Monthly Archives: February 2015

Dodgy advertising, Pseudoscience

How to spot dishonest nutribollocks

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I saw a post on Facebook earlier today from GDZ Supplements, a manufacturer of nutribollocks products aimed at gullible sports people.

The post claimed that “Scientific studies suggest that substances in milk thistle protect the liver from toxins.” This was as part of their sales spiel for their “Milk Thistle Liver Cleanse”. No doubt we are supposed to believe that taking the product makes your liver healthier.

Well, if there really are scientific studies, it should be possible to cite them. So I commented on their Facebook post to ask them. They first replied to say that they would email me information if I shared my email address with them, and then when I asked why they couldn’t simply post the links on their Facebook page, they deleted my question and blocked me from their Facebook page.

Screenshot from 2015-02-21 11:40:18

This, folks, is not the action of someone selling things honestly. If there were really scientific studies that supported the use of their particular brand of nutribollocks, it would have been perfectly easy to simply post the citation on their Facebook page.

But as it is, GDZ Supplements clearly don’t want anyone asking about the alleged scientific studies. It is hard to think of any explanation for that other than dishonesty on GDZ Supplements’ part.

Healthcare, Politics

What my hip tells me about the Saatchi bill

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I have a hospital appointment tomorrow, at which I shall have a non-evidence-based treatment.

This is something I find somewhat troubling. I’m a medical statistician: I should know about evidence for the efficacy of medical interventions. And yet even I find myself ignoring the lack of good evidence when it comes to my own health.

I have had pain in my hip for the last few months. It’s been diagnosed by one doctor as trochanteric bursitis and by another as gluteus medius tendinopathy. Either way, something in my hip is inflammed, and is taking longer than it should to settle down.

So tomorrow, I’m having a steroid injection. This seems to be the consensus among those treating me. My physiotherapist was very keen that I should have it. My GP thought it would be a good idea. The consultant sports physician I saw last week thought it was the obvious next step.

And yet there is no good evidence that steroid injections work. I found a couple of open label randomised trials which showed reasonably good short-term effects for steroid injections, albeit little evidence of benefit in the long term. Here’s one of them. The results look impressive on a cursory glance, but something that really sticks out at me is that the trials weren’t blinded. Pain is subjective, and I fear the results are entirely compatible with a placebo effect. Perhaps my literature searching skills are going the same way as my hip, but I really couldn’t find any double-blind trials.

So in other words, I have no confidence whatsoever that a steroid injection is effective for inflammation in the hip.

So why am I doing this? To be honest, I’m really not sure. I’m bored of the pain, and even more bored of not being able to go running, and I’m hoping something will help. I guess I like to think that the health professionals treating me know what they’re doing, though I really don’t see how they can know, given the lack of good evidence from double blind trials.

What this little episode has taught me is how powerful the desire is to have some sort of treatment when you’re ill. I have some pain in my hip, which is pretty insignificant in the grand scheme of things, and yet even I’m getting a treatment which I have no particular reason to think is effective. Just imagine how much more powerful that desire must be if you’re really ill, for example with cancer. I have no reason to doubt that the health professionals treating me are highly competent and well qualified professionals who have my best interests at heart. But it has made me think how easy it must be to follow advice from whichever doctor is treating you, even if that doctor might be less scrupulous.

This has made me even more sure than ever that the Saatchi bill is a really bad thing. If a medical statistician who thinks quite carefully about these things is prepared to undergo a non-evidence-based treatment for what is really quite a trivial condition, just think how much the average person with a serious disease is going to be at the mercy of anyone treating them. The last thing we want to do is give a free pass for quacks to push completely cranky treatments at anyone who will have them.

And that’s exactly what the Saatchi bill will facilitate.

Cancer, Correlation does not equal causation, Epidemiology

Ovarian cancer and HRT

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Yesterday’s big health story in the news was the finding that HRT ‘increases ovarian cancer risk’. The scare quotes there, of course, tell us that that’s probably not really true.

So let’s look at the study and see what it really tells us. The BBC can be awarded journalism points for linking to the actual study in the above article, so it was easy enough to find the relevant paper in the Lancet.

This was not new data: rather, it was a meta-analysis of existing studies. Quite a lot of existing studies, as it turns out. The authors found 52 epidemiological studies investigating the association between HRT use and ovarian cancer. This is quite impressive. So despite ovarian cancer being a thankfully rare disease, the analysis included over 12,000 women who had developed ovarian cancer. So whatever other criticisms we might make of the paper, I don’t think a small sample size is going to be one of them.

But what other criticisms might we make of the paper?

Well, the first thing to note is that the data are from epidemiological studies. There is a crucial difference between epidemiological studies and randomised controlled trials (RCTs). If you want to know if an exposure (such as HRT) causes an outcome (such as ovarian cancer), then the only way to know for sure is with an RCT. In an epidemiological study, where you are not doing an experiment, but merely observing what happens in real life, it is very hard to be sure if an exposure causes an outcome.

The study showed that women who take HRT are more likely to develop ovarian cancer than women who don’t take HRT. That is not the same thing as showing that HRT caused the excess risk of ovarian cancer. It’s possible that HRT was the cause, but it’s also possible that women who suffer from unpleasant menopausal symptoms (and so are more likely to take HRT than those women who have an uneventful menopause) are more likely to develop ovarian cancer. That’s not completely implausible. Ovaries are a pretty relevant organ in the menopause, and so it’s not too hard to imagine some common factor that predisposes both to unpleasant menopausal symptoms and an increased ovarian cancer risk.

And if that were the case, then the observed association between HRT use and ovarian cancer would be completely spurious.

So what this study shows us is a correlation between HRT use and ovarian cancer, but as I’ve said many times before, correlation does not equal causation. I know I’ve been moaned at by journalists for endlessly repeating that fact, but I make no apology for it. It’s important, and I shall carry on repeating it until every story in the mainstream media about epidemiological research includes a prominent reminder of that fact.

Of course, it is certainly possible that HRT causes an increased risk of ovarian cancer. We just cannot conclude it from that study.

It would be interesting to look at how biologically plausible it is. Now, I’m no expert in endocrinology, but one little thing I’ve observed makes me doubt the plausibility. We know from a large randomised trial that HRT increases breast cancer risk (at least in the short term). There also seems to be evidence that oral contraceptives increase breast cancer risk but decrease ovarian cancer risk. With my limited knowledge of endocrinology, I would have thought the biological effects of HRT and oral contraceptives on cancer risk would be similar, so it just strikes me as odd that they would have similar effects on breast cancer risk but opposite effects on ovarian cancer risk. Anyone who knows more about this sort of thing than I do, feel free to leave a comment below.

But leaving aside the question of whether the results of the latest study imply a causal relationship (though of course we’re not really going to leave it aside, are we? It’s important!), I think there may be further problems with the study.

The paper tells us, and this was widely reported in the media, that “women who use hormone therapy for 5 years from around age 50 years have about one extra ovarian cancer per 1000 users”.

I’ve been looking at how they arrived at that figure, and it’s not totally clear to me how it was calculated. The crucial data in the paper is this table.  The table is given in a bit more detail in their appendix, and I’m reproducing the part of the table for 5 years of HRT use below.

 

 Age group  Baseline risk (per 1000)  Relative excess risk Absolute excess risk (per 1000)
 50-54  1.2  0.43  0.52
 55-59  1.6  0.23  0.37
 60-64  2.1  0.05  0.10
 Total  0.99

The table is a bit complicated, so some words or explanation are probably helpful. The baseline risk is the probability (per 1000) of developing ovarian cancer over a 5 year period in the relevant age group. The relative excess risk is the proportional amount by which that risk is increased by 5 years of HRT use starting at age 50. The absolute excess risk is the baseline risk multiplied by the relative excess risk.

The risk in each 5 year period is then added together to give the total excess lifetime risk of ovarian cancer for a woman who takes HRT for 5 years starting at age 50. I assume excess risks at older age groups are ignored as there is no evidence that HRT increases the risk after such a long delay. It’s important to note here that the figure of 1 in 1000 excess ovarian cancer cases refers to lifetime risk: not the excess in a 5 year period.

The figures for incidence seem plausible. The figures for absolute excess risk are correct if the relative excess risk is correct. However, it’s not completely clear where the figures for relative risk come from. We are told they come from figure 2 in the paper. Maybe I’m missing something, but I’m struggling to match the 2 sets of figures. The excess risk of 0.43 for the 50-54 year age group matches the relative risk 1.43 for current users with duration < 5 years (which will be true while the women are still in that age group), but I can’t see where the relative excess risks of 0.23 and 0.05 come from.

Maybe it doesn’t matter hugely, as the numbers in figure 2 are in the same ballpark, but it always makes me suspicious when numbers should match and don’t.

There are some further statistical problems with the paper. This is going to get a bit technical, so feel free to skip the next two paragraphs if you’re not into statistical details. To be honest, it all pales into insignificance anyway beside the more serious problem that correlation does not equal causation.

The methods section tells us that cases were matched with controls. We are not told how the matching was done, which is the sort of detail I would not expect to see left out of a paper in the Lancet. But crucially, a matched case control study is different to a non-matched case control study, and it’s important to analyse it in a way that takes account of the matching, with a technique such as conditional logistic regression. Nothing in the paper suggests that the matching was taken into account in the analysis. This may mean that the confidence intervals for the relative risks are wrong.

It also seems odd that the data were analysed using Poisson regression (and no, I’m not going to say “a bit fishy”). Poisson regression makes the assumption that the baseline risk of developing ovarian cancer remains constant over time. That seems a highly questionable assumption here. It would be interesting to see if the results were similar using a method with more relaxed assumptions, such as Cox regression. It’s also a bit fishy (oh damn, I did say it after all) that the paper tells us that Poisson regression yielded odds ratios. Poisson regression doesn’t normally yield odds ratios: the default statistic is an incidence rate ratio. Granted, the interpretation is similar to an odds ratio, but they are not the same thing. Perhaps there is some cunning variation on Poisson regression in which the analysis can be coaxed into giving odds ratios, but if there is, I’m not aware of it.

I’m not sure how much those statistical issues matter. I would expect that you’d get broadly similar results with different techniques. But as with the opaque way in which the lifetime excess risk was calculated, it just bothers me when statistical methods are not as they should be. It makes you wonder if anything else was wrong with the analysis.

Oh, and a further oddity is that nowhere in the paper are we told the total sample size for the analysis. We are told the number of women who developed ovarian cancer, but we are not told the number of controls that were analysed. That’s a pretty basic piece of information that I would expect to see in any journal, never mind a top-tier journal such as the Lancet.

I don’t know whether those statistical oddities have a material impact on the analysis. Perhaps they do, perhaps they don’t. But ultimately, I’m not sure it’s the most important thing. The really important thing here is that the study has not shown that HRT causes an increase in ovarian cancer risk.

Remember folks, correlation does not equal causation.

Correlation does not equal causation, Healthcare, Politics

Hospital special measures and regression to the mean

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Forgive me for writing 2 posts in a row about regression to the mean. But it’s an important statistical concept, which also happens to be widely misunderstood. Sometimes with important consequences.

Last week, I blogged about a claim that student tuition fees had not put off disadvantaged applicants. The research was flawed, because it defined disadvantage on the basis of postcode areas, and not on the individual characteristics of applicants. This means that an increase in university applications from disadvantaged areas could have simply been due to regression to the mean (ie the most disadvantaged areas becoming less disadvantaged) rather than more disadvantaged individual students applying to university.

Today, we have a story in the news where exactly the same statistical phenomenon is occurring. The story is that putting hospitals into “special measures” has been effective in reducing their death rates, according to new research by Dr Foster.

The research shows no such thing, of course.

The full report, “Is [sic] special measures working?” is available here. I’m afraid the authors’ statistical expertise is no better than their grammar.

The research looked at 11 hospital trusts that had been put into special measures, and found that their mortality rates fell faster than hospitals on average. They thus concluded that special measures were effective in reducing mortality.

Wrong, wrong, wrong. The 11 hospital trusts had been put into special measures not at random, but precisely because they had higher than expected mortality. If you take 11 hospital trusts on the basis of a high mortality rate and then look at them again a couple of years later, you would expect the mortality rate to have fallen more than in other hospitals simply because of regression to the mean.

Maybe those 11 hospitals were particularly bad, but maybe they were just unlucky. Perhaps it’s a combination of both. But if they were unusually unlucky one year, you wouldn’t expect them to be as unlucky the next year. If you take the hospitals with the worst mortality, or indeed the most extreme examples of anything, you would expect it to improve just by chance.

This is a classic example of regression to the mean. The research provides no evidence whatsoever that special measures are doing anything. To do that, you would need to take poorly performing hospitals and allocate them at random either to have special measures or to be in a control group. Simply observing that the worst trusts got better after going into special measures tells you nothing about whether special measures were responsible for the improvement.

Dodgy reporting, Economics, Politics

Student tuition fees and disadvantaged applicants

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Those of you who have known me for a while will remember that I used to blog on the now defunct Dianthus Medical website. The Internet Archive has kept some of those blogposts for posterity, but sadly not all of them. As I promised when I started this blog, I will get round to putting all those posts back on the internet one of these days, but I’m afraid I haven’t got round to that just yet.

But in the meantime, I’m going to repost one of those blogposts here, as it has just become beautifully relevant again. About this time last year, UCAS (the body responsible for university admissions in the UK) published a report which claimed to show that applications to university from disadvantaged young people  were increasing proportionately more than applications from the more affluent, or in other words, the gap between rich and poor was narrowing.

Sadly, the report showed no such thing. The claim was based on a schoolboy error in statistics.

Anyway, UCAS have recently published their next annual report. Again, this claims to show that the gap between rich and poor is narrowing, but doesn’t. Again, we see the same inaccurate headlines in the media that naively take the report’s conclusions at face value, and we see exactly the same schoolboy error in the way the statistics were analysed in the report.

So as what I wrote last year is still completely relevant today, here goes…

One of the most significant political events of the current Parliament has been the huge increase in student tuition fees, which mean that most university students now need to pay £9000 per year for their education.

One of the arguments against this rise used by its opponents was that it would put off young people from disadvantaged backgrounds from applying to university. Supporters of the new system argued that it would not, as students can borrow the money via a student loan to be paid back over a period of decades, so no-one would have to find the money up front.

The new fees came into effect in 2012, so we should now have some empirical data that should allow us to find out who was right. So what do the statistics show? Have people from disadvantaged backgrounds been deterred from applying to university?

A report was published earlier this year by UCAS, the organisation responsible for handling applications to university. This specifically addresses the question of applications from disadvantaged areas. This shows (see page 17 of the report) that although there was a small drop in application rates from the most disadvantaged areas immediately after the new fees came into effect, from 18.0% in 2011 to 17.5% in 2012, the rates have since risen to 20.5% in 2014. And the ratio of the rate of applications from the most advantaged areas to the most disadvantaged areas fell from 3.0 in 2011 to 2.5 in 2014.

So, case closed, then? Clearly the new fees have not stopped people from disadvantaged areas applying to university?

Actually, no. It’s really not that simple. You see, there is a big statistical problem with the data.

That problem is known as regression to the mean. This is a tendency of characteristics with particularly high or low values to become more like average values over time. It’s something we know all about in clinical trials, and is one of the reasons why clinical trials need to include control groups if they are going to give reliable data. For example, in a trial of a medication for high blood pressure, you would expect patients’ blood pressure to decrease during the trial no matter what you do to them, as they had to have high blood pressure at the start of the trial or they wouldn’t have been included in it in the first place.

In the case of the university admission statistics, the specific problem is the precise way in which “disadvantaged areas” and “advantaged areas” were defined.

The advantage or disadvantage of an area was defined by the proportion of young people participating in higher education during the period 2000 to 2004. Since the “disadvantaged” areas were specifically defined as those areas that had previously had the lowest participation rates, it is pretty much inevitable that those rates would increase, no matter what the underlying trends were.

Similarly, the most advantaged areas were almost certain to see decreases in participation rates (at least relatively speaking, though this is somewhat complicated by the fact that overall participation rates have increased since 2004).

So the finding that the ratio of applications from most advantaged areas to those from least advantaged areas has decreased was exactly what we would expect from regression to the mean. I’m afraid this does not provide evidence that the new tuition fee regime has been beneficial to people from disadvantaged backgrounds. It is very had to disentangle any real changes in participation rates from different backgrounds from the effects of regression to the mean.

Unless anyone can point me to any better statistics on university applications from disadvantaged backgrounds, I think the question of whether the new tuition fee regime has helped or hindered social inequalities in higher education remains open.