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Alternative birthing practices increase risk of infection
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
All three have been associated with sporadic, serious neonatal infections.
The U.S. prevalence of water births – delivering a baby underwater – is currently unknown, but in the United Kingdom the practice is common. According to a 2015 National Health Service maternity survey, approximately 9% of women who underwent vaginal delivery opted for water birth (Arch Dis Child Fetal Neonatal Ed. 2016 Jul;101[4]:F357-65). Both the Royal College of Obstetricians and Gynaecologists and the Royal College of Midwives endorse this practice for healthy women with uncomplicated term pregnancies. According to a 2009 Cochrane Review, immersion during the first phase of labor reduces the use of epidural/spinal analgesia (Cochrane Database Syst Rev. 2009. doi: 10.1002/14651858.CD000111.pub3). The maternal benefits of delivery under water, though, have not been clearly defined.
Legionella pneumophila is an uncommon pathogen in children, but cases of neonatal Legionnaires’ disease have been reported after water birth. Two affected babies born in Arizona in 2016 were successfully treated and survived (MMWR Morb Mortal Wkly Rep. 2017. doi: 10.15585/mmwr.mm6622a4). A baby born in Texas in 2014 died of sepsis and respiratory failure (Emerg Infect Dis. 2015. doi: 10.3201/eid2101.140846). Canadian investigators have reported fatal disseminated herpes simplex virus infection in an infant after water birth; the mother had herpetic whitlow and a recent blister concerning for HSV on her thigh (J Pediatric Infect Dis Soc. 2017 May 16. doi: 10.1093/jpids/pix035).
Admittedly, each of these cases might have been prevented by adherence to recommended infection control practices, and the absolute risk of infection after water birth is unknown and likely to be small. Still, neither the American Academy of Pediatrics nor the American College of Obstetricians and Gynecologists currently recommend the practice. ACOG suggests that “births occur on land, not in water” and has called for well-designed, prospective studies of the maternal and perinatal benefits and risks associated with immersion during labor and delivery (Obstet Gynecol. 2016;128:1198-9).
Placentophagia – consuming the placenta after birth – has been promoted by celebrity moms, including Katherine Heigl and Kourtney Kardashian. Placenta can be cooked, blended raw into a smoothie, or dehydrated and encapsulated.
Proponents of placentophagia claim health benefits of this practice, including improved mood and energy, and increased breast milk production. There are few published data to support these claims. A recent case report suggests the practice has the potential to harm the baby. In June 2017, Oregon public health authorities described a neonate with recurrent episodes of group B streptococcal (GBS) bacteremia. An identical strain of GBS was cultured from capsules containing the mother’s dehydrated placenta – she had consumed six of the capsules daily beginning a few days after the baby’s birth. According to the Morbidity and Mortality Weekly Report communication, “no standards exist for processing placenta for consumption” and the “placenta encapsulation process does not eradicate infectious pathogens per se. … Placenta capsule ingestion should be avoided”(MMWR Morb Mortal Wkly Rep. 2017;66:677-8. doi: 10.15585/mmwr.mm6625a4).
Finally, the ritual practice of umbilical cord nonseverance or lotus birth deserves a mention. In a lotus birth, the umbilical cord is left uncut, allowing the placenta to remain attached to the baby until the cord dries and naturally separates, generally 3-10 days after delivery. Describing a spiritual connection between the baby and the placenta, proponents claim lotus birth promotes bonding and allows for a gentler transition between intra- and extrauterine life.
A review of PubMed turned up no formal studies of this practice, but case reports describe complications such as neonatal idiopathic hepatitis and neonatal sepsis. The Royal College of Obstetricians and Gynaecologists has issued a warning about lotus births, advising that babies be monitored closely for infection. RCOG spokesperson Dr. Patrick O’Brien said in a 2008 statement, “If left for a period of time after the birth, there is a risk of infection in the placenta which can consequently spread to the baby. The placenta is particularly prone to infection as it contains blood. Within a short time after birth, once the umbilical cord has stopped pulsating, the placenta has no circulation and is essentially dead tissue.”
Interestingly, a quick scan of Etsy, the popular e-commerce website, turned up a number of lotus birth kits for sale. These generally contain a decorative cloth bag as well as an herb mix containing lavender and eucalyptus to promote drying and mask the smell of the decomposing placenta.
In contrast, many pediatricians, me included, are not well informed about these practices and don’t routinely ask expectant moms about their plans. I propose that we can advocate for our patients-to-be by learning about these practices so that we can engage in an honest, respectful discussion about potential risks and benefits. For me, for now, the risks outweigh the benefits.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at pdnews@frontlinemedcom.com.
From the Editors: Your call is important to us
There they were – dropping like a stone toward the lunar surface some 48 years ago. Buzz Aldrin looked at his onboard computer and it reported Error 1202, and alarms started going off in the Lunar Module. Fortunately for Neil Armstrong and Buzz Aldrin, they had a healthy relationship with their computer systems and IT support. Mission control was only 1.5 seconds away and had a huge team of experts that told them they could ignore the error message. The rest is, of course, history. Human beings, not computer software, landed the Eagle. They used their own judgment and experience and data provided by the computer to make their landing decisions.
At 25,000 feet Mission Control answers. Buzz describes the error code. Mission Control reports that his computer is made by Grumman and that Mission Control uses Lockheed-based software. He is advised to call the Grumman help line. At 15,000 feet Grumman responds. They report that Buzz’s password expired about the time the lunar descent burn occurred. He needs to put in a new password and confirm it. He will receive a confirmation email within the next 24 hours. Neil is getting increasingly restive despite his famously bland emotional responses in crises.
At 10,000 feet Buzz gets a new password confirmation, but Error 1202 remains on the display. The moon is enormous in the windshield. Grumman support responds that the error is likely because Buzz put in the wrong weight for the Lunar Module. Buzz begins again feeding in the data to the onboard computer. Grumman suggests that had Buzz simply created the right template, this problem would not have occurred. Buzz, through gritted teeth, asks how he was supposed to create a template for a problem that no one seemed to expect.
They are down to 150 feet now. Neil tells Buzz what he thinks of the computer systems and is told by Mission Control his microphone is hot and that such comments are not appropriate. At Mission Control, a notation is made on their system that Neil will need to discuss this pilot error with the astronaut office upon his return. Neil simply turns off the onboard computer and lands the Lunar Module with seconds of fuel left as he avoids a large boulder field and finds just the right spot. Tranquility Base reports in to Mission Control. Mankind has landed on the Moon.
The alternative history is what surgeons are experiencing every day because of the unhealthy relationship existing between American health care today and our institutional computer systems. Like Neil and Buzz, these surgeons are heroes who avoid boulder fields despite so many obstacles unrelated to their missions. No wonder burnout (a missile term) is so prevalent. We’ve gone from inconvenient to intolerable. Our health care computer systems must be interoperable to have any meaningful use. Our formats need to be understandable. Surgeons need computers to help them make judgments based on easily accessible data in real time. Surgeons need to “fly” the missions and computer systems need to be our servants, not our masters.
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
There they were – dropping like a stone toward the lunar surface some 48 years ago. Buzz Aldrin looked at his onboard computer and it reported Error 1202, and alarms started going off in the Lunar Module. Fortunately for Neil Armstrong and Buzz Aldrin, they had a healthy relationship with their computer systems and IT support. Mission control was only 1.5 seconds away and had a huge team of experts that told them they could ignore the error message. The rest is, of course, history. Human beings, not computer software, landed the Eagle. They used their own judgment and experience and data provided by the computer to make their landing decisions.
At 25,000 feet Mission Control answers. Buzz describes the error code. Mission Control reports that his computer is made by Grumman and that Mission Control uses Lockheed-based software. He is advised to call the Grumman help line. At 15,000 feet Grumman responds. They report that Buzz’s password expired about the time the lunar descent burn occurred. He needs to put in a new password and confirm it. He will receive a confirmation email within the next 24 hours. Neil is getting increasingly restive despite his famously bland emotional responses in crises.
At 10,000 feet Buzz gets a new password confirmation, but Error 1202 remains on the display. The moon is enormous in the windshield. Grumman support responds that the error is likely because Buzz put in the wrong weight for the Lunar Module. Buzz begins again feeding in the data to the onboard computer. Grumman suggests that had Buzz simply created the right template, this problem would not have occurred. Buzz, through gritted teeth, asks how he was supposed to create a template for a problem that no one seemed to expect.
They are down to 150 feet now. Neil tells Buzz what he thinks of the computer systems and is told by Mission Control his microphone is hot and that such comments are not appropriate. At Mission Control, a notation is made on their system that Neil will need to discuss this pilot error with the astronaut office upon his return. Neil simply turns off the onboard computer and lands the Lunar Module with seconds of fuel left as he avoids a large boulder field and finds just the right spot. Tranquility Base reports in to Mission Control. Mankind has landed on the Moon.
The alternative history is what surgeons are experiencing every day because of the unhealthy relationship existing between American health care today and our institutional computer systems. Like Neil and Buzz, these surgeons are heroes who avoid boulder fields despite so many obstacles unrelated to their missions. No wonder burnout (a missile term) is so prevalent. We’ve gone from inconvenient to intolerable. Our health care computer systems must be interoperable to have any meaningful use. Our formats need to be understandable. Surgeons need computers to help them make judgments based on easily accessible data in real time. Surgeons need to “fly” the missions and computer systems need to be our servants, not our masters.
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
There they were – dropping like a stone toward the lunar surface some 48 years ago. Buzz Aldrin looked at his onboard computer and it reported Error 1202, and alarms started going off in the Lunar Module. Fortunately for Neil Armstrong and Buzz Aldrin, they had a healthy relationship with their computer systems and IT support. Mission control was only 1.5 seconds away and had a huge team of experts that told them they could ignore the error message. The rest is, of course, history. Human beings, not computer software, landed the Eagle. They used their own judgment and experience and data provided by the computer to make their landing decisions.
At 25,000 feet Mission Control answers. Buzz describes the error code. Mission Control reports that his computer is made by Grumman and that Mission Control uses Lockheed-based software. He is advised to call the Grumman help line. At 15,000 feet Grumman responds. They report that Buzz’s password expired about the time the lunar descent burn occurred. He needs to put in a new password and confirm it. He will receive a confirmation email within the next 24 hours. Neil is getting increasingly restive despite his famously bland emotional responses in crises.
At 10,000 feet Buzz gets a new password confirmation, but Error 1202 remains on the display. The moon is enormous in the windshield. Grumman support responds that the error is likely because Buzz put in the wrong weight for the Lunar Module. Buzz begins again feeding in the data to the onboard computer. Grumman suggests that had Buzz simply created the right template, this problem would not have occurred. Buzz, through gritted teeth, asks how he was supposed to create a template for a problem that no one seemed to expect.
They are down to 150 feet now. Neil tells Buzz what he thinks of the computer systems and is told by Mission Control his microphone is hot and that such comments are not appropriate. At Mission Control, a notation is made on their system that Neil will need to discuss this pilot error with the astronaut office upon his return. Neil simply turns off the onboard computer and lands the Lunar Module with seconds of fuel left as he avoids a large boulder field and finds just the right spot. Tranquility Base reports in to Mission Control. Mankind has landed on the Moon.
The alternative history is what surgeons are experiencing every day because of the unhealthy relationship existing between American health care today and our institutional computer systems. Like Neil and Buzz, these surgeons are heroes who avoid boulder fields despite so many obstacles unrelated to their missions. No wonder burnout (a missile term) is so prevalent. We’ve gone from inconvenient to intolerable. Our health care computer systems must be interoperable to have any meaningful use. Our formats need to be understandable. Surgeons need computers to help them make judgments based on easily accessible data in real time. Surgeons need to “fly” the missions and computer systems need to be our servants, not our masters.
Dr. Hughes is clinical professor in the department of surgery and director of medical education at the Kansas University School of Medicine, Salina Campus, and Co-Editor of ACS Surgery News.
From the Washington Office: The Mission Zero Act
Surgeons are well familiar with the statistic from the Centers for Disease Control and Prevention (CDC) identifying trauma as the leading cause of death for children and adults under age 44. More Americans lose their lives each year to trauma than to AIDS and stroke combined. Unfortunately, nearly 45 million Americans live in areas more than an hour away from either a Level I or II trauma center. Ensuring access to trauma care requires many crucial components including trauma centers and appropriately trained physicians and nurses, all of which must dedicate extensive resources around the clock so that seriously injured patients have the best possible chance for survival.
It has long been a top legislative priority of the ACS to establish and maintain adequate funding for high-quality trauma systems throughout the United States, including those systems operated by our armed forces.The ACS was a sponsor of the National Academy of Medicine (NAM) report entitled, A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. This report, released in June of 2016, outlines the steps necessary to secure a national trauma system and sets the goal of achieving zero preventable traumatic deaths.
In an effort to facilitate the achievement of the goals laid out in the report, The Mission Zero Act (H.R. 880) was introduced in the House of Representatives by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Cathy Castor (D-FL), Gene Green (D-TX), and Richard Hudson (R-NC). Identical companion legislation was introduced in the Senate (S.1022) by Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL). The Mission Zero Act creates a grant program to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality of trauma care in times of peace and war, thus taking a step in the direction of the NAM report recommendations.
Specifically, the legislation provides for:
• $40 million in grants to fund military trauma teams and providers to embed into civilian trauma facilities.
o Trauma centers are eligible for a $1 million grant to host military trauma teams at eligible high-acuity level 1 trauma centers
o Trauma centers are also eligible for grants to host individual providers ($100,000 for physician or $50,000 for non-physician providers) at eligible level I, II, or III trauma centers
As of today, the House and Senate versions of the Mission Zero Act have 25co-sponsors and 2 co-sponsors respectively. The ACS would very much like to build some momentum for the Mission Zero Act going into the fall when it is expected that there will be several large “must pass” pieces of legislation working their way through Congress to which the Mission Zero Act could potentially be attached. Accordingly, I respectfully ask all Fellows to take a few moments to visit the SurgeonsVoice website at www.surgeonsvoice.org, click on the Take Action tab on the right side of the page and send a message to their individual representatives and senators seeking support for this important legislation.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Surgeons are well familiar with the statistic from the Centers for Disease Control and Prevention (CDC) identifying trauma as the leading cause of death for children and adults under age 44. More Americans lose their lives each year to trauma than to AIDS and stroke combined. Unfortunately, nearly 45 million Americans live in areas more than an hour away from either a Level I or II trauma center. Ensuring access to trauma care requires many crucial components including trauma centers and appropriately trained physicians and nurses, all of which must dedicate extensive resources around the clock so that seriously injured patients have the best possible chance for survival.
It has long been a top legislative priority of the ACS to establish and maintain adequate funding for high-quality trauma systems throughout the United States, including those systems operated by our armed forces.The ACS was a sponsor of the National Academy of Medicine (NAM) report entitled, A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. This report, released in June of 2016, outlines the steps necessary to secure a national trauma system and sets the goal of achieving zero preventable traumatic deaths.
In an effort to facilitate the achievement of the goals laid out in the report, The Mission Zero Act (H.R. 880) was introduced in the House of Representatives by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Cathy Castor (D-FL), Gene Green (D-TX), and Richard Hudson (R-NC). Identical companion legislation was introduced in the Senate (S.1022) by Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL). The Mission Zero Act creates a grant program to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality of trauma care in times of peace and war, thus taking a step in the direction of the NAM report recommendations.
Specifically, the legislation provides for:
• $40 million in grants to fund military trauma teams and providers to embed into civilian trauma facilities.
o Trauma centers are eligible for a $1 million grant to host military trauma teams at eligible high-acuity level 1 trauma centers
o Trauma centers are also eligible for grants to host individual providers ($100,000 for physician or $50,000 for non-physician providers) at eligible level I, II, or III trauma centers
As of today, the House and Senate versions of the Mission Zero Act have 25co-sponsors and 2 co-sponsors respectively. The ACS would very much like to build some momentum for the Mission Zero Act going into the fall when it is expected that there will be several large “must pass” pieces of legislation working their way through Congress to which the Mission Zero Act could potentially be attached. Accordingly, I respectfully ask all Fellows to take a few moments to visit the SurgeonsVoice website at www.surgeonsvoice.org, click on the Take Action tab on the right side of the page and send a message to their individual representatives and senators seeking support for this important legislation.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Surgeons are well familiar with the statistic from the Centers for Disease Control and Prevention (CDC) identifying trauma as the leading cause of death for children and adults under age 44. More Americans lose their lives each year to trauma than to AIDS and stroke combined. Unfortunately, nearly 45 million Americans live in areas more than an hour away from either a Level I or II trauma center. Ensuring access to trauma care requires many crucial components including trauma centers and appropriately trained physicians and nurses, all of which must dedicate extensive resources around the clock so that seriously injured patients have the best possible chance for survival.
It has long been a top legislative priority of the ACS to establish and maintain adequate funding for high-quality trauma systems throughout the United States, including those systems operated by our armed forces.The ACS was a sponsor of the National Academy of Medicine (NAM) report entitled, A National Trauma Care System: Integrating Military and Civilian Trauma Systems to Achieve Zero Preventable Deaths After Injury. This report, released in June of 2016, outlines the steps necessary to secure a national trauma system and sets the goal of achieving zero preventable traumatic deaths.
In an effort to facilitate the achievement of the goals laid out in the report, The Mission Zero Act (H.R. 880) was introduced in the House of Representatives by Chairman of the House Energy and Commerce Health Subcommittee, Michael Burgess, MD (R-TX), Representatives Cathy Castor (D-FL), Gene Green (D-TX), and Richard Hudson (R-NC). Identical companion legislation was introduced in the Senate (S.1022) by Senators Johnny Isakson (R-GA), John Cornyn (R-TX), and Tammy Duckworth (D-IL). The Mission Zero Act creates a grant program to assist civilian trauma centers in partnering with military trauma professionals to establish a pathway to provide patients with the highest quality of trauma care in times of peace and war, thus taking a step in the direction of the NAM report recommendations.
Specifically, the legislation provides for:
• $40 million in grants to fund military trauma teams and providers to embed into civilian trauma facilities.
o Trauma centers are eligible for a $1 million grant to host military trauma teams at eligible high-acuity level 1 trauma centers
o Trauma centers are also eligible for grants to host individual providers ($100,000 for physician or $50,000 for non-physician providers) at eligible level I, II, or III trauma centers
As of today, the House and Senate versions of the Mission Zero Act have 25co-sponsors and 2 co-sponsors respectively. The ACS would very much like to build some momentum for the Mission Zero Act going into the fall when it is expected that there will be several large “must pass” pieces of legislation working their way through Congress to which the Mission Zero Act could potentially be attached. Accordingly, I respectfully ask all Fellows to take a few moments to visit the SurgeonsVoice website at www.surgeonsvoice.org, click on the Take Action tab on the right side of the page and send a message to their individual representatives and senators seeking support for this important legislation.
Until next month …
Dr. Bailey is a pediatric surgeon and Medical Director, Advocacy, for the Division of Advocacy and Health Policy in the ACS offices in Washington, DC.
Unexplained leukocytosis in a hospitalized patient
A 70-year-old man is evaluated for a persistent leukocytosis. He was hospitalized 10 days ago for a severe exacerbation of chronic obstructive pulmonary disease. He was intubated for 3 days, was diagnosed with a left lower lobe pneumonia, and was treated with antibiotics. His white blood cell count on admission was 20,000 per mcL. It dropped as low as 15,000 on day 6 but is now 25,000, with 23,000 polymorphonuclear leukocytes (10% band forms). He is on oral prednisone 15 mg once daily. Chest x-ray shows no infiltrate. Urinalysis without WBCs.
What is the most likely cause of his leukocytosis?
A) Pulmonary embolus.
B) Lung abscess.
C) Perinephric abscess.
D) Prednisone.
E) Clostridium difficile infection.
The most likely diagnosis in otherwise unexplained leukocytosis in a hospitalized patient is C. difficile.
Anna Wanahita, MD, of the St. John Clinic in Tulsa, Okla., and her colleagues prospectively studied 60 patients admitted to a VA hospital who had unexplained leukocytosis.1 All patients had stool specimens sent for C. difficile toxin; in addition, 26 hospitalized control patients without leukocytosis also had stool sent for C. difficile toxin. For study purposes, leukocytosis was defined as a WBC greater than 15,000 per mcL. Any patient for whom C. difficile toxin was sent because of clinical suspicion and who was positive was excluded from the study results.
Almost 60% of the patients with unexplained leukocytosis (35 of 60) had a positive C. difficile toxin, compared with 12% of the controls (P less than .001). More than half of the patients with a positive C. difficile test had the onset of leukocytosis prior to any symptoms of colitis. Leukocytosis responded to treatment with metronidazole in 83% of the patients with a positive C. difficile toxin, and 75% of the patients who had leukocytosis did not have a positive C. difficile toxin.
In another study, Mamatha Bulusu, and colleagues did a retrospective study of 70 hospitalized patients who had diarrhea and underwent testing for C. difficile.2 They evaluated the pattern of white blood cell counts in patients who were positive and negative for C. difficile toxin. The mean WBC for C. difficile–positive patients was 15,800, compared with 7,700 for the patients who were C. difficile negative (P less than .01). They described three patterns: one in which leukocytosis occurred at the onset of diarrhea; a pattern in which unexplained leukocytosis occurred days prior to diarrhea; and a pattern in which patients treated for infection with leukocytosis had a worsening of their leukocytosis at the onset of diarrheal symptoms. Treatment with metronidazole led to a resolution of leukocytosis in all the C. difficile–positive patients.
Another possibility in this case was WBC elevation because of the patient’s prednisone. Prednisone can increase WBC as early as the first day of therapy.3 The elevation and rapidity of increase are dose related. The important pearl is that steroid-induced leukocytosis involves an increase of polymorphonuclear white blood cells with a rise in monocytes and a decrease in eosinophils and lymphocytes.
Pearl: Think of underlying C. difficile infection in your hospitalized patient with unexplained leukocytosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Am J Med. 2003 Nov;115(7):543-6.
2. Am J Gastroenterol. 2000 Nov;95(11):3137-41.
3. J Clin Invest. 1975 Oct;56(4):808-13.
4. Am J Med. 1981 Nov;71(5):773-8.
A 70-year-old man is evaluated for a persistent leukocytosis. He was hospitalized 10 days ago for a severe exacerbation of chronic obstructive pulmonary disease. He was intubated for 3 days, was diagnosed with a left lower lobe pneumonia, and was treated with antibiotics. His white blood cell count on admission was 20,000 per mcL. It dropped as low as 15,000 on day 6 but is now 25,000, with 23,000 polymorphonuclear leukocytes (10% band forms). He is on oral prednisone 15 mg once daily. Chest x-ray shows no infiltrate. Urinalysis without WBCs.
What is the most likely cause of his leukocytosis?
A) Pulmonary embolus.
B) Lung abscess.
C) Perinephric abscess.
D) Prednisone.
E) Clostridium difficile infection.
The most likely diagnosis in otherwise unexplained leukocytosis in a hospitalized patient is C. difficile.
Anna Wanahita, MD, of the St. John Clinic in Tulsa, Okla., and her colleagues prospectively studied 60 patients admitted to a VA hospital who had unexplained leukocytosis.1 All patients had stool specimens sent for C. difficile toxin; in addition, 26 hospitalized control patients without leukocytosis also had stool sent for C. difficile toxin. For study purposes, leukocytosis was defined as a WBC greater than 15,000 per mcL. Any patient for whom C. difficile toxin was sent because of clinical suspicion and who was positive was excluded from the study results.
Almost 60% of the patients with unexplained leukocytosis (35 of 60) had a positive C. difficile toxin, compared with 12% of the controls (P less than .001). More than half of the patients with a positive C. difficile test had the onset of leukocytosis prior to any symptoms of colitis. Leukocytosis responded to treatment with metronidazole in 83% of the patients with a positive C. difficile toxin, and 75% of the patients who had leukocytosis did not have a positive C. difficile toxin.
In another study, Mamatha Bulusu, and colleagues did a retrospective study of 70 hospitalized patients who had diarrhea and underwent testing for C. difficile.2 They evaluated the pattern of white blood cell counts in patients who were positive and negative for C. difficile toxin. The mean WBC for C. difficile–positive patients was 15,800, compared with 7,700 for the patients who were C. difficile negative (P less than .01). They described three patterns: one in which leukocytosis occurred at the onset of diarrhea; a pattern in which unexplained leukocytosis occurred days prior to diarrhea; and a pattern in which patients treated for infection with leukocytosis had a worsening of their leukocytosis at the onset of diarrheal symptoms. Treatment with metronidazole led to a resolution of leukocytosis in all the C. difficile–positive patients.
Another possibility in this case was WBC elevation because of the patient’s prednisone. Prednisone can increase WBC as early as the first day of therapy.3 The elevation and rapidity of increase are dose related. The important pearl is that steroid-induced leukocytosis involves an increase of polymorphonuclear white blood cells with a rise in monocytes and a decrease in eosinophils and lymphocytes.
Pearl: Think of underlying C. difficile infection in your hospitalized patient with unexplained leukocytosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Am J Med. 2003 Nov;115(7):543-6.
2. Am J Gastroenterol. 2000 Nov;95(11):3137-41.
3. J Clin Invest. 1975 Oct;56(4):808-13.
4. Am J Med. 1981 Nov;71(5):773-8.
A 70-year-old man is evaluated for a persistent leukocytosis. He was hospitalized 10 days ago for a severe exacerbation of chronic obstructive pulmonary disease. He was intubated for 3 days, was diagnosed with a left lower lobe pneumonia, and was treated with antibiotics. His white blood cell count on admission was 20,000 per mcL. It dropped as low as 15,000 on day 6 but is now 25,000, with 23,000 polymorphonuclear leukocytes (10% band forms). He is on oral prednisone 15 mg once daily. Chest x-ray shows no infiltrate. Urinalysis without WBCs.
What is the most likely cause of his leukocytosis?
A) Pulmonary embolus.
B) Lung abscess.
C) Perinephric abscess.
D) Prednisone.
E) Clostridium difficile infection.
The most likely diagnosis in otherwise unexplained leukocytosis in a hospitalized patient is C. difficile.
Anna Wanahita, MD, of the St. John Clinic in Tulsa, Okla., and her colleagues prospectively studied 60 patients admitted to a VA hospital who had unexplained leukocytosis.1 All patients had stool specimens sent for C. difficile toxin; in addition, 26 hospitalized control patients without leukocytosis also had stool sent for C. difficile toxin. For study purposes, leukocytosis was defined as a WBC greater than 15,000 per mcL. Any patient for whom C. difficile toxin was sent because of clinical suspicion and who was positive was excluded from the study results.
Almost 60% of the patients with unexplained leukocytosis (35 of 60) had a positive C. difficile toxin, compared with 12% of the controls (P less than .001). More than half of the patients with a positive C. difficile test had the onset of leukocytosis prior to any symptoms of colitis. Leukocytosis responded to treatment with metronidazole in 83% of the patients with a positive C. difficile toxin, and 75% of the patients who had leukocytosis did not have a positive C. difficile toxin.
In another study, Mamatha Bulusu, and colleagues did a retrospective study of 70 hospitalized patients who had diarrhea and underwent testing for C. difficile.2 They evaluated the pattern of white blood cell counts in patients who were positive and negative for C. difficile toxin. The mean WBC for C. difficile–positive patients was 15,800, compared with 7,700 for the patients who were C. difficile negative (P less than .01). They described three patterns: one in which leukocytosis occurred at the onset of diarrhea; a pattern in which unexplained leukocytosis occurred days prior to diarrhea; and a pattern in which patients treated for infection with leukocytosis had a worsening of their leukocytosis at the onset of diarrheal symptoms. Treatment with metronidazole led to a resolution of leukocytosis in all the C. difficile–positive patients.
Another possibility in this case was WBC elevation because of the patient’s prednisone. Prednisone can increase WBC as early as the first day of therapy.3 The elevation and rapidity of increase are dose related. The important pearl is that steroid-induced leukocytosis involves an increase of polymorphonuclear white blood cells with a rise in monocytes and a decrease in eosinophils and lymphocytes.
Pearl: Think of underlying C. difficile infection in your hospitalized patient with unexplained leukocytosis.
Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. Contact Dr. Paauw at dpaauw@uw.edu.
References
1. Am J Med. 2003 Nov;115(7):543-6.
2. Am J Gastroenterol. 2000 Nov;95(11):3137-41.
3. J Clin Invest. 1975 Oct;56(4):808-13.
4. Am J Med. 1981 Nov;71(5):773-8.
Opening the door to gene editing?
In early August, in Portland, Ore. The scale and success of such experimentation with human embryos is unprecedented in the United States. Given the highly experimental nature of fertility clinics in the United States and abroad, many suggest that these findings open the door to designer babies. A careful read of the report, however, indicates that the door is still quite closed, perhaps cracked open just a little.
The research team used a new method of cutting the genome, called CRISPR-Cas9. CRISPR utilizes two key components that the team combined in a test tube together: a Cas9 protein that can cut the DNA and a synthetic RNA that can guide the protein to cut a 20-letter sequence in the human genome specifically. In these experiments, the Cas9-RNA protein was designed to cut a pathogenic mutation in the MYBPC3 gene, which can cause hypertrophic cardiomyopathy. The research team could not obtain human zygotes with this mutation on both copies of the genome (a rare homozygous genotype). Such zygotes would have the most severe phenotype and be the most compelling test case for CRISPR. Instead, they focused on gene editing heterozygous human zygotes that have one normal maternal copy of the MYBPC3 gene and one pathogenic paternal copy. The heterozygous zygotes were produced by the research team via in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using sperm donated by males carrying the pathogenic mutation (Nature. 2017 Aug 2. doi: 10.1038/nature23305).
When researchers injected the Cas9-RNA protein targeting the mutation into already fertilized zygotes, they found that 67% of the resulting embryos had two normal copies of the MYBPC3 gene. Without gene editing, approximately 50% of the embryos would have two normal copies, because the male sperm donor would produce equal numbers of sperm with normal and pathogenic genotypes. Thus, editing likely corrected only about 17% of the embryos that would have otherwise had one pathogenic paternal mutation. Thirty-six percent of embryos had additional mutations from imprecise gene editing. Further, some of the gene edits and additional mutations were mosaic, meaning that the resulting embryo harbored many different genotypes.
To overcome these challenges, the research team precisely controlled the timing of CRISPR injection to coincide with fertilization. With controlled timing, gene editing was restricted to only the paternal pathogenic mutation, resulting in 72% of all injected embryos having two normal copies of the gene in all cells without any mosaicism. Whole genome sequencing revealed no additional mutations above the detection limit of the assay. Finally, preimplantation development proceeded normally to the blastocyst stage, suggesting that the edited embryos have no functional deficits from the procedure.
A surprising finding was that new sequences could not be put into the embryo. The research team had coinjected a synthetic DNA template that differed from the normal maternal copy, but never saw this sequence incorporated into any embryo. Instead, the zygote utilized the maternal copy of the gene with the normal sequence as a template for repairing the DNA cut in the paternal copy produced by CRISPR. The biology behind this repair process is poorly understood and has not been previously reported with other human cell types. These observations suggest that we cannot easily “write” our genome. Instead, our vocabulary is limited to what is already within either the maternal or paternal copy of the genome. In other words, designer babies are not around the corner. While preimplantation genetic diagnosis (PGD) is still currently the safest way to avoid passing on autosomal dominant mutations, these new findings could enable correction of such mutations within IVF embryos, resulting in a larger pool of embryos for IVF clinics to work with.
Apart from these technical challenges, the National Academies has not given a green light to implant edited human embryos. Instead, the organization calls for several requirements to be met, including “broad societal consensus” on the need for this type of intervention. While it is not clear whether or how consensus could be achieved, it is clear that scientists, clinicians, and patients will need help from the rest of society for this research to have an impact clinically.
Dr. Saha is assistant professor of biomedical engineering at the Wisconsin Institute for Discovery at the University of Wisconsin, Madison. His lab works on gene editing of human cells. He has patent filings through the Wisconsin Alumni Research Foundation on gene editing inventions.
In early August, in Portland, Ore. The scale and success of such experimentation with human embryos is unprecedented in the United States. Given the highly experimental nature of fertility clinics in the United States and abroad, many suggest that these findings open the door to designer babies. A careful read of the report, however, indicates that the door is still quite closed, perhaps cracked open just a little.
The research team used a new method of cutting the genome, called CRISPR-Cas9. CRISPR utilizes two key components that the team combined in a test tube together: a Cas9 protein that can cut the DNA and a synthetic RNA that can guide the protein to cut a 20-letter sequence in the human genome specifically. In these experiments, the Cas9-RNA protein was designed to cut a pathogenic mutation in the MYBPC3 gene, which can cause hypertrophic cardiomyopathy. The research team could not obtain human zygotes with this mutation on both copies of the genome (a rare homozygous genotype). Such zygotes would have the most severe phenotype and be the most compelling test case for CRISPR. Instead, they focused on gene editing heterozygous human zygotes that have one normal maternal copy of the MYBPC3 gene and one pathogenic paternal copy. The heterozygous zygotes were produced by the research team via in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using sperm donated by males carrying the pathogenic mutation (Nature. 2017 Aug 2. doi: 10.1038/nature23305).
When researchers injected the Cas9-RNA protein targeting the mutation into already fertilized zygotes, they found that 67% of the resulting embryos had two normal copies of the MYBPC3 gene. Without gene editing, approximately 50% of the embryos would have two normal copies, because the male sperm donor would produce equal numbers of sperm with normal and pathogenic genotypes. Thus, editing likely corrected only about 17% of the embryos that would have otherwise had one pathogenic paternal mutation. Thirty-six percent of embryos had additional mutations from imprecise gene editing. Further, some of the gene edits and additional mutations were mosaic, meaning that the resulting embryo harbored many different genotypes.
To overcome these challenges, the research team precisely controlled the timing of CRISPR injection to coincide with fertilization. With controlled timing, gene editing was restricted to only the paternal pathogenic mutation, resulting in 72% of all injected embryos having two normal copies of the gene in all cells without any mosaicism. Whole genome sequencing revealed no additional mutations above the detection limit of the assay. Finally, preimplantation development proceeded normally to the blastocyst stage, suggesting that the edited embryos have no functional deficits from the procedure.
A surprising finding was that new sequences could not be put into the embryo. The research team had coinjected a synthetic DNA template that differed from the normal maternal copy, but never saw this sequence incorporated into any embryo. Instead, the zygote utilized the maternal copy of the gene with the normal sequence as a template for repairing the DNA cut in the paternal copy produced by CRISPR. The biology behind this repair process is poorly understood and has not been previously reported with other human cell types. These observations suggest that we cannot easily “write” our genome. Instead, our vocabulary is limited to what is already within either the maternal or paternal copy of the genome. In other words, designer babies are not around the corner. While preimplantation genetic diagnosis (PGD) is still currently the safest way to avoid passing on autosomal dominant mutations, these new findings could enable correction of such mutations within IVF embryos, resulting in a larger pool of embryos for IVF clinics to work with.
Apart from these technical challenges, the National Academies has not given a green light to implant edited human embryos. Instead, the organization calls for several requirements to be met, including “broad societal consensus” on the need for this type of intervention. While it is not clear whether or how consensus could be achieved, it is clear that scientists, clinicians, and patients will need help from the rest of society for this research to have an impact clinically.
Dr. Saha is assistant professor of biomedical engineering at the Wisconsin Institute for Discovery at the University of Wisconsin, Madison. His lab works on gene editing of human cells. He has patent filings through the Wisconsin Alumni Research Foundation on gene editing inventions.
In early August, in Portland, Ore. The scale and success of such experimentation with human embryos is unprecedented in the United States. Given the highly experimental nature of fertility clinics in the United States and abroad, many suggest that these findings open the door to designer babies. A careful read of the report, however, indicates that the door is still quite closed, perhaps cracked open just a little.
The research team used a new method of cutting the genome, called CRISPR-Cas9. CRISPR utilizes two key components that the team combined in a test tube together: a Cas9 protein that can cut the DNA and a synthetic RNA that can guide the protein to cut a 20-letter sequence in the human genome specifically. In these experiments, the Cas9-RNA protein was designed to cut a pathogenic mutation in the MYBPC3 gene, which can cause hypertrophic cardiomyopathy. The research team could not obtain human zygotes with this mutation on both copies of the genome (a rare homozygous genotype). Such zygotes would have the most severe phenotype and be the most compelling test case for CRISPR. Instead, they focused on gene editing heterozygous human zygotes that have one normal maternal copy of the MYBPC3 gene and one pathogenic paternal copy. The heterozygous zygotes were produced by the research team via in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) using sperm donated by males carrying the pathogenic mutation (Nature. 2017 Aug 2. doi: 10.1038/nature23305).
When researchers injected the Cas9-RNA protein targeting the mutation into already fertilized zygotes, they found that 67% of the resulting embryos had two normal copies of the MYBPC3 gene. Without gene editing, approximately 50% of the embryos would have two normal copies, because the male sperm donor would produce equal numbers of sperm with normal and pathogenic genotypes. Thus, editing likely corrected only about 17% of the embryos that would have otherwise had one pathogenic paternal mutation. Thirty-six percent of embryos had additional mutations from imprecise gene editing. Further, some of the gene edits and additional mutations were mosaic, meaning that the resulting embryo harbored many different genotypes.
To overcome these challenges, the research team precisely controlled the timing of CRISPR injection to coincide with fertilization. With controlled timing, gene editing was restricted to only the paternal pathogenic mutation, resulting in 72% of all injected embryos having two normal copies of the gene in all cells without any mosaicism. Whole genome sequencing revealed no additional mutations above the detection limit of the assay. Finally, preimplantation development proceeded normally to the blastocyst stage, suggesting that the edited embryos have no functional deficits from the procedure.
A surprising finding was that new sequences could not be put into the embryo. The research team had coinjected a synthetic DNA template that differed from the normal maternal copy, but never saw this sequence incorporated into any embryo. Instead, the zygote utilized the maternal copy of the gene with the normal sequence as a template for repairing the DNA cut in the paternal copy produced by CRISPR. The biology behind this repair process is poorly understood and has not been previously reported with other human cell types. These observations suggest that we cannot easily “write” our genome. Instead, our vocabulary is limited to what is already within either the maternal or paternal copy of the genome. In other words, designer babies are not around the corner. While preimplantation genetic diagnosis (PGD) is still currently the safest way to avoid passing on autosomal dominant mutations, these new findings could enable correction of such mutations within IVF embryos, resulting in a larger pool of embryos for IVF clinics to work with.
Apart from these technical challenges, the National Academies has not given a green light to implant edited human embryos. Instead, the organization calls for several requirements to be met, including “broad societal consensus” on the need for this type of intervention. While it is not clear whether or how consensus could be achieved, it is clear that scientists, clinicians, and patients will need help from the rest of society for this research to have an impact clinically.
Dr. Saha is assistant professor of biomedical engineering at the Wisconsin Institute for Discovery at the University of Wisconsin, Madison. His lab works on gene editing of human cells. He has patent filings through the Wisconsin Alumni Research Foundation on gene editing inventions.
Psoriasis, psoriatic arthritis research makes headway at GRAPPA meeting
The agenda for this year’s Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting included sessions on juvenile psoriatic arthritis (PsA), the microbiome in psoriasis and PsA, and setting up longitudinal cohort studies. There was also a workshop to define the clinical fit and feasibility of PsA outcome measures for clinical trials and updates on several GRAPPA-associated projects.
The meeting, held July 13-15 in Amsterdam, opened with the annual trainee session. This year’s trainee session attracted more than 40 abstracts, of which 6 were selected for oral presentations on a variety of topics including outcome measure assessment, imaging, the microbiome in PsA, and T-cell subsets in synovial fluid.
The jPsA session also emphasized the need for efforts to better define this disease entity and to study outcomes related to it. The current International League of Associations for Rheumatology criteria for juvenile idiopathic arthritis split jPsA into other subgroups (for example, enthesitis-associated arthritis, undifferentiated arthritis, etc).
Three investigators – Matt Stoll, MD, PhD, Devy Zisman, MD, and Elizabeth Mellins, MD – also presented studies of the epidemiology of jPsA.
Among the most intriguing sessions at the GRAPPA meeting was a series of three talks by Jose Scher, MD, Hok Bing Thio, MD, PhD, and Dirk Elewaut, PhD, that introduced the audience to the complexity of the micro-organisms that call the human host “home” and the potential role in the development of inflammatory conditions, in particular psoriasis and PsA. These talks touched on the potential uses of the microbiome of the gut, skin, and oral mucosa in predicting therapy response and modulating the immune system.
Dafna Gladman, MD, led a session on “how to set up a cohort.” In this session, speakers provided a road map for setting up a longitudinal cohort and discussed opportunities and challenges along the way. This session provided a foundation for a meeting that followed the annual meeting, the GRAPPA Research Collaborative Network meeting (held July 15-16). The RCN meeting aimed to develop a plan for a GRAPPA research network supporting collaborative research to identify biomarkers and outcomes in psoriasis and PsA. Speakers/panelists from academics and industry kicked off the meeting with a discussion of prior experiences in establishing international cohort studies. Subsequent sessions presented individual aspects of beginning a longitudinal cohort study for biomarkers, including methods for sample collection, regulatory processes, and data collected at potential sites; capturing and harmonizing clinical data for such studies; and policies for publication of RCN studies.
This year’s workshop was focused on the GRAPPA-Outcome Measures in Rheumatology (OMERACT) working group’s plan to develop a Core Outcome Measure Set, a collection of outcome measurement instruments to be used in randomized, controlled trials (RCTs) for PsA. During the plenary session, the team presented a process for the group to evaluate instruments, including assessment of match to the domain or concept of interest, feasibility, construct validity, and discrimination (including reliability and the ability to distinguish between two groups such as responders and nonresponders). Breakout groups then discussed one of the six tools being considered and voted on match to the domain of interest and feasibility for RCTs.
In a skin session, ongoing efforts to standardize and simplify the measurement of skin psoriasis in both the clinic and RCTs were presented. While the Psoriasis Area and Severity Index (PASI) is the current standard for measuring psoriasis severity and response to therapy in RCTs, the PASI is challenging for use in clinical practice. Joseph Merola, MD, presented data to support the use of the psoriasis Physician Global Assessment (PGA) x body surface area (BSA), a simpler measure than the PASI, as a potential substitute for the PASI. Updates from the International Dermatology Outcome Measures board included reporting of the psoriasis core domain set and a summary of the PsA symptoms working group’s efforts to identify patient-reported outcomes to identify and measure PsA among patients enrolled in psoriasis RCTs. April Armstrong, MD, discussed the National Psoriasis Foundation’s efforts to develop treat-to-target goals for psoriasis. Finally, Laura Coates, MBChB, PhD, presented a report on her efforts to examine a variety of psoriasis cut points for minimal disease activity and very low disease activity outcomes.
Dr. Ogdie is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.
The agenda for this year’s Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting included sessions on juvenile psoriatic arthritis (PsA), the microbiome in psoriasis and PsA, and setting up longitudinal cohort studies. There was also a workshop to define the clinical fit and feasibility of PsA outcome measures for clinical trials and updates on several GRAPPA-associated projects.
The meeting, held July 13-15 in Amsterdam, opened with the annual trainee session. This year’s trainee session attracted more than 40 abstracts, of which 6 were selected for oral presentations on a variety of topics including outcome measure assessment, imaging, the microbiome in PsA, and T-cell subsets in synovial fluid.
The jPsA session also emphasized the need for efforts to better define this disease entity and to study outcomes related to it. The current International League of Associations for Rheumatology criteria for juvenile idiopathic arthritis split jPsA into other subgroups (for example, enthesitis-associated arthritis, undifferentiated arthritis, etc).
Three investigators – Matt Stoll, MD, PhD, Devy Zisman, MD, and Elizabeth Mellins, MD – also presented studies of the epidemiology of jPsA.
Among the most intriguing sessions at the GRAPPA meeting was a series of three talks by Jose Scher, MD, Hok Bing Thio, MD, PhD, and Dirk Elewaut, PhD, that introduced the audience to the complexity of the micro-organisms that call the human host “home” and the potential role in the development of inflammatory conditions, in particular psoriasis and PsA. These talks touched on the potential uses of the microbiome of the gut, skin, and oral mucosa in predicting therapy response and modulating the immune system.
Dafna Gladman, MD, led a session on “how to set up a cohort.” In this session, speakers provided a road map for setting up a longitudinal cohort and discussed opportunities and challenges along the way. This session provided a foundation for a meeting that followed the annual meeting, the GRAPPA Research Collaborative Network meeting (held July 15-16). The RCN meeting aimed to develop a plan for a GRAPPA research network supporting collaborative research to identify biomarkers and outcomes in psoriasis and PsA. Speakers/panelists from academics and industry kicked off the meeting with a discussion of prior experiences in establishing international cohort studies. Subsequent sessions presented individual aspects of beginning a longitudinal cohort study for biomarkers, including methods for sample collection, regulatory processes, and data collected at potential sites; capturing and harmonizing clinical data for such studies; and policies for publication of RCN studies.
This year’s workshop was focused on the GRAPPA-Outcome Measures in Rheumatology (OMERACT) working group’s plan to develop a Core Outcome Measure Set, a collection of outcome measurement instruments to be used in randomized, controlled trials (RCTs) for PsA. During the plenary session, the team presented a process for the group to evaluate instruments, including assessment of match to the domain or concept of interest, feasibility, construct validity, and discrimination (including reliability and the ability to distinguish between two groups such as responders and nonresponders). Breakout groups then discussed one of the six tools being considered and voted on match to the domain of interest and feasibility for RCTs.
In a skin session, ongoing efforts to standardize and simplify the measurement of skin psoriasis in both the clinic and RCTs were presented. While the Psoriasis Area and Severity Index (PASI) is the current standard for measuring psoriasis severity and response to therapy in RCTs, the PASI is challenging for use in clinical practice. Joseph Merola, MD, presented data to support the use of the psoriasis Physician Global Assessment (PGA) x body surface area (BSA), a simpler measure than the PASI, as a potential substitute for the PASI. Updates from the International Dermatology Outcome Measures board included reporting of the psoriasis core domain set and a summary of the PsA symptoms working group’s efforts to identify patient-reported outcomes to identify and measure PsA among patients enrolled in psoriasis RCTs. April Armstrong, MD, discussed the National Psoriasis Foundation’s efforts to develop treat-to-target goals for psoriasis. Finally, Laura Coates, MBChB, PhD, presented a report on her efforts to examine a variety of psoriasis cut points for minimal disease activity and very low disease activity outcomes.
Dr. Ogdie is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.
The agenda for this year’s Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) annual meeting included sessions on juvenile psoriatic arthritis (PsA), the microbiome in psoriasis and PsA, and setting up longitudinal cohort studies. There was also a workshop to define the clinical fit and feasibility of PsA outcome measures for clinical trials and updates on several GRAPPA-associated projects.
The meeting, held July 13-15 in Amsterdam, opened with the annual trainee session. This year’s trainee session attracted more than 40 abstracts, of which 6 were selected for oral presentations on a variety of topics including outcome measure assessment, imaging, the microbiome in PsA, and T-cell subsets in synovial fluid.
The jPsA session also emphasized the need for efforts to better define this disease entity and to study outcomes related to it. The current International League of Associations for Rheumatology criteria for juvenile idiopathic arthritis split jPsA into other subgroups (for example, enthesitis-associated arthritis, undifferentiated arthritis, etc).
Three investigators – Matt Stoll, MD, PhD, Devy Zisman, MD, and Elizabeth Mellins, MD – also presented studies of the epidemiology of jPsA.
Among the most intriguing sessions at the GRAPPA meeting was a series of three talks by Jose Scher, MD, Hok Bing Thio, MD, PhD, and Dirk Elewaut, PhD, that introduced the audience to the complexity of the micro-organisms that call the human host “home” and the potential role in the development of inflammatory conditions, in particular psoriasis and PsA. These talks touched on the potential uses of the microbiome of the gut, skin, and oral mucosa in predicting therapy response and modulating the immune system.
Dafna Gladman, MD, led a session on “how to set up a cohort.” In this session, speakers provided a road map for setting up a longitudinal cohort and discussed opportunities and challenges along the way. This session provided a foundation for a meeting that followed the annual meeting, the GRAPPA Research Collaborative Network meeting (held July 15-16). The RCN meeting aimed to develop a plan for a GRAPPA research network supporting collaborative research to identify biomarkers and outcomes in psoriasis and PsA. Speakers/panelists from academics and industry kicked off the meeting with a discussion of prior experiences in establishing international cohort studies. Subsequent sessions presented individual aspects of beginning a longitudinal cohort study for biomarkers, including methods for sample collection, regulatory processes, and data collected at potential sites; capturing and harmonizing clinical data for such studies; and policies for publication of RCN studies.
This year’s workshop was focused on the GRAPPA-Outcome Measures in Rheumatology (OMERACT) working group’s plan to develop a Core Outcome Measure Set, a collection of outcome measurement instruments to be used in randomized, controlled trials (RCTs) for PsA. During the plenary session, the team presented a process for the group to evaluate instruments, including assessment of match to the domain or concept of interest, feasibility, construct validity, and discrimination (including reliability and the ability to distinguish between two groups such as responders and nonresponders). Breakout groups then discussed one of the six tools being considered and voted on match to the domain of interest and feasibility for RCTs.
In a skin session, ongoing efforts to standardize and simplify the measurement of skin psoriasis in both the clinic and RCTs were presented. While the Psoriasis Area and Severity Index (PASI) is the current standard for measuring psoriasis severity and response to therapy in RCTs, the PASI is challenging for use in clinical practice. Joseph Merola, MD, presented data to support the use of the psoriasis Physician Global Assessment (PGA) x body surface area (BSA), a simpler measure than the PASI, as a potential substitute for the PASI. Updates from the International Dermatology Outcome Measures board included reporting of the psoriasis core domain set and a summary of the PsA symptoms working group’s efforts to identify patient-reported outcomes to identify and measure PsA among patients enrolled in psoriasis RCTs. April Armstrong, MD, discussed the National Psoriasis Foundation’s efforts to develop treat-to-target goals for psoriasis. Finally, Laura Coates, MBChB, PhD, presented a report on her efforts to examine a variety of psoriasis cut points for minimal disease activity and very low disease activity outcomes.
Dr. Ogdie is director of the Penn Psoriatic Arthritis Clinic at the University of Pennsylvania, Philadelphia, and is a member of the GRAPPA Steering Committee.
Federal medical tort reform: Has its time come?
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Question: Congressional proposals on medical tort reform can be expected to include the following, except:
A. A no-fault system akin to automobile no-fault insurance.
B. A cap on noneconomic damages.
C. “Safe-harbor” immunity against medical negligence.
D. Health courts in place of the judge/jury system to adjudicate claims.
E. Promotion of laws that encourage apologies and error disclosures.
Answer: A. Under the current Republican administration, one can expect legislative efforts at federal tort reform, especially given that Thomas E. Price, MD, the new secretary of the Department of Health & Human Services, is an orthopedic surgeon who has spoken passionately about defensive medicine, damage caps, health tribunals, and practice guidelines. As a former House representative for Georgia, Dr. Price has introduced several tort reform bills, so it is likely that any omnibus federal law will incorporate some of his proposals.1
Over the decades, many states have gone ahead in enacting their own statutes while awaiting federal action. Iowa is the latest example. It recently passed legislation that included a noneconomic damages cap of $250,000, stronger expert witness standards, a certificate of merit in all medical liability lawsuits, and an expansion of its “candor” protections.2 Additional reforms in other states include pretrial screening panels; arbitration; structured periodic payments in lieu of lump sum payments; penalties for frivolous suits; shortened statutes of limitations; making the loser bear all litigation costs; abolishing the collateral source rule, as well as joint and several liability; and limiting attorney contingency fees.
The best-known reform is a cap on noneconomic losses, such as pain and suffering, that doesn’t abridge compensation for economic losses, i.e., medical expenses and lost wages. This provides some predictability because noneconomic damages are difficult to quantify, and jury sympathy may result in unrealistically high payments.
Interestingly, Dr. Price himself has not pushed for a federal cap on noneconomic damages, but other Republican bills have proposed a cap of $250,000. Many states, such as California, Kansas, and Texas, have seen their cap statutes withstand constitutional challenge. However, other jurisdictions, notably Georgia, Illinois, and Missouri, have ruled them unconstitutional.
California’s law, popularly known as MICRA (Medical Injury Compensation Reform Act), came under renewed attack in 2015 with a wrongful death suit from hemorrhagic complications related to Coumadin (warfarin) use following heart surgery.3 The plaintiff’s constitutional challenges included violation of equal protection, due process, and the right to a jury trial, but these were essentially all grounded on an entitlement to recover additional noneconomic damages sufficient to cover attorney fees. The trial court had reduced her $1 million noneconomic damages to $250,000, as required under MICRA. A California court of appeal rejected her claim as being “contrary to many well-established legal principles.”
On the other hand, Florida’s Supreme Court recently held in a closely divided decision of 4-3 that the state’s caps were unconstitutional.4 The law limited noneconomic damages in malpractice cases to either $500,000 or $1 million if the injuries were catastrophic. The court ruled that the caps were arbitrary and unfairly hurt the most severely injured. It was unconvinced that they would reduce malpractice insurance rates; at any rate, there was no present crisis to justify the caps. The decision came 3 years after the court had struck down caps in a case of wrongful death.5
Three relative newcomers to the legal landscape – health courts, apology laws, and safe harbors – appear to be taking center stage in any forthcoming federal reform measures.
Health courts
Under this proposal, so-called health panels and tribunals would now adjudicate malpractice claims. Such health courts would dispense with the jury; further, regular judges would be replaced with specialized judges who would make binding determinations. In one version, a panel of medical experts would initially screen the complaint, followed by an administrative health care tribunal that would feature judges with medical expertise. These tribunals would issue binding rulings, but either party could appeal to a state court for a reversal.
In countries such as Scandinavia and New Zealand, these administrative compensation approaches are coupled to a no-fault system and appear to work well. However, unlike auto no-fault and workers’ compensation, the notion of medical no-fault has never caught on in the United States.
As currently construed, health courts evince dramatic departures from traditional rules of civil procedure. For one, the panels may render decisions before discovery has occurred, which would substantially limit a patient’s ability to learn the facts of what had happened to cause the injury. The panel may rely on a standard of “gross negligence” instead of “ordinary negligence,” requiring evidence not merely of substandard care but of recklessness. This would be a heavier burden on the victim, and could be expected to generate stiff opposition from the plaintiff’s bar. In addition, evidentiary rules may be modified, requiring that an appeal show with clear and convincing proof that the tribunal had erred.
Apology law
Disclosure of medical errors to the injured patient is believed to serve as an ethical and effective way of thwarting potential malpractice claims. Many states have enacted so-called apology laws that disallow statements of sympathy from being admitted into evidence. In some cases, these laws may assist the physician.
For example, the Ohio Supreme Court ruled that a surgeon’s comments and alleged admission of guilt (“I take full responsibility for this” regarding accidentally sectioning the common bile duct) were properly shielded from discovery by the state’s apology statute.6 Apology laws vary from state to state, and some do not shield admissions regarding causation of error or fault.
However, it is unclear if apology laws work. A recent study from Vanderbilt University reported that, for physicians who do not regularly perform surgery, apology laws actually increased the probability of facing a lawsuit.7 And for surgeons, apology laws do not have a substantial effect on the probability of facing a claim or the average payment made to resolve a claim.
Safe harbors
A proposal released by U.S. House Speaker Paul Ryan (R-Wis.) in June 2016 made reference to “safe harbors” from liability for those adhering to clinical practice guidelines. The Institute of Medicine defines practice guidelines as “systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”
There are thousands of guidelines that have been developed by medical organizations and governmental agencies, as well as by insurance carriers, managed care organizations, and others. They purport to define the best evidence-based medicine, and if they were arrived at by the consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards.
Theoretically, adherence to guidelines could reduce the practice of defensive medicine and improve the quality of care. However, the available evidence does not indicate that guideline-based safe harbors will prove very effective in reducing malpractice claims: They are inapplicable in 85% of cases, and they have been estimated to eliminate defendants’ payments in less than 1% of claims.
Whether any form of tort reform emerges from the current Congress is as much about politics as it is about justice. It comes at an inopportune time, given the impasse over the health care debate. Still, on June 29, 2017, the U.S. House passed a medical liability reform bill with a vote of 218-210 along party lines that would cap noneconomic damages at $250,000, shorten the statute of limitations to 3 years after the date of injury, and abolish joint and several liability.8 The outlook in the U.S. Senate, however, is anything but certain.
References
1. N Engl J Med. 2017 May 11;376(19):1806-8.
2. “Sweeping new tort reforms will protect Iowa physicians” AMA Wire. June 1, 2017.
3. Chan v. Curran, 237 CA 4th 601 (2015).
4. N. Broward Hospital District v. Kalitan, (Florida Supreme Court, decided June 8, 2017).
5. Estate of Michelle Evette McCall v. U.S., 2014 Fla LEXIS 933 (No. SC 11-1148; March 13, 2014).
6. Estate of Johnson v. Randall Smith, Inc., 135 Ohio St.3d 440 (2013).
7. “Sorry is Never Enough: The Effect of State Apology Laws on Medical Malpractice Liability Risk” SSRN. 2016 Dec 10.
8. Protecting Access to Care Act of 2017 (H.R. 1215).
Now boarding: How we can skip coach and bump our patients up to first class
Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.
The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.
Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.
First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).
There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.
Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.
In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.
Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.
As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.
Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.
The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.
Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.
First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).
There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.
Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.
In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.
Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.
As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.
Cruising above the earth at 37,000 feet on the way back from vacation, my mind starts wandering. The impending reality of returning to work is setting in, and I can’t help but reflect on how the experience of a weary traveler trying to get home is like that of a weary patient trying to navigate modern health care. As it turns out, there are more than a few similarities, and that is not necessarily a good thing.
The modern airline industry is often cited by experts as a model for safety, efficiency, and innovation, though just a few decades ago this wasn’t the case. Several factors (for example, catastrophic crashes; the events of September 11th, 2001; the economic downturn) forced airlines to make radical improvements in how they operated – many of which I am quite thankful for as I gaze down upon America’s heartland from my window seat. Still, there are many who would say that in spite of (and sometimes because of) these improvements, air travel is the worst it’s ever been; airport lines are longer than ever, costs have steadily increased, and customer service has become little more than a quaint idea from a bygone era.
Most people deride the frustrations of air travel yet accept them as normal. The same expectations have unfortunately been set in health care. Patients wait, though waiting only contributes to anxiety and leads them to question the quality of their care. They also expect their journey to have many layover stops, though these involve even more waiting and often unnecessary redundancy. We need to streamline the care delivery process, and this is where technology can help.
First of all, we need to address the waiting. In health care, we tend to call this “access,” an ever-present problem for patients and providers. Thankfully, some recent innovations have helped significantly. The first of these innovations is online scheduling, which allows patients to find openings and schedule visits without the need to pick up the phone. Much like the ability to book a dinner reservation online, this is becoming an expectation for health care consumers. Participating practices and health systems can also use it as a marketing advantage; it is a fantastic way to recruit new patients as they search for a new provider online (that is, seeing that a physician has immediate openings may make the decision easier).
There are several companies providing third-party online scheduling services, and many of these can interface directly with electronic health records. EHR vendors themselves also provide this functionality to existing patients through an online web portal or mobile app. Either way, if you haven’t considered it yet, you should. It’s a great way to fill last-minute schedule openings and increase your patient base, all while improving access and patient satisfaction.
Another way to improve access is through telemedicine. We’ve written about this in prior columns, but it has certainly become more prevalent and available since then. Now more insurers are reimbursing for telemedicine services, and consumers are starting to embrace it as well. Consider some advantages: it’s more convenient for patients and often less expensive for those without insurance – cash prices tend to be in the $50-$75 range. It can also be more convenient for providers, as the typical telemedicine visit lasts only about 10 minutes and can be easily fit in last-minute. Better still, telemedicine can be a way for providers to now be paid for services they might have previously provided for free by telephone. It is critical to choose patients and conditions appropriate for these “virtual visits.” Medication checks, lab follow-ups, or rash evaluations are just a few examples, but with a little bit of thought it is easy to find dozens of other opportunities to use telemedicine to improve access.
In addition to access, we need to look for ways to improve efficiency and decrease redundancy when sending patients for testing and consultations. Recently, I had the experience of visiting a specialist for a minor medical issue. In spite of the fact that the specialist was a member of the same health system as my PCP, I still spent the first 15 minutes of my visit filling out paperwork that requested information easily available from my health record. There must be a better way.
Patients are beginning to question why, in the world of ubiquitous social media and connectivity, our computerized medical records can’t communicate. This is especially true when they are seeing physicians who are part of the same health system (as in my case). Thankfully, vendors have gotten the message and have begun allowing providers to collaborate, not only with physicians using the same software, but also with those using other EHRs through Health Information Exchanges (HIEs). Unfortunately, this alone won’t be enough. We must continue to promote the notion of patient-owned medical records, as that will be the only way to ensure true patient-centered care. In a future column, we’ll explore this concept in greater detail, but for now we’ll confirm our belief that universal interoperability is reasonable and possible.
As we are getting ready to land, I reflect on the wonderful vacation I just had and the tasks ahead at home, most of which I enjoy. Patients aren’t always as lucky; they are accessing medical care because they have to, not because they want to. Their “destination” is all too often an unfortunate diagnosis, unexpected surgical procedure, or lifetime of chronic discomfort. It is therefore incumbent on us, their care providers, to use the tools at our disposal to offer them the most efficient, most comfortable, and most connected journey possible.
Dr. Notte is a family physician and clinical informaticist for Abington (Pa.) Memorial Hospital. He is also a partner in EHR Practice Consultants, a firm that aids physicians in adopting electronic health records. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.
Crisis in psychiatry: Top 5 problems, many solutions
Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.
The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.
As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.
The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.
1. Workforce development
Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.
Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.
2. Improved efficiency of service delivery
Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.
Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.
3. Reducing burdensome regulations and confidentiality restrictions
Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.
4. Broader implementation of innovative models
The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.
The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.
5. Adoption of novel reimbursement methods
Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.
Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.
The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.
Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.
Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.
The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.
As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.
The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.
1. Workforce development
Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.
Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.
2. Improved efficiency of service delivery
Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.
Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.
3. Reducing burdensome regulations and confidentiality restrictions
Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.
4. Broader implementation of innovative models
The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.
The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.
5. Adoption of novel reimbursement methods
Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.
Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.
The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.
Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.
Lack of access to psychiatric services has been a challenge for decades, resulting in significant delays to treatment with associated consequences in reduced quality of care, low patient satisfaction, poor patient outcomes, and higher costs.
The problem is exacerbated by a growing shortage of psychiatrists, an increased demand for psychiatric services, and inadequate payment rates. The result is a crisis that is resonating throughout the U.S. health care system.
As many know, a few months ago, the Medical Director Institute of the National Council for Behavioral Health, in partnership with the American Psychiatric Association, convened an expert panel to develop a report responding to this evolving quandary. The findings of our 60-page report, “The Psychiatric Shortage: Causes and Solutions,” suggest that psychiatry is uniquely positioned to address the issues that face our specialty.
The institute identified five areas of critical concern: workforce development, improved efficiency of service delivery, reducing burdensome regulations and confidentiality restrictions, broader implementation of innovative models, and adoption of novel reimbursement methods.
1. Workforce development
Psychiatrists come out of residency training without the skills they need to practice in today’s rapidly evolving health care environment. We need better preparation in measurement-based care, telepsychiatry, collaborative care, and other methods of efficient team collaboration with primary care.
Funding for graduate medical education and training programs must be expanded with an infusion of new funding – not only for psychiatrists – but also for psychiatric nurse practitioners and psychiatric physician assistants.
2. Improved efficiency of service delivery
Providers of psychiatric services in outpatient psychiatric programs face a cramped daily routine with increasingly briefer appointments scheduled back-to-back that limit in-depth clinical assessment, collaboration with other members of the treatment team, and consultation with primary care providers outside of the program. Such a schedule leads to lower-quality care.
Psychiatrists must have the same level of nurse and paraprofessional assistance and support provided to other medical specialties. In addition, regulations that prevent the broader use of telepsychiatry must be revised. All behavioral health providers should implement open access scheduling, a proven modality for reducing missed appointments.
3. Reducing burdensome regulations and confidentiality restrictions
Excessive documentation requirements, especially necessarily detailed, lengthy assessments and treatment must be revised and 42 CFR Part 2 must be made consistent with HIPAA requirements.
4. Broader implementation of innovative models
The shortage of psychiatrists will only worsen with the integration of primary care and behavioral health, and the shift to Accountable Care Organizations as part of health care reform (which, as of this writing, faces much uncertainty). Thanks to more efficient screening for mental health and substance use disorders now occurring in primary care, there will be growing demand for access to psychiatric services.
The collaborative care model for providing psychiatric services should be implemented throughout primary care. Behavioral health organizations must develop their own version of collaborative care that targets the limited psychiatric resource where it is most needed by using measurement-based care and collaborating more effectively with other team members.
5. Adoption of novel reimbursement methods
Inappropriately low rates limit access to care. Today, 40% of psychiatrists choose cash-only private practices, the second-highest among medical specialties after dermatologists, and 75% of provider organizations employing psychiatrists report that they lose money on their psychiatric services. At the same time, the shrinking number of inpatient psychiatric services has become a significant obstacle to improved access. Beds have been eliminated because of lower rates of reimbursement, compared with other medical-surgical procedures and difficulty in recruiting psychiatrists to staff inpatient units.
Psychiatric service rates must be reset to be consistent with the actual cost of providing care. Prospective payment models like Certified Community Behavioral Health Clinics should be expanded, and bundled payments for services like collaborative care and complex care should be covered by payers.
The Medical Director Institute recommends these solutions so that access to psychiatric services does not remain a barrier to the overall success of health care reform and service delivery improving the health of Americans. Multiple stakeholders – federal and state governments, payers, providers, provider trade associations, and advocates – must take action within their spheres of influence in the design, funding, regulation, and delivery of behavioral health care to improve access to psychiatric services. Such broad collaboration is imperative for our patients to get the care they need.
Dr. Parks is the medical director for the National Council for Behavioral Health. He practices psychiatry on an outpatient basis at Family Health Center, a federally funded community health center established to expand services to uninsured and underinsured patients in central Missouri. He also holds the position of Distinguished Research Professor of Science at the University of Missouri–St. Louis and is a clinical assistant professor of psychiatry at the University of Missouri–Columbia.
Diabetes’ social determinants: What they mean in our practices
More than many other pregnancy complications, diabetes exemplifies the impact of social determinants of health.
The medical management of diabetes during pregnancy involves major lifestyle changes. Diabetes care is largely a patient-driven social experience involving complex and demanding self-care behaviors and tasks.
The pregnant woman with diabetes is placed on a diet that is often novel to her and may be in conflict with the eating patterns of her family. She is advised to exercise, read nutrition labels, and purchase and cook healthy food. She often has to pick up prescriptions, check finger sticks and log results, accurately draw up insulin, and manage strict schedules.
Management requires a tremendous amount of daily engagement during a period of time that, in and of itself, is cognitively demanding.
Outcomes, in turn, are impacted by social context and social factors – by the patient’s economic stability and the safety and characteristics of her neighborhood, for instance, as well as her work schedule, her social support, and her level of health literacy. Each of these factors can influence behaviors and decision making, and ultimately glycemic control and perinatal outcomes.
The social determinants of diabetes-related health are so individualized and impactful that they must be realized and addressed throughout our care, from the way in which we communicate at the initial prenatal checkup to the support we offer for self-management.
Barriers to diabetes self-care
While the incidence of type 2 diabetes is increasing among all social, ethnic, and racial groups, its prevalence among nonpregnant U.S. adults is greatest among racial/ethnic minorities, as well as in individuals with a low-income status. Women who enter pregnancy with preexisting diabetes are more likely to be racial/ethnic minorities.
In pregnancy, minority women (especially Hispanic, but also Asian and non-Hispanic black women), and women with low-income status are similarly predisposed to developing gestational diabetes mellitus (GDM).
Social determinants of health are interwoven with inequities stemming from race/ethnicity, income, and other factors that affect outcomes. For example, not only do non-Hispanic black women experience a greater incidence of GDM than non-Hispanic white women, but when they have GDM, they also appear to experience worse pregnancy outcomes compared with white women who also have GDM. In addition, they have a greater likelihood of developing type 2 diabetes after a pregnancy with GDM.
I care for a population that consists largely of minority, low-income women with either gestational or pregestational diabetes. Despite their best intentions and efforts – and despite seemingly high motivation levels – these women struggle to achieve the levels of glycemic control necessary for preventing maternal and fetal complications.
Several years ago, I sought to better understand the barriers to diabetes self-care and behavioral change these women face. Through a series of in-depth, semi-structured interviews with 10 English-speaking women (half with pregestational diabetes) over the course of their pregnancies, we found that the barriers to self-care related to the following: disease novelty, social and economic instability, nutrition challenges, psychological stressors, a failure of outcome expectations, and the burden of disease management (J Health Care Poor Underserved. 2015 Aug;26[3]:926-40; J Nutr Educ Behav. 2016 Mar;48[3]:170-80.e1).
Some of these barriers, such as the lack of any prior experience with diabetes (through a family member, for instance) or the inability to believe that behavior change and other treatment could impact her diabetes and her fetus’ health, echoed other limited published data. However, women in our study also appeared to be affected by barriers driven by social instability (e.g., a lack of partner or family support, family conflict, or neighborhood violence), inadequate access to healthy food, and the psychological impact of diabetes.
They often felt isolated and overwhelmed by their diabetes; the condition amplified stresses they were already experiencing and contributed to worsening mental health in those who already had depression or anxiety. In the other direction, women also described how preexisting mental health challenges affected their ability to sustain recommended behavior changes.
However, we also identified factors that empowered women in this community to succeed with their diabetes during pregnancy – these included having prior familiarity and diabetes self-efficacy, being motivated by the health of the fetus or older children, having a supportive social and physical environment, and having the ability to self-regulate or set and achieve goals (J Perinatol. 2016 Jan;36[1]:13-8).
To address these barriers, my group has undertaken a series of projects aimed at improving care for pregnant women with diabetes. We developed a diabetes-specific text message support system, for instance, and are now transitioning this support to an advanced mobile health tool that can help patients beyond our site.
What we can do
Much of what we can do in our practices to identify and address social determinants and alleviate barriers to effective diabetes management is about finding the “sweet spot” – about being able to convey the right information in the right amount, with the right timing and the right delivery.
While we can’t improve a woman’s neighborhood or resolve food instability, I believe that we can still work to improve outcomes for women who experience these problems. Here are some key strategies for optimal support of our patients:
Inquire about social factors
Identify hurdles by asking questions such as: Where do you live? Is it safe to walk in your neighborhood? If not, where’s your closest mall? What kind of job do you have, and does your employer allow breaks to take care of your health? How are things going at home? Who is at home to help you? Are you having any trouble affording food? How can we help you learn to adapt your personal or cultural food preferences to healthier options?
Look for small actions to take. I often write letters to my patients’ employers requesting that they be given short, frequent breaks to accommodate their care regimens. I also work to ensure that diet recommendations and medication/insulin regimens are customized for patients with irregular meal and sleep schedules, such as those working night shifts.
Employ a social worker if possible, especially if your practice cares for large numbers of underserved women.
Serve as a resource center, and engage your team in doing so. Be prepared to refer women for social services support, food banks, intimate partner violence support services, and other local resources.
Take a low-health-literacy approach
Health literacy is the ability to obtain and utilize health information. It has been widely investigated outside of pregnancy (and to some extent during pregnancy), and has been found to be at the root of many disparities in health care and health outcomes. Numeracy, a type of health literacy, is the ability to understand numbers, perform basic calculations, and use simple math skills in a way that helps one’s health.
The barriers created by inadequate health literacy are distinct from language barriers. I’ve had patients who can read the labels on their insulin vials but cannot distinguish the short-acting from the long-acting formulation, or who can read the words on a nutrition label but don’t know how to interpret the amount of carbohydrates and determine if a food fits the diet plan.
Moreover, while health literacy is correlated with cognitive ability, it still is a distinct skill set. Studies have shown that patients educated in a traditional sense – college-educated professionals, for instance – will not necessarily understand health-related words and instructions.
Research similarly suggests that a low-health-literacy approach that uses focused, simple, and straightforward messages benefits everyone. This type of approach involves the following:
Simple language
Teach-back techniques (“tell me you what your understanding is of what I just told you”)
Diagrams, handouts, and brochures written at a sixth-grade level.
Teaching that is limited to five to eight key messages per session, and reinforcement of these messages over time.
Promote self-efficacy
Self-efficacy is the confidence in one’s ability to perform certain health behaviors. It involves motivation as well as knowledge of the disease, the rationale for treatment, and the specific behaviors that are required for effective self-care.
Help patients understand “why it matters” – that diabetes raises the risk of macrosomia, shoulder dystocia, hypertension, long-term diabetes, and other adverse maternal and neonatal outcomes. Explain basic physiologic concepts and provide background information. This builds self-efficacy.
Do not issue recommendations for exercising and eating well without asking: How can I help you do this? What do you need to be able to eat healthy? Do you need an appointment with a nutritionist? Do you need to see a social worker?
Inquire about and help patients identify supportive family members or other “champions.” Look for ways to incorporate these support people into the patient’s care. At a minimum, encourage the patient to ask her support person to eat healthy with her and/or to understand her daily tasks so that this individual can offer reminders and be a source of support when she feels exhausted or overwhelmed.
If possible, facilitate some type of “diabetes buddy” program to offer peer support and help patients stay engaged in their care, or use group education sessions.
Piggyback on your patients’ own motivating factors. Research has shown that women are extraordinarily motivated to stop smoking during pregnancy because of the health of the fetus. This should extend as well to the difficult lifestyle changes required for diabetes self-care.
View pregnancy as a “golden opportunity” to promote healthy life changes that endure because of the often-extraordinary levels of motivation that women feel or can be encouraged to feel.
Facilitate access
The ability to attend frequent appointments and to juggle the logistics of transportation, child care, and time off work (all part of the burden of disease management) is a social determinant of health. It’s something we should ask about, and it is often something we can positively impact by modifying our practice hours and/or using telehealth or mobile health techniques.
Coordinating newborn and pediatric care with the mother’s subsequent primary care is optimal. Women often prioritize their babies’ health over their own health and they rarely miss pediatric appointments. Coordinating care through medical homes or other mechanisms may help women remain engaged and may lessen the gaps between obstetrical and subsequent primary care.
For me, facilitating doctor-to-doctor transitions sometimes entails picking up the phone or sending communication to a primary care doctor to say, for instance, “I’m worried about my patient’s lifetime risk of type 2 diabetes, and I’d like to hand off her care to you.” This is one of many small but meaningful steps we can take.
Dr. Yee is an assistant professor in the division of maternal-fetal medicine at Northwestern University, Chicago. She reported having no relevant financial disclosures.
More than many other pregnancy complications, diabetes exemplifies the impact of social determinants of health.
The medical management of diabetes during pregnancy involves major lifestyle changes. Diabetes care is largely a patient-driven social experience involving complex and demanding self-care behaviors and tasks.
The pregnant woman with diabetes is placed on a diet that is often novel to her and may be in conflict with the eating patterns of her family. She is advised to exercise, read nutrition labels, and purchase and cook healthy food. She often has to pick up prescriptions, check finger sticks and log results, accurately draw up insulin, and manage strict schedules.
Management requires a tremendous amount of daily engagement during a period of time that, in and of itself, is cognitively demanding.
Outcomes, in turn, are impacted by social context and social factors – by the patient’s economic stability and the safety and characteristics of her neighborhood, for instance, as well as her work schedule, her social support, and her level of health literacy. Each of these factors can influence behaviors and decision making, and ultimately glycemic control and perinatal outcomes.
The social determinants of diabetes-related health are so individualized and impactful that they must be realized and addressed throughout our care, from the way in which we communicate at the initial prenatal checkup to the support we offer for self-management.
Barriers to diabetes self-care
While the incidence of type 2 diabetes is increasing among all social, ethnic, and racial groups, its prevalence among nonpregnant U.S. adults is greatest among racial/ethnic minorities, as well as in individuals with a low-income status. Women who enter pregnancy with preexisting diabetes are more likely to be racial/ethnic minorities.
In pregnancy, minority women (especially Hispanic, but also Asian and non-Hispanic black women), and women with low-income status are similarly predisposed to developing gestational diabetes mellitus (GDM).
Social determinants of health are interwoven with inequities stemming from race/ethnicity, income, and other factors that affect outcomes. For example, not only do non-Hispanic black women experience a greater incidence of GDM than non-Hispanic white women, but when they have GDM, they also appear to experience worse pregnancy outcomes compared with white women who also have GDM. In addition, they have a greater likelihood of developing type 2 diabetes after a pregnancy with GDM.
I care for a population that consists largely of minority, low-income women with either gestational or pregestational diabetes. Despite their best intentions and efforts – and despite seemingly high motivation levels – these women struggle to achieve the levels of glycemic control necessary for preventing maternal and fetal complications.
Several years ago, I sought to better understand the barriers to diabetes self-care and behavioral change these women face. Through a series of in-depth, semi-structured interviews with 10 English-speaking women (half with pregestational diabetes) over the course of their pregnancies, we found that the barriers to self-care related to the following: disease novelty, social and economic instability, nutrition challenges, psychological stressors, a failure of outcome expectations, and the burden of disease management (J Health Care Poor Underserved. 2015 Aug;26[3]:926-40; J Nutr Educ Behav. 2016 Mar;48[3]:170-80.e1).
Some of these barriers, such as the lack of any prior experience with diabetes (through a family member, for instance) or the inability to believe that behavior change and other treatment could impact her diabetes and her fetus’ health, echoed other limited published data. However, women in our study also appeared to be affected by barriers driven by social instability (e.g., a lack of partner or family support, family conflict, or neighborhood violence), inadequate access to healthy food, and the psychological impact of diabetes.
They often felt isolated and overwhelmed by their diabetes; the condition amplified stresses they were already experiencing and contributed to worsening mental health in those who already had depression or anxiety. In the other direction, women also described how preexisting mental health challenges affected their ability to sustain recommended behavior changes.
However, we also identified factors that empowered women in this community to succeed with their diabetes during pregnancy – these included having prior familiarity and diabetes self-efficacy, being motivated by the health of the fetus or older children, having a supportive social and physical environment, and having the ability to self-regulate or set and achieve goals (J Perinatol. 2016 Jan;36[1]:13-8).
To address these barriers, my group has undertaken a series of projects aimed at improving care for pregnant women with diabetes. We developed a diabetes-specific text message support system, for instance, and are now transitioning this support to an advanced mobile health tool that can help patients beyond our site.
What we can do
Much of what we can do in our practices to identify and address social determinants and alleviate barriers to effective diabetes management is about finding the “sweet spot” – about being able to convey the right information in the right amount, with the right timing and the right delivery.
While we can’t improve a woman’s neighborhood or resolve food instability, I believe that we can still work to improve outcomes for women who experience these problems. Here are some key strategies for optimal support of our patients:
Inquire about social factors
Identify hurdles by asking questions such as: Where do you live? Is it safe to walk in your neighborhood? If not, where’s your closest mall? What kind of job do you have, and does your employer allow breaks to take care of your health? How are things going at home? Who is at home to help you? Are you having any trouble affording food? How can we help you learn to adapt your personal or cultural food preferences to healthier options?
Look for small actions to take. I often write letters to my patients’ employers requesting that they be given short, frequent breaks to accommodate their care regimens. I also work to ensure that diet recommendations and medication/insulin regimens are customized for patients with irregular meal and sleep schedules, such as those working night shifts.
Employ a social worker if possible, especially if your practice cares for large numbers of underserved women.
Serve as a resource center, and engage your team in doing so. Be prepared to refer women for social services support, food banks, intimate partner violence support services, and other local resources.
Take a low-health-literacy approach
Health literacy is the ability to obtain and utilize health information. It has been widely investigated outside of pregnancy (and to some extent during pregnancy), and has been found to be at the root of many disparities in health care and health outcomes. Numeracy, a type of health literacy, is the ability to understand numbers, perform basic calculations, and use simple math skills in a way that helps one’s health.
The barriers created by inadequate health literacy are distinct from language barriers. I’ve had patients who can read the labels on their insulin vials but cannot distinguish the short-acting from the long-acting formulation, or who can read the words on a nutrition label but don’t know how to interpret the amount of carbohydrates and determine if a food fits the diet plan.
Moreover, while health literacy is correlated with cognitive ability, it still is a distinct skill set. Studies have shown that patients educated in a traditional sense – college-educated professionals, for instance – will not necessarily understand health-related words and instructions.
Research similarly suggests that a low-health-literacy approach that uses focused, simple, and straightforward messages benefits everyone. This type of approach involves the following:
Simple language
Teach-back techniques (“tell me you what your understanding is of what I just told you”)
Diagrams, handouts, and brochures written at a sixth-grade level.
Teaching that is limited to five to eight key messages per session, and reinforcement of these messages over time.
Promote self-efficacy
Self-efficacy is the confidence in one’s ability to perform certain health behaviors. It involves motivation as well as knowledge of the disease, the rationale for treatment, and the specific behaviors that are required for effective self-care.
Help patients understand “why it matters” – that diabetes raises the risk of macrosomia, shoulder dystocia, hypertension, long-term diabetes, and other adverse maternal and neonatal outcomes. Explain basic physiologic concepts and provide background information. This builds self-efficacy.
Do not issue recommendations for exercising and eating well without asking: How can I help you do this? What do you need to be able to eat healthy? Do you need an appointment with a nutritionist? Do you need to see a social worker?
Inquire about and help patients identify supportive family members or other “champions.” Look for ways to incorporate these support people into the patient’s care. At a minimum, encourage the patient to ask her support person to eat healthy with her and/or to understand her daily tasks so that this individual can offer reminders and be a source of support when she feels exhausted or overwhelmed.
If possible, facilitate some type of “diabetes buddy” program to offer peer support and help patients stay engaged in their care, or use group education sessions.
Piggyback on your patients’ own motivating factors. Research has shown that women are extraordinarily motivated to stop smoking during pregnancy because of the health of the fetus. This should extend as well to the difficult lifestyle changes required for diabetes self-care.
View pregnancy as a “golden opportunity” to promote healthy life changes that endure because of the often-extraordinary levels of motivation that women feel or can be encouraged to feel.
Facilitate access
The ability to attend frequent appointments and to juggle the logistics of transportation, child care, and time off work (all part of the burden of disease management) is a social determinant of health. It’s something we should ask about, and it is often something we can positively impact by modifying our practice hours and/or using telehealth or mobile health techniques.
Coordinating newborn and pediatric care with the mother’s subsequent primary care is optimal. Women often prioritize their babies’ health over their own health and they rarely miss pediatric appointments. Coordinating care through medical homes or other mechanisms may help women remain engaged and may lessen the gaps between obstetrical and subsequent primary care.
For me, facilitating doctor-to-doctor transitions sometimes entails picking up the phone or sending communication to a primary care doctor to say, for instance, “I’m worried about my patient’s lifetime risk of type 2 diabetes, and I’d like to hand off her care to you.” This is one of many small but meaningful steps we can take.
Dr. Yee is an assistant professor in the division of maternal-fetal medicine at Northwestern University, Chicago. She reported having no relevant financial disclosures.
More than many other pregnancy complications, diabetes exemplifies the impact of social determinants of health.
The medical management of diabetes during pregnancy involves major lifestyle changes. Diabetes care is largely a patient-driven social experience involving complex and demanding self-care behaviors and tasks.
The pregnant woman with diabetes is placed on a diet that is often novel to her and may be in conflict with the eating patterns of her family. She is advised to exercise, read nutrition labels, and purchase and cook healthy food. She often has to pick up prescriptions, check finger sticks and log results, accurately draw up insulin, and manage strict schedules.
Management requires a tremendous amount of daily engagement during a period of time that, in and of itself, is cognitively demanding.
Outcomes, in turn, are impacted by social context and social factors – by the patient’s economic stability and the safety and characteristics of her neighborhood, for instance, as well as her work schedule, her social support, and her level of health literacy. Each of these factors can influence behaviors and decision making, and ultimately glycemic control and perinatal outcomes.
The social determinants of diabetes-related health are so individualized and impactful that they must be realized and addressed throughout our care, from the way in which we communicate at the initial prenatal checkup to the support we offer for self-management.
Barriers to diabetes self-care
While the incidence of type 2 diabetes is increasing among all social, ethnic, and racial groups, its prevalence among nonpregnant U.S. adults is greatest among racial/ethnic minorities, as well as in individuals with a low-income status. Women who enter pregnancy with preexisting diabetes are more likely to be racial/ethnic minorities.
In pregnancy, minority women (especially Hispanic, but also Asian and non-Hispanic black women), and women with low-income status are similarly predisposed to developing gestational diabetes mellitus (GDM).
Social determinants of health are interwoven with inequities stemming from race/ethnicity, income, and other factors that affect outcomes. For example, not only do non-Hispanic black women experience a greater incidence of GDM than non-Hispanic white women, but when they have GDM, they also appear to experience worse pregnancy outcomes compared with white women who also have GDM. In addition, they have a greater likelihood of developing type 2 diabetes after a pregnancy with GDM.
I care for a population that consists largely of minority, low-income women with either gestational or pregestational diabetes. Despite their best intentions and efforts – and despite seemingly high motivation levels – these women struggle to achieve the levels of glycemic control necessary for preventing maternal and fetal complications.
Several years ago, I sought to better understand the barriers to diabetes self-care and behavioral change these women face. Through a series of in-depth, semi-structured interviews with 10 English-speaking women (half with pregestational diabetes) over the course of their pregnancies, we found that the barriers to self-care related to the following: disease novelty, social and economic instability, nutrition challenges, psychological stressors, a failure of outcome expectations, and the burden of disease management (J Health Care Poor Underserved. 2015 Aug;26[3]:926-40; J Nutr Educ Behav. 2016 Mar;48[3]:170-80.e1).
Some of these barriers, such as the lack of any prior experience with diabetes (through a family member, for instance) or the inability to believe that behavior change and other treatment could impact her diabetes and her fetus’ health, echoed other limited published data. However, women in our study also appeared to be affected by barriers driven by social instability (e.g., a lack of partner or family support, family conflict, or neighborhood violence), inadequate access to healthy food, and the psychological impact of diabetes.
They often felt isolated and overwhelmed by their diabetes; the condition amplified stresses they were already experiencing and contributed to worsening mental health in those who already had depression or anxiety. In the other direction, women also described how preexisting mental health challenges affected their ability to sustain recommended behavior changes.
However, we also identified factors that empowered women in this community to succeed with their diabetes during pregnancy – these included having prior familiarity and diabetes self-efficacy, being motivated by the health of the fetus or older children, having a supportive social and physical environment, and having the ability to self-regulate or set and achieve goals (J Perinatol. 2016 Jan;36[1]:13-8).
To address these barriers, my group has undertaken a series of projects aimed at improving care for pregnant women with diabetes. We developed a diabetes-specific text message support system, for instance, and are now transitioning this support to an advanced mobile health tool that can help patients beyond our site.
What we can do
Much of what we can do in our practices to identify and address social determinants and alleviate barriers to effective diabetes management is about finding the “sweet spot” – about being able to convey the right information in the right amount, with the right timing and the right delivery.
While we can’t improve a woman’s neighborhood or resolve food instability, I believe that we can still work to improve outcomes for women who experience these problems. Here are some key strategies for optimal support of our patients:
Inquire about social factors
Identify hurdles by asking questions such as: Where do you live? Is it safe to walk in your neighborhood? If not, where’s your closest mall? What kind of job do you have, and does your employer allow breaks to take care of your health? How are things going at home? Who is at home to help you? Are you having any trouble affording food? How can we help you learn to adapt your personal or cultural food preferences to healthier options?
Look for small actions to take. I often write letters to my patients’ employers requesting that they be given short, frequent breaks to accommodate their care regimens. I also work to ensure that diet recommendations and medication/insulin regimens are customized for patients with irregular meal and sleep schedules, such as those working night shifts.
Employ a social worker if possible, especially if your practice cares for large numbers of underserved women.
Serve as a resource center, and engage your team in doing so. Be prepared to refer women for social services support, food banks, intimate partner violence support services, and other local resources.
Take a low-health-literacy approach
Health literacy is the ability to obtain and utilize health information. It has been widely investigated outside of pregnancy (and to some extent during pregnancy), and has been found to be at the root of many disparities in health care and health outcomes. Numeracy, a type of health literacy, is the ability to understand numbers, perform basic calculations, and use simple math skills in a way that helps one’s health.
The barriers created by inadequate health literacy are distinct from language barriers. I’ve had patients who can read the labels on their insulin vials but cannot distinguish the short-acting from the long-acting formulation, or who can read the words on a nutrition label but don’t know how to interpret the amount of carbohydrates and determine if a food fits the diet plan.
Moreover, while health literacy is correlated with cognitive ability, it still is a distinct skill set. Studies have shown that patients educated in a traditional sense – college-educated professionals, for instance – will not necessarily understand health-related words and instructions.
Research similarly suggests that a low-health-literacy approach that uses focused, simple, and straightforward messages benefits everyone. This type of approach involves the following:
Simple language
Teach-back techniques (“tell me you what your understanding is of what I just told you”)
Diagrams, handouts, and brochures written at a sixth-grade level.
Teaching that is limited to five to eight key messages per session, and reinforcement of these messages over time.
Promote self-efficacy
Self-efficacy is the confidence in one’s ability to perform certain health behaviors. It involves motivation as well as knowledge of the disease, the rationale for treatment, and the specific behaviors that are required for effective self-care.
Help patients understand “why it matters” – that diabetes raises the risk of macrosomia, shoulder dystocia, hypertension, long-term diabetes, and other adverse maternal and neonatal outcomes. Explain basic physiologic concepts and provide background information. This builds self-efficacy.
Do not issue recommendations for exercising and eating well without asking: How can I help you do this? What do you need to be able to eat healthy? Do you need an appointment with a nutritionist? Do you need to see a social worker?
Inquire about and help patients identify supportive family members or other “champions.” Look for ways to incorporate these support people into the patient’s care. At a minimum, encourage the patient to ask her support person to eat healthy with her and/or to understand her daily tasks so that this individual can offer reminders and be a source of support when she feels exhausted or overwhelmed.
If possible, facilitate some type of “diabetes buddy” program to offer peer support and help patients stay engaged in their care, or use group education sessions.
Piggyback on your patients’ own motivating factors. Research has shown that women are extraordinarily motivated to stop smoking during pregnancy because of the health of the fetus. This should extend as well to the difficult lifestyle changes required for diabetes self-care.
View pregnancy as a “golden opportunity” to promote healthy life changes that endure because of the often-extraordinary levels of motivation that women feel or can be encouraged to feel.
Facilitate access
The ability to attend frequent appointments and to juggle the logistics of transportation, child care, and time off work (all part of the burden of disease management) is a social determinant of health. It’s something we should ask about, and it is often something we can positively impact by modifying our practice hours and/or using telehealth or mobile health techniques.
Coordinating newborn and pediatric care with the mother’s subsequent primary care is optimal. Women often prioritize their babies’ health over their own health and they rarely miss pediatric appointments. Coordinating care through medical homes or other mechanisms may help women remain engaged and may lessen the gaps between obstetrical and subsequent primary care.
For me, facilitating doctor-to-doctor transitions sometimes entails picking up the phone or sending communication to a primary care doctor to say, for instance, “I’m worried about my patient’s lifetime risk of type 2 diabetes, and I’d like to hand off her care to you.” This is one of many small but meaningful steps we can take.
Dr. Yee is an assistant professor in the division of maternal-fetal medicine at Northwestern University, Chicago. She reported having no relevant financial disclosures.