Richard Lehman’s journal review—27 August 2015

richard_lehmanNEJM 6-13 Aug 2015 Vol 373

503 Outcomes in early breast cancer surgery just keep on getting better. But between 20-40% of patients who have a partial mastectomy need to undergo further surgery soon afterwards because the excision margin shows possible tumour involvement. A team at Yale decided to see if this could be averted by routinely performing a further shave of the cavity margins after all grossly visible tumour had been completely removed. Randomization—either to close the wound or to perform extra shaves—occurred at the moment of decision during the operation. And sure enough, those who had the extra shave were half as likely to need re-excision surgery, and had no increase in complications.

521 Surgery used to be swayed by fashion and dogma, and it’s good to see that this is changing on all fronts. For example, for most of the twentieth century American women with breast cancer underwent mutilating radical mastectomy, decades after it had gone out of fashion elsewhere, simply because the great American surgeon William Halsted had declared it to be the best guarantee of cure in the 1890s. In head and neck cancer surgery, there has been equipoise between a policy of elective lymph node dissection and therapeutic removal of nodes if they show later infiltration. A single large randomized trial has now settled this question. Five hundred patients with lateralized stage T1 or T2 oral squamous-cell carcinomas (245 in the elective-surgery group and 255 in the therapeutic-surgery group) were enrolled with a median follow-up of 39 months. There were 81 recurrences and 50 deaths in the elective-surgery group and 146 recurrences and 79 deaths in the therapeutic-surgery group. So in this case the proactive approach is definitely better.

589 A few months ago Lisa Rosenbaum was given the space of three long articles in the NEJM to question the importance of conflicts of interest in medicine. I couldn’t find much to engage with, let alone agree with. It’s different with her piece called The Paternalism Preference — Choosing Unshared Decision Making. Here she is talking about the actuality of medical decision making, as a patient, a friend and a doctor. What she illustrates is that despite decades of advocacy, shared decision making is a skill that doctors have hardly begun to develop. But to me that’s a call to action, not a call to paternalism like Rosenbaum’s idealized “leave it to me, I’ll always be there for you.” I was as good a doctor as I could be to the same people for 30 years, and some of them still kiss me in the supermarket, five years on. Others just walk by, probably having forgotten all about me. I have jolts of guilt seeing others: I didn’t help them much. The next generation of doctors, armed with shareable knowledge and better consultation skills—and please, more time—need to be trained to share medicine better.

610 While I’m in old-man-looking-back mode, I hereby declare that the blood test which has made the most difference to patients in my working lifetime has been cardiac troponin. And that’s odd, because I’ve never ordered a single such test. If I thought someone was having an acute cardiac event in my surgery, I would make sure they were removed to the nearby hospital emergency department within ten minutes. None of your sexy medicine on our premises, thank you. As troponin testing became universal, new abbreviations would increasingly appear on the discharge sheets which followed. NSTEMI ->PCI. This was less than 15 years ago and I can remember that even the younger GPs were initially baffled by these new terms. The fact is that troponins are relatively new biochemical markers for myocardial cell death and their utility has not yet been fully explored. This paper describes a bold attempt to use troponins as a marker for cardiac intervention in a high risk group. They measured troponin levels in 2285 patients with type 2 diabetes and stable coronary artery disease, and found that 897 (39.3%) had abnormal troponin T concentrations at baseline. Over five years, the latter group showed twice the rate of a composite end point of death from cardiovascular causes, myocardial infarction, or stroke. They then randomized the patients with high troponin levels (>14ng/L) to have prompt revascularization or maximal medical therapy. Outcomes were the same in both groups, proving once more that cardiology is more complicated than plumbing.

JAMA 4-11 Aug 2015 Vol 314

501 Does This Patient Have Post Traumatic Stress Disorder? asks the latest in the Rational Clinical Examination series. I’ve been a fan of the series since its inception, because it was a pioneering attempt—set up by Dave Sackett—to bring order into the study of clinical diagnosis. At that time—the early 1990s—we all had great optimism about developing ever better methods of meta-analysis and bringing the results to bear on clinical practice. Twenty plus years on, I think we’re all sadder and wiser. One issue is the so-called gold standard. If this standard is so golden, why not use it all the time? Here we’re dealing with a psychiatric diagnosis, so the gold standard is a structured clinical interview by a psychiatrist. And this article is about how well short-cut assessment tools for PTSD compare with a psychiatrist’s opinion as to what constitutes PTSD in any given individual. The best tools around seem to be the PC-PTSD and the PTSD Checklist, which apparently can be used with ease and speed in primary care. But then comes the question of what to do about the condition. Do these tools predict response to any particular kinds of treatment? In the utilitarian world of practical medicine, diagnosis has always to be thought of in terms of its consequences.

604 In the fantasy-land of politicians and industry lobbyists, every new medical device is a breakthrough and a potential export gain, while regulatory bodies are just people who get in the way. In the UK, NICE has been ordered to stop assessing safe staff numbers in NHS hospitals and instead to seek ways of involving device manufacturers in speeding up the adoption of new technologies.

So let’s look at the track record of device manufacturers in the USA. Here’s another great study (OK, some authors are friends) from the CORE team at Yale. They looked at how well the manufacturers of high-risk medical devices comply with the Food and Drug Administration’s stipulations about post-marketing studies. I’ll just give you the bottom line: “Among high-risk therapeutic devices approved via the FDA PMA pathway, total product life cycle evidence generation varied in both the number and quality of premarket and postmarket studies, with approximately 13% of initiated postmarket studies completed between three and five years after FDA approval.” So an 87% non-compliance rate. If NICE sits down to dinner with these guys, it will need to order in some very long spoons.

JAMA Intern Med Aug 2015 Vol 175

OL In the Netherlands and Belgium, the law permits voluntary euthanasia in a much wider sense than the closely restricted permission to help terminally ill people die which is going to be debated in parliament soon. So when this article talks about a “slippery slope” in relation to the Low Countries, it has little relation to the debate going on here. In Flanders, the percentage of deaths by voluntary euthanasia has gone up from 1.9% in 2007 to 4.6% in 2013. In 2012, the figure for the Netherlands was 3.3%. To be helped to die in this way, individuals must have constant and unbearable physical or psychological suffering and make repeated, voluntary requests. To me, that seems a perfectly acceptable way for an advanced secular society to proceed, and the fact that more people are taking that route does not make it either slippery or a slope. It is just a personal choice. To argue against personal autonomy you must believe that you have some superior insight into societal values.

OL If you need persuading that assisted dying should be made possible for those who want it, visit a few people with advanced heart failure. I did a review of the literature on their symptom load when I helped to put together the first book on palliative care and heart failure in 2006, and I gave the book to Sarwat Chaudhry three years ago. Now she joins in reporting a new survey of the symptom burden among patients who were hospitalized for heart failure at Yale-New Haven hospital in 2013-2014. It’s the same story: pain, fatigue, drowsiness, nausea, lack of appetite, dyspnoea, depression, anxiety, feeling awful, and oedema. These dying people—who invariably have other comorbidities too—need the best care we can give them, but it is futile to imagine that we can palliate everything.

Lancet 8-15 Aug 2015 Vol 386

552 After a three week break from these reviews, I find to my horror that the printed Lancet features two trials of new psoriasis drugs which first appeared on the website in June. They now stare at me, challenging me to say something sensible about them. Here goes. The standard treatment for moderate-to-severe plaque psoriasis is placebo, right? If wrong, why was it allowed as a comparator in both these trials? Perhaps, though, it is etanercept, which was also a comparator in both these trials. Or is it methotrexate, which appears in neither of these trials? I am the wrong person to ask, so I turned to the editorial called “Do we need more psoriasis therapies?” There I learn that an international survey shows that “more than 80% of patients with moderate-to-severe disease are treated only with topical therapy or not at all.” So the placebo arm was justified, perhaps. But the editorialist never actually answers his own question, and leaves me wondering whether we first need to get psoriasis patients aware of existing treatment choices before creating all sorts of new ones. The new kids on the block are called ixekizumab (yes) and tofacitinib. Are you paying attention? Oh, I give up. Click on the links if you need to know about them.

655 Now for three articles about interventional cardiology. My joy is complete. The first one attempts to discover the best strategy for treating in-stent restenosis, by means of a network meta-analysis. OK. Here goes: the top two are “restenting with everolimus-eluting stents because that produces the best angiographic and clinical outcomes, and drug coated balloon inflation because of its ability to provide favourable results without adding a new stent layer.” Do you believe this to be the last word on the subject? I think it will be mine.

665 Now what do interventional cardiologists like to do? The clue is in the name. They like to intervene. Once their catheters are in a coronary artery, the oculostenotic reflex comes into action, and every time they see a stenosis, in goes a stent. Does this produce better clinical outcomes when done at the time of acute ST-elevation MI? Well, not within the 27-month follow-up period of the DANAMI-3 – PRIMULTI trial, if you judge by cardiac death and non-fatal MI. But it did reduce the number of times the interventional cardiologists decided to put more stents in afterwards.

672 Some interventional cardiologists also love to try pathway ablation for paroxysmal atrial fibrillation: rates of this procedure vary wildly depending on local enthusiasm. The reason the procedure often fails is because there are dormant conduction pathways adjacent to the pulmonary veins which elude radio-ablation. The way to find these is by adenosine testing. This trial shows that it adenosine-guided ablation reduces the absolute risk of recurrent PAF by 27%.

BMJ 8-15 Aug 2015 Vol 351

I groaned when I saw the publicity about this study linking spicy food with longevity, but reading the full paper makes me wonder if this hypothesis is worth further testing. It comes from a really big Chinese population study: nearly 200,000 men and 288,000 women. OK, not big by Chinese standards, but impressive nonetheless, and covering a large geographical range. The data come from food diaries and a median follow-up period of 7.2 years. Compared with those who ate spicy foods less than once a week, those who consumed spicy foods 6 or 7 days a week showed a 14% relative risk reduction in total mortality. “Spicy” here is a synonym for chilli, a South American fruit which arrived in China around the end of the sixteenth century, brought by Portuguese traders, and therefore a very recent arrival in terms of Chinese culinary history. I guess we need more such studies from other countries blessed with the same introduction, such as India and Korea; and from Hungary, to see if the milder form called paprika is as effective.

It has long struck me that if the NHS can learn from any health system, it is likely to be the Swedish, which has always had to contend with the problem of providing access to high quality acute hospital services for a very scattered population. This study shows that despite this, case mix standardised 30 day mortality from acute myocardial infarction is lower in Swedish hospitals (8.4%) than in UK hospitals (9.7%), with less variation between hospitals (interquartile range 2.6% v 3.5%). The really impressive thing is that despite the challenges of climate and rapid access to primary percutaneous intervention, at least some of the difference in outcome is due to Swedes with heart attacks having more immediate PCI than comparable Britons.

Now for more dietary observations, this time pooled from lots of prospective cohort studies about saturated fat and trans fats in relation to all cause mortality, total coronary heart disease, and CHD mortality. The quality of evidence is not good, but there is nothing to suggest any link between animal fat and these conditions (or type 2 diabetes). This has been apparent for ages but you still get strange looks when you eat Parma ham rolled round pure butter, one of the loveliest morsels in the world. Trans fats are guilty by association and should vanish accordingly, since they have no possible culinary value.

Plant of the Week: Roscoea purpurea “Red Gurkha

This is an outrageously exotic looking little plant, with fat dark red stems and big bearded flowers of clear brick red to glorify the late summer garden. It is a member of the ginger family and is said to be fully hardy in the UK. We have yet to decide where to plant ours.

When it goes dormant I’ll be tempted to have a tiny taste of its rhizome. Gingerly, of course.