Testing sore throats at pharmacies won’t solve anything | Margaret McCartney

Are GPs to throw away the traditional box of wooden tongue depressors? People with sore throats are soon to be offered a new service – at the pharmacy. The NHS Innovation Accelerator, an organisation responsible for helping “with the adoption of promising new treatments and technologies”, has approved a new Sore Throat Test and Treat service that NHS England says is “evidence based and cost saving”.

My head is in my hands. This is neither evidence based nor shown to be cost effective, and may actually make pressure on the NHS worse.

Faced with a wait for to see a GP, it means effectively people will be able to access care faster if they pay for it

The pilot study – which occurred in Boots stores (whose head office analysed the data) – was not a randomised controlled trial. It showed it was possible for pharmacies to assess people with sore throats and use a “point of care” rapid antigen test to determine who should get antibiotics. This might sound superficially sensible. But the National Institute for Health and Care Excellence (Nice) does not recommend this rapid antigen test because it has a poor sensitivity for picking up relevant bugs.

It is already known – from randomised clinical trials – that this test does not help beyond normal care. Furthermore there has been no full cost-effectiveness analysis – let alone an independent cost-effectiveness analysis – of the Boots scheme. Without comparing the pilot to usual care, we have no way of knowing whether more or fewer antibiotics were prescribed. It is a travesty of evidence-based policymaking.

This scheme may actually increase demand on the NHS, fragmenting services but without improving care. More than half of the patients in the study said that if the pilot had not been available, they would have either have done nothing or treated themselves without assistance.This, if it held true, meant that antibiotics were subsequently used just because the scheme was there. Isn’t that good? Not necessarily.

The study concluded that if the pilot hadn’t been available then there could have been a “delay seeking medical treatment when it was needed”. But it didn’t show this, and not all bacterial throat infections need to be treated. In fact, antibiotics reduce the length of time of a sore throat by an average of 16 hours, with only a modest impact on complications such as ear infections. Balanced against common side-effects of antibiotics such as diarrhoea, as well as antibiotic resistance, there is often not a clear-cut reason to prescribe. This scheme expands the market for medicine, without clear benefits. Earlier is not always better. It gets worse.

In the pilot, patients paid £7.50 for the test and £10 for “antibiotics if required”. This is a clear subversion of the free at the point of use principle of the NHS. NHS England has not been able to tell me what the funding for the new service will be, where it will come from, or whether patients will still have to pay. Faced with a wait for a free appointment with a GP, it effectively means that people will be able to access care faster if they pay for it. Commissioners with stretched budgets may be content with that. But it should be absolutely resisted.

The relentless argument from rightwing thinktanks is that we need to charge for NHS appointments; and that the funding deficit in the NHS is so acute that all options should be on the table. But it is a dreadful argument. People who are poor have the biggest risk of earlier death and earlier disease. The very principle of the NHS – based on need, not ability to pay – subverts the otherwise natural course of allowing better healthcare to be only in the domain of the already better off.

This scheme isn’t the kind of change we need in the NHS. Sir Bruce Keogh, NHS England’s medical director, has said of it “innovation is not an option but a necessity if we are to built a sustainable NHS”. But “innovation” should not be an excuse for policymaking that isn’t evidence-based. There are far better ways to ensure that the NHS is sustainable.

The NHS does need more money. But it also needs to stop wasting money and effort on inadequately tested – or proven to be non-cost effective – but popular political policies. Take the health checks scheme or dementia screenings, for example – known to be ineffective and even harmful, through causing false positive diagnosis and over-treatment. Millions have been needlessly wasted that should have spent on useful care.

Similarly, there are multiple pressures on general practice that have been generated by appalling but avoidable political policy. The current benefits system is associated with worsening people’s mental health and has created an enormous amount of bureaucracy for GPs, which reduces the availability of appointments. And that is even before we get to the money and time spent administering to the competition and commissioning of the Health and Social Care Act, without evidence of gains for patients.

We are in the midst of an NHS financial crisis. If we want it to survive, we need real innovation. That means the bravery to stand up for evidence-based policymaking, and ensure that NHS policy always considers harms, and aims to reduce waste – and health inequalities.

Testing sore throats at pharmacies won’t solve anything | Margaret McCartney

When it comes to menopausal hormone therapy, women are left guessing at the risks | Margaret McCartney

As a freshly minted doctor in the early 1990s, I attended lectures describing hormone replacement therapy – which is now known, in this context, as MHT, menopausal hormone therapy – as close to a miracle cure-all. Women shouldn’t worry their pretty little heads, it was implied at the time, because doctors knew best – and this treatment would not only make them feel fantastically sexy, but prevent cardiovascular disease and strokes. Promotion, back then, went beyond recommending it for menopausal symptoms. It was the elixir of life, preventing future illness and making women look younger.

Let’s sidestep the sexist and ageist undertones of that era, and fast forward to the publication of the Women’s Health Initiative study in 2002, which found that the treatment increased the risk of breast cancer. For every 10,000 person-years of combination menopausal hormone therapy use (oestrogen plus progesterone), there were seven more heart attacks, eight more strokes, eight more blood clots on the lungs, and eight more invasive breast cancers. In the ensuing years, the amount of menopausal hormone replacement being prescribed fell by half.

In November 2015, the National Institute for Health and Care Excellence (Nice) published new guidance on treating the menopause. In a press release, it suggested that menopausal hormonal treatment was being underprescribed, and GPs needed to prescribe it more. “For the last decade, some GPs have been worried about prescribing HRT, and women worried about taking it …” it wrote. “For health professionals, the guideline should boost their confidence in prescribing HRT, having fully discussed the woman’s individual circumstances with her.”

That seemed pretty clear, but now a new UK study apparently shows that the risks of breast cancer have been underestimated and “nearly tripled” when women were taking hormone treatment for menopause.

So should I still feel confident about prescribing it? Is this a high or a low risk? Is it a risk worth taking? Well, that depends on the patient. There will be women who regard the risks as reasonable because they experience such enormous benefits. Then there are other women who would consider a much smaller risk of serious harm unacceptable. Autonomy rules, and there is no “correct” answer (although I suspect the General Medical Council would be quick to hold doctors to account for what was viewed as reckless prescribing). But to make that autonomy meaningful, we have to be able to make a rational, informed choice. That needs quality data. So what does the latest study tell us?

It’s a prospective, cohort study, which specifically looked for hormone use and age at menopause, which many other studies have not. Just over 39,000 women had their age at menopause documented, and 775 of these developed breast cancer. They found that the women who used combination MHT were more likely to develop breast cancer by a factor of 2.7; this risk dissipated when the women stopped the MHT, but rose the longer it continued.

The NHS offers detailed decision aids for treatments for everything from arthritis to angina – but none on the menopause

We need to put this into context: 2.7 times a small number is still a small number, so you need to know what your risk was to start with. For a woman aged between 50-70, the risk of breast cancer is about 5%. Is an increase to about 13% for the years a woman is taking the hormones worth it? I don’t know. But I am also concerned as to whether this cohort are truly representative of the population at large, because the women who volunteered for this study were not asked to participate randomly, but were recruited through newsletters sent out by a breast cancer charity. They may, therefore, have been more likely to have a family member with breast cancer, or share the same environmental risks as friends with breast cancer, and so faced a higher risk to start with.

I also don’t reliably know how much the change in breast cancer risk is per woman: as one of the authors, Dr Michael Jones, told me: “Our results are internally consistent and we can talk about relative changes, but we cannot make external extrapolations in absolute risk to the whole UK.” In other words, care is needed – and we will need this data to be replicated in other data sets before we can be confident that it applies equally to other women.

Uncertainty is a hallmark of medical decision making. If a woman develops breast cancer while taking MHT, no one can be sure whether it would have happened in any case. We need context. We can’t control our genes, but what other risk factors can we at least partially control? Cancer Research UK says that 9% of breast cancers are linked to obesity, 6% to excess alcohol, and 3% to insufficient physical activity. In context, MHT is linked to 3% of all breast cancers. If this has been underestimated, as the new study claims, by up to 60%, that means that up to 5% of all breast cancers could be linked to MHT. But there are so many ongoing uncertainties that I think pinning it down to the last percentage point makes this look more accurate than it is.

So what do we do in the meantime? GPs are under enormous pressure anyway – each of our appointments is just 10-12 minutes long, with an average of 2.5 problems being discussed, so there’s barely time to make a safe diagnosis, never mind discuss most of the side effects for each possible treatment. There has been a quiet revolution in medicine in the last decade, a realisation that making choices is often hard to do well. There are now a wealth of “shared decision aids” online, based on high-quality evidence and with the emphasis on assisting patients, not dictating “choice”. They work in different ways; some are online or DVD-based, and they usually try and lay out the pros and cons of treatments in a logical way, giving the person enough time and information to make high-quality decsions.

These have been shown to help people make better decisions about treatment choices – and using them before or after GP appointments is a useful way of making oneself surer of healthcare choices.

The NHS has a website devoted to detailed decision aids for treatments for everything from arthritis to angina – but none, so far, on the menopause. Nice does have an information section on its website about the pros and cons of hormone treatment for menopause, but doesn’t provide any numbers about the risks – or define what they mean by “low-risk”, in common with other US decision aids – and while that might be enough information for some women, it’s unlikely to be detailed enough for others.

We need better quality information that doesn’t offer more certainty than we actually have: we are in a new era of medicine, and honesty about the knowns and unknowns, and the limitations of our knowledge is essential. I will continue to prescribe MHT, but when it comes to discussing risks and benefits, I suspect I will be answering many questions with an honest “I don’t know”.

When it comes to menopausal hormone therapy, women are left guessing at the risks | Margaret McCartney

Patients deserve the reality: overall health screening can do a lot more harm than excellent | Margaret McCartney

In breast cancer screening, ‘false positives’ trigger huge anxiety and expose individuals to the dangers of radiotherapy and surgery. Photograph: Rex Attributes

There was some very good news shortly prior to the Christmas break: the Parliamentary Science and Technological innovation Committee announced an enquiry into health screening.

The need to have for a assessment is pressing. Screening constantly sounds very good – catch illness early, whilst it can even now be taken care of – but the reality is a lot more complicated and screening has side results. The dilemma is that physicians and researchers have identified about these downsides of screening for decades, but the message has not received by means of to sufferers.

It is this failure of communication that has led a number of prominent Uk medical doctors to say publicly that they have chosen not to have breast cancer screening, like the editor of the BMJ, Fiona Godlee, who is a former president of the Royal School of GPs, Iona Heath, a London GP, and professor of complicated obstetrics Susan Bewley. As Heath writes in the BMJ, “My fear is that I have created my choice on the basis of data that is not readily accessible to my patients.”

So what is this crucial information? Overdiagnosis – choosing up “illnesses” that had been by no means going to cause any difficulty – is a main issue in most screening programmes.

In the case of breast cancer screening, the mammograms will locate lesions of uncertain significance – cancers that do not behave aggressively. Simply because we do not normally have the capacity to operate out which of these cancers will spread and cause death, all ladies are supplied remedy, which can consist of mastectomy and radiation therapy. These therapies can do harm. For illustration, radiotherapy slightly raises the danger of later heart disease and surgical treatment comes with the typical risks from the anaesthetic and the prospective for infection. These hazards could well be worth taking if the breast ailment threatens your daily life, but it is far less clear what to do when the screening has picked up a probably harmless lesion.

Another problem with assessing the advantages of screening is “lead time bias”. Take two guys with prostate cancer that started in 2011. One particular is picked up in 2011 through PSA (prostate-particular antigen) screening, and the other is picked up in 2013, since symptoms have created. They both die in 2015. It will appear as though the man detected by screening lived for longer after his diagnosis compared with the guy who was picked up by means of signs. The screening didn’t truly lengthen daily life, but if we just count the years of survival after diagnosis it will look as even though screening did lead to a longer life. Analysis of screening usually falls into this trap, making it seem far better than it is.

Publish-mortem examinations have estimated that all around a third of men over 50 who died of anything unrelated also have prostate cancer. Far fewer males actually die of prostate cancer, and the harms of treatment for it can consist of impotence and incontinence. Indeed, a Cochrane review has found that there is no all round advantage from PSA screening, and, in the US, the Preventative Solutions Task Force has recommended it should not be done at all.

This did not cease yearly men’s overall health campaign Movember from calling for males to have PSA screening in 2012. Its recent tips is to take into account screening but does not explain in sufficiently explicit detail why this is this kind of a contentious test. This require for honest information about harms from prostate cancer screening is critical, because when men are given greater information about PSA screening, more decide on not to have it. Quality data is, thus, essential.

Then there is the effectiveness of the screening intervention. GPs have not too long ago been contracted to screen at-threat men and women for dementia. But the tests utilised are hugely inaccurate. For instance, if 6 out of one hundred people have dementia, then testing will pick up four of them – but will also recognize 23 individuals as having dementia who in reality do not. Making so many false positives and negatives creates considerably misery and anxiety. Yet since the screening exams are offered “opportunistically”, when GPs are seeing individuals who have come about one thing else, men and women may be taken unaware and not get a chance to think about whether or not or not they want to chance the possible harms caused by this kind of a poor check.

All this indicates that individuals could not know if their screening test has triggered them harm. This prospects to the “acceptance paradox” where a bad screening test creates several false positives, and significantly pointless remedy, but folks end up feeling that they have “owed their daily life” to screening when, in reality, they have been subjected to needless therapies – and the resultant risks.

Even medical professionals find the rewards of screening challenging to analyse properly. Psychologist Gerd Gigerenzer has tested this example, about a screening check for bowel cancer. If the prevalence of cancer is .3%, the sensitivity of the test was 50% and the false positive rate was 3%, the doctors had been asked, what is the probability that somebody who tests positive truly has colorectal cancer? 

Half the medical professionals gave the answer as 50%, when the end result is truly significantly less than 5%. Imagine you have a representative sample of 10,000 individuals: .3%, or 30, of them will have bowel cancer. The check is 50% sensitive, choosing up 15 of them. Even so, the false optimistic charge is three%, which will be three% of the 9,970 who do not have bowel cancer, or 299 men and women. So there are 299 + 15 good tests, but only 15 out of 314 are true positives. In other words, when a test end result comes back good, the probability that the patient has bowel cancer is only five%. Screening exams can frequently carry out much less nicely than the numbers may possibly search.

The NHS has made some efforts to enhance the data that patients get when they are invited to NHS Screening, but it nonetheless does not make explicit the dangers of treatment for “cancers” that would never ever otherwise have accomplished harm. The media launch of the new leaflet for breast cancer screening final 12 months was marred by a spokesperson from the Breast Cancer Campaign telling females they should be mindful of the hazards of screening but must “attend screening appointments when invited”.. This is nonsensical – grownups must be capable to make a decision for themselves which hazards they would choose to accept.

It is exactly because screening is a mixed bag of advantage and harm that no one ought to impose their personal values onto another individual. Nevertheless at current, NHS Screening is judged by how many people attend, and not by how several people make an informed decision to attend – or not. Similarly, GPs are paid according to how several screenings are accomplished – not how effectively informed their patients are.

In addition, it misleads individuals that invitations to NHS Screening often appear to come from the trusted GP rather than exactly where they do come from – a central NHS Screening workplace. Apparently this increases uptake.

We want a debate about the expense-effectiveness of our screening sacred cows, but we also want a debate about how to give autonomous adults fair details about screening that respects their proper to decline. Till patients are provided unbiased information – which includes that screening can maim as well as help – we will carry on to fall quick of the best of patient consent, “no decision about me – without having me”.

Patients deserve the reality: overall health screening can do a lot more harm than excellent | Margaret McCartney