1 - My doctor and I have come to an agreement as I listened to her and she actually listened to and heard me. She armed me with all the information I needed to make an educated decision regarding testing. She no longer brings up the subject of mammograms and colonoscopies and such because she understands I won't have the results treated. I respect that she respects my decision.
2 - This philosophy of sharing information and including the patient is actually what hospice does. Yes, I realize I am dealing with patients (families) at EOL, but the crux of the care given and denied is the same. [I use patient and family interchangeably because sometimes it is the family voicing the wishes of the patient who is aphasic]. We put the patient's wishes into practice. It is my job and the job of the Medical Director to give the family all of the information they need to make an educated decision of taking the medication, accepting the treatment, or not doing any of the above. Our families get on Google and Wikipedia frequently and base their decisions on what the internet says. We want, jointly, to give the best care to the patient and we can only do that by supplying him/her/them with honest information so they can join in an educated way in the plan of care.
This is excellent. Thank you so much. With this approach you express respect for the patient as well as allowing the doctor to do his/her job to the best of their ability. Medicine has been working while handcuffed for many years now
I have read the article three times and am still not sure about what the recommendations are. Doctors and patients should discuss the pluses and minuses of the various treatment options for whatever the patient's medical problems may be? Isn't that pretty much what the practice of medicine is all about? Guidelines may be a useful way to frame the discussion but, as we have often seen on this website, the "standard of care" for a number of disorders often turns out to be untrue when subjected to scientific analysis.
Until practitioners are rewarded for encouraging true patient autonomy and competence and not for simply prescribing more treatment to guideline nothing will change
After reading this article I thought how the phrase “one size fits all” can be applied to Clinical Guidelines. But of course this statement was proven false when I accidentally pulled a pair of my son’s pants out of the dryer and tried to put them on.
Very much agree - the big question is can it be done. The answer is a big YES. Our PEER group has been producing these sorts of national guidelines for almost a decade. https://peerevidence.ca/simplified-guidelines/
We have done lipids (recently updated), chronic pain, cannabinoids, opioid use disorder and presently we are working on type 2 diabetes.
To do this we follow these simple “rules”
1) We make it as simple as possible but not simpler – we keep them to no more than ~10 pages
2) The entire focus is on shared-decision making
3) We have discussion thresholds, NOT treatment thresholds
4) Always provide decision aids/calculators that give the benefit/harm numbers in absolute terms and also provide patient information sheets with that information
5) We don’t allow financial conflicts of interest
6) They are primarily written by primary care clinicians
7) We do a thorough systematic review of the evidence by PEER using the GRADE framework
Guideline Committee uses the review of evidence to create the guideline
Great article up to the conclusion: "Traditional clinical guidelines have probably provided some benefits to patient care" which appears stronger and less evidence based than the body of the article.
Also, why is an "increase in therapeutic uncertainty" necessarily a bad thing?
Guidelines should be a compendium of the state of the science. Instead, they are now no more than cookbook recipes. Not only that, but even the details of the science are dumbed down so as to favour the overarching goal of ease of compliance, at the expense of the specifics and nuances of the individual landmark trials upon which the guideline recommendations are purportedly based.
In my field, imo this is never more in vogue than with various iterations of HFrEF guidelines over the past 10 years. “GDMT” is the stated goal in the majority of clinical notes. 100% uptake by 100% of patients is something that would be celebrated. These days, it’s 4 drugs for everyone, never mind their symptom and functional status, or their actual LV function, which actually differed in the inclusion criteria of the landmark trials for each of the “foundational” classes.
I would prefer guidelines that only listed recommendations clearly backed by large trials and replicated data showing benefit. The few and far between scenarios that actually deserve a class 1 recommendation (and not the current era where these are dispensed like candy). Likewise, a section of clearly harmful things that should definitely be avoided. Then a large swath of tweeners that have some data and could be worthy of consideration, but hardly something to reach for every time for every patient (this is the swamp in which I would stick every last one of the “expert opinions”).
I’ve never read or tried using a guideline that does not provide specific recommendations, or one that is geared foremost to discussion of risks vs benefits and of patient preferences. But I’d be willing to give it a try.
I imagine there is no perfect guideline structure. But I also find the current generation of guidelines to be far from it. But I’m not hopeful for change, given the industrial complex at play when it comes to guideline generation, and their relationship with industry who stand to benefit from such “seals of approval”.
Clinical guidelines are not guidelines. In many cases they are mandates where a physician can be called to task for not adhering to them. This will not get better as physicians continue to come under the control of large medical systems that essentially mandate the use of guidelines that do not take into account, as the author says, the individual. One question for the author: you say guidelines may benefit care. Is there any data to support that?
But, can the physicians be "called to task" if the patient refuses the advice and it is documented more than once that the patient has been educated and has made a decision to or not to .....?
I agree with most of Dr. Rasudasoja's recommendations. There was a JAMA study (2023?) that evaluated if national medical specialty task forces followed National Academy of Medicines guidelines for practice guideline task forces. One key finding was that 80% of national medical specialty task forces did not have an expert in data analysis and interpretation as a member. As Sensible Medicine has reported repeatedly, there is a high incidence of flaw analysis and interpretations in papers published in medical journals. Most task forces members don't have the expertise to determine if journals made peer review errors.
Ultimately the success of any intervention will be largely determined by the motivation of the patient to implement it as described, especially those interventions carried out by the patient (vs by the doctor). A great deal of evidence from research on Self Determination Theory has demonstrated that there are 3 main factors that serve as the basis for motivation: autonomy, competence, and relatedness (link #1). This approach will address the autonomy component and to some extent, the relatedness component, but not the competence component. This is certainly a step in the right direction, but for success, I think that patient competence will also need to be addressed. It will vary by patient and would need to be assessed. This approach reminds me of the proposal of "The Drug Facts Box." Schwartz and Woloshin demonstrated in a series of studies beginning in 2007 that this simple tool was effective in helping patients understand the risks and benefits of pharmaceuticals (link #2). In 2009, an FDA advisory committee voted unanimously that the FDA require a drug fact box for new products. Congress also asked the FDA to create concise and standardized summaries of the risks and benefits of drugs in the Affordable Care Act in 2011. The FDA chose not to implement these recommendations (including The Drug Facts Box), instead issuing guidance for better risk communication in direct-to-consumer drug ads. (link #3) We all know how well that worked. (Woloshin and Schwartz attempted to implement their own online Drug Facts Box but ran out of money). The unfortunate moral of the story: expect extreme resistance from Pharma on whatever you issue about medications (and perhaps hindrance from the FDA), and most likely resistance from practitioners who don't want to change. In other words, it is not just patient motivation you will need to address. It will take a medical culture sea change at all levels, but if you understand what you're dealing with, you will address it more effectively. Good luck!
I may be confused here, so feel free to correct me if I am: It seems to me that the Achilles Heel of leaning too strongly on guidelines for making clinical care decisions is that the Ecological Fallacy always lurks in the background -- bluntly stated, that well-known fallacy in epidemiology involves a presumption that "what is true for some defined group of patients will be also true for each of the individual patients belonging to that group". The linguistic wrinkle that sets up this fallacy should be obvious in every medical or surgical specialty --- what is observed for any group of size N receiving treatment X (viz. what gets published in books and journals) is the AVERAGED resulting outcome over all N patients. It follows that, for any given treatment X (whether X is prophylactic or therapeutic) that results in "nearly the same" excellent outcome in every patient, choosing X for the patient sitting before you right now will very likely be a "winning" decision. The same logic will apply to observed complications of using a given X. Thus, the actual problem when following guidelines too religiously in cook-book or knee-jerk, algorithm-driven fashion to craft clinical care decisions is that the great majority of our pills, potions, powders, poultices, ointments, and operations do NOT act with perfection. Some teachers in my career have opined that "lay folks do not often understand the concept of probability so that clinicians should shy away from mentioning that concept". I think that is a bullshit notion. In my experience as an academic surgeon (now retired) very few adult patients will not understand a sentence that sounds like the following example: "Mr./Mrs. Jones, the problem we must face together is that the operation (or drug) needed for you is not perfect in every patient, but it is known from multiple investigations to act perfectly *on average* in about 85-90 percent of patients like you". In sum, what needs to happen when counseling patients is absolutely not like attempting to decode mysterious material on the level of explaining details of quantum mechanics, nuclear fission, or plate tectonics.
One of the challenges is that “guidelines” are guidelines and they are from a population view.
They are not clinical mandates for every individual.
“Guidelines” also often do a poor job at relating the issues of absolute risk/benefit vs relative risk/benefit. Especially as it relates to subpopulations.
They also often do a poor job at relating the cost/risk/benefit analysis to the individual.
“Level of evidence” utilization has not done an effective job at stratifying decision making.
Sensible Medicine is doing a great job at disseminating the ability to critically appraise medical literature.
That mission is worthy and necessary as too many providers rely on “guidelines/recommendations” from “authorities” that are often inadequate assessments and should not be utilized as blanket absolutes nor recommendations.
We continue to need well designed studies to help guide decision making.
We also need to acknowledge that, the absence of evidence that something works is not the same thing as the presence of evidence that something does not work.
In addition, patient selection/inclusion criteria in studies is important because in many studies there may be responder sub groups that we were unable to identify to help clarify potential benefit.
' Let’s have the courage to trust the clinician’s and patient’s ability to make the best individual choice. '
From my lay perspective I fully agree.
I see guidelines as an opportunity for pharma and others to have a resident salesforce at zero cost.
The concept of SDM is flawed, we need personalised care. As a patient I make the decision, either within the consultation or later outside (eg poor meds adherence, not attending tests etc) ; the hcp provides the evidence.
Great post, agree 100%! I wrote a master's thesis in philosophy of science last year arguing pretty much the same thing. I used multimorbitidy to show the epistemological limitations of a guideline-driven EBM.
2 scenarios come to mind.
1 - My doctor and I have come to an agreement as I listened to her and she actually listened to and heard me. She armed me with all the information I needed to make an educated decision regarding testing. She no longer brings up the subject of mammograms and colonoscopies and such because she understands I won't have the results treated. I respect that she respects my decision.
2 - This philosophy of sharing information and including the patient is actually what hospice does. Yes, I realize I am dealing with patients (families) at EOL, but the crux of the care given and denied is the same. [I use patient and family interchangeably because sometimes it is the family voicing the wishes of the patient who is aphasic]. We put the patient's wishes into practice. It is my job and the job of the Medical Director to give the family all of the information they need to make an educated decision of taking the medication, accepting the treatment, or not doing any of the above. Our families get on Google and Wikipedia frequently and base their decisions on what the internet says. We want, jointly, to give the best care to the patient and we can only do that by supplying him/her/them with honest information so they can join in an educated way in the plan of care.
This is excellent. Thank you so much. With this approach you express respect for the patient as well as allowing the doctor to do his/her job to the best of their ability. Medicine has been working while handcuffed for many years now
I have read the article three times and am still not sure about what the recommendations are. Doctors and patients should discuss the pluses and minuses of the various treatment options for whatever the patient's medical problems may be? Isn't that pretty much what the practice of medicine is all about? Guidelines may be a useful way to frame the discussion but, as we have often seen on this website, the "standard of care" for a number of disorders often turns out to be untrue when subjected to scientific analysis.
Until practitioners are rewarded for encouraging true patient autonomy and competence and not for simply prescribing more treatment to guideline nothing will change
After reading this article I thought how the phrase “one size fits all” can be applied to Clinical Guidelines. But of course this statement was proven false when I accidentally pulled a pair of my son’s pants out of the dryer and tried to put them on.
Very much agree - the big question is can it be done. The answer is a big YES. Our PEER group has been producing these sorts of national guidelines for almost a decade. https://peerevidence.ca/simplified-guidelines/
We have done lipids (recently updated), chronic pain, cannabinoids, opioid use disorder and presently we are working on type 2 diabetes.
To do this we follow these simple “rules”
1) We make it as simple as possible but not simpler – we keep them to no more than ~10 pages
2) The entire focus is on shared-decision making
3) We have discussion thresholds, NOT treatment thresholds
4) Always provide decision aids/calculators that give the benefit/harm numbers in absolute terms and also provide patient information sheets with that information
5) We don’t allow financial conflicts of interest
6) They are primarily written by primary care clinicians
7) We do a thorough systematic review of the evidence by PEER using the GRADE framework
Guideline Committee uses the review of evidence to create the guideline
I am a fan, keep up the excellent work!
Great article up to the conclusion: "Traditional clinical guidelines have probably provided some benefits to patient care" which appears stronger and less evidence based than the body of the article.
Also, why is an "increase in therapeutic uncertainty" necessarily a bad thing?
Great post.
Guidelines should be a compendium of the state of the science. Instead, they are now no more than cookbook recipes. Not only that, but even the details of the science are dumbed down so as to favour the overarching goal of ease of compliance, at the expense of the specifics and nuances of the individual landmark trials upon which the guideline recommendations are purportedly based.
In my field, imo this is never more in vogue than with various iterations of HFrEF guidelines over the past 10 years. “GDMT” is the stated goal in the majority of clinical notes. 100% uptake by 100% of patients is something that would be celebrated. These days, it’s 4 drugs for everyone, never mind their symptom and functional status, or their actual LV function, which actually differed in the inclusion criteria of the landmark trials for each of the “foundational” classes.
I would prefer guidelines that only listed recommendations clearly backed by large trials and replicated data showing benefit. The few and far between scenarios that actually deserve a class 1 recommendation (and not the current era where these are dispensed like candy). Likewise, a section of clearly harmful things that should definitely be avoided. Then a large swath of tweeners that have some data and could be worthy of consideration, but hardly something to reach for every time for every patient (this is the swamp in which I would stick every last one of the “expert opinions”).
I’ve never read or tried using a guideline that does not provide specific recommendations, or one that is geared foremost to discussion of risks vs benefits and of patient preferences. But I’d be willing to give it a try.
I imagine there is no perfect guideline structure. But I also find the current generation of guidelines to be far from it. But I’m not hopeful for change, given the industrial complex at play when it comes to guideline generation, and their relationship with industry who stand to benefit from such “seals of approval”.
Clinical guidelines are not guidelines. In many cases they are mandates where a physician can be called to task for not adhering to them. This will not get better as physicians continue to come under the control of large medical systems that essentially mandate the use of guidelines that do not take into account, as the author says, the individual. One question for the author: you say guidelines may benefit care. Is there any data to support that?
But, can the physicians be "called to task" if the patient refuses the advice and it is documented more than once that the patient has been educated and has made a decision to or not to .....?
Yes yes great catch on point
I agree with most of Dr. Rasudasoja's recommendations. There was a JAMA study (2023?) that evaluated if national medical specialty task forces followed National Academy of Medicines guidelines for practice guideline task forces. One key finding was that 80% of national medical specialty task forces did not have an expert in data analysis and interpretation as a member. As Sensible Medicine has reported repeatedly, there is a high incidence of flaw analysis and interpretations in papers published in medical journals. Most task forces members don't have the expertise to determine if journals made peer review errors.
Ultimately the success of any intervention will be largely determined by the motivation of the patient to implement it as described, especially those interventions carried out by the patient (vs by the doctor). A great deal of evidence from research on Self Determination Theory has demonstrated that there are 3 main factors that serve as the basis for motivation: autonomy, competence, and relatedness (link #1). This approach will address the autonomy component and to some extent, the relatedness component, but not the competence component. This is certainly a step in the right direction, but for success, I think that patient competence will also need to be addressed. It will vary by patient and would need to be assessed. This approach reminds me of the proposal of "The Drug Facts Box." Schwartz and Woloshin demonstrated in a series of studies beginning in 2007 that this simple tool was effective in helping patients understand the risks and benefits of pharmaceuticals (link #2). In 2009, an FDA advisory committee voted unanimously that the FDA require a drug fact box for new products. Congress also asked the FDA to create concise and standardized summaries of the risks and benefits of drugs in the Affordable Care Act in 2011. The FDA chose not to implement these recommendations (including The Drug Facts Box), instead issuing guidance for better risk communication in direct-to-consumer drug ads. (link #3) We all know how well that worked. (Woloshin and Schwartz attempted to implement their own online Drug Facts Box but ran out of money). The unfortunate moral of the story: expect extreme resistance from Pharma on whatever you issue about medications (and perhaps hindrance from the FDA), and most likely resistance from practitioners who don't want to change. In other words, it is not just patient motivation you will need to address. It will take a medical culture sea change at all levels, but if you understand what you're dealing with, you will address it more effectively. Good luck!
https://selfdeterminationtheory.org/theory/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3752172/
https://www.vox.com/2015/9/26/9398641/informulary-woloshin-schwartz
This I believe is one of our best contributions. Thank you AR. I agree with it 100%
I may be confused here, so feel free to correct me if I am: It seems to me that the Achilles Heel of leaning too strongly on guidelines for making clinical care decisions is that the Ecological Fallacy always lurks in the background -- bluntly stated, that well-known fallacy in epidemiology involves a presumption that "what is true for some defined group of patients will be also true for each of the individual patients belonging to that group". The linguistic wrinkle that sets up this fallacy should be obvious in every medical or surgical specialty --- what is observed for any group of size N receiving treatment X (viz. what gets published in books and journals) is the AVERAGED resulting outcome over all N patients. It follows that, for any given treatment X (whether X is prophylactic or therapeutic) that results in "nearly the same" excellent outcome in every patient, choosing X for the patient sitting before you right now will very likely be a "winning" decision. The same logic will apply to observed complications of using a given X. Thus, the actual problem when following guidelines too religiously in cook-book or knee-jerk, algorithm-driven fashion to craft clinical care decisions is that the great majority of our pills, potions, powders, poultices, ointments, and operations do NOT act with perfection. Some teachers in my career have opined that "lay folks do not often understand the concept of probability so that clinicians should shy away from mentioning that concept". I think that is a bullshit notion. In my experience as an academic surgeon (now retired) very few adult patients will not understand a sentence that sounds like the following example: "Mr./Mrs. Jones, the problem we must face together is that the operation (or drug) needed for you is not perfect in every patient, but it is known from multiple investigations to act perfectly *on average* in about 85-90 percent of patients like you". In sum, what needs to happen when counseling patients is absolutely not like attempting to decode mysterious material on the level of explaining details of quantum mechanics, nuclear fission, or plate tectonics.
Appreciate your thoughts on “guidelines”.
One of the challenges is that “guidelines” are guidelines and they are from a population view.
They are not clinical mandates for every individual.
“Guidelines” also often do a poor job at relating the issues of absolute risk/benefit vs relative risk/benefit. Especially as it relates to subpopulations.
They also often do a poor job at relating the cost/risk/benefit analysis to the individual.
“Level of evidence” utilization has not done an effective job at stratifying decision making.
Sensible Medicine is doing a great job at disseminating the ability to critically appraise medical literature.
That mission is worthy and necessary as too many providers rely on “guidelines/recommendations” from “authorities” that are often inadequate assessments and should not be utilized as blanket absolutes nor recommendations.
We continue to need well designed studies to help guide decision making.
We also need to acknowledge that, the absence of evidence that something works is not the same thing as the presence of evidence that something does not work.
In addition, patient selection/inclusion criteria in studies is important because in many studies there may be responder sub groups that we were unable to identify to help clarify potential benefit.
' Let’s have the courage to trust the clinician’s and patient’s ability to make the best individual choice. '
From my lay perspective I fully agree.
I see guidelines as an opportunity for pharma and others to have a resident salesforce at zero cost.
The concept of SDM is flawed, we need personalised care. As a patient I make the decision, either within the consultation or later outside (eg poor meds adherence, not attending tests etc) ; the hcp provides the evidence.
Great post, agree 100%! I wrote a master's thesis in philosophy of science last year arguing pretty much the same thing. I used multimorbitidy to show the epistemological limitations of a guideline-driven EBM.