SGLT2is are the most annoying. Cardiologists have a month or two of samples. The patient likes the meds; we adjust their diabetes regimen so they don't become hypoglycemic; the samples end; the copay is a ridiculous amount of money; the patient wants us to explore all the options to get it affordably; we can't find an affordable option; we revert their diabetes regimen. It's not the best use of anyone's time, not the safest thing for the patients, or the most effective thing for the patients. I would like a trial where patients go on and off the meds, screw up their stable diabetes regimen, have an episode of hypo- or hyper- glycemia or two, and because we spent the time screwing around with the SGLT2i have some other need not met or maybe just have to find a new primary care doctor earlier than expected because she ran screaming off into the woods, unable to cope with yet another unexpected medication change.
“Thought leaders” (esp in the HF space) are no longer “thinkers” of any desirable repute. It’s 4 drugs for everyone, all day everyday, regardless of the nuances even within the foundational studies themselves. Never mind the patient characteristics that make most patients you see in clinic different from those enrolled in those foundational studies.
So when a patient resembles those in the trials, by all means apply that data. But one should recognize when they don’t.
This penchant for “knowledge translation” has merely resulted in the dumbing down of the profession, and overuse of the products of Pharma.
I often return to Sackett. The “evidence” is only one sphere within the EBM paradigm. Those who ignore unique patient characteristics/comorbidities (“clinical experience”) and/or patient values and preferences are NOT practicing EBM in any rigorous form.
As an HF patient, I have never received a satisfactory answer (emphasis on satisfactory) as to how we can conclude that the addition of sacubatril to old-school Valsartan is helpful when they didn’t compare it to Valsartan without the addition of sacubatril. Vinay has been all over this. It’s nuts.
Without well-run, large-scale RCTs, we would have no idea if a drug or approach or device works consistently better than current approaches. But these are studies. That is, they are experiments. To get the clearest answer to the experimental question, strict entry criteria ensure that patients are similar enough in the most relevant ways, and the investigators hope that all other differences among patients are randomly distributed between the control and experimental arms. If 20% of your large group of patients can’t tolerate the drug, it doesn’t make sense to include them in a seminal study. Otherwise, we’d never learn anything about whether our drug works when it’s given its best chance to do so. It’s how good science makes progress.
But as John so clearly points out, the findings of a large RCT are only applicable to the kinds of patients who made it through the study. The guideline makers who confuse experiments with real life would do well to remember the difference.
I'm still another retired family doc. I guess this is the place we like to hang out.
Two things come to mind. One is not only is the HF population in a community setting different than in an academic study, when I was still seeing hospital patients we were encouraged to assign every diagnosis possible in order to increase reimbursement. If there was any hint of HF in the chart there would be a reviewer coming by to encourage you to add that diagnosis to the current hospitalization. That then gets them into the QA protocols of course.
The second is something I learned early in my career - in order for the conclusions of a study to be applied to a given patient, the conditions of that study have to be replicated. I think that is saying the same thing Dr Mandrola is saying in a different way. The academic studies are being applied to patients in much different settings, and the study conclusions may or may not be valid.
Drug trials are always for the benefit of the drug maker (they do the trials, not the FDA) in order to get approval. Whether any drug offers anything positive is a flip of the coin. No attention is ever paid to the direct reasons why people have heart troubles. That sorry old excuse of cholesterol being the culprit shows you just how archaic modern cardiology still is.
Statins, stents and surgery is not the answer. Unless you need a cushy income.
The more I read Sensible Medicine, the more I realize medical studies are a den of Will Rogers paradox. It's no different than private companies playing with EBIDTA to make themselves look more profitable. It's all the same. You might as well as use the old "FM happens here" explanation in the papers (FM==F'in Magic) But then again....the origin of Deus Ex Machina goes back thousands of years. Why should I be surprised.
Well stated accurate appraisal of community medicine these days.This theme of an unrealistic care paradigm is ubiquitous in our profession and forms the basis for the frustration we feel in the course of the workday. The answer? Get informed about the limitations of clinical research and be skeptical when you encounter the words”standard of care”.
"be skeptical of words like 'standard of care'." Laugh. Told my BMT doc to think outside the box if she thought it would be more successful. Said to her, I don't trust cookbook medicine. Makes me laugh to tell this story and reminds me of others. I really liked her and her team spoke highly of her. As usual takes it in stride. "Well, there's a reason it's called 'standard of care'," she replied. I looked at her. We both laughed and I said, "Just don't stop using your head. I don't care. Do what makes sense." We both kept laughing. She did save my life and do a lot right. I'll never know if she innovated, but I know she had the courage to.
As a now retired Family Physician, I fully agree with you. While I always attempted to apply EBM to my patient care, the reality that frail patients, in many cases, cannot tolerate multiple medications is certainly there.
SGLT2is are the most annoying. Cardiologists have a month or two of samples. The patient likes the meds; we adjust their diabetes regimen so they don't become hypoglycemic; the samples end; the copay is a ridiculous amount of money; the patient wants us to explore all the options to get it affordably; we can't find an affordable option; we revert their diabetes regimen. It's not the best use of anyone's time, not the safest thing for the patients, or the most effective thing for the patients. I would like a trial where patients go on and off the meds, screw up their stable diabetes regimen, have an episode of hypo- or hyper- glycemia or two, and because we spent the time screwing around with the SGLT2i have some other need not met or maybe just have to find a new primary care doctor earlier than expected because she ran screaming off into the woods, unable to cope with yet another unexpected medication change.
Very informative, thank you.
That was no misunderstanding.
“Thought leaders” (esp in the HF space) are no longer “thinkers” of any desirable repute. It’s 4 drugs for everyone, all day everyday, regardless of the nuances even within the foundational studies themselves. Never mind the patient characteristics that make most patients you see in clinic different from those enrolled in those foundational studies.
So when a patient resembles those in the trials, by all means apply that data. But one should recognize when they don’t.
This penchant for “knowledge translation” has merely resulted in the dumbing down of the profession, and overuse of the products of Pharma.
I often return to Sackett. The “evidence” is only one sphere within the EBM paradigm. Those who ignore unique patient characteristics/comorbidities (“clinical experience”) and/or patient values and preferences are NOT practicing EBM in any rigorous form.
As an HF patient, I have never received a satisfactory answer (emphasis on satisfactory) as to how we can conclude that the addition of sacubatril to old-school Valsartan is helpful when they didn’t compare it to Valsartan without the addition of sacubatril. Vinay has been all over this. It’s nuts.
Without well-run, large-scale RCTs, we would have no idea if a drug or approach or device works consistently better than current approaches. But these are studies. That is, they are experiments. To get the clearest answer to the experimental question, strict entry criteria ensure that patients are similar enough in the most relevant ways, and the investigators hope that all other differences among patients are randomly distributed between the control and experimental arms. If 20% of your large group of patients can’t tolerate the drug, it doesn’t make sense to include them in a seminal study. Otherwise, we’d never learn anything about whether our drug works when it’s given its best chance to do so. It’s how good science makes progress.
But as John so clearly points out, the findings of a large RCT are only applicable to the kinds of patients who made it through the study. The guideline makers who confuse experiments with real life would do well to remember the difference.
I'm still another retired family doc. I guess this is the place we like to hang out.
Two things come to mind. One is not only is the HF population in a community setting different than in an academic study, when I was still seeing hospital patients we were encouraged to assign every diagnosis possible in order to increase reimbursement. If there was any hint of HF in the chart there would be a reviewer coming by to encourage you to add that diagnosis to the current hospitalization. That then gets them into the QA protocols of course.
The second is something I learned early in my career - in order for the conclusions of a study to be applied to a given patient, the conditions of that study have to be replicated. I think that is saying the same thing Dr Mandrola is saying in a different way. The academic studies are being applied to patients in much different settings, and the study conclusions may or may not be valid.
Drug trials are always for the benefit of the drug maker (they do the trials, not the FDA) in order to get approval. Whether any drug offers anything positive is a flip of the coin. No attention is ever paid to the direct reasons why people have heart troubles. That sorry old excuse of cholesterol being the culprit shows you just how archaic modern cardiology still is.
Statins, stents and surgery is not the answer. Unless you need a cushy income.
Amen to that
The more I read Sensible Medicine, the more I realize medical studies are a den of Will Rogers paradox. It's no different than private companies playing with EBIDTA to make themselves look more profitable. It's all the same. You might as well as use the old "FM happens here" explanation in the papers (FM==F'in Magic) But then again....the origin of Deus Ex Machina goes back thousands of years. Why should I be surprised.
Word, bra!
The last five years of my practice (until my recent retirement) were bedeviled by the "guideline police".
And they love, love, love Entresto, which I have always thought is WAY over-hyped.
And special lashes with a wet noodle to those who call it "goal directed medical therapy".
“I don’t send the lady with kyphosis, COPD, CKD and no one at home to help them.”
Yes! Exactly
"lest we fail quality measures"
Facility with Excel software may not be a basis for individual treatment
Bravo!!! The real world is very unlike the Academy.
Well stated accurate appraisal of community medicine these days.This theme of an unrealistic care paradigm is ubiquitous in our profession and forms the basis for the frustration we feel in the course of the workday. The answer? Get informed about the limitations of clinical research and be skeptical when you encounter the words”standard of care”.
"be skeptical of words like 'standard of care'." Laugh. Told my BMT doc to think outside the box if she thought it would be more successful. Said to her, I don't trust cookbook medicine. Makes me laugh to tell this story and reminds me of others. I really liked her and her team spoke highly of her. As usual takes it in stride. "Well, there's a reason it's called 'standard of care'," she replied. I looked at her. We both laughed and I said, "Just don't stop using your head. I don't care. Do what makes sense." We both kept laughing. She did save my life and do a lot right. I'll never know if she innovated, but I know she had the courage to.
Well said. I am still wondering why phase III trials are allowed to have "run-in periods" . . .
As a now retired Family Physician, I fully agree with you. While I always attempted to apply EBM to my patient care, the reality that frail patients, in many cases, cannot tolerate multiple medications is certainly there.