7% (10/1452) 0.88 (0.41 to 1.91) 6-12 weeks 0.5% (10/2194) 0.5% (5/1058) 0.96 (0.33 to 2.81) All 0.91 (0.49 to 1.70)*Female, 0-20 months: 5-17 months 1.6% (47/2967) 0.9% (14/1503) 1.70 (0.94 to 3.08) 6-12 weeks 2.1% (44/2124) 1.2% (13/1100) 1.75 (0.95 to 3.24) All 1.73 (1.13 to 2.64)*Female, 21 months to study end: 5-17 months 0.7% (20/2920) 0.2% (3/1489) 3.40 (1.01 to 11.42) 6-12 weeks 0.6% (12/2080) 0.3% (3/1087) 2.09 (0.59 to 7.39) All 2.75 (1.15 to 6.57)*All, 0-20 months: 5-17 months 1.2% (74/5948) 1.1% (33/2974) 1.12 (0.75 to 1.69) 6-12 weeks 1.9% (84/4358) 1.6% (34/2179) 1.24 (0.83 to 1.83) All 1.18 (0.89 to 1.57)*All, 21 months to study end: 5-17 months 0.6% (38/5874) 0.4% (13/2941) 1.46 (0.78 to 2.74) 6-12 weeks 0.5% (22/4274) 0.4% (8/2145) 1.38 (0.62 to 3.09) All 1.43 (0.87 to 2.35)**All estimate was calculated as the meta estimate of those for the individual age groups using Stata’s “meta” command. GlaxoSmithKline data reported events for the first 20 months until the time of booster vaccination and for the full study period. The number of enrolled children in the period after the booster dose (21 months to study end) was calculated by subtracting the number of deaths in the first 20 months from the total events. The control group received three comparator vaccines at the start and then a comparator vaccine for the booster dose.

Other non-live vaccines and increased female mortality

Other vaccines have been associated with increased female mortality. In 1989, WHO recommended the high titre measles vaccine (HTMV) in areas with a high risk of measles infection. However, five randomised controlled trials subsequently showed that HTMV was associated with doubled female mortality.18 19 WHO withdrew HTMV in 1992. Subsequent analyses showed that the increased female mortality was most likely due to the non-live diphtheria, tetanus, and pertussis (DTP) vaccine being given after HTMV.18 Receiving DTP has consistently been associated with higher female mortality, including when given after a measles containing vaccine.20 21 We have subsequently shown that other non-live vaccines—including the hepatitis B vaccine,22 inactivated polio vaccine,23 pentavalent vaccine,24 and H1N1 influenza vaccine25—are also associated with higher female mortality. As a non-live vaccine, RTS,S fits this pattern, reducing the likelihood that the higher female mortality is a chance finding.

We don’t know of any biological explanation for non-live vaccines being associated with female mortality, but two recent immunological studies showed that the influenza vaccine and non-live vaccines containing DTP were associated with immunological tolerance towards stimulation with unrelated pathogens.26 27

Malaria vaccine pilot study

Given the safety concerns for meningitis, cerebral malaria, and female mortality, the EMA’s risk management plan said that the vaccine should be evaluated for these potential risks, 6 and WHO’s Strategic Advisory Group of Experts on immunisation (SAGE) recommended that this evaluation be carried out in large enough numbers to detect a possible sex difference in mortality and to provide evidence of a beneficial effect of the vaccine on overall mortality.11 The pilot study was funded by Gavi, the Vaccine Alliance, the Global Fund to Fight AIDS, Tuberculosis, and Malaria, Path, and

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Unitaid, and is sponsored by WHO and the national ministries of health in the three participating countries.

In their April 2019 meetings, SAGE and the WHO Malaria Policy Advisory Committee (MPAC) approved a framework for policy on RTS,S.28 The study protocol has not been made available, but the framework says that different districts in each country will be randomly allocated to receive malaria vaccine or no malaria vaccine (no placebo or control vaccine is being used).28 To assess the risk of meningitis and cerebral malaria, between four and eight sentinel hospitals in each country will conduct inpatient surveillance. The plan is to capture information on deaths by means of “resident village reporters” and to supplement this information with adverse events data reported by the routine pharmacovigilance systems.28

The pilot study is expected to last about 50 months to be able to provide the mortality data. But SAGE and MPAC plan to make a decision about the broader use of RTS,S after only 24 months, for two reasons. First, given increasing drug resistance, further control measures against malaria are urgently needed. Second, GlaxoSmithKline might have problems maintaining the production line if the decision is delayed.28

Thus, at the meeting in April, SAGE and MPAC agreed that a recommendation could be made in the absence of mortality data.28 29 They consider the vaccine’s effect on severe malaria to be an acceptable surrogate indicator for mortality.29

A registration of a smaller study to evaluate the feasibility, safety, and impact of the introduction of RTS,S in pilot programmes in Ghana, Kenya, and Malawi based on 15 800 households was registered in March 2019 (NCT03806465). In January 2020 the registration was updated to specify that with 120 000 participants enrolled at each site each year, the pilot study will have “80% power to detect, at the 5% significance level, a decrease of at least 10% in overall mortality in each country” and “an increased risk of mortality in girls of 1.035, compared with the 1.9-fold increase in risk among girls receiving RTS,S/AS01 in the RTS,S phase III trial.” Written informed consent is not obtained. What participants are told about the outstanding safety concerns is unclear.

Table 2 | Female:male mortality ratios for RTS,S recipients and controls

Period of follow-up

Female:male mortality ratio (95% CI)Ratio of F/M mortality for RTS,S v controls (95% CI)

RTS,S vaccinated (with and without booster RTS,S) Controls

0-20 months: 5-17 months 1.75 (1.09 to 2.80) 0.72 (0.36 to 1.43) 2.43 (1.05 to 6.61) 6-12 weeks 1.16 (0.76 to 1.79) 0.61 (0.31 to 1.21) 1.90 (0.85 to 4.25) All 2.14 (1.20 to 3.82)*21 months to study end: 5-17 months 1.12 (0.60 to 2.12) 0.29 (0.08 to 1.06) 3.86 (0.92 to 16.3) 6-12 weeks 1.27 (0.55 to 2.92) 0.58 (0.14 to 2.43) 2.19 (0.42 to 11.44) All 3.02 (1.02 to 8.94)**All estimate was calculated as the meta estimate of those for the individual age groups using Stata’s “meta” command. GlaxoSmithKline data reported events for the first 20 months until the time of booster vaccination and for the full study period. The number of enrolled children in the period after the booster dose (21 months to study end) was calculated by subtracting the number of deaths in the first 20 months from the total events. The control group received three comparator vaccines at the start and then a comparator vaccine for the booster dose.

We should be particularly careful about introducing new vaccines amid unresolved safety concerns

Concerns

The decision to use severe malaria as a surrogate marker for all cause mortality seems strange. The case fatality for severe malaria for RTS,S recipients was double that for controls in phase III trials,13 and malaria deaths accounted for only 20-25% of all deaths in the previous trials.15 Hence, even though RTS,S might slightly reduce the risk of severe malaria, recipients might be at higher risk of dying (from malaria and overall).15 Each pilot study country is estimated to have around 2040 deaths before 24 months of follow-up (240 000 children recruited over two years with an average follow-up of one year per person with a mortality rate of 8.5 per 1000 person years), so there should be no need for a surrogate marker. The mortality data collected from village reporters and through the routine pharmacovigilance system, however, might not be complete—both types of data collection might have major quality problems.30 31

Importantly, the decision to make a recommendation about the wider scale use of RTS,S after just 24 months might bias the decision in favour of the malaria vaccine.

Firstly, at the 24 month mark of a study in which participants were recruited over two years 75% of the follow-up time will be in the first year after the enrolment, where the vaccine efficacy against clinical malaria was 50.4% in the phase III trials.32 Subsequently, vaccine efficacy fell dramatically.32

Secondly, an assessment after just two years will include virtually no observation time after the booster dose of RTS,S given 20 months after first dose. This is problematic because cerebral malaria12 and the excess in female mortality compared with controls seemed to increase after the booster dose (table 1, table 2). This might be related to the booster dose of the non-live malaria vaccine being given after the measles vaccine; other non-live vaccines have been associated with

negative effects when given after measles vaccine.33-37

Finally, the pilot study is designed to have 90% power to rule out the possibility that the female-male mortality ratio is 20% higher among malaria vaccine recipients than in controls. Because the effectiveness of malaria vaccination declines over time5 38 and malaria infection might lead to higher case fatality in those who receive the vaccine, the excess mortality might become apparent only after longer follow-up, particularly for females (tables 1 and 2).

Conclusion

The idea that the malaria vaccine “will go global in two years’ time” has already been sold to the public.39 With its very large sample size, the pilot study could conceivably confirm some of the safety concerns in the first 24 months. If there is a substantial difference in the female-male mortality ratio between malaria vaccine recipients and controls, for example, the pilot study will presumably be stopped by the Data Safety and Monitoring Board.

But if no serious safety signal is found in the first 24 months, the pilot study should run for the full follow-up time to properly assess the three safety concerns before any decisions are made about broader use of RTS,S in Africa. There is no room for wishful thinking. Decision making must be grounded in robust evidence.Peter Aaby, professor [email protected] Ane B Fisker, associate professor, Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-BissauAnders Björkman, professor, Department of Microbiology, Tumour and Cell Biology, Karolinska Institutet, Stockholm, SwedenChristine Stabell Benn, professor, Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-BissauCite this as: BMJ 2020;368:l6920 A

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LETTERS Selected from rapid responses on bmj.com LETTER OF THE WEEK

We need to improve postnatal careJakes and colleagues’ paper on the maternal six week postnatal check is timely but anachronistic (10 Minute Consultation, 14 December). Although not stated, this is aimed at GPs. A letter to the Guardian from four royal colleges and the Better for Women report from the Royal College of Obstetricians and Gynaecologists also emphasise the need to improve care at this check. This is against a background of lack of investment and fragmentation of postnatal care.

A maternal postnatal check is not currently included in the NHS GP contract, which defines the “postnatal period” as lasting until only day 14. This aspect of the contract is being re-negotiated currently, but we do not know the outcome.

In 2017 the Royal College of General Practitioners agreed a position statement saying that GPs were now unskilled for their role in maternity care. NHS England does not consider GPs to be part of either maternity or mental health workforces, although they clearly provide care to women after birth. Health Education England does not fund GP education beyond core training.

Health visitors are involved in postnatal care after discharge from midwifery care at 10-12 days. They are now employed in cash strapped local authority services, often unable to meet their mandated roles.

In 2014 one of us (JS) co-wrote a chapter on post-pregnancy care for the chief medical officer’s annual review, concluding that postnatal care was “not fit for purpose.” Since then, care has been further fragmented; only the service available for women with severe mental illness has improved.

A group of senior interested parties met recently to debate why postnatal care is such a low priority for NHS England. We plan to lobby for better postnatal care. Funding and training for the maternal six week check, as described in this paper, would be a start.Judy Shakespeare, retired GP, Oxford; Cheryll Adams, executive director, Institute of Health Visiting; Stephanie deGiorgio, portfolio GP, Dover; Elizabeth Duff, senior policy adviser, NCT;Sarah Hillman, academic clinical fellow, Coventry;Judith Stephenson, professor, LondonCite this as: BMJ 2020;368:m252

SIX WEEK POSTNATAL CHECK

Postnatal anxiety needs attentionThe maternal six week postnatal check is an important and integral part of primary care, giving GPs the opportunity to make a huge difference to new mothers and their children (10 Minute Consultation, 14 December).

We were disappointed that the article mentioned anxiety only in the context of sleep. Perinatal anxiety might affect 22% of women—higher than the 14% often quoted for perinatal depression. Our work indicates that awareness and understanding of perinatal anxiety among healthcare professionals is limited, with care being fragmented and interprofessional communication poor.

An article discussing what to cover in the maternal six week health check should have emphasised the important role of the GP in identifying postnatal mental health problems and the particular need to identify and manage postnatal anxiety.Victoria Silverwood, academic GP; Carolyn Chew-Graham, professor of general practice research; Tom Kingstone, research associate, mental health, KeeleCite this as: BMJ 2020;368:m256

SELECTIVE NSAID DANGERS

COX-2 inhibitors are safe and effective

I am disappointed The BMJ published a poorly referenced letter on the dangers of selective NSAID prescribing in the Quality and Outcomes Framework (Letters, 7 December). Guidance advocating prescription of selective COX-2 inhibitors for patients at high risk of gastrointestinal complications is correct and evidence based.

COX-2 inhibitors were initially affected by pharmaceutical hype and opaque reporting of clinical trial results. But they are clearly much safer than non-selective NSAIDs for the gastrointestinal tract, including when combined with aspirin in those at highest risk of gastrointestinal and cardiovascular adverse effects. There is no convincing evidence that cardiovascular risk is higher with COX-2 inhibitors; the risks of stroke might actually be lower.

Continuing to use other non-selective NSAIDs in those with a high risk of gastrointestinal complications will expose patients to avoidable risk. The BMJ has an important role in stimulating debate, but such debates must always be fully informed.Ian L P Beales, consultant gastroenterologist, NorwichCite this as: BMJ 2020;368:m311

RESULTS TO PARTICIPANTS

Sharing research findings with participantsI support Taylor’s call for research findings to be shared with the patients who took part (Editorial, 30 November). Patients have told me that they won’t participate in another study because the findings of the last one were not shared with them or they were never thanked for their time. These are small asks for maintaining, and perhaps growing, patient and public confidence in research.

In 2014, the Health Research Authority published guidance on setting study participants’ expectations about what would happen at the end of the study and inform them of how and when they might access a summary of the study findings. It applies to all clinical trials and other interventional and diagnostic studies. The guidance was initially mandatory except for phase I trials. But after a judicial review, the wording was changed in 2015 to make it good practice.Amanda J Hunn freelance research consultant, SheffieldCite this as: BMJ 2020;368:m1


False assertions lead to false beliefs

The Ponseti method for clubfoot management is an example of many things: the advantages of immigration, the spread of good ideas through the internet, the benefits of simple treatments. But not reverse innovation (Editor’s Choice and Analysis, 23 November). The method was developed and used in the US and then introduced to the developing world by surgeons, who either visited or chose to practise in other parts of the world.

The distinction is important because false assertion, particularly when reiterated, is the germ for the development of false ideas and beliefs, such as the antivaccination movement. Perhaps studying how the Ponseti method spread in the US and Europe would be better, as it is an example of the strategies recommended by Perera and colleagues in their essay on resisting antivaccination campaigners. Families on the

east coast of the US found and promoted Ponseti’s method largely through self-supporting groups and the internet. James B Hunter, paediatric orthopaedic surgeon, NottinghamCite this as: BMJ 2020;368:m33

Authors’ replyHunter questions whether the Ponseti technique can be described as a low income country innovation. We agree, the Ponseti technique could be called a “spillback innovation” or a “developing country spillover innovation,” but both are types of reverse innovation.

Codifying the spread of some innovations is a challenge. How do you ascertain where an idea first begins? Ponseti didn’t invent plaster of Paris, but he did find a new application for it. This is clearly more than a semantic issue because calling innovations, such as the Ponseti technique, reverse innovation elicits such strong reactions.

Hunter draws parallels between attributing the Ponseti technique

to low income countries and “false ideas and beliefs such as the antivaccination movement.” This implies that acknowledging the ingenuity and innovation of low income countries is a dangerous myth that can put people’s lives at stake. That in itself is a dangerous myth.Matthew Harris, clinical senior lecturer in public health medicine; Mark Skopec, research assistant; Hamdi Issa, doctoral student, LondonCite this as: BMJ 2020;368:m36

Avoiding cultural appropriation

Skopec and colleagues' essay on reverse innovation could herald an age of increased cultural humility for the global north and assist with dissipating prejudices towards innovations from the global south. Bringing in new ideas from “outside” requires disrupting entrenched power and value systems around knowledge. This is essential to the process of decolonising medicines and devices.

Linguistic interaction—the words and terms we use—convey and reproduce social, cultural, and political structures. By labelling innovation as reverse, or indeed other incentives like “reverse” mentoring, we might be reinstating the power dynamic we are seeking to undo. Could there be a new term for this type of collaboration? We must avoid the pitfalls of cultural appropriation—whereby aspects of an oppressed culture are taken out of context by a historically dominant people, who lack the cultural context to properly understand, respect, or use these elements.Amali U Lokugamage, consultant obstetrician and gynaecologist; Christine Douglass, independent researcher; Faye Gishen, consultant physician;Molly V Fyfe, senior teaching fellow, London

Cite this as: BMJ 2019;367:l7003

Improving doctor-patient communication

Maskrey asks why progress in shared decision making has been slow (Essay, 7 December). Communication skills training is delivered as prescriptions, without basic teaching of personal dynamics in asymmetric talks. This is like teaching how to prescribe drugs without teaching pharmacology.

Decision aids for shared decision making present risks and benefits framed in numbers. The personal experience and knowledge of doctors are not included. If doctors do not provide shared decision making with familiarity and ease patient trust might be undermined.

The benevolent power of doctors silences patients, even when they are dissatisfied. In Norway, we have started to use the personal vulnerability of young doctors under supervision to gain insight into the effects of power in asymmetric dialogues.

When teaching how to supervise, we adapt principles of doctor-patient communication to the consultant-registrar dyad. We hope that this will lead to proficient communication of shared decision making permeating our healthcare system.Pål Gulbrandsen, professor, Nordbyhagen Cite this as: BMJ 2020;368:m97

Doctors have expertise that patients wantThe problem with shared decision making is that it has always been about ideology rather than evidence.

The shared decision making movement fails to acknowledge that patients consult doctors because they have problems they cannot solve on their own. This is not deference but a fundamental property of the division of labour. Doctors have expertise that patients want or need.

It might be good practice to not impose a solution or to withhold information that skews a patient’s ability to make an informed choice, but it is equally paternalistic to not make clear where expert knowledge leads to, if patients are seeking that knowledge. When doctors decline to act as experts, patients are reduced to interactional strategies that try to divine clues from gnomic utterances.

Is shared decision making merely a style of evangelism that is ultimately—if unintentionally—unhelpful to those it claims to serve?Robert Dingwall, consulting sociologist and professor of sociology; Alison Pilnick professor of language, medicine, and society, Nottingham Cite this as: BMJ 2020;368:m128

REVERSE INNOVATION

SHARED DECISION MAKING


OBITUARIES

Ghulam Jeelani Drabu General practitioner Salford (b 1926; q King Edward Medical College, Lahore, Pakistan, 1948), died from cardiac failure on 5 November 2019 Ghulam Jeelani Drabu was born in Kashmir, India, and studied medicine in Lahore. He witnessed the partition of the Indian subcontinent and as a result was not able to return home for 18 years. During the partition he worked in refugee camps and felt deeply sad about the human suffering brought about by this political upheaval. In 1957 he won a scholarship to pursue postgraduate studies in England. His wife and children joined him in 1959. He eventually settled in Manchester and worked as a general practitioner in Salford from 1965 until his retirement in the mid-1990s. During his life he was actively engaged in community and charitable work and bringing people together. Ghulam Jeelani Drabu leaves his wife, Ayesha, and four children (three doctors and a dentist). Khalid J Drabu, Tariq J Drabu, Yasmin J Drabu Reefat K Drabu Cite this as: BMJ 2020;368:m86

John Edgar Dalby Consultant radiotherapist Clatterbridge Cancer Centre (b 1926; q Trinity Hall, Cambridge, 1946; MA, FRCR), died after a short illness on 13 November 2019 John Edgar Dalby trained in radiotherapy at the Christie Hospital in Manchester, where he learnt many brachytherapy techniques and co-wrote a pivotal paper on the management of anal carcinoma. In 1962 he was appointed as a consultant radiotherapist at the regional cancer centre at Clatterbridge Hospital, where he spent the rest of his career, retiring in 1988. He also held weekly clinics in Southport and the Royal Liverpool University Hospital. He contributed to the management of head and neck cancers with brachytherapy for many patients who were not suitable for surgery. Outside medicine he was a keen golfer, traveller, and gardener, with a love of classical music, history, architecture, food, and wine. John leaves his wife, Muriel (also a doctor), and three sons. Arthur Sun Myint , Jonathan Dalby , Simon Dalby Cite this as: BMJ 2020;368:m89

Frank Green Ophthalmic surgeon (b 1950; q Glasgow 1974; MRCP, FRCS, FRCOphth), died from colon cancer on 9 October 2019 Frank Green was a consultant in the ophthalmology department at Aberdeen Royal Infirmary from 1984 to 2011. His contribution to the reorganisation and rejuvenation of an ailing ophthalmology service at that time was central to its growth and development . For much of his life he devoted his skills to humanitarian work. In 1990 the Christian Medical Fellowship was seeking an ophthalmologist to provide eye care for Karen refugees in Myanmar. Frank, with his team, set about developing a primary eye care facility. They visited Thailand several times a year and taught the local medics new skills. Throughout his time in Thailand and Myanmar, Frank performed over 20 000 operations. Having been diagnosed with leukaemia in 2010, he was diagnosed with metastatic colon cancer in April 2018. He leaves his wife, Ruth, and five children. Allan Green, J Forrester, P Ambler Cite this as: BMJ 2020;368:m95

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

W B Stewart General practitioner Nairn, Scotland (b 1932; q Glasgow 1958), died from old age on 8 October 2019 W B Stewart (“Bryce”) was born on a tea plantation in Assam in the days of the British Empire. His upbringing was disrupted by the second world war. An only child, he was sent first to Scotland and then to America to be cared for by relatives and returned to Scotland only when the war ended. After qualifying Bryce joined as a GP partner to form the Lodgehill Clinic practice in Nairn and in 1963 build the first custom built health centre in the Highlands. He enjoyed being a trainer and loved the variety of work and was committed to the holistic plan for a new Nairn community hospital and integrated health centre. He was a Rotarian, director of the Hydrotherapy Trust, and a church elder. He leaves his wife, Mhari, and three children. Alastair Noble Cite this as: BMJ 2020;368:m87

Frances Mary Halle General practitioner (b 1921; q Sheffield 1946), died from Parkinson’s disease and frailty of old age on 9 December 2019 Frances Mary Halle attended Girton College, Cambridge, for preclinical studies before moving to Sheffield University to complete her medical degree. In July 1948, days before the inception of the NHS, she started to work with her husband, Hugh Max Halle, as partners in general practice on the Manor Estate in Sheffield. They ran the practice together for 39 years. Frances also served as a Justice of the Peace in Sheffield from 1966 until 1991. After retiring at the age of 64, she spent the following decade as an area visitor for the Royal Medical Benevolent Fund. She developed bilateral macular degeneration but remained active into her late 80s, enjoying walking in the Lake District. Predeceased by her husband of 72 years, Frances leaves three children, seven grandchildren, and eight great grandchildren. Caroline Halle Cite this as: BMJ 2020;368:m85

Joseph M Kelly Consultant orthopaedic surgeon (b 1938; q 1963; FRCSI, MCh Orth Liverpool), died from subdural haematoma on 28 May 2019 As a medical student at the Royal College of Surgeons of Ireland, Joseph M Kelly (“Joe”) was awarded the Lyons memorial medal in surgery and medicine and the Fitzsimmons medal in surgery. He was also a member of the RCSI’s rugby team. He obtained his masters degree (orthopaedics) from the University of Liverpool while working at Clatterbridge Hospital. He returned to Ireland in 1973 and worked at Navan Hospital, County Meath. He was appointed consultant orthopaedic surgeon in Merlin Park Hospital, Galway, in 1975 and lecturer in orthopaedics in University College Galway. He had many interests including art, history, archaeology, genealogy, and the Irish language. He was a keen golfer and spent many happy years sailing up the west coast. He leaves his wife, Angela; children; and grandchildren. Tomás Kelly Cite this as: BMJ 2020;368:m93


In 1956 medical student Jonathan Miller was invited to direct the University College Hospital Christmas show. He rose to the challenge: his 12 Days of Christmas brought the house down. A gifted mimic with a piercing intellect, Miller said he was helped by learning in medicine to study small details in people’s body language.

Miller used to say much of his career was the result of “yielding to unsolicited invitations,” or, as his family put it, “he couldn’t resist being asked to come out and play.” In 1960, while a house surgeon at University College Hospital, he was asked to take part in “Beyond the

Fringe” with Alan Bennett, Peter Cook, and Dudley Moore, and had to accept.

The revue was a huge success, igniting the satire boom. It ran for three years, transferring from Edinburgh to London and then to New York, and marked the start of Miller’s glittering artistic career. He became the artistic director at London’s Old Vic theatre, directed more than 50 operas around the world, presented numerous TV and radio programmes, and wrote 15 books.

He hankered, however, after medicine. Periodically he returned to it and was wistful that he had not become a neuropsychologist. Friends and colleagues, however, said that neuropsychology at that time might not have been able to contain his energy and erudition.

Early lifeMiller was born in London’s St John’s Wood, to a family of cultivated Jewish intellectuals. His mother, Betty (née Spiro), published her first novel at 23, and his father, Emmanuel, was a paediatric psychiatrist. Miller attended St Paul’s School with classmate Oliver Sacks, where they were greatly inspired by the biology teacher Sidney Pask. It was also at school that Miller met Rachel Collet, who was described by a friend as “a wonderful anchor of serenity” in Miller’s frenetic life. She became a GP and married Miller in 1956.

In 1953 Miller won a scholarship to St John’s College, Cambridge, to read natural sciences. A contemporary said that even then Miller stood out, sometimes coming to classes barefoot or engaging the lecturer afterwards in conversation. He received a double first and moved to University College Hospital London, qualifying in medicine in 1959.

Film, theatre, and operaIn 1964 Miller returned from Beyond the Fringe in New York and was offered a job as editor of the BBC arts programme Monitor. When Monitor folded, he directed startlingly imaginative film interpretations of classics, including Alice in Wonderland (1966) and a chilling version of MR James’s Whistle and I’ll Come To You (1968). He directed plays too, first at the Nottingham Playhouse and then at the Old Vic, where in 1970 he directed Laurence Olivier as Shylock in The Merchant of Venice. He went on to join the BBC’s project to televise all of Shakespeare’s plays, directing six of them including The Taming of the Shrew with John Cleese.

Despite not being able to read music, Miller became an acclaimed opera director. He had a 40 year association with the English National Opera, where his creativity and rigorous focus on the composer’s vision led to many

memorable productions, such as Verdi’s Rigoletto, which he set it in 1950s Little Italy, and a version of Gilbert and Sullivan’s Mikado (1986) inspired by the Marx brothers’ film Duck Soup.

Medical research and broadcastingIn 1970-73 Miller was a research fellow in the history of medicine at University College London. He wrote and presented the landmark BBC TV series The Body in Question in 1978 and States of Mind, a series of conversations with eminent psychologists, in 1983. A year later, he studied neuropsychology at McMaster University in Canada, and became a research fellow at the University of Sussex.

He was fascinated with neuropsychology’s collaboration between patient and doctor, and presented the Horizon programme Ivan in 1984, about a man’s daily struggle with Parkinson’s disease. A documentary about an amnesiac musician—Equinox: Prisoner of Consciousness—followed in 1986, and Madness, a five part series on mental illness, in 1991.

Miller was haunted by his mother’s death at 55 from Alzheimer’s disease and helped found the Alzheimer’s Society. He became its president in 1984 and campaigned to raise money and improve awareness of what was still largely a silent epidemic.

Later yearsMiller continued to work into his 70s and in 2004 presented Atheism: A Rough History of Disbelief to counter widespread suspicion of humanism. He received many honours, including a CBE in 1983, and was knighted in 2002.

Diagnosed with Alzheimer’s disease, Miller spent his last years at home in Gloucester Crescent, north London. He leaves his wife, Rachel; three children; and four grandchildren.Penny Warren, London [email protected] this as: BMJ 2019;367:l6980

OBITUARIES

Periodically he returned to medicine and was wistful that he had not become a neuropsychologist

Jonathan MillerTheatre and opera director, broadcaster, communicator, and doctor

Sir Jonathan Wolfe Miller (b 1934; q 1959; CBE, FRCP, FRCPEd), died from Alzheimer’s disease on 27 November 2019

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