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Sir Michael Rawlins, Chair of the National Institute for Health and Clinical Excellence, has recently criticised our use of RCTs (Randomised Clinical Trials). This particular type of research study is promoted by many decision makers as a “gold standard” but Sir Michael listed a number of objections to this practice. He gave examples of situations where RCTs are either unneccessary or impossible, questioned the practice of failure to complete studies (30% of recent trials in oncology have been stopped early because of apparent benefit from the treatment), and expressed his concern about the high costs of conducting such research. However, perhaps his most interesting remarks related to the generalisability of RCT findings and the elevation of this methodology above others.

RCTs are often carried out on specific types of patients for a relatively short period of time, whereas in clinical practice the treatment will be used on a much greater variety of patients – often suffering from other medical conditions – and for much longer. There is a presumption that, in general, the benefits shown in an RCT can be extrapolated to a wide population; but there is abundant evidence to show that the harmfulness of an intervention is often missed in RCTs. Sir Michael argues that observational studies are also useful and, with care in the interpretation of the results, can provide an important source of evidence about both the benefits and harms of therapeutic interventions. These particularly include historical controlled trials and case-control studies but other forms of observational data can also reveal important issues. Sir Michael rejects the trend to grade various kinds of clinical trials and studies on scales of merit which he says has come to dominate the development of some aspects of clinical decision making. “Hierarchies attempt to replace judgement with an oversimplistic, pseudo-quantative, assessment of the quality of the available evidence.” Sir Michael believes that arguments about the relative importance of different kinds of evidence are an unnecessary distraction. What is needed instead is for “investigators to continue to develop and improve their methodologies; for decision makers to avoid adopting entrenched positions about the nature of evidence; and for both to accept that the interpretation of evidence requires judgement.

The generalisation issue has been raised so often it’s surprising that it is dismissed so easily by decision makers. Not only are trials artificially created clinical experiences but the entry and exclusion criteria for patients admitted to such trials always excludes “co-morbidity”. In other words if somebody had more than one clinical problem they won’t be admitted to the study. However, in actual clinical practice patients presenting with more than one disease at a time occurs so frequently that it is considered usual. Other criteria also make it difficult to generalise the results of RCTs. But, Sir Michael’s main criticism is about safety. The problems with a new drug are rarely picked up by RCTs. The problems indeed are not usually evident until many more patients have taken the drug in real life circumstances. So if we want to understand the real life potential of a drug, then we need larger, observational studies to pick up the side effects and harms which the drug can cause.

His final point is about the use of “hierarchies of evidence” which give greater credence to some methodologies over others. His contention that this distorts both the nature of evidence and that it is used as a substitute for clinical judgement is an important one

Rain

The other day I looked out of my consulting room window and saw the rain pouring down in the garden

driving autumn rain

I took a wander outside and photographed the effects of the rain on different surfaces. Here it is on wood –

rainy wood

Here it is on stone –

rainy stones

And here it is on leaves –

rainy leaves

beautiful, huh?

The “self-help” industry has been around for many years, but it seems to be growing ever larger. There are countless books, websites and courses on this subject. However, it’s hard to find anything which takes a fresh angle on the subject. One change is that increasingly the explicit language used is about “happiness” or “wellbeing”. But the focus is still, largely, the same – SELF. We read about “self-help”, about “getting what you want”, about “personal growth”. Has it ever struck you how often it’s about “me”!

There’s a change in the air however. Roman Krznaric writes about “outrospection” as a counter to the predominance of “introspection”.  And Mark Vernon has recently written a book on “Wellbeing” which also seems to develop this way of thinking. Here’s a great review of his book on Mark’s own blog. The review is by John Armstrong, and he writes…

Losing weight, taking exercise and eating the right food, improving your looks, making a sea change or a tree change, simplifying your life: these are strategies for wellbeing and they are the stock topics of a million and one newspaper articles. But the avalanche of advice suggests collective desperation: we have to tell ourselves so much about how to be happy, and say it so often, because things aren’t going well. It’s striking that the kind of advice that’s given tends to target the body first: it’s all about how you look, how healthy, fit and active you are.

He goes on to say….

In this pointed little book, British philosopher Mark Vernon argues that we’ve been looking for happiness in the wrong places. He draws attention to two aspects of life that are deeply connected to living well: love and what he calls transcendence. Love involves caring profoundly for something apart from yourself, and doing so requires that you discover capacities for generosity and self-sacrifice. Love, in a curious way, is intensely unfashionable. That’s because love isn’t egotistical; it isn’t cool; it doesn’t focus on how sexy or hip one is; and you can’t possibly love another person for being trendy or famous or rich or wearing the right clothes. So real love is counter-intuitive in a shallow world. And that’s ironic because love is central to leading a good life, and to being happy. Our world is addicted to the idea of happiness but rejects a crucial way in which happiness isattained.

That particular sentence about love – “Love involves caring profoundly for something apart from yourself, and doing so requires that you discover capacities for generosity and self-sacrifice.’ – really struck home for me. I think “health” is a positive experience which has distinct characteristics, and one of these characteristics is “engagement”. When we are engaged with what lies outside us – Nature; other people; Art; community, and so on – then we experience “flow”, “happiness” and “wellbeing”. In that sense, “health”, strangely, isn’t really found inside a person, it’s found in the contextualised person, the connected person, not in a separate, discrete individual.

Even more of a challenge is what Armstrong writes about the place of suffering in life –

These are not in any way recipes for a painless life and that’s how it should be. Understandably, we seek to avoid pain. But much of what is important and valuable in life is inescapably connected to suffering. You cannot form a deep relationship with another person unless you worry about them, fear what could happen, get bitterly disappointed with yourself for letting them down or for causing them anguish or frustration. And eventually you will have to mourn for them or they will have to mourn for you. You can’t engage with the things that make for a good life unless you are able to cope with suffering. It’s the same with any worthwhile creative effort, with noble political hopes, with any desire to improve the world: worthwhile, valuable, but a hard road.

What this paragraph provoked for me was Wim Wenders “Wings of Desire” (remade in English as “City of Angels“) which tells the story of an angel who becomes a human in order to fully experience the pleasures and the suffering (ultimately, the mortality) of human life. It’s a great movie and is, I think, one of the greatest celebrations of what it is to be human.

There’s definitely something worthwhile and interesting here. What I like about it is a change of direction away from looking inwards, towards emphasising what we’re connected to which is greater than ourselves, towards looking outwards – it’s about becoming more loving.

Vitamin D

I read some research recently linking low vitamin D levels to chronic pain in women. As the Scottish population is well known to be rather deficient in vitamin D (not enough sunlight, poor diet), and as I see a lot of patients with chronic pain, I’ve started sharing this research with female patients who have chronic pain. Already I’ve had back reports of quite dramatic reductions in pain levels in some of these patients. I hadn’t been aware of such a connection before but I had been aware that vitamin D insufficiency might be one of the factors behind the high levels of Multiple Sclerosis in Scotland. Well, it seems that vitamin D may have an even more extensive role to play in health than we realised

In a paper published in the August issue of the American Journal of Clinical Nutrition, Norman identifies vitamin D’s potential for contributions to good health in the adaptive and innate immune systems, the secretion and regulation of insulin by the pancreas, the heart and blood pressure regulation, muscle strength and brain activity. In addition, access to adequate amounts of vitamin D is believed to be beneficial towards reducing the risk of cancer. Norman also lists 36 organ tissues in the body whose cells respond biologically to vitamin D. The list includes bone marrow, breast, colon, intestine, kidney, lung, prostate, retina, skin, stomach and the uterus. According to Norman, deficiency of vitamin D can impact all 36 organs. Already, vitamin D deficiency is associated with muscle strength decrease, high risk for falls, and increased risk for colorectal, prostate and breast and other major cancers.

This research group is recommending that people take 2000 international units of vitamin D a day. This is considerably higher than other recommendations which range from 200 to 400 units depending on age (older people need more). It is possible to take too much vitamin D and be harmed by it but this is unlikely at doses under 10,000 units daily so the 2,000 units recommendation is well within safety limits.

This seems to be a developing story, but I think we’re going to see more attention being paid to this somewhat neglected vitamin!

Selecting the evidence

There’s a strange presumption in some quarters that “science” (as if there was a “thing” called “science”) is the only way to know the TRUTH about reality. Research is a fascinating phenomenon to consider, and the more you consider it, the less straight forward it appears! One of the issues in medical research is the issue of bias produced by the funds for a study being put up by the pharmaceutical company which makes the drug. This is an issue which has been, and will continue to be, discussed and debated extensively. I’m not going to go down that road in this post. What I would like to draw your attention to however is an article published in PloS Medicine. The authors argue that the sheer size of the output from labs and research groups so outweighs the number of outlets for publication that there is an intense publication bias through the necessary highly limited selection process of the journals, that what is published amounts to a serious distortion of the reality of scientific endeavour.

The scarcity of available outlets is artificial, based on the costs of printing in an electronic age and a belief that selectivity is equivalent to quality. Science is subject to great uncertainty: we cannot be confident now which efforts will ultimately yield worthwhile achievements. However, the current system abdicates to a small number of intermediates an authoritative prescience to anticipate a highly unpredictable future. In considering society’s expectations and our own goals as scientists, we believe that there is a moral imperative to reconsider how scientific data are judged and disseminated.

An example of the kind of distortion of reality this selection process produces was highlighted in the New England Journal of Medicine which found this –

Results Among 74 FDA-registered studies, 31%, accounting for 3449 study participants, were not published. Whether and how the studies were published were associated with the study outcome. A total of 37 studies viewed by the FDA as having positive results were published; 1 study viewed as positive was not published. Studies viewed by the FDA as having negative or questionable results were, with 3 exceptions, either not published (22 studies) or published in a way that, in our opinion, conveyed a positive outcome (11 studies). According to the published literature, it appeared that 94% of the trials conducted were positive. By contrast, the FDA analysis showed that 51% were positive. Separate meta-analyses of the FDA and journal data sets showed that the increase in effect size ranged from 11 to 69% for individual drugs and was 32% overall.

The PloS article makes some suggestions for improving the system, not least recommending the digital publication of any research without significant errors rather than selection on the basis of what someone considers “important”. That would be a start! But the most important point here is that published research is not equivalent to Truth. We should consider it, but remain wary of claims to certainty.

When I recently made myself a visual diary, I explored the origins of the names of the days of the week. In fact, a while ago, when I went to Japanese language evening class, I was struck by how the days of the week in Japanese were named after certain planets, and knowing a bit of French I was struck by the fact that the French too named the days of the week after the same planets. It’s not so clear in English because we’ve swapped the Greek and Roman Gods for Norse ones – like Woden and Thor, but in fact, these Gods are associated with exactly the same planets for each of the days as we find in the Japanese and French traditions.

One of the things which makes human beings unique is our ability to handle and play with metaphors and symbols. We are great at both applying and discovering meanings. Absolutely everything can be considered to be a representation of something else. This allows us to experience life in a rich variety of ways. So I got to wondering about the Classical myths associated with each of the planets and their associated gods. How would a Monday feel if I was more aware of its association with the Moon? Any different? How about a Friday and its association with Venus? Would the week develop a different rhythm if I reflected on each day and the different qualities related to the myths and stories we’ve associated with each of the planets? Let me be clear, I’m not talking about astrology, I’m talking about myth, narrative and symbolism……the way we use these ways of colouring and even creating our experiences.

I’m still working on this but before I say more about it, there’s another factor affecting my thoughts about it. I’ve just finished reading “La sagesse des jours”, by Andre Guigot. The translation of the book’s title would be “The Wisdom of the Days”, and in it, this French philosopher considers how each day has its own unique qualities which can stimulate our thoughts about different aspects of life and living depending on which particular issues are predominant on specific days of the week. In fact, it wouldn’t be possible to write a book like this in English, certainly not for a UK audience (and probably not for a US audience either), because we’ve lost the kinds of rhythms to life which the French still enjoy. To give you a flavour of his book, he identifies Saturday as market day for example, (I don’t know any towns in France which don’t have a market on a Saturday!) and he identifies Tuesday as the first day of commerce in the week (many shops in France, in fact most shops in smaller towns, close on a Monday) It’s an inspiring little book but translating it into a UK context isn’t very easy.

So I’m wondering how to ascribe certain qualities to particular days of the week. And I’ve come up with a few ideas already. For example, the moon is usually associated with feelings and with reflection. Could Mondays be days to be more aware of what’s going on inside? To be more aware of my emotional reactions throughout the day? Then, Tuesday is Mars day. Themes associated with Mars are themes of physical strength and fitness, and themes of the urge to distinguish oneself as a unique individual. This contrasts a lot with Friday which is associated with Venus. Whilst Mars is associated with maleness, or with yang energy, Venus is associated with femaleness, or yin energy. Whilst Mars is associated with distinguishing ourselves as individuals, Venus is associated with togetherness, with love, relationships and belonging. Wednesday’s name comes from Mercury, the “winged messenger”, a day to play with words and symbols, to be linguistically creative….hey, maybe a day for writing poetry, or for communicating. Thursday is named after Thor, or Jupiter, associated with expansion, of reaching out, of empathy and the understanding of others which comes with travel. Whilst Saturday is associated with Saturn and themes of conservation, of strengthening and consolidating. Which leaves Sunday as a day to celebrate Life and being alive.

You get the idea? This is just a brief outline, but I hope you can see the germ of an idea here. I hope you can see a way of creating your own personal rhythm to the week. I’ll work on this and return to it, but meantime, I’d be really interested to hear your own take on this. How do you distinguish the days of the week from each other? What qualities or characteristics would you ascribe to particular days?

A Visual Diary

It’s come to that time of year when I’m needing to put some events, meetings, trips and so on into a 2009 diary. For the last couple of years I’ve been using a small moleskine week over two pages diary but I’ve grown disenchanted with the linearity of such diaries. They are all divided up into sections (either per day, or per week, or month) and all the sections are of the same size but because days are all different (well, they are in my life anyway!) I find that some days the entries are spilling over into surrounding days and other days are virtually blank. This all comes down to how you use a diary. I’m pretty minimalist. Key points only for me.

So, having looked around in the stationery stores I decided to MAKE a diary which was better suited to my purposes. I won’t lay out here all the steps involved in the creative process but I thought I’d share the result. Maybe you’ll be inspired by some element of this, make your own, or borrow some of the ideas I’ve used.

I decided to stick with Moleskine, but to use what they call a “Japanese fold” notebook – like this –
Japanese fold moleskine
This is a continuous single sheet of paper which is folded instead of cut to make the separate pages. I wanted to use a double page spread for each week. I mark the top right hand corner of the right hand page with the starting and ending dates of that week (my week starts on Monday and ends on the Sunday).
I want to use the whole spread to lay out my commitments and information in a kind of “mind map” style, so I thought I’d put the days of the week down the middle of the spread. That looked pretty ugly and I am a very visual person (which you’ll have realised from all the photography on this blog!), so I decided instead to use a symbol for each day of the week. Well, it turns out that in many languages of the world the names of the days are related to the names of the sun, the moon and five planets – the same ones in many, many languages.
Sunday = Sun
Monday (French; Lundi) = Moon
Tuesday (French; Mardi) = Mars
Wednesday (French; Mercredi) = Mercury
Thursday (French; Jeudi) = Jupiter
Friday (French; Vendredi) = Venus
Saturday = Saturn
I didn’t want to draw all the symbols every week so I made a jpeg of the symbols and uploaded it to moo.com to get stickers made. Here they are –
moo stickers days of the week
I place one sticker just to the left of the centrefold (I have more entries usually on Monday, Tuesday, Wednesday, than I do on Thursday, Friday and Saturday). You’ll see I’ve got the Sun in the middle (it’s not a day I usually enter any commitments). There are Monday, Tuesday and Wednesday on the right, and Thursday, Friday and Saturday on the left, and they follow the sequence like a clock face (time goes clockwise in my life! 🙂 )
one week spread

To enter a new piece of info I draw a pencil line out from the day of the week and enter the details. I can follow this item out with branching lines, mindmap style, if necessary. (I’ve found it useful to put the actual date (numerical day of the month) at the root of the line.)
That’s it really.
I’m enjoying it. It’s aesthetically pleasing and it suits the way I think and I organise.
I’ve added two additional features to make it more functional. In the pocket at the back of the moleskine I put 3 x 5 index cards, one for each month ahead (carrying only 3 or 4 at a time). This gives me a kind of planner overview.
monthly index cards

And I’ve attached two small post-it pads inside the back cover, to write details of any dates not covered by the existing spreads or cards.
post-its

I’ve been using this new diary for about a month now and I’m finding it’s sparking off a whole chain of thought I hadn’t predicted. But I’ll tell you about that in a separate post!

Finding hotspots

There are more and more wifi hotspots around the world. It’s getting easier and easier to connect wherever you are.

Look at these two students I spotted one night on my way through Aix en Provence. I’m guessing someone inside that building has got a wireless router on! Look at the way the light of their laptop screens lights not only their faces, but casts both a shadow and a shine onto the wall behind them.

night time hot spot aix

I read a short article in the Glasgow Herald yesterday about a London based financier, Kirk Stephenson, Chief Operating Officer of a private equity company called Olivant. Originally a New Zealander, he had a senior position in his company. He was a wealthy man who had a £3.6M Chelsea home, a home in the West Country and who loved to travel, acquiring a formidable knowledge of boutique hotels and loved going to opera. He was married and had an 8 year old son. Here’s how his family described him –

a life-enhancer – not with a showy, life and soul of the party sort of charisma, but as a planner and coordinator who quietly and with no fuss ensured everyone around him had a marvellous time. A dedicated father and a devoted husband, he valued his family above all else. At the same time he had a gift for friendship and was a generous and exceptional host, gathering his wide circle around him in summer villas all over Europe, as well as for parties, dinners and opera. Any occasion with Kirk was a wonderful experience. He spent many a fine – and less than fine – summer evening listening to opera at Garsington, Glyndebourne and the Grange with friends. (He) also loved board games and tennis, passions he shared with his treasured eight-year old son Lucas.

Aged 47, he killed himself by throwing himself in front of a train last week.

How do you make sense of that? You’ll find so much in self-help books, books about happiness, websites which advise you how to have a good life……..but just what constitutes a GOOD life? By good life, I mean one worth living, one you want to hold onto, one you don’t want to give up.

Obviously I only know what the papers published about this man, but the details are desperately perturbing. Those little details paint a picture of a successful professional, a materially wealthy man, a loved man with many friends, a young son…….a man who committed suicide at 47.

I don’t have any answers here. It’s just the story really disturbed me, and it’s continued to niggle away at me since I read it.

I am because you are

One of greatest joys of blogging is how it facilitates the discovery, and creation, of connections. My daughter, Amy, who writes the wonderful lessordinary, has developed a whole online network of friends through her blog. She’s a great networker and deliberately creates her blog to make and develop connections with others. Let me tell you a little story which will illustrate how this is such a core quality of hers. When she left school, she was accepted for an English Literature course at Stirling University. We drove her to the halls of residence in the grounds of the university at the start of the first semester and helped her unpack her small collection of belongings from the boot of the car and pile them in bags and cardboard boxes into her small room. If you’ve ever been to a student hall of residence you’ll have an idea of what they are like. This one was typical in my experience – a series of corridors full of identical box like rooms each with the same furniture (most of it custom built to fit the room exactly and screwed to the floor or the walls). At first sight its a bit bleak and very impersonal. It wasn’t easy to leave her there. I shouldn’t have worried though because the very next day she phoned and said when the door closed behind her and she sat in that bleak room alone she cried. Then she thought, well, everyone else in this corridor is in the same boat as me, I’ll go and say hello. So she set off down the corridor, knocking on all the doors, introducing herself and inviting the “freshers” down to the pub for a drink and a chat. She never looked back.

It strikes me that blogging can be a bit like that. Each of these posts is like a little room, something to be discovered, a door to knock on. I’ve been blogging for about 18 months now and there have been over 55,000 visitors in that time. Almost 2000 comments have been left and every one of those comments is like a little knock on the door.

I hope that some of the posts you read here will be like little discoveries for you, that you’ll hear that knock on the door, and that you’ll find new connections and new possibilities in your life. But let me tell you of a recent experience where it’s happened the other way around for me.

A couple of weeks ago a new commenter, Ian, came along and left comments on a few different posts. At the same time he emailed me and introduced himself. In his introduction he described the trail which led to our connection. Ian said he’d been in Ullapool recently and had picked up a copy of “Why do people get ill?”, completely resonated with it and decided to read some reviews online. One of those reviews was the one I wrote on this blog. He browsed my blog and discovered a like mind. He also recognised my name and remembered a poet friend of his mentioning me to him some time back – Larry Butler. Well, not only has Ian left some really interesting links other sites in his comments, but last week he emailed me and asked if I’d like to go to a traditional music concert at the Tolbooth in Stirling. It was an eye-opener for me. Or maybe, more accurately, and ear-opener. Too much to say about it here in this post but here’s the bit which is most relevant to this story. The three musicians, for some of their tunes, all played mandolins. I can’t say I’ve ever been attracted to the mandolin, but one of the people I’ve met through blogging is the wonderful Dr Tom Bibey. He plays mandolin in a bluegrass band and as I listened to the music I not only heard the mandolin differently from how I’ve heard it ever before but – and here’s my point – I heard it differently BECAUSE of the connection with Tom Bibey – and enjoyed it as never before, but the whole evening, and the people I met there, showed me another possibility – that of playing music. I listen to music all the time. But I haven’t played music since I was a teenager. I think it’s probably time to change that. That thought, the possibility of picking up a musical instrument again, is like a rediscovery of part of me. But several decades on, its a rediscovery of a different me, as I’m obviously much changed by my experiences and my connections of the last thirty years or so.

We are who we are because of the people we connect with. Human beings are highly social creatures. It’s impossible to know what a person is like by putting them into a room all by themselves. We reveal ourselves through our relationships. We create ourselves through our relationships. The patients I meet every day change me because they tell me their own, unique stories. Their stories are told from their own, unique perspectives. They are the heroes of their own stories. And in the telling of their stories they show me different ways of seeing and experiencing the world. The world is different after a story. I am different after a story.

Remember that a story has several components – a teller, a tale, something told about, and a recipient of the tale. Through the sharing of our stories we change each other. We create each other.

One of Ian’s links was to Roman Krznaric who has written a fabulous downloadable booklet called “Empathy and the Art of Living”. Go get it and read it. I highly recommend it. Here’s a key extract –

Most books or courses on the art of living focus on how we can
discover ways of improving our own lives. The emphasis is,
unashamedly, on what can be done to help me. I find this kind
of self-help approach too narrow, individualistic and narcissistic.
In my experience, those people who have lived the most joyful
and fulfilling lives have dedicated much of their time to thinking
about and helping others. It has given them not only personal
satisfaction but also a sense of meaning. They have, in effect,
lived a philosophy of ‘You are, therefore I am’.
Einstein recognised the need to move beyond self-help when
he said: ‘Strange is our situation here upon earth. Each of us
comes for a short visit, not knowing why, yet sometimes
seeming to divine a purpose. From the standpoint of daily life,
however, there is one thing we do know: that man is here for
the sake of other men.’ We will always feel something missing if
we attempt to live alone, hermetically sealed in an isolation of
our own making, thinking only of our own pleasures and pains.
The mystery of existence is constituted by our relations with
each other.
The twentieth century was an age of introspection, when
psychoanalysis impelled us to search for who we are by looking
inside our own heads. But the art of living involves escaping
from the prison of our own feelings and desires, and embracing
the lives of others. The twenty-first century should be the age of
outrospection, where we discover ourselves by learning about
other people, and finding out how they live, think and look at
the world.
Empathy is at the heart of how to live and what to do, and is
the ultimate art form for the age of outrospection.

Now I don’t know if Roman has invented that word – outrospection. But if he has then it’s hats off to him! This SO hits the spot! I find myself completely agreeing with this viewpoint. There’s way too much in the world of self-help which turns people in on themselves but most of what I’ve read about happiness includes an emphasis on the human need to connect to others, to connect to a sense of whatever is greater and more than ourselves, to be engaged with the world.

Who I am evolves and changes every day as I live in the world. I’m changed by my daily experiences, not least because of the other people I meet and connect with each day. This very fact brings back to my mind one of the books I have most enjoyed in recent months – Linked by Albert-Laszlo Barabasi.

Barabasi makes it crystal clear that to understand anything in this world we need to examine the connections, the links – how very Deleuzean!

I am because you are