Since the landmark ARMA trial, use of low tidal volume ventilation (LTVV) at 6 mL/kg predicted body weight (PBW) has become our gold standard for ventilator management in acute respiratory distress syndrome (ARDS) (Brower RG, et al. N Engl J Med. 2000;342[18]:1301). While other studies have suggested that patients without ARDS may also benefit from lower volumes, the recently published Protective Ventilation in Patients Without ARDS (PReVENT) trial found no benefit to using LTVV in non-ARDS patients (Simonis FD, et al. JAMA. 2018;320[18]:1872). Does this mean we let physicians set volumes at will? Is tidal volume (VT) even clinically relevant anymore in the non-ARDS population?

Prior to the PReVENT trial, our practice of LTVV for patients without ARDS was informed primarily by observational data. In 2012, a meta-analysis comparing LTVV with “conventional” VT (10-12 mL/kg IBW) in non-ARDS patients found that those given LTVV had a lower incidence of acute lung injury and lower overall mortality (Neto AS, et al. JAMA. 2012 308[16]:1651). While these were promising findings, there was limited follow-up poststudy onset, and the majority of included studies were based on a surgical population. Additionally, the use of VT > 10 mL/kg PBW has become uncommon in routine clinical practice. How comparable are those previous studies to today’s clinical milieu? When comparing outcomes for ICU patients who were ventilated with low (≤7mL/kg PBW), intermediate (>7, but <10 mL/kg PBW), and high (≥10 mL/kg PBW) VT, a second meta-analysis found a 28% risk reduction in the development of ARDS or pneumonia with low vs high, but the similar difference was not seen when comparing low vs intermediate groups (Neto AS, et al. Crit Care Med. 2015;43[10]:2155). This research suggested that negative outcomes were driven by the excessive VT.

To investigate the importance of timing of LTVV in ARDS, Needham and colleagues performed a prospective cohort study in patients with ARDS, examining the effect of VT received over time on the outcome of ICU mortality (Needham DM, et al. Am J Respir Crit Care Med. 2015;191[2]:177). They found that every 1 mL/kg increase in VT setting was associated with a 23% increase in mortality and, indeed, increases in subsequent VT compared with baseline setting were associated with increasing mortality. One may, therefore, be concerned that if we miss the ARDS diagnosis, the default to higher VT at the time of intubation may harm our patients. With or without clinician recognition of ARDS, LUNG SAFE revealed that the average VT for the patients with confirmed ARDS was 7.6 (95% CI 7.5-7.7) mL/kg PBW. While this mean value is well within the range of lung protective ventilation (less than 8 mL/kg PBW), over one-third of patients were exposed to larger VT. A recently published study by Sjoding and colleagues showed that VT of >8 mL/kg PBW was used in 40% of the cohort, and continued exposure to 24 total hours of these high VT was associated with increased risk of mortality (OR 1.82 (95% CI, 1.20–2.78) (Sjoding MW, et al. Crit Care Med. 2019;47[1]:56). All three studies support early administration of lung protective ventilation, considering the high mortality associated with ARDS.

Before consolidating what we know about empiric use of LTVV, we also must highlight the important concerns about LTVV that were investigated in the PReVENT trial. Over-sedation to maintain low VT, increased delirium, ventilator asynchrony, and possibility of effort-induced lung injury are some of the potential risks associated with LTVV. While there were no differences in the use of sedatives or neuromuscular blocking agents between groups in the PReVENT trial, more delirium was seen in the LTVV group with a P = .06, which may be a signal deserving further exploration.

Therefore, now understanding both the upside and downside of LTVV, what’s our best approach? While we lack prospective clinical trial data showing benefit of LTVV in patients without ARDS, we do not have conclusive evidence to show its harm. Remembering that even intensivists can fail to recognize ARDS at its onset, default utilization of LTVV, or at least lung protective ventilation of <8 mL/kg PBW, may be the safest approach for all patients. To be clear, this approach would still allow for active physician decision-making to personalize the settings to the individual patient’s needs, including the use of higher VT if needed for patient comfort, effort, and sedation needs. Changing the default settings and implementing friendly reminders about how to manage the ventilator has already been shown to be helpful for the surgical population (O’Reilly-Shah VN, et al. BMJ Qual Saf. 2018;27[12]:1008).

We must also consider the process of health-care delivery and the implementation of best practices, after considering the facilitators and barriers to adoption of said practices. Many patients decompensate and require intubation prior to ICU arrival, with prolonged boarding in the ED or medical wards being a common occurrence for many hospitals. As such, we need to consider a ventilation strategy that allows for best practice implementation at a hospital-wide level, appealing to an interprofessional approach to ventilator management, employing physicians outside of critical care medicine, respiratory therapists, and nursing. The PReVENT trial had a nicely constructed protocol with clear instructions on ventilator adjustments with frequent plateau pressure measurements and patient assessments. In the real world setting, especially in a non-ICU setting, ventilator management is not as straightforward. Considering that plateau pressures were only checked in approximately 40% of the patients in LUNG SAFE cohort, active management and attention to driving pressure may be a stretch in many settings.

Until we get 100% sensitive in timely recognition (instantaneous, really) of ARDS pathology augmented by automated diagnostic tools embedded in the medical record and/or incorporate advanced technology in the ventilator management to avoid human error, employing simple defaults to guarantee a protective setting in case of later diagnosis of ARDS seems logical. We can even go further to separate the defaults into LTVV for hypoxemic respiratory failure and lung protective ventilation for everything else, with future development of more algorithms, protocols, and clinical decision support tools for ventilator management. For the time being, a simpler intervention of setting a safer default is a great universal start.

Dr. Mathews and Dr. Howell are with the Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine; Dr. Mathews is also with the Department of Emergency Medicine; Icahn School of Medicine at Mount Sinai, New York, NY.

Since the landmark ARMA trial, use of low tidal volume ventilation (LTVV) at 6 mL/kg predicted body weight (PBW) has become our gold standard for ventilator management in acute respiratory distress syndrome (ARDS) (Brower RG, et al. N Engl J Med. 2000;342[18]:1301). While other studies have suggested that patients without ARDS may also benefit from lower volumes, the recently published Protective Ventilation in Patients Without ARDS (PReVENT) trial found no benefit to using LTVV in non-ARDS patients (Simonis FD, et al. JAMA. 2018;320[18]:1872). Does this mean we let physicians set volumes at will? Is tidal volume (VT) even clinically relevant anymore in the non-ARDS population?

Prior to the PReVENT trial, our practice of LTVV for patients without ARDS was informed primarily by observational data. In 2012, a meta-analysis comparing LTVV with “conventional” VT (10-12 mL/kg IBW) in non-ARDS patients found that those given LTVV had a lower incidence of acute lung injury and lower overall mortality (Neto AS, et al. JAMA. 2012 308[16]:1651). While these were promising findings, there was limited follow-up poststudy onset, and the majority of included studies were based on a surgical population. Additionally, the use of VT > 10 mL/kg PBW has become uncommon in routine clinical practice. How comparable are those previous studies to today’s clinical milieu? When comparing outcomes for ICU patients who were ventilated with low (≤7mL/kg PBW), intermediate (>7, but <10 mL/kg PBW), and high (≥10 mL/kg PBW) VT, a second meta-analysis found a 28% risk reduction in the development of ARDS or pneumonia with low vs high, but the similar difference was not seen when comparing low vs intermediate groups (Neto AS, et al. Crit Care Med. 2015;43[10]:2155). This research suggested that negative outcomes were driven by the excessive VT.

To investigate the importance of timing of LTVV in ARDS, Needham and colleagues performed a prospective cohort study in patients with ARDS, examining the effect of VT received over time on the outcome of ICU mortality (Needham DM, et al. Am J Respir Crit Care Med. 2015;191[2]:177). They found that every 1 mL/kg increase in VT setting was associated with a 23% increase in mortality and, indeed, increases in subsequent VT compared with baseline setting were associated with increasing mortality. One may, therefore, be concerned that if we miss the ARDS diagnosis, the default to higher VT at the time of intubation may harm our patients. With or without clinician recognition of ARDS, LUNG SAFE revealed that the average VT for the patients with confirmed ARDS was 7.6 (95% CI 7.5-7.7) mL/kg PBW. While this mean value is well within the range of lung protective ventilation (less than 8 mL/kg PBW), over one-third of patients were exposed to larger VT. A recently published study by Sjoding and colleagues showed that VT of >8 mL/kg PBW was used in 40% of the cohort, and continued exposure to 24 total hours of these high VT was associated with increased risk of mortality (OR 1.82 (95% CI, 1.20–2.78) (Sjoding MW, et al. Crit Care Med. 2019;47[1]:56). All three studies support early administration of lung protective ventilation, considering the high mortality associated with ARDS.

Before consolidating what we know about empiric use of LTVV, we also must highlight the important concerns about LTVV that were investigated in the PReVENT trial. Over-sedation to maintain low VT, increased delirium, ventilator asynchrony, and possibility of effort-induced lung injury are some of the potential risks associated with LTVV. While there were no differences in the use of sedatives or neuromuscular blocking agents between groups in the PReVENT trial, more delirium was seen in the LTVV group with a P = .06, which may be a signal deserving further exploration.

Therefore, now understanding both the upside and downside of LTVV, what’s our best approach? While we lack prospective clinical trial data showing benefit of LTVV in patients without ARDS, we do not have conclusive evidence to show its harm. Remembering that even intensivists can fail to recognize ARDS at its onset, default utilization of LTVV, or at least lung protective ventilation of <8 mL/kg PBW, may be the safest approach for all patients. To be clear, this approach would still allow for active physician decision-making to personalize the settings to the individual patient’s needs, including the use of higher VT if needed for patient comfort, effort, and sedation needs. Changing the default settings and implementing friendly reminders about how to manage the ventilator has already been shown to be helpful for the surgical population (O’Reilly-Shah VN, et al. BMJ Qual Saf. 2018;27[12]:1008).

We must also consider the process of health-care delivery and the implementation of best practices, after considering the facilitators and barriers to adoption of said practices. Many patients decompensate and require intubation prior to ICU arrival, with prolonged boarding in the ED or medical wards being a common occurrence for many hospitals. As such, we need to consider a ventilation strategy that allows for best practice implementation at a hospital-wide level, appealing to an interprofessional approach to ventilator management, employing physicians outside of critical care medicine, respiratory therapists, and nursing. The PReVENT trial had a nicely constructed protocol with clear instructions on ventilator adjustments with frequent plateau pressure measurements and patient assessments. In the real world setting, especially in a non-ICU setting, ventilator management is not as straightforward. Considering that plateau pressures were only checked in approximately 40% of the patients in LUNG SAFE cohort, active management and attention to driving pressure may be a stretch in many settings.

Until we get 100% sensitive in timely recognition (instantaneous, really) of ARDS pathology augmented by automated diagnostic tools embedded in the medical record and/or incorporate advanced technology in the ventilator management to avoid human error, employing simple defaults to guarantee a protective setting in case of later diagnosis of ARDS seems logical. We can even go further to separate the defaults into LTVV for hypoxemic respiratory failure and lung protective ventilation for everything else, with future development of more algorithms, protocols, and clinical decision support tools for ventilator management. For the time being, a simpler intervention of setting a safer default is a great universal start.

Dr. Mathews and Dr. Howell are with the Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine; Dr. Mathews is also with the Department of Emergency Medicine; Icahn School of Medicine at Mount Sinai, New York, NY.

Since the landmark ARMA trial, use of low tidal volume ventilation (LTVV) at 6 mL/kg predicted body weight (PBW) has become our gold standard for ventilator management in acute respiratory distress syndrome (ARDS) (Brower RG, et al. N Engl J Med. 2000;342[18]:1301). While other studies have suggested that patients without ARDS may also benefit from lower volumes, the recently published Protective Ventilation in Patients Without ARDS (PReVENT) trial found no benefit to using LTVV in non-ARDS patients (Simonis FD, et al. JAMA. 2018;320[18]:1872). Does this mean we let physicians set volumes at will? Is tidal volume (VT) even clinically relevant anymore in the non-ARDS population?

Prior to the PReVENT trial, our practice of LTVV for patients without ARDS was informed primarily by observational data. In 2012, a meta-analysis comparing LTVV with “conventional” VT (10-12 mL/kg IBW) in non-ARDS patients found that those given LTVV had a lower incidence of acute lung injury and lower overall mortality (Neto AS, et al. JAMA. 2012 308[16]:1651). While these were promising findings, there was limited follow-up poststudy onset, and the majority of included studies were based on a surgical population. Additionally, the use of VT > 10 mL/kg PBW has become uncommon in routine clinical practice. How comparable are those previous studies to today’s clinical milieu? When comparing outcomes for ICU patients who were ventilated with low (≤7mL/kg PBW), intermediate (>7, but <10 mL/kg PBW), and high (≥10 mL/kg PBW) VT, a second meta-analysis found a 28% risk reduction in the development of ARDS or pneumonia with low vs high, but the similar difference was not seen when comparing low vs intermediate groups (Neto AS, et al. Crit Care Med. 2015;43[10]:2155). This research suggested that negative outcomes were driven by the excessive VT.

To investigate the importance of timing of LTVV in ARDS, Needham and colleagues performed a prospective cohort study in patients with ARDS, examining the effect of VT received over time on the outcome of ICU mortality (Needham DM, et al. Am J Respir Crit Care Med. 2015;191[2]:177). They found that every 1 mL/kg increase in VT setting was associated with a 23% increase in mortality and, indeed, increases in subsequent VT compared with baseline setting were associated with increasing mortality. One may, therefore, be concerned that if we miss the ARDS diagnosis, the default to higher VT at the time of intubation may harm our patients. With or without clinician recognition of ARDS, LUNG SAFE revealed that the average VT for the patients with confirmed ARDS was 7.6 (95% CI 7.5-7.7) mL/kg PBW. While this mean value is well within the range of lung protective ventilation (less than 8 mL/kg PBW), over one-third of patients were exposed to larger VT. A recently published study by Sjoding and colleagues showed that VT of >8 mL/kg PBW was used in 40% of the cohort, and continued exposure to 24 total hours of these high VT was associated with increased risk of mortality (OR 1.82 (95% CI, 1.20–2.78) (Sjoding MW, et al. Crit Care Med. 2019;47[1]:56). All three studies support early administration of lung protective ventilation, considering the high mortality associated with ARDS.

Before consolidating what we know about empiric use of LTVV, we also must highlight the important concerns about LTVV that were investigated in the PReVENT trial. Over-sedation to maintain low VT, increased delirium, ventilator asynchrony, and possibility of effort-induced lung injury are some of the potential risks associated with LTVV. While there were no differences in the use of sedatives or neuromuscular blocking agents between groups in the PReVENT trial, more delirium was seen in the LTVV group with a P = .06, which may be a signal deserving further exploration.

Therefore, now understanding both the upside and downside of LTVV, what’s our best approach? While we lack prospective clinical trial data showing benefit of LTVV in patients without ARDS, we do not have conclusive evidence to show its harm. Remembering that even intensivists can fail to recognize ARDS at its onset, default utilization of LTVV, or at least lung protective ventilation of <8 mL/kg PBW, may be the safest approach for all patients. To be clear, this approach would still allow for active physician decision-making to personalize the settings to the individual patient’s needs, including the use of higher VT if needed for patient comfort, effort, and sedation needs. Changing the default settings and implementing friendly reminders about how to manage the ventilator has already been shown to be helpful for the surgical population (O’Reilly-Shah VN, et al. BMJ Qual Saf. 2018;27[12]:1008).

We must also consider the process of health-care delivery and the implementation of best practices, after considering the facilitators and barriers to adoption of said practices. Many patients decompensate and require intubation prior to ICU arrival, with prolonged boarding in the ED or medical wards being a common occurrence for many hospitals. As such, we need to consider a ventilation strategy that allows for best practice implementation at a hospital-wide level, appealing to an interprofessional approach to ventilator management, employing physicians outside of critical care medicine, respiratory therapists, and nursing. The PReVENT trial had a nicely constructed protocol with clear instructions on ventilator adjustments with frequent plateau pressure measurements and patient assessments. In the real world setting, especially in a non-ICU setting, ventilator management is not as straightforward. Considering that plateau pressures were only checked in approximately 40% of the patients in LUNG SAFE cohort, active management and attention to driving pressure may be a stretch in many settings.

Until we get 100% sensitive in timely recognition (instantaneous, really) of ARDS pathology augmented by automated diagnostic tools embedded in the medical record and/or incorporate advanced technology in the ventilator management to avoid human error, employing simple defaults to guarantee a protective setting in case of later diagnosis of ARDS seems logical. We can even go further to separate the defaults into LTVV for hypoxemic respiratory failure and lung protective ventilation for everything else, with future development of more algorithms, protocols, and clinical decision support tools for ventilator management. For the time being, a simpler intervention of setting a safer default is a great universal start.

Dr. Mathews and Dr. Howell are with the Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine; Dr. Mathews is also with the Department of Emergency Medicine; Icahn School of Medicine at Mount Sinai, New York, NY.

Michelle Cao, DO, FCCP

Dr. Michelle Cao is a Clinical Associate Professor in the Division of Sleep Medicine and Division of Neuromuscular Medicine, at the Stanford University School of Medicine. Her clinical expertise is in complex sleep-related respiratory disorders and home mechanical ventilation for chronic respiratory failure syndromes. She oversees the Noninvasive Ventilation Program for the Stanford Neuromuscular Medicine Center. Dr. Cao also holds the position of Vice-Chair for the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork with CHEST and is a member of the Scientific Presentations and Awards Committee.

Michelle Cao, DO, FCCP

Dr. Michelle Cao is a Clinical Associate Professor in the Division of Sleep Medicine and Division of Neuromuscular Medicine, at the Stanford University School of Medicine. Her clinical expertise is in complex sleep-related respiratory disorders and home mechanical ventilation for chronic respiratory failure syndromes. She oversees the Noninvasive Ventilation Program for the Stanford Neuromuscular Medicine Center. Dr. Cao also holds the position of Vice-Chair for the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork with CHEST and is a member of the Scientific Presentations and Awards Committee.

Michelle Cao, DO, FCCP

Dr. Michelle Cao is a Clinical Associate Professor in the Division of Sleep Medicine and Division of Neuromuscular Medicine, at the Stanford University School of Medicine. Her clinical expertise is in complex sleep-related respiratory disorders and home mechanical ventilation for chronic respiratory failure syndromes. She oversees the Noninvasive Ventilation Program for the Stanford Neuromuscular Medicine Center. Dr. Cao also holds the position of Vice-Chair for the Home-Based Mechanical Ventilation and Neuromuscular Disease NetWork with CHEST and is a member of the Scientific Presentations and Awards Committee.

We are so excited to once again host the NetWorks Challenge. During the next 3 months, you have the opportunity to be a Champion and make a donation to the CHEST Foundation. Every time you contribute, you can designate a NetWork of your choice to benefit from your gift. Each NetWork is eligible to receive travel grants to CHEST 2019 based on the amount raised. Last year, we more than doubled the number of early career clinician travel grants to attend CHEST 2018. This year, we want to raise the bar again. Don’t delay, make a donation today by visiting Chestfoundation.org/donate and be a Champion for your NetWork!

Length: This year, the NetWorks Challenge will span 3 months. Contributions made between April 1 and June 30 count toward your NetWork’s fundraising total! Just be sure to list your NetWork when making your contribution on chestfoundation.org/donate. Additionally, any contributions made to the CHEST Foundation during your membership renewal will count toward your NetWorks total amount raised - no matter when your membership is up for renewal. Contributions made in this manner after June 30 will count toward your Network’s 2020 amount raised.

We are so excited to once again host the NetWorks Challenge. During the next 3 months, you have the opportunity to be a Champion and make a donation to the CHEST Foundation. Every time you contribute, you can designate a NetWork of your choice to benefit from your gift. Each NetWork is eligible to receive travel grants to CHEST 2019 based on the amount raised. Last year, we more than doubled the number of early career clinician travel grants to attend CHEST 2018. This year, we want to raise the bar again. Don’t delay, make a donation today by visiting Chestfoundation.org/donate and be a Champion for your NetWork!

Length: This year, the NetWorks Challenge will span 3 months. Contributions made between April 1 and June 30 count toward your NetWork’s fundraising total! Just be sure to list your NetWork when making your contribution on chestfoundation.org/donate. Additionally, any contributions made to the CHEST Foundation during your membership renewal will count toward your NetWorks total amount raised - no matter when your membership is up for renewal. Contributions made in this manner after June 30 will count toward your Network’s 2020 amount raised.

We are so excited to once again host the NetWorks Challenge. During the next 3 months, you have the opportunity to be a Champion and make a donation to the CHEST Foundation. Every time you contribute, you can designate a NetWork of your choice to benefit from your gift. Each NetWork is eligible to receive travel grants to CHEST 2019 based on the amount raised. Last year, we more than doubled the number of early career clinician travel grants to attend CHEST 2018. This year, we want to raise the bar again. Don’t delay, make a donation today by visiting Chestfoundation.org/donate and be a Champion for your NetWork!

Length: This year, the NetWorks Challenge will span 3 months. Contributions made between April 1 and June 30 count toward your NetWork’s fundraising total! Just be sure to list your NetWork when making your contribution on chestfoundation.org/donate. Additionally, any contributions made to the CHEST Foundation during your membership renewal will count toward your NetWorks total amount raised - no matter when your membership is up for renewal. Contributions made in this manner after June 30 will count toward your Network’s 2020 amount raised.

While CHEST 2019 will have your days busy, don’t forget to find time to explore entertaining, cultural, and historic places around New Orleans. Grab your friends and colleagues for some fun, and try out a few of these places!

1. House of Blues New Orleans

If you’re already heading to the city known for jazz and blues, there’s no better place to experience that than the House of Blues New Orleans. Enjoy live music and great food under one roof. Be sure to check the House of Blues website as the annual meeting draws nearer to see which concerts and events will be happening in October.



2. Audubon Aquarium of the Americas

Located just north of the convention center, head over to the Audubon Aquarium of the Americas. During the fall and winter months, the aquarium has less traffic, which allows you to take in all the animals and exhibits at your own pace. See exhibits like the Great Maya Reef, a walk-through tunnel into a submerged Maya city of the Yucatan peninsula; the penguins, sea otters, or the sharks and rays in the 400,000-gallon Gulf of Mexico Exhibit.



Hours: Monday - Sunday | 10 AM - 5 PM

While CHEST 2019 will have your days busy, don’t forget to find time to explore entertaining, cultural, and historic places around New Orleans. Grab your friends and colleagues for some fun, and try out a few of these places!

1. House of Blues New Orleans

If you’re already heading to the city known for jazz and blues, there’s no better place to experience that than the House of Blues New Orleans. Enjoy live music and great food under one roof. Be sure to check the House of Blues website as the annual meeting draws nearer to see which concerts and events will be happening in October.



2. Audubon Aquarium of the Americas

Located just north of the convention center, head over to the Audubon Aquarium of the Americas. During the fall and winter months, the aquarium has less traffic, which allows you to take in all the animals and exhibits at your own pace. See exhibits like the Great Maya Reef, a walk-through tunnel into a submerged Maya city of the Yucatan peninsula; the penguins, sea otters, or the sharks and rays in the 400,000-gallon Gulf of Mexico Exhibit.



Hours: Monday - Sunday | 10 AM - 5 PM

While CHEST 2019 will have your days busy, don’t forget to find time to explore entertaining, cultural, and historic places around New Orleans. Grab your friends and colleagues for some fun, and try out a few of these places!

1. House of Blues New Orleans

If you’re already heading to the city known for jazz and blues, there’s no better place to experience that than the House of Blues New Orleans. Enjoy live music and great food under one roof. Be sure to check the House of Blues website as the annual meeting draws nearer to see which concerts and events will be happening in October.



2. Audubon Aquarium of the Americas

Located just north of the convention center, head over to the Audubon Aquarium of the Americas. During the fall and winter months, the aquarium has less traffic, which allows you to take in all the animals and exhibits at your own pace. See exhibits like the Great Maya Reef, a walk-through tunnel into a submerged Maya city of the Yucatan peninsula; the penguins, sea otters, or the sharks and rays in the 400,000-gallon Gulf of Mexico Exhibit.



Hours: Monday - Sunday | 10 AM - 5 PM

Sleep: It Does a Body Good by Dr. Nancy Stewart

Sleep: it does a body good. No really, it does. When asked to write this month’s blog on sleep for Sleep Awareness Month, although honored, it was somewhat comical because the night prior I had one of my worst nights of sleep in a long time, taking care of a sick child. As health-care providers, we often lead stressful lives and pack way too much into our schedules. Both the Centers for Disease Control and the American Academy of Sleep Medicine recommend obtaining 7 to 9 hours of sleep per night for adults; unfortunately, many of us are not getting the recommended 7 to 9 hours of sleep.

Find the entire blog at https://goo.gl/sp9wWn.


 

Sleep: It Does a Body Good by Dr. Nancy Stewart

Sleep: it does a body good. No really, it does. When asked to write this month’s blog on sleep for Sleep Awareness Month, although honored, it was somewhat comical because the night prior I had one of my worst nights of sleep in a long time, taking care of a sick child. As health-care providers, we often lead stressful lives and pack way too much into our schedules. Both the Centers for Disease Control and the American Academy of Sleep Medicine recommend obtaining 7 to 9 hours of sleep per night for adults; unfortunately, many of us are not getting the recommended 7 to 9 hours of sleep.

Find the entire blog at https://goo.gl/sp9wWn.


 

Sleep: It Does a Body Good by Dr. Nancy Stewart

Sleep: it does a body good. No really, it does. When asked to write this month’s blog on sleep for Sleep Awareness Month, although honored, it was somewhat comical because the night prior I had one of my worst nights of sleep in a long time, taking care of a sick child. As health-care providers, we often lead stressful lives and pack way too much into our schedules. Both the Centers for Disease Control and the American Academy of Sleep Medicine recommend obtaining 7 to 9 hours of sleep per night for adults; unfortunately, many of us are not getting the recommended 7 to 9 hours of sleep.

Find the entire blog at https://goo.gl/sp9wWn.


 

MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.

The Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.

In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.

The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.

First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”

Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”

The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.

[email protected]

MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.

The Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.

In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.

The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.

First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”

Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”

The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.

[email protected]

MILWAUKEE – Congress has allocated a half billion dollars annually to the National Institutes of Health for a program that seeks to end America’s opioid crisis. The agency is putting in place over two-dozen projects spanning basic and translational research, clinical trials, and implementation of new strategies to address pain and fight addiction.

The Helping to End Addiction Long-term (HEAL) initiative has over $850 million in total obligated for fiscal year 2019, said Walter Koroshetz, MD, speaking at the scientific meeting of the American Pain Society. This represents carryover from 2018, a planning year for the initiative, along with the 2019 $500 million annual supplement to the NIH’s base appropriation.

In 2018, NIH and other federal agencies successfully convinced Congress that funding a coordinated use of resources was necessary to overcome the country’s dual opioid and chronic pain crises. “Luck happens to the prepared,” said Dr. Koroshetz, director of the National Institute of Neurological Disorders and Stroke (NINDS), Bethesda, Md., adding that many hours went into putting together a national pain strategy that is multidisciplinary and multi-layered, and involves multiple players.

The two aims of research under the initiative are to improve treatments for misuse and addiction, and to enhance pain management. Focusing on this latter aim, Dr. Koroshetz said that the initiative has several research priorities to enhance pain management.

First, the biological basis for chronic pain needs to be understood in order to formulate effective therapies and interventions. “We need to understand the transition from acute to chronic pain,” he commented. “We need to see if we can learn about the risk factors for developing chronic pain; if we get really lucky, we might identify some biological markers” that identify who is at risk for this transition “in a high-risk acute pain situation.”

Next, a key request of industry and academia will be development of more drugs that avoid the dual-target program of opioids, which affect reward circuitry along with pain circuitry. “Drugs affecting the pain circuit and the reward circuit will always result in addiction” potential, said Dr. Koroshetz. “We’re still using drugs for pain from the poppy plant that were discovered 8,000 years ago.”

The hope with the HEAL initiative is to bring together academic centers with patient populations and research capabilities with industry, to accelerate moving nonaddictive treatments through to phase 3 trials.

[email protected]

Recently, two studies were published addressing the potential association of childhood cancer and assisted reproductive technology. For more than a decade and a half, it has been acknowledged that ART is associated with increased concern both with structural birth defects, as well as imprinting disorders. As both of these issues have been linked to greater cancer risk in children, it is important to decipher the impact of ART on childhood cancer risk.

Published online April 1 in JAMA Pediatrics, the study, “Association of in vitro fertilization [IVF] with childhood cancer in the United States,”¹ by LG Spector et al. looked retrospectively at birth and cancer registries in 14 states with 8 years of data on 275,686 children were conceived via ART through 2013, who were compared with 2,266,847 children selected randomly.

The overall cancer rate per 1,000,000 person-years was low in both groups: 252 for the IVF group and 193 for the control group, for an overall hazard risk of 1.17. Of note, the rate of hepatic tumors was higher among the IVF group than the non-IVF group (18 vs. 5.7; hazard ratio, 2.46). There appeared to be no association with specific IVF treatments, whether children were conceived by donor egg vs. autologous egg; frozen embryos vs. fresh embryos; use of intracytoplasmic sperm injection (ICSI) vs. none; assisted hatching vs. none; and day-3 vs. day-5 transfer. The researchers concluded that the “increased rate of embryonal cancers, particularly hepatic tumors, that could not be attributed to IVF rather than to underlying infertility.”

This first and largest cohort study of association between IVF and the risk of childhood cancer ever published showed little evidence of excess risk of most cancers, including more common cancers such as leukemia.

The authors did note limitations in their study. Mothers who conceived via IVF were more likely to be white, non-Hispanic, more educated, and older. Could this patient population undergoing ART be at greater risk of producing offspring with cancer concerns? If that were the case – and not great risk of childhood cancer in ART, per se – one therefore would extrapolate that couples undergoing ART vs. alternative infertility treatment should not show a treatment-biased risk (i.e., ART vs. non-ART).

This was demonstrated recently in the study, “Risk of cancer in children and young adults conceived by assisted reproductive technology.”² This Dutch historical cohort study with prospective follow-up of a median 21 years evaluated 47,690 live-born children, of which 24,269 were ART conceived, 13,761 naturally conceived, and 9,660 conceived naturally or with fertility drugs but not by ART.

Overall, cancer risk was not increased in ART-conceived children, compared with naturally conceived subfertile women or even the general population. A nonsignificant increased risk was observed in children conceived by ICSI or cryopreservation.

On the basis of these two studies, there appears to be no significant increased risk of cancer in children conceived through fertility treatment, including ART.

Although these studies do not support the conclusion reached by a 2013 meta-analysis of 9 studies that specifically looked at ART and 16 other studies that looked at other types of medically assisted reproduction (such medically assisted reproduction as reproduction achieved through ovulation induction; controlled ovarian stimulation; ovulation triggering; intrauterine, intracervical, or intravaginal insemination) which reported a significant increased risk of overall cancers (1.33), including leukemia, CNS cancer, and neuroblastoma,³ they do agree more closely with two prospective studies conducted in the United Kingdom and Nordic countries.

In the U.K. study,⁴ there was no overall increased risk of cancer associated with ART, but two types of cancer were noted to be higher in the ART-conceived group – hepatoblastoma (3.27 risk) and rhabdomyosarcoma (2.62 risk) – but the absolute risk of these two types of cancer was small in this 17-year study of 106,013 children. This, of course, would be consistent with the JAMA Pediatrics study. In the Nordic study,⁵ similar to the Dutch Study, IVF was not associated with a significant increased risk of cancer (1.08). The Nordic study included 91,796 children born of ART-assisted pregnancies, compared with 358,419 children born after spontaneous conceptions.

The evidence so far shows that there appears to be no significant increased risk of cancer overall associated with fertility treatments, including IVF.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He also is a member of Ob.Gyn. News editorial advisory board. Dr. Miller disclosed that he is president of the Advanced IVF Institute in Park Ridge and Naperville, Ill.

References

1. JAMA Pediatr. 2019 Apr 1. doi: 10.1001/jamapediatrics.2019.0392.

2. Hum Reprod. 2019 Apr 1;34(4):740-50.

3. Fertil Steril. 2013 Jul. doi: 10.1016/j.fertnstert.2013.03.017.

4. N Engl J Med. 2013 Nov 7;369(19):1819-27.

5. Hum Reprod. 2014 Sep;29(9):2050-7.

Recently, two studies were published addressing the potential association of childhood cancer and assisted reproductive technology. For more than a decade and a half, it has been acknowledged that ART is associated with increased concern both with structural birth defects, as well as imprinting disorders. As both of these issues have been linked to greater cancer risk in children, it is important to decipher the impact of ART on childhood cancer risk.

Published online April 1 in JAMA Pediatrics, the study, “Association of in vitro fertilization [IVF] with childhood cancer in the United States,”¹ by LG Spector et al. looked retrospectively at birth and cancer registries in 14 states with 8 years of data on 275,686 children were conceived via ART through 2013, who were compared with 2,266,847 children selected randomly.

The overall cancer rate per 1,000,000 person-years was low in both groups: 252 for the IVF group and 193 for the control group, for an overall hazard risk of 1.17. Of note, the rate of hepatic tumors was higher among the IVF group than the non-IVF group (18 vs. 5.7; hazard ratio, 2.46). There appeared to be no association with specific IVF treatments, whether children were conceived by donor egg vs. autologous egg; frozen embryos vs. fresh embryos; use of intracytoplasmic sperm injection (ICSI) vs. none; assisted hatching vs. none; and day-3 vs. day-5 transfer. The researchers concluded that the “increased rate of embryonal cancers, particularly hepatic tumors, that could not be attributed to IVF rather than to underlying infertility.”

This first and largest cohort study of association between IVF and the risk of childhood cancer ever published showed little evidence of excess risk of most cancers, including more common cancers such as leukemia.

The authors did note limitations in their study. Mothers who conceived via IVF were more likely to be white, non-Hispanic, more educated, and older. Could this patient population undergoing ART be at greater risk of producing offspring with cancer concerns? If that were the case – and not great risk of childhood cancer in ART, per se – one therefore would extrapolate that couples undergoing ART vs. alternative infertility treatment should not show a treatment-biased risk (i.e., ART vs. non-ART).

This was demonstrated recently in the study, “Risk of cancer in children and young adults conceived by assisted reproductive technology.”² This Dutch historical cohort study with prospective follow-up of a median 21 years evaluated 47,690 live-born children, of which 24,269 were ART conceived, 13,761 naturally conceived, and 9,660 conceived naturally or with fertility drugs but not by ART.

Overall, cancer risk was not increased in ART-conceived children, compared with naturally conceived subfertile women or even the general population. A nonsignificant increased risk was observed in children conceived by ICSI or cryopreservation.

On the basis of these two studies, there appears to be no significant increased risk of cancer in children conceived through fertility treatment, including ART.

Although these studies do not support the conclusion reached by a 2013 meta-analysis of 9 studies that specifically looked at ART and 16 other studies that looked at other types of medically assisted reproduction (such medically assisted reproduction as reproduction achieved through ovulation induction; controlled ovarian stimulation; ovulation triggering; intrauterine, intracervical, or intravaginal insemination) which reported a significant increased risk of overall cancers (1.33), including leukemia, CNS cancer, and neuroblastoma,³ they do agree more closely with two prospective studies conducted in the United Kingdom and Nordic countries.

In the U.K. study,⁴ there was no overall increased risk of cancer associated with ART, but two types of cancer were noted to be higher in the ART-conceived group – hepatoblastoma (3.27 risk) and rhabdomyosarcoma (2.62 risk) – but the absolute risk of these two types of cancer was small in this 17-year study of 106,013 children. This, of course, would be consistent with the JAMA Pediatrics study. In the Nordic study,⁵ similar to the Dutch Study, IVF was not associated with a significant increased risk of cancer (1.08). The Nordic study included 91,796 children born of ART-assisted pregnancies, compared with 358,419 children born after spontaneous conceptions.

The evidence so far shows that there appears to be no significant increased risk of cancer overall associated with fertility treatments, including IVF.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He also is a member of Ob.Gyn. News editorial advisory board. Dr. Miller disclosed that he is president of the Advanced IVF Institute in Park Ridge and Naperville, Ill.

References

1. JAMA Pediatr. 2019 Apr 1. doi: 10.1001/jamapediatrics.2019.0392.

2. Hum Reprod. 2019 Apr 1;34(4):740-50.

3. Fertil Steril. 2013 Jul. doi: 10.1016/j.fertnstert.2013.03.017.

4. N Engl J Med. 2013 Nov 7;369(19):1819-27.

5. Hum Reprod. 2014 Sep;29(9):2050-7.

Recently, two studies were published addressing the potential association of childhood cancer and assisted reproductive technology. For more than a decade and a half, it has been acknowledged that ART is associated with increased concern both with structural birth defects, as well as imprinting disorders. As both of these issues have been linked to greater cancer risk in children, it is important to decipher the impact of ART on childhood cancer risk.

Published online April 1 in JAMA Pediatrics, the study, “Association of in vitro fertilization [IVF] with childhood cancer in the United States,”¹ by LG Spector et al. looked retrospectively at birth and cancer registries in 14 states with 8 years of data on 275,686 children were conceived via ART through 2013, who were compared with 2,266,847 children selected randomly.

The overall cancer rate per 1,000,000 person-years was low in both groups: 252 for the IVF group and 193 for the control group, for an overall hazard risk of 1.17. Of note, the rate of hepatic tumors was higher among the IVF group than the non-IVF group (18 vs. 5.7; hazard ratio, 2.46). There appeared to be no association with specific IVF treatments, whether children were conceived by donor egg vs. autologous egg; frozen embryos vs. fresh embryos; use of intracytoplasmic sperm injection (ICSI) vs. none; assisted hatching vs. none; and day-3 vs. day-5 transfer. The researchers concluded that the “increased rate of embryonal cancers, particularly hepatic tumors, that could not be attributed to IVF rather than to underlying infertility.”

This first and largest cohort study of association between IVF and the risk of childhood cancer ever published showed little evidence of excess risk of most cancers, including more common cancers such as leukemia.

The authors did note limitations in their study. Mothers who conceived via IVF were more likely to be white, non-Hispanic, more educated, and older. Could this patient population undergoing ART be at greater risk of producing offspring with cancer concerns? If that were the case – and not great risk of childhood cancer in ART, per se – one therefore would extrapolate that couples undergoing ART vs. alternative infertility treatment should not show a treatment-biased risk (i.e., ART vs. non-ART).

This was demonstrated recently in the study, “Risk of cancer in children and young adults conceived by assisted reproductive technology.”² This Dutch historical cohort study with prospective follow-up of a median 21 years evaluated 47,690 live-born children, of which 24,269 were ART conceived, 13,761 naturally conceived, and 9,660 conceived naturally or with fertility drugs but not by ART.

Overall, cancer risk was not increased in ART-conceived children, compared with naturally conceived subfertile women or even the general population. A nonsignificant increased risk was observed in children conceived by ICSI or cryopreservation.

On the basis of these two studies, there appears to be no significant increased risk of cancer in children conceived through fertility treatment, including ART.

Although these studies do not support the conclusion reached by a 2013 meta-analysis of 9 studies that specifically looked at ART and 16 other studies that looked at other types of medically assisted reproduction (such medically assisted reproduction as reproduction achieved through ovulation induction; controlled ovarian stimulation; ovulation triggering; intrauterine, intracervical, or intravaginal insemination) which reported a significant increased risk of overall cancers (1.33), including leukemia, CNS cancer, and neuroblastoma,³ they do agree more closely with two prospective studies conducted in the United Kingdom and Nordic countries.

In the U.K. study,⁴ there was no overall increased risk of cancer associated with ART, but two types of cancer were noted to be higher in the ART-conceived group – hepatoblastoma (3.27 risk) and rhabdomyosarcoma (2.62 risk) – but the absolute risk of these two types of cancer was small in this 17-year study of 106,013 children. This, of course, would be consistent with the JAMA Pediatrics study. In the Nordic study,⁵ similar to the Dutch Study, IVF was not associated with a significant increased risk of cancer (1.08). The Nordic study included 91,796 children born of ART-assisted pregnancies, compared with 358,419 children born after spontaneous conceptions.

The evidence so far shows that there appears to be no significant increased risk of cancer overall associated with fertility treatments, including IVF.
 

Dr. Miller is a clinical associate professor at the University of Illinois in Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago and the director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill. He also is a member of Ob.Gyn. News editorial advisory board. Dr. Miller disclosed that he is president of the Advanced IVF Institute in Park Ridge and Naperville, Ill.

References

1. JAMA Pediatr. 2019 Apr 1. doi: 10.1001/jamapediatrics.2019.0392.

2. Hum Reprod. 2019 Apr 1;34(4):740-50.

3. Fertil Steril. 2013 Jul. doi: 10.1016/j.fertnstert.2013.03.017.

4. N Engl J Med. 2013 Nov 7;369(19):1819-27.

5. Hum Reprod. 2014 Sep;29(9):2050-7.

The U.S. Food and Drug Administration has approved the first two-drug, fixed-dose, complete regimen for HIV-infected adults, according to an FDA press announcement.

Dovato (dolutegravir and lamivudine), a product of ViiV Healthcare, is intended to serve “as a complete regimen” for the treatment of HIV-1 infection in adults who have had no previous antiretroviral treatment and who have an infection with no known or suspected genetic substitutions associated with resistance to the individual components of Dovato.

“With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, MD, director of the FDA’s Division of Antiviral Products.

The Dovato labeling includes a Boxed Warning that patients infected with both HIV and hepatitis B should add additional treatment for their HBV or consider a different drug regimen. The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. In addition, the FDA warned that, as there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy.

[email protected]

The U.S. Food and Drug Administration has approved the first two-drug, fixed-dose, complete regimen for HIV-infected adults, according to an FDA press announcement.

Dovato (dolutegravir and lamivudine), a product of ViiV Healthcare, is intended to serve “as a complete regimen” for the treatment of HIV-1 infection in adults who have had no previous antiretroviral treatment and who have an infection with no known or suspected genetic substitutions associated with resistance to the individual components of Dovato.

“With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, MD, director of the FDA’s Division of Antiviral Products.

The Dovato labeling includes a Boxed Warning that patients infected with both HIV and hepatitis B should add additional treatment for their HBV or consider a different drug regimen. The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. In addition, the FDA warned that, as there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy.

[email protected]

The U.S. Food and Drug Administration has approved the first two-drug, fixed-dose, complete regimen for HIV-infected adults, according to an FDA press announcement.

Dovato (dolutegravir and lamivudine), a product of ViiV Healthcare, is intended to serve “as a complete regimen” for the treatment of HIV-1 infection in adults who have had no previous antiretroviral treatment and who have an infection with no known or suspected genetic substitutions associated with resistance to the individual components of Dovato.

“With this approval, patients who have never been treated have the option of taking a two-drug regimen in a single tablet while eliminating additional toxicity and potential drug interactions from a third drug,” said Debra Birnkrant, MD, director of the FDA’s Division of Antiviral Products.

The Dovato labeling includes a Boxed Warning that patients infected with both HIV and hepatitis B should add additional treatment for their HBV or consider a different drug regimen. The most common adverse reactions with Dovato were headache, diarrhea, nausea, insomnia, and fatigue. In addition, the FDA warned that, as there is a known risk for neural tube defects with dolutegravir, patients are advised to avoid use of Dovato at the time of conception through the first trimester of pregnancy.

[email protected]

Clinicians should offer biennial mammography to screen for breast cancer in asymptomatic average-risk women aged 50-74 years and should abandon clinical breast examinations (CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.

Catherine Yeulet/Thinkstock

Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.

The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.

“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.

However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.

The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.

It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.

Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.

“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”

The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.

An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.

The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.

Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”

“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”

Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”

Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”

“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.

The guidance authors reported having no conflicts of interest.

[email protected]

SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.

Clinicians should offer biennial mammography to screen for breast cancer in asymptomatic average-risk women aged 50-74 years and should abandon clinical breast examinations (CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.

Catherine Yeulet/Thinkstock

Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.

The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.

“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.

However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.

The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.

It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.

Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.

“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”

The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.

An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.

The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.

Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”

“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”

Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”

Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”

“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.

The guidance authors reported having no conflicts of interest.

[email protected]

SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.

Clinicians should offer biennial mammography to screen for breast cancer in asymptomatic average-risk women aged 50-74 years and should abandon clinical breast examinations (CBE) for screening in such women of any age, according to a new guideline from the American College of Physicians.

Catherine Yeulet/Thinkstock

Further, clinicians should discuss whether to screen with mammography in average-risk women aged 40-49 years and consider potential harms and benefits, as well as patient preferences. Providers should discontinue screening average-risk women at age 75 years and women with a life expectancy of 10 years or less, Amir Qaseem, MD, PhD, of the ACP and colleagues wrote on behalf of the ACP Clinical Guidelines Committee.

The ACP guidance also addresses the varying recommendations from other organizations on the age at which to start and stop screening and on screening intervals, noting that “areas of disagreement include screening in women aged 40 to 49 years, screening in women aged 75 years or older, and recommended screening intervals,” and stresses the importance of patient input.

“Women should be informed participants in personalized decisions about breast cancer screening,” the authors wrote, adding that those under age 50 years without a clear preference for screening should not be screened.

However, the evidence shows that most average-risk women with no symptoms will benefit from mammography every other year beginning at age 50 years, they said.

The statement, published online April 8 in the Annals of Internal Medicine, was derived from a review of seven existing English-language breast cancer screening guidelines and the evidence cited in those guidelines. It’s intended to be a resource for all clinicians.

It differs from the 2017 American College of Obstetricians and Gynecologists (ACOG) guidelines in that ACOG recommends CBE and does not address screening in those with a life expectancy of less than 10 years. It also differs from the 2016 U.S. Preventive Services Task Force (USPSTF) guidelines, which make no recommendation on CBE and also do not address screening in those with a life expectancy of less than 10 years.

Other guidelines, such as those from the American College of Radiology, American Cancer Society (ACS), the Canadian Task Force on Preventive Health Care, and the National Comprehensive Cancer Network, recommend CBE, and the World Health Organization guidelines recommend CBE in low resource settings.

“Although CBE continues to be used as part of the examination of symptomatic women, data are sparse on screening asymptomatic women using CBE alone or combined with mammography,” the ACP guideline authors wrote. “The ACS recommends against CBE in average-risk women of any age because of the lack of demonstrated benefit and the potential for false-positive results.”

The guidance, which does not apply to patients with prior abnormal screening results or those at higher breast cancer risk, also includes an evidence-driven “talking points with patients” section based on frequently asked questions.

An important goal of the ACP Clinical Guidelines Committee in developing the guidance is to reduce overdiagnosis and overtreatment, which affects about 20% of women diagnosed over a 10-year period.

The committee reviewed all national guidelines published in English between January 1, 2013, and November 15, 2017, in the National Guideline Clearinghouse or Guidelines International Network library, and it also selected other guidelines commonly used in clinical practice. The committee evaluated the quality of each by using the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument.

Alex Krist, MD, the USPSTF vice-chairperson, offered support for the “shift toward shared decision making that is emerging” and added it’s “part of a larger movement toward empowering people with information not only about the potential benefits but also the potential harms of screening tests.”

“In its 2016 recommendation, the Task Force found that the value of mammography increases with age, with women ages 50-74 benefiting most from screening. For women in their 40s, the Task Force also found that mammography screening every two years can be effective,” he told this publication. “We recommend that the decision to start screening should be an individual one, taking into account a woman’s health history, preferences, and how she values the different potential benefits and harms.”

Dr. Krist further noted that the USPSTF, ACP, and many others “have all affirmed that mammography is an important tool to reduce breast cancer mortality and that the benefits of mammography increase with age.”

Likewise, Robert Smith, PhD, vice president of cancer screening for the ACS, noted that the ACP guidance generally aligns with ACS and USPSTF guidelines because all “support informed decision making starting at age 40, and screening every two years starting at age 50 (USPSTF) or 55 (ACS).”

“The fact that all guidelines are not totally in sync is not unexpected. ... The most important thing to recognize is that all of these guidelines stress that regular mammography plays an important role in breast cancer early detection, and women should be aware of its benefits and limitations, and also remain vigilant and report any breast changes,” he said.

The guidance authors reported having no conflicts of interest.

[email protected]

SOURCE: Qaseem A et al., Ann Intern Med. 2019. doi: 10.7326/M18-2147.

A small study offers a tantalizing hint that the gout drug colchicine could help reduce inflammation-related complications of metabolic syndrome.

The 3-month trial did not meet its primary endpoint – change in insulin sensitivity as measured by a glucose tolerance test – but it did hit several secondary goals, all of which were related to the inflammation that accompanies prediabetes, Jack A. Yanovski, MD, and colleagues wrote in Diabetes, Obesity, and Metabolism.

“Colchicine is well-known to have anti-inflammatory properties, although its effect on obesity-associated inflammation has not previously been investigated,” said Dr. Yanovski of the National institutes of Health and his coauthors. “Classically, it has been posited that colchicine blocks inflammation by impeding leukocyte locomotion, diapedesis, and, ultimately, recruitment to sites of inflammation. ... Recently, it has been shown that colchicine also inhibits the formation of the NLRP3 [NOD-like receptor family pyrin domain-containing 3] inflammasome, an important component of the obesity-associated inflammatory cascade.”

The NLRP3 inflammasome has been shown to play an important part in promoting the inflammatory state of obesity, the authors noted. When a cell senses danger, NLRP3 uses microtubules to create an inflammasome that then produces interleukin-1 beta gene and interleukin-18. One of colchicine’s known actions is to inhibit microtubule formation, suggesting that it could put the brakes on this process.

The study comprised 40 patients who had metabolic syndrome, significant insulin resistance, and elevated inflammatory markers. Among the exclusionary criteria were having a significant medical illness, a history of gout, and recent or current use of colchicine.

The patients were randomized to colchicine 0.6 mg or placebo twice daily for 3 months. No dietary advice was given during the study period. Of the 40 randomized patients, 37 completed the 3-month study, though none left because of adverse events.

Although there were no significant between-group differences in levels of fasting insulin, colchicine did significantly decrease inflammatory markers, compared with placebo. C-reactive protein dropped by 2.8 mg/L in the active group but increased slightly in the placebo group. The erythrocyte sedimentation rate also decreased in the colchicine group, compared with placebo (difference, –5.9 mm/hr; P = .07). The active group experienced an improvement in fasting insulin as measured by the homeostasis model assessment–estimated insulin resistance index and in glucose effectiveness, which suggests metabolic improvement.

“Larger trials are needed to investigate whether colchicine has efficacy in improving insulin resistance and/or preventing the onset of diabetes mellitus in at-risk individuals with obesity-associated inflammation,” the authors concluded.

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Institutes of Health. None of the authors reported any disclosures or conflicts of interest relating to this study.

[email protected]

SOURCE: Yanovski JA et al. Diabetes Obes Metab. 2019 Mar 14. doi: 10.1111/dom.13702.

A small study offers a tantalizing hint that the gout drug colchicine could help reduce inflammation-related complications of metabolic syndrome.

The 3-month trial did not meet its primary endpoint – change in insulin sensitivity as measured by a glucose tolerance test – but it did hit several secondary goals, all of which were related to the inflammation that accompanies prediabetes, Jack A. Yanovski, MD, and colleagues wrote in Diabetes, Obesity, and Metabolism.

“Colchicine is well-known to have anti-inflammatory properties, although its effect on obesity-associated inflammation has not previously been investigated,” said Dr. Yanovski of the National institutes of Health and his coauthors. “Classically, it has been posited that colchicine blocks inflammation by impeding leukocyte locomotion, diapedesis, and, ultimately, recruitment to sites of inflammation. ... Recently, it has been shown that colchicine also inhibits the formation of the NLRP3 [NOD-like receptor family pyrin domain-containing 3] inflammasome, an important component of the obesity-associated inflammatory cascade.”

The NLRP3 inflammasome has been shown to play an important part in promoting the inflammatory state of obesity, the authors noted. When a cell senses danger, NLRP3 uses microtubules to create an inflammasome that then produces interleukin-1 beta gene and interleukin-18. One of colchicine’s known actions is to inhibit microtubule formation, suggesting that it could put the brakes on this process.

The study comprised 40 patients who had metabolic syndrome, significant insulin resistance, and elevated inflammatory markers. Among the exclusionary criteria were having a significant medical illness, a history of gout, and recent or current use of colchicine.

The patients were randomized to colchicine 0.6 mg or placebo twice daily for 3 months. No dietary advice was given during the study period. Of the 40 randomized patients, 37 completed the 3-month study, though none left because of adverse events.

Although there were no significant between-group differences in levels of fasting insulin, colchicine did significantly decrease inflammatory markers, compared with placebo. C-reactive protein dropped by 2.8 mg/L in the active group but increased slightly in the placebo group. The erythrocyte sedimentation rate also decreased in the colchicine group, compared with placebo (difference, –5.9 mm/hr; P = .07). The active group experienced an improvement in fasting insulin as measured by the homeostasis model assessment–estimated insulin resistance index and in glucose effectiveness, which suggests metabolic improvement.

“Larger trials are needed to investigate whether colchicine has efficacy in improving insulin resistance and/or preventing the onset of diabetes mellitus in at-risk individuals with obesity-associated inflammation,” the authors concluded.

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Institutes of Health. None of the authors reported any disclosures or conflicts of interest relating to this study.

[email protected]

SOURCE: Yanovski JA et al. Diabetes Obes Metab. 2019 Mar 14. doi: 10.1111/dom.13702.

A small study offers a tantalizing hint that the gout drug colchicine could help reduce inflammation-related complications of metabolic syndrome.

The 3-month trial did not meet its primary endpoint – change in insulin sensitivity as measured by a glucose tolerance test – but it did hit several secondary goals, all of which were related to the inflammation that accompanies prediabetes, Jack A. Yanovski, MD, and colleagues wrote in Diabetes, Obesity, and Metabolism.

“Colchicine is well-known to have anti-inflammatory properties, although its effect on obesity-associated inflammation has not previously been investigated,” said Dr. Yanovski of the National institutes of Health and his coauthors. “Classically, it has been posited that colchicine blocks inflammation by impeding leukocyte locomotion, diapedesis, and, ultimately, recruitment to sites of inflammation. ... Recently, it has been shown that colchicine also inhibits the formation of the NLRP3 [NOD-like receptor family pyrin domain-containing 3] inflammasome, an important component of the obesity-associated inflammatory cascade.”

The NLRP3 inflammasome has been shown to play an important part in promoting the inflammatory state of obesity, the authors noted. When a cell senses danger, NLRP3 uses microtubules to create an inflammasome that then produces interleukin-1 beta gene and interleukin-18. One of colchicine’s known actions is to inhibit microtubule formation, suggesting that it could put the brakes on this process.

The study comprised 40 patients who had metabolic syndrome, significant insulin resistance, and elevated inflammatory markers. Among the exclusionary criteria were having a significant medical illness, a history of gout, and recent or current use of colchicine.

The patients were randomized to colchicine 0.6 mg or placebo twice daily for 3 months. No dietary advice was given during the study period. Of the 40 randomized patients, 37 completed the 3-month study, though none left because of adverse events.

Although there were no significant between-group differences in levels of fasting insulin, colchicine did significantly decrease inflammatory markers, compared with placebo. C-reactive protein dropped by 2.8 mg/L in the active group but increased slightly in the placebo group. The erythrocyte sedimentation rate also decreased in the colchicine group, compared with placebo (difference, –5.9 mm/hr; P = .07). The active group experienced an improvement in fasting insulin as measured by the homeostasis model assessment–estimated insulin resistance index and in glucose effectiveness, which suggests metabolic improvement.

“Larger trials are needed to investigate whether colchicine has efficacy in improving insulin resistance and/or preventing the onset of diabetes mellitus in at-risk individuals with obesity-associated inflammation,” the authors concluded.

The study was supported by the Intramural Research Program of the Eunice Kennedy Shriver National Institute of Child Health and Human Development and by the National Institutes of Health. None of the authors reported any disclosures or conflicts of interest relating to this study.

[email protected]

SOURCE: Yanovski JA et al. Diabetes Obes Metab. 2019 Mar 14. doi: 10.1111/dom.13702.