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Nueva guía hipertensión ACC-AHA: escasa en valorar beneficios/daños/costes/-un saludo juan gérvas @JuanGrvaspreferencias.
Hypertension. New ACC-AHA: the guideline falls short in weighing the potential benefits/harms, costs, and anticipated variation in individual patient preferences.
http://annals.org/aim/article-abstract/2670323/hypertension- limbo-balancing-benefits- harms-patient-preferences- before-we-lower 2018-01-19 10:56 GMT+01:00 Juan Gérvas <[log in to unmask]>:¿Nueva guía para hipertensión? Reserve el bajar a 130/80 mm Hg para pacientes con algo riesgo. Los demás van bien con 140/90. Vía @sanoysalvoblog-un saludo juan gérvas @JuanGrvas
While a blood-pressure treatment target of less than 130/80 mm Hg makes sense for high-risk patients, for everyone else it seems more reasonable to continue defining hypertension as a blood pressure of 140/90 mm Hg or higher.
http://www.nejm.org/doi/full/10.1056/NEJMp1716193 2017-12-23 1:16 GMT+01:00 Rod Jackson <[log in to unmask]>:Hi Michael- these are good points and there clearly is uncertainty around estimated CVD risk using various calculators and the estimated benefit of treatment calculated by applying the RRRs from RCTs to these risk estimates.
However one of the many benefits of using a multi variable risk equation to inform treatment decisions is that variability in any single risk factor, like BP, has limited influence on the estimated risk.
Moreover the benefit of treatment of say BP, is more closely related to pretreatment predicted risk, than the pretreatment BP.
Cheers Rod
* * * * * * * *
sent from my phone
Hi Rod et al
I have been following this conversation with interest, and would like to widen the scope beyond decisions around hypertension and CVD to include all health conditions.
When making a decision, there are two kinds of information that I would like to include in my options appraisal, but which have not been discussed: what the stakes are, and what the uncertainties are.
If it is a low stakes decision, e.g. whether to invest a few minutes to find paracetamol for an inconvenient headache (or to throw the loose change in my pocket away on a lottery ticket), it basically comes down to what I find convenient or attractive.
If it is a high stakes, imminent life or death situation, I would like to know what the predictive interval is around the risk prediction so that I know how seriously to plan for the worst outcome and how optimistically to plan for the best outcome,
The risk calculators and shared decision-making tools that I have seen (from an experience that is way less than that provided by a systematic review) ignore the uncertainties in predictions and do not help much in taking account of the best and worst case scenarios in my decision-making.
To bring the focus back to hypertension: what is the uncertainty around the blood pressure estimate that is used in CVD risk calculators? My personal experience is that there are some people whose blood pressure fluctuates quite widely even when a white coat is out of sight and out of mind.
Michael
On 21 Dec 2017, at 21:56, Rod Jackson <[log in to unmask]> wrote:
Hi Owen. Like James and Bill, I enjoyed reading your response and share some of your concerns. I am particularly concerned about anti-democratic decisions which is why I have spent the last 25 years developing guidelines and conducting research aimed at facilitating a change from traditional single risk factor based CVD risk management guidelines to multi variable CVD risk prediction informed management guidelines.
As I have mentioned in previous posts, you cannot make an informed decision about lowering blood pressure (or LDL cholesterol etc) with knowledge of the likely absolute risk associated with no intervention and the absolute risk reduction associated with an intervention. Without this information the management of CVD risk will always be un-democratic, because individual risk factors are hopeless measures of absolute risk.
I am in my early 60s and meet current US recommendations for statins, based on my predicted 10-year CVD risk using the 2013 AHA/ACC Pooled Cohort Equations. However a recommendation is a recommendation, not a rule, and as the 2014 US high cholesterol guidelines first recommend assessing CVD risk, I (and my general practitioner) am able to make an informed decision based on the best estimates we have of risks and benefits.
I have decided not to follow the US recommendations to start statins at this stage for several reasons. First, I have used predicted CVD risk as the starting point for estimating my risk. I then qualitatively individualised this risk based on my clinical and epidemiological judgement about the variables not included in the equation that are likely to increase or decrease my personal risk. Based on this individualised risk, I think my true risk is somewhat lower than the initial predicted risk, so I am now on the borderline of the recommended treatment threshold. Second, having estimated my risk without treatment (based on my qualitatively individualised version of a quantitative predicted risk) I then applied the relative risk reduction I could expect from statins (based on meta-analyses of RCTs) to determine the likely absolute treatment benefit. Informed by this estimated treatment benefit, I decided that the costs (to a New Zealander the costs are mainly the hassle of taking drugs every day because statins cost a few cents a day, plus the likelihood that I would incorrectly blame the muscle aches I get anyway on statins) don’t currently justify the benefits. I will probably change my mind sometime in the future when the balance of risk, benefit and cost changes.
Granted, I know more about CVD risk/benefit than most people, but most of what I have described could be integrated into an electronic support system. There are a number of rudimentary systems already and they will get better with time.
I consider this a more ‘democratic’ approach to CVD risk management than previous approaches. It is not perfect but I am convinced it is a step in the right direction.
Or am I missing your point Owen?
Cheers RodHi Owen - thanks for your response - your ideas are definitely interesting and I enjoyed your response but you haven’t answered what you specifically would do for these people. The questions aren’t the results of the logic of anticipatory care they are real life scenarios which require a decision - and one option is doing nothing. I think Rod and I are VERY aware of all the negative things that can happen when one treats risk factors and for me it is why I have a huge problem with population thresholds.
Can I infer you believe one should never measure anyones blood pressure and if blood pressure is measured it shouldn’t be treated regardless of the number?
Or would you do something differently than what I am describing for these two scenarios?
James
On Dec 21, 2017, at 6:35 AM, Owen Dempsey <[log in to unmask]> wrote:
Dear Rod and James, to paraphrase both of your questions:
Your question Rod:
“Should we inform patients (or indeed their doctors) about their predicted absolute CVD risk?”
And your question James:
For a, “60 y/o male/female patient with no HX of CVD - otherwise “normal” lipids and glucose non-smoker - family history is neither good nor bad” with various BP measurements, 200/110, 145/95. You ask:
“What would you suggest be done?”
These questions are the result of 'the logic of (anticipatory) care' where 'something must be done' because something has already been done (Mol, 2006). But, I think these aren’t the right questions.
What if we ask whether the CVD risk assessment should have been done at all?
What if we ask:
"What are the overall impacts of anticipatory care such as CVD risk assessments for the asymptomatic (footnote 1)?"
I outline seven consequences.
1. A label
First, a CVD risk screening provides a statistical probablity of risk that is presented to a particular prospective patient.
2. Loss of individuality
Second, the presentation of the risk is received as an ‘unconditional demand’ (no matter who ‘you’ are in your uniqueness as a human being, this ‘is’ your risk, your responsibility, which you shall be motivated to reduce, and there is treatment for it). In this way ‘a’ particular prospective patient is transformed into ‘the’ universal patient (for a good summary see Vanheule, 2002).
3. Exploitation of desire
Third, the risk statistic inevitably provokes a feeling of avoidable mortality, and fear is incited. The demand to take responsibility, alongside the feeling of precarity, incites a desire to take advantage of the promise of prevention. Because desire is inflicted through demand and fear the offer, in effect, coerces compliance. Thus, all in all, screening exploits the desire it incites through our need to feel adequate to the demand perceived.
4. Agency but at a price
Fourth, true, some may reject this particular demand to be ‘the’ patient, and refuse to be recruited, but this may be accompanied by loss of trust in the practitioners, confusion, anxiety, guilt, and stress (for an insightful interview with two patients listen to The Today Programme, 2012).
5. An Anti-democratic decision
Fifth (a key point), the decision making is not democratic for three reasons: a) the inevitable power imbalance, which can’t be helped, b) the way the perceived demand coerces compliance, and c) because it is impossible for ‘a’ patient to value the high probablity of over-treatment as a harm as such. No individual can ever say: ‘Oh, this is what over-treatment (or over-diagnosis) feels like.’ And, if a harm can’t be imagined it can’t be adequately valued as a harm. And because over diagnosis is un-valueable, a) it is not taken into account by policymakers when deciding whether such care is a good thing', and b) it maybe ignored by patients or may creates confusion, distrust and a loss of feeling cared-for.
6. Destruction of loving care
Sixth, the transformation of ‘a’ particular patient into ‘the’ universal patient, not only creates a feeling of inadequacy (as described above), it also transforms the caregiving relationship into a mechanical transaction without compassion(Vanheule, 2002). It destroys love in the caregiving relation.
7. Suffering is sacrificed
Seventh, three forms of opportunity cost are incurred: a) the expansion of this type of care costs money that can’t be spent on care to relieve suffering (McCabe et al, 2008; Garner and Littlejohns, 2011; Dillon, 2015), b) the expansion of new forms of anticipatory care, such as genetic profiling, reduces the cost effectivness of health services (footnote 2), and c) the practitioners time spent on anticipatory care is time taken away from relieving suffering (Vanheule, 2001).
Conclusion
The market driven 'system' will continue to expand this mode of care regardless of the consequences. Simply put, caregivers and practitioners are incited to try to do too much.
Although the the consultation is always anti-democratic because of the power held by the caregiver, anticipatory care is both anti-democratic and de
structive of lives and care. Therefore individual practitioners should confront and refuse to implement anticipatory care wh
ich is a destructive form of oppression. Owen
references
Mol, A. (2006) The Logic of Care - Health and the Problem of Patient Choice. Abingdon: Rutledge.
Dillon, A. (2015) Carrying NICE over the threshold, https://www.nice.or
g.uk/news/blog/carrying-nice-o .ver-the-threshold Garner, S. & Littlejohns, P. (2011) Disinvestment from low value clinical interventions: NICEly done? BMJ, 343.
McCabe, C., Claxton, K., & Culyer, A. (2008) The NICE Cost-Effectiveness Threshold: What it is and What that Means. IDEAS Working Paper Series from RePEc.
The Today Programme (2012) I was railroaded into cancer surgery, London BBC radio 4
Vanheule, S. (2001) Burnout and Psychoanalysis: A Freudo-Lacanian Point of View. Journal for the Psychoanalysis of Culture and Society, 6(2), 2001, pp.265-271, 6(2): 7.
Vanheule, S. (2002) Caring and its Impossibilities: A Lacanian Perspective. Organizational and Social Dynamics, 2(2): 21.
Wakefield, J. (2016) Diagnostic Issues and Controversies in DSM-5: Return of the False Positives Problem. Annu. Rev. Clin. Psychol., 12: 28.
1. Anticipatory care, anti- in advance, cipere- to take in hand, consists of care of asymptomatic individuals, that predicts and determines future health states as pathological and also determines the action that msut be taken to prevent those states. It includes, for example, evoking symptoms, cancer screening, risk stratification, and innovative diagnostic labelling (Wakefield, 2016).
On Wed, Dec 20, 2017 at 10:39 PM, Rod Jackson <[log in to unmask]> wrote:
Hi Juan – I have to challenge your statement that the new 2017 ACC/AHA High Blood Pressure Guidelines are bizarre. I think that is probably a fair description of the previous US guidelines which recommended treating low risk younger people while not treating higher risk older people and was mainly based on blood pressure thresholds.
I also have to admit to finding your statement: ‘i do not agree that risk estimates should be made to help inform patient choice’ somewhat bizarre.
Measuring someone’s blood pressure is measuring their CVD risk. It is just an extremely poor measure of absolute risk and therefore an extremely poor indicator of absolute treatment benefit. Can I ask you, are you inferring that you would never measure blood pressure or tell someone what their blood pressure is?
Unfortunately, I think your interpretation of what is good evidence is too rigid and too simplistic. There are no perfect RCTs and we always have to do our best to integrate the totality of evidence. Evidence hierarchies are simply guides not rules and should not be applied too literally. You also do not appear to have acknowledged that the evidence you appear to expect (a large high quality long term RCT randomising people to a risk prediction-based strategy versus a risk factor-based strategy with CVD events as the outcome) is an impossibility, as reflected in the multiple failed attempts to do this.
While the 2017 ACC/AHA Guidelines on High Blood Pressure are nowhere near perfect, at least by by explicitly including a risk prediction step, they are moving in the right direction. James has clearly articulated the importance of informed shared decision making and neither clinicians nor patients can take part in an informed decision about CVD risk management without having an estimate of patients’ CVD risk.
I agree that in their current form the new Guidelines are likely to lead to a significant increase in treatment, but whether this represents overtreatment depends on what one considers ‘ideal treatment,’ which will differ from person to person. At least by recommending use of a quantitative risk assessment for some patients, an informed discussion about risks and benefits is possible. Treatment recommendations based on a blood pressure level alone precludes any meaningfully informed decision by either the doctor or the patient.
Best wishes and Merry Christmas.
Rod Jackson
CVD epidemiologist
University of Auckland, New Zealand
From: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAI
L.AC.UK > on behalf of Juan Gérvas <[log in to unmask]>
Reply-To: Juan Gérvas <[log in to unmask]>
Date: Wednesday, 20 December 2017 at 10:18 PM
To: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK >
Subject: Re: new hypertension guidelines, controversy
-no, James, i do not agree that risk estimates should be made to help inform patient choice
-this estimation has no predictive value and cannot guide any decision
-it is like helping patients with a cristal ball in astrology
-the new bizarre 2017 ACC/AHA Guidelines for hypertencion increase the number of people harm without benefits
There is currently no evidence that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality
http://bmjopen.bmj.com/content/7/3/e013650?rss=1
2017-12-20 8:32 GMT+01:00 McCormack, James <[log in to unmask]>:
Hi Owen - I’m also confused - as Rod says, a patient scenario would be very useful - may I suggest 2 different ones.
1) A 60 y/o male/female patient with no HX of CVD - otherwise “normal” lipids and glucose non-smoker - family history is neither good nor bad
Blood pressure is 200/110mmHg - properly measured on many occasions over a number of weeks or months - non-drug measures haven’t worked etc - no symptoms of end-organ damage
2) A similar patient but in this case the blood pressure is 145/95 mmHg - again measured appropriately etc
My question would be, what would you suggest be done for these two individuals to deal with the anticipatory care issue you are describing.
Hope this makes sense.
James
On Dec 19, 2017, at 11:10 PM, Rod Jackson <[log in to unmask]> wrote:
Hi Owen. I have read your two recent posts several times and unfortunately I don’t understand what you are trying to say.
Would you mind explaining your key points using a patient scenario.
Are you suggesting that we shouldn’t inform patients (or indeed their doctors) about their predicted absolute CVD risk and our best estimate of the likely absolute treatment benefit? Or are you suggesting the opposite?
Unless one predicts the patient’s absolute risk, it is impossible to determine the likely absolute treatment benefit. As you know the traditional practice of making treatment decisions on blood pressure alone is also a decision based on estimated risk and benefit (albeit relative risk and relative benefit which are not clinically meaningful).
Regards Rod Jackson
From: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAI
L.AC.UK > on behalf of Owen Dempsey <[log in to unmask]>
Reply-To: Owen Dempsey <[log in to unmask]>
Date: Wednesday, 20 December 2017 at 2:49 AM
To: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK >
Subject: Re: new hypertension guidelines, controversy
Dear all,
I'm responding to further my argument that anticipatory care is anti-democratic, and to respond to James’ comments about: ‘much of health being about managing expectations’ etc..
James, you introduced a few concepts along the way so I apologise for the length of this post. To avoid us talking past each other I try to clarify some points.
First, consider a) health and b) anticipatory care.
First, health: for me, as a clinician, is about maximising an individual’s personal capacity to adjust to life’s slings and arrows, ageing etc, and not, as the WHO might have it, an aspiration of wellbeing etc to be achieved by care. My view on this follows Canguilhem’s (the French Philosopher of Medicine) conceptions of health and disease (Horton, 1995). Health care, for me is about relieving suffering and being very careful not to injure the individual human's delicate ecosystem with injudicious, hopeful interference, in order to prolong life.
And, second, for me the discussion here is about what I call anticipatory care, I define this as care applied to asymptomatic individuals with tests or diagnoses that determine predicted future states as pathological, and for which preventive action is specified. Anti - in advance; cipere – to take in hand.
'expectations'
I agree that ‘managing expectations’ and ‘correcting’ misguided ‘assumptions’ is an important part of a clinician’s role. However managing expectations is necessary because expectations are actually being created, and these prey on people's fear and exploit desire. Some, as you say, ’don’t want to be told what to do’ - I agree, they may walk away, or not uncommonly in my experience, end up confused, or even distressed and railroaded into care (The Today Programme, 2012). One way to 'manage' this would be to avoid creating the expectations in the first place by refusing to offer this kind of care.
'the only way'
You say ‘the only way’ is to have an ‘open discussion’. However, this already assumes that these forms of care are ‘a good thing’ to offer, and so a discussion has already been enforced. Another way might be to follow the Amercian famiily physicians and refuse to follow harmful guidelines in the first place.
'the issue'
You also say ‘the issue is that the magnitude of the benefit vs the side effects, cost and inconvenience re often of similar magnitude’. But I would argue that ‘the issue’ at stake here is broader than this. Thus, anticipatory care often comes with professional guidelines that determine clinical practice, recruiting practitioners to harmful practices, and these forms of care cause opportunity costs elsewhere. The market dictates what shall become standard of care, and NICE for example routinely sanctions care that is less cost effective than care that will be discontinued to afford the ‘new model’.
For example, a very expensive new genetic prediction test for cancer recurrence may, for example, cause cost saving cuts elsewhere in the publicly funded service and indirectly, lead to withdrawal of, for example, mental health services for young people with depression (McCabe et al, 2008). Expensive anticipatory care, of dubious value, also bankrupts individuals prey to fear, the private health care sector and insurance companies (Baum, 2015, personal communication, article available on request).
The anticipatory care paradox by which expanding care destroys care and lives is what I call neoliberalism's ‘Perverse Care Law’.
'open discussion about … harms'
Harms such as over-diagnosis are never personally actually experienced as such. This means, I think, that it is impossible for a prospective patient to imagine over diagnosis as a harm as such, and to take it into account when a decision is being enforced. What some patients may be valuing instead, in the light of their knowledge about over-diagnosis, is a lack of their trust in the profession’s offer of care.
‘everybody has different values and prejudices’
Yes – but each person is also vulnerable to the way care can act as a commodity ‘promising the potential to prolong life’ in ways that exploit desire. There is a contradiction, perhaps even an irony here, in the way health care science make such profound assumptions about the human condition and at the same time silences any commentary on the essential features of that condition as always prone to desire and fantasy, by calling such commentary unscientific.
I think that professional caregivers have a role to protect lay people from having their desires exploited.
So I would stand by my view that anticipatory care under neoliberalism is anti-democratic, it: a) exploits desire, b) coerces compliance, c) causes distress, d) bankrupts and e) destroys health and care for many. It should be distrusted, first and foremost by professional caregivers.
Owen
Owen Dempsey
Baum, M. (2015) Oncotype Dx Use in Node-Negative Luminal A Breast Cancer Adds Only Cost
Horton, R. (1995) Georges Canguilhem: philosopher of disease.
J R Soc Med 88: 4.
McCabe, C., Claxton, K., & Culyer, A. (2008) The NICE Cost-Effectiveness Threshold: What it is and What that Means. IDEAS Working Paper Series from RePEc.
The Today Programme (2012) I was railroaded into cancer surgery, London BBC radio 4
Sorry to burst happy bubble.
This doesn't sound like real world medicine for real patients to me.
Don't most 'patients' assume that risk measurements are offered because there is treatment available to reduce that risk / it doesn't matter how great a communicator you are the patient is unable to imagine being overdiagnosed/treated (taking treatment based on population data that will harm them as an individual) and so is de facto pressured to ask for treatment - equals a happy drugs market.
Anticipatory care is fundamentally anti democratic and should be a priori distrusted.
Owen
On Tue, Dec 19, 2017 at 12:37 PM, Mohammed T. Ansari <[log in to unmask]> wrote:
Interesting discussion. Just adding my two cents on impact.
Impact of guidelines is not practically possible to estimate without first implementing the guidelines -- whether guidelines of therapy or risk prediction/diagnostic testing guided therapy. Impact assessment is a post-guideline implementation step.
Please see this Knowledge-to-Action Framework: Straus SE, Tetroe J, Graham I: Defining knowledge translation. CMAJ. 2009, 181: 165-168.
On Tue, Dec 19, 2017 at 6:57 AM, Juan Gérvas <[log in to unmask]> wrote:
-thanks for the information and suggestions
-your guide, James, is an excellent one, no doubt “Simplified Lipid Guidelines” https://www.ncbi.n
lm.nih.gov/pmc/articles/PMC460 7330/ -but you have covered just one step in the development of a clinical prediction rule (risk table, etc)
-there are three:
(1) development of the prediction rule; (2) external validation of the prediction rule (‘‘validation’’), that is, testing the rule’s accuracy and thus generalizability in data that was not used for the development of the rule, and subsequent updating if validity is disappointing; and (3) studying the clinical impact of a rule on physician’s behavior and patient outcome
https://www.ncbi.nlm.nih.gov/pubmed/19208371 -this is exactly the problem with the 2017 ACC/AHA Guidelines and my critic to John Ioannidis for not signaling it in his Viewpoint in JAMA
-we cannot accept this guideline (and transform almost half of the Humanity in "siskness persons") without having validation (accuracy) and formal impact analysis
-un saludo juan gérvas @JuanGrvas
2017-12-19 11:41 GMT+01:00 Dr Geoff Schrecker <[log in to unmask]>:
This is a really interesting discussion, but I would like to add one more factor to the challenge of making global risk assessment useful in shared decision making, that is the education of those using the risk assessment to understand the factors and how they contribute to the final global assessment.
Using the CV risk as an example: there may be two patients each with a global risk of 25%, one who is smoking 40 cigarettes per day, and another non-smoker whose major factor influencing risk is their age. The clinician must understand this in order to hold an informed conversation with the patient on how best to proceed in terms of treatments and lifestyle intervention.
A key factor for this is the implementation of these tools in the clinical environment in a manner that will support this type of informed shared decision making.
Cheers,
Geoff Schrecker
MB BChir MBCS FRCGP FFCI
Retired GP
Clinical Informatician
RCGP Clinical Champion for Patient Data Choices
Mail signed using GPGMail
Public key available from hkps://hkps.pool.sks-keyservers.net
> On 19 Dec 2017, at 08:17, McCormack, James <[log in to unmask]> wrote:
>
> Much of health is about managing expectations and helping people if they have incorrect assumptions - you are correct, many risks can be reduced - the issue is that the magnitude of the benefit vs the side effects cost and inconvenience are often of a similar magnitude and everybody has different values and preferences.
>
> So even if most just want to be told what to do - a bunch don’t - the only way to figure out which group your patient falls into is to have an open discussion about benefits and harms.
>
> Are you suggesting that patients don’t want that or couldn’t understand that sort of discussion? Not all can but many do in my experience and I believe the evidence supports my observation.
>
> Thoughts?
>
>> On Dec 18, 2017, at 11:40 PM, Owen Dempsey <[log in to unmask]> wrote:
>>
>> Sorry to burst happy bubble.
>>
>> This doesn't sound like real world medicine for real patients to me.
>>
>> Don't most 'patients' assume that risk measurements are offered because there is treatment available to reduce that risk / it doesn't matter how great a communicator you are the patient is unable to imagine being overdiagnosed/treated (taking treatment based on population data that will harm them as an individual) and so is de facto pressured to ask for treatment - equals a happy drugs market.
>>
>> Anticipatory care is fundamentally anti democratic and should be a priori distrusted.
>>
>> Owen
>>
>> On Tue, 19 Dec 2017 at 05:21, McCormack, James <[log in to unmask]> wrote:
>> Thanks Rod - I just wish all (or any) of the diabetes, lipid, HTN guideline groups felt the same way - virtually none of them support or encourage "real” shared decision making and they never will as long as they mandate having specific surrogate treatment thresholds. The only guideline I am aware of that actually supports real SDM is this one “Simplified Lipid Guidelines” https://www.ncbi.nlm.nih.gov/pmc/articles/PMC460 and it was written by primary care clinicians and I was somewhat involved.7330/
>>
>> James
>>
>>
>>> On Dec 18, 2017, at 7:52 PM, Rod Jackson <[log in to unmask]> wrote:
>>>
>>> Hi James – I agree with you. I don’t think you are missing anything and the papers I reference provide excellent empirical evidence for your second point.
>>>
>>> Cheers Rod
>>>
>>> From: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK > on behalf of "McCormack, James" <[log in to unmask]>
>>> Reply-To: "McCormack, James" <[log in to unmask]>
>>> Date: Tuesday, 19 December 2017 at 1:28 PM
>>> To: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@JISCMAIL.AC.UK >
>>> Subject: Re: new hypertension guidelines, controversy
>>>
>>> Hi Juan and Rod
>>>
>>> In my mind, I believe the point of making a CVD risk assessment (say a 10 year risk) on an individual patient is so that you can
>>>
>>> 1) inform them of their approximate CVD risk
>>> 2) make a reasonable approximation of the theoretical/potential benefit of treatment
>>> 3) discuss the harms of treatment - adverse effects, costs, inconvenience
>>> 4) work with them to make a shared-decision
>>> 5) and then support whatever decision THEY make
>>>
>>> Whether or not this leads to an increase or decrease in CVD is irrelevant - in my mind shouldn’t the fact that a well informed shared decision was made be the gold standard endpoint that we are looking for. I believe it is totally reasonable for someone to say they would like to reduce their risk by “2%" and accept all the harms but to also say no, that “2%” is not enough given the harms you have mentioned.
>>>
>>> Or maybe I’m missing something.
>>>
>>> James
>>>
>>>
>>>
>>>
>>>
>>>> On Dec 18, 2017, at 1:31 PM, Juan Gérvas <[log in to unmask]> wrote:
>>>>
>>>> -thanks for your comments and suggestions, i will consider sending a letter to the journal
>>>> -about the question of the the prospective use of global cardiovascular risk assessment, Rod, i agree with your point about two risk factors, LDL cholesterol and hypertension, but my point is about the "global" assessment (the aplication of the table of cardiovascular risk)
>>>> -having no formal impact analysis means that global cardiovasular assessment is only a risk assessment and cannot be used for taking decisions; the cardiovascular tables of risk are only tables of risk, no tables of decision>>>> Translating clinical research into clinical practice: impact of using prediction rules to make decisions. Clinical prediction rules, sometimes called clinical decision rules, have proliferated in recent years. However, very few have undergone formal impact analysis, the standard of evidence to assess their impact on patient care. Without impact analysis, clinicians cannot know whether using a prediction rule will be beneficial or harmful.https://www.ncbi.nlm.n
ih.gov/pubmed/16461965
>>>>
>>>> Global cardiovascular risk assessment in the primary prevention of cardiovascular disease in adults: systematic review of systematic reviews. The quality of existing systematic reviews was generally poor and there is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality. http://bmjopen.bmj.com/content/7/3/e013650?rss=1
>>>> -un saludo juan gérvas @JuanGrvas
>>>>
>>>> 2017-12-18 16:54 GMT+01:00 Bill Cayley, Jr <00000084192e7b72-dmarc-reques[log in to unmask] >:
>>>>> I think it's been a great discussion, I think a response letter to JAMA is a good idea, and I also think it would move the discourse forward to keep it in dispassionate terms about the merits of the evidence and the arguments - I don't think either sides are presenting "horrible" points of view.
>>>>>
>>>>> Bill Cayley, Jr, MDMDiv
>>>>> [log in to unmask]
>>>>> [log in to unmask]m
>>>>> http://twitter.com/bcayley
>>>>> Work: 715.286.2270
>>>>> Pager: 715.838.7940
>>>>> Mobile: 715.828.4636
>>>>>
>>>>> A voice of one calling: "In the desert prepare the way for the LORD; make straight in the wilderness a highway for our God." (Isaiah 40:3)
>>>>>
>>>>>
>>>>> On Monday, December 18, 2017 9:51 AM, Anoop B <[log in to unmask]> wrote:
>>>>>
>>>>>
>>>>> Thank you Juan and Rod for the excellent discussion!
>>>>>
>>>>> Juan any chance you will submit your reply to the journal formally? You do have some great points and I don't think Dr.Loannidis reply was very convincing. I really think you should.
>>>>>
>>>>>
>>>>>
>>>>> On Mon, Dec 18, 2017 at 12:27 AM, Rod Jackson <[log in to unmask]> wrote:
>>>>>> Hi Juan and all. While I agree with a couple of your points, with respect, I would like to disagree in particular with your point 4 about impact analysis. You state that ‘There is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality.’
>>>>>>
>>>>>> I believe we actually have some very good evidence that global risk assessment translates into reductions in CVD.
>>>>>>
>>>>>> Before I mention the two key papers supporting my argument, it is important to point out that it is impossible to conduct a good RCT of a global risk assessment-based intervention versus an individual risk factor-based assessment. There are a number of trials that have tried to do this and they are all seriously flawed, because they are impossible to do without substantial crossover. Also, all of the studies have used poor risk assessment tools that have not been integrated into routine practice workflow so the uptake has been uniformly poor. You should read some of the studies; they really are very flawed. This is not a reflection on the researchers but simply a reflection on an intervention that cannot be practically randomized.
>>>>>>
>>>>>> In contrast, there are two individual patient meta-analyses of RCTs (references below); one on lipid lowering with statins and the other on blood pressure-lowering that provide compelling evidence on the benefits of CVD risk-based management. In both studies, a CVD risk prediction equation was developed in the control groups and retrospectively applied to all participants at baseline. This in effect resulted in a double blind assessment of a risk-based intervention without any cross-over and both studies demonstrate that participants at higher predicted risk had greater reductions in CVD events than low risk participants and this effect was apparent at different levels of the individual risk factors. Just check out Figure 5 in the statin paper and Figure 4 in the blood pressure paper.
>>>>>>
>>>>>> Mihaylova B, Emberson J, Blackwell L, et al. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 2012; 380: 581-90.
>>>>>> Sundström J, Jackson R, Neal B, for the BPLTTC. Blood pressure-lowering treatment based on cardiovascular risk: a meta-analysis of individual patient data. Lancet 2014; 384: 591-98.
>>>>>>
>>>>>> I think we need to look beyond the traditional approach of the ideal RCT when they are impossible to do well, as is the case here. There is also a huge amount of other evidence to support this approach and the totality of the evidence supports a risk-based approach.
>>>>>>
>>>>>> The relationship between saturated fat consumption and CHD is another example where we have been misled by RCTs. Like CVD risk assessment, it is impossible to undertake a good long term RCT of high versus low SF consumption and CHD because there is so much crossover between study groups. Unfortunately many people (and some national societies) have misconstrued the inconsistent findings of the trials that have been done as showing either no relationship or a weak relationship rather than concluding that such trials are impossible to do well.
>>>>>>
>>>>>> Beware the findings of theoretically ideal RCTs that are impossible to do well. High quality RCTs are great when they are possible but frequently misleading when they are not.
>>>>>>
>>>>>> Regards Rod Jackson
>>>>>>
>>>>>> Professor of Epidemiology
>>>>>> University of Auckland
>>>>>> New Zealand
>>>>>>
>>>>>>
>>>>>> From: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@ JISCMAIL.AC.UK > on behalf of Juan Gérvas <[log in to unmask]>
>>>>>>
>>>>>> Reply-To: Juan Gérvas <[log in to unmask]>
>>>>>> Date: Monday, 18 December 2017 at 10:46 AM
>>>>>> To: "Evidence based health (EBH)" <EVIDENCE-BASED-HEALTH@ JISCMAIL.AC.UK >
>>>>>> Subject: Re: new hypertension guidelines, controversy
>>>>>>
>>>>>> John P. A. Ioannidis
>>>>>> Diagnosis and Treatment of Hypertension in the 2017 ACC/AHA Guidelines and in the Real World
>>>>>> https://jamanetwork.com/ jgournals/jama/fullarticle/ 2666624
>>>>>>
>>>>>> A critic by Juan Gérvas (JG) @JuanGrvas and answers by John P. A. Ioannidis (JPAI) from 14th to 17th December 2017.
>>>>>>
>>>>>> JG 1/ ignore the work done by the Cochrane (last published review 8t Aug 2017, SPRINT results included):
>>>>>> At the present time there is insufficient evidence to know whether a higher BP target (less than150 to 160/95 to 105 mmHg) or a lower BP target (less than 140/90 mmHg) is better for older adults with high BP.
>>>>>> http://www.cochrane.org/ CD011575/HTN_blood-pressure- targets-hypertension-older- adults
>>>>>>
>>>>>> JPAI: I think my main point is entirely in line with the Cochrane review, I am questioning whether we can reap theoretical benefits in practice, even the title of my viewpoint implies this. A Viewpoint article is limited to 1300 words and 10 references, there is no way to cite everything.
>>>>>>
>>>>>> JG. references should include the "key" references, and the Cochrane on is "the golden key". Cochrane' authors are very clear:
>>>>>> "There is insufficient evidence to know whether a higher BP target (less than150 to 160/95 to 105 mmHg) or a lower BP target (less than 140/90 mmHg)"
>>>>>>
>>>>>> JPAI: "You did not cite Cochrane": I am one of the most fervent supporters of Cochrane worldwide, but I cannot agree to an almost religious imperative to must-cite Cochrane reviews as the "golden key".
>>>>>>
>>>>>>
>>>>>> JG 2/ ignore the social determinants; it is not "style of living" but "conditions of living"
>>>>>> Clinical decision rules relying on classic cardiovascular risk scoring could result in delayed drug therapy for patients with depression or low educational attainment or members of lower socioeconomic classes
>>>>>> http://www.sciencedirect.com/ science/article/pii/ S0091743511001599
>>>>>> https://academic.oup.com/ eurpub/article/15/5/441/526262
>>>>>>
>>>>>> JPAI: the last paragraph of the viewpoint alludes to the “many high-risk patients remain undiagnosed even with very high blood pressure. Many others receive suboptimal treatment, even according to more conservative definitions of hypertension.” This includes the kind of patients that you mention.
>>>>>>
>>>>>> JG: i agree. But it is very obscure. Why not to mention directly something like "Social determinants are absent in the new guidelines, as usual, but we need to go to the ‘causes of the causes" as poverty".
>>>>>>
>>>>>> JPAI: I will continue telling people to exercise, if they can. I also see no diminution of dignity in telling people not to smoke. I wish I could solve poverty, but I can't.
>>>>>>
>>>>>>
>>>>>> JG 3/ the rethoric of "shifting the health care system more toward prevention" has no scientific base, and may harm patients
>>>>>> A reconstituted National Health Service that prioritises prevention of sickness would fail all those who are ill now
>>>>>> http://www.bmj.com/content/ 334/7583/19
>>>>>> The concept of prevention: a good idea gone astray?.
>>>>>> http://equipocesca.org/en/the- concept-of-prevention-a-good- idea-gone-astray/
>>>>>>
>>>>>> JPAI: same point as above, although we don’t fully agree here. I am one of the harshest critics of unnecessary, expensive prevention with all its labeling, overdiagnsosis and biases; but here we are talking about basic prevention, like smoking and exercise. If you think that eliminating smoking and encouraging people to exercise are not worthy goals, we disagree.
>>>>>>
>>>>>> JG: in general, the health systems in developep countries are not yet even answering basic needs as helping patients to die with dignity, so we must be carefull when proposing more "prevention" because generally prevention means inequity because in many cases translate resources to "concern people": from patients to healthy, from poor to rich, form illiterate to universitary, from elderly to young (Iona Heath). Of course, i agree about smoking tobacco both in the consultation and in public health; about encouraging people to exercise, mainly in public health.. "Prevention is no always better than cure" http://equipocesca.org/is- clinical-prevention-better- than-cure/
>>>>>>
>>>>>> JPAI: SPRINT has many problems (which I discuss), but it would be unfair to not recognize its effort and strengths. Even when I think that something is potentially horrible, my preference is to start by acknowledging its strengths (if any), because this establishes fairness. Then, list its problems, so as to let others conclude in what ways it is problematic rather than call it horrible. But this is a matter of style and we can certainly disagree on style.
>>>>>>
>>>>>>
>>>>>> JG 4/ ignore that tables of risk without impact analysis are useless
>>>>>> Translating clinical research into clinical practice: impact of using prediction rules to make decisions.
>>>>>> There is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality
>>>>>> https://www.ncbi.nlm.nih.gov/ pubmed/16461965
>>>>>> http://bmjopen.bmj.com/content/7/3/e013650?rss=1
>>>>>>
>>>>>> JPAI: I mention that “the risk estimator has also been criticized for lacking proper calibration and for overestimating risk, particularly in young individuals. This may lead more low-risk people to aggressive drug treatment with questionable benefit-to-harm ratios.” I have written a previous viewpoint in JAMA dedicated to the cholesterol guidelines that introduced this risk-approach and I think it does cover what you say in more detail: https://www.ncbi.nlm.nih.gov/ pubmed/24296612
>>>>>>
>>>>>> JG: i agree. But the key point is that tables of cardiovascular risk lack impact analysis. So they are in fact "cristal balls".
>>>>>>
>>>>>>
>>>>>> JG 5/ ignore the low value of SPRINT results for people age 70 years and more
>>>>>> SPRINT, over age 70. The results are both unimpressive and of questionable significance.
>>>>>> https://www.curingmedicare . com/single-post/2015/11/12/ The-SPRINT-Blood-Pressure- Study-Small-Numbers- Questionable-Significance
>>>>>>
>>>>>> JPAI: most of my Viewpoint is a pretty aggressive critique of SPRINT and its inappropriate translation to create these guidelines. I don’t think that the point that you raise, a subgroup analysis, is among the most important of SPRINT’s problems. If anything, the age subgroup analysis shows a trend for larger benefit in the elderly and the benefit expressed as absolute risk difference is >3-fold higher in the elderly than in younger patients.
>>>>>> JG: this is personal appreciation but you viewpoint is a so soft critique of SPRINT that is sound like a prise. Verbattin: "SPRINT was a well-done study,.."
>>>>>>
>>>>>>>>>>>> 6/ did note mention that SPRINT included randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher AND patients with an increased cardiovascular risk http://www.nejm.org/doi/f
ull/ 10.1056/NEJMoa1511939#t= article Just only says: "SPRINT randomized 9361 patients with SBP greater than 130 mm Hg to intensive blood pressure control of SBP to less than 120 mm Hg vs less than 140 mm Hg" https://jamanetwork.com/ journals/jama/fullarticle/ 2666624
>>>>>>
>>>>>> JPAI: I agree this could have been made clearer, although it is implicitly stated, e.g. in my third to last paragraph. At any rate, I thought you don’t believe risk calculations anyhow.
>>>>>>
>>>>>> JG: SPRINT has problems of internal and external validity, but in any case its results could be apply only to persons with a systolic blood pressure of 130 mm Hg or higher AND patients with an increased cardiovascular risk
>>>>>>
>>>>>> 7/ ignore that lifestyle counselling might be good for your health...but has no impact on mortality
>>>>>> A community based, individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease, stroke, or mortality at the population level after 10 years.
>>>>>> http://www.bmj.com/content/ 348/bmj.g3617
>>>>>> Multiple risk factor interventions for primary prevention of coronary heart disease. The pooled effects suggest multiple risk factor intervention has no effect on mortality.
>>>>>> https://www.ncbi.nlm.nih.gov/ pubmed/10796813
>>>>>>
>>>>>> JPAI: You cite the 2000 Cochrane review, while this has been updated several times since then. E.g. the 2011 update (https://www.ncbi.nlm.nih.gov/pubmed/21249647) already shows clearly a mortality/clinical benefit for patients with hypertension (of relevance to what we are discussing) and diabetes: “Total mortality and combined fatal and non-fatal cardiovascular events showed benefits from intervention when confined to trials involving people with hypertension (16 trials) and diabetes (5 trials): OR 0.78 (95% CI 0.68 to 0.89) and OR 0.71 (95% CI 0.61 to 0.83), respectively.” For low-risk, general population people of course you will not see a clear benefit in mortality over modest follow-up, but are you arguing that anti-smoking efforts or telling people to exercise are unreasonable? If so, I respectfully disagree.
>>>>>>
>>>>>> JG: The new hypertension guideline is for the general population, not for "patients with hypertension and diabetes" Cochrane 2011: "Interventions using counselling and education aimed at behaviour change do not reduce total or CHD mortality or clinical events in general populations but may be effective in reducing mortality in high-risk hypertensive and diabetic populations". By the way, hypertension defines according to previous definition, no the AHA/ACC new guideline.
>>>>>> Anti-smoking efforts are important in the public setting and in the clinical ones, but telling people to exercise in the clinical setting has very little impact/scientific base (grade C); see the USPSTF "The USPSTF recommends that primary care professionals individualize the decision to offer or refer adults without obesity who do not have hypertension, dyslipidemia, abnormal blood glucose levels, or diabetes to behavioral counseling to promote a healthful diet and physical activity. Existing evidence indicates a positive but small benefit of behavioral counseling for the prevention of CVD in this population. Persons who are interested and ready to make behavioral changes may be most likely to benefit from behavioral counseling. (C recommendation)" https://www.ncbi.nlm.nih.gov/ pubmed/28697260
>>>>>>
>>>>>> and 8/ ignore that the AHA/ACC guideline wasn't based on a systematic evidence review
>>>>>> https://www.aafp.org/news/ health-of-the-public/ 20171212notendorseaha- accgdlne.html
>>>>>>
>>>>>> JPAI: I kindly disagree, the report is a 481 page document that includes a systematic review and there is a separate publication of the systematic review published in multiple journals concurrently, e.g.https://www.ncbi.nlm.nih.gov/ pubmed/29133355
>>>>>>
>>>>>> JG."The [AHA/ACC] guideline provided more than 100 recommendations, but a systematic review performed as part of the guideline's development considered only four key questions. Also, harms of treating a patient to a lower blood pressure were not assessed in the systematic review".
>>>>>>
>>>>>> 2017-12-17 14:53 GMT+01:00 Anoop B <[log in to unmask]>:
>>>>>>> Interesting to note that that the guidelines did not review the quality of individual studies, risk of taking the medication, and how the SPRINT trial was heavily favored.
>>>>>>>
>>>>>>> Why don't you write a response to his letter Juan?
>>>>>>>
>>>>>>> Thank you juan for all your contribution here.
>>>>>>>
>>>>>>> On Sat, Dec 16, 2017 at 4:22 PM, Juan Gérvas <[log in to unmask]> wrote:
>>>>>>>> La American Academy of Family Physician (más de 115.900 miembros) ha decidido no aceptar la nueva guía de hipertensión propuesta por la American Heart Association y otras organizaciones profesionales.
>>>>>>>> The American Academy of Family Physicians (more than 115,900 members) has decided to not endorse the recent hypertension guideline from the American Heart Association, the American College of Cardiology and 9 other health professional organizations.
>>>>>>>> https://www.aafp.org/…/…/ 20171212notendorseaha- accgdlne.html
>>>>>>>> https://www.aafp.org/news/ health-of-the-public/ 20171212notendorseaha- accgdlne.html
>>>>>>>>
>>>>>>>> -horrible paper by
>>>>>>>> John P. A. Ioannidis
>>>>>>>> Diagnosis and Treatment of Hypertension in the 2017 ACC/AHA Guidelines and in the Real World
>>>>>>>> https://jamanetwork.com/ journals/jama/fullarticle/ 2666624
>>>>>>>> -why is "horrible"? because
>>>>>>>> 1/ ignore the work done by the Cochrane (last published review 8t Aug 2017, SPRINT results included):
>>>>>>>> At the present time there is insufficient evidence to know whether a higher BP target (less than150 to 160/95 to 105 mmHg) or a lower BP target (less than 140/90 mmHg) is better for older adults with high BP.
>>>>>>>> http://www.cochrane.org/ CD011575/HTN_blood-pressure- targets-hypertension-older- adults
>>>>>>>> 2/ ignore the social determinants; it is not "style of living" but "conditions of living"
>>>>>>>> Clinical decision rules relying on classic cardiovascular risk scoring could result in delayed drug therapy for patients with depression or low educational attainment or members of lower socioeconomic classes
>>>>>>>> http://www.sciencedirect.com/ science/article/pii/ S0091743511001599
>>>>>>>> https://academic.oup.com/ eurpub/article/15/5/441/526262
>>>>>>>> 3/ the rethoric of "shifting the health care system more toward prevention" has no scientific base, and may harm patients
>>>>>>>> A reconstituted National Health Service that prioritises prevention of sickness would fail all those who are ill now
>>>>>>>> http://www.bmj.com/content/ 334/7583/19
>>>>>>>> The concept of prevention: a good idea gone astray?.
>>>>>>>> http://equipocesca.org/en/the- concept-of-prevention-a-good- idea-gone-astray/
>>>>>>>> 4/ ignore that tables of risk without impact analysis are useless
>>>>>>>> Translating clinical research into clinical practice: impact of using prediction rules to make decisions.
>>>>>>>> There is currently no evidence reported in these reviews that the prospective use of global cardiovascular risk assessment translates to reductions in CVD morbidity or mortality
>>>>>>>> https://www.ncbi.nlm.nih.gov/ pubmed/16461965
>>>>>>>> http://bmjopen.bmj.com/ content/7/3/e013650?rss=1
>>>>>>>> 5/ ignore the low value of SPRINT results for people age 70 years and more
>>>>>>>> SPRINT, over age 70. The results are both unimpressive and of questionable significance.
>>>>>>>> https://www.curingmedicare . com/single-post/2015/11/12/ The-SPRINT-Blood-Pressure- Study-Small-Numbers- Questionable-Significance>>>>>>>> 6/ did note mention that SPRINT included randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher AND patients with an increased cardiovascular riskhttp://www.nejm.org/doi/fu
ll/ 10.1056/NEJMoa1511939#t= article Just only says: "SPRINT randomized 9361 patients with SBP greater than 130 mm Hg to intensive blood pressure control of SBP to less than 120 mm Hg vs less than 140 mm Hg" https://jamanetwork.com/ journals/jama/fullarticle/ 2666624
>>>>>>>> 7/ ignore that lifestyle counselling might be good for your health...but has no impact on mortality
>>>>>>>> A community based, individually tailored intervention programme with screening for risk of ischaemic heart disease and repeated lifestyle intervention over five years had no effect on ischaemic heart disease, stroke, or mortality at the population level after 10 years.
>>>>>>>> http://www.bmj.com/content/ 348/bmj.g3617
>>>>>>>> Multiple risk factor interventions for primary prevention of coronary heart disease. The pooled effects suggest multiple risk factor intervention has no effect on mortality.
>>>>>>>> https://www.ncbi.nlm.nih.gov/ pubmed/10796813
>>>>>>>> and 8/ ignore that the AHA/ACC guideline wasn't based on a systematic evidence review
>>>>>>>> https://www.aafp.org/news/ health-of-the-public/ 20171212notendorseaha- accgdlne.html
>>>>>>>> -un saludo juan gérvas @JuanGrvas
>>>>>>>>
>>>>>>>
>>>>>>
>>>>>
>>>>>
>>>>>
>>>>
>>>
>>>> --
>>
>>
>> https://myownprivatemedicine.com/
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