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Gold, incentives and meh

NICE recommends introduction of 10% statin threshold into QOF despite GP opposition

NICE has given the green light to a new QOF indicator rewarding practices for how many patients they treat with statins at the 10% primary prevention threshold, despite unease among GP members on the independent advisory panel.

The introduction of the 10% threshold for prescribing statins to patients newly diagnosed diabetes and hypertension was discussed this afternoon at the first meeting of the newly convened QOF committee.

The indicator will now be put forward for GPC and NHS Employers to negotiate its introduction into the contract for 2015/16.

It comes after the RCGP, the GPC and the former chair of the QOF advisory panel all strongly spoke out against the introduction of the indicator.

Several GP members of the panel voiced concerns about the proposed indicator rewarding practices only for treatment with statins and not lifestyle advice - which they said goes against the NICE lipid modification guidelines which emphasise lifestyle advice should be offered before statin therapy.

They argued for the indicator to be reworded to reward offering lifestyle advice and other interventions as appropriate, including statins, to allow GPs room to discuss the option of statins with patients. They also proposed the term ‘offer’ a statin be used rather than ‘treated with’ a statin to allow more room for GPs to give patients the option of a statin rather than be paid only if the patient ended up with a prescription.

However, other committee members, including one GP, argued that NICE guidelines were clear that GPs should be prescribing statins at the 10% threshold, and that GPs would be able to exception report patients who chose not to take the drug option.

The panel agreed instead to introduce a new indicator incentivising lifestyle advice in these groups, as well as a new indicator incentivising statin treatment at the 10% threshold - and to introduce new business codes to allow for the exception reporting.

NICE QOF Committee chair Professor Danny Keenan said patients in these risk groups at the 10% risk threshold ‘should be on a statin’.

He added: ‘We have very clear guidelines, they couldn’t be clearer - and we’ve been over and over this. We’ve introduced the lifestyle indicator and allowed for exception reporting and we should go ahead with this.’

Dr Andrew Green, chair of the GPC prescribing committee, said it was ‘obviously disappointing that NICE have chosen to ignore the views of both the body that represents GPs as well as our royal college’.

However, he added, ‘whether this eventually becomes part of QOF remains subject to negotiation’.

Dr Green said: ‘I have no doubt the proposed indicator 11a [the proposal to measure the prescription of statins] will be a measure of prescribing activity but not of the quality of patient care, which depends on many more factors than a simple tablet-count. As general practice becomes more complex it is vital that measures of performance are sophisticated enough maintain validity, and have the confidence of GPs; this proposal meets neither of these requirements.’

Pulse revealed today, the former chair of the committee - Dr Colin Hunter, a GP in Westhill, Aberdeenshire - said that NICE had ‘lost the plot’ to consider introducing the new indicators.

He said: ‘I personally am completely against the 10%. I don’t think there is enough evidence to support it and I think it’s a societal question.

‘I think it is where NICE has lost the plot – when you end up with the majority of people over 65 needing a statin because the economics tell you that. The economics are far from a good science.’

Dr Hunter’s intervention followed those of the RCGP and the GPC, who both strongly opposed the proposals in their consultation responses.

The GPC said that it was ‘vital for the credibility of QOF’ that indicators have a robust evidence base, make significant difference to patients and are backed for the profession, adding that these proposals ‘fail on all these counts’.

The RCGP warned that the proposals risked ‘the loss of professional confidence in the healthcare targets they are being asked to meet’.

Proposed wording of new indicators

  • IND-11: % of patients aged 25-84, with a new diagnosis of hypertension or type 2 diabetes* who have a recorded cardiovascular risk assessment score of 10% or greater who have been given lifestyle advice;
  • IND-11a: % of patients aged 25-84, with a new diagnosis of hypertension or diabetes* who have a recorded cardiovascular risk assessment score of 10% or greater who are currently treated with statins.

* this may include ‘three months either side of diagnosis’

 

Readers' comments (44)

  • I'm struggling with Tony Copperfields lets me positive

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  • Crazy. Why not just add atorvastatin to the water supply and be done with it.

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  • Please note the American guidelines are to start statins at 7.5% risk, although they have to pay for privilege of being Statinised!
    Theoretically NICE are correct, however given the lack of adequate funding for healthcare even for many mainstream diseases, this would be in the bottom of my list.
    NICE maybe be clever but certainly not wise!
    Interestingly I look forward to 75% exception reporting!

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  • Sorry but is there any evidence for 7.5%? or is it big pharma speaking again?? Should we care what the Americans are doing?

    Prof Keenan says 'should', but if we don't, we don't get paid or we get sued by the patient's family or whoever....... right........

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  • Ivan Benett

    Anon 3.48pm - I really don't think this is appropriate language. You should knw better.
    As for the headline, I this it's rather inflamatory, since NICE isn't forcing anyone to take anything. QOF is using this quality standard to incentivise prescribing of statins, which rightly should b after discussion of lifestyle and other risk factor modification.
    As 3.54pm says, the Americans have an even lower threshold.
    My own view is that we should adopt an holistic approach to the issue of prescribing drugs in this and any other situation. Discuss pros and cons dispationately with patients and share decision making. Not the foul mouthed approach of 3.48pm who frankly should have his comment withdrawn

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  • Hi Dr Benett - the headline was changed to reflect this.

  • Ivan Benett

    Anon3.58, the American College of Cardiology and the American Heart Assocition have joint guideline, ebvidence based, and published in NEJM to support their decision. Obviously the lower the threshold the great the impact on outcomes, but higher costs and side effects. It is nothing to do with Pharma who do not benefit from these gudelines.
    Should we care what the Americans say, well yes we should since they are leaders in Health Care whether we agree with them or not - doesn't mean we have to do what they say, but we should listen, and often learn.

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  • Well Ivan, I think 3.48 is just venting, and yes its not forcing, but incentivising is pretty much almost the same thing. How was it foul anyways, there was no bad language. I also think we all know on here you're a pro-govt, pro-workload GP from manchester and nobody takes you seriously. Pharma might not benefit from the guidelines, but they do benefit from increased prescribing eh. How do you determine leading in healthcare? strength of evidence? or biggest influence by big pharma?

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  • Silence the computer alerts with "patient declined" after you have persuaded them that there is more to life than a risk calculator and HmG-CoA reductase inhibitors. Next problem please.

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  • I really don't think this is appropriate language. You should know better.

    Hardly - many people are genuinely concerned about the effects of medicalizing so many people with this trendy 'pre-disease' and the risks of over-treatment. It's fairly obvious that this threshold has been lowered as a proxy pay-cut to GPs as the target will be damn near impossible to achieve.

    As for the headline, I this it's rather inflammatory, since NICE isn't forcing anyone to take anything.

    Again, not true. NICE have once again rode rough-shod over the medical profession's advice which is why this magazine wrote an article about NICE becoming a 'laughing stock'. Furthermore as we know, QOF has a tenancy towards mission creep tightening up target definitions year on year.

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  • Whilst I think that we would all agree that we should adopt a holistic approach this certainly is not it.
    The indicator as approved says that you must prescribe statins. You can exception report but it is quite clear that many comissioners reporting exception reporting as a form of cheating. Also if you don't persuade anyone to take the things (perhaps put off but 100,000 tablets it will take to prevent one event) you will get no points at all.

    The other indicator is fairly bizarre as well as it suggests that if you have a risk of less than ten percent, even with a new diagnosis of hypertension or diabetes, you don't need lifestyle advice.

    This is NICE as its most paternalistic and least holistic.

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  • NICE holistic? with no GP on its QOF advisory committee? don't make me laugh. You wouldn't expect a rock to taste nice would you

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  • Let's hand all QoF to protocol droids that just dish out whatever the algorithm states.
    For me the unmeasurable / unQoFable stuff is far more important to patients.
    I'm afraid this is just another nail that is tacked and ready to be driven in to general practice's coffin.
    Can anyone come up with QoF for TATT?
    Question one We're or are you a GP?
    Indicator 1: Counsel them to retire. We have a computer waiting for their job.

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  • Patient centered holistic individualised care?
    Utter nonsense hipocrits! Target driven harmful generic care. NICE and their lab based professors and clinical advisors. The real world is more wild than they could handle.

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  • What would be very useful is NICE publishing NNTs which we can use as the basis for providing standard information to allow the patient to make an informed consent.

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  • Dear Ivan,
    I am not sure if anon at 3.48 p.m means that if the threshold is low enough it maybe worthwhile offering it to everyone over a certain age, rather than an individualized plan which although ideal may not be feasible to deliver with the lack of appointments for acute illness leave alone preventive medicine ( however statistically better it maybe on paper).
    Also adding same to water supply is not necessarily a flippant remark-rather sarcastic reference to an BMJ article in 2003- as the concept of a "polypill" -Atenolol, statins, aspirin and ACEI- have been bandied about for more than a decade and the exact term "we are not suggesting adding it to the water supply" was an editorial interview with guardian.
    Link provided.
    http://www.theguardian.com/society/2003/jun/27/highereducation.medicineandhealth
    I who wrote about the 7.5% risk threshold at 3.54 pm-so aware of many of the latest guidelines.

    I think you need to look up the difference between Knowledge and wisdom!

    Alternatively you can see all those with CVD risk >10% and < 20% in the extended hour clinics and have leisurely chat as it seems most pilots are shutting down on Sundays due to lack of demand!

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  • wish i had been quicker off the mark to read the 3;48 comment! by far the most intriguing bit in this entire article!

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  • I am 3.48 lol, I said, in more direct terms, that I wish I will be the one to force statins to Prof Keenan, WHEN, not IF, his risk hits 10%.

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  • Dr Bennett

    You should not be "disciplining" your colleagues! While I did not read the deleted comment, in general, I believe in free speech and unless violence or clearly libellous comments are made you MUST tolerate views other than yours-in fact it is YOUR DUTY to tolerate such views-this site cannot tolerate suppression of such views.

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  • Vinci Ho

    No surprise from the authority
    No surprise from the usual suspects
    'True gold fears no fire.' Chinese saying .
    The truth remains the truth despite the judgement of time and history.
    Who is the genius ? Who is the fool?
    There will be an answer , let it be at the mean time......

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  • Be aware that failure to follow NICE "guidance" is actionable - defence union "expert independent" GP opinion regards failure to adhere to such "guidance" as a breach of duty of care and you can/ will be sued if you fail to tow the line - trust me I know to my cost!!!!

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  • 18.18 Pretty much sums up everything that is wrong with the NHS these days...

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  • Another Bennett, no relation, but I do think that I trained at Manchester about the same time as Ivan.
    I don't intend to comment about the research evidence for offering statins at 10%, 15% or whatever, but prefer to reflect on the day to day consequences of this type of target.
    Having recently lost the argument with my colleagues about adding an HbA1c to the list of blood tests we already do in relation to our longterm condition patients I now finding that I am receiving more and more slightly abnormal test results which take time to action, require repeating or a letter/ telephone appointment with the patient concerned.
    My practice age profile is already heavy with the workload arising from an elderly population, many in care homes, perhaps some who have been enabled to live long enough to suffer from dementia which wouldn't have been the case in previous generations.
    Has anybody looked at the long term comsequences of prescribing statins and whether or not there is a downside healthwise in other directions?
    Lastly having been a partner in my practice for 30 years I find that we are now finding it difficult to attract new doctors, as are other practices in Stoke on Trent. Does a newly qualified GP really want to spend all his/ her time filing/ actioning results of blood tests, discussing statins endlessly with (mostly) sceptical patients?
    I am retiring at the end of July, but will continue to work as a locum after that, hopefully freed from the strait jacket of the worst aspects of NICE, QOF etc.

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  • I'm sorry but there is no evidence that Statins actually reduce mortality ... Yes, they may reduce cardiovascular events in men but not mortaility!

    Furthermore , even this slight reduction in cardiovascular events does not seem to manifest in women, it's completely pointless to put women on statins...but alas The Ivan bennetts who like kowtowing to current trends will unsurprisingly disagree!!

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  • Knowledge is Porridge

    10.04pm. cochrane review says they do reduce mortality...
    Hate being told what to do by "the man", but statins are not a bad thing for me to offer.

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  • This is not clinical guidance, it is governance

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  • @ 11:23 -- I suggest you read the Cochrane review carefully , they have highlighted serious concerns about the true benefits of statins in large trials claiming that they reduce mortality

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  • As most people will be aware none of the individual trials in primary prevention have shown a reduction in all cause mortality - even (almost) all of the meta-analysis has shown the same thing. The only analysis that has shown a significant reduction in all cause mortality is that done by Prof Collins at the CTSU - an organisation funded by the industry and one which refuses to allow anyone else to analyse the data. Somehow, Collins magically came up with beautiful reductions in ACM even though none of the trials themselves showed this. Yes, you can argue that its only seen when we have bigger numbers, but he won't let us see the data to confirm. This is covered in a new documentary film:
    http://www.statinnation.net/ctsu

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  • Dr Bennett is hardly one to talk - forcing his "Manchester standards" on his colleagues.

    I guess some people simply like to lord it over others. Some people just like boxticking beaurucracy.

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  • The NNTs are available for the 10% cut-off and as soon as you explain them to patients they lose interest in being on a statin. So are we supposed to just mention the 10% risk and use it as a sword of Damocles to frighten people into starting a statin or have a rationale discussion about the benefits / risks even if this means they decide they do not want to go onto them..... Oh well, as long as we can exception report the majority who decline our kind offer....

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  • Samuel Lewis

    Statins are cost-effective down to ten-year cvd risk of 10% . The higher the risk the lower the nnt., and the greater the chance of individual benefiting. Trust me - NICE are the experts at this.

    But we GPs are the experts on patients, and will only treat consenting adults. I recommend Simva or Astorva at 10mg to minimise sideeffects and maximise cost-benefit reduction in morbidity. It's true that at 10% risk threshold mortality reduction has not reached statistical significance.

    But that also means that most women will not qualify. Only hypertension and diabetes patients are included.. and if they live heart attack free, and do not have a prolonged life into dementia, then that objection is also invalid.

    Offer 10mg, repeat script, no tests, no followup. Workload will reduce as you cut your heart attacks. Wake up and smell the coffee.

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  • 10mg sounds a placebo dose.Why bother ? What dose were all the trials using ?

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  • How many heart attacks do statins prevent? Given that statins increase calcification and have a number of other effects that could make CHD worse:
    http://www.ncbi.nlm.nih.gov/pubmed/25655639

    Several people have also commented on the cost effectiveness of statins, however the cost effectiveness calculation NICE did is a complete joke. If you read the report you will find that the cost of adverse effects is completely ignored. In addition, the lack of any reduction in ACM of course indicates that the statin is just as likely to cause another serious condition, even if a heart attack was 'prevented'. If you do a calculation only looking at the up side of course you will come out with a number that is favourable to mass treatment.

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  • Any half intelligent 80yr old is going to question our motives when we suggest a statin might prolong their life, when they've just complained about their arthritis, poor sight and hearing, having to get up 6x a night to pee.... Who decided we should all be living longer anyway? Old age is not for cissies

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  • Has anyone on NICE asked patients what they want? I bet they haven't and I bet they would say no to this if given the NNTs.
    .

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  • My patients do not believe the "no side effects" mantra, and I am very unconvinced that the small benefit would be considered worthwhile if explained with proper NNT tables for individuals at the lower end of risk. We should prescribe very cautiously to healthy individuals. Our patients, once convinced that a statin is good will want to consider rosuvastatin if they experience side effects. This is not cost effective, but once convinced that a statin is beneficial, the patients won't care about that- "surely you're not going t let me have a heart attack or stroke just because of cost?"

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  • Samuel Lewis

    Justin smith asks how many heart attacks will be prevented.

    Answer = one third of them.

    100 people with 10 to 20% risk will have about 15 heart attacks in ten years. So 5 will be prevented.

    The arthritic nocturic octogenarian and the fit 50 year old should have the right to decide ..

    Next question?

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  • Samuel Lewis

    In answer to anonymous of 12.42

    Statin has a plateau dose- response curve. The first 10mg of simva produces 30% cholesterol lowering. Each dose doubling adds a mere 6%.


    SEARCH compared 20mg versus 80mg = no significant difference in benefits, but 25-fold less risk of myopathy.

    10 20 40 all cheap.

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  • Samuel Lewis clarified the reduction in heart attacks as 5 prevented if 100 people are treated over 10 years.

    Of course, none of the trials have been 10 years long so we don't really know. I think there are a number of reasons to be sceptical about the long-term suggested cardio-protective role of statins. However, assuming that 5 are prevented (or postponed). How many of the 100 people treated will develop type 2 diabetes or suffer one of the many unknown fates of statin use?

    Obviously, the current system makes it impossible to know the harms. Quite simply, the commercial interest is not in pursuing that part of the equation with full openness. One example being that the Cochrane heart group highlighted the fact that around half of all the trials did not report on adverse effects at all. Another example would be Professor Collins industry supported CTT group who refuse to let anyone have access to their data, for commercial reasons.

    Its conceivable that the 5 prevented heart attacks could easily be countered by the increased diabetes risk in the longer term, yet alone the many unknowns.

    In my mind, the numbers don't add up for mass use. And the general belief that lowering cholesterol can only be a good thing ignores the consistent finding of low cholesterol and significantly increased mortality - which studies have shown is not reverse causality as was previously suggested.

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  • Samuel Lewis

    dear justin.

    i fear your mind is closed to any evidence i offer, since you do not seem to subscribe to the credo of RCT trumping all other evidence. 'none of these trials have been ten years long' ? wrong. check it out. even if it were true, then a five year trial showing significant delay in heart attack and death , would be enough evidence for me !

    Another example :- "the general belief that lowering cholesterol can only be a good thing ignores the consistent finding of low cholesterol and significantly increased mortality" is entirely irrelevant, even if it were true. The RCT evidence that taking a statin reduces CVD events by 30%, and all-cause death by upto 20% regardless of age , cholesterol level, or CVD risk trumps that argument, ever since the 4S trial (and consistently repeated in all RCTs since). I thought as you did, until I attended Pederson's 4S launch over 20 years ago in Portugal ( paid for by big Pharma, I admit, but VERY educational). When the facts changed, I changed my mind ( Maynard-Keynes). The diabetes risk is small. and clearly outweighed by the improved net outcomes of death and disability. Whether CTT are driven by Big Pharma became irrelevant when simva and atorva went off-patent cheap as chips.

    but if i have mistaken you, and "the current system makes it impossible to know the harms". why not look at your own practice experience to judge the acceptability and harm rates of statin ? you must have hundreds of cases ??

    in our practice a half of people at lower end of risk refused statin, with many citing Daily Mail 'putative side-effects'. As risk increased , our patients are much more inclined to stick with their statin. After a heart attack nearly all of them tell me they take their statin. the pharmacist confirms they do collect it!

    what does your audit tell you?

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  • Dear Samuel,

    You’re mistaken. I’m talking primarily about RCT data. And none of the RCTs on statins have been anything like 10 years in duration. They have all been around 5 years or less. We have a couple of follow-up studies covering about 11/12 years total duration, however, these are not RCTs. For example there was a follow-up study done on the WOSCOPS trial, however, for the follow-up period some people who were in the placebo group now started on a statin, and some people in the statin group had now stopped their statin. Hence, the follow-up study was not very meaningful and of course no longer has a control arm.

    The 4S study you mentioned was of course a secondary prevention trial on super-high risk population - it doesn’t really fit into our discussion of low risk populations, and I’m not questioning the role of statins in secondary prevention.

    You said that RCT evidence shows reductions in all-cause death by unto 20% and CVD events 30%. As you know, these are relative percentages which are very misleading. Relative percentages are a very good tool for spinning the results. Absolute percentages are the most important.

    For example, in the JUPITER trial the risk of heart attack was reduced by 0.41% in absolute terms (0.76% placebo vs 0.35% statin) however, the press release issued by the sponsor of the trial quoted a 54% reduction in relative terms - which was unfortunately copied by the world’s media. And incidentally, CVD deaths were the same in both groups.

    By using relative percentages to exaggerate the benefits and then just saying that the risk of diabetes and other adverse effects is small compared to this is a gross misrepresentation of the data. In the JUPITER trial the risk of diabetes was about 0.6%, which is greater than the reduction in heart attach risk. Some people might say, well having diabetes is better than having a heart attack, but this is the illusion of certainty principle

    Combining the data from RCTs on all-cause deaths shows that 1 person in 1000 could live longer - a number that is consistent with the play of chance.

    I have checked this out - as I said previously the numbers do not add up for primary prevention and especially not at increasingly lower levels of risk. I hope others will also consider this.

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  • Samuel Lewis

    dear justin,

    you confirm my suspicions as to your mindset.

    you are of course quite right to decry the use of relative risk reduction in isolation, even at 30% across the entire risk ranges studied.

    but everyone here is talking about ABSOLUTE risks of 10 to 20%, from which we can infer an Absolute Risk reduction of circa 15% x 30% ( AR x RRR)..

    of course the absolute benefit falls as AR falls. But the cheaper the statin becomes, the lower the affordability threshold for cost-benefit savings, as NICE argues.

    NICE is saying you should give more patients the chance and the choice, but you seem to want to make the decision for them.

    At what level of risk would you prescribe, and why ?

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  • Samuel Lewis

    oh, and yes you are right that none of the RCTSs per se continued to 10 years, although lots of follow-up does continue, confirming that benefit is sustained. 4S follow-up is now 20+ years.

    The reason is of course because the trials all achieved significant benefits within about 5 years, and hence MUST be stopped according to the Helsinki ethic, so that the control group can be offered the chance of treatment. Just can't win, can we ?

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  • Samuel Lewis

    for a thorough analysis of the Numbers Expected To be Treated, and the estimated costs and benefits downsized to one practice, see

    http://www.bmj.com/content/348/bmj.g1899/rr/689666

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