Great information. But in real life how does this work for the patient? Son has J-pouch. Developed lymphoma last April. Had been on Remicade, Stellara and Skyrizi. R-CHOP chemo until August 2024. Pouchitis now with recommended treatment Entyvio. Asked gasteroenterologist, oncologist, and colorectal surgeon about drug safety with history of lymphoma. I ended up doing the research myself. Drug insert listed B-cell lymphoma as an adverse effect during clinical trial. Contacted the drug company to see how many patients in the clinical trial developed lymphoma. Drug company wrote response that Entyvio not recommended for pouchitis. In US not approved for pouchitis, so this is off-label use. The clinical trial information for drug use in moderate-severe Chrons/UC sent by the drug company indicated one person diagnosed with lymphoma during the extended trial period. The clinical trial information for drug use for pouchitis provided by the drug company indicated no lymphoma adverse effects. I had my PhD nurse practioner/researcher sister look at the trials to determine if the results were reliable. Now what decision does he make? Is the clinical trial period for pouchitis long enough? or would an extended trial period show lymphoma as well. I have the time to review all this information and am a nurse with 40 years of clinical background. All of our physicians, who are wonderful, are in their 40’s with young children. Do we ask them to spend their extra time researching Entyvio instead of going to their children’s sports events on a Saturday. Should I expect the 3 physicians to call each other to discuss the research? Does any physician have hours during their week to just research dilemmas like this? I just started reading Blind Spots by Marty Makary, MD. It is overwhelming.
About STATINS: I asked my PCP for a low-dose Rosuvastatin prescription, because my LDL remained at 70-80 despite healthy diet. Low-dose Rosuvastatin (5mg) 3x/week lead to muscle problems and reduced LDL to 46. I read that Pitavastatin appears comparably effective and less likely to cause muscle problems. So my PCP switched my prescription to low-dose Pitavastatin (1mg), which I take 3x/week. My LDL is 46, and my muscle problems vanished. This is what I wanted!
I have high Lp(a), a risk factor for CV events, so I prefer to minimize other risk factors. Also, I have subclinical atherosclerosis; there is some evidence that statins can reduce or control non-calcified plaque.
As several others have commented below, and in other past posts, these critical appraisal skills need to be taught in medical school and continued through residencies and fellowships. Is the Sensible Medicine crew, or anyone else, trying to promote this? I'm thinking about reaching out to the medical school where I live now, though it's not the one I attended decades ago.
Also, do you have suggestions about how to make critical appraisal approachable to the layperson? I've written about various aspects of healthcare to a general audience in the past, and would like to start writing about the ideas put forth in Sensible Medicine and Ending Medical Reversal. I don't want to dumb anything down, but do feel like I'm going to need to pick out the most salient and digestible issues.
Unsurprisingly, nurses receive very little education about critical appraisal of the literature even at the master's level. My EdD has featured very little, as well. Most of what I have learned has been on my own or from Vinay!
Great introduction that should whet everyone's appetite for this series. Dr. John Ioannidis pointed out that 95% of medical journal articles are nothing but junk science. One can quibble about the percentages but, in my opinion, he is pretty close to the truth. I am especially interested in analysis of studies that purport to show the benefits of statin drugs since all three of you seem to support their use for optimal medical therapy to prevent the complications of coronary artery disease.
Shouldn't this kind of teaching be part of standard pre-medical teaching too? I don't think it is--correct me if I'm wrong. Especially if it's not even standard in 4-year medical training. (I'm surprised by the suggestion below to wait until the 4th year. I think first-year med students could handle reading Prasad's Malignant.) I'm a political scientist, and I know that standard training in quantitative methods is quite sophisticated at the graduate level, possibly even more sophisticated than in medical schools (?). That's not to say I'm all that impressed by published quantitative research in my field. And see what Ioannadis says about what gets published in economics journals! But in the end, that doesn't matter as much. As I like to say, as PhD's we're doctors too, but a big difference is that we can't kill people legally.
Have any medical schools expressed interest in this course or have any integrated them into their curriculum? I wonder if 4th year in medical school might be a better time for med students to hear this information after getting a little experience under their belts?
Regarding the issue of bias in RCTs, hope you will discuss the increasing use of complex combined and surrogate endpoints. This has led to degradation of information quality in cardiology and probably other fields. Also, run-in periods like they used in the ARNI pivotal trial - they seem designed to "weed out" subjects destined to have a bad reaction to the agent. Is there a legitimate use for them?
Finally, the deepest source of bias is that investigators have a strong professional stake in the outcome of an RCT. This is understandable, given the amount of time and effort invested and the differential professional consequences of a "positive" and "negative" trial, but if we are really acting as scientists, we should not care whether the null hypothesis is true or not, only what the truth is.
Or at least more wider ranging political discussions, and perhaps more detailed pros and cons of using untrammeled (unconstitutional) executive power to club universities (along with law firms, news organizations, judges, etc.,) into submission--with lots of collateral damage to innocent people and American values.
This is very real.
Ask the right question.
Don't spend time and money on a trivial issue.
Does the result of a study lead to life improvement or extension?
How do I sign up for the course?
Great information. But in real life how does this work for the patient? Son has J-pouch. Developed lymphoma last April. Had been on Remicade, Stellara and Skyrizi. R-CHOP chemo until August 2024. Pouchitis now with recommended treatment Entyvio. Asked gasteroenterologist, oncologist, and colorectal surgeon about drug safety with history of lymphoma. I ended up doing the research myself. Drug insert listed B-cell lymphoma as an adverse effect during clinical trial. Contacted the drug company to see how many patients in the clinical trial developed lymphoma. Drug company wrote response that Entyvio not recommended for pouchitis. In US not approved for pouchitis, so this is off-label use. The clinical trial information for drug use in moderate-severe Chrons/UC sent by the drug company indicated one person diagnosed with lymphoma during the extended trial period. The clinical trial information for drug use for pouchitis provided by the drug company indicated no lymphoma adverse effects. I had my PhD nurse practioner/researcher sister look at the trials to determine if the results were reliable. Now what decision does he make? Is the clinical trial period for pouchitis long enough? or would an extended trial period show lymphoma as well. I have the time to review all this information and am a nurse with 40 years of clinical background. All of our physicians, who are wonderful, are in their 40’s with young children. Do we ask them to spend their extra time researching Entyvio instead of going to their children’s sports events on a Saturday. Should I expect the 3 physicians to call each other to discuss the research? Does any physician have hours during their week to just research dilemmas like this? I just started reading Blind Spots by Marty Makary, MD. It is overwhelming.
About STATINS: I asked my PCP for a low-dose Rosuvastatin prescription, because my LDL remained at 70-80 despite healthy diet. Low-dose Rosuvastatin (5mg) 3x/week lead to muscle problems and reduced LDL to 46. I read that Pitavastatin appears comparably effective and less likely to cause muscle problems. So my PCP switched my prescription to low-dose Pitavastatin (1mg), which I take 3x/week. My LDL is 46, and my muscle problems vanished. This is what I wanted!
The idea with a medication is to achieve the desired result with minimal or no side effects.
BTW there is nothing wrong with a LDL of 70-80. Coronary disease involves a lot more than just a cholesterol level!
I have high Lp(a), a risk factor for CV events, so I prefer to minimize other risk factors. Also, I have subclinical atherosclerosis; there is some evidence that statins can reduce or control non-calcified plaque.
Wonderful start!
As several others have commented below, and in other past posts, these critical appraisal skills need to be taught in medical school and continued through residencies and fellowships. Is the Sensible Medicine crew, or anyone else, trying to promote this? I'm thinking about reaching out to the medical school where I live now, though it's not the one I attended decades ago.
Also, do you have suggestions about how to make critical appraisal approachable to the layperson? I've written about various aspects of healthcare to a general audience in the past, and would like to start writing about the ideas put forth in Sensible Medicine and Ending Medical Reversal. I don't want to dumb anything down, but do feel like I'm going to need to pick out the most salient and digestible issues.
Is there a way to access the PPT slides without doing screenshots?
Unsurprisingly, nurses receive very little education about critical appraisal of the literature even at the master's level. My EdD has featured very little, as well. Most of what I have learned has been on my own or from Vinay!
Haven’t watched it but already worth the price of admission. Excited to dive in.
Great introduction that should whet everyone's appetite for this series. Dr. John Ioannidis pointed out that 95% of medical journal articles are nothing but junk science. One can quibble about the percentages but, in my opinion, he is pretty close to the truth. I am especially interested in analysis of studies that purport to show the benefits of statin drugs since all three of you seem to support their use for optimal medical therapy to prevent the complications of coronary artery disease.
Even from just the first video, I can tell that this needs to be required viewing in every medical school in the country
Shouldn't this kind of teaching be part of standard pre-medical teaching too? I don't think it is--correct me if I'm wrong. Especially if it's not even standard in 4-year medical training. (I'm surprised by the suggestion below to wait until the 4th year. I think first-year med students could handle reading Prasad's Malignant.) I'm a political scientist, and I know that standard training in quantitative methods is quite sophisticated at the graduate level, possibly even more sophisticated than in medical schools (?). That's not to say I'm all that impressed by published quantitative research in my field. And see what Ioannadis says about what gets published in economics journals! But in the end, that doesn't matter as much. As I like to say, as PhD's we're doctors too, but a big difference is that we can't kill people legally.
Looking forward to this. Been fooled for 45 years.
Have any medical schools expressed interest in this course or have any integrated them into their curriculum? I wonder if 4th year in medical school might be a better time for med students to hear this information after getting a little experience under their belts?
Great start, I will look forward to this series.
Regarding the issue of bias in RCTs, hope you will discuss the increasing use of complex combined and surrogate endpoints. This has led to degradation of information quality in cardiology and probably other fields. Also, run-in periods like they used in the ARNI pivotal trial - they seem designed to "weed out" subjects destined to have a bad reaction to the agent. Is there a legitimate use for them?
Finally, the deepest source of bias is that investigators have a strong professional stake in the outcome of an RCT. This is understandable, given the amount of time and effort invested and the differential professional consequences of a "positive" and "negative" trial, but if we are really acting as scientists, we should not care whether the null hypothesis is true or not, only what the truth is.
This is the valuable stuff I expected when I signed up for your newsletter- not political comments about quashing Harvard
Or at least more wider ranging political discussions, and perhaps more detailed pros and cons of using untrammeled (unconstitutional) executive power to club universities (along with law firms, news organizations, judges, etc.,) into submission--with lots of collateral damage to innocent people and American values.
This is exactly what I’ve been looking for! 👏