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Commentary

This commentary on One Health, written by MSD Manuals physician editor Ernest Yeh, MD and MSD Veterinary Manual editor Nicholas Roman, DVM, MPH, explores One Health from a veterinarian’s and a physician’s perspective. They tackle topics ranging from the connection between human and animal health, the human-animal bond, and what One Health means for both the medical and veterinary fields moving forward.


    What is One Health?
    
        NR: One Health is the idea that the health of humans, other animals, and the environment are vitally linked. Therefore, medical and veterinary professionals as well as those in other scientific, health, and environmental disciplines should communicate and collaborate, rather than work in isolation.
        EY: I agree with Nick’s summary – One Health can help bridge the gap between human and veterinary health.
    
    
    How is One Health viewed, both in human health and veterinary health?
    
        NR: Many governmental and international agencies (the CDC, FDA, USDA, AVMA, WHO, FAO, and others) support One Health. In the veterinary clinic, however, One Health is not something that is often discussed. The average veterinarian in clinical practice may not have One Health at the top of mind as they go about their day-to-day job.
        EY: Within human health, One Health is not often emphasized or discussed. In medical schools, One Health is very rarely specifically called out within the curriculum. They touch on infectious diseases and zoonotic diseases, but do not typically speak about it under the guise of One Health. I think medical schools could do more to bring One Health to the forefront by calling out its importance. Similar to medical students, the average physician probably does not have One Health top of mind. They look at diseases like Lyme disease, which is a One Health issue as it is tick borne, but don’t think of it outside of how it affects humans. We could do more to bridge that gap in thinking.
    
    
    How have human and veterinary medicine helped contribute to the development of one another?
    
        NR: In many ways, human medicine sets the bar that veterinarians strive for—working to make the same level of care available to animals; for instance, advanced imaging modalities like CT and MRI are increasingly commonplace in vet med. Veterinarians also take an oath to use their scientific training for the advancement of medical knowledge. Since the genus Salmonella was named for Daniel Salmon—the first veterinarian to graduate in the US—veterinary research has made many groundbreaking contributions to the science of medicine as applied to human health.
        EY: A lot of discoveries in human medicine are now used in veterinary medicine, and vice versa. This is a result of identifying new practices and applying them across species.
    
    
    How is the concept of One Health currently used in practice, both in the veterinary and medical fields?
    
        NR: A sign of growing recognition of the One Health idea is expanding roles for veterinarians, such as at the CDC, FDA, and NIH. Medical school and colleges of veterinary medicine are also seeking to break down traditional silos and foster scholarly collaborations. Despite this, many individual practitioners may believe that One Health is only peripheral to their areas of focus and interest.
        EY: I don’t believe One Health is currently used within the medical field in practice – at least not directly. We may be using it (such as when treating animal borne diseases, or advising someone to use a therapy animal), but we’re not necessarily realizing we’re using One Health concepts.
    
    
    How does the human-animal bond impact human health?
    
        NR: Human-animal interaction promotes health in many ways, such as increased physical and social activity (like a trip to the dog park). The physiological benefits of pet ownership, or even just regular brief interaction with animals, have been well-documented. At the loss of a pet, pet owners often experience severe grief, with accompanying physiological effects like sleep disturbances—a testimony to the reality and the strength of the human-animal bond.
        EY: As Nick spoke about, human-animal interaction can promote health in many ways. A lot of people view their pets as a family member, which can play a large role in promoting mental health.
    
    
    More specifically, how does the human-animal bond impact mental health?
    
        NR: Animal companionship enriches our lives and improves our mental and emotional well-being. Animal-assisted therapy is helpful in a wide array of mental health issues, including post-traumatic stress, mood disorders, and OCD. On the dark end of the spectrum, mental health issues contribute to animal hoarding, and animal cruelty and abuse are linked to violence against people.
        EY: As Nick spoke about, companionship with animals can be beneficial to human health. On the other hand, it can have a negative affect on mental health when we lose a pet. Similar to losing a family member or friend, we go through the stages of grief.
    
    
    How do service & therapy animals benefit human health?
    
        NR: Service animals provide comfort, companionship, and a healthy distraction in settings like nursing homes, hospitals, and prisons. Assistance animals are trained to help individuals with sensory and other impairments. Some service dogs can even alert their owners to oncoming seizures.
        EY: Service animals are trained to perform a specific task for people with specific conditions. For example, a person with seizures may have a service animal trained to detect that the person is about to have a seizure and alert the person (or anyone else around) that a seizure is about to start. The person might then sit or lie down to avoid injuries from falling while having a seizure. The service animal may also try and protect the person’s head thereby preventing any additional injury. On the other hand, therapy dogs provide the opportunity for stress relieving interactions (petting, playful interactions) in a variety of settings such as hospitals, nursing homes and assisted living centers. Therapy dogs receive training to ensure they can interact appropriately and safely in their intended environments.
    
    
    How does environmental health impact human and animal health?
    
        NR: Environmental factors drive outbreaks of disease in wildlife, domestic animals, and humans, and environmental change affects disease risk for animals and human beings alike. Farmers raising animals in greater numbers and density than ever before to feed a growing population… conservationists working to save endangered species and ecosystems… a canine rescue working to rehome stray dogs following a hurricane…these scenarios highlight how the environment, humans, and animals are all interconnected. To quote The Lion King, “Everything [...] exists together in a delicate balance. [...] We are all connected in the great circle of life.”
        EY: As population density increases, we are encroaching upon wild, uninhabited areas. This can lead to interactions with wildlife that could be determinantal, both to environmental, human, and animal health. Our increasing population also has impacts on our food supply, which is largely animal dependent at the moment. These are just some examples of the interconnected nature of human, animal, and environmental health.
    
    
    How does One Health affect our understanding of diseases, such as COVID-19 and monkeypox (Mpox)?
    
        NR: Most emerging infectious diseases are zoonotic (spread between people and animals). Non-human animals may be the reservoirs of infection in nature; disease in animals can be a warning that disease might emerge in people. Appreciation of the connection between how humans impact the environment (climate change, loss of wildlife habitat) and the way this in turn affects human health is a cornerstone of the One Health concept. Interdisciplinary, science-based collaborations are going to be needed to tackle these kinds of problems.
        EY: We realize there is a huge interaction between the animal and human populations. As we continue surveillance and research we are going to discover more about the interaction and connection between the two.
    
    
    1How does the One Health approach affect the long-term potential for medical & veterinary progress?
    
        NR: One application of the One Health concept is biomedical research linking human and veterinary health. The comparative medicine approach has been very productive and holds great promise for progress in the medical and veterinary sciences. Increased veterinary/medical cross-interactions have potential for advancing the development of new therapeutics.
        EY: I think One Health has the potential to better connect human and veterinary health, and how we understand one another. Some work needs to be done within the human field, specifically within medical schools, to better emphasize One Health.
    
    
    How does One Medicine relate to One Health?
    
        NR: One Medicine is the collaborative effort of veterinary and human health professionals to combat shared diseases. One Health builds on that concept to include the health of the environment. Prevention and elimination of lead contamination in the environment is one example, affecting both people and animals and encompassing more than the practice of medicine but also the health of the environment.
        EY: I agree with Nick’s summary of One Medicine, and how it relates to and impacts our understanding of One Health.
    
    
    How can the average physician or veterinarian embrace One Health in their practice?
    
        NR: Many may see One Health as only applicable to large, complex, transboundary issues, like a global pandemic. Administering vaccines, prescribing parasite preventatives or antimicrobials, talking to an owner about preventing dog bites in children, or spaying a feral cat—these are all One Health activities. There are myriad opportunities for every veterinarian to protect public health and the environment.
        EY: As One Health advocates continue to expand their reach, it will impact the average physician more. This may lend itself to a broader understanding of One Health and help bridge the silos between human and animal health. This could lead to greater understanding and collaboration.
    
    


Understanding One Health

understanding-one-health

This commentary on One Health, written by MSD Manuals physician editor Ernest Yeh, MD and MSD Veterinary Manual editor Nicholas Roman, DVM, MPH, explores One Health from a veterinarian’s and...

Get acquainted with our new One Health page, designed to foster conversation around the connection between human and animal health. Our One Health page features a Q &A co-authored by one of our physician editors, Ernest Yeh, MD, and a Veterinary Manual editor, Nicholas Roman, DVM, MPH, as well as relevant content from our site ranging from zoonotic diseases to the human-animal bond, to the role of the veterinarian in One Health. Alongside this content, our site highlights blogs authored by our student veterinarian and physician authors as well as additional source material.
Explore here: One Health 



 





 



Explore Our One Health Page

one-health

Get acquainted with our new One Health page, designed to foster conversation around the connection between human and animal health. Our One Health page features a Q &A co-authored by one of...

In July 2020, Griffin et al. (1) reported in The New England Journal of Medicine on the use of nirsevimab, a monoclonal antibody with an extended half-life, against respiratory syncytial virus (RSV) to prevent RSV infection. After a single dose, patients had fewer RSV lower respiratory tract infections (LRTI) requiring medical attention and fewer hospitalizations for RSV through the next 150 days than with placebo. The study included healthy infants < 1 year of age, born between 29 weeks 0 days and 34 weeks 6 days at the start of their first RSV season, and who did not meet the American Academy of Pediatrics (AAP) guidelines to receive RSV prophylaxis (2). The incidence of medically attended RSV LRTI was 70.1% lower in those receiving nirsevimab than placebo; incidence of hospitalization was 78.4% lower. Nirsevimab had a favorable safety profile.
More recently, Hammitt et al. published the results of a phase 3 randomized clinical trial of nirsevimab. This study examined the same endpoints as the Griffin trial but was conducted in infants > 35 weeks gestation (3). The results were consistent with the Griffin trial with respect to lower medically attended LRTI in the nirsevimab group and maintenance of nirsevimab levels through 150 days. No reported significant adverse events or deaths were attributed to nirsevimab or placebo. This trial found a relatively lower efficacy of nirsevimab among infants who were < 3 months of age or who weighed < 5 kg at the injection time.
Every winter, primary care offices and hospitals are overwhelmed by infants coughing and wheezing with RSV, the leading cause of LRTI in infants < 1 year of age, with the sickest being those < 35 weeks gestation, those with chronic lung disease of prematurity (CLDP), and those with congenital heart disease (CHD). 
In the US, palivizumab, a monoclonal antibody administered monthly during RSV season, is the only immunoprophylaxis approved by the Food and Drug Administration (FDA) for severe RSV LRTI in infants born < 35 weeks’ gestation and those with CLDP or hemodynamically significant CHD. In 2014, the AAP updated their recommendations on the use of palivizumab, restricting the target population to infants born at < 29 weeks and children with CHD or CLDP given high cost, limited benefit from palivizumab prophylaxis, and lower community burden of disease (2). 
Since publication of the revised AAP guidelines, reports have multiplied of increased hospitalization and severity of illness in infants with RSV and decreased use of palivizumab even in populations for which the AAP still recommends its use (4,5). Given this increased burden of RSV disease, in 2018, the National Perinatal Association published separate guidelines for palivizumab use, which are closer to the original FDA indications for use (6).
Nirsevimab’s first regulatory body review is currently underway with the European Medicines Agency with further global regulatory submissions planned in 2022. The availability of a safe, effective, cost-effective alternative to palivizumab that can be administered as a single dose and that provides protection for an entire RSV season would be a welcome intervention for vulnerable infants and those caring for them. We eagerly await results of these reviews.
 
References

    Griffin MP, Yuan Y, Takas T, et al: Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. N Engl J Med 383(5):415-425, 2020. doi: 10.1056/NEJMoa1913556. Erratum in: N Engl J Med 383(7):698, 2020. 
    American Academy of Pediatrics Committee on Infectious Diseases; American Academy of Pediatrics Bronchiolitis Guidelines Committee: Updated guidance for palivizumab prophylaxis among infants and young children at increased risk of hospitalization for respiratory syncytial virus infection. Pediatrics 134(2):415-420, 2014. doi: 10.1542/peds.2014-1665. Erratum in: Pediatrics 134(6):1221, 2014. 
    Hammitt LL, Dagan R, Yuan Y et al: Nirsevimab for prevention of RSV in healthy late-preterm and term infants. N Engl J Med 386: 837–846, 2022.
    Domachowske JB, Anderson EJ, Goldstein, M: The Future of Respiratory Syncytial Virus Disease Prevention and Treatment. Infect Dis Ther 10: 47–60, 2021. https://doi.org/10.1007/s40121-020-00383-6
    Krilov LR, Anderson EJ: Respiratory syncytial virus hospitalizations in US preterm infants after the 2014 change in immunoprophylaxis guidance by the American Academy of Pediatrics. J Perinatol 40(8):1135-1144, 2020. doi:10.1038/s41372-020-0689-y
    Goldstein M, Phillips R, DeVincenzo JP, et al: National Perinatal Association 2018 respiratory syncytial virus (RSV) prevention clinical practice guideline: an evidence-based interdisciplinary collaboration. Neonatol Today 12(10):1–14, 2017.


Commentary: Nirsevimab Prevents Bronchiolitis in Premature Infants

nirsevimab-prevents-bronchiolitis-in-premature-infants

In July 2020, Griffin et al. (1) reported in The New England Journal of Medicine on the use of nirsevimab, a monoclonal antibody with an extended half-life, against respiratory syncytial virus...

The MSD Manuals are available in 12 languages and are now publishing in a thirteenth: Ukrainian. 

In response to an urgent request from the MSD Ukraine team to help medical professionals deliver the best care during the invasion of Ukraine, The Manuals team has launched an all-hands-on-deck effort to create the new translation in record time. The first Ukrainian language content was released on April 8, and a dedicated Ukrainian site went live on April 25.

“The volume of traumatic injuries is overwhelming, and care is taking place outside usual medical settings. Health care professionals are called on to deliver care whenever and wherever it is needed,” said Dr. Sandy Falk, editor-in-chief, The MSD Manuals. “Doctors are dealing not just with injuries, but also with providing acute care for common conditions, like myocardial infarction or childbirth. The Manuals content is ideal as a resource in this kind of situation, and we want to help in any way we can.” 

The Manuals are a comprehensive medical information source covering thousands of topics in all fields of medicine, and they’re available for free to professionals and patients around the world.

The team got to work on the Ukrainian translation when colleagues in Global Medical Affairs told them about the urgent need for medical information among first responders dealing with a wide array of emergencies. 
  
The Manuals team is working on the project with translators, as well as colleagues in Ukraine. They began with a chapter on responding to mass injury events, now available as a PDF download on The MSD Manuals sites, and they launched the Ukrainian website just two weeks later. 

“Normally, a project like this would take six to nine months,” said Melissa Adams, director, awareness and partnerships. “This time around, the team is aiming to have the first 25 chapters translated and published online within two to three weeks.”
  
“The hybrid Ukrainian/English translation model is a first for us, and The Manuals team has done an amazing job innovating at a rapid pace,” said Michael DeFerrari, director, digital publishing. 

Adams added, “This effort shows the resilience of our company and how we come together to help in times of crisis.”

Visit msdmanuals.com and click on the yellow banner at the bottom of the page to download the Ukrainian translation, or visit msdmanuals.com and click on the language drop-down menu to visit the Ukrainian site. 

How the MSD Manuals team is helping first responders in Ukraine

ukraine

The MSD Manualsare available in 12 languages and are now publishing in a thirteenth: Ukrainian.In response to an urgent request from the MSD Ukraine team to help medical professionals deliver...

The MSD Manuals play an integral role the field of medicine, past, present, and future. In 1899, a slim volume gave rise to the longest continuously published general textbook of medicine in the English language. In doing so, The Manuals created the blueprint for providing useful medical information. Since 1899, The Manuals have evolved and adapted in many ways, while still fulfilling this core mission.
I am honored to become the new Editor-in-Chief of The Manuals. As with any change in leadership, first steps are to evaluate where we are, what should stay the same, and what should change. Change is already here. Medical diagnosis and treatment are advancing at breathtaking speed. Health care has undergone a digital revolution, for both clinicians and patients. Communication is global. Personalized medicine takes many forms, from genomics to awareness of individual differences.
The Manuals are always changing, they are digital and global. They are for consumers, not just clinicians. They are not limited by species; in 1955, The Manuals introduced a veterinary manual. As with any organization that has survived for more than a century, we have not done so by standing still. Charles Darwin said, “It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.”
The most important elements will not change, these include:
Excellent quality. The content is correct, current, and evidence based. Content is written and peer reviewed by leading medical experts and edited by inhouse physicians. This is a model that ensures quality. 
Comprehensive. If there is a medical issue you need to look up, you’ll find it in The Manuals. 
Clear and concise. This emphasis on clarity and brevity should not be underestimated. The Manuals are written in a style that allows a reader to go from a question to a useful level of understanding in few minutes. There is an art to this; it is more difficult to communicate well in a few words than in many. This is the work of our experienced and talented editorial team. 
As I write this in 2022, still in the midst of the COVID-19 pandemic, the need for accurate health information is front and center. We hear a lot about the 1918 influenza pandemic, and I was interested to see how The Manuals responded at that time. Here is the coverage in the editions of The Manual before and after:
INFLUENZA.—GRIPPE.—An epidemic disease with cold in the head, pains over the body, fever and other uncomfortable symptoms. (4th ed., published 1911)
INFLUENZA.—GRIPPE.—A pandemic disease caused by the Influenza Bacillus. Incubation: 1 to 4 days. (5th ed., published 1923)
In a few words, we see a significant shift in medical knowledge. The understanding that influenza was not just epidemic, but that it could be pandemic, came at the cost of 50 million lives worldwide. We also see that it was not yet known that influenza was caused by a virus, not a bacterium – the virus identified in 1930.
At that time, it took years to bring updates to The Manuals’ readers. Now we can update our content as fast as new information emerges. We are living in an era when new medical discoveries are emerging so quickly; the speed itself makes it hard to stay current and can even be concerning to people. What is known about a new disease or treatment? Is a new treatment safe, can you trust it?
The Manuals are a resource that provide trustworthy information to clinicians and to any person interested in good health. I am delighted to become the Editor-in-Chief of this wonderful institution. The motto of the original edition still holds true today, “Every addition to true knowledge is an addition to human power.”

The MSD Manuals Have a New Editor-in-Chief

new-editor-in-chief

The MSD Manuals play an integral role the field of medicine, past, present, and future. In 1899, a slim volume gave rise to the longest continuously published general textbook of medicine in...

More than two decades ago, the Institute of Medicine defined “lab stewardship” as a management tool to guide clinical decisions through care that is respectful of and responsible to patient preferences, values, and needs (1). Interpretation of this definition evolved to include patient-focused considerations, such as access to the correct lab tests at a time during care that addresses the most salient clinical requirements.  
During the COVID-19 pandemic, U.S. patients experienced unprecedented access to lab testing that was made possible through smart-phone assisted conveniences of telemedicine and self/mobile-collection of various sample types. This was an inflection point in access-to-care that served clinical needs and mitigated infection exposures (2).  
However, increased access to testing without concordant clinical laboratory management (CLM) guidance will distract from patient-focused care. Test reports with corresponding reference ranges are equally important as ordering correct tests. For example, a reference range (RR) for some assays affected by third-spacing of fluids may differ between a non-pregnant and a pregnant female. To further illustrate this point, consider that the RR indicates test values corresponding to studies performed in a cohort of “normal” individuals with an absence of clinical conditions, including medications that may affect the test results. In the case of establishing an INR range for patients taking warfarin, for instance, such confounding variables would invalidate a RR study for a normal population. Therefore, an INR reference range of 2.0–3.0s is not normal because it’s the range for individuals on standard-intensity warfarin therapy. The INR RR for individuals on high-intensity warfarin therapy may be closer to 2.5–3.5s, and 0.9–1.1s for an apparently healthy population not taking anticoagulants.
In addition to maintaining clinical actionable lab reports and robust lab stewardship, CLM teams and individual providers must continuously ensure the right tests are ordered at the right time for the right patients. Furthermore, CLM teams must ensure that laboratory stewardship is not devalued through testing described as: Aberrant, Excessive, Incorrect, Obsolete, and/or Useless (AEIOU). To be successful in providing superior clinical services and to mitigate patient harm, lab stewardship operations must proactively target test-use through CLM that focuses on patient-centered guidance and directs efforts to eliminate “AEIOU” testing and asks WHY the test is being ordered. If the “why” cannot be answered, then ask, “What alternate course of action should be taken?” The illustrations below demonstrate the “AEIOU and always Why” in navigating lab stewardship operations.
A = Aberrant: Aberrant ordering is usually associated with high-volume or costly genetic testing in patients with low pretest probabilities (LPP). For example, for a patient being tested for hereditary hemochromatosis, ordering mutation panels for HFE gene variants is usually a common reactionary practice if iron studies, hemoglobin, and liver enzymes are minimally abnormal. Instead of rushing to genetic testing, transferrin saturation, a test usually performed in the hospital lab, should be ordered first to assess iron overload. Genetic testing should be performed only if an elevated transferrin saturation can’t be attributed to a reason for iron overload (eg, chronic transfusion). CLM teams could also use a SOFT approach when deciding to approve requests for expensive genetic testing. This approach explores: 
S: Screening options (alternate targeted testing)
O: potential Outcomes (will management change based on test result) 
F: curtailing ‘Fishing’ expeditions (ie, endless testing)
T: evaluating the request in the context of available Treatment (3) 
Ordering approaches must also be considered in high pretest probability (HPP) cases. D-dimer testing is a good example of a test that should not be ordered in patients with a HPP for a venous thromboembolism (VTE). This is because the test depends on negative predictive value (based on low pre-test probability [LPP]), which makes its use inappropriate in groups with a high prevalence of VTE. Many results would incorrectly rule-out VTE in HPP patients. D-dimer testing should be used to rule-out VTE in patients with LPP, otherwise patient safety may be compromised.  
E = Excessive: Excessive ordering can be due to Fear-Of-Missing-Out (FOMO). Ordering serial cardiac troponin (cTn) based on FOMO of the peak and/or trough level contradicts American College of Cardiology guidelines. Knowing cTn peak or trough levels provides no additional value in assessing acute myocardial infarctions (AMI) once the rise-and-fall pattern is identified using a high-sensitive (hs) cTn test. Other FOMO examples include selecting multipanel allergy testing that usually provides useless additional information and potentially confusing false-positive results. A more patient-focused approach could include using guidelines in the setting of a HPP related to allergen exposure or referral to an allergist. FOMO-induced excessive testing can lead to unwarranted blood draws, incorrect order times, and patient harm, exacerbated in the context of delayed diagnoses.
I = Incorrect: Incorrect testing orders can result from failures to follow or implement processes. Process failures may occur if a routine parathyroid hormone (PTH) is ordered when the intraoperative (i.o.) PTH is required for a patient undergoing parathyroidectomy. Both tests are analytically identical. However, ordering routine PTH for a patient who requires the i.o-PTH is in complete disregard for lab preparation, which is essential for timely testing, reporting i.o-PTH results, having a successful parathyroidectomy, and ensuring patient safety. Incorrect orders can also be due to misunderstanding of analyte names. For example, ordering total testosterone to evaluate testosterone status would not account for free (ie, active) testosterone. Furthermore, for the most accurate and clinically actionable results (eg, for diagnosing “low-T”), the Endocrine Society recommends that testosterone testing should be performed on samples drawn from patients who are fasting and within 3-hours after waking, but testing is not restricted for patients who are receiving testosterone replacement therapy or androgen deprivation therapy. Another case in which the analyte name is often confused is vitamin D. Total 25-hydroxyvitamin D (25-OHD) levels, the sum of 25-OH-vitamin D2 and 25-OH-vitamin D3, is the appropriate indicator of vitamin D body stores and is available in most clinical labs. The most biologically active form, 1,25-dihydroxy-vitamin D, should not be used to assess vitamin D status because it can vary with calcium status. Therefore, measurement of 1,25-di-OHD is not useful in screening nutritional vitamin D deficiency. It can be misleading with normal values in patients with potentially severe vitamin D deficiency (4); 25-OHD should be used instead. The 1,25-di-OHD is a much more expensive send-out test that measures bioactive vitamin D and is in the differential of hypocalcemia, renal osteodystrophy, or chronic renal failure. The expensive 1,25-di-OHD is neither suitable for diagnosis of vitamin D deficiency nor for monitoring supplementation in most patients. Therefore, the combination of inappropriate testing and increased cost diminishes the quality of care when 1,25-di-OHD is ordered instead of 25-OHD. To reduce confusion between these tests, orders for 1,25-di-OHD could being changed to “Calcitriol” and restricted to orders from endocrinologists or through a lab approval process. 
 
O = Obsolete: Obsolete tests are often antiquated and have been replaced with tests that are more technically designed to manage care. No one would consider ordering a pregnancy test in which hCG in the patient’s urine would induce egg production in a frog that received an injection of the patient’s urine. However, this was a common pregnancy test from the 1940s–1960s, boasting a turn-around-time of < 2 days (5). The bleeding time test (BTT), a “newer” obsolete assay, was/is used to evaluate platelet function and vascular integrity that would be better evaluated using coagulation tests (PT and aPTT, platelet count, and ruling out von- Willebrand’s disease). If the results of these tests are negative, a platelet function disorder can be investigated with platelet aggregation testing. Furthermore, the relationship between bleeding time and the risk of a patient’s actually bleeding has not been established and is not supported by the American Society for Clinical Pathology; therefore, the BTT should be removed from lab menus. It is highly operator–dependent, lacks reproducibility, and is confounded by technical variables such as incision location, pressure applied, operator experience, and patient factors (eg, age, gender, diet, hematocrit, skin laxity, medications). Some cardiac markers have also become obsolete in assessing AMI. Specifically, cTn has replaced the antiquated lactate dehydrogenase, creatinine kinase-MB (CK-MB), and myoglobin assays (6). The American College of Cardiology recommends hs-cTn as the only lab analyte for assessing acute chest pain.
 
U = Useless: Useless orders can be defined as those tests whose results will not change management and play no part in patient care. Ordering against guidelines, such as requesting a PSA on a 95-year-old male, has no clinical utility. Other cases may not be as obvious. For example, there is minimal justification for routine orders of reverse T3 (rT3) in thyroid function assessment. Perhaps the main use of rT3 is a prognostic marker of non-thyroidal illness or to monitor patients receiving amiodarone (7). Another example of a useless order is for methylmalonic acid (MMA) to assess B12 deficiency. Some providers use MMA results to identify a cause of low vitamin B12 levels. However, treatment for mild deficiencies has little value because disease progression in severity is rare. Furthermore, while elevated MMA can indicate vitamin B12 deficiency, it is not specific, does not implicate vitamin B12 deficiency in elderly patients, and provides no information on severity or likelihood of progression. Contributing to the low utility of MMA testing, HIBCH gene polymorphisms in people of European ancestry demonstrate elevated MMA levels, irrespective of vitamin B12 status (8). Perhaps MMA testing should be reserved for cases of suspected methylmalonic acidemia, a rare cause of devastating intellectual disability. 
 
Summary points to remember

    Lab information computerization can be used to inform providers of appropriate reference ranges, to prevent duplicate orders, and to guide testing based on evidence-based medicine.
    Managing genetic testing approval based on prevalence, pretest probability, and clinical outcome supports laboratory stewardship and patient care.
    A multi-pronged approach, required to maximize value of lab use, must focus on test menus, reduce AEIOU orders, and implement processes to guide all in-house and send-out testing.
    To maintain the right test orders at the right time for the right patient, CLM teams must continuously maintain SOFT approaches in communicating with providers to mitigate AEIOU testing. After all, the most significant errors in lab medicine are those that compromise patient safety due to neglected stewardship when ordering tests and those that lead to failures related to inaction or misinterpretation of the results.

 
References    

    Institute of Medicine: Crossing the quality chasm: A new health system for the 21st century. Washington DC: National Academy Press 2001. 
    Roberts AJ, Malik F, Pihoker C, et al : Adapting to telemedicine in the COVID-19 era: Feasibility of dried blood spot testing for hemoglobin A1c. Diabetes Metab Syndrome 15:433–437, 2021. 
    Abadie JM: Laboratory perspectives on test ordering and interpretation: Or when is a cholesterol test better than a $5,400 send-out? LabMedicine July 2007 Volume 38 No. 7; 401-403. 2007. doi: 10.1309/R9NEJWUP74KQ4A8V
    Amrein, K., Scherkl, M., Hoffmann, M. et al: Vitamin D deficiency 2.0: an update on the current status worldwide. Eur J Clin Nutr 74:1498–1513, 2020. https://doi.org/10.1038/s41430-020-0558-y 
    Sulman F, Sulman E: Pregnancy test with the male frog (Rana ridibunda). J Clin Endocrinol Metab 10 (8):933–938, 1950. https://doi.org/10.1210/jcem-10-8-933 
    Abadie JM: Cardiac injury markers and a failed algorithm: can accurate assessment of acute myocardial infarction be cost effective? Mil Med 167(8):683–687, 2002. doi: 10.1093/milmed/167.8.683 
    Gomes-Lima C, Burman KD: Reverse T(3) or perverse T(3)? Still puzzling after 40 years. Cleve Clin J Med 85:450–455, 2018. 
    Molloy AM, Pangilinan F, Mills JL, et al: A common polymorphism in HIBCH influences methylmalonic acid concentrations in blood independently of cobalamin. Am J Hum Genet 98(5):869–882, 2016. doi: 10.1016/j.ajhg.2016.03.005

 
 

Commentary: Avoiding the vowels in pursuit of good laboratory stewardship: AEIOU…..And always “Why”

laboratory-stewardship

More than two decades ago, the Institute of Medicine defined “lab stewardship” as a management tool to guide clinical decisions through care that is respectful of and responsible to patient...

Over the last 18 months, ensuring the health of our families and our communities has taken on a newfound significance and meaning. The ongoing COVID-19 pandemic has driven us to reexamine how healthcare, public health, and society intersect. Many people have learned more about topics like respiratory illness, viral loads, and vaccine efficacy than we ever expected. At the same time, healthcare professionals have been called on to answer hard questions and help patients navigate unprecedented pandemic challenges, while at the same time navigating new care delivery models like telehealth. 
As circumstances and challenges surrounding COVID-19 have evolved, it’s clear that trusted, reliable medical information has become more important than ever. Physicians, public health experts, patients, and families rely on accurate, objective information to make better decisions to drive better health outcomes. This need for quality health resources extends far beyond pandemic-related information, and it’s clear many are actively seeking out more medical information today. 
In fact, according to a recent survey from the MSD Manuals, three in five Americans (60%) say they’re reading, accessing, or consuming more medical information today than they were 24 months ago. Many Americans are looking to online sources for those resources. About 58% of Americans say they get more medical information online than from doctors, the study found. 
Challenges in Evaluating Medical Information Persist
Yet, with this increased focus on finding and interpreting medical information comes challenges. Finding trusted, reputable information, particularly online, presented difficulties even before the pandemic. Today, nearly 6 in 10 Americans (58%) say they are overwhelmed by the amount of medical information out there. 
What’s more, many struggle to stay current on the latest information. Nearly two-thirds (64%) say they get confused because medical information is constantly changing. Finally, accessing and evaluating medical sources and information can pose challenges in how we connect with others. About 68% of Americans say they often hear conflicting medical information from family and friends. 
“Our recent survey underscores what many health care professionals and people in the general public intuitively feel – online health information is easy to access, but the volume can be overwhelming and it is hard to know what to trust. Making health care decisions for yourself or your loved ones is so important and a lot of people talk about doing their own research, but how do you sort through it all? Through every chapter, medication or lab test explanation, video, 3D model, editorial, podcast episode, and more, the MSD Manuals remains committed to giving medical professionals and consumers accurate, vetted information that helps them make the best decisions.”
																	– Dr. Sandy Falk, M.D., MSD Manuals Editor-in-Chief
A Renewed Commitment to Global Medical Knowledge
Last year, the MSD Manuals celebrated a major milestone. Our trusted, current medical information is now available to more than 3 billion people in 241 countries around the globe. The Manuals has been translated into a dozen languages, with tens of thousands of resources available for patients, parents, physicians, and healthcare professionals worldwide. 
It’s a significant accomplishment in an ongoing ambitious journey to fulfill our mission to protect, preserve and share the best current medical information to enable more informed decisions, enhance relationships between patients and professionals and improve health care outcomes around the world. We’re just as committed to this mission as ever. And as the last 18 months and our recent research shows, the need for this information remains critical. 
In addition to developing and updating a wide range of medical materials and resources for medical professionals and consumers, the Manuals has drawn on existing consensus criteria to create an easy-to-remember pneumonic that guides people looking for online health information.
Patients and parents, as well as physicians and medical practitioners, can use the STANDS method to evaluate online resources:

    Source: Does the resource cite recognized authorities and provide their credentials?
    Transparency: Is it open and obvious whether the site’s mission is educational or commercial?
    Accessibility: Is the site available without registration, and is there a way for users to contact someone with questions or concerns?
    Neutrality: Is the information available purely as a resource, or does the site benefit financially from what its users do (such as buying products or visiting advertised websites)?
    Documentation: Is the site updated when needed by recognized medical experts?
    Security: Can users access content without forfeiting personal information?

 
Celebrate Global Medical Knowledge on October 15
The COVID-19 pandemic has highlighted how our medical choices can impact not just our own health, but the health of our loved ones and our community. On October 15, the MSD Manuals will celebrate Global Medical Knowledge Day—a chance to recognize and celebrate the power that trusted, reliable medical info has in fostering better health outcomes and healthier communities. It’s a natural continuation of our Global Medical Knowledge 2020 initiative while highlighting the urgent need to help all people around the world find and access medical information that drives better medical decision-making.
We hope you’ll join us on October 15 in acknowledging accurate, timely and reliable medical information as a universal right. Medical knowledge is power. Pass it on. 

Commentary: As We Seek Out More Medical Information, Trusted Sources Remain Essential

as-we-seek-out-more-medical-information-trusted-sources-remain-essential

Over the last 18 months, ensuring the health of our families and our communities has taken on a newfound significance and meaning. The ongoing COVID-19 pandemic has driven us to reexamine how...

 
Kim et al. recently published the results of a prospective cohort study of the association between self-reported coffee consumption at baseline and incident cardiac tachyarrhythmias using a sample of 386,253 patients from the UK Biobank database.1 Contrary to the expectations of conventional medical wisdom, they report that patients who drank coffee had fewer tachyarrhythmias than those who did not in a dose-dependent manner. Each daily cup of coffee was associated with 3% fewer tachyarrhythmias (HR, 0.97; 95% CI, 0.96–0.98) over a 4.5 ± 3.1 year follow-up in a multivariate analysis adjusting for 19 other potential confounders. The specific tachyarrhythmias with statistically significant associations were atrial fibrillation and/or atrial flutter and supraventricular tachycardia. Of course, even with multivariate analysis, for many reasons, an observational study cannot conclusively prove that coffee consumption protects against tachyarrhythmias. In this case, reasons include self-report bias, time-dependent changes in coffee consumption, residual/unmeasured confounding, and reverse-causation. On the other hand, a randomized clinical trial of habitual coffee consumption is unlikely to ever be performed. Accordingly, data of this sort are the best that we have to guide recommendations for our patients.
Hill proposed nine characteristics of an observational trial that lend credence to ascribing causation to an observed association between an environmental factor and subsequent disease (sometimes referred to as the “Bradford Hill Criteria”).2 Relative to the study of Kim et al., causation would translate into protection and the most applicable of these characteristics would be biological plausibility, consistency, and biological gradient (ie, dose-response relationship). With respect to biological plausibility, the major, although not the only, pharmacologically active constituent of coffee is the methylxanthine caffeine. The direct effects of caffeine on arrhythmogenesis are complex with both potentially arrhythmic effects (including sympathetic activation) and potentially antiarrhythmic effects (including adenosine receptor blockade and antioxidant properties). When one also considers the indirect effects of caffeine and the possibility of effects of other active ingredients in coffee, it quickly becomes evident that prediction of the effects of habitual coffee ingestion on the propensity to tachyarrhythmias, in the general population or in a specific individual, is not possible. Accordingly, any association between coffee consumption and tachyarrhythmias is biologically plausible. With respect to consistency of results, other observational studies have reported that coffee consumption is associated with an increase in, a decrease in, or no change in the incidence of tachyarrhythmias. Nevertheless, a meta-analysis3 of six prospective studies involving 228,465 subjects published before 2014 concluded that habitual caffeine exposure was associated with a trend to reduction in incident atrial fibrillation (RR 0.90; 95% CI 0.81–1.01; p = 0.07) that narrowly missed statistical significance. These confidence intervals include the point estimate of the association between coffee intake and the risk of atrial fibrillation and/ or atrial flutter in the study of Kim et al. (HR 0.97; 95% CI 0.96–0.98, p < 0.001). Indeed, if the results of Kim et al. were included in a formal meta-analysis, the apparent association with a lower incidence of atrial fibrillation would likely be statistically significant. Accordingly, the results of the study of Kim et al. are consistent with previous studies. The presence of a biological gradient, or dose response, strengthens the inference of causality in an observational trial because, at least up to a point, the magnitude of an outcome associated with exposure to a truly causative environmental factor increases with the magnitude of the exposure. As indicated above, Kim et al. report that the inverse association between habitual coffee intake and incident tachyarrhythmias shows a dose-response relationship with each daily cup of coffee consumption being associated with 3% fewer tachyarrhythmias (HR, 0.97; 95% CI, 0.96–0.98). This observation is also consistent with those of the previous meta-analysis,3 which noted a decrease in incident atrial fibrillation of 6% (RR, 0.94; 95% CI, 0.90–0.99) for each 300 mg of habitual daily caffeine intake (equivalent to approximately 2–3 cups of coffee).
The study of Kim et al. adds a newer wrinkle to previous studies of this sort—Mendelian randomization analysis. Such an analysis is based on the concept that, if randomization to habitual coffee intake is not possible, then the next best thing would be to use another random process that determines coffee intake or another random process that determines caffeine exposure secondary to variations in caffeine metabolism. Genome-wide association studies have identified single-nucleotide polymorphisms (SNPs) associated with coffee intake and caffeine metabolism. Individuals genetically predisposed to higher levels of coffee intake or with slow metabolism of caffeine would be expected to have higher caffeine levels. Given that these SNPs are inherited randomly (Mendel’s Law of Segregation), provided that the SNPs are not associated with other confounders, nature provides a randomized trial of caffeine exposure that provides evidence of causation if the presence of the SNPs predicting higher caffeine exposure are associated with protection from cardiac tachyarrhythmias.  Unfortunately for the hypothesis, the Mendelian randomization analysis reported by Kim et al. provided no evidence of causation. With respect to Hill’s characteristic of consistency, it is noteworthy that a previous report4 of a Mendelian randomization analysis of the association between coffee consumption and the risk of atrial fibrillation in a different subject population also found no evidence to support causation.
The patient population of Kim et al. included 1346 patients with known tachyarrhythmias at baseline – 0.3% of the overall sample. The analyses in this group of patients were comparable to the analyses in the overall group with each daily cup of coffee consumption being associated with 7% fewer tachyarrhythmias (HR, 0.93; 95% CI, 0.90-0.96).
How might we integrate these observations into clinical practice? Taken in conjunction with pre-existing literature, data of the report of Kim et al. do not convincingly support the inference that habitual coffee intake is causally related to a reduced probability of incident cardiac tachyarrhythmias. Thus, it would not be advisable for our patients to drink coffee for this purpose alone. Nevertheless, the probability that habitual coffee intake is causally related to an increased probability of cardiac tachyarrhythmias in the overall population is small. Accordingly, it seems unnecessary for our patients to avoid drinking coffee because of this concern. These conclusions also appear to be applicable to patients with known cardiac tachyarrhythmias, albeit with less certainty. In patients with known tachyarrhythmias, it would be appropriate to move away from the current practice of recommending avoidance of coffee or caffeine intake for all patients to reserving this recommendation for those patients who have recognized an association between their intake and tachyarrhythmia recurrences. 
 
 
References

    Kim EJ, Hoffman TJ, Nah G, Vittinghoff E, Delling F, Marcus GM. Coffee consumption and incident tachyarrhythmias: reported behavior, Mendelian randomization, and their interactions. July 19, 2021. JAMA Intern Med doi:10.1001/jamainternmed.2021.3616
    Hill AB. The environment and disease: association or causation. Proc R Soc Med 58:295–300, 1965.
    Cheng M, Hu Z, Lu X, Huang J, Gu D. Caffeine intake and atrial fibrillation incidence: dose response meta-analysis of prospective studies. Can J Cardiol 30:448–454, 2014.
    Yuan S, Larsson SC. No association between coffee consumption and risk of atrial fibrillation: a Mendelian randomization study. Nutr Metab Cardiovasc Dis 29:1185–1188, 2019.


Commentary—Coffee and Cardiac Tachyarrhythmias

coffee-and-cardiac-tachyarrhythmias

Kim et al. recently published the results of a prospective cohort study of the association between self-reported coffee consumption at baseline and incident cardiac tachyarrhythmias using a...

Suffering a cardiac arrest out of the hospital portends poorly. The topic frustrated researchers for decades in their search for something to improve the abysmal outcomes. Early defibrillation for pulseless ventricular tachycardia or ventricular fibrillation made a dent in the mortality rate, but few other interventions showed promise. 
 
In the early 2000s two small studies, one from Australia (Bernard et al; 2002) and one from Europe (The Hypothermia After Cardiac Arrest Study Group; 2002), seemed to offer a glimmer of hope that cooling patients who remained comatose after return of spontaneous circulation (ROSC) would result in not only improved survival, but improved survival with good neurologic outcomes. 
 
Despite grumblings that these studies were tiny and deeply flawed, this concept got integrated into virtually every resuscitation guideline. Emergency departments and hospitals worldwide stocked cooling gadgets and anointed patients with bags of ice on necks, groins, and armpits in an attempt to salvage as many neurons as possible in these patients, dutifully following said guidelines. 
 
The grumblings grew louder as subsequent studies were unable to duplicate the results of those first two. A study of 950 randomized patients published in 2013 (Nielsen et al; 2013) showed no significant difference in outcomes in patients cooled to 33°C versus those with “enforced normothermia” to 36°C. Despite the fact that the total number of patients in this study was significantly higher than in those first two combined, the practice remains cemented in resuscitation guidelines calling for cooling the patient to 32 to 36°C “as soon as possible” and maintaining that temperature for at least 24 hours. 
 
Undaunted, the targeted temperature management (TTM) researchers who published the 2013 study did a larger study (Dankiewicz et al; 2021), published in the June 17, 2021, issue of the New England Journal of Medicine. Dankeiwicz et al enrolled 1900 comatose adults after out-of-hospital cardiac arrest (OOHCA) and randomized them to either targeted hypothermia to 33°C or normothermia (body temperature ≥ 37.8°C) with early treatment of fever. There was no significant difference in death or functional outcome at 6 months. In addition to no improved outcomes, the study showed some harm (more unstable dysrhythmias, longer time on a ventilator) than the normothermia group. 
 
So, what now? The two studies by the TTM researchers done eight years apart show no benefit and imply possible harm from making post-arrest patients hypothermic. It seems that keeping a patient normothermic (ie, not letting them develop a fever) should be the focus at this point. Time to change those guidelines. 
 
References
Bernard SA, Gray TW, Buist MD, et al: Treatment of comatose survivors of out-of-hospital cardiac arrest with induced hypothermia. New Engl J Med 346:557-563, 2002. Doi: 10.1056/NEJMoa003289
The Hypothermia After Cardiac Arrest Study Group: Mild therapeutic hypothermia to improve the neurologic outcome after cardiac arrest. New Engl J Med 346:549-556, 2002. Doi: 10.1056/NEJMoa012689
Nielsen N, Wetterslev J, Cronberg T, et al: Targeted temperature management at 33°C vs 36°C after cardiac arrest. New Engl J Med 369:2197-2206, 2013. Doi: 10.1056/NEJMoa1310519
Dankiewicz J, Cronberg T, Lilja G, et al: Hypothermia vs. normothermia after out-of-hospital cardiac arrest. New Engl J Med 384:2283-2294, 2021. Doi: 10.1056/NEJMoa2100591

Commentary: It’s Time to Deep Freeze Hypothermia After Cardiac Arrest

hypothermia-after-out-of-hospital-cardiac-arrest

Suffering a cardiac arrest out of the hospital portends poorly. The topic frustrated researchers for decades in their search for something to improve the abysmal outcomes. Early defibrillation...

The BMJ recently reported the results of a multicenter, randomized, placebo-controlled n-of-1 trial (n = 200) that showed no overall effects of atorvastatin 20 mg once a day on muscle symptoms compared with placebo in individuals who previously reported severe muscle symptoms when taking statins [1]. In this study, participants who recently stopped or were considering stopping statins because of muscle symptoms were randomized to a sequence of six double-blinded treatment periods (two months each) of atorvastatin 20 mg once a day or placebo. About 70% of participants had known cardiovascular disease requiring statin for secondary cardiovascular risk reduction. The primary analysis compared participants’ rated muscle symptoms on a visual analogue scale (0-10) during the statin and placebo periods. The 151 participants included in the primary analysis showed no difference in muscle symptom scores between statin and placebo periods (mean difference statin minus placebo -0.11, 95% confidence interval -0.36 to 0.14; p = 0.40). Medication withdrawal because of intolerable muscle symptoms was 9% during the statin period and 7% during the placebo period. Two-thirds of participants who completed the trial reported restarting long-term treatment with statins. 
This study is an important addition to the expanding evidence busting the myth of the need to stop statin therapy because of vague non-severe muscle symptoms, which as the BMJ study shows, are common in both placebo and statin-treated patients. Optimal treatment of dyslipidemia, a serious, globally prevalent cardiovascular disease risk factor, is an important public health priority, and high-quality evidence accumulated over several decades consistently shows that statins significantly reduce atherosclerotic cardiovascular disease events across all age groups. Statins are generally well tolerated with a good safety profile. Severe statin-associated adverse effects on muscle such as myopathy (1 in 10,000 people treated annually) and rhabdomyolysis (0.2 in 10,000 people treated annually) are rare [2]. However, as the BMJ study suggests, the causal relationship between statins and less severe muscle symptoms is unclear. The findings from unblinded observational studies and controversial media reports have raised unfounded concerns about statins in the general population. This has led to resistance to initiating statin and non-adherence to prescribed therapy despite its profound benefits, exposing patients to unnecessary and increased risk of cardiovascular disease. Hence, large, well-controlled, randomized trials assessing statin-associated muscle symptoms have become the focus of research attention to address this literature gap.
This study appears to be well conducted, and the results are likely valid. The findings are consistent with other studies assessing similar research endpoints. The n-of-1 randomized SAMSON trial (n = 60) showed no significant difference in symptoms between participants given placebo and those given 20 mg of atorvastatin once a day (p = 0.39) [3]. Pooled results showed 90% of the symptoms attributable to the nocebo effect. In the GAUSS-3 trial, during re-challenge with a statin, 26.5% in the placebo group (but not statin group) reported muscle symptoms, suggesting that symptoms are not always related to statin use [4].
These findings do not mean that clinicians can dismiss muscle symptoms reported by patients taking a statin. A comprehensive evaluation to identify possible etiologies of reported symptoms must be performed. The pattern of symptoms, timing of onset, and timing of improvement after statin discontinuation can help identify true statin-associated adverse effects. However, the findings of clinical trials such as this study provide a strong foundation for discussion of low-dose statin re-challenge and might help clinicians reassure patients with mild non-specific muscle symptoms.
References
1. Herrett E, Williamson E, Brack K, et al: Statin treatment and muscle symptoms: series of randomized, placebo-controlled n-of-1 trials. BMJ. 2021;372:n135. Published 2021 Feb 24. doi:10.1136/bmj.n135
2. Collins R, Reith C, Emberson J, et al: Interpretation of the evidence for the efficacy and safety of statin therapy [published correction appears in Lancet. 2017 Feb 11;389(10069):602]. Lancet. 2016;388(10059):2532-2561. doi:10.1016/S0140-6736(16)31357-5
3. Wood FA, Howard JP, Finegold JA, et al: N-of-1 Trial of a statin, placebo, or no treatment to assess side effects. N Engl J Med 2020;383(22):2182-2184. doi:10.1056/NEJMc2031173
4. Nissen SE, Stroes E, Dent-Acosta RE, et al: Efficacy and tolerability of evolocumab vs ezetimibe in patients with muscle-related statin intolerance: The GAUSS-3 randomized clinical trial. JAMA 2016;315(15):1580-1590. doi:10.1001/jama.2016.3608

Commentary: Study Finds That Statins Did Not Cause Muscle Symptoms in Individuals who Previously Reported Severe Muscle Symptoms When Taking Statins

statins-and-muscle-symptoms

The BMJ recently reported the results of a multicenter, randomized, placebo-controlled n-of-1 trial (n = 200) that showed no overall effects of atorvastatin 20 mg once a day on muscle symptoms...

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