GPT 3.5 vs 4 for the decision, MRI or CT for Stroke?

 GPT 3.5

If a patient is hospitalized with a severe stroke, nurses will do "neuro checks" (for sudden worsening) every 2 hours.   the patient will also have a CT or MRI at about 6 hours and again at about 24 hours, to assess stability or progression of the stroke.  Which is better, a CT or an MRI?

ChatGPT 3.5

Both CT and MRI are important tools for diagnosing and assessing stroke, but they have different strengths and limitations.

CT (computed tomography) is a quick and widely available test that uses X-rays to produce detailed images of the brain. It can help diagnose a stroke by showing areas of bleeding or damage in the brain caused by the stroke. CT is often used in the early stages of stroke when time is critical, as it can quickly identify a hemorrhagic stroke and help guide treatment decisions.

MRI (magnetic resonance imaging), on the other hand, uses magnetic fields and radio waves to produce detailed images of the brain. It is more sensitive than CT for detecting subtle changes in brain tissue, and can provide more detailed information about the size, location, and extent of the stroke. MRI is often used after the acute phase of stroke to assess the extent of brain damage and to help predict outcomes.

In general, both CT and MRI are important in the evaluation of stroke patients, and the choice of imaging modality depends on the individual patient and the clinical situation. In the acute setting, CT is often preferred because it can quickly identify hemorrhagic strokes, which may require urgent intervention. In the subacute or chronic setting, MRI is often preferred for its ability to provide more detailed information about the extent and location of brain damage.

GPT 4

If a patient is hospitalized with a severe stroke, nurses will do "neuro checks" (for sudden worsening) every 2 hours.   the patient will also have a CT or MRI at about 6 hours and again at about 24 hours, to assess stability or progression of the stroke.  Which is better, a CT or an MRI?

ChatGPT 4

Both CT (Computed Tomography) scans and MRI (Magnetic Resonance Imaging) scans are diagnostic tools used in the evaluation and management of stroke patients, and each has its advantages and disadvantages.

A CT scan is typically the first imaging modality used in the setting of an acute stroke because it can be performed quickly, is widely available, and can immediately rule out a hemorrhagic stroke (bleeding in the brain). A CT scan is particularly good at detecting bleeding in the brain, and is faster and less expensive than an MRI.

An MRI, on the other hand, is more sensitive in detecting smaller and more subtle areas of brain injury, particularly in the case of ischemic stroke (stroke caused by a clot). MRI can provide more detailed images of brain tissue and can identify changes in brain tissue within the first few hours of stroke symptoms, which may not always be apparent on a CT scan.

Generally, the choice between CT and MRI will depend on the specific clinical circumstances. In the acute setting (such as the first few hours of a suspected stroke), a CT scan is usually preferred due to its speed and ability to quickly rule out a hemorrhagic stroke, which requires different treatment. However, an MRI may be used later on for a more detailed assessment of the brain tissue and to assess the extent and location of the stroke, which can be important for guiding rehabilitation and prognosis.

It's important to note that the treating physician will make the decision based on the patient's individual case, including the type of stroke suspected, the timing of symptoms, the patient's overall health status, and the resources available at the hospital.

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A later question to GPT4 got a reply that CT may take 5-10 minutes, 30 total, and MRI 30 minutes, 60 total.  Varies with details.

ChatPDF Looks at CMS "TCET" Plan

 

from CHATPDF
Note, I think this is summarizing a CMS 1-pager about the JAMA article, not the original JAMA article.
https://content.govdelivery.com/attachments/USCMS/2022/10/12/file_attachments/2295783/TCET%20JAMA%20Article%20Summary%20FINAL.pdf

Welcome to this informative PDF file about Medicare coverage for new and emerging technologies! In this document, you will learn about the Centers for Medicare & Medicaid Services' commitment to ensuring that Medicare beneficiaries have access to the latest medical devices. Here are three questions you might have about this PDF file:
What specific types of medical devices will be covered under this new accelerated approval pathway?
How will CMS determine the strength of the evidence collected during early evidence review?
What benefits will Medicare beneficiaries see as a result of this new policy?
What specific types of medical devices will be covered under this new accelerated approval pathway?
According to the information on page 1 of this PDF file, the accelerated approval pathway will be limited to medical devices that fall within the Medicare statute and that are relevant to the Medicare population. The proposed rule will allow manufacturers to enter the process on a voluntary basis.
How will CMS determine the strength of the evidence collected during early evidence review?
As stated on page 1 of this PDF file, CMS may conduct early evidence review before the device secures FDA marking authorization and discuss with the manufacturer the best Medicare coverage pathway, depending upon the strength of the evidence collected. If CMS determines that further evidence development is the best coverage pathway, the agency would explore how to reduce the burden on manufacturers, clinicians and patients while maintaining rigorous evidence requirements.
What benefits will Medicare beneficiaries see as a result of this new policy?
The PDF file on page 1 does not provide specific information about the benefits that Medicare beneficiaries will see as a result of this new policy. However, the overall goal of this policy is to ensure that Medicare beneficiaries have access to emerging medical technologies. By creating an accelerated approval pathway, CMS hopes to reduce barriers to access and speed up the process of getting new medical devices covered by Medicare.
DO beneficaries want the latest medical technologies?
The PDF file on page 1 does not provide specific information about whether beneficiaries want the latest medical technologies. However, CMS is committed to ensuring that Medicare beneficiaries have access to emerging technologies, which suggests that there is a demand for these types of medical devices among some beneficiaries. Ultimately, the decision to use a particular medical technology will depend on a variety of factors, including the patient's individual needs and preferences, as well as the recommendations of their healthcare provider.

FDA Court Decision Alarms Many People; Courts Can Overturn Patent and CMS Decisions Quietly

 Recently, assume that stakeholders have approached federal district courts, and invalidate an FDA drug approval on the grounds that FDA failed to appropriately applies rules in the FDA statute.  Assume that the case won at the federal district court level, and the judge issued a stay against marketing the drug, effectively immediately.  This led to a public protest.     Now, let's compare three situations where judges overrule a federal agency.  In the first situation, Patent Office issued patents, following its statute carefully.   But these patents are often overturned in court, which we all accept as a routine event.   Iin the second situation, CMS, the Medicare agency, issues complicated rules of diverse types, many in the form of regulations.  Sometimes, courts overturn these CMS agency regulations or decisions.  While not common, the result is accepted by stakeholders without grand concerns.   However, in a third situation, a district court bans a drug based on its conclusion that FDA failed to follow some aspect of its own statute in approving the drug.  This leads to an uproar.    Discuss these three situations (Patent, CMS, and FDA) and how they compare and contrast.

The three situations you described all involve a federal agency making a decision that is subsequently challenged in a court of law. In each case, the court has the power to overturn the agency's decision if it finds that the agency did not follow the law or its own rules in making that decision. Let's explore these scenarios in depth:

Patent Office: The United States Patent and Trademark Office (USPTO) is responsible for granting patents. If a patent is granted and then challenged in court, the court may overturn the patent if it finds that the USPTO did not appropriately apply patent law in granting the patent. This is a relatively common occurrence and is generally accepted by the public. This acceptance is likely due to a few factors. First, patent law is complex, and there is an understanding that the USPTO might not always get it right. Second, the stakes are often seen as lower—while a patent can be financially significant for the entities involved, it usually doesn't have a direct, immediate impact on the health or welfare of the general public.

CMS: The Centers for Medicare & Medicaid Services (CMS) issue a variety of rules and regulations governing healthcare provision and reimbursement. Courts may overturn these decisions if they are found to be inconsistent with the law or with the CMS's own rules. While less common than with patents, such overturns are generally accepted. This may be because, like with patents, the decisions of the CMS, while important, are seen as one part of a large, complex system. The impacts of a single decision are typically dispersed and not immediately life-changing for most individuals.

FDA: The Food and Drug Administration (FDA) is responsible for ensuring the safety and efficacy of drugs. When the FDA approves a drug, it is signaling to doctors and patients that the drug is safe and effective for its intended use. If a court overturns an FDA drug approval, it can cause significant public concern. This is likely because of the high stakes involved—people's health and lives. If the court finds that the FDA did not follow its own rules in approving the drug, it raises questions about the safety and effectiveness of that drug. This can lead to confusion and fear among patients and healthcare providers, and a loss of trust in the FDA's oversight process.

In summary, while all three agencies can have their decisions overturned by a court, the public reaction to these overturns can vary widely. This is likely due to the perceived impact of the agency's decisions on individuals' lives and wellbeing. In the case of the FDA, the public's reaction is likely amplified due to the direct and immediate impact on people's health.

 

Thank you for your concise answer, "Drug approvals involve people's health and lives."   Can you elaborate on that, but also, elaborate on other reasons why stakeholders might be highly concerned about the revocation of an FDA drug decision, by a single Federal judge in one jurisdiction.   Ideally, your answer will include 3 or 4 separate reasons.

 Certainly, I can provide more detail on why stakeholders might be highly concerned about the revocation of an FDA drug decision by a single federal judge in one jurisdiction. There are several reasons for this heightened concern:

Impact on health and lives: As mentioned earlier, drug approvals involve people's health and lives. When an FDA-approved drug is revoked by a judge, it raises concerns about the safety and efficacy of the drug. Patients who are already using the drug might worry about potential side effects or whether they should continue their treatment. Doctors and healthcare providers might be uncertain about prescribing the drug or managing the care of patients who are already using it.

Public trust in regulatory systems: A revocation of an FDA drug decision by a judge can undermine public trust in the regulatory system. People rely on the FDA to ensure that the drugs they take are safe and effective. If a judge determines that the FDA did not follow its own rules in approving a drug, it may lead to questions about the agency's competency and the rigor of its approval process. This could potentially have a broader impact on trust in other drugs approved by the FDA and even in the agency itself.

Impact on pharmaceutical companies: Drug development is a costly and time-consuming process, often taking several years and involving significant investment by pharmaceutical companies. A revocation of an FDA drug decision by a judge can have serious financial consequences for the companies involved. The loss of an approved drug can lead to reduced revenue, and the company may have to halt or adjust its marketing and distribution plans. Additionally, investor confidence in the company might be shaken, impacting stock prices and future investments.

Legal uncertainty: When a single federal judge in one jurisdiction revokes an FDA drug decision, it can create legal uncertainty, particularly if there are conflicting decisions from other jurisdictions. This may lead to a complex legal landscape, with different courts potentially reaching different conclusions about the same drug. This can further complicate matters for healthcare providers, patients, and the pharmaceutical industry, as they navigate a patchwork of legal rulings.

These are just a few of the reasons why stakeholders might be highly concerned about the revocation of an FDA drug decision by a single federal judge in one jurisdiction. The combination of direct impacts on people's health, trust in regulatory systems, consequences for pharmaceutical companies, and legal uncertainty all contribute to heightened concern in these situations.

Healthcare Nation AI Summary

 AI GPT4 SUMMARY

 Original post - http://www.discoveriesinhealthpolicy.com/2023/04/hey-im-on-podcast.html 

(LONGER SUMMARY)

In this podcast, health policy expert Bruce Quinn joined Rick Gannotta to discuss several topics related to healthcare innovation, policy, and regulation, including precision medicine, legislation, and the challenges faced by startups in the health sector.

In part one, they discussed precision medicine and its applications, particularly in oncology. Bruce explained how genetic testing helps identify specific cancer mutations, which can lead to personalized treatments targeting those mutations. Additionally, he mentioned that Medicare directs most of its genomic reimbursement dollars to a few comprehensive tests. This does not limit patient access but rather tends to create a "winner-take-all" distribution, favoring a few large companies and making it difficult for smaller companies to succeed in the market.

 

In part two, they touched upon the regulatory and legislative aspects of healthcare innovation. Bruce mentioned that the Centers for Medicare and Medicaid Services (CMS) plays a crucial role in reimbursement and regulation. He highlighted the need for better alignment between FDA approval and CMS coverage. The discussion also covered the concept of Local Coverage Determination (LCD) and the challenges faced by startups in obtaining Medicare coverage for their innovative products.

 

Part three delved into the concept of breakthrough devices, their origin in the 21st Century Cures Act, and their implications for Medicare coverage. Bruce mentioned the transition from the Trump administration's Medicare Coverage of Innovative Technologies (MCIT) to the Biden administration's Transitional Coverage for Emerging Technologies (TCET). He emphasized the importance of supporting innovation in the health sector, especially in biotech, bio-manufacturing, and med tech.

 

Rick and Bruce also discussed the impact of ARPA-H (Advanced Research Projects Agency for Health), which is a new initiative aimed at funding innovative projects in healthcare. They acknowledged the need for greater collaboration between public and private sectors to speed up innovation and address the challenges faced by startups.

 

In conclusion, Bruce advocated for a more comprehensive vision of healthcare innovation, focusing on all aspects of the innovation pathway, from genomic breakthroughs to the final stages of insurance plans and reimbursement policies. He stressed the importance of addressing the "elephants in the room" – the unspoken problems and bottlenecks in healthcare innovation – in order to foster a more conducive environment for progress.

Hearflow Lobbying

 https://www.opensecrets.org/federal-lobbying/clients/summary?cycle=2022&id=D000083773

About $1.8M in 6 years (end 2022).

Documents from 2018 era:

https://brucedocumentblog.blogspot.com/2018/06/some-heartflow-document-links.html

July 2019:

http://www.discoveriesinhealthpolicy.com/2019/07/two-offbeat-policy-quirks-in-outpatient.html

August 2019:

http://www.discoveriesinhealthpolicy.com/2019/08/cms-proposes-big-heartflow-price-cut.html

April 2018:

http://www.discoveriesinhealthpolicy.com/2018/04/medicare-nerdism-and-heartflows-240m.html

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zheartflow

tagheartflow

How to Discuss MCED with a Patient Today, per GPT4

 Citation to Selby et al. and the 3-talk model, re MCED here:

http://www.discoveriesinhealthpolicy.com/2023/04/ai-actually-helps-citation-to-doctor.html

Below, I ask GPT4 for a poor man's version of the same goal (info for talking to patient about MCED)

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I am a medical doctor.   Patients are coming to me with questions about Multi  Cancer Early Detection tests.  (Can be abbreviated MCED).   They would like to discuss pro's and con's of these tests with me.  Please provide me a structured guide to how I can discuss the most likely benefits and most likely risks of these tests with a patient who is concerned or curious about this type of testing for himself or herself.  Thank you.

GPT4

As a medical doctor, it is crucial to present balanced and accurate information about Multi-Cancer Early Detection (MCED) tests to your patients. Here is a structured guide to help you discuss the potential benefits and risks of MCED tests with your patients:

Introduction:

Start by explaining what MCED tests are, how they work, and their purpose. Mention that these tests are designed to detect multiple types of cancer in their early stages, which may improve treatment outcomes and survival rates.

Benefits:

a. Early detection: Emphasize that detecting cancer in its early stages often results in better treatment outcomes and higher survival rates. MCED tests can potentially identify cancers that might otherwise go undetected until they progress to more advanced stages.

b. Non-invasive testing: Explain that MCED tests typically involve blood samples or other non-invasive methods, which can be more comfortable and less risky than invasive diagnostic procedures, such as biopsies.

c. Comprehensive screening: Highlight that MCED tests can screen for multiple cancer types simultaneously, which may be particularly beneficial for individuals with a high risk of developing various cancers due to genetic predispositions or other factors.

Risks and Limitations:

a. False positives: Explain that MCED tests may produce false-positive results, which can lead to unnecessary follow-up testing, anxiety, and emotional distress for patients.

b. False negatives: Mention that MCED tests may also produce false-negative results, potentially providing a false sense of security and delaying the diagnosis and treatment of cancer.

c. Uncertain clinical utility: Discuss that the effectiveness of MCED tests in reducing cancer mortality is still being studied, and more data is needed to determine their overall impact on patient outcomes.

d. Cost and accessibility: Address the potential financial burden associated with MCED tests, as they may not be covered by insurance and could be costly for some patients. Additionally, the availability of these tests may vary depending on the healthcare system and location.

Personal considerations:

Encourage the patient to consider their personal risk factors, family history, and preferences when deciding whether to undergo MCED testing. Discuss the patient's specific concerns and address any questions they may have.

Decision-making:

Guide the patient through weighing the potential benefits and risks of MCED testing in light of their individual circumstances. Encourage them to consider their values, preferences, and overall goals for their health.

Next steps:

If the patient decides to proceed with MCED testing, provide information on the testing process, follow-up care, and potential next steps based on the test results. If the patient decides against MCED testing, discuss alternative cancer screening and prevention strategies that may be more appropriate for their situation.

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By providing a structured and balanced discussion of the benefits and risks associated with MCED tests, you can help your patients make informed decisions about their healthcare and cancer screening options.