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28 May 2018

Are-parachutes-useful?-Evidence-Based-Medicine-and-a-plea-for-common-sense…

We are all making decisions every moment of the day. Some big. Some inconsequential.

So how do we decide what to do?

Current mainstream medicine loves describing itself as “Evidence Based”. The implication is that all decisions are made based upon “good scientific evidence”, with randomized trials being the “gold standard”.

But would you volunteer for a randomized controlled study into the efficacy of parachutes?

Maybe not; so this week, an exploration of what really does constitute “good scientific evidence” - and where does common sense fit in; but first



       Thought for the day

Simple can be harder than complex :
You have to work hard
To get your thinking clean
To make it simple.

But it is worth it in the end
Because once you get there,
You can move mountains.

                         Steve Jobs






To quote the authors of a landmark research paper published in the prestigious British Medical Journal (BMJ) way back in 2003, “As with many interventions intended to prevent ill health, the effectiveness of parachutes has not been subjected to rigorous evaluation by using randomised controlled trials.



Advocates of evidence based medicine have criticised the adoption of interventions evaluated by using only observational data. 

We think that everyone might benefit if the most radical protagonists of evidence based medicine organised and participated in a double blind, randomised, placebo controlled, crossover trial of the parachute.”




Simple really! We use the best available evidence for any decision we face.

In medicine, drugs are one type of intervention that often can be evaluated well using double blind, crossover trials.

But let us not even go into how often drug companies and researchers under all sorts of pressures (both external and internal) have been proven to falsify results.

The truth is that it is estimated around 75% of all recommendations made in common medical practice do not have high level scientific evidence to support them.

A good example is the treatment of early bowel cancer. Everyone accepts surgery is the best option; yet there has never been a randomized trial to confirm this - probably never will be; the fact remains this option is based entirely on clinical experience.

So it may be helpful to point out what the definition for “Evidence Based Medicine is. The commonly accepted definition first appeared in the BMJ, this time back in 1996 :

Evidence based medicine (EBM) is the conscientious, explicit, judicious and reasonable use of modern, best evidence in making decisions about the care of individual patients. EBM integrates clinical experience and patient values with the best available research information.

Key points? 
Not just “best available research”, but “clinical experience and patient values”. This is the definition. This is EMB. Clinical experience is important. And the patient and what is important to them needs to be taken into account. You need a good clinician!

The problem? 
Current medicine in my opinion has been railroaded by those who overly value scientific research.

My sense of it is that many current practitioners have lost confidence in their own abilities.

It seems that unless a test confirms something for them, they are unable to trust their own clinical acumen.

Rather than examining their patients, they send them off for tests - blood tests, XRays, CAT scans; and often it seems the more complex the tests the better.

And this reliance on investigations is certainly driving and being supported by big business in medicine. An MRI costs a lot more than palpating an abdomen.

And the lawyers have a lot to answer for as well. If challenged - as in sued - a doctor has a better chance of defending themselves these days if they can refer to the evidence of pathology and other tests rather then clinical examinations.

So what to do?

Firstly be aware that evidence has a hierarchy.
There is good evidence and bad evidence, or should we say evidence with greater or lesser weight. In science and medicine there is what actually is called “The Hierarchy of Evidence”. This describes the quality of evidence as follows…

1. Systematic reviews and meta-analyses of "Randomised Controlled Studies (RCTs) with definitive results".
2. RCTs with definitive results (confidence intervals that do not overlap the threshold clinically significant effect)
3. RCTs with non-definitive results (a point estimate that suggests a clinically significant effect but with confidence intervals overlapping the threshold for this effect)
4. Cohort studies
5. Case control studies
6. Cross sectional surveys
7. Case reports

No need to bother with the detail of the above unless you are really into it; where a read of Wiki on this matter may be useful (3).

Clearly when it comes to evaluating research evidence, this hierarchy has some use; the implication being that the higher up the hierarchy you go, the better the quality of evidence.

But be aware that even when the research evidence is good, it still needs to be personalised for you as an individual and there may be several if not many other factors to take into account as well as the scientific research.

An example?

It is summed up by what in the definition of EBM was described as “patient values”.



Finally, note how the hierarchy of evidence starts with case reports (reports in journals of individual or similar case histories with details of diagnosis, treatments and outcomes, but no systematic research)- which scientific types commonly describe as “anecdotes” and demean.

However, case reports often are the best evidence available - as in the only evidence available -  and as such they constitute the basis for correctly informed EBM.

An example?
For many years it could well be argued that the best way to treat cancer nutritionally was to follow the diet as recommended in You Can Conquer Cancer (4).

The reason for this assertion is that for many years there was no better evidence; the Foundation through the clinical experience of myself and all my colleagues had amassed more clinical experience with treating cancer with nutrition than anyone else in the country, so to be Evidence based, we had the best evidence!

How do you like that idea???

Anyway, what to do now? 
Now there is more formal research evidence for cancer nutrition, as well as so much bogus stuff floating around the net and in the press. How to make the best decision we can in any circumstances - medical or elsewhere???

So a push for common sense.

That is it.

That is where this post ends.

A push for common sense.

And more trust in, and support for doctors who do actually talk with their patients and do actually physically examine them.



And avoid any suggestion you take part in a RCT to do with parachutes.

REFERENCES 
1. Smith GCS and Pell JP : Parachute use to prevent death and major trauma related to gravitational challenge: systematic review of randomised controlled trials. BMJ 2003; 327:1459

2. Sackett DL et al : Evidence based medicine: what it is and what it isn't. BMJ 1996;312:71

3. Greenhaigh T : How to read a paper. Getting your bearings (deciding what a paper is about)  1997  BMJ. 315 (7102): 243–6.

EDITOR’s NOTE This is a very useful paper if you are interested in reading original research papers and interpreting their qualities.

4. You Can Conquer Cancer : First published 1984, revised current edition 2015, Wilkinson Publishing, Melbourne. Also available as a spoken book - from my website...

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Just give me the facts


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6 comments:

  1. This is the most fantastic blog Ian,a long overdue call for commonsense is needed and look at the history of the situation ,I remember you saying many years ago ,it only takes one person to do well to know that it can be replicated in others.Hold onto your own power of thought do not surrender your recovery plan to others ,hold onto how you can participate yourself and become a JV with your Dr or health team..Love Love love this blog

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    Replies
    1. It is a bit like the parachute test for common sense Jen, we only needed to get one person to the moon to know it could be done ... :)

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  2. Everyone is different - it must be really hard to know what the results actually are - particularly thinking about the placebo effect.

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    Replies
    1. Exactly the point Nicola; it is complex and to attempt to simplify things by saying research evidence is all that needs to be taken account of is simply poor science.

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  3. What a great article. Unfortunately even choice magazine has hopped on the bandwagon of accusing natural therapies as non evidence based and therefore no basis for health. I attempted to post in a discussion on there on the weekend and was attacked for saying that natural treatments work by just about everyone on there. Huge add where they are bagging out natural therapies. The people on there were so closed minded and biased. Pity I didn't have your analogy of parachutes then hey :)

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    Replies
    1. The difficulty Jenetta is that strong lobby and marketing forces have managed in our current climate to stifle open debate/discussion on some of these crucial issues. It is a sad day when it is politically incorrect to champion the benefits of natural therapies. More power to you and all we can do is keep on putting out the message for balance and common sense.

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