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Rapid responses are electronic letters to the editor. They enable our users to debate issues raised in articles published on thebmj.com. Although a selection of rapid responses will be included online and in print as readers' letters, their first appearance online means that they are published articles. If you need the url (web address) of an individual response, perhaps for citation purposes, simply click on the response headline and copy the url from the browser window. Letters are indexed in PubMed.

Re: Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data from Minnesota Coronary Experiment (1968-73) Steven K Broste, Robert P Frantz, John M Davis, Amit Ringel, et al. 353:doi 10.1136/bmj.i1246

While the results of the RCTs clearly show that reducing serum cholesterol does not affect mortality, it is noteworthy that all of the RCTs cited by Ramsden et al. [1] were relatively short term, and many were conducted on middle-aged people, in whom we would expect to see significant atherosclerosis anyway.

In 1996, Uusitalo and coworkers [2] reported an interesting experiment in Mauritius. Because of concerns about the high rate of CHD, the government of Mauritius decided in 1987 to change the composition of the cooking oil produced by the one (government owned) factory in the country, from one based on palm oil (and hence high in saturated fatty acids) to one based on soy bean oil, and therefore high in poly-unsaturated fatty acids. Five years later (1992) there was the expected significant reduction in mean serum cholesterol, but no mention of CHD mortality. The WHO Noncommunicable Disease Country profile for Mauritius in 2014 [3] shows a significant fall in CHD mortality starting in 2003 and continuing to 2012 (the last year for which the data were available). Overall from 2003 to 2012 there was a 32% reduction in CHD mortality among men and 40% among women.

The 16 year time lag between the start of the intervention and the beginning of the decrease in CHD mortality can be explained. During the early years, older people with significant atherosclerosis, and therefore already at risk of death, did not benefit from the dietary change – it was too late for them. It was only as younger people, who had been exposed to the improved oil from early adulthood, reached middle age that there was evidence of benefit; they had accumulated less atherosclerotic plaque throughout their lives.

This highlights a key problem in research on the effects of diet on health – if we want to see survival and improved health into our 8th or 9th decade, we are looking at long-term (life-long) experiments. Obviously these cannot be RCTs or other intervention trials.

References
1) Ramsden CE et al. 2016. Re-evaluation of the traditional diet-heart hypothesis: analysis of recovered data form the Minnesota Coronary Experiment (1968-73). BMJ 353: i246. http: //dx.doi.org/bmj.i1246
2) Uusitalo U et al. 1996. Fall in total cholesterol concentration over five years in association with changes in fatty acid composition of cooking oil in Mauritius: cross sectional survey. BMJ 313: 1044-6.
3) WHO 2014. Noncommunicable Diseases (NCD) Country profiles. www.who.int/nmh/countries/mus_en.pdf

Competing interests: No competing interests

15 August 2017
David A Bender
Emeritus Professor of Nutritional. Biochemistry
University College London
Amersham
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Re: Alcohol consumption and fecundability: prospective Danish cohort study Kenneth J Rothman, Heidi T Cueto, Henrik Toft Sørensen, et al. 354:doi 10.1136/bmj.i4262

Dear Sir,

It is with great interest that I see the findings of your work looking into the fecundability of females and how this is affected by the quantity of alcohol they consume.

With the interesting finding that in females who claim to consume greater than 14 servings per week there is associated 18% decrease in fecundability compared with females claiming to consume no alcohol, was there any attempt to determine illicit and illegal drug use in these subgroups? I saw no mention of this in the study's Methodology.

With the correlation between increased alcohol consumption and illicit drug use along with the reduced rates fecundability associated with illicit drug use, it would strike me as an interesting cofactor to measure as it could also affect the rates of fecundability in this cohort.

Perhaps an area for further analysis if that data was recorded, or if not an area for future study.

Competing interests: No competing interests

14 August 2017
Daniel R Taylor-Sweet
Academic Foundation Doctor
Ninewells Hospital
Dundee, UK
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Re: Law, ethics, and emotion: the Charlie Gard case Clare Dyer. 358:doi 10.1136/bmj.j3152

When looking to the Charlie Gard case, we must appreciate the influence the media had on the situation. Where there might exist a gap between public knowledge and an organisation like the NHS, the media often serves as the bridge. In doing so, there is a duty to report in an impartial manner.

When ethical dilemmas arise, however, they are seldom reported impartially. As a medical student, we cover ethics: respect for autonomy, nonmaleficence, beneficence and justice are all cornerstones in medical ethics can conflict with one another and cause a shift in public opinion. The recent case of Charlie Gard is a perfect example, with news headings such as ‘UK doctors refuse Vatican offer to take Charlie Gard’. Understandably, in an emotional case like this, as highlighted by Clare Dyer, different angles like this inevitably exist. However, when the public send in death threats to health care workers at Great Ormond Street Hospital based on information from the media, we must review the influence that reporting has on the trust between the public and healthcare workers.

The Charlie Gard case is just one instance of what could be many more skewed representations in the media of the healthcare provided by doctors and nurses in the NHS. The British Social Attitudes Survey reported a drop in levels of trust in healthcare professionals from 30 percent in 2002 to 21 percent in 2014, with negative media reporting as a possible influencer in individuals with no recent personal contact with the NHS. In a system, dedicated to the British public, strained now more than ever by budget cuts, a shortage of doctors and lack of adequate resources, public trust is imperative, which can be helped or hindered by media reporting.

Competing interests: No competing interests

14 August 2017
Iqraa B Haq
Medical Student
Imperial College London BMA Rep
London
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Re: David Oliver: Is the NHS trying to help or bully social care? David Oliver. 358:doi 10.1136/bmj.j3623

David Oliver rightly draws attention to the woes and wherefores of NHS helping or "bullying" social care. But reshuffling these current structures has failed thus far and seems unlikely to resolve the challenges of a rapidly growing population of older people largely dependent as a consequence of neurodegenerative disease any time soon.

This population have little or no prospect of regaining independence and autonomy - the key objectives of social care - and have little liklihood of gain from medical investigation or extended hospital treatment. With around 80% of social care budgets going to care homes and large numbers of NHS acute beds being misused for their care, the only reasonable comment about the present is that it is not only wasteful and unsustainable but lacks real understnding of its purpose. Collectively the population we are concerned over are most expensive for both the NHS and SS budget.

So, both the NHS and SS could benefit being relieved of the responsibility for this population, nether have shown the committment needed to make a success of their care. A new third arm of public service funded by significant portions of NHS and SS funding could manage the purchasing of care home beds. National policies, national procedures and practices, an end to reinvernting the wheel and sensible determined adoption of technology and management of scarce resources such as professional nurses. Radical? Well over 400,000 beds and no clear leadership in policy terms or gov isn't really very conservative.... the default may be to rebrand public hospitals as Infirmaries.

Competing interests: I am an NED of a Care Home group and chair a health tech company

14 August 2017
Clive E Bowman
Dr
London City University
Penarth
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Re: The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews Susanna Dodd, Rebecca Smyth, Paula R Williamson, et al. 340:doi 10.1136/bmj.c365

To the Editor: The prevalence and impact of outcome reporting bias in randomized controlled trials (RCTs) within Cochrane systematic reviews has previously been investigated [1]. A recommendation from this research was that studies should not be excluded from reviews on the basis that there was ‘no relevant outcome data’ (NROD), as failure to report on review outcomes does not imply that the outcomes were not measured. Moreover, this recommendation is an expected methodological standard for Cochrane intervention reviews [2]. Quality assurance screening of reviews carried out by the Cochrane Editorial Unit (CEU) has identified that reviews still exclude studies on the basis of NROD. We investigated the proportion of Cochrane reviews excluding studies on the basis of NROD and whether the proportion had changed following the implementation of review screening.

Methods. New Cochrane reviews were included from all Cochrane review groups published from June to August in 2013 (pre-screening), 2014 (screening of all new reviews), 2015 (screening of all new reviews) and 2016 (screening based on a referral basis by the Cochrane review groups). For each included review, investigators extracted the number of included studies, the number of excluded studies and the number of excluded studies due to NROD. To determine whether studies were excluded due to NROD, the relevant methods, results and characteristics of studies section of the review were scrutinised. Any uncertainties regarding the reasons for excluded studies were resolved through discussion between the investigators. If a review excluded a study due to NROD, the review protocol was checked to ascertain whether exclusion based on NROD was a pre-specified criterion for study exclusion. The proportion of reviews excluding studies due to NROD for each year was calculated. Relative risks (RR) and 95% confidence intervals (CI) were calculated to determine whether full screening or referred screening reduced the number of reviews excluding studies due to NROD.

Results. 434 new reviews were identified in the reference period. Over a quarter of reviews excluded studies based on NROD in the pre-screening period, while this figure reduced to under a quarter in the new review screen and referred screening phases (TABLE See http://www.outcome-reporting-bias.org/Uploads/ExcludedStudies.pdf). The result was almost significant for a reduced risk of reviews excluding studies due to NROD if all new reviews were screened (RR 0.91 CI (0.81, 1.03)) or were referred for screening (RR 0.93 CI (0.80, 1.08)) compared to pre-screening. Results were similar when removing reviews that pre-specified that studies would be excluded due to NROD.

Comment. Since the CEU introduced the screening programme the percentage of reviews excluding studies on the basis of NROD has reduced. However, around a fifth of reviews are still excluding studies based on the lack of reporting of outcomes of interest in trial reports. Restricting synthesis to only studies that report on relevant outcome constitutes research waste, if other, otherwise eligible studies are discarded based on failure to report outcome data. Excluding outcome data from meta-analysis in this way has previously been shown to overestimate the treatment effect, which may potentially lead to incorrect recommendations regarding treatment [1]. Potential missing outcome data from excluded studies could be obtained from contact with trial authors or results posted on trial registries. Methods are available to help authors identify whether outcomes are likely to have been measured [1, 3] and sensitivity analyses have been developed to assess whether the exclusion of data from studies is likely to impact on the results [4]. Future strategies are needed (e.g. specific checks at an earlier point in the process) to prevent authors publishing reviews with NROD as a reason for exclusion and reasons for exclusions need to be improved.

References
1. Kirkham, J.J., et al., The impact of outcome reporting bias in randomised controlled trials on a cohort of systematic reviews. BMJ, 2010. 340: p. c365.
2. Higgins, J.P.T., et al., Methodological Expectations of Cochrane Intervention Reviews. 2016, Cochrane: London.
3. Saini, P., et al., Selective reporting bias of harm outcomes within studies: findings from a cohort of systematic reviews. BMJ, 2014. 349: p. g6501.
4. Copas, J., et al., A model-based correction for outcome reporting bias in meta-analysis. Biostatistics, 2014. 15(2): p. 370-83.

Competing interests: KMD is Statistical Editor for Cochrane. JJK and PRW have no competing interests.

14 August 2017
Kerry M Dwan
Statistical Editor
Paula R Williamson and Jamie J Kirkham
Cochrane
St Albans House, 57-59 Haymarket, London SW1Y 4QX, UK
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Re: Burnout among doctors Jane B Lemaire, Jean E Wallace. 358:doi 10.1136/bmj.j3360

As final year medical students, we read ‘A system level problem requiring a system level response’(1) with interest. During our time at medical school, we have been made acutely aware of the pressure on doctors and the consequences of burnout on both our seniors and our peers. We are concerned about the repercussions of the stressed system not only on current doctors but also on the future generation of doctors. This is a pertinent issue as we see morale plummet in our peers and as we read of increasing numbers of students considering leaving medicine(2).

Burnout affects students both directly (35–45% prevalence(3)), and indirectly due to the consequences of working alongside burnt-out doctors. Factors which contribute to burnout in students are important to recognise not only for the sake of students, but also because they offer further insight into the current problem and possible solutions. Factors cited by the authors which contribute to burnout in doctors (individual, medical profession and healthcare organisation factors) also affect students, and there are further student-specific factors(1).

Students are particularly affected by feeling uncertain about their role in the team, examination pressure, and negative doctor-student interactions(4). Stressful relationships with supervisors and a disregard for personal needs are not only associated with burnout(4) but are unfortunately not an uncommon experience. This is a symptom of a sick system and stretched clinicians, whose emotional reserves have been depleted

Furthermore, advice and role-modelling given by burnt-out seniors may contribute to burnout in students. The authors state that ‘Learners witness and adopt their teachers maladaptive behaviours’(1), and this unfortunately is something we witness frequently. For example, it seems commonplace to encourage students to forge a work-life separation, and to ‘leave the day at the hospital door’. However, does this kind of sentiment give permission, let alone encourage, students to reflect and process difficult emotions; essential in preventing burnout?

Preventing burnout in doctors and students is essential to minimise the risk to the current workforce and their patients, but also to prevent a burnout ‘epidemic’(1) affecting the next generation. The swathes of junior doctors leaving the NHS to work abroad(2) is a testament to the dangers of this. We believe that improving the dialogue between medical student and doctor is a crucial aspect to addressing the problem. Students are responsive to senior clinicians taking an interest in their wellbeing and to positive role modelling(3). However, it is unfair to expect burnt out doctors to have the capacity to engage with medical students on a personal level and to model healthy behaviours. System-level change is required to ease the pressure on senior doctors and allow them to nurture the next generation.  This, in time, will help nurture safer and happier doctors who in turn will foster a more supportive culture and be more resilient to burnout when working pressures mount(2).

1. Lemaire JB, Wallace JE. Burnout among doctors. BMJ (Clinical research ed.). England; 2017. p. j3360.
2. Rimmer A. Half of doctors don ’ t go straight into specialty training. 2017;672:1–2.
3. Dyrbye L, Shanafelt T. maintaining well-being A narrative review on burnout experienced by medical students and residents. 2016;132–49.
4. Shanafelt, Tait D; Bradley, Katharine A; Wipf, Joyce E; L. Back A. Burnout and Self-Reported Patient Care in an Internal Medicine Residency Program. 2017;(February 2001).

Competing interests: No competing interests

14 August 2017
Michael David
Medical Student
Rebekah Judge
Imperial College London
London
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Re: Why I’ve changed my views on assisted dying David Nicholl. 358:doi 10.1136/bmj.j3566

Dear Editors

Dr Pablo's rapid response stated:

"Why do we need a law of euthanasia? Fabienne Vanheuverbeke committed suicide with the help of a doctor (1) but she could have done so without his help and without having to involve the medical profession.

To introduce assisted suicide, it would be better to contract trained executioners, without involving doctors. Our profession is not meant to kill but to help die. We doctors value human life with functional limitations, and we do know that loss of functional autonomy does not lead to loss of dignity"

Dr Pablo may not realise that for those people who advocate for a law for assisted dying, do so to:

1. Ensure that the process of dying in comfort is assisted by professionals who have medical expertise in symptom relief and drugs, to minimise any risk of the process being botched and inevidently causing unintentional pain and suffering of the person dying and their loved ones. In such a sensitive time, only health professionals who can prescribe and dispense medicine to keep people comfortable is in the best position to look after those who are dying, whether it is facilitated or not..

2. Ensure that people who assisted in persons dying, professionals and otherwise, will not be persecuted by the police, judicial system or frivolous lawsuits by someone who claims to advocate for the departed.

3. Ensure that there is an option for people to retain their own autonomy over their properties including their bodies. While some can claim that loss of functional autonomy does not lead to loss of dignity, there will be plenty others who will think otherwise. Perhaps other readers should be aware that the quote extracted by Dr Pablo attributed to a published reference (1) is actually a personal opinion by Dr Krahn, and not a conclusion from any research study.

"Paradoxically, while the APHA* vote supported aid in dying, my personal values were clarified as lying in the other direction. Through this intensely emotional process, I gained greater comfort with my own mortality and the self-knowledge that, for me, loss of my functional autonomy does not need to lead to loss of dignity or hastening of my own death."

*American Public Health Association

Perhaps Dr Pablo did not intend for his opinions to be misleading; afterall, I for one would not know where to start looking for contract killers in Spain or any other country.

Reference:
1. Krahn GL. Reflections on the debate on disability and aid in dying. Disabil Health J. 2010 Jan;3(1):51-5.

Competing interests: No competing interests

14 August 2017
Shyan Goh
Orthopaedic Surgeon
Sydney, Australia
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Re: Global climate is warming rapidly, US draft report warns Michael McCarthy. 358:doi 10.1136/bmj.j3824


Scare-care is a poor substitute for healthcare. Healthcare experts who manufacture public hysteria about controversial issues, without acknowledging the legitimacy of opposing points of view, are not advancing public health. Healthcare is not monolithic, and there are legitimate questions about such sacred cows as vaccines, statins, antibiotics, tranquilizers, antidepressants, and global warming (climate change). Healthcare requires balance and fairness, not bias or fear.


Competing interests: No competing interests

13 August 2017
Hugh Mann
Physician
Retired
New York, NY, USA
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Re: Restoring balance to “best interests” disputes in children Dominic Wilkinson. 358:doi 10.1136/bmj.j3666

A number of authors have captured the ethics, emotions and medicine evoked in the Charlie Gard case(1,2,3,4). However much of the narrative centres on the dilemma where parents disagree with doctors on the matter of best interests. However this case really turns on how parents and patients respond when doctors disagree as to what constitutes the best course of action. The parents' stance was predicated almost exclusively on the offer from the American professor of neurology that he may be able to improve their son's quality of life(3,4). Similarly hospitals both in Europe and the USA offered to care for the child, Charlie; further reinforcing the notion that this course of action was not medically futile(3,4). Had the professor advised the family that his techniques were only experimental and the chances of any clinical improvement were from zero to negligible, it is inconceivable that the parents would have pursued a course of action to keep their son alive, with no prospect of amelioration of his condition.

There can be the popular perception that science consists only of incontrovertible truths, when there is disagreement, both sides of the argument must be viable alternatives, rather than one being necessarily inapposite, inferior or incorrect. However doctors disagree on a host of matters; most recently the appropriateness of near global statin therapy for men and women over 60 and 75 respectively or, for example, the need for mandatory immunisation(5,6). There is even no unanimity on traditional medical dogma such as the utility of bisphosphonates(7). Patients will invariably affiliate themselves to one side of a medical argument, and pursue that. If the debate is public, as in this case, eminent political and religious figures will equally align themselves to one side and eschew the other. To suggest that public opinion is only a manifestation of ochlocracy is in some ways a misrepresentation. The debate is only nubile in the public arena as two rival medical prepositions are presented. As a profession we must learn how best to engage with patients where there exists disagreement between doctors and lack of consensus within the profession. The age of paternalism, where patients are excluded from the debate, and effectively told "be quiet sweetie, mummy and daddy are talking"; is dead. The seminal case of Montgomery v Lanakshare Healthcare Board 2015 was the fatal injection for this attitude(8). However intriguingly where there is a dispute in medical opinion, as a profession, is there a tendancy to revert to a Bolamesque paradigm, where the patient has to comply with what the main or most influential body of the profession believes is best?

In 2014 the British Medical Journal published an instructive piece on an analogous case entitled "Lessons from the Ashya King case"(9). In this case, which also attracted significant global interest, doctors in the UK and Europe disagreed on the use of proton beam therapy. Ashya's parents took him from hospital, with a view of submitting him for such treatment in Europe, however this was without notifying his healthcare team. They were ultimately arrested and incarcerated. The general consensus what that this response was disproportionate and the parents were released(9). The child eventually underwent photon therapy. Again the BMJ piece centred entirely on disputes between families and their care teams. However, as in the case of Charlie, this disagreement only had force because there was no consensus amongst clinicians. It would appear that there are still lessons to be learnt from the Ashya King case; not least of all how to involve patients in the decision-making process when doctors disagree. Even further we must introgress some medical method into the legal profession such that it gains a greater appreciation of how to integrate conflicting medical evidence into the deliberative process. As a profession, if we fail to find a formula to address these polemics the courts will increasingly be the arbiter of medical disputes, which has, in the past, resulted in some verdicts which seem somewhat antithetical to our profession(10).

1. Wilkinson D Restoring balance to “best interests” disputes in children BMJ 2017; 358
2. Hurley R. How a fight for Charlie Gard became a fight against the state BMJ 2017; 358
3. Truog RD.The United Kingdom Sets Limits on Experimental Treatments: The Case of Charlie Gard. JAMA. 2017 Jul 20. doi: 10.1001/jama.2017.10410
4. Sokol D. Charlie Gard case: an ethicist in the courtroom. BMJ. 2017 Jul 19;358:j3451
5. https://www.doctors.net.uk/News/Article.aspx?newsid=26753
6. Moberly T.UK doctors re-examine case for mandatory vaccination.Wise J.Teenage boys shouldn't be given HPV vaccine, says joint committee. BMJ. 2017 Jul 20;358:j3523 BMJ. 2017 Jul 18;358:j3414.
7. Järvinen TL, Michaëlsson K, Jokihaara J, Collins GS, Perry TL, Mintzes B, Musini V, Erviti J, Gorricho J, Wright JM, Sievänen H.Overdiagnosis of bone fragility in the quest to prevent hip fracture. BMJ. 2015; 350:h2088.
8. Chan SW, Tulloch E, Cooper ES, Smith A, Wojcik W, Norman JE. Montgomery and informed consent: where are we now? BMJ. 2017 May 12;35
9. O'Brien A, Sokol DK. Lessons from the Ashya King case. BMJ. 2014 Sep 10;349:g5563
10. Dyer C. Courts can decide that vaccine has caused harm despite lack of evidence. BMJ. 2017 Jun 26;357:j308

Competing interests: No competing interests

13 August 2017
Chika E Uzoigwe
Doctor
Jagdeva Mehet
Harcourt House
Sheffield
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Re: Trainee GP who was warned over falsifying timesheets to get new sanction after GMC appeal Clare Dyer. 358:doi 10.1136/bmj.j3864

The BMJ declares, the GMC won!

I can’ t quite workout if the BMJ are being triumphalistic, high fiving in the office clutching their organic, ethically sourced Venti Soy Quadruple Shot Latte with No Foam or if they are lamenting the success of the mighty over the weak.

Maybe there is no answer and their moral compass now acts as a desk fan.

Please don’ t misunderstand me I would not wish to condone Nwachuku’s Misdemeanour anymore than I would:

1. Colleagues who make a financial claim for ‘extra-clinical’ work during their contractual hours
2. Those who misrepresent the criticism they receive from the Appeal court or the Coroner.
3. Those doctors who pervert the course of Justice.
4. Those who defraud the public purse by manipulating waiting lists
5. The colleagues who still enjoy a platinum merit award long after they stopped doing anything meritorious.

Greed and corruption are corrosive and repulsive. They provoke indignation which would make most of us respond to the call of Victor Hugo’s student revolutionaries to “man the barricades!”

But, on the theme of French Romantics, would we really side with the Police Inspector, Javert, in his misguided and self-destructive pursuit of justice or even the GMC in this case?

Aside from the fact the success of the GMC undermines the independence of the Medical Practitioners Tribunal Service. The crime and charge in this case is surely the profligate misuse of our GMC subscriptions.

For any normal human being going to the High Court usually involves risking large sums or even your home. It is not something any of us would do lightly or over a trivial matter but not so with the GMC who take no personal risk and spend our funds.

Like Cicero, I ask Cui bono? "For whose benefit?" 1

This is a disturbing trend when one notes recently a three day hearing was conducted for a doctor already serving a 15 year prison sentence.

It is well understood that there are few winners if natural justice prevails. The exception, of course, are those who enjoy the gravy train, which is becoming ever richer and distasteful!

1. "Cicero: Pro Sex. Roscio Amerino". thelatinlibrary.com.

Competing interests: No competing interests

13 August 2017
Michael Bowen
Consultant Gynaecologist
Oxford
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