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Errors In Disease Diagnosis Lead To Nearly 800,000 Deaths, Disabilities In US Each Year: Study

Misdiagnoses in the U.S. Lead to hundreds of thousands of deaths and major disabilities each year, according to a recent report from Johns Hopkins School of Medicine in Maryland.

Each year, an estimated 795,000 Americans become permanently disabled or die due to a misdiagnosis, the study found.

It was published in The BMJ, a peer-reviewed medical trade journal.

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The top five misdiagnosed conditions were stroke, sepsis, pneumonia, venous thromboembolism (formation of a blood clot in a vein) and lung cancer — which together made up 38.7% of all cases.

More than half of all serious harm cases were made up of only 15 dangerous diseases, which led researchers to believe the issue may be more manageable than expected.

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The top five misdiagnosed conditions were stroke, sepsis, pneumonia, venous thromboembolism and lung cancer, which made up 38.7% of all cases, according to a new study.

Study co-author Dr. David Newman-Toker, a neurology professor at the Johns Hopkins University School of Medicine and director of the Armstrong Institute Center for Diagnostic Excellence, told Fox News Digital in an interview how he and his team determined the number of affected people.

The "very simple" math, he said, included tallying up the total number of dangerous disease cases — such as heart attack, stroke, infections, vascular events and cancer — and multiplying that by both the error rate for each disease and the "risk of harm" associated with each error.

While these findings offer useful insights toward preventing misdiagnoses, Newman-Toker pointed out that this is the "most underfunded" sector of public health.

The researchers used a "complex set of data sources" for each of these factors, according to Newman-Toker.

These included population-based data such as the National Inpatient Sample and national cancer registries, as well as systematic reviews.

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"For the final totals, we used nine different methods to assess the impact of various assumptions we made along the way," he said, "as well as to externally validate using other data sources and methods that our numbers were reasonable."

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Researchers from Johns Hopkins School of Medicine in Maryland found that misdiagnoses in the U.S. Have led to hundreds of thousands of deaths and major disabilities each year.

Regarding the total number of nearly 800,000 harmful outcomes, Newman-Toker said the results were "sort of unsurprising."

He added, "We've known for quite some time that diagnostic errors are a significant hidden source of harm from medical error."

And so, "to see a number that exceeded all the prior totals from medical error wasn't that surprising to us."

He added, "Most of those totals basically ignore diagnostic errors, and they're sort of the bottom of the iceberg of patient safety and quality."

What was surprising, Newman-Toker noted, was the relatively small number of diseases that accounted for a majority of errors.

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"Fifteen diseases accounted for half of all the serious harms and just five diseases accounted for nearly 40%," he said.

"That's an important insight because it makes the problem more tractable, and the diagnostic errors are a problem across all sectors of medicine, with all diseases and in all contexts."

To prevent misdiagnoses, patients should come prepared to doctor's appointments by asking questions and remaining vigilant, said the lead researcher of a new study.

"It's easy for it to start to feel overwhelming from a problem-fixing standpoint," Newman-Toker said.

"But this gives us an opportunity to actually tackle some of the highest harm problems and make a big dent in reducing the harms to patients."

The researcher said he is hopeful that this kind of research could help curb major errors in the future.

"It points us in the direction we need to go," he said. "It tells us where the majority of harms are occurring."

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While these findings offer useful insights toward preventing misdiagnoses, Newman-Toker pointed out that this is the "most underfunded" sector of public health.

For anyone concerned about a potential misdiagnosis, patients should come prepared to doctor's appointments, ask plenty of questions and remain vigilant, said the researcher.

While these findings offer useful insights toward preventing misdiagnoses, Newman-Toker pointed out that this is the "most underfunded" sector of public health.

Being prepared, according to Newman-Toker, means showing up with a "simple summary" of symptoms, as well as the patient's medical history.

"The most important question to ask your doctor is, 'What's the worst thing this could be? And why is it not that?'" he said.

Rather than asking if they need a different medicine, patients should ask, "Are we sure the diagnosis was right?" said Newman-Moker.

"Those are the main things patients must do to protect themselves."


New Chronic Heart Disease Guidelines Update Roles Of GDMT, Imaging, And Revascularization

The American College of Cardiology (ACC) and American Heart Association (AHA), along with several other professional bodies, have released new guidelines for the management of patients with chronic coronary disease.

The wide-ranging document contains updated recommendations on the use of beta-blockers, as well as new directions on the use of sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide-1 (GLP1) receptor agonists in select patients. The guidelines also provide direction on the use of optimal medical therapy, such as medications to relieve angina, those to control cardiovascular risk factors (eg, statins), adjunctive lipid-lowering therapy when necessary, antihypertensive medications, and antiplatelet therapy.

In addition, there are recommendations on how to evaluate, diagnose, and risk stratify patients with suspected coronary disease and recommendations about the role of coronary revascularization when medical therapy fails to control symptoms.

Salim Virani, MD, PhD (Baylor College of Medicine, Houston, TX, and Aga Khan University, Karachi, Pakistan), chair of the ACC/AHA writing committee, said the emphasis of the guideline is a team-based, patient-centered approach that incorporates shared decision-making.

Virani pointed out that the guidelines also ask physicians, or the CV team, to assess the various social factors that impact the patient's health. These social determinants of health include such variables as insurance coverage, health literacy and education, economic stability, physical environment, biases experienced as a result of systemic racism, gender considerations, culture and language, and social support.

"We can prescribe guideline-directed medical therapy, but if the patient has financial constraints, if they're homeless, if they don't have a safe space to walk, or if they live in a food desert, a lot of those recommendations aren't going to lead to any meaningful impact," he told TCTMD. "It's important to keep all of this in mind when we're assessing patients."

The guidelines also take economics into account, and specifically advise physicians to discuss and assess out-of-pocket costs for medications, both at the time any drug is started and at least every year thereafter (class 1 recommendation). High out-of-pocket costs, said Virani, are often the reason patients forego medication, delay refilling prescriptions, or reduce doses. Patients also should be encouraged to tell physicians what supplements they might be taking because these are an added expense and are largely ineffective.

"The number of medications that patients end up needing to take has increased appreciably as the evidence base has evolved," he said. "It becomes that much more important for patients to ask questions of their clinicians about why they're taking what they're taking so they understand. We know adherence to lifestyle and medications is extremely low in any chronic condition, just like in chronic coronary disease."

William Boden, MD (Boston University School of Medicine/VA New England Healthcare System, MA), who led the COURAGE trial, praised the writing group responsible for drafting the new guidelines, calling it a massive undertaking given the complexities and challenges of reaching consensus with such a diverse group. 

One issue with the guideline, said Boden, is a seemingly small one: nomenclature. The new document shifts from stable ischemic heart disease to chronic coronary disease, which differs from the European Society of Cardiology's (ESC) terminology that preferences chronic coronary syndrome. Boden believes this is a missed opportunity for the ACC/AHA and ESC to harmonize their terms, and while that might be a small quibble, it potentially has larger implications.

"The reason I say that is that the words that we use—coronary and disease—connote obstructive coronary disease," Boden told TCTMD. "That has been in our vernacular for the better part of 35 or 40 years, and it underscores the fact that many people continue to believe that obstructive coronary disease has to be treated in a procedural fashion."

Chronic coronary syndrome, on the other hand, would allow different conditions, particularly ischemia with nonobstructive coronary arteries (INOCA), to be emphasized a little more than they are currently (the new guidelines do include recommendations on how to manage several special populations, including INOCA). Several studies in the last decade have demonstrated that only about 40% of patients with noninvasively documented ischemia who go to the cath lab have obstructive epicardial disease, said Boden.

He stressed, however, that this shouldn't detract from the "extraordinary" guideline, noting that it isn't a criticism, but rather something he hopes future writing groups address.  

Updates on Revascularization

The guideline, which was developed in collaboration with the American College of Clinical Pharmacy (ACCP), American Society of Preventive Cardiology (ASPC), National Lipid Association (NLA), and Preventive Cardiovascular Nurses Association (PCNA), is published today in Circulation. Roughly 18 months in the making, it tops out at 111 pages, 36 of which are references alone.

The ACC/AHA/ACCP/ASPC/NLA/PCNA guideline updates the 2012 stable ischemic heart disease recommendations (and 2014 focused update) and includes a full review of all available evidence published since that time. It applies to patients with chronic coronary disease, which includes those stabilized and discharged after ACS or coronary revascularization; those with LV dysfunction and known/suspected CAD (or those with ischemic cardiomyopathy); patients with stable angina; and patients with chronic coronary disease based on the results of a screening test.

One of the important changes compared with prior guidelines pertains to the use of beta-blockers, said Virani. Long-term use is no longer recommended to improve outcomes in patients with chronic coronary disease without MI in the past year, without LVEF ≤ 50%, or without another primary indication, such as angina, arrhythmias, or hypertension, for beta-blocker therapy. In patients who've had an MI in the past year, physicians are advised to reassess the indication for long-term use (> 1 year) for reducing MACE (class 2b recommendation).

With respect to coronary revascularization, Virani said their advice was informed by the 2021 ACC/AHA revascularization guidelines and continues to make similar recommendations. For example, revascularization with either surgery or PCI is a class 1 recommendation to improve symptoms in patients with lifestyle-limiting angina despite guideline-directed medical therapy while CABG surgery is a class 1 recommendation over medical therapy alone to improve survival in patients with significant left main CAD or multivessel disease with severe LV dysfunction (LVEF ≤ 35%). PCI is awarded a class 2a recommendation as a reasonable alternative to surgery in select patients with left main CAD.

"Revascularization is a very small subsection of this guideline," said Virani. "The guideline really covers the entire spectrum of management of stable coronary artery disease."

Boden said the new guidelines emphasize patient-centered care and shared decision-making, but "the reality of the situation, to me, is that these are more aspirational goals" given the way the US healthcare system is structured with the fee-for-service reimbursement model. Hospitals derive an enormous amount of revenue from procedures, he said, and there's little disincentive to perform less of them. "And so, I think often when it comes down to patient-centered outcomes and shared decision-making, we put it to the patient, what would you prefer?" said Boden.

"We have these three choices: medical therapy, PCI, bypass surgery. What would you like? It's kind of like, you know, picking from a menu. Yet, I think most patients don't really have the ability to make informed choices because they're not given all of the options presented in a clear, full disclosure and balanced fashion," he added.

In an editorial, Sunil Rao, MD, Harmony Reynolds, MD, and Judith Hochman, MD (NYU Langone Health System, New York), state that medical therapy "aimed at aggressive control of risk factors and angina remains the foundation" of treatment in chronic coronary disease, but revascularization can play a role when medical therapy fails to control symptoms.

They note that the new guidelines suggest severe ischemia may warrant a referral for coronary revascularization. However, because the ISCHEMIA trial saw no benefit with PCI or CABG surgery related to ischemia severity, the editorialists believe risk assessment might be better achieved by quantifying the extent of CAD.

The guidelines contain recommendations on the use of antiplatelet therapy and oral anticoagulation, with directions tracking with other US guidelines. For example, dual antiplatelet therapy (DAPT) for 6 months after PCI is a class 1 recommendation, while it's reasonable to go with a 1- to 3-month course of DAPT—followed by 12 months of monotherapy with a P2Y12 inhibitor—in DES-treated patients to reduce bleeding risks (class 2a recommendation).

Advice on Beta-blockers

As in all cardiovascular guidelines, lifestyle changes, including a healthy diet and exercise, are recommended for patients with chronic coronary disease. Smoking should be curbed, but e-cigarettes are not recommended to help patients quit. Additionally, patients should be advised that nonprescription or dietary supplements, including omega-3 fatty acids, vitamins, beta-carotene, and calcium, are not beneficial for reducing acute CV events. 

SGLT2 inhibitors and GLP-1 receptor agonists with a proven cardiovascular benefit are class 1 recommendations for stable CAD patients with type 2 diabetes, while an SGLT2 inhibitor is also a class 1 recommendation for reducing the risk of CV death and HF hospitalization in chronic CAD patients with LVEF ≤ 40%, irrespective of diabetes status.

High-intensity statins are the backbone of lipid management (class 1 recommendation) with adjunctive therapies recommended depending on patient risk and baseline LDL-cholesterol levels, just as in existing ACC/AHA cholesterol guidelines. Similarly, there are recommendations on blood-pressure control that adhere to the current US hypertension guidelines. Cardiac rehabilitation is recommended for all patients after a recent MI, PCI, or CABG surgery, as well as for those with stable angina or those who had a recent heart transplant.

When it comes to diagnoses, the document was informed largely by the recent US chest pain guidelines. Routine periodic testing with coronary CT angiography or stress testing is not recommended to guide treatment decisions (class 3 recommendation), nor is the routine assessment of LV function in patients who haven't had a change in clinical or functional status (class 3 recommendation).

For Boden, the recommendations on pharmacotherapy for chronic coronary disease are excellent, but he was struck by the pronounced endorsement of inclisiran (Leqvio; Novartis) and bempedoic acid (Nexletol; Esperion), noting that inclisiran lacks outcomes data and bempedoic acid, while proven to lower CVD events, does not have very long-term follow-up data. Additionally, he would have liked to have seen more guidance on just how low LDL cholesterol targets should be in high-risk CAD patients, noting that the ESC recommends an aggressive goal of less than 55 mg/dL, and in some instances, a target less than 40 mg/dL.   

With respect to routine surveillance, the ACC/AHA guidelines got it right, said Boden. "If the patient is asymptomatic, don't go on a fishing expedition and keep testing patients with either stress perfusion imaging or [coronary CT angiography]," he said. "Just leave people be. If they have symptoms, that's a different matter."

In the editorial, Rao and colleagues say the new guidelines "provide an important framework for the management of a heterogenous group of patients" with chronic coronary disease.

"The foundation of the treatment approach is shared-decision making, taking into account the degree of functional impairment due to symptoms, ability to adhere to recommendations, and equitable care to reduce treatment disparities," they write. "Importantly, the guidelines exist to provide guidance, and are meant to complement, not supplant, clinical judgment."


Anemia Of Chronic Disease: What To Know

Found in Some People With Long-Term Conditions That Involve Inflammation

gpointstudio / Getty Images

Medically reviewed by Gagandeep Brar, MD

Anemia of chronic disease is a type of anemia caused by inflammation from long-term disorders. Anemia is when you have reduced numbers or function of red blood cells (RBCs), which carry oxygen throughout the body.

Inflammation causes changes in how the body uses iron, which is needed for the oxygen-carrying hemoglobin in red blood cells. The condition results from other long-term health conditions that affect your ability to create red blood cells. It is also known as chronic anemia or anemia of inflammation. About 1 million Americans over age 65 have anemia of inflammation.

This article will define anemia of chronic disease, including what it is, what type of anemia it is, and common causes, symptoms, features, levels, and characteristics.

It will discuss the testing and lab values required for a diagnosis of chronic anemia and what happens as the disease progresses, as well as the difference between iron-deficiency anemia and anemia of chronic disease.

gpointstudio / Getty Images

What Is Anemia of Chronic Disease?

Anemia is a lack of healthy red blood cells with enough protein called hemoglobin. Hemoglobin requires iron to bring oxygen from the lungs to organs and tissues throughout the body.

If the body has too few red blood cells, if these cells are not fully formed and healthy, or if they don't have enough hemoglobin or iron, they won't be able to transport enough oxygen. Without enough oxygen, the body parts can't function correctly. This is called anemia.

There are many different types of anemia. Anemia of chronic disease is one of the more common types. The most common type of anemia is iron-deficiency anemia, but this has different characteristics, causes, and treatments from anemia of chronic disease.

Anemia of chronic disease is anemia caused by inflammation from a long-term or chronic illness. It is also called anemia of inflammation.

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People with anemia of chronic disease may have normal or even high levels of iron in the body's tissues. But they have low iron in the blood and not enough healthy red blood cells.

Underlying Conditions That Cause Chronic Anemia

Several long-term conditions can cause anemia of chronic disease. For instance, anemia of chronic disease can develop in people with cancers, especially blood cancers like lymphoma, including Hodgkin's disease.

Anemia of chronic disease is also common in people with varying types of autoimmune conditions. These can include:

People with chronic infections can develop anemia of inflammation. These include:

  • Tuberculosis

  • Human immunodeficiency virus (HIV)

  • Hepatitis B or C

  • Infection of the heart lining (bacterial endocarditis)

  • Bone infections (osteomyelitis)

  • Lung abscess

  • People with chronic kidney disease, diabetes, and heart failure are also at a high risk of developing anemia of inflammation.

    Risk Factors for Anemia of Chronic Disease

    The biggest risk factor for developing anemia of chronic disease is having a long-term illness that causes inflammation. It is more likely to develop as a person ages since older people are more likely to have a chronic disease.

    When dealing with chronically high levels of inflammation, your body changes in ways that may lead to anemia. These include:

  • The body changes the ways it stores and uses iron.

  • The kidneys may make less of the hormone erythropoietin (EPO) that tells the bone marrow to make red blood cells.

  • The bone marrow stops responding to EPO.

  • The red blood cells that the bone marrow makes are more fragile. They die faster than usual and faster than they can be replaced.

  • Other Causes of Chronic Anemia

    Aside from inflammation, other symptoms and bodily changes caused by the chronic illness can also work to cause or worsen anemia.

    For example, in chronic kidney disease, EPO levels may be low not only because of inflammation but because the kidneys struggle to produce enough of the hormone due to kidney damage. A person with a restricted diet due to chronic kidney disease may not get enough nutrients to make red blood cells. Losing blood due to hemodialysis can also lead to iron-deficiency anemia.

    Blood loss is also likely a factor in anemia brought on by chronic digestive conditions like inflammatory bowel disease (IBD). IBD includes ulcerative colitis and Crohn's disease), which may cause both iron-deficiency anemia due to blood loss and anemia of chronic disease.

    Anemia due to cancer is often a mix of blood loss, side effects from treatments such as chemotherapy and radiation, and due to cancers that affect or spread to the bone marrow, where red blood cells are made.

    It is also possible for older adults to develop anemia of inflammation without having a chronic disease or infection.

    Symptoms of Anemia of Chronic Disease

    Early in its course, anemia of inflammation may not have symptoms. It develops slowly. As it progresses, anemia can have mild to severe symptoms. Symptoms of anemia of chronic disease include:

  • Feeling weak or tired, especially during physical activity

  • Headache

  • Looking pale

  • Being short of breath

  • Speedy heartbeat

  • Body aches

  • Being dizzy or light-headed

  • What Tests Diagnose Chronic Anemia?

    A healthcare provider will examine you to check for anemia and ask about your symptoms and your chronic disease. They'll run many blood tests to see if your chronic condition is causing anemia. Tests and related lab values that indicate anemia of chronic disease include the following.

    Laboratory normal ranges used to diagnose anemia vary by the sex assigned at birth. (Note that in this article, the terms for sex or gender from the sources cited are used.)

    A complete blood count (CBC), peripheral smear, and reticulocyte count to study the blood cells include these indications of anemia:

  • RBC count: The number of red blood cells in your blood should be 4.7 to 6.1 million cells per microliter (mcL) for adult males and 4.2 to 5.4 million cells/mcL for adult females. Lower numbers indicate anemia.

  • Hemoglobin: Hemoglobin under 13.8 grams per deciliter (g/dL) for adult males or 12.1 g/dL for adult females would indicate anemia.

  • RBC indices and appearance: The CBC and peripheral smear also examine the red blood cells' size, shape, and color, which can provide clues to the type or cause of anemia.

  • Reticulocyte count: The reticulocyte count is the number of developing red blood cells. A normal result for healthy adults not anemic is 0.5% to 2.5%.

  • Blood tests to check iron levels include:

  • Serum iron: The normal range for this is 40 to 165 micrograms per liter (μg/L). Levels below this indicate anemia.

  • Serum transferrin: Transferrin is a protein in your blood that carries iron into the cells. Normal serum transferrin level is between 200 and 400 milligrams per deciliter (mg/dL).

  • Transferrin saturation: Transferrin levels are used to calculate transferrin saturation, which tells the healthcare provider how much iron is available to your body. A transferrin saturation below 20% indicates anemia.

  • Serum ferritin: Ferritin is a protein that stores iron in your body's cells. If ferritin falls below 100 μg/L in a person with a chronic condition, that would indicate that your body doesn't have enough iron.

  • Other tests include:

  • C-reactive protein level between 1.0 to 10.0 mg/dL or higher indicates that the body is experiencing systemic inflammation, often caused by chronic diseases.

  • The erythrocyte sedimentation rate (ESR), or sed rate, is a measurement that indicates how much inflammation is in the body. For adults over 50, ESR should be less than 20 millimeters per hour (mm/hr) in men and less than 30 mm/hr in women.

  • Rarely a bone marrow biopsy is performed to rule out cancer.

  • Treatment for Anemia of Chronic Disease

    Anemia is often mild enough that it does not need treatment. The first line of treatment for anemia of chronic disease is treating the condition causing the inflammation or working to reduce the inflammation caused by the disease. Treatment may improve or cure anemia.

    Procedures that might be needed include:

  • Blood transfusions can quickly increase the hemoglobin in your blood and boost oxygen. This is a short-term fix.

  • Intravenous medicines and iron supplements given during hemodialysis can reduce and prevent anemia in people with chronic kidney disease.

  • Medicines:

  • EPO itself can be given as a shot.

  • Shots of erythropoiesis-stimulating agents (ESAs), epoetin alpha or darbepoetin alpha, can trigger the bone marrow to make more red blood cells.

  • Depending on the characteristics of your illness (but not in all cases), your healthcare provider may suggest Iron supplements as pills or shots.

  • Anemia of Chronic Disease vs. Iron-Deficiency Anemia

    Anemia of chronic disease is different from iron-deficiency anemia.

  • In iron-deficiency anemia, the body doesn't have enough stored iron to make enough healthy red blood cells. Iron levels are low in both body tissues and the blood.

  • In anemia of chronic disease, the body has iron stores in the body tissues, but the body can't use it to make enough healthy red blood cells. Typically, iron levels are high in the body but low in the blood.

  • The symptoms of the two are similar, but the causes are different. In some cases, such as diseases that result in blood loss, people can have both types of anemia.

    Possible Complications of Anemia of Chronic Disease

    Most of the time, the symptoms of anemia are the most significant complication. Anemia of chronic disease can increase the risk of death in people with heart failure. In people with chronic kidney disease, severe anemia can lead to heart problems. And untreated, severe anemia can be life-threatening.

    Does Anemia of Chronic Disease Get Better?

    Generally, the outlook for people with anemia of chronic disease is promising. Most people improve when the anemia cause is discovered and treated.

    Dietary and Lifestyle Changes for Chronic Anemia

    A healthy diet is recommended. Your healthcare provider can share information on what you should be eating and refer you to a dietitian for nutritional counseling.

    Depending on the underlying condition and how it affects nutrient absorption and use, a healthcare provider may recommend changes to address specific nutrient deficiencies, like iron, folic acid, or vitamin B12.

    When to Contact a Healthcare Provider

    If you have a long-term disorder or chronic disease and start showing anemia symptoms, let your healthcare provider know. They'll do an exam and blood tests to diagnose anemia and work with you to treat the cause. Treatment helps most people with anemia of chronic disease feel better.

    Summary

    Anemia of chronic disease is a common type of anemia. Inflammation from long-term or chronic diseases causes it. It is also known as anemia of inflammation.

    Cancer, autoimmune conditions, chronic infections, and other conditions can all cause anemia of chronic disease. Symptoms may include weakness, fatigue, headache, pale appearance, and shortness of breath.

    Blood tests for anemia include a complete blood count and iron and iron-related protein levels. Treatment involves addressing the underlying chronic disease or reducing inflammation.

    Blood transfusions, EPO, and medicines to stimulate red blood cells can treat anemia. Supplemental iron may or may not be recommended, as this type of anemia differs from iron-deficiency anemia, but they can occur together. With treatment, the outlook for people with anemia of chronic disease is generally favorable.






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