BOSTON—Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta-amyloid brain plaques well before cognitive problems arise. The changes can be measured with equipment present already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

A Potential Window to the Brain

The retina begins to form in the third week of embryologic life, arising from the neural tube cells that also form the brain and spinal cord. It makes sense, then, that early neuronal changes in Alzheimer’s disease could occur in the retina as well, said Dr. Snyder, Professor of Neurology and Surgery (Ophthalmology) at Rhode Island Hospital and Brown University in Providence.

“The retina is really a protrusion of the brain, and it is part and parcel of the CNS,” Dr. Snyder said. “In terms of the neuronal structure, the retina develops in layers with specific cell types that are neurochemically and physiologically the same as the nervous tissue in the brain. That is why it is, potentially, literally a window that could let us see what is happening in the brain in early Alzheimer’s disease.”

Prior studies have examined the retina as a predictive marker for Alzheimer’s disease. At the 2016 Alzheimer’s Association International Conference, Fang Sarah Ko, MD, an ophthalmologist in Tallahassee, Florida, presented three-year data associating retinal nerve fiber layer thinning to cognitive decline in the UK Biobank, an ongoing prospective health outcomes study.

Other researchers have explored amyloid in the lens and retina as a possible early Alzheimer’s identification tool. But Dr. Snyder’s study is the first to demonstrate a longitudinal association between neuronal changes in the eye and amyloid burden in the brain among clinically normal subjects.

Patients Had Subjective Memory Complaints

For 27 months, he followed 56 people who had normal cognition but were beginning to experience subjective memory complaints. All subjects had at least one parent with Alzheimer’s disease. Everyone underwent an amyloid PET scan at baseline. Of the cohort, 15 had PET imaging evidence of abnormal beta-amyloid protein aggregation in the neocortex. This group was deemed to have preclinical Alzheimer’s disease, while the remainder served as a control group.

Dr. Snyder imaged each subject’s retinas at baseline and at 27 months, when everyone underwent a second amyloid PET scan. He examined the retina with spectral domain optical coherence tomography, a relatively new method of imaging the retina that typically is used to detect retinal and ocular changes associated with diabetes, macular degeneration, glaucoma, and multiple sclerosis.

Dr. Snyder examined the optic nerve head and macula at both time points and assessed volumetric changes in the peripapillary retinal nerve fiber layer, the macular retinal nerve fiber layer, the ganglion cell layer, the inner plexiform layer, the outer nuclear layer, the outer plexiform layer, and the inner nuclear layer. He also computed changes in total retinal volume.

Between-Group Differences

At baseline assessment, Dr. Snyder found a significant difference between the groups. Among the amyloid-positive subjects, the inner plexiform layer was slightly larger in volume. “This seems a bit counterintuitive, but … it suggests that there may be inflammatory processes going on in this early stage and that we are catching that inflammation.” An independent research group has replicated this finding with a larger sample of participants and plans to report its results later this year, Dr. Snyder noted.

At 27 months, the total retinal volume and the macular retinal nerve fiber layer volume were significantly lower in the preclinical Alzheimer’s disease group than in the control group. There was also a volume reduction in the peripapillary retinal nerve fiber layer, although the between-group difference was not statistically significant.

In a multivariate linear regression model that controlled for age and total amyloid burden, the mean volume change in the macular retinal nerve fiber layer accounted for about 10% of the variation in PET binding to brain amyloid by 27 months. Volume reductions in all the other layers appeared to be associated only with age, representing normal age-related changes in the eye.

Using Advances in Imaging

This volume loss in the retinal nerve fiber layer probably represents early demyelination or degeneration of axons, Dr. Snyder said. “This finding in the retina appears analogous, and possibly directly related, to a similar loss of white matter that is readily observable in the early stages of Alzheimer’s disease,” he said. “At the same time, patients are beginning to experience cholinergic changes in the basal forebrain and the abnormal aggregation of fibrillar beta-amyloid plaques. I do not know to what extent these changes are mechanistically dependent on each other, but they appear to also be happening, in the earliest stages of the disease course, in the retina.”

More research is needed before retinal scanning can be employed as a risk-assessment tool, however. “Every time we have a major advance in imaging, the technical engineering breakthroughs precede our detailed understanding of what we are looking at and what to measure,” Dr. Snyder said. “This is where we are right now with retinal imaging. Biologically, it makes sense to be looking at this as a marker of risk in those who are clinically healthy, and maybe later as a marker of disease progression. But there is a lot of work to be done here yet.”

Dr. Snyder’s project was supported by a research award from Pfizer and a grant from Avid Radiopharmaceuticals.

—Michele G. Sullivan

BOSTON—Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta-amyloid brain plaques well before cognitive problems arise. The changes can be measured with equipment present already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

A Potential Window to the Brain

The retina begins to form in the third week of embryologic life, arising from the neural tube cells that also form the brain and spinal cord. It makes sense, then, that early neuronal changes in Alzheimer’s disease could occur in the retina as well, said Dr. Snyder, Professor of Neurology and Surgery (Ophthalmology) at Rhode Island Hospital and Brown University in Providence.

“The retina is really a protrusion of the brain, and it is part and parcel of the CNS,” Dr. Snyder said. “In terms of the neuronal structure, the retina develops in layers with specific cell types that are neurochemically and physiologically the same as the nervous tissue in the brain. That is why it is, potentially, literally a window that could let us see what is happening in the brain in early Alzheimer’s disease.”

Prior studies have examined the retina as a predictive marker for Alzheimer’s disease. At the 2016 Alzheimer’s Association International Conference, Fang Sarah Ko, MD, an ophthalmologist in Tallahassee, Florida, presented three-year data associating retinal nerve fiber layer thinning to cognitive decline in the UK Biobank, an ongoing prospective health outcomes study.

Other researchers have explored amyloid in the lens and retina as a possible early Alzheimer’s identification tool. But Dr. Snyder’s study is the first to demonstrate a longitudinal association between neuronal changes in the eye and amyloid burden in the brain among clinically normal subjects.

Patients Had Subjective Memory Complaints

For 27 months, he followed 56 people who had normal cognition but were beginning to experience subjective memory complaints. All subjects had at least one parent with Alzheimer’s disease. Everyone underwent an amyloid PET scan at baseline. Of the cohort, 15 had PET imaging evidence of abnormal beta-amyloid protein aggregation in the neocortex. This group was deemed to have preclinical Alzheimer’s disease, while the remainder served as a control group.

Dr. Snyder imaged each subject’s retinas at baseline and at 27 months, when everyone underwent a second amyloid PET scan. He examined the retina with spectral domain optical coherence tomography, a relatively new method of imaging the retina that typically is used to detect retinal and ocular changes associated with diabetes, macular degeneration, glaucoma, and multiple sclerosis.

Dr. Snyder examined the optic nerve head and macula at both time points and assessed volumetric changes in the peripapillary retinal nerve fiber layer, the macular retinal nerve fiber layer, the ganglion cell layer, the inner plexiform layer, the outer nuclear layer, the outer plexiform layer, and the inner nuclear layer. He also computed changes in total retinal volume.

Between-Group Differences

At baseline assessment, Dr. Snyder found a significant difference between the groups. Among the amyloid-positive subjects, the inner plexiform layer was slightly larger in volume. “This seems a bit counterintuitive, but … it suggests that there may be inflammatory processes going on in this early stage and that we are catching that inflammation.” An independent research group has replicated this finding with a larger sample of participants and plans to report its results later this year, Dr. Snyder noted.

At 27 months, the total retinal volume and the macular retinal nerve fiber layer volume were significantly lower in the preclinical Alzheimer’s disease group than in the control group. There was also a volume reduction in the peripapillary retinal nerve fiber layer, although the between-group difference was not statistically significant.

In a multivariate linear regression model that controlled for age and total amyloid burden, the mean volume change in the macular retinal nerve fiber layer accounted for about 10% of the variation in PET binding to brain amyloid by 27 months. Volume reductions in all the other layers appeared to be associated only with age, representing normal age-related changes in the eye.

Using Advances in Imaging

This volume loss in the retinal nerve fiber layer probably represents early demyelination or degeneration of axons, Dr. Snyder said. “This finding in the retina appears analogous, and possibly directly related, to a similar loss of white matter that is readily observable in the early stages of Alzheimer’s disease,” he said. “At the same time, patients are beginning to experience cholinergic changes in the basal forebrain and the abnormal aggregation of fibrillar beta-amyloid plaques. I do not know to what extent these changes are mechanistically dependent on each other, but they appear to also be happening, in the earliest stages of the disease course, in the retina.”

More research is needed before retinal scanning can be employed as a risk-assessment tool, however. “Every time we have a major advance in imaging, the technical engineering breakthroughs precede our detailed understanding of what we are looking at and what to measure,” Dr. Snyder said. “This is where we are right now with retinal imaging. Biologically, it makes sense to be looking at this as a marker of risk in those who are clinically healthy, and maybe later as a marker of disease progression. But there is a lot of work to be done here yet.”

Dr. Snyder’s project was supported by a research award from Pfizer and a grant from Avid Radiopharmaceuticals.

—Michele G. Sullivan

BOSTON—Changes in the retina seem to mirror changes that begin to reshape the brain in preclinical Alzheimer’s disease.

Manifested as a reduction in volume in the retinal nerve fiber layer, these changes appear to track the aggregation of beta-amyloid brain plaques well before cognitive problems arise. The changes can be measured with equipment present already in many optometry offices, Peter J. Snyder, PhD, said at the Clinical Trials in Alzheimer’s Disease conference.

A Potential Window to the Brain

The retina begins to form in the third week of embryologic life, arising from the neural tube cells that also form the brain and spinal cord. It makes sense, then, that early neuronal changes in Alzheimer’s disease could occur in the retina as well, said Dr. Snyder, Professor of Neurology and Surgery (Ophthalmology) at Rhode Island Hospital and Brown University in Providence.

“The retina is really a protrusion of the brain, and it is part and parcel of the CNS,” Dr. Snyder said. “In terms of the neuronal structure, the retina develops in layers with specific cell types that are neurochemically and physiologically the same as the nervous tissue in the brain. That is why it is, potentially, literally a window that could let us see what is happening in the brain in early Alzheimer’s disease.”

Prior studies have examined the retina as a predictive marker for Alzheimer’s disease. At the 2016 Alzheimer’s Association International Conference, Fang Sarah Ko, MD, an ophthalmologist in Tallahassee, Florida, presented three-year data associating retinal nerve fiber layer thinning to cognitive decline in the UK Biobank, an ongoing prospective health outcomes study.

Other researchers have explored amyloid in the lens and retina as a possible early Alzheimer’s identification tool. But Dr. Snyder’s study is the first to demonstrate a longitudinal association between neuronal changes in the eye and amyloid burden in the brain among clinically normal subjects.

Patients Had Subjective Memory Complaints

For 27 months, he followed 56 people who had normal cognition but were beginning to experience subjective memory complaints. All subjects had at least one parent with Alzheimer’s disease. Everyone underwent an amyloid PET scan at baseline. Of the cohort, 15 had PET imaging evidence of abnormal beta-amyloid protein aggregation in the neocortex. This group was deemed to have preclinical Alzheimer’s disease, while the remainder served as a control group.

Dr. Snyder imaged each subject’s retinas at baseline and at 27 months, when everyone underwent a second amyloid PET scan. He examined the retina with spectral domain optical coherence tomography, a relatively new method of imaging the retina that typically is used to detect retinal and ocular changes associated with diabetes, macular degeneration, glaucoma, and multiple sclerosis.

Dr. Snyder examined the optic nerve head and macula at both time points and assessed volumetric changes in the peripapillary retinal nerve fiber layer, the macular retinal nerve fiber layer, the ganglion cell layer, the inner plexiform layer, the outer nuclear layer, the outer plexiform layer, and the inner nuclear layer. He also computed changes in total retinal volume.

Between-Group Differences

At baseline assessment, Dr. Snyder found a significant difference between the groups. Among the amyloid-positive subjects, the inner plexiform layer was slightly larger in volume. “This seems a bit counterintuitive, but … it suggests that there may be inflammatory processes going on in this early stage and that we are catching that inflammation.” An independent research group has replicated this finding with a larger sample of participants and plans to report its results later this year, Dr. Snyder noted.

At 27 months, the total retinal volume and the macular retinal nerve fiber layer volume were significantly lower in the preclinical Alzheimer’s disease group than in the control group. There was also a volume reduction in the peripapillary retinal nerve fiber layer, although the between-group difference was not statistically significant.

In a multivariate linear regression model that controlled for age and total amyloid burden, the mean volume change in the macular retinal nerve fiber layer accounted for about 10% of the variation in PET binding to brain amyloid by 27 months. Volume reductions in all the other layers appeared to be associated only with age, representing normal age-related changes in the eye.

Using Advances in Imaging

This volume loss in the retinal nerve fiber layer probably represents early demyelination or degeneration of axons, Dr. Snyder said. “This finding in the retina appears analogous, and possibly directly related, to a similar loss of white matter that is readily observable in the early stages of Alzheimer’s disease,” he said. “At the same time, patients are beginning to experience cholinergic changes in the basal forebrain and the abnormal aggregation of fibrillar beta-amyloid plaques. I do not know to what extent these changes are mechanistically dependent on each other, but they appear to also be happening, in the earliest stages of the disease course, in the retina.”

More research is needed before retinal scanning can be employed as a risk-assessment tool, however. “Every time we have a major advance in imaging, the technical engineering breakthroughs precede our detailed understanding of what we are looking at and what to measure,” Dr. Snyder said. “This is where we are right now with retinal imaging. Biologically, it makes sense to be looking at this as a marker of risk in those who are clinically healthy, and maybe later as a marker of disease progression. But there is a lot of work to be done here yet.”

Dr. Snyder’s project was supported by a research award from Pfizer and a grant from Avid Radiopharmaceuticals.

—Michele G. Sullivan

Influenza vaccine needs some help with its image.

I suspect most health care providers have heard the complaint, “The vaccine doesn’t work. One year I got the vaccine, and I still came down with the flu.”

Over the years, I’ve polished my responses to vaccine naysayers.

Influenza vaccine doesn’t protect you against every virus that can cause cold and flu symptoms. It only prevents influenza. It’s possible you had a different virus, such as adenovirus, coronavirus, parainfluenza virus, or respiratory syncytial virus.

KatarzynaBialasiewicz/Thinkstock

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

Influenza vaccine needs some help with its image.

I suspect most health care providers have heard the complaint, “The vaccine doesn’t work. One year I got the vaccine, and I still came down with the flu.”

Over the years, I’ve polished my responses to vaccine naysayers.

Influenza vaccine doesn’t protect you against every virus that can cause cold and flu symptoms. It only prevents influenza. It’s possible you had a different virus, such as adenovirus, coronavirus, parainfluenza virus, or respiratory syncytial virus.

KatarzynaBialasiewicz/Thinkstock

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

Influenza vaccine needs some help with its image.

I suspect most health care providers have heard the complaint, “The vaccine doesn’t work. One year I got the vaccine, and I still came down with the flu.”

Over the years, I’ve polished my responses to vaccine naysayers.

Influenza vaccine doesn’t protect you against every virus that can cause cold and flu symptoms. It only prevents influenza. It’s possible you had a different virus, such as adenovirus, coronavirus, parainfluenza virus, or respiratory syncytial virus.

KatarzynaBialasiewicz/Thinkstock

Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].

The past year brought new information and guidance from the American College of Obstetricians and Gynecologists (ACOG) on many relevant obstetric topics, making it difficult to choose just a few for this Update. Opioid use in pregnancy was an obvious choice given the national media attention and the potential opportunity for intervention in pregnancy for both the mother and the fetus/newborn. Postpartum hemorrhage, an “oldie but goodie,” was chosen for several reasons: It got a new definition, a new focus on multidisciplinary care, and an exciting novel tool for the treatment toolbox. Finally, given the rapidly changing technology, new screening recommendations, and the complexity of counseling, carrier screening was chosen as a genetic hot topic for this year.

Opioids, obstetrics, and opportunities

Reddy UM, Davis JM, Ren Z, Greene MF; Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes Workshop Invited Speakers. Opioid use in pregnancy, neonatal abstinence syndrome, and childhood outcomes: Executive summary of a joint workshop. Obstet Gynecol. 2017;130(1):10-28.

ACOG Committee on Obstetric Practice. ACOG committee opinion No. 711: Opioid use and opioid use disorder in pregnancy. Obstet Gynecol. 2017;130(2):e81-e94.

The term "opioid epidemic" is omnipresent in both the lay media and the medical literature. In the past decade, the United States has had a huge increase in the number of opioid prescriptions, the rate of admissions and deaths due to prescription opioid misuse and abuse, and an increased rate of heroin use attributed to prior prescription opioid use.

Obstetrics is unique in that opioid use and abuse disorders affect 2 patients simultaneously (the mother and fetus), and the treatment options are somewhat at odds in that they need to balance a stable maternal status and intrauterine environment with the risk of neonatal abstinence syndrome (NAS). Additionally, pregnancy is an opportunity for a woman with opioid use disorder to have access to medical care (possibly for the first time) leading to the diagnosis and treatment of her disease. As the clinicians on the front line, obstetricians therefore require education and guidance on best practice for management of opioid use in pregnancy.

In 2017, Reddy and colleagues, as part of a joint workshop on opioid use in pregnancy, and a committee opinion from ACOG provided the following recommendations.

Screening

Universally screen for substance use, starting at the first prenatal visit; this is recommended over risk factor-based screening.

Use a validated screening tool. A tool such as a questionnaire is recommended as the first-line screening test (for example, the 4Ps screen, the National Institute on Drug Abuse Quick Screen, and the CRAFFT Screening Interview).

Do not universally screen urine and hair for drugs. This type of screening has many limitations, such as the limited number of substances tested, false-positive results, and inaccurate determination of the frequency or timing of drug use. Information regarding the consequences of the test must be provided, and patient consent must be obtained prior to performing the test.

Treatment

Use medication-assisted treatment with buprenorphine or methadone, which is preferred to medically supervised withdrawal. Medication-assisted treatment prevents withdrawal symptoms and cravings, decreases the risk of relapse, improves compliance with prenatal care and addiction treatment programs, and leads to better obstetric outcomes (higher birth weight, lower rate of preterm birth, lower perinatal mortality).

Know that buprenorphine has several advantages over methadone, including the convenience of an outpatient prescription, a lower risk of overdose, and improved neonatal outcomes (higher birth weight, lower doses of morphine to treat NAS, shorter treatment duration).

Prioritize methadone as the preferred option for pregnant women who are already receiving methadone treatment (changing to buprenorphine may precipitate withdrawal), those with a long-standing history of or multi-substance abuse, and those who have failed other treatment programs.

Prenatal care

Screen for comorbid conditions such as sexually transmitted infections, other medications or substance use, social conditions, and mental health disorders.

Perform ultrasonography serially to monitor fetal growth because of the increased risk of fetal growth restriction.

Consult with anesthesiology for pain control recommendations for labor and delivery and with neonatalogy/pediatrics for NAS counseling.

Intrapartum/postpartum care

Recognize heightened pain. Women with opioid use disorder have increased sensitivity to painful stimuli.

Continue the maintenance dose of methadone or buprenorphine throughout hospitalization, with short-acting opioids added for a brief period for postoperative pain.

Prioritize regional anesthesia for pain control in labor or for cesarean delivery.

Consider alternative therapies such as regional blocks, nonopioid medications (nonsteroidal anti-inflammatory drugs, acetaminophen), or relaxation/mindfulness training.

Avoid mixed antagonist and agonist narcotics (butorphanol, nalbuphine, pentazocine) as they may cause acute withdrawal.

Encourage breastfeeding to decrease the severity of NAS and maternal stress and increase maternal-child bonding and maternal confidence.

Offer contraceptive counseling and services immediately postpartum in the hospital, with strong consideration for long-acting reversible contraception.

Opioid prescribing practices

Opioids are prescribed in excess post–cesarean delivery. Several recent studies have demonstrated that most women are prescribed opioids post–cesarean delivery in excess of the amount they use (median 30–40 tablets prescribed, median 20 tablets used).^1,2 The leftover opioid medication usually is not discarded and therefore is at risk for diversion or misuse. A small subset of patients will use all the opioids prescribed and feel as though they have not received enough medication.

Prescribe post–cesarean delivery opioids more appropriately by considering individual inpatient opioid requirements or a shared decision-making model.³

Prioritize acetaminophen and ibuprofen during breastfeeding. In a recent editorial in OBG Management, Robert L. Barbieri, MD, recommended that whenever possible, acetaminophen and ibuprofen should be the first-line treatment for breastfeeding women, and narcotics that are metabolized by CYP2D6 should be avoided to reduce the risk to the newborn.⁴

Read about new strategies for postpartum hemorrhage.

Postpartum hemorrhage: New definitions and new strategies for stemming the flow

ACOG Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin No. 183: Postpartum hemorrhage. Obstet Gynecol. 2017;130(4):e168-e186.

From the very first sentence of the new ACOG practice bulletin, postpartum hemorrhage (PPH) is redefined as "cumulative blood loss greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process (includes intrapartum loss) regardless of route of delivery." Although this does not seem to be a huge change from the traditional teaching of a 500-mL blood loss at vaginal delivery and a 1,000-mL loss at cesarean delivery, it reflects a shift in focus from simply responding to a certain amount of bleeding to using a multidisciplinary action plan for treating this leading cause of maternal mortality worldwide.

Focus on developing a PPH action plan

As part of the shift toward a multidisciplinary action plan for PPH, all obstetric team members should be aware of the following:  

• For most postpartum women, by the time they begin to show signs of hemodynamic compromise, the amount of blood loss approaches 25% of their total blood volume (1,500 mL). Lactic acidosis, systemic inflammation, and a consumptive coagulopathy result.  
• Risk stratification prior to delivery, recognition and identification of the source of bleeding, and aggressive early resuscitation to prevent hypovolemia are paramount. Experience gleaned from trauma massive transfusion protocols suggests that judicious transfusion of packed red blood cells, fresh frozen plasma, and platelets in a 1:1:1 ratio is appropriate for obstetric patients. Additionally, patients with low fibrinogen levels should be treated with cryoprecipitate.  
• The use of fixed transfusion ratios and standardized protocols for recognition and management of PPH has been demonstrated to increase earlier intervention and resolution of hemorrhage at an earlier stage, although the maternal outcomes results have been mixed.  
• Multidisciplinary team drills and simulation exercises also should be considered to help solidify training of an institution's teams responsible for PPH response.

Novel management option: Tranexamic acid

In addition to these strategies, there is a new recommendation for managing refractory PPH: tranexamic acid, which works by binding to lysine receptors on plasminogen and plasmin, inhibiting plasmin-mediated fibrin degradation.5 Previously, tranexamic acid was known to be effective in trauma, heart surgery, and in patients with thrombophilias. Pacheco and colleagues recently demonstrated reduced mortality from obstetric bleeding if tranexamic acid was given within 3 hours of delivery, without increased thrombotic complications.⁵ ACOG recommends its use if initial medical therapy fails, while the World Health Organization strongly recommends that tranexamic acid be part of a standard PPH package for all cases of PPH (TABLE).⁶

Read about new ACOG guidance on prepregnancy and prenatal screening.

ACOG Committee on Genetics. Committee opinion No. 690: Carrier screening in the age of genomic medicine. Obstet Gynecol. 2017;129(3):e35-e40.

ACOG Committee on Genetics. Committee opinion No. 691: Carrier screening for genetic conditions. Obstet Gynecol. 2017;129(3):e41-e55.

Ideally, carrier screening should be offered prior to pregnancy to fully inform couples of their reproductive risks and options for pregnancy. If not performed in the preconception period, carrier screening should be offered to all pregnant women. If a patient chooses screening and screens positive for a particular disorder, her reproductive partner should then be offered screening so that the risk of having an affected child can be determined.

New ACOG guidance on prepregnancy and prenatal screening

Carrier screening recommendations have evolved as the technology available has expanded. All 3 of the following strategies now are considered "acceptable" according to 2 recently published ACOG committee opinions.

Traditional ethnic-specific carrier screening, previously ACOG's sole recommendation, involves offering specific genetic screening to patients from populations with a high prevalence for certain conditions. One such example is Tay-Sachs disease screening in Ashkenazi Jewish patients.

Panethnic screening, which takes into account mixed or uncertain backgrounds, involves screening for a certain panel of disorders and is available to all patients regardless of their background (for example, cystic fibrosis screening offered to all pregnant patients).

Expanded carrier screening is when a large number of disorders can be screened for simultaneously for a lower cost than previous testing strategies. Expanded carrier screening panels vary in number and which conditions are tested by the laboratory. An ideal expanded carrier screening panel has been debated in the literature but not agreed on.⁷

ObGyns and practices therefore are encouraged to develop a standard counseling and screening protocol to offer to all their patients while being flexible to make available any patient-requested screening that is outside their protocol. Pretest and posttest counseling, including a thorough family history, is essential (as with any genetic testing) and should include residual risk after testing, potential need for specific familial mutation testing instead of general carrier screening, and issues with consanguinity.

Three essential screens

Regardless of the screening strategy chosen from the above options, 3 screening tests should be offered to all pregnant women or couples considering pregnancy (either individually or in the context of an expanded screening panel):

• Cystic fibrosis. At the least, a panel of the 23 most common mutations should be used. More expanded panels, which include hundreds of mutations, increase detection in non-Caucasian populations and for milder forms of the disease or infertility-related mutations.
• Hemoglobinopathies (sickle cell, α- and β-thalassemia). Complete blood count and red blood indices are recommended for all, with hemoglobin electrophoresis recommended for patients of African, Middle Eastern, Mediterranean, or West Indian descent or if mean corpuscular volume is low.
• Spinal muscular atrophy (SMA). The most recent addition to ACOG's recommendations for general carrier screening due to the relatively high carrier frequency (1-in-40 to 1-in-60) and the severity of the disease, SMA causes degeneration of the spinal cord neurons, skeletal muscular atrophy, and overall weakness. Screening is via polymerase chain reaction for SMN1 copy number: 2 copies are normal, and 1 copy indicates a carrier of the SMN1 deletion. About 3% to 4% of patients will screen negative but still will be "carriers" due to having 2 copies of the SMN1 gene on 1 chromosome and no copies on the other chromosome.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The past year brought new information and guidance from the American College of Obstetricians and Gynecologists (ACOG) on many relevant obstetric topics, making it difficult to choose just a few for this Update. Opioid use in pregnancy was an obvious choice given the national media attention and the potential opportunity for intervention in pregnancy for both the mother and the fetus/newborn. Postpartum hemorrhage, an “oldie but goodie,” was chosen for several reasons: It got a new definition, a new focus on multidisciplinary care, and an exciting novel tool for the treatment toolbox. Finally, given the rapidly changing technology, new screening recommendations, and the complexity of counseling, carrier screening was chosen as a genetic hot topic for this year.

Opioids, obstetrics, and opportunities

Reddy UM, Davis JM, Ren Z, Greene MF; Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes Workshop Invited Speakers. Opioid use in pregnancy, neonatal abstinence syndrome, and childhood outcomes: Executive summary of a joint workshop. Obstet Gynecol. 2017;130(1):10-28.

ACOG Committee on Obstetric Practice. ACOG committee opinion No. 711: Opioid use and opioid use disorder in pregnancy. Obstet Gynecol. 2017;130(2):e81-e94.

The term "opioid epidemic" is omnipresent in both the lay media and the medical literature. In the past decade, the United States has had a huge increase in the number of opioid prescriptions, the rate of admissions and deaths due to prescription opioid misuse and abuse, and an increased rate of heroin use attributed to prior prescription opioid use.

Obstetrics is unique in that opioid use and abuse disorders affect 2 patients simultaneously (the mother and fetus), and the treatment options are somewhat at odds in that they need to balance a stable maternal status and intrauterine environment with the risk of neonatal abstinence syndrome (NAS). Additionally, pregnancy is an opportunity for a woman with opioid use disorder to have access to medical care (possibly for the first time) leading to the diagnosis and treatment of her disease. As the clinicians on the front line, obstetricians therefore require education and guidance on best practice for management of opioid use in pregnancy.

In 2017, Reddy and colleagues, as part of a joint workshop on opioid use in pregnancy, and a committee opinion from ACOG provided the following recommendations.

Screening

Universally screen for substance use, starting at the first prenatal visit; this is recommended over risk factor-based screening.

Use a validated screening tool. A tool such as a questionnaire is recommended as the first-line screening test (for example, the 4Ps screen, the National Institute on Drug Abuse Quick Screen, and the CRAFFT Screening Interview).

Do not universally screen urine and hair for drugs. This type of screening has many limitations, such as the limited number of substances tested, false-positive results, and inaccurate determination of the frequency or timing of drug use. Information regarding the consequences of the test must be provided, and patient consent must be obtained prior to performing the test.

Treatment

Use medication-assisted treatment with buprenorphine or methadone, which is preferred to medically supervised withdrawal. Medication-assisted treatment prevents withdrawal symptoms and cravings, decreases the risk of relapse, improves compliance with prenatal care and addiction treatment programs, and leads to better obstetric outcomes (higher birth weight, lower rate of preterm birth, lower perinatal mortality).

Know that buprenorphine has several advantages over methadone, including the convenience of an outpatient prescription, a lower risk of overdose, and improved neonatal outcomes (higher birth weight, lower doses of morphine to treat NAS, shorter treatment duration).

Prioritize methadone as the preferred option for pregnant women who are already receiving methadone treatment (changing to buprenorphine may precipitate withdrawal), those with a long-standing history of or multi-substance abuse, and those who have failed other treatment programs.

Prenatal care

Screen for comorbid conditions such as sexually transmitted infections, other medications or substance use, social conditions, and mental health disorders.

Perform ultrasonography serially to monitor fetal growth because of the increased risk of fetal growth restriction.

Consult with anesthesiology for pain control recommendations for labor and delivery and with neonatalogy/pediatrics for NAS counseling.

Intrapartum/postpartum care

Recognize heightened pain. Women with opioid use disorder have increased sensitivity to painful stimuli.

Continue the maintenance dose of methadone or buprenorphine throughout hospitalization, with short-acting opioids added for a brief period for postoperative pain.

Prioritize regional anesthesia for pain control in labor or for cesarean delivery.

Consider alternative therapies such as regional blocks, nonopioid medications (nonsteroidal anti-inflammatory drugs, acetaminophen), or relaxation/mindfulness training.

Avoid mixed antagonist and agonist narcotics (butorphanol, nalbuphine, pentazocine) as they may cause acute withdrawal.

Encourage breastfeeding to decrease the severity of NAS and maternal stress and increase maternal-child bonding and maternal confidence.

Offer contraceptive counseling and services immediately postpartum in the hospital, with strong consideration for long-acting reversible contraception.

Opioid prescribing practices

Opioids are prescribed in excess post–cesarean delivery. Several recent studies have demonstrated that most women are prescribed opioids post–cesarean delivery in excess of the amount they use (median 30–40 tablets prescribed, median 20 tablets used).^1,2 The leftover opioid medication usually is not discarded and therefore is at risk for diversion or misuse. A small subset of patients will use all the opioids prescribed and feel as though they have not received enough medication.

Prescribe post–cesarean delivery opioids more appropriately by considering individual inpatient opioid requirements or a shared decision-making model.³

Prioritize acetaminophen and ibuprofen during breastfeeding. In a recent editorial in OBG Management, Robert L. Barbieri, MD, recommended that whenever possible, acetaminophen and ibuprofen should be the first-line treatment for breastfeeding women, and narcotics that are metabolized by CYP2D6 should be avoided to reduce the risk to the newborn.⁴

Read about new strategies for postpartum hemorrhage.

Postpartum hemorrhage: New definitions and new strategies for stemming the flow

ACOG Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin No. 183: Postpartum hemorrhage. Obstet Gynecol. 2017;130(4):e168-e186.

From the very first sentence of the new ACOG practice bulletin, postpartum hemorrhage (PPH) is redefined as "cumulative blood loss greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process (includes intrapartum loss) regardless of route of delivery." Although this does not seem to be a huge change from the traditional teaching of a 500-mL blood loss at vaginal delivery and a 1,000-mL loss at cesarean delivery, it reflects a shift in focus from simply responding to a certain amount of bleeding to using a multidisciplinary action plan for treating this leading cause of maternal mortality worldwide.

Focus on developing a PPH action plan

As part of the shift toward a multidisciplinary action plan for PPH, all obstetric team members should be aware of the following:  

• For most postpartum women, by the time they begin to show signs of hemodynamic compromise, the amount of blood loss approaches 25% of their total blood volume (1,500 mL). Lactic acidosis, systemic inflammation, and a consumptive coagulopathy result.  
• Risk stratification prior to delivery, recognition and identification of the source of bleeding, and aggressive early resuscitation to prevent hypovolemia are paramount. Experience gleaned from trauma massive transfusion protocols suggests that judicious transfusion of packed red blood cells, fresh frozen plasma, and platelets in a 1:1:1 ratio is appropriate for obstetric patients. Additionally, patients with low fibrinogen levels should be treated with cryoprecipitate.  
• The use of fixed transfusion ratios and standardized protocols for recognition and management of PPH has been demonstrated to increase earlier intervention and resolution of hemorrhage at an earlier stage, although the maternal outcomes results have been mixed.  
• Multidisciplinary team drills and simulation exercises also should be considered to help solidify training of an institution's teams responsible for PPH response.

Novel management option: Tranexamic acid

In addition to these strategies, there is a new recommendation for managing refractory PPH: tranexamic acid, which works by binding to lysine receptors on plasminogen and plasmin, inhibiting plasmin-mediated fibrin degradation.5 Previously, tranexamic acid was known to be effective in trauma, heart surgery, and in patients with thrombophilias. Pacheco and colleagues recently demonstrated reduced mortality from obstetric bleeding if tranexamic acid was given within 3 hours of delivery, without increased thrombotic complications.⁵ ACOG recommends its use if initial medical therapy fails, while the World Health Organization strongly recommends that tranexamic acid be part of a standard PPH package for all cases of PPH (TABLE).⁶

Read about new ACOG guidance on prepregnancy and prenatal screening.

ACOG Committee on Genetics. Committee opinion No. 690: Carrier screening in the age of genomic medicine. Obstet Gynecol. 2017;129(3):e35-e40.

ACOG Committee on Genetics. Committee opinion No. 691: Carrier screening for genetic conditions. Obstet Gynecol. 2017;129(3):e41-e55.

Ideally, carrier screening should be offered prior to pregnancy to fully inform couples of their reproductive risks and options for pregnancy. If not performed in the preconception period, carrier screening should be offered to all pregnant women. If a patient chooses screening and screens positive for a particular disorder, her reproductive partner should then be offered screening so that the risk of having an affected child can be determined.

New ACOG guidance on prepregnancy and prenatal screening

Carrier screening recommendations have evolved as the technology available has expanded. All 3 of the following strategies now are considered "acceptable" according to 2 recently published ACOG committee opinions.

Traditional ethnic-specific carrier screening, previously ACOG's sole recommendation, involves offering specific genetic screening to patients from populations with a high prevalence for certain conditions. One such example is Tay-Sachs disease screening in Ashkenazi Jewish patients.

Panethnic screening, which takes into account mixed or uncertain backgrounds, involves screening for a certain panel of disorders and is available to all patients regardless of their background (for example, cystic fibrosis screening offered to all pregnant patients).

Expanded carrier screening is when a large number of disorders can be screened for simultaneously for a lower cost than previous testing strategies. Expanded carrier screening panels vary in number and which conditions are tested by the laboratory. An ideal expanded carrier screening panel has been debated in the literature but not agreed on.⁷

ObGyns and practices therefore are encouraged to develop a standard counseling and screening protocol to offer to all their patients while being flexible to make available any patient-requested screening that is outside their protocol. Pretest and posttest counseling, including a thorough family history, is essential (as with any genetic testing) and should include residual risk after testing, potential need for specific familial mutation testing instead of general carrier screening, and issues with consanguinity.

Three essential screens

Regardless of the screening strategy chosen from the above options, 3 screening tests should be offered to all pregnant women or couples considering pregnancy (either individually or in the context of an expanded screening panel):

• Cystic fibrosis. At the least, a panel of the 23 most common mutations should be used. More expanded panels, which include hundreds of mutations, increase detection in non-Caucasian populations and for milder forms of the disease or infertility-related mutations.
• Hemoglobinopathies (sickle cell, α- and β-thalassemia). Complete blood count and red blood indices are recommended for all, with hemoglobin electrophoresis recommended for patients of African, Middle Eastern, Mediterranean, or West Indian descent or if mean corpuscular volume is low.
• Spinal muscular atrophy (SMA). The most recent addition to ACOG's recommendations for general carrier screening due to the relatively high carrier frequency (1-in-40 to 1-in-60) and the severity of the disease, SMA causes degeneration of the spinal cord neurons, skeletal muscular atrophy, and overall weakness. Screening is via polymerase chain reaction for SMN1 copy number: 2 copies are normal, and 1 copy indicates a carrier of the SMN1 deletion. About 3% to 4% of patients will screen negative but still will be "carriers" due to having 2 copies of the SMN1 gene on 1 chromosome and no copies on the other chromosome.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The past year brought new information and guidance from the American College of Obstetricians and Gynecologists (ACOG) on many relevant obstetric topics, making it difficult to choose just a few for this Update. Opioid use in pregnancy was an obvious choice given the national media attention and the potential opportunity for intervention in pregnancy for both the mother and the fetus/newborn. Postpartum hemorrhage, an “oldie but goodie,” was chosen for several reasons: It got a new definition, a new focus on multidisciplinary care, and an exciting novel tool for the treatment toolbox. Finally, given the rapidly changing technology, new screening recommendations, and the complexity of counseling, carrier screening was chosen as a genetic hot topic for this year.

Opioids, obstetrics, and opportunities

Reddy UM, Davis JM, Ren Z, Greene MF; Opioid Use in Pregnancy, Neonatal Abstinence Syndrome, and Childhood Outcomes Workshop Invited Speakers. Opioid use in pregnancy, neonatal abstinence syndrome, and childhood outcomes: Executive summary of a joint workshop. Obstet Gynecol. 2017;130(1):10-28.

ACOG Committee on Obstetric Practice. ACOG committee opinion No. 711: Opioid use and opioid use disorder in pregnancy. Obstet Gynecol. 2017;130(2):e81-e94.

The term "opioid epidemic" is omnipresent in both the lay media and the medical literature. In the past decade, the United States has had a huge increase in the number of opioid prescriptions, the rate of admissions and deaths due to prescription opioid misuse and abuse, and an increased rate of heroin use attributed to prior prescription opioid use.

Obstetrics is unique in that opioid use and abuse disorders affect 2 patients simultaneously (the mother and fetus), and the treatment options are somewhat at odds in that they need to balance a stable maternal status and intrauterine environment with the risk of neonatal abstinence syndrome (NAS). Additionally, pregnancy is an opportunity for a woman with opioid use disorder to have access to medical care (possibly for the first time) leading to the diagnosis and treatment of her disease. As the clinicians on the front line, obstetricians therefore require education and guidance on best practice for management of opioid use in pregnancy.

In 2017, Reddy and colleagues, as part of a joint workshop on opioid use in pregnancy, and a committee opinion from ACOG provided the following recommendations.

Screening

Universally screen for substance use, starting at the first prenatal visit; this is recommended over risk factor-based screening.

Use a validated screening tool. A tool such as a questionnaire is recommended as the first-line screening test (for example, the 4Ps screen, the National Institute on Drug Abuse Quick Screen, and the CRAFFT Screening Interview).

Do not universally screen urine and hair for drugs. This type of screening has many limitations, such as the limited number of substances tested, false-positive results, and inaccurate determination of the frequency or timing of drug use. Information regarding the consequences of the test must be provided, and patient consent must be obtained prior to performing the test.

Treatment

Use medication-assisted treatment with buprenorphine or methadone, which is preferred to medically supervised withdrawal. Medication-assisted treatment prevents withdrawal symptoms and cravings, decreases the risk of relapse, improves compliance with prenatal care and addiction treatment programs, and leads to better obstetric outcomes (higher birth weight, lower rate of preterm birth, lower perinatal mortality).

Know that buprenorphine has several advantages over methadone, including the convenience of an outpatient prescription, a lower risk of overdose, and improved neonatal outcomes (higher birth weight, lower doses of morphine to treat NAS, shorter treatment duration).

Prioritize methadone as the preferred option for pregnant women who are already receiving methadone treatment (changing to buprenorphine may precipitate withdrawal), those with a long-standing history of or multi-substance abuse, and those who have failed other treatment programs.

Prenatal care

Screen for comorbid conditions such as sexually transmitted infections, other medications or substance use, social conditions, and mental health disorders.

Perform ultrasonography serially to monitor fetal growth because of the increased risk of fetal growth restriction.

Consult with anesthesiology for pain control recommendations for labor and delivery and with neonatalogy/pediatrics for NAS counseling.

Intrapartum/postpartum care

Recognize heightened pain. Women with opioid use disorder have increased sensitivity to painful stimuli.

Continue the maintenance dose of methadone or buprenorphine throughout hospitalization, with short-acting opioids added for a brief period for postoperative pain.

Prioritize regional anesthesia for pain control in labor or for cesarean delivery.

Consider alternative therapies such as regional blocks, nonopioid medications (nonsteroidal anti-inflammatory drugs, acetaminophen), or relaxation/mindfulness training.

Avoid mixed antagonist and agonist narcotics (butorphanol, nalbuphine, pentazocine) as they may cause acute withdrawal.

Encourage breastfeeding to decrease the severity of NAS and maternal stress and increase maternal-child bonding and maternal confidence.

Offer contraceptive counseling and services immediately postpartum in the hospital, with strong consideration for long-acting reversible contraception.

Opioid prescribing practices

Opioids are prescribed in excess post–cesarean delivery. Several recent studies have demonstrated that most women are prescribed opioids post–cesarean delivery in excess of the amount they use (median 30–40 tablets prescribed, median 20 tablets used).^1,2 The leftover opioid medication usually is not discarded and therefore is at risk for diversion or misuse. A small subset of patients will use all the opioids prescribed and feel as though they have not received enough medication.

Prescribe post–cesarean delivery opioids more appropriately by considering individual inpatient opioid requirements or a shared decision-making model.³

Prioritize acetaminophen and ibuprofen during breastfeeding. In a recent editorial in OBG Management, Robert L. Barbieri, MD, recommended that whenever possible, acetaminophen and ibuprofen should be the first-line treatment for breastfeeding women, and narcotics that are metabolized by CYP2D6 should be avoided to reduce the risk to the newborn.⁴

Read about new strategies for postpartum hemorrhage.

Postpartum hemorrhage: New definitions and new strategies for stemming the flow

ACOG Committee on Practice Bulletins—Obstetrics. ACOG practice bulletin No. 183: Postpartum hemorrhage. Obstet Gynecol. 2017;130(4):e168-e186.

From the very first sentence of the new ACOG practice bulletin, postpartum hemorrhage (PPH) is redefined as "cumulative blood loss greater than or equal to 1,000 mL or blood loss accompanied by signs or symptoms of hypovolemia within 24 hours after the birth process (includes intrapartum loss) regardless of route of delivery." Although this does not seem to be a huge change from the traditional teaching of a 500-mL blood loss at vaginal delivery and a 1,000-mL loss at cesarean delivery, it reflects a shift in focus from simply responding to a certain amount of bleeding to using a multidisciplinary action plan for treating this leading cause of maternal mortality worldwide.

Focus on developing a PPH action plan

As part of the shift toward a multidisciplinary action plan for PPH, all obstetric team members should be aware of the following:  

• For most postpartum women, by the time they begin to show signs of hemodynamic compromise, the amount of blood loss approaches 25% of their total blood volume (1,500 mL). Lactic acidosis, systemic inflammation, and a consumptive coagulopathy result.  
• Risk stratification prior to delivery, recognition and identification of the source of bleeding, and aggressive early resuscitation to prevent hypovolemia are paramount. Experience gleaned from trauma massive transfusion protocols suggests that judicious transfusion of packed red blood cells, fresh frozen plasma, and platelets in a 1:1:1 ratio is appropriate for obstetric patients. Additionally, patients with low fibrinogen levels should be treated with cryoprecipitate.  
• The use of fixed transfusion ratios and standardized protocols for recognition and management of PPH has been demonstrated to increase earlier intervention and resolution of hemorrhage at an earlier stage, although the maternal outcomes results have been mixed.  
• Multidisciplinary team drills and simulation exercises also should be considered to help solidify training of an institution's teams responsible for PPH response.

Novel management option: Tranexamic acid

In addition to these strategies, there is a new recommendation for managing refractory PPH: tranexamic acid, which works by binding to lysine receptors on plasminogen and plasmin, inhibiting plasmin-mediated fibrin degradation.5 Previously, tranexamic acid was known to be effective in trauma, heart surgery, and in patients with thrombophilias. Pacheco and colleagues recently demonstrated reduced mortality from obstetric bleeding if tranexamic acid was given within 3 hours of delivery, without increased thrombotic complications.⁵ ACOG recommends its use if initial medical therapy fails, while the World Health Organization strongly recommends that tranexamic acid be part of a standard PPH package for all cases of PPH (TABLE).⁶

Read about new ACOG guidance on prepregnancy and prenatal screening.

ACOG Committee on Genetics. Committee opinion No. 690: Carrier screening in the age of genomic medicine. Obstet Gynecol. 2017;129(3):e35-e40.

ACOG Committee on Genetics. Committee opinion No. 691: Carrier screening for genetic conditions. Obstet Gynecol. 2017;129(3):e41-e55.

Ideally, carrier screening should be offered prior to pregnancy to fully inform couples of their reproductive risks and options for pregnancy. If not performed in the preconception period, carrier screening should be offered to all pregnant women. If a patient chooses screening and screens positive for a particular disorder, her reproductive partner should then be offered screening so that the risk of having an affected child can be determined.

New ACOG guidance on prepregnancy and prenatal screening

Carrier screening recommendations have evolved as the technology available has expanded. All 3 of the following strategies now are considered "acceptable" according to 2 recently published ACOG committee opinions.

Traditional ethnic-specific carrier screening, previously ACOG's sole recommendation, involves offering specific genetic screening to patients from populations with a high prevalence for certain conditions. One such example is Tay-Sachs disease screening in Ashkenazi Jewish patients.

Panethnic screening, which takes into account mixed or uncertain backgrounds, involves screening for a certain panel of disorders and is available to all patients regardless of their background (for example, cystic fibrosis screening offered to all pregnant patients).

Expanded carrier screening is when a large number of disorders can be screened for simultaneously for a lower cost than previous testing strategies. Expanded carrier screening panels vary in number and which conditions are tested by the laboratory. An ideal expanded carrier screening panel has been debated in the literature but not agreed on.⁷

ObGyns and practices therefore are encouraged to develop a standard counseling and screening protocol to offer to all their patients while being flexible to make available any patient-requested screening that is outside their protocol. Pretest and posttest counseling, including a thorough family history, is essential (as with any genetic testing) and should include residual risk after testing, potential need for specific familial mutation testing instead of general carrier screening, and issues with consanguinity.

Three essential screens

Regardless of the screening strategy chosen from the above options, 3 screening tests should be offered to all pregnant women or couples considering pregnancy (either individually or in the context of an expanded screening panel):

• Cystic fibrosis. At the least, a panel of the 23 most common mutations should be used. More expanded panels, which include hundreds of mutations, increase detection in non-Caucasian populations and for milder forms of the disease or infertility-related mutations.
• Hemoglobinopathies (sickle cell, α- and β-thalassemia). Complete blood count and red blood indices are recommended for all, with hemoglobin electrophoresis recommended for patients of African, Middle Eastern, Mediterranean, or West Indian descent or if mean corpuscular volume is low.
• Spinal muscular atrophy (SMA). The most recent addition to ACOG's recommendations for general carrier screening due to the relatively high carrier frequency (1-in-40 to 1-in-60) and the severity of the disease, SMA causes degeneration of the spinal cord neurons, skeletal muscular atrophy, and overall weakness. Screening is via polymerase chain reaction for SMN1 copy number: 2 copies are normal, and 1 copy indicates a carrier of the SMN1 deletion. About 3% to 4% of patients will screen negative but still will be "carriers" due to having 2 copies of the SMN1 gene on 1 chromosome and no copies on the other chromosome.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

A one-two combination consisting of a drug to deplete amyloid fibrils from circulation and a monoclonal antibody to mop up residual amyloid protein appears to be safe and shows promising activity against systemic amyloidosis in an early clinical trial.

Pairing the investigational small molecule agent miridesap and the experimental monoclonal antibody dezamizumab resulted in clearance or reductions in amyloid deposits in the livers, spleens, and kidneys of adults with systemic amyloidosis, reported Prof. Sir Mark B. Pepys of University College, London, and his colleagues.

©Nephron/Wikimedia Commons/CC BY SA 3.0

Source: Richards D et al. Sci. Transl. Med. 2018. doi: 10.1126/scitranslmed.aan3128.

A one-two combination consisting of a drug to deplete amyloid fibrils from circulation and a monoclonal antibody to mop up residual amyloid protein appears to be safe and shows promising activity against systemic amyloidosis in an early clinical trial.

Pairing the investigational small molecule agent miridesap and the experimental monoclonal antibody dezamizumab resulted in clearance or reductions in amyloid deposits in the livers, spleens, and kidneys of adults with systemic amyloidosis, reported Prof. Sir Mark B. Pepys of University College, London, and his colleagues.

©Nephron/Wikimedia Commons/CC BY SA 3.0

Source: Richards D et al. Sci. Transl. Med. 2018. doi: 10.1126/scitranslmed.aan3128.

A one-two combination consisting of a drug to deplete amyloid fibrils from circulation and a monoclonal antibody to mop up residual amyloid protein appears to be safe and shows promising activity against systemic amyloidosis in an early clinical trial.

Pairing the investigational small molecule agent miridesap and the experimental monoclonal antibody dezamizumab resulted in clearance or reductions in amyloid deposits in the livers, spleens, and kidneys of adults with systemic amyloidosis, reported Prof. Sir Mark B. Pepys of University College, London, and his colleagues.

©Nephron/Wikimedia Commons/CC BY SA 3.0

Source: Richards D et al. Sci. Transl. Med. 2018. doi: 10.1126/scitranslmed.aan3128.

For ObGyns to be successful, understanding the basics of quality and cost measurement is essential, along with devoting more attention to what they are being evaluated on and held accountable for. But how will ObGyns be impacted by the push to incentivize them for delivering value in their work?

Although much of health care policy has become politically divisive lately, one area of agreement is that, in the United States, we have unsustainable health costs and the exorbitant amount our country pays for health care does not translate to improved outcomes. The United States spends more than most other developed nations on health care (roughly, $9,403 per capita in 2014) but has some of the lowest life expectancies, along with the highest maternal and infant mortality rates, compared with peer nations.^1–4

One of the key culprits in our health system’s inefficiencies is the fee-for-service payment model. Fee-for-service incentivizes the delivery of a high volume of care without any way to determine whether that care is achieving the desired outcomes of improved health and quality of life. Not only does fee-for-service drive up the volume of care but it also rewards the delivery of high-cost services, regardless of whether those services provide what is best for the patient.

During the previous administration, Secretary of Health and Human Services Sylvia Mathews Burwell set goals for moving away from fee-for-service in Medicare and in the health system more broadly. Congress also passed legislation that provides incentives for Medicare providers to transition away from fee-for-service with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). While fee-for-service remains the predominant form of payment for many physicians, value-based payment arrangements are gaining a toehold. In 2014, 86% of physicians reported working in a practice receiving fee-for-service. Those fees accounted for nearly 72% of revenue.⁵ This percentage likely will continue to decrease over the next few years as government and private payers seek to promote value-based payment systems.

Assessing quality

“Value” in the context of health care is often defined as quality or outcomes relative to costs.⁶ Before payers can reward value, there must be measurement of performance to determine the quality of care being delivered. Quality measures are tools to help quantify access to care, processes, outcomes, patient experience, and organizational structure within the health care system. ObGyns likely encounter process, outcome, and patient experience measures most frequently in their practice.

Although outcome measures are generally held as the gold standard for quality measurement, they are often hard to obtain—either because of issues of temporality and rarity of events or because the data are hard to capture through existing formats. In lieu of measuring outcomes, process measures are often used to determine whether certain services that are known to be tied to desired health outcomes were delivered. Patient experience measures are also rising in popularity and are seen as a critical tool to ensuring that care that purports to be patient-centered actually is so.

Measures are specified to different levels of accountability, ranging from the individual physician all the way to the population. Some measures also can be specified at multiple levels. One major concern is the problem of attribution—that is, the difficulty of assigning who is primarily responsible for a specific quality metric result. Because obstetrics and gynecology is an increasingly team-based specialty, the American College of Obstetricians and Gynecologists (ACOG) recommends that measures that are used to reward or penalize providers should reflect performance at the care team or practice level, not at the individual physician or health care provider level.⁷ As consolidation of providers continues, it is expected that team-based care will increase and that the use of advanced practice providers will increase.⁸

Data to determine performance can come from a variety of sources, including claims, electronic health records (EHRs), paper medical record abstraction, birth certificates, registries, surveys, and separate reporting mechanisms. There are pros and cons of these various sources. Because administrative claims data are so easily obtainable, many measures have been developed based on this data source, but there are significant limitations to assessments made with such data. These limitations include inherent problems with translating clinical diagnoses into specific codes and inadequate documentation to support particular diagnoses and procedure codes.⁹ Claims data are limited by what physicians and other health care providers code for in their claims, making proper coding an essential skill for ObGyns to master.

Although there has been an increase in measures that rely on clinical data found in EHRs and registries—which are more robust and capture a wider breadth of indicators—claims-based measures still form the basis for many reporting programs because of standardization and ease of access to data. Data quality will become increasingly more important in a value-based payment world because completeness, risk adjustment, and specificity will be determined by the data recorded. This need for data quality will require that improvements be made in the user interface of EHRs and that providers pay specific attention to making sure their documentation is complete. New designs for EHRs should assist in that task, and data extraction should become a by-product of documentation.¹⁰

Read about alternative payment models and how ObGyns can succeed.

Paying for value

In an attempt to move away from fee-for-service medicine, payers and employers are adopting alternative payment models (APMs) that are intended to reward physicians and other health care providers for delivering value. Although APMs can be a catchall term, the Health Care Payment Learning and Action Network (LAN), a multi-stakeholder collaborative convened by the US Centers for Medicare & Medicaid Services, has laid out a framework for the different types of APMs¹¹ (FIGURE). This framework provides a common reference point for concepts related to value-based care.

Although ACOG does not endorse all the concepts and principles included in the LAN white paper, it does support moving away from fee-for-service payments that lack any link to quality or outcomes. Originally, the LAN envisioned that all physicians, providers, and hospital systems would move in the direction of adopting Category 4 APMs, but in the recent “refresh” of the LAN’s white paper, the authors recognized that not all entities will be able to move toward population-based payments—nor will it be beneficial for all providers to do so. ACOG agrees that not all ObGyns will be able to thrive under population-based payments, so we must lead the way in developing models and measures that appropriately assess value in the care that ObGyns provide.

ACOG has undertaken its first foray into value-based payments by developing an “episode group” related to benign hysterectomy, with attendant quality measures. (An episode group is a collection of services associated with treating a condition or performing a procedure that are both clinically and temporally related.) The goal in creating episode groups is to create alignment across payers so that ObGyns are not faced with multitudinous payer-specific metrics and reporting requirements. As the benign hysterectomy episode group is refined and adopted by payers, ACOG plans to expand to other treatments and, eventually, develop condition-based episode groups that incentivize the most appropriate treatment options for patients.

Current forms of APMs are mostly Category 2 and 3 models. Rates of proper screening for cervical and breast cancer have been used as performance metrics for bonus payments. Major payers have pushed specific metrics as cutoffs for limiting narrow networks.¹² For example, Covered California, the state health care exchange, has set a nulliparous term singleton vertex cesarean rate of 23.9% by 2018 as a necessary standard for inclusion of a hospital’s entire services (obstetric and nonobstetric) in their network. Episode group payments for total obstetric care included in the episode routine services, such as ultrasonography, have been previously utilized to discourage overutilization.

Such payment incentives can lead to underutilization of resources, however, which might lead to poorer outcomes and therefore result in overall greater cost. For example, poor screening for fetal anomalies or poorly managed medical conditions such as diabetes can lead to markedly increased costs in neonatal management. Therefore, some authorities have proposed tying incentives for obstetric care to performance outcome measures in neonatal care as a method of finding “sweet spots” for utilization of complex services and episode groups. Such models will depend on more robust clinical information sources and standardization.⁸

How can ObGyns succeed?

So what does success look like under these value-based payments for ObGyns? This is new territory, in a rapidly changing environment in which providers who flourished under the fee-for-service system will only survive under the new system if they become knowledgeable about the nuances of the new payment methods. Providers should understand that success is going to be defined as reaching the “Triple Aim”¹³ of improving the health of the population, containing costs, and improving the experience of health care.

Practice patient-centered care. One way to better position yourself is to focus on delivering patient-centered care and improving customer service in your practice. By implementing patient satisfaction surveys, you can identify where you are most vulnerable. One option is to utilize the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey, developed by the US Department of Health and Human Services’ Agency for Healthcare Research & Quality. However, there are other assessment tools available, and you should investigate what works best for your practice.

Code properly. Another key to making sure you are in an optimal position is to properly document and code the services you deliver. Accurately capturing the clinical complexity of your patients will help down the road with risk adjustment and risk stratification for cost and quality measures. Many payment models, including episode groups, are built on the fee-for-service system, so coding for services is still important in the transition to alternative models. Modern EHRs are building new tools to assist clinician documentation, such as tools that aid coding. Carefully groomed and up-to-date problem lists can help providers keep track of appropriate testing and screening by enabling decision support tools that are imbedded in the systems. Although upgrading can be expensive, especially for small group practices, the development of “software as a service” or cloud-based EHRs will likely drive individual costs down.¹⁰

One example of point-of-care decision support that ACOG is spearheading to support our Fellows is the ACOG Prenatal Record (APR) by Dorsata.¹⁴ The APR is an application designed by ObGyns to work seamlessly with an existing EHR system to improve clinical workflow, save time, and help ObGyns support high-quality prenatal outcomes. The APR uses the same simplicity, flexibility, and familiarity of the original paper-based flowsheet, but in an electronic format to integrate ACOG guidance, which provides a more robust solution. The APR uses information such as gestational age, pregnancy history, the problem list, and other risk factors to provide patient and visit-specific care plans based on ACOG clinical practice guidelines. It was designed to help reduce physician burden by creating an easy-to-navigate electronic flowsheet that provides everything ObGyns need to know about each patient, succinctly captured in a single view.

ACOG also offers comprehensive coding workshops across the country and webinars on special coding topics to help Fellows learn to properly code their services. Availing yourself of these educational opportunities now so that you are better prepared to transition to value-based payment is a great way to ensure success in the future.

Chances are that some of your payers are already requiring you to report on metrics or tracking your performance using claims data. Pay attention to the performance measures that you are being held accountable for by payers when you review your payer contracts. Make sure you understand how your patients may fall into and out of the measure numerators and denominators. Ask yourself whether these metrics are ones that you can reasonably influence and that are within your control.

Of course, you can also reach out to ACOG for help. We are here to educate, inform, and guide you on these changes and provide assistance to ensure your success. Send inquiries to: [email protected].

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For ObGyns to be successful, understanding the basics of quality and cost measurement is essential, along with devoting more attention to what they are being evaluated on and held accountable for. But how will ObGyns be impacted by the push to incentivize them for delivering value in their work?

Although much of health care policy has become politically divisive lately, one area of agreement is that, in the United States, we have unsustainable health costs and the exorbitant amount our country pays for health care does not translate to improved outcomes. The United States spends more than most other developed nations on health care (roughly, $9,403 per capita in 2014) but has some of the lowest life expectancies, along with the highest maternal and infant mortality rates, compared with peer nations.^1–4

One of the key culprits in our health system’s inefficiencies is the fee-for-service payment model. Fee-for-service incentivizes the delivery of a high volume of care without any way to determine whether that care is achieving the desired outcomes of improved health and quality of life. Not only does fee-for-service drive up the volume of care but it also rewards the delivery of high-cost services, regardless of whether those services provide what is best for the patient.

During the previous administration, Secretary of Health and Human Services Sylvia Mathews Burwell set goals for moving away from fee-for-service in Medicare and in the health system more broadly. Congress also passed legislation that provides incentives for Medicare providers to transition away from fee-for-service with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). While fee-for-service remains the predominant form of payment for many physicians, value-based payment arrangements are gaining a toehold. In 2014, 86% of physicians reported working in a practice receiving fee-for-service. Those fees accounted for nearly 72% of revenue.⁵ This percentage likely will continue to decrease over the next few years as government and private payers seek to promote value-based payment systems.

Assessing quality

“Value” in the context of health care is often defined as quality or outcomes relative to costs.⁶ Before payers can reward value, there must be measurement of performance to determine the quality of care being delivered. Quality measures are tools to help quantify access to care, processes, outcomes, patient experience, and organizational structure within the health care system. ObGyns likely encounter process, outcome, and patient experience measures most frequently in their practice.

Although outcome measures are generally held as the gold standard for quality measurement, they are often hard to obtain—either because of issues of temporality and rarity of events or because the data are hard to capture through existing formats. In lieu of measuring outcomes, process measures are often used to determine whether certain services that are known to be tied to desired health outcomes were delivered. Patient experience measures are also rising in popularity and are seen as a critical tool to ensuring that care that purports to be patient-centered actually is so.

Measures are specified to different levels of accountability, ranging from the individual physician all the way to the population. Some measures also can be specified at multiple levels. One major concern is the problem of attribution—that is, the difficulty of assigning who is primarily responsible for a specific quality metric result. Because obstetrics and gynecology is an increasingly team-based specialty, the American College of Obstetricians and Gynecologists (ACOG) recommends that measures that are used to reward or penalize providers should reflect performance at the care team or practice level, not at the individual physician or health care provider level.⁷ As consolidation of providers continues, it is expected that team-based care will increase and that the use of advanced practice providers will increase.⁸

Data to determine performance can come from a variety of sources, including claims, electronic health records (EHRs), paper medical record abstraction, birth certificates, registries, surveys, and separate reporting mechanisms. There are pros and cons of these various sources. Because administrative claims data are so easily obtainable, many measures have been developed based on this data source, but there are significant limitations to assessments made with such data. These limitations include inherent problems with translating clinical diagnoses into specific codes and inadequate documentation to support particular diagnoses and procedure codes.⁹ Claims data are limited by what physicians and other health care providers code for in their claims, making proper coding an essential skill for ObGyns to master.

Although there has been an increase in measures that rely on clinical data found in EHRs and registries—which are more robust and capture a wider breadth of indicators—claims-based measures still form the basis for many reporting programs because of standardization and ease of access to data. Data quality will become increasingly more important in a value-based payment world because completeness, risk adjustment, and specificity will be determined by the data recorded. This need for data quality will require that improvements be made in the user interface of EHRs and that providers pay specific attention to making sure their documentation is complete. New designs for EHRs should assist in that task, and data extraction should become a by-product of documentation.¹⁰

Read about alternative payment models and how ObGyns can succeed.

Paying for value

In an attempt to move away from fee-for-service medicine, payers and employers are adopting alternative payment models (APMs) that are intended to reward physicians and other health care providers for delivering value. Although APMs can be a catchall term, the Health Care Payment Learning and Action Network (LAN), a multi-stakeholder collaborative convened by the US Centers for Medicare & Medicaid Services, has laid out a framework for the different types of APMs¹¹ (FIGURE). This framework provides a common reference point for concepts related to value-based care.

Although ACOG does not endorse all the concepts and principles included in the LAN white paper, it does support moving away from fee-for-service payments that lack any link to quality or outcomes. Originally, the LAN envisioned that all physicians, providers, and hospital systems would move in the direction of adopting Category 4 APMs, but in the recent “refresh” of the LAN’s white paper, the authors recognized that not all entities will be able to move toward population-based payments—nor will it be beneficial for all providers to do so. ACOG agrees that not all ObGyns will be able to thrive under population-based payments, so we must lead the way in developing models and measures that appropriately assess value in the care that ObGyns provide.

ACOG has undertaken its first foray into value-based payments by developing an “episode group” related to benign hysterectomy, with attendant quality measures. (An episode group is a collection of services associated with treating a condition or performing a procedure that are both clinically and temporally related.) The goal in creating episode groups is to create alignment across payers so that ObGyns are not faced with multitudinous payer-specific metrics and reporting requirements. As the benign hysterectomy episode group is refined and adopted by payers, ACOG plans to expand to other treatments and, eventually, develop condition-based episode groups that incentivize the most appropriate treatment options for patients.

Current forms of APMs are mostly Category 2 and 3 models. Rates of proper screening for cervical and breast cancer have been used as performance metrics for bonus payments. Major payers have pushed specific metrics as cutoffs for limiting narrow networks.¹² For example, Covered California, the state health care exchange, has set a nulliparous term singleton vertex cesarean rate of 23.9% by 2018 as a necessary standard for inclusion of a hospital’s entire services (obstetric and nonobstetric) in their network. Episode group payments for total obstetric care included in the episode routine services, such as ultrasonography, have been previously utilized to discourage overutilization.

Such payment incentives can lead to underutilization of resources, however, which might lead to poorer outcomes and therefore result in overall greater cost. For example, poor screening for fetal anomalies or poorly managed medical conditions such as diabetes can lead to markedly increased costs in neonatal management. Therefore, some authorities have proposed tying incentives for obstetric care to performance outcome measures in neonatal care as a method of finding “sweet spots” for utilization of complex services and episode groups. Such models will depend on more robust clinical information sources and standardization.⁸

How can ObGyns succeed?

So what does success look like under these value-based payments for ObGyns? This is new territory, in a rapidly changing environment in which providers who flourished under the fee-for-service system will only survive under the new system if they become knowledgeable about the nuances of the new payment methods. Providers should understand that success is going to be defined as reaching the “Triple Aim”¹³ of improving the health of the population, containing costs, and improving the experience of health care.

Practice patient-centered care. One way to better position yourself is to focus on delivering patient-centered care and improving customer service in your practice. By implementing patient satisfaction surveys, you can identify where you are most vulnerable. One option is to utilize the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey, developed by the US Department of Health and Human Services’ Agency for Healthcare Research & Quality. However, there are other assessment tools available, and you should investigate what works best for your practice.

Code properly. Another key to making sure you are in an optimal position is to properly document and code the services you deliver. Accurately capturing the clinical complexity of your patients will help down the road with risk adjustment and risk stratification for cost and quality measures. Many payment models, including episode groups, are built on the fee-for-service system, so coding for services is still important in the transition to alternative models. Modern EHRs are building new tools to assist clinician documentation, such as tools that aid coding. Carefully groomed and up-to-date problem lists can help providers keep track of appropriate testing and screening by enabling decision support tools that are imbedded in the systems. Although upgrading can be expensive, especially for small group practices, the development of “software as a service” or cloud-based EHRs will likely drive individual costs down.¹⁰

One example of point-of-care decision support that ACOG is spearheading to support our Fellows is the ACOG Prenatal Record (APR) by Dorsata.¹⁴ The APR is an application designed by ObGyns to work seamlessly with an existing EHR system to improve clinical workflow, save time, and help ObGyns support high-quality prenatal outcomes. The APR uses the same simplicity, flexibility, and familiarity of the original paper-based flowsheet, but in an electronic format to integrate ACOG guidance, which provides a more robust solution. The APR uses information such as gestational age, pregnancy history, the problem list, and other risk factors to provide patient and visit-specific care plans based on ACOG clinical practice guidelines. It was designed to help reduce physician burden by creating an easy-to-navigate electronic flowsheet that provides everything ObGyns need to know about each patient, succinctly captured in a single view.

ACOG also offers comprehensive coding workshops across the country and webinars on special coding topics to help Fellows learn to properly code their services. Availing yourself of these educational opportunities now so that you are better prepared to transition to value-based payment is a great way to ensure success in the future.

Chances are that some of your payers are already requiring you to report on metrics or tracking your performance using claims data. Pay attention to the performance measures that you are being held accountable for by payers when you review your payer contracts. Make sure you understand how your patients may fall into and out of the measure numerators and denominators. Ask yourself whether these metrics are ones that you can reasonably influence and that are within your control.

Of course, you can also reach out to ACOG for help. We are here to educate, inform, and guide you on these changes and provide assistance to ensure your success. Send inquiries to: [email protected].

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

For ObGyns to be successful, understanding the basics of quality and cost measurement is essential, along with devoting more attention to what they are being evaluated on and held accountable for. But how will ObGyns be impacted by the push to incentivize them for delivering value in their work?

Although much of health care policy has become politically divisive lately, one area of agreement is that, in the United States, we have unsustainable health costs and the exorbitant amount our country pays for health care does not translate to improved outcomes. The United States spends more than most other developed nations on health care (roughly, $9,403 per capita in 2014) but has some of the lowest life expectancies, along with the highest maternal and infant mortality rates, compared with peer nations.^1–4

One of the key culprits in our health system’s inefficiencies is the fee-for-service payment model. Fee-for-service incentivizes the delivery of a high volume of care without any way to determine whether that care is achieving the desired outcomes of improved health and quality of life. Not only does fee-for-service drive up the volume of care but it also rewards the delivery of high-cost services, regardless of whether those services provide what is best for the patient.

During the previous administration, Secretary of Health and Human Services Sylvia Mathews Burwell set goals for moving away from fee-for-service in Medicare and in the health system more broadly. Congress also passed legislation that provides incentives for Medicare providers to transition away from fee-for-service with the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). While fee-for-service remains the predominant form of payment for many physicians, value-based payment arrangements are gaining a toehold. In 2014, 86% of physicians reported working in a practice receiving fee-for-service. Those fees accounted for nearly 72% of revenue.⁵ This percentage likely will continue to decrease over the next few years as government and private payers seek to promote value-based payment systems.

Assessing quality

“Value” in the context of health care is often defined as quality or outcomes relative to costs.⁶ Before payers can reward value, there must be measurement of performance to determine the quality of care being delivered. Quality measures are tools to help quantify access to care, processes, outcomes, patient experience, and organizational structure within the health care system. ObGyns likely encounter process, outcome, and patient experience measures most frequently in their practice.

Although outcome measures are generally held as the gold standard for quality measurement, they are often hard to obtain—either because of issues of temporality and rarity of events or because the data are hard to capture through existing formats. In lieu of measuring outcomes, process measures are often used to determine whether certain services that are known to be tied to desired health outcomes were delivered. Patient experience measures are also rising in popularity and are seen as a critical tool to ensuring that care that purports to be patient-centered actually is so.

Measures are specified to different levels of accountability, ranging from the individual physician all the way to the population. Some measures also can be specified at multiple levels. One major concern is the problem of attribution—that is, the difficulty of assigning who is primarily responsible for a specific quality metric result. Because obstetrics and gynecology is an increasingly team-based specialty, the American College of Obstetricians and Gynecologists (ACOG) recommends that measures that are used to reward or penalize providers should reflect performance at the care team or practice level, not at the individual physician or health care provider level.⁷ As consolidation of providers continues, it is expected that team-based care will increase and that the use of advanced practice providers will increase.⁸

Data to determine performance can come from a variety of sources, including claims, electronic health records (EHRs), paper medical record abstraction, birth certificates, registries, surveys, and separate reporting mechanisms. There are pros and cons of these various sources. Because administrative claims data are so easily obtainable, many measures have been developed based on this data source, but there are significant limitations to assessments made with such data. These limitations include inherent problems with translating clinical diagnoses into specific codes and inadequate documentation to support particular diagnoses and procedure codes.⁹ Claims data are limited by what physicians and other health care providers code for in their claims, making proper coding an essential skill for ObGyns to master.

Although there has been an increase in measures that rely on clinical data found in EHRs and registries—which are more robust and capture a wider breadth of indicators—claims-based measures still form the basis for many reporting programs because of standardization and ease of access to data. Data quality will become increasingly more important in a value-based payment world because completeness, risk adjustment, and specificity will be determined by the data recorded. This need for data quality will require that improvements be made in the user interface of EHRs and that providers pay specific attention to making sure their documentation is complete. New designs for EHRs should assist in that task, and data extraction should become a by-product of documentation.¹⁰

Read about alternative payment models and how ObGyns can succeed.

Paying for value

In an attempt to move away from fee-for-service medicine, payers and employers are adopting alternative payment models (APMs) that are intended to reward physicians and other health care providers for delivering value. Although APMs can be a catchall term, the Health Care Payment Learning and Action Network (LAN), a multi-stakeholder collaborative convened by the US Centers for Medicare & Medicaid Services, has laid out a framework for the different types of APMs¹¹ (FIGURE). This framework provides a common reference point for concepts related to value-based care.

Although ACOG does not endorse all the concepts and principles included in the LAN white paper, it does support moving away from fee-for-service payments that lack any link to quality or outcomes. Originally, the LAN envisioned that all physicians, providers, and hospital systems would move in the direction of adopting Category 4 APMs, but in the recent “refresh” of the LAN’s white paper, the authors recognized that not all entities will be able to move toward population-based payments—nor will it be beneficial for all providers to do so. ACOG agrees that not all ObGyns will be able to thrive under population-based payments, so we must lead the way in developing models and measures that appropriately assess value in the care that ObGyns provide.

ACOG has undertaken its first foray into value-based payments by developing an “episode group” related to benign hysterectomy, with attendant quality measures. (An episode group is a collection of services associated with treating a condition or performing a procedure that are both clinically and temporally related.) The goal in creating episode groups is to create alignment across payers so that ObGyns are not faced with multitudinous payer-specific metrics and reporting requirements. As the benign hysterectomy episode group is refined and adopted by payers, ACOG plans to expand to other treatments and, eventually, develop condition-based episode groups that incentivize the most appropriate treatment options for patients.

Current forms of APMs are mostly Category 2 and 3 models. Rates of proper screening for cervical and breast cancer have been used as performance metrics for bonus payments. Major payers have pushed specific metrics as cutoffs for limiting narrow networks.¹² For example, Covered California, the state health care exchange, has set a nulliparous term singleton vertex cesarean rate of 23.9% by 2018 as a necessary standard for inclusion of a hospital’s entire services (obstetric and nonobstetric) in their network. Episode group payments for total obstetric care included in the episode routine services, such as ultrasonography, have been previously utilized to discourage overutilization.

Such payment incentives can lead to underutilization of resources, however, which might lead to poorer outcomes and therefore result in overall greater cost. For example, poor screening for fetal anomalies or poorly managed medical conditions such as diabetes can lead to markedly increased costs in neonatal management. Therefore, some authorities have proposed tying incentives for obstetric care to performance outcome measures in neonatal care as a method of finding “sweet spots” for utilization of complex services and episode groups. Such models will depend on more robust clinical information sources and standardization.⁸

How can ObGyns succeed?

So what does success look like under these value-based payments for ObGyns? This is new territory, in a rapidly changing environment in which providers who flourished under the fee-for-service system will only survive under the new system if they become knowledgeable about the nuances of the new payment methods. Providers should understand that success is going to be defined as reaching the “Triple Aim”¹³ of improving the health of the population, containing costs, and improving the experience of health care.

Practice patient-centered care. One way to better position yourself is to focus on delivering patient-centered care and improving customer service in your practice. By implementing patient satisfaction surveys, you can identify where you are most vulnerable. One option is to utilize the Consumer Assessment of Healthcare Providers and Systems Clinician and Group Survey, developed by the US Department of Health and Human Services’ Agency for Healthcare Research & Quality. However, there are other assessment tools available, and you should investigate what works best for your practice.

Code properly. Another key to making sure you are in an optimal position is to properly document and code the services you deliver. Accurately capturing the clinical complexity of your patients will help down the road with risk adjustment and risk stratification for cost and quality measures. Many payment models, including episode groups, are built on the fee-for-service system, so coding for services is still important in the transition to alternative models. Modern EHRs are building new tools to assist clinician documentation, such as tools that aid coding. Carefully groomed and up-to-date problem lists can help providers keep track of appropriate testing and screening by enabling decision support tools that are imbedded in the systems. Although upgrading can be expensive, especially for small group practices, the development of “software as a service” or cloud-based EHRs will likely drive individual costs down.¹⁰

One example of point-of-care decision support that ACOG is spearheading to support our Fellows is the ACOG Prenatal Record (APR) by Dorsata.¹⁴ The APR is an application designed by ObGyns to work seamlessly with an existing EHR system to improve clinical workflow, save time, and help ObGyns support high-quality prenatal outcomes. The APR uses the same simplicity, flexibility, and familiarity of the original paper-based flowsheet, but in an electronic format to integrate ACOG guidance, which provides a more robust solution. The APR uses information such as gestational age, pregnancy history, the problem list, and other risk factors to provide patient and visit-specific care plans based on ACOG clinical practice guidelines. It was designed to help reduce physician burden by creating an easy-to-navigate electronic flowsheet that provides everything ObGyns need to know about each patient, succinctly captured in a single view.

ACOG also offers comprehensive coding workshops across the country and webinars on special coding topics to help Fellows learn to properly code their services. Availing yourself of these educational opportunities now so that you are better prepared to transition to value-based payment is a great way to ensure success in the future.

Chances are that some of your payers are already requiring you to report on metrics or tracking your performance using claims data. Pay attention to the performance measures that you are being held accountable for by payers when you review your payer contracts. Make sure you understand how your patients may fall into and out of the measure numerators and denominators. Ask yourself whether these metrics are ones that you can reasonably influence and that are within your control.

Of course, you can also reach out to ACOG for help. We are here to educate, inform, and guide you on these changes and provide assistance to ensure your success. Send inquiries to: [email protected].

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Daily application of topical fluorouracil for 4 weeks reduced the risk of developing squamous cell cancer (SCC) requiring surgery by 75% in a population of high-risk older adults.

The findings were published online Jan. 3 in JAMA Dermatology.

Although topical fluorouracil can help reduce actinic keratoses and cure some superficial basal cell and squamous cell carcinomas, it has not been studied as a strategy to prevent the development of lesions that might require surgery, wrote Martin A. Weinstock, MD, PhD, of Providence (R.I.) Veterans Affairs Medical Center, and his colleagues (JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631).

SOURCE: Weinstock, M et al. JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631.

Daily application of topical fluorouracil for 4 weeks reduced the risk of developing squamous cell cancer (SCC) requiring surgery by 75% in a population of high-risk older adults.

The findings were published online Jan. 3 in JAMA Dermatology.

Although topical fluorouracil can help reduce actinic keratoses and cure some superficial basal cell and squamous cell carcinomas, it has not been studied as a strategy to prevent the development of lesions that might require surgery, wrote Martin A. Weinstock, MD, PhD, of Providence (R.I.) Veterans Affairs Medical Center, and his colleagues (JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631).

SOURCE: Weinstock, M et al. JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631.

Daily application of topical fluorouracil for 4 weeks reduced the risk of developing squamous cell cancer (SCC) requiring surgery by 75% in a population of high-risk older adults.

The findings were published online Jan. 3 in JAMA Dermatology.

Although topical fluorouracil can help reduce actinic keratoses and cure some superficial basal cell and squamous cell carcinomas, it has not been studied as a strategy to prevent the development of lesions that might require surgery, wrote Martin A. Weinstock, MD, PhD, of Providence (R.I.) Veterans Affairs Medical Center, and his colleagues (JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631).

SOURCE: Weinstock, M et al. JAMA Dermatol. 2017 Jan 3. doi: 10.1001/jamadermatol.2017.3631.

ATLANTA – Adding the targeted agent sorafenib (Nexavar) to standard induction and consolidation chemotherapy in adults with acute myeloid leukemia (AML) significantly extended event-free survival out to more than 6 years and improved relapse-free survival, updated results from the SORAML trial showed.

At a median follow-up of 78 months, median event-free survival (EFS) – the primary endpoint – was 26 months in the chemotherapy plus sorafenib arm, compared with 9 months for chemotherapy plus placebo; these results translate to a hazard ratio for progression or death with sorafenib of 0.68 (P = .011), reported Christoph Röllig, MD, MSc, of University Hospital Carl Gustav Carus in Dresden, Germany.

SOURCE: Röllig C et al. ASH 2017 Abstract 721.

ATLANTA – Adding the targeted agent sorafenib (Nexavar) to standard induction and consolidation chemotherapy in adults with acute myeloid leukemia (AML) significantly extended event-free survival out to more than 6 years and improved relapse-free survival, updated results from the SORAML trial showed.

At a median follow-up of 78 months, median event-free survival (EFS) – the primary endpoint – was 26 months in the chemotherapy plus sorafenib arm, compared with 9 months for chemotherapy plus placebo; these results translate to a hazard ratio for progression or death with sorafenib of 0.68 (P = .011), reported Christoph Röllig, MD, MSc, of University Hospital Carl Gustav Carus in Dresden, Germany.

SOURCE: Röllig C et al. ASH 2017 Abstract 721.

ATLANTA – Adding the targeted agent sorafenib (Nexavar) to standard induction and consolidation chemotherapy in adults with acute myeloid leukemia (AML) significantly extended event-free survival out to more than 6 years and improved relapse-free survival, updated results from the SORAML trial showed.

At a median follow-up of 78 months, median event-free survival (EFS) – the primary endpoint – was 26 months in the chemotherapy plus sorafenib arm, compared with 9 months for chemotherapy plus placebo; these results translate to a hazard ratio for progression or death with sorafenib of 0.68 (P = .011), reported Christoph Röllig, MD, MSc, of University Hospital Carl Gustav Carus in Dresden, Germany.

SOURCE: Röllig C et al. ASH 2017 Abstract 721.

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

SAN ANTONIO – Adjuvant endocrine therapies improve outcomes of premenopausal breast cancer in the long term, with absolute benefit varying somewhat by therapy and by patient and disease characteristics, according to planned updates of a pair of pivotal phase 3 trials.

The trials – TEXT (Tamoxifen and Exemestane Trial) and SOFT (Suppression of Ovarian Function Trial) – are coordinated by the International Breast Cancer Study Group and together randomized more than 5,000 premenopausal women with early hormone receptor–positive breast cancer to 5 years of various types of adjuvant endocrine therapy. Their initial results, reported several years ago, form part of treatment guidelines that are used worldwide.

Clinical implications

These updates, along with other emerging data, can be used to optimize endocrine therapy for younger women with breast cancer, according to invited discussant Ann H. Partridge, MD, of Dana Farber Cancer Institute in Boston.

“For higher-risk disease, we should be considering OFS. At this point in time, I don’t think HER2 status alone should drive this decision,” she commented. “If you are getting OFS, what do we do, AI versus tamoxifen? Well, we do see a large improvement in disease-free survival [with AIs], so many women will want to use AIs. Yet tamoxifen is still reasonable, especially in light of the survival data.”

Data on switch strategies and extended-duration therapy are generally lacking at present for the premenopausal population, Dr. Partridge noted. “That’s something that we still need to extrapolate from data that’s predominantly in postmenopausal women.”

Another compelling question is whether OFS can be used instead of chemo for some patients. “We are increasingly recognizing that women with higher-risk anatomy and lower-risk biology having endocrine-responsive tumors may get more bang for the buck from the optimizing of hormonal therapy, and chemo may not add much,” she said.

Both short- and long-term toxicities of the various endocrine therapies and, for aromatase inhibitors, the potential for breakthrough (return of estradiol levels to premenopausal levels) also need to be considered, Dr. Partridge stressed. “And ultimately, patient preference and tolerance are key. After all, the best treatment is the one the patient will take.”

“We need to follow these women on TEXT and SOFT very long term. It would be a crime not to follow these women further out,” she maintained. “We need to conduct real-world comparative effectiveness research to understand the risks and benefits of OFS more fully in our survivors. Then, as we start to suppress more ovaries in more women with breast cancer, we need to be aware clinically of these risks, and we need to share this awareness with their primary care providers because we need to optimize in particular their cardiovascular risk factors, and screen and treat for potential comorbidities that they may be at higher risk for.”
 

Joint TEXT and SOFT update

Initial results of the joint TEXT and SOFT analysis, reported after a median follow-up of 5.7 years, showed that exemestane plus OFS was superior to tamoxifen plus OFS for the primary outcome, providing a significant 3.8% absolute gain in 5-year disease-free survival (N Engl J Med. 2014;371:107-18).

The updated joint analysis, now with a median follow-up of 9 years and based on data from 4,690 women, showed that the 8-year rate of disease-free survival was 86.8% with exemestane plus OFS versus 82.8% with tamoxifen plus OFS (hazard ratio, 0.77; P = .0006), for a similar absolute benefit of 4.0%, reported Prudence Francis, MD, of the University of Melbourne, head of Medical Oncology in the Breast Service at the Peter MacCallum Cancer Centre, Melbourne.

In stratified analysis, absolute benefit tended to be greater among women in TEXT who received chemotherapy (6.0%); intermediate among women in TEXT who did not receive chemotherapy (3.7%) and women in SOFT who received prior chemotherapy (3.7%); and less among women in SOFT who did not receive chemotherapy (1.9%).

Exemestane plus OFS was also superior to tamoxifen plus OFS in terms of breast cancer–free interval, with an absolute 4.1% benefit (P = .0002), and distant recurrence–free interval, with an absolute 2.1% benefit (P = .02). Overall survival did not differ significantly between arms.

Among the 86% of patients with HER2-negative disease, exemestane plus OFS netted an absolute disease-free survival gain of 5.4% and an absolute distant recurrence–free interval gain of 3.4%. There was a consistent relative treatment benefit across subgroups, but larger absolute benefit, on the order of 5%-9%, in women given chemotherapy and in those younger than 35 years.

“Results for the HER2-positive subgroup require further investigation,” Dr. Francis said. “The trials enrolled both before and after the routine use of adjuvant trastuzumab, and a significant proportion of the patients with HER2-positive breast cancer did not receive adjuvant HER2-targeted therapy.”

In the entire joint-analysis population, exemestane plus OFS was associated with higher rates of musculoskeletal events of grade 3 or 4 (11% vs. 6%) and osteoporosis of grade 2-4 (15% vs. 7%), while tamoxifen plus OFS was associated with a higher rate of thrombosis/embolism of grade 2-4 (2.3% vs. 1.2%) and more cases of endometrial cancer (9 vs. 4 cases). At 4 years, early discontinuation of oral endocrine therapy was greater for exemestane than for tamoxifen (25% vs. 19%).

“After longer follow-up, with a median of 9 years, the combined analysis results confirm a statistically significant improvement in disease outcomes with exemestane plus ovarian suppression. As is critical given the long natural history of estrogen receptor–positive breast cancer, follow-up in these trials is currently continuing,” Dr. Francis summarized.

“To optimally translate the observed absolute trial improvements into clinical practice, oncologists need to discuss and weigh the potential benefits and toxicities in each individual patient who is premenopausal with hormone receptor–positive breast cancer,” she recommended.

Session attendee Hope S. Rugo, MD, of the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, noted that exemestane had superior benefit despite the 25% rate of early discontinuation. “I wonder if one of the interpretations of that, given the toxicity of this therapy for very young women, is that we need some but maybe not so much. Maybe they don’t need 5 years altogether,” she said.

“The fact that they stopped their assigned endocrine therapy doesn’t mean that they didn’t continue any therapy. They may have switched over to tamoxifen or they may have decided they wanted to have a baby or there may have been many other things,” Dr. Francis replied, noting that analyses sorting out the reasons for early discontinuation are planned.

Session attendee Mark E. Sherman, MD, of the Mayo Clinic, Jacksonville, Fla., asked, “Do you have any ability to test for tamoxifen metabolites? It’s possible that a third to a half of patients got reduced benefit from that drug.”

Banked samples are available and a substudy is planned, according to Dr. Francis. “We haven’t got data on that yet, but yes, we are analyzing that.”
 

SOFT update

Initial results of the SOFT trial, reported after a median follow-up of 5.6 years, showed that adding OFS to tamoxifen did not significantly improve disease-free survival over tamoxifen alone in the entire trial population (N Engl J Med. 2015;372:436-46). However, there was benefit for women who received chemotherapy and remained premenopausal.

The updated SOFT analysis, now with a median follow-up of 8 years, focused mainly on the 1,018 women given tamoxifen alone and the 1,015 women given tamoxifen plus OFS. (Another 1,014 women were given exemestane plus OFS.)

“SOFT is now positive for its primary endpoint,” reported first author Gini Fleming, MD, director of the Medical Oncology Breast Program and medical oncology director of Gynecologic Oncology at University of Chicago Medicine. The 8-year disease-free survival rate was 83.2% with tamoxifen plus OFS, compared with 78.9% with tamoxifen alone (HR, 0.76; P = .009), corresponding to a 4.2% gain in this outcome. The relative benefit was identical whether patients had received chemotherapy or not, but absolute benefit was greater for those who had (5.3%), as well as for patients younger than 35 years (8.7%).

In addition, exemestane plus OFS was superior to tamoxifen alone (85.9% vs. 78.9%; HR, 0.65), with an absolute benefit of 7.0%. Again, absolute benefit was more pronounced among women who had received prior chemotherapy (9.0%) or were younger than 35 years (13.1%).

The relative disease-free survival benefit of tamoxifen plus OFS over tamoxifen alone was similar across most subgroups stratified by disease characteristics, but patients with HER2-positive disease derived greater relative benefit from the combination as compared with their HER2-negative counterparts (P = .04 for interaction). “When we look at the combination of exemestane plus OFS versus tamoxifen, this heterogeneity is no longer seen,” Dr. Fleming noted.

In the entire trial population, there was no significant benefit of tamoxifen plus OFS over tamoxifen alone for distant recurrence-free interval and a small, significant absolute 1.9% gain in overall survival.

“The cohort who had elected to receive no prior chemotherapy did exceedingly well regardless of therapy,” she said, with little difference in overall survival across the three arms. “There were only 24 deaths total in this cohort, and 12 of those deaths were in the setting of no distant recurrence.”

On the other hand, among the women who received chemotherapy, there were significant absolute overall survival benefits of 4.3% with tamoxifen plus OFS and 2.1% with exemestane plus OFS, over tamoxifen alone. “This late emergence of an overall survival benefit is consistent with the time course of events in estrogen receptor–positive breast cancer,” Dr. Fleming commented.

The proportion of patients who stopped their oral endocrine therapy early was 22.5% with tamoxifen alone and 18.5% with tamoxifen plus OFS. (It was 27.8% with exemestane plus OFS.) “Almost a quarter of the patients on either tamoxifen arm were using extended oral endocrine therapy at 6 years or later prior to any disease progression. Only about 12% of patients in the exemestane group were doing so,” she noted.

There were more cases of endometrial cancer with tamoxifen alone than with tamoxifen plus OFS (7 vs. 4 cases). Thrombosis/embolism of grade 2-4 occurred in 2.2% of each group (and 0.9% of the exemestane plus OFS group). Musculoskeletal symptoms of grade 3 or 4 occurred in 6.7% of patients with tamoxifen alone and 5.9% with tamoxifen plus OFS, but 12.0% with exemestane plus OFS. Respective rates of osteoporosis grade 2-4 were 3.9%, 6.1%, and 11.9%.

“The addition of OFS to tamoxifen significantly improves disease-free survival at 8 years’ median follow-up, and disease-free survival benefits are further improved by the use of exemestane plus OFS,” Dr. Fleming summarized. “Follow-up, which is critically important given the long natural history of ER-positive disease, continues.”

Session attendee Matthew P. Goetz, MD, of the Mayo Clinic, Rochester, Minn., commented, “For the primary endpoint, I was looking at the tail for tamoxifen. It seemed that there was a relatively rapid drop-off between year 5 and this 8-year follow-up. Have you looked carefully to see whether there is a difference between those who stayed on their therapy versus those who went off it per protocol? That is, extended versus not extended? The question is whether there is a carry-over effect, if you will, that is different in those with OFS versus those not.”

“The percent who went on to extended therapy between the tamoxifen and the tamoxifen plus OFS was fairly similar,” Dr. Fleming replied. “But the answer is no, we have not yet done any sort of per protocol analysis.”

Session attendee Steven Vogl, MD, of Montefiore Medical Center, New York, commented, “I worry about your control group. I’m worried, first, how many of your tamoxifen patients lost their menses and became postmenopausal in those 5 years? And of those, why didn’t they switch to an aromatase inhibitor? Only 25% of the patients continued after the 5 years according to your slide, and all of those patients should either have stayed on tamoxifen or switched to an aromatase inhibitor, now probably for 2 years at least.”

“We have not yet looked at data for who became amenorrheic during treatment, although we have it. However, it’s certainly possible to become amenorrheic on tamoxifen and not be postmenopausal, and we didn’t regularly collect estradiol levels on any but the very small subset of women in the SOFT-S trial. So I don’t know that we have exactly the data that you’re looking for,” Dr. Fleming said. “Many of these women are obviously at very, very low risk and have done well with 5 years of tamoxifen alone, and I don’t know, even given current guidelines, that extended tamoxifen would add a lot to that.”

Finally, session attendee Richard Gray, professor of medical statistics at the University of Oxford (England), wondered, “What is the certainty that follow-up will happen? Because obviously, prolonged follow-up is expensive and there are controversies about that. But this would be the one study you would really want to have 15- and 20-year data on.”

“We are working very, very hard on that,” Dr. Fleming replied. “NCI granted additional funds to institutions for prolonging follow-up, and IBCSG has been ceaselessly working to look for funding to continue it. So I think it’s relatively certain that it will happen.”

Dr. Francis disclosed that she has received fees for non-CME services from AstraZeneca and has given an overseas lecture for Pfizer. Dr. Fleming disclosed that she had no relevant financial relationships with commercial interests. The trials received financial support from Pfizer and Ipsen.

SOURCES: Francis et al. SABCS Abstract GS4-02; Fleming et al. SABCS Abstract GS4-03
 

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

[email protected]

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

[email protected]

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

[email protected]

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

In the United States, circumcision is the fourth most common surgical procedure—behind cataract removal, cesarean delivery, and joint replacement.¹ This operation, which dates to ancient times, is chosen for medical, personal, or religious reasons. It is performed on 77% of males born in the United States and on 42% of those born elsewhere who are living in this country.² Whether it is performed depends not only on the parents’ race, ethnic background, and religion but also on region: US circumcision rates range from 74% in the Midwest to 30% in the West, and in between are the Northeast (67%) and the South (61%).³

Circumcision is not without controversy. Some claim that it is unnecessary cosmetic surgery, that it is genital mutilation, that the patient cannot choose it or object to it, or that it decreases sexual satisfaction.

In this article, I review 8 common questions about circumcision and provide data-based answers to them.

1. Should a newborn be circumcised?

For many years, the medical benefits of circumcision were scientifically ambiguous. With no clear answers, some thought that parents should base their decision for or against circumcision not on any potential medical benefit but rather on their family or religious tradition, or on a social standard, that is, what the majority of families in their community do.

Over the past 20 years, a growing body of evidence has demonstrated real medical benefits of circumcision. In 2012, the American Academy of Pediatrics (AAP), which previously had been neutral on the subject, issued a task force report concluding that the health benefits of circumcision outweigh its risks and justify access to the procedure.^3,4 However, the report stopped short of recommending circumcision.

Opponents have expressed several concerns about circumcision. First, they say, it is painful and unnecessary, and performing it when life has just begun takes the decision away from the adult-to-be, who may want to be uncircumcised as an adult but will have no recourse. Second, they say circumcision will diminish the adult’s sexual pleasure. However, there is no proof this occurs, and it is unclear how the claim could be adequately verified.⁵

2. What is the best analgesia for circumcision?

Although in decades past circumcision was often performed without any analgesia, in the United States analgesia is now standard of care. The AAP Task Force on Circumcision formalized this standard in a 2012 policy statement.⁴ For newborn circumcision, analgesia can be given in the form of analgesic cream, penile ring block, or dorsal nerve block.

Analgesic EMLA cream (a mixture of local anesthetics such as lidocaine 2.5%/prilocaine 2.5%) is easy to use but is minimally effective in relieving circumcision pain,⁶ although some investigators have reported it is efficacious compared with placebo.⁷ When used, the analgesic cream is applied 30 to 60 minutes before circumcision.

Both penile ring block and dorsal nerve block with 1% lidocaine are easy to administer and are very effective.^8,9 They are best used with buffered lidocaine, which partially relieves the burning that occurs with injection. With both methods, the smaller the needle used (preferably 30 gauge), the better.

These 2 block methods have different injection sites. For the ring block, small amounts of lidocaine (1 to 1.5 mL) are given in a series of injections around the entire circumference of the base of the penis. The dorsal block targets the 2 dorsal nerves located at 10 o’clock and 2 o’clock at the base of the penis. Epinephrine, given its vasoconstrictive properties and the potential for necrosis, should never be used with local analgesia for penile infiltration.

Analgesia can be supplemented with comfort measures, such as a pacifier, sugar water, gentle rubbing on the forehead, and soothing speech.¹⁰

Related article:
Circumcision impedes viral disease. Will opposition fade?

3. What conditions are required for safe circumcision?

As circumcision is not medically required and need not occur in the days immediately after birth, it should be performed only when conditions are optimal:

• A pediatrician or other practitioner must first examine the newborn.
• The newborn must be full-term, healthy, and stable.
  • The best time to circumcise a baby born prematurely is right before discharge from the intensive care nursery.
• The penis must be of normal size and without anatomical defect—no micropenis, hypospadias, or penoscrotal webbing.
• The lower abdominal fat pad must not be so large that it will cause the shaft’s skin to cover the exposed penile head.
• If there is a family history of a bleeding disorder, the newborn must be evaluated for the disorder before the circumcision.
• The newborn must have received his vitamin K shot.

4. What is the best circumcision method?

Circumcision can be performed with the Gomco circumcision clamp, the Mogen circumcision clamp, or the PlastiBell circumcision device. Each device works well, provides excellent results, and has its pluses and minuses. Practitioners should use the device with which they are most familiar and comfortable, which likely will be the device they used in training.

In the United States, the Gomco clamp is perhaps the most commonly used device. It provides good cosmetic results, and its metal “bell” protects the entire head of the penis. Of the 3 methods, however, it is the most difficult—the partially cut foreskin must be threaded between the bell and the clamp frame before the clamp is tightened. In many cases, too, there is bleeding at the penile frenulum.

The Mogen clamp, another commonly used device, also is used in traditional Jewish circumcisions. Of the 3 methods, it is the quickest, produces the best hemostasis, and is associated with the least discomfort.¹⁰ To those unfamiliar with the method, there may seem to be a potential for amputation of the head of the penis, but actually there virtually is no risk, as an indentation on the penile side of the clamp protects the penile head.

The PlastiBell device is very easy to use but must stay on until the foreskin becomes necrotic and the bell and foreskin fall off on their own—a process that takes 7 to 10 days. Many parents dislike this method because its final result is not immediate and they have to contend with a medical implement during their newborn’s first week home.

Electrocautery is not recommended. Some clinicians, especially urologists, use electrocautery as the cutting mechanism for circumcision. A review of the literature, however, reveals that electrocautery has not been studied head-to-head against traditional techniques, and that various significant complications—transected penile head, severe burns, meatal stenosis—have been reported.^11,12 It is certainly not a mainstream procedure for neonatal circumcision.

Evaluate penile anatomy for abnormalities

Before performing any circumcision, the head of the penis should be examined to rule out hypospadias or other penile abnormalities. This is because the foreskin is utilized in certain penile repair procedures. The pediatrician should perform an initial examination of the penis at the formal newborn physical within 24 hours of delivery. The clinician performing the circumcision should re-examine the penis just before the procedure is begun—by pushing back the foreskin as much as possible—as well as during the procedure, once the foreskin is lifted off the penile head but before the foreskin is excised.

Read about how to ensure the best outcome of circumcision.

5. When is the best time to perform a circumcision?

The medical literature provides no firm answer to this question. The younger the baby, the easier it is to perform a circumcision as a simple procedure with local anesthesia. The older the baby, the larger the penis and the more aware the baby will be of his surroundings. Both these factors will make the procedure more difficult.

Most clinicians would be reluctant to perform a circumcision in the office or clinic after the baby is 6 to 8 weeks old. If a family desires their son to be circumcised after that time—or a medical condition precludes earlier circumcision—the procedure is best performed by a pediatric urologist in the operating room.

Related article:
Circumcision accident: $1.3M verdict

6. What are the potential complications of circumcision?

The rate of circumcision complications is very low: 0.2%.¹³ That being said, the 3 most common types of complications are postoperative bleeding, infection, and damage to the penis.

Far and away the most common complication is postoperative bleeding , usually at the frenulum of the head of the penis (the 6 o’clock position). In most cases, the bleeding is light to moderate. It is controlled with direct pressure applied for several minutes, the use of processed gelatin (Gelfoam) or cellulose (Surgicel), sparing use of silver nitrate, or placement of a polyglycolic acid (Vicryl) 5-0 suture.

Infection, an unusual occurrence, is seen within 24 to 72 hours after circumcision. It is marked by swelling, redness, and a foul-smelling mucus discharge. This discharge must be differentiated from dried fibrin, which is commonly seen on the head of the penis in the days after circumcision but has no odor or association with erythema, fever, or infant fussiness. True infection should be treated, in collaboration with the child’s pediatrician, with a staphylococcal-sensitive penicillin (such as dicloxacillin).

More serious is damage to the penis, which ranges from accidental dilation of the meatus to partial amputation of the penile glans. Any such injury should immediately prompt a consultation with a pediatric urologist.

More of a nuisance than a complication is the sliding of the penile shaft’s skin up and over the glans. This is a relatively frequent occurrence after normal, successful circumcisions. Parents of an affected newborn should be instructed to gently slide the skin back until the head of the penis is completely exposed again. After several days, the skin will adhere to its proper position on the shaft.

7. What is a Jewish ritual circumcision?

For their newborn’s circumcision, Jewish parents may choose a bris ceremony, formally called a brit milah, in fulfillment of religious tradition. The ceremony involves a brief religious service, circumcision with the traditional Mogen clamp, a special blessing, and an official religious naming rite. The bris traditionally is performed by a mohel, a rabbi or other religious official trained in circumcision. Many parents have the bris done by a mohel who is a medical doctor. In the United States, the availability of both types of mohels varies.

8. Who should perform circumcisions—obstetricians or pediatricians?

The answer to this question depends on where you practice. In some communities or hospitals, the obstetrician performs newborn circumcision, while in other places the pediatrician does. In addition, depending on local circumstances or the specific population involved, circumcisions may be performed by a pediatric urologist, nurse practitioner, or even out of hospital by a trained religiously affiliated practitioner.

Obstetricians began doing circumcisions for 2 reasons. First, obstetricians are surgically trained whereas pediatricians are not. It was therefore thought to be more appropriate for obstetricians to do this minor surgical procedure. Second, circumcisions used to be done right in the delivery room shortly after delivery. It was thought that the crying induced by performing the circumcision helped clear the baby’s lungs and invigorated sluggish babies. Now, however, in-hospital circumcisions are usually done in the days following delivery, after the baby has had the opportunity to undergo his first physical examination to make sure that all is well and that the penile anatomy is normal.

Clinician experience, proper protocol contribute to a safe procedure

In the United States, a large percentage of male infants are circumcised. Although circumcision has known medical benefits, the procedure generally is performed for family, religious, or cultural reasons. Circumcision is a safe and straightforward procedure but has its risks and potential complications. As with most surgeries, the best outcomes are achieved by practitioners who are well trained, who perform the procedure under supervision until their experience is sufficient, and who follow correct protocol during the entire operation.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In the United States, circumcision is the fourth most common surgical procedure—behind cataract removal, cesarean delivery, and joint replacement.¹ This operation, which dates to ancient times, is chosen for medical, personal, or religious reasons. It is performed on 77% of males born in the United States and on 42% of those born elsewhere who are living in this country.² Whether it is performed depends not only on the parents’ race, ethnic background, and religion but also on region: US circumcision rates range from 74% in the Midwest to 30% in the West, and in between are the Northeast (67%) and the South (61%).³

Circumcision is not without controversy. Some claim that it is unnecessary cosmetic surgery, that it is genital mutilation, that the patient cannot choose it or object to it, or that it decreases sexual satisfaction.

In this article, I review 8 common questions about circumcision and provide data-based answers to them.

1. Should a newborn be circumcised?

For many years, the medical benefits of circumcision were scientifically ambiguous. With no clear answers, some thought that parents should base their decision for or against circumcision not on any potential medical benefit but rather on their family or religious tradition, or on a social standard, that is, what the majority of families in their community do.

Over the past 20 years, a growing body of evidence has demonstrated real medical benefits of circumcision. In 2012, the American Academy of Pediatrics (AAP), which previously had been neutral on the subject, issued a task force report concluding that the health benefits of circumcision outweigh its risks and justify access to the procedure.^3,4 However, the report stopped short of recommending circumcision.

Opponents have expressed several concerns about circumcision. First, they say, it is painful and unnecessary, and performing it when life has just begun takes the decision away from the adult-to-be, who may want to be uncircumcised as an adult but will have no recourse. Second, they say circumcision will diminish the adult’s sexual pleasure. However, there is no proof this occurs, and it is unclear how the claim could be adequately verified.⁵

2. What is the best analgesia for circumcision?

Although in decades past circumcision was often performed without any analgesia, in the United States analgesia is now standard of care. The AAP Task Force on Circumcision formalized this standard in a 2012 policy statement.⁴ For newborn circumcision, analgesia can be given in the form of analgesic cream, penile ring block, or dorsal nerve block.

Analgesic EMLA cream (a mixture of local anesthetics such as lidocaine 2.5%/prilocaine 2.5%) is easy to use but is minimally effective in relieving circumcision pain,⁶ although some investigators have reported it is efficacious compared with placebo.⁷ When used, the analgesic cream is applied 30 to 60 minutes before circumcision.

Both penile ring block and dorsal nerve block with 1% lidocaine are easy to administer and are very effective.^8,9 They are best used with buffered lidocaine, which partially relieves the burning that occurs with injection. With both methods, the smaller the needle used (preferably 30 gauge), the better.

These 2 block methods have different injection sites. For the ring block, small amounts of lidocaine (1 to 1.5 mL) are given in a series of injections around the entire circumference of the base of the penis. The dorsal block targets the 2 dorsal nerves located at 10 o’clock and 2 o’clock at the base of the penis. Epinephrine, given its vasoconstrictive properties and the potential for necrosis, should never be used with local analgesia for penile infiltration.

Analgesia can be supplemented with comfort measures, such as a pacifier, sugar water, gentle rubbing on the forehead, and soothing speech.¹⁰

Related article:
Circumcision impedes viral disease. Will opposition fade?

3. What conditions are required for safe circumcision?

As circumcision is not medically required and need not occur in the days immediately after birth, it should be performed only when conditions are optimal:

• A pediatrician or other practitioner must first examine the newborn.
• The newborn must be full-term, healthy, and stable.
  • The best time to circumcise a baby born prematurely is right before discharge from the intensive care nursery.
• The penis must be of normal size and without anatomical defect—no micropenis, hypospadias, or penoscrotal webbing.
• The lower abdominal fat pad must not be so large that it will cause the shaft’s skin to cover the exposed penile head.
• If there is a family history of a bleeding disorder, the newborn must be evaluated for the disorder before the circumcision.
• The newborn must have received his vitamin K shot.

4. What is the best circumcision method?

Circumcision can be performed with the Gomco circumcision clamp, the Mogen circumcision clamp, or the PlastiBell circumcision device. Each device works well, provides excellent results, and has its pluses and minuses. Practitioners should use the device with which they are most familiar and comfortable, which likely will be the device they used in training.

In the United States, the Gomco clamp is perhaps the most commonly used device. It provides good cosmetic results, and its metal “bell” protects the entire head of the penis. Of the 3 methods, however, it is the most difficult—the partially cut foreskin must be threaded between the bell and the clamp frame before the clamp is tightened. In many cases, too, there is bleeding at the penile frenulum.

The Mogen clamp, another commonly used device, also is used in traditional Jewish circumcisions. Of the 3 methods, it is the quickest, produces the best hemostasis, and is associated with the least discomfort.¹⁰ To those unfamiliar with the method, there may seem to be a potential for amputation of the head of the penis, but actually there virtually is no risk, as an indentation on the penile side of the clamp protects the penile head.

The PlastiBell device is very easy to use but must stay on until the foreskin becomes necrotic and the bell and foreskin fall off on their own—a process that takes 7 to 10 days. Many parents dislike this method because its final result is not immediate and they have to contend with a medical implement during their newborn’s first week home.

Electrocautery is not recommended. Some clinicians, especially urologists, use electrocautery as the cutting mechanism for circumcision. A review of the literature, however, reveals that electrocautery has not been studied head-to-head against traditional techniques, and that various significant complications—transected penile head, severe burns, meatal stenosis—have been reported.^11,12 It is certainly not a mainstream procedure for neonatal circumcision.

Evaluate penile anatomy for abnormalities

Before performing any circumcision, the head of the penis should be examined to rule out hypospadias or other penile abnormalities. This is because the foreskin is utilized in certain penile repair procedures. The pediatrician should perform an initial examination of the penis at the formal newborn physical within 24 hours of delivery. The clinician performing the circumcision should re-examine the penis just before the procedure is begun—by pushing back the foreskin as much as possible—as well as during the procedure, once the foreskin is lifted off the penile head but before the foreskin is excised.

Read about how to ensure the best outcome of circumcision.

5. When is the best time to perform a circumcision?

The medical literature provides no firm answer to this question. The younger the baby, the easier it is to perform a circumcision as a simple procedure with local anesthesia. The older the baby, the larger the penis and the more aware the baby will be of his surroundings. Both these factors will make the procedure more difficult.

Most clinicians would be reluctant to perform a circumcision in the office or clinic after the baby is 6 to 8 weeks old. If a family desires their son to be circumcised after that time—or a medical condition precludes earlier circumcision—the procedure is best performed by a pediatric urologist in the operating room.

Related article:
Circumcision accident: $1.3M verdict

6. What are the potential complications of circumcision?

The rate of circumcision complications is very low: 0.2%.¹³ That being said, the 3 most common types of complications are postoperative bleeding, infection, and damage to the penis.

Far and away the most common complication is postoperative bleeding , usually at the frenulum of the head of the penis (the 6 o’clock position). In most cases, the bleeding is light to moderate. It is controlled with direct pressure applied for several minutes, the use of processed gelatin (Gelfoam) or cellulose (Surgicel), sparing use of silver nitrate, or placement of a polyglycolic acid (Vicryl) 5-0 suture.

Infection, an unusual occurrence, is seen within 24 to 72 hours after circumcision. It is marked by swelling, redness, and a foul-smelling mucus discharge. This discharge must be differentiated from dried fibrin, which is commonly seen on the head of the penis in the days after circumcision but has no odor or association with erythema, fever, or infant fussiness. True infection should be treated, in collaboration with the child’s pediatrician, with a staphylococcal-sensitive penicillin (such as dicloxacillin).

More serious is damage to the penis, which ranges from accidental dilation of the meatus to partial amputation of the penile glans. Any such injury should immediately prompt a consultation with a pediatric urologist.

More of a nuisance than a complication is the sliding of the penile shaft’s skin up and over the glans. This is a relatively frequent occurrence after normal, successful circumcisions. Parents of an affected newborn should be instructed to gently slide the skin back until the head of the penis is completely exposed again. After several days, the skin will adhere to its proper position on the shaft.

7. What is a Jewish ritual circumcision?

For their newborn’s circumcision, Jewish parents may choose a bris ceremony, formally called a brit milah, in fulfillment of religious tradition. The ceremony involves a brief religious service, circumcision with the traditional Mogen clamp, a special blessing, and an official religious naming rite. The bris traditionally is performed by a mohel, a rabbi or other religious official trained in circumcision. Many parents have the bris done by a mohel who is a medical doctor. In the United States, the availability of both types of mohels varies.

8. Who should perform circumcisions—obstetricians or pediatricians?

The answer to this question depends on where you practice. In some communities or hospitals, the obstetrician performs newborn circumcision, while in other places the pediatrician does. In addition, depending on local circumstances or the specific population involved, circumcisions may be performed by a pediatric urologist, nurse practitioner, or even out of hospital by a trained religiously affiliated practitioner.

Obstetricians began doing circumcisions for 2 reasons. First, obstetricians are surgically trained whereas pediatricians are not. It was therefore thought to be more appropriate for obstetricians to do this minor surgical procedure. Second, circumcisions used to be done right in the delivery room shortly after delivery. It was thought that the crying induced by performing the circumcision helped clear the baby’s lungs and invigorated sluggish babies. Now, however, in-hospital circumcisions are usually done in the days following delivery, after the baby has had the opportunity to undergo his first physical examination to make sure that all is well and that the penile anatomy is normal.

Clinician experience, proper protocol contribute to a safe procedure

In the United States, a large percentage of male infants are circumcised. Although circumcision has known medical benefits, the procedure generally is performed for family, religious, or cultural reasons. Circumcision is a safe and straightforward procedure but has its risks and potential complications. As with most surgeries, the best outcomes are achieved by practitioners who are well trained, who perform the procedure under supervision until their experience is sufficient, and who follow correct protocol during the entire operation.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

In the United States, circumcision is the fourth most common surgical procedure—behind cataract removal, cesarean delivery, and joint replacement.¹ This operation, which dates to ancient times, is chosen for medical, personal, or religious reasons. It is performed on 77% of males born in the United States and on 42% of those born elsewhere who are living in this country.² Whether it is performed depends not only on the parents’ race, ethnic background, and religion but also on region: US circumcision rates range from 74% in the Midwest to 30% in the West, and in between are the Northeast (67%) and the South (61%).³

Circumcision is not without controversy. Some claim that it is unnecessary cosmetic surgery, that it is genital mutilation, that the patient cannot choose it or object to it, or that it decreases sexual satisfaction.

In this article, I review 8 common questions about circumcision and provide data-based answers to them.

1. Should a newborn be circumcised?

For many years, the medical benefits of circumcision were scientifically ambiguous. With no clear answers, some thought that parents should base their decision for or against circumcision not on any potential medical benefit but rather on their family or religious tradition, or on a social standard, that is, what the majority of families in their community do.

Over the past 20 years, a growing body of evidence has demonstrated real medical benefits of circumcision. In 2012, the American Academy of Pediatrics (AAP), which previously had been neutral on the subject, issued a task force report concluding that the health benefits of circumcision outweigh its risks and justify access to the procedure.^3,4 However, the report stopped short of recommending circumcision.

Opponents have expressed several concerns about circumcision. First, they say, it is painful and unnecessary, and performing it when life has just begun takes the decision away from the adult-to-be, who may want to be uncircumcised as an adult but will have no recourse. Second, they say circumcision will diminish the adult’s sexual pleasure. However, there is no proof this occurs, and it is unclear how the claim could be adequately verified.⁵

2. What is the best analgesia for circumcision?

Although in decades past circumcision was often performed without any analgesia, in the United States analgesia is now standard of care. The AAP Task Force on Circumcision formalized this standard in a 2012 policy statement.⁴ For newborn circumcision, analgesia can be given in the form of analgesic cream, penile ring block, or dorsal nerve block.

Analgesic EMLA cream (a mixture of local anesthetics such as lidocaine 2.5%/prilocaine 2.5%) is easy to use but is minimally effective in relieving circumcision pain,⁶ although some investigators have reported it is efficacious compared with placebo.⁷ When used, the analgesic cream is applied 30 to 60 minutes before circumcision.

Both penile ring block and dorsal nerve block with 1% lidocaine are easy to administer and are very effective.^8,9 They are best used with buffered lidocaine, which partially relieves the burning that occurs with injection. With both methods, the smaller the needle used (preferably 30 gauge), the better.

These 2 block methods have different injection sites. For the ring block, small amounts of lidocaine (1 to 1.5 mL) are given in a series of injections around the entire circumference of the base of the penis. The dorsal block targets the 2 dorsal nerves located at 10 o’clock and 2 o’clock at the base of the penis. Epinephrine, given its vasoconstrictive properties and the potential for necrosis, should never be used with local analgesia for penile infiltration.

Analgesia can be supplemented with comfort measures, such as a pacifier, sugar water, gentle rubbing on the forehead, and soothing speech.¹⁰

Related article:
Circumcision impedes viral disease. Will opposition fade?

3. What conditions are required for safe circumcision?

As circumcision is not medically required and need not occur in the days immediately after birth, it should be performed only when conditions are optimal:

• A pediatrician or other practitioner must first examine the newborn.
• The newborn must be full-term, healthy, and stable.
  • The best time to circumcise a baby born prematurely is right before discharge from the intensive care nursery.
• The penis must be of normal size and without anatomical defect—no micropenis, hypospadias, or penoscrotal webbing.
• The lower abdominal fat pad must not be so large that it will cause the shaft’s skin to cover the exposed penile head.
• If there is a family history of a bleeding disorder, the newborn must be evaluated for the disorder before the circumcision.
• The newborn must have received his vitamin K shot.

4. What is the best circumcision method?

Circumcision can be performed with the Gomco circumcision clamp, the Mogen circumcision clamp, or the PlastiBell circumcision device. Each device works well, provides excellent results, and has its pluses and minuses. Practitioners should use the device with which they are most familiar and comfortable, which likely will be the device they used in training.

In the United States, the Gomco clamp is perhaps the most commonly used device. It provides good cosmetic results, and its metal “bell” protects the entire head of the penis. Of the 3 methods, however, it is the most difficult—the partially cut foreskin must be threaded between the bell and the clamp frame before the clamp is tightened. In many cases, too, there is bleeding at the penile frenulum.

The Mogen clamp, another commonly used device, also is used in traditional Jewish circumcisions. Of the 3 methods, it is the quickest, produces the best hemostasis, and is associated with the least discomfort.¹⁰ To those unfamiliar with the method, there may seem to be a potential for amputation of the head of the penis, but actually there virtually is no risk, as an indentation on the penile side of the clamp protects the penile head.

The PlastiBell device is very easy to use but must stay on until the foreskin becomes necrotic and the bell and foreskin fall off on their own—a process that takes 7 to 10 days. Many parents dislike this method because its final result is not immediate and they have to contend with a medical implement during their newborn’s first week home.

Electrocautery is not recommended. Some clinicians, especially urologists, use electrocautery as the cutting mechanism for circumcision. A review of the literature, however, reveals that electrocautery has not been studied head-to-head against traditional techniques, and that various significant complications—transected penile head, severe burns, meatal stenosis—have been reported.^11,12 It is certainly not a mainstream procedure for neonatal circumcision.

Evaluate penile anatomy for abnormalities

Before performing any circumcision, the head of the penis should be examined to rule out hypospadias or other penile abnormalities. This is because the foreskin is utilized in certain penile repair procedures. The pediatrician should perform an initial examination of the penis at the formal newborn physical within 24 hours of delivery. The clinician performing the circumcision should re-examine the penis just before the procedure is begun—by pushing back the foreskin as much as possible—as well as during the procedure, once the foreskin is lifted off the penile head but before the foreskin is excised.

Read about how to ensure the best outcome of circumcision.

5. When is the best time to perform a circumcision?

The medical literature provides no firm answer to this question. The younger the baby, the easier it is to perform a circumcision as a simple procedure with local anesthesia. The older the baby, the larger the penis and the more aware the baby will be of his surroundings. Both these factors will make the procedure more difficult.

Most clinicians would be reluctant to perform a circumcision in the office or clinic after the baby is 6 to 8 weeks old. If a family desires their son to be circumcised after that time—or a medical condition precludes earlier circumcision—the procedure is best performed by a pediatric urologist in the operating room.

Related article:
Circumcision accident: $1.3M verdict

6. What are the potential complications of circumcision?

The rate of circumcision complications is very low: 0.2%.¹³ That being said, the 3 most common types of complications are postoperative bleeding, infection, and damage to the penis.

Far and away the most common complication is postoperative bleeding , usually at the frenulum of the head of the penis (the 6 o’clock position). In most cases, the bleeding is light to moderate. It is controlled with direct pressure applied for several minutes, the use of processed gelatin (Gelfoam) or cellulose (Surgicel), sparing use of silver nitrate, or placement of a polyglycolic acid (Vicryl) 5-0 suture.

Infection, an unusual occurrence, is seen within 24 to 72 hours after circumcision. It is marked by swelling, redness, and a foul-smelling mucus discharge. This discharge must be differentiated from dried fibrin, which is commonly seen on the head of the penis in the days after circumcision but has no odor or association with erythema, fever, or infant fussiness. True infection should be treated, in collaboration with the child’s pediatrician, with a staphylococcal-sensitive penicillin (such as dicloxacillin).

More serious is damage to the penis, which ranges from accidental dilation of the meatus to partial amputation of the penile glans. Any such injury should immediately prompt a consultation with a pediatric urologist.

More of a nuisance than a complication is the sliding of the penile shaft’s skin up and over the glans. This is a relatively frequent occurrence after normal, successful circumcisions. Parents of an affected newborn should be instructed to gently slide the skin back until the head of the penis is completely exposed again. After several days, the skin will adhere to its proper position on the shaft.

7. What is a Jewish ritual circumcision?

For their newborn’s circumcision, Jewish parents may choose a bris ceremony, formally called a brit milah, in fulfillment of religious tradition. The ceremony involves a brief religious service, circumcision with the traditional Mogen clamp, a special blessing, and an official religious naming rite. The bris traditionally is performed by a mohel, a rabbi or other religious official trained in circumcision. Many parents have the bris done by a mohel who is a medical doctor. In the United States, the availability of both types of mohels varies.

8. Who should perform circumcisions—obstetricians or pediatricians?

The answer to this question depends on where you practice. In some communities or hospitals, the obstetrician performs newborn circumcision, while in other places the pediatrician does. In addition, depending on local circumstances or the specific population involved, circumcisions may be performed by a pediatric urologist, nurse practitioner, or even out of hospital by a trained religiously affiliated practitioner.

Obstetricians began doing circumcisions for 2 reasons. First, obstetricians are surgically trained whereas pediatricians are not. It was therefore thought to be more appropriate for obstetricians to do this minor surgical procedure. Second, circumcisions used to be done right in the delivery room shortly after delivery. It was thought that the crying induced by performing the circumcision helped clear the baby’s lungs and invigorated sluggish babies. Now, however, in-hospital circumcisions are usually done in the days following delivery, after the baby has had the opportunity to undergo his first physical examination to make sure that all is well and that the penile anatomy is normal.

Clinician experience, proper protocol contribute to a safe procedure

In the United States, a large percentage of male infants are circumcised. Although circumcision has known medical benefits, the procedure generally is performed for family, religious, or cultural reasons. Circumcision is a safe and straightforward procedure but has its risks and potential complications. As with most surgeries, the best outcomes are achieved by practitioners who are well trained, who perform the procedure under supervision until their experience is sufficient, and who follow correct protocol during the entire operation.

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