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HHS finalizes controversial conscience regulation
Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.
The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.
This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”
The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).
Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.
“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.
HHS officials denied accusations that the regulation puts the needs of providers over those of patients.
By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.
However, the American Civil Liberties Union and others see the new regulation as license to discriminate.
“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”
The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.
Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.
The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.
This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”
The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).
Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.
“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.
HHS officials denied accusations that the regulation puts the needs of providers over those of patients.
By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.
However, the American Civil Liberties Union and others see the new regulation as license to discriminate.
“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”
The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.
Health care professionals may not be compelled to provide medical care, including abortion services or even referrals, if they object on religious or moral grounds under a federal regulation finalized May 2.
The regulation also requires health care entities that receive federal funding to alert their employees to their federal conscience rights.
This final rule “replaces a 2011 rule that has proven inadequate, and ensures that HHS implements the full set of tools appropriate for enforcing the conscience protections passed by Congress,” HHS officials said in a statement. “These federal laws protect providers, individuals, and other health care entities from having to provide, participate in, pay for, provide coverage of, or refer for, services such as abortion, sterilization, or assisted suicide. It also includes conscience protections with respect to advance directives.”
The regulation was first proposed in January 2018, shortly after the formation of the Conscience and Religious Freedom Division within the HHS Office of Civil Rights (OCR).
Application of the regulation extends beyond the clinic and hospital. The regulation notes that, on a case-by-case basis, those providing emergency services such as EMTs or even ambulance drivers could be protected should they choose to exercise their conscience and not provide services based on their religious beliefs.
“With this final rule, the Department seeks to educate protected entities and covered entities as to their legal rights and obligations; to encourage individuals and organizations with religious beliefs or moral convictions to enter, or remain in, the health care industry; and to prevent others from being dissuaded from filing complaints due to prior OCR complaint resolutions or sub-regulatory guidance that no reflect the views of the Department,” according to the regulation.
HHS officials denied accusations that the regulation puts the needs of providers over those of patients.
By “protecting a diversity of beliefs among health care providers, these protections ensure that options are available to patients who desire, and would feel most comfortable with, a provider whose religious beliefs or moral convictions match their own. Even where a patient and provider do not share the same religious beliefs or moral convictions, it is not necessarily the case that patients would want providers to be forced to violate their religious beliefs or moral convictions,” according to the regulation.
However, the American Civil Liberties Union and others see the new regulation as license to discriminate.
“Once again, this administration shows itself to be determined to use religious liberty to harm communities it deems less worthy of equal treatment under the law,” Louise Melling, ACLU deputy legal director, said in a statement. “This rule threatens to prevent people from accessing critical medical care and may endanger people’s lives. Religious liberty is a fundamental right, but it does not include the right to discriminate or harm others. Denying patients health care is not religious liberty. Discriminating against patients based on their gender or gender expression is not religious liberty. Medical standards, not religious beliefs, should guide medical care.”
The regulation does not yet have a scheduled publication date in the Federal Register, nor has it been posted as a preview document on the publication’s website. It will become effective 60 days after publication.
Isradipine for Parkinson’s disease fails in phase 3 study
PHILADELPHIA - There was no significant difference in Unified Parkinson’s Disease Rating Scale (UPDRS) scores between patients who received the calcium channel blocker isradipine and those who received placebo, according to the final results of the STEADY-PD III study, which will be presented at the annual meeting of the American Academy of Neurology.
Use of the drug to treat high blood pressure has been linked to lower risk of developing Parkinson’s disease, said study author Tanya Simuni, MD, a professor of neurology at Northwestern University, Chicago, in a news release.
“Unfortunately, the people who were taking isradipine did not have any difference in their Parkinson’s symptoms over the 3 years of the study, compared with the people who took a placebo,” Dr. Simuni said in the press release.
Hopes were high that isradipine might be the first drug to slow progression of Parkinson’s disease after promising animal studies and a phase 2 study showing no safety concerns, according to the news release.
The STEADY-PD III study, which was conducted at 54 Parkinson Study Group sites in the United States and Canada, included 336 participants with early Parkinson’s disease randomized to isradipine 10 mg daily or placebo. The median age of patients in the study was 62 years, and 68% were male. The median time from diagnosis was 0.9 years, and the mean UPDRS I-III score at baseline was 23.1, according to an abstract describing the study results.
The primary endpoint was change in UPDRS Part I-III score measured in the ON state from baseline to month 36 of treatment. That change over 36 months was 2.99 points in the isradipine arm and 3.26 points in the placebo arm, for a treatment effect of 0.27 points (95% confidence interval, –2.5 to 3.0; P = 0.85), investigators reported in the abstract. Adjustment for use of symptomatic therapy did not affect the comparison, the researchers noted.
Isradipine had no effect on secondary outcomes, including change in UPDRS-III in the OFF state, use of dopaminergic therapy, motor complications, or quality of life, investigators said in the abstract. Edema was the most notable side effect of isradipine treatment, investigators said.
These findings are “disappointing” but will not deter researchers in their work to find a treatment that will slow Parkinson’s disease progression, Dr. Simuni said in the news release. “Negative results are important because they provide a clear answer, especially for a drug that is commercially available,” she added.
Secondary analyses in progress will explore “biological and clinical correlates of disease progression” among the study participants, researchers said in their study abstract.
The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS) and also received some funding from The Michael J. Fox Foundation for Parkinson’s Research. Dr. Simuni reported disclosures related to AbbVie, Acadia, Accorda, Adamas, Allergan, Anavex, Biogen, Denali, the Michael J. Fox Foundation, Neurocrine, NeuroDerm, NINDS, the Parkinson Foundation, PhotoPharmics, Revance, Roche, Sanofi, Sunovion, Sun Pharma, Takeda, Teva, Voyager, and US World Meds.
PHILADELPHIA - There was no significant difference in Unified Parkinson’s Disease Rating Scale (UPDRS) scores between patients who received the calcium channel blocker isradipine and those who received placebo, according to the final results of the STEADY-PD III study, which will be presented at the annual meeting of the American Academy of Neurology.
Use of the drug to treat high blood pressure has been linked to lower risk of developing Parkinson’s disease, said study author Tanya Simuni, MD, a professor of neurology at Northwestern University, Chicago, in a news release.
“Unfortunately, the people who were taking isradipine did not have any difference in their Parkinson’s symptoms over the 3 years of the study, compared with the people who took a placebo,” Dr. Simuni said in the press release.
Hopes were high that isradipine might be the first drug to slow progression of Parkinson’s disease after promising animal studies and a phase 2 study showing no safety concerns, according to the news release.
The STEADY-PD III study, which was conducted at 54 Parkinson Study Group sites in the United States and Canada, included 336 participants with early Parkinson’s disease randomized to isradipine 10 mg daily or placebo. The median age of patients in the study was 62 years, and 68% were male. The median time from diagnosis was 0.9 years, and the mean UPDRS I-III score at baseline was 23.1, according to an abstract describing the study results.
The primary endpoint was change in UPDRS Part I-III score measured in the ON state from baseline to month 36 of treatment. That change over 36 months was 2.99 points in the isradipine arm and 3.26 points in the placebo arm, for a treatment effect of 0.27 points (95% confidence interval, –2.5 to 3.0; P = 0.85), investigators reported in the abstract. Adjustment for use of symptomatic therapy did not affect the comparison, the researchers noted.
Isradipine had no effect on secondary outcomes, including change in UPDRS-III in the OFF state, use of dopaminergic therapy, motor complications, or quality of life, investigators said in the abstract. Edema was the most notable side effect of isradipine treatment, investigators said.
These findings are “disappointing” but will not deter researchers in their work to find a treatment that will slow Parkinson’s disease progression, Dr. Simuni said in the news release. “Negative results are important because they provide a clear answer, especially for a drug that is commercially available,” she added.
Secondary analyses in progress will explore “biological and clinical correlates of disease progression” among the study participants, researchers said in their study abstract.
The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS) and also received some funding from The Michael J. Fox Foundation for Parkinson’s Research. Dr. Simuni reported disclosures related to AbbVie, Acadia, Accorda, Adamas, Allergan, Anavex, Biogen, Denali, the Michael J. Fox Foundation, Neurocrine, NeuroDerm, NINDS, the Parkinson Foundation, PhotoPharmics, Revance, Roche, Sanofi, Sunovion, Sun Pharma, Takeda, Teva, Voyager, and US World Meds.
PHILADELPHIA - There was no significant difference in Unified Parkinson’s Disease Rating Scale (UPDRS) scores between patients who received the calcium channel blocker isradipine and those who received placebo, according to the final results of the STEADY-PD III study, which will be presented at the annual meeting of the American Academy of Neurology.
Use of the drug to treat high blood pressure has been linked to lower risk of developing Parkinson’s disease, said study author Tanya Simuni, MD, a professor of neurology at Northwestern University, Chicago, in a news release.
“Unfortunately, the people who were taking isradipine did not have any difference in their Parkinson’s symptoms over the 3 years of the study, compared with the people who took a placebo,” Dr. Simuni said in the press release.
Hopes were high that isradipine might be the first drug to slow progression of Parkinson’s disease after promising animal studies and a phase 2 study showing no safety concerns, according to the news release.
The STEADY-PD III study, which was conducted at 54 Parkinson Study Group sites in the United States and Canada, included 336 participants with early Parkinson’s disease randomized to isradipine 10 mg daily or placebo. The median age of patients in the study was 62 years, and 68% were male. The median time from diagnosis was 0.9 years, and the mean UPDRS I-III score at baseline was 23.1, according to an abstract describing the study results.
The primary endpoint was change in UPDRS Part I-III score measured in the ON state from baseline to month 36 of treatment. That change over 36 months was 2.99 points in the isradipine arm and 3.26 points in the placebo arm, for a treatment effect of 0.27 points (95% confidence interval, –2.5 to 3.0; P = 0.85), investigators reported in the abstract. Adjustment for use of symptomatic therapy did not affect the comparison, the researchers noted.
Isradipine had no effect on secondary outcomes, including change in UPDRS-III in the OFF state, use of dopaminergic therapy, motor complications, or quality of life, investigators said in the abstract. Edema was the most notable side effect of isradipine treatment, investigators said.
These findings are “disappointing” but will not deter researchers in their work to find a treatment that will slow Parkinson’s disease progression, Dr. Simuni said in the news release. “Negative results are important because they provide a clear answer, especially for a drug that is commercially available,” she added.
Secondary analyses in progress will explore “biological and clinical correlates of disease progression” among the study participants, researchers said in their study abstract.
The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS) and also received some funding from The Michael J. Fox Foundation for Parkinson’s Research. Dr. Simuni reported disclosures related to AbbVie, Acadia, Accorda, Adamas, Allergan, Anavex, Biogen, Denali, the Michael J. Fox Foundation, Neurocrine, NeuroDerm, NINDS, the Parkinson Foundation, PhotoPharmics, Revance, Roche, Sanofi, Sunovion, Sun Pharma, Takeda, Teva, Voyager, and US World Meds.
FROM AAN 2019
A telemedicine compromise
It’s late on a Thursday afternoon. Even through the six walls that separate you from the waiting room you can feel the impatient throng of families as you struggle to see the tympanic membrane of a feverish and uncooperative 3-year-old. You already have scraped his auditory canal once with your curette. Your gut tells you that he must have an otitis but deeper in your soul there are other voices reminding you that to make the diagnosis you must visualize his ear drum. Your skill and the technology on hand has failed you.
It’s a Sunday morning, weekend hours, and you are seeing a 12-year-old with a sore throat and fever. Her physical exam suggests that she has strep pharyngitis but the team member in charge of restocking supplies has forgotten to reorder rapid strep kits and you used the last one yesterday afternoon.
Do you ignore your training and treat these sick children with antibiotics?
If you are someone who perceives the world in black and white, your response to these scenarios is simple because you NEVER prescribe antibiotics without seeing a tympanic membrane or confirming your suspicion with a rapid strep test. There are unrealistic solutions that could include requesting an immediate ear/nose/throat consult or sending the patient on an hour-long odyssey to the hospital lab. But for the rest of us who see in shades of gray, we may have to compromise our principles and temporarily become poor antibiotic stewards. The question is, how often do you compromise? Once a week, once a month, twice a year, or twice a day?
A study published in Pediatrics looks at the issue of antibiotic stewardship as it relates to telemedicine (“Antibiotic Prescribing During Pediatrics Direct-to-Consumer Telemedicine Visits,” Pediatrics. 2019 May. doi: 10.1542/peds.2018-2491).
The investigators found that children with acute respiratory infections were more likely to receive antibiotics and less likely to receive guideline concordant management at direct-to-consumer (DTC) telemedicine visits than when they were seen by their primary care physician or at an urgent care center.
In their discussion, the researchers note several possible explanations for the discrepancies they observed. DTC telemedicine visits are limited by the devices used by the families and physicians and generally lack availability of otoscopy and strep testing. The authors also wonder whether “there may be differential expectations for antibiotics among children and parents who use DTC telemedicine versus in person care.” Does this mean that families who utilize DTC telemedicine undervalue in-person care and/or are willing to compromise by accepting what they may suspect is substandard care for the convenience of DTC telemedicine?
Which brings me to my point. A physician who accepts the challenge of seeing pediatric patients with acute respiratory illnesses knowing that he or she will not be able to visualize tympanic membranes or perform strep testing also has accepted the fact that he or she will be compromising the principles of antibiotic stewardship he or she must have – or maybe should have – learned in medical school or residency.
We all occasionally compromise our principles when technology fails us or when the situations are extraordinary. But I am troubled that there some physicians who are willing to practice in an environment in which they are aware that they will be compromising their antibiotic stewardship on a daily or even hourly basis.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
It’s late on a Thursday afternoon. Even through the six walls that separate you from the waiting room you can feel the impatient throng of families as you struggle to see the tympanic membrane of a feverish and uncooperative 3-year-old. You already have scraped his auditory canal once with your curette. Your gut tells you that he must have an otitis but deeper in your soul there are other voices reminding you that to make the diagnosis you must visualize his ear drum. Your skill and the technology on hand has failed you.
It’s a Sunday morning, weekend hours, and you are seeing a 12-year-old with a sore throat and fever. Her physical exam suggests that she has strep pharyngitis but the team member in charge of restocking supplies has forgotten to reorder rapid strep kits and you used the last one yesterday afternoon.
Do you ignore your training and treat these sick children with antibiotics?
If you are someone who perceives the world in black and white, your response to these scenarios is simple because you NEVER prescribe antibiotics without seeing a tympanic membrane or confirming your suspicion with a rapid strep test. There are unrealistic solutions that could include requesting an immediate ear/nose/throat consult or sending the patient on an hour-long odyssey to the hospital lab. But for the rest of us who see in shades of gray, we may have to compromise our principles and temporarily become poor antibiotic stewards. The question is, how often do you compromise? Once a week, once a month, twice a year, or twice a day?
A study published in Pediatrics looks at the issue of antibiotic stewardship as it relates to telemedicine (“Antibiotic Prescribing During Pediatrics Direct-to-Consumer Telemedicine Visits,” Pediatrics. 2019 May. doi: 10.1542/peds.2018-2491).
The investigators found that children with acute respiratory infections were more likely to receive antibiotics and less likely to receive guideline concordant management at direct-to-consumer (DTC) telemedicine visits than when they were seen by their primary care physician or at an urgent care center.
In their discussion, the researchers note several possible explanations for the discrepancies they observed. DTC telemedicine visits are limited by the devices used by the families and physicians and generally lack availability of otoscopy and strep testing. The authors also wonder whether “there may be differential expectations for antibiotics among children and parents who use DTC telemedicine versus in person care.” Does this mean that families who utilize DTC telemedicine undervalue in-person care and/or are willing to compromise by accepting what they may suspect is substandard care for the convenience of DTC telemedicine?
Which brings me to my point. A physician who accepts the challenge of seeing pediatric patients with acute respiratory illnesses knowing that he or she will not be able to visualize tympanic membranes or perform strep testing also has accepted the fact that he or she will be compromising the principles of antibiotic stewardship he or she must have – or maybe should have – learned in medical school or residency.
We all occasionally compromise our principles when technology fails us or when the situations are extraordinary. But I am troubled that there some physicians who are willing to practice in an environment in which they are aware that they will be compromising their antibiotic stewardship on a daily or even hourly basis.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
It’s late on a Thursday afternoon. Even through the six walls that separate you from the waiting room you can feel the impatient throng of families as you struggle to see the tympanic membrane of a feverish and uncooperative 3-year-old. You already have scraped his auditory canal once with your curette. Your gut tells you that he must have an otitis but deeper in your soul there are other voices reminding you that to make the diagnosis you must visualize his ear drum. Your skill and the technology on hand has failed you.
It’s a Sunday morning, weekend hours, and you are seeing a 12-year-old with a sore throat and fever. Her physical exam suggests that she has strep pharyngitis but the team member in charge of restocking supplies has forgotten to reorder rapid strep kits and you used the last one yesterday afternoon.
Do you ignore your training and treat these sick children with antibiotics?
If you are someone who perceives the world in black and white, your response to these scenarios is simple because you NEVER prescribe antibiotics without seeing a tympanic membrane or confirming your suspicion with a rapid strep test. There are unrealistic solutions that could include requesting an immediate ear/nose/throat consult or sending the patient on an hour-long odyssey to the hospital lab. But for the rest of us who see in shades of gray, we may have to compromise our principles and temporarily become poor antibiotic stewards. The question is, how often do you compromise? Once a week, once a month, twice a year, or twice a day?
A study published in Pediatrics looks at the issue of antibiotic stewardship as it relates to telemedicine (“Antibiotic Prescribing During Pediatrics Direct-to-Consumer Telemedicine Visits,” Pediatrics. 2019 May. doi: 10.1542/peds.2018-2491).
The investigators found that children with acute respiratory infections were more likely to receive antibiotics and less likely to receive guideline concordant management at direct-to-consumer (DTC) telemedicine visits than when they were seen by their primary care physician or at an urgent care center.
In their discussion, the researchers note several possible explanations for the discrepancies they observed. DTC telemedicine visits are limited by the devices used by the families and physicians and generally lack availability of otoscopy and strep testing. The authors also wonder whether “there may be differential expectations for antibiotics among children and parents who use DTC telemedicine versus in person care.” Does this mean that families who utilize DTC telemedicine undervalue in-person care and/or are willing to compromise by accepting what they may suspect is substandard care for the convenience of DTC telemedicine?
Which brings me to my point. A physician who accepts the challenge of seeing pediatric patients with acute respiratory illnesses knowing that he or she will not be able to visualize tympanic membranes or perform strep testing also has accepted the fact that he or she will be compromising the principles of antibiotic stewardship he or she must have – or maybe should have – learned in medical school or residency.
We all occasionally compromise our principles when technology fails us or when the situations are extraordinary. But I am troubled that there some physicians who are willing to practice in an environment in which they are aware that they will be compromising their antibiotic stewardship on a daily or even hourly basis.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
CMS pushing primary care with two new payment models
“We’re launching CMS Primary Cares, an initiative of two new payment models that will enroll a quarter or more of traditional Medicare beneficiaries and a quarter of providers in arrangements that pay for keeping patients healthy, rather than ordering procedures,” Alex Azar, secretary of Health and Human Services, said April 22 during a press conference.
“Today’s announcement creates innovation in primary care that has the potential to entirely transform our fee-for-service system – which is about 65% of the Medicare program – into one that drives value,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said during the press conference.
The voluntary models are an array of “new payment options that are all designed to reward [physicians] for keeping people healthy, improving quality of life and delivering positive health outcomes,” Ms. Verma said. “These models are intended to allow clinicians to focus on patient care, not billing, and to do what they’ve been trained to do.”
One option, the Primary Care First model, is aimed at small and solo primary care practices.
The model will “provide participating practices with a predictable payment stream, including a partial cap and some fee-for-service spend,” Ms. Verma said, adding that payments will be adjusted for performance in reducing hospitalizations.
Under Primary Care First, practices will receive a flat payment per beneficiary, allowing clinicians to focus more on care than on revenue cycle management, according to CMS. Practices will be able to receive bonuses of up to 50% or penalties of up to 10%, based on performance, as an incentive to reduce costs and improve quality. Performance will be assessed and paid quarterly. Specifics on the per-beneficiary payment were not released.
Participation in Primary Care First is limited to primary care professionals certified in internal medicine, general medicine, geriatric medicine, family medicine, and hospice and palliative medicine. Practices must provide services to at least 125 Medicare beneficiaries and primary care services must account for at least 70% of billing revenue. Practices also must have experience in value-based payments.
There also will be an option for enhanced payment for caring for patients with chronic illnesses.
“When a patient stays healthy and out of the hospital, these practices will get paid a bonus,” Secretary Azar said. “But if the patient ends up sicker than expected, these practices will bear responsibility for the extra spending up to a certain share of their practices’ revenue.”
More information about participating in the Primary Care First model will be available later in the spring of 2019, with the model launching in 2020.
A second option, the Direct Contracting model is “more ambitious and aimed at larger practices,” Mr. Azar said – those that serve at least 5,000 Medicare beneficiaries.
“Just like in Primary Care First, when patients have a better experience and stay healthier, these practices will make more money,” he continued. “But if patients end up sicker, Direct Contracting Practices will bear the risk for the extra health spending, not just at their own practice, but throughout the system.”
Options under the Direct Contracting model are designed for organizations ready to take on full financial risk that have experience managing large populations with accountable care organizations or working with Medicare Advantage plans, Ms. Verma explained.
The Direct Contracting model will start with two options. The Professional population-based payment (PBP) model offers a lower risk-sharing arrangement (50% savings/losses), while the Global PBP offers a 100% savings/losses risk-sharing arrangement.
CMS also is requesting information on a third payment model, the Geographic PBP model, which would have a similar risk-sharing arrangement as the Global PBP, but participants would assume responsibility for the total cost of care for all Medicare fee-for-service beneficiaries in a defined region.
This model also will launch in 2020.
The new Medicare primary care options were commended by quarters not always supportive of the current government.
Andy Slavitt, CMS administrator under President Obama, voiced his support for the new models.
“There are several watershed moments in the history of the Medicare program, like the coverage of prescription drugs and the shift to paying for better care,” he tweeted April 22. This announcement is “another one as it eases the connection of Medicare beneficiaries to a primary care physician and gives doctors the freedom, rewards, and tools to keep people healthy.”
He continued: “With this great starting point, even as CMS listens to input, physicians and patient groups should be considering who this helps move ... to a healthier country with a more sustainable system.”
The American Medical Association also voiced its support.
“Providing adequate financial support for high-quality primary care must be an essential element of any strategy to improve the quality and affordability of our country’s health care system, Gerald E. Harmon, MD, immediate past chair of the AMA Board of Trustees, said in a statement. “Many primary care physicians have been struggling to deliver the care their patients need and to financially sustain their practices under current Medicare payments. The new primary care payment models announced today will provide practices with more resources and more flexibility to deliver the highest-quality care to their patients.”
The American College of Physicians also noted their support of the new models.
“ACP is optimistic that the new models will emphasize the important role primary care plays in value-based care delivery, that models are voluntary and have a range of risk options, and that practices should use population health management data to reap potential benefits,” Robert McLean, MD, ACP president, said in a statement.
The success and viability of these models will depend on the extent that they are supported by payers in addition to Medicare and Medicaid, are adequately adjusted for differences in the risk and health status of patients seen by each practice, are provided predictable and adequate payments to support and sustain practices (especially smaller independent ones), are appropriately scaled for the financial risk expected of a practice, are provided meaningful and timely data to support improvement, and are truly able to reduce administrative tasks and costs, among other things.”
We are pretty excited about Primary Care First, for what it symbolizes.
The academy has long suggested that fee for service is not congruent with the core elements of advanced primary care, and our internal policies have asked for payments for primary care patients to be realigned in a way that would facilitate or drive this type of care.
There are a lot of details that we need to understand, but I think this model represents a really significant step towards prospective population-based payments. This model enables primary care physicians to continue to provide continuous and comprehensive care to their patients. It is a big step away from fee for service and we think that’s good for primary care.
I think primary care when it functions at its best really relies upon three elements; continuity and comprehensiveness are probably the two most important elements, and the third is coordination. These three elements are associated with better outcomes and lower cost in several studies. The idea that a patient would have a longitudinal (continuous) relationship with a primary care physician who provides comprehensive services is a desired policy objective.
This model, by implementing prospective, per patient payments, allows practices to focus on longitudinal patient-centered care versus episodes of care that drive revenue. The fee for service, in contrast, offers a payment by service, so it creates individual episodes of care. For the last decade we have questioned whether fee for service can really drive the key elements of primary care of the patient.
There’s always a place for fee for service, but as a foundation, I think the prospective nature of payments is a really important element of what the CMS did. Since physicians would receive payments in advance for providing comprehensive care, they won’t have to generate services to manage their revenue cycle.
I think the Direct Contracting payment model is interesting in that it requires a practice to have a minimum of 5,000 beneficiaries and involves the practice taking on risk for a large population of people. There are a lot more questions on the direct contracting side, but I think, philosophically, we could see why it would be a successful payment model.
From a 30,000 foot perspective, the Primary Care First program should allow any physician practice, regardless of size, to participate. It’s conceivable even for a solo practice to participate in this model.
Our main concern about this model is its geographic restrictions, and we would like to see more states added to this program quickly.
R. Shawn Martin is president of advocacy, practice advancement and policy of the American Academy of Family Physicians. He made these comments in an interview.
We are pretty excited about Primary Care First, for what it symbolizes.
The academy has long suggested that fee for service is not congruent with the core elements of advanced primary care, and our internal policies have asked for payments for primary care patients to be realigned in a way that would facilitate or drive this type of care.
There are a lot of details that we need to understand, but I think this model represents a really significant step towards prospective population-based payments. This model enables primary care physicians to continue to provide continuous and comprehensive care to their patients. It is a big step away from fee for service and we think that’s good for primary care.
I think primary care when it functions at its best really relies upon three elements; continuity and comprehensiveness are probably the two most important elements, and the third is coordination. These three elements are associated with better outcomes and lower cost in several studies. The idea that a patient would have a longitudinal (continuous) relationship with a primary care physician who provides comprehensive services is a desired policy objective.
This model, by implementing prospective, per patient payments, allows practices to focus on longitudinal patient-centered care versus episodes of care that drive revenue. The fee for service, in contrast, offers a payment by service, so it creates individual episodes of care. For the last decade we have questioned whether fee for service can really drive the key elements of primary care of the patient.
There’s always a place for fee for service, but as a foundation, I think the prospective nature of payments is a really important element of what the CMS did. Since physicians would receive payments in advance for providing comprehensive care, they won’t have to generate services to manage their revenue cycle.
I think the Direct Contracting payment model is interesting in that it requires a practice to have a minimum of 5,000 beneficiaries and involves the practice taking on risk for a large population of people. There are a lot more questions on the direct contracting side, but I think, philosophically, we could see why it would be a successful payment model.
From a 30,000 foot perspective, the Primary Care First program should allow any physician practice, regardless of size, to participate. It’s conceivable even for a solo practice to participate in this model.
Our main concern about this model is its geographic restrictions, and we would like to see more states added to this program quickly.
R. Shawn Martin is president of advocacy, practice advancement and policy of the American Academy of Family Physicians. He made these comments in an interview.
We are pretty excited about Primary Care First, for what it symbolizes.
The academy has long suggested that fee for service is not congruent with the core elements of advanced primary care, and our internal policies have asked for payments for primary care patients to be realigned in a way that would facilitate or drive this type of care.
There are a lot of details that we need to understand, but I think this model represents a really significant step towards prospective population-based payments. This model enables primary care physicians to continue to provide continuous and comprehensive care to their patients. It is a big step away from fee for service and we think that’s good for primary care.
I think primary care when it functions at its best really relies upon three elements; continuity and comprehensiveness are probably the two most important elements, and the third is coordination. These three elements are associated with better outcomes and lower cost in several studies. The idea that a patient would have a longitudinal (continuous) relationship with a primary care physician who provides comprehensive services is a desired policy objective.
This model, by implementing prospective, per patient payments, allows practices to focus on longitudinal patient-centered care versus episodes of care that drive revenue. The fee for service, in contrast, offers a payment by service, so it creates individual episodes of care. For the last decade we have questioned whether fee for service can really drive the key elements of primary care of the patient.
There’s always a place for fee for service, but as a foundation, I think the prospective nature of payments is a really important element of what the CMS did. Since physicians would receive payments in advance for providing comprehensive care, they won’t have to generate services to manage their revenue cycle.
I think the Direct Contracting payment model is interesting in that it requires a practice to have a minimum of 5,000 beneficiaries and involves the practice taking on risk for a large population of people. There are a lot more questions on the direct contracting side, but I think, philosophically, we could see why it would be a successful payment model.
From a 30,000 foot perspective, the Primary Care First program should allow any physician practice, regardless of size, to participate. It’s conceivable even for a solo practice to participate in this model.
Our main concern about this model is its geographic restrictions, and we would like to see more states added to this program quickly.
R. Shawn Martin is president of advocacy, practice advancement and policy of the American Academy of Family Physicians. He made these comments in an interview.
“We’re launching CMS Primary Cares, an initiative of two new payment models that will enroll a quarter or more of traditional Medicare beneficiaries and a quarter of providers in arrangements that pay for keeping patients healthy, rather than ordering procedures,” Alex Azar, secretary of Health and Human Services, said April 22 during a press conference.
“Today’s announcement creates innovation in primary care that has the potential to entirely transform our fee-for-service system – which is about 65% of the Medicare program – into one that drives value,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said during the press conference.
The voluntary models are an array of “new payment options that are all designed to reward [physicians] for keeping people healthy, improving quality of life and delivering positive health outcomes,” Ms. Verma said. “These models are intended to allow clinicians to focus on patient care, not billing, and to do what they’ve been trained to do.”
One option, the Primary Care First model, is aimed at small and solo primary care practices.
The model will “provide participating practices with a predictable payment stream, including a partial cap and some fee-for-service spend,” Ms. Verma said, adding that payments will be adjusted for performance in reducing hospitalizations.
Under Primary Care First, practices will receive a flat payment per beneficiary, allowing clinicians to focus more on care than on revenue cycle management, according to CMS. Practices will be able to receive bonuses of up to 50% or penalties of up to 10%, based on performance, as an incentive to reduce costs and improve quality. Performance will be assessed and paid quarterly. Specifics on the per-beneficiary payment were not released.
Participation in Primary Care First is limited to primary care professionals certified in internal medicine, general medicine, geriatric medicine, family medicine, and hospice and palliative medicine. Practices must provide services to at least 125 Medicare beneficiaries and primary care services must account for at least 70% of billing revenue. Practices also must have experience in value-based payments.
There also will be an option for enhanced payment for caring for patients with chronic illnesses.
“When a patient stays healthy and out of the hospital, these practices will get paid a bonus,” Secretary Azar said. “But if the patient ends up sicker than expected, these practices will bear responsibility for the extra spending up to a certain share of their practices’ revenue.”
More information about participating in the Primary Care First model will be available later in the spring of 2019, with the model launching in 2020.
A second option, the Direct Contracting model is “more ambitious and aimed at larger practices,” Mr. Azar said – those that serve at least 5,000 Medicare beneficiaries.
“Just like in Primary Care First, when patients have a better experience and stay healthier, these practices will make more money,” he continued. “But if patients end up sicker, Direct Contracting Practices will bear the risk for the extra health spending, not just at their own practice, but throughout the system.”
Options under the Direct Contracting model are designed for organizations ready to take on full financial risk that have experience managing large populations with accountable care organizations or working with Medicare Advantage plans, Ms. Verma explained.
The Direct Contracting model will start with two options. The Professional population-based payment (PBP) model offers a lower risk-sharing arrangement (50% savings/losses), while the Global PBP offers a 100% savings/losses risk-sharing arrangement.
CMS also is requesting information on a third payment model, the Geographic PBP model, which would have a similar risk-sharing arrangement as the Global PBP, but participants would assume responsibility for the total cost of care for all Medicare fee-for-service beneficiaries in a defined region.
This model also will launch in 2020.
The new Medicare primary care options were commended by quarters not always supportive of the current government.
Andy Slavitt, CMS administrator under President Obama, voiced his support for the new models.
“There are several watershed moments in the history of the Medicare program, like the coverage of prescription drugs and the shift to paying for better care,” he tweeted April 22. This announcement is “another one as it eases the connection of Medicare beneficiaries to a primary care physician and gives doctors the freedom, rewards, and tools to keep people healthy.”
He continued: “With this great starting point, even as CMS listens to input, physicians and patient groups should be considering who this helps move ... to a healthier country with a more sustainable system.”
The American Medical Association also voiced its support.
“Providing adequate financial support for high-quality primary care must be an essential element of any strategy to improve the quality and affordability of our country’s health care system, Gerald E. Harmon, MD, immediate past chair of the AMA Board of Trustees, said in a statement. “Many primary care physicians have been struggling to deliver the care their patients need and to financially sustain their practices under current Medicare payments. The new primary care payment models announced today will provide practices with more resources and more flexibility to deliver the highest-quality care to their patients.”
The American College of Physicians also noted their support of the new models.
“ACP is optimistic that the new models will emphasize the important role primary care plays in value-based care delivery, that models are voluntary and have a range of risk options, and that practices should use population health management data to reap potential benefits,” Robert McLean, MD, ACP president, said in a statement.
The success and viability of these models will depend on the extent that they are supported by payers in addition to Medicare and Medicaid, are adequately adjusted for differences in the risk and health status of patients seen by each practice, are provided predictable and adequate payments to support and sustain practices (especially smaller independent ones), are appropriately scaled for the financial risk expected of a practice, are provided meaningful and timely data to support improvement, and are truly able to reduce administrative tasks and costs, among other things.”
“We’re launching CMS Primary Cares, an initiative of two new payment models that will enroll a quarter or more of traditional Medicare beneficiaries and a quarter of providers in arrangements that pay for keeping patients healthy, rather than ordering procedures,” Alex Azar, secretary of Health and Human Services, said April 22 during a press conference.
“Today’s announcement creates innovation in primary care that has the potential to entirely transform our fee-for-service system – which is about 65% of the Medicare program – into one that drives value,” Seema Verma, administrator of the Centers for Medicare & Medicaid Services, said during the press conference.
The voluntary models are an array of “new payment options that are all designed to reward [physicians] for keeping people healthy, improving quality of life and delivering positive health outcomes,” Ms. Verma said. “These models are intended to allow clinicians to focus on patient care, not billing, and to do what they’ve been trained to do.”
One option, the Primary Care First model, is aimed at small and solo primary care practices.
The model will “provide participating practices with a predictable payment stream, including a partial cap and some fee-for-service spend,” Ms. Verma said, adding that payments will be adjusted for performance in reducing hospitalizations.
Under Primary Care First, practices will receive a flat payment per beneficiary, allowing clinicians to focus more on care than on revenue cycle management, according to CMS. Practices will be able to receive bonuses of up to 50% or penalties of up to 10%, based on performance, as an incentive to reduce costs and improve quality. Performance will be assessed and paid quarterly. Specifics on the per-beneficiary payment were not released.
Participation in Primary Care First is limited to primary care professionals certified in internal medicine, general medicine, geriatric medicine, family medicine, and hospice and palliative medicine. Practices must provide services to at least 125 Medicare beneficiaries and primary care services must account for at least 70% of billing revenue. Practices also must have experience in value-based payments.
There also will be an option for enhanced payment for caring for patients with chronic illnesses.
“When a patient stays healthy and out of the hospital, these practices will get paid a bonus,” Secretary Azar said. “But if the patient ends up sicker than expected, these practices will bear responsibility for the extra spending up to a certain share of their practices’ revenue.”
More information about participating in the Primary Care First model will be available later in the spring of 2019, with the model launching in 2020.
A second option, the Direct Contracting model is “more ambitious and aimed at larger practices,” Mr. Azar said – those that serve at least 5,000 Medicare beneficiaries.
“Just like in Primary Care First, when patients have a better experience and stay healthier, these practices will make more money,” he continued. “But if patients end up sicker, Direct Contracting Practices will bear the risk for the extra health spending, not just at their own practice, but throughout the system.”
Options under the Direct Contracting model are designed for organizations ready to take on full financial risk that have experience managing large populations with accountable care organizations or working with Medicare Advantage plans, Ms. Verma explained.
The Direct Contracting model will start with two options. The Professional population-based payment (PBP) model offers a lower risk-sharing arrangement (50% savings/losses), while the Global PBP offers a 100% savings/losses risk-sharing arrangement.
CMS also is requesting information on a third payment model, the Geographic PBP model, which would have a similar risk-sharing arrangement as the Global PBP, but participants would assume responsibility for the total cost of care for all Medicare fee-for-service beneficiaries in a defined region.
This model also will launch in 2020.
The new Medicare primary care options were commended by quarters not always supportive of the current government.
Andy Slavitt, CMS administrator under President Obama, voiced his support for the new models.
“There are several watershed moments in the history of the Medicare program, like the coverage of prescription drugs and the shift to paying for better care,” he tweeted April 22. This announcement is “another one as it eases the connection of Medicare beneficiaries to a primary care physician and gives doctors the freedom, rewards, and tools to keep people healthy.”
He continued: “With this great starting point, even as CMS listens to input, physicians and patient groups should be considering who this helps move ... to a healthier country with a more sustainable system.”
The American Medical Association also voiced its support.
“Providing adequate financial support for high-quality primary care must be an essential element of any strategy to improve the quality and affordability of our country’s health care system, Gerald E. Harmon, MD, immediate past chair of the AMA Board of Trustees, said in a statement. “Many primary care physicians have been struggling to deliver the care their patients need and to financially sustain their practices under current Medicare payments. The new primary care payment models announced today will provide practices with more resources and more flexibility to deliver the highest-quality care to their patients.”
The American College of Physicians also noted their support of the new models.
“ACP is optimistic that the new models will emphasize the important role primary care plays in value-based care delivery, that models are voluntary and have a range of risk options, and that practices should use population health management data to reap potential benefits,” Robert McLean, MD, ACP president, said in a statement.
The success and viability of these models will depend on the extent that they are supported by payers in addition to Medicare and Medicaid, are adequately adjusted for differences in the risk and health status of patients seen by each practice, are provided predictable and adequate payments to support and sustain practices (especially smaller independent ones), are appropriately scaled for the financial risk expected of a practice, are provided meaningful and timely data to support improvement, and are truly able to reduce administrative tasks and costs, among other things.”
Myc signaling, monocytes predict NSCLC response to second-line entinostat + pembro
ATLANTA – Combination entinostat and pembrolizumab showed promising activity in a phase 2 study of non–small cell lung cancer patients who progressed on or after anti-programmed death-ligand 1 (PD-L1) therapy, and new analyses have identified gene signatures associated with treatment response.
Gene set analysis in tumors from 43 of the patients – 4 responders and 39 nonresponders – who participated in the open-label ENCORE-601 study revealed that Myc gene signaling was enriched in responders vs. nonresponders, Suresh S. Ramalingam, MD, said at the annual meeting of the American Association for Cancer Research.
High Myc gene activity is known from previous studies to be associated with response to immune checkpoint inhibition, and this has been attributed to high PD-L1 expression, decrease in interferon signatures, and exclusion of lymphocytes, he noted.
“And we know from other publications that entinostat is known to decrease Myc activity,” he said. “Therefore, our putative hypothesis at this time – albeit on a small set of patients – is that for patients with baseline high Myc activity, when they have developed resistance to PD-1 or PD-L1 inhibition ... giving them entinostat drives down the Myc activity and results in a change in the tumor microenvironment to one where immune checkpoint inhibition could be rendered effective.”
Patients from ENCORE-601 also were evaluated by baseline circulating classical monocyte levels as prior findings showed improved overall survival and progression-free survival (PFS) in melanoma patients with higher vs. lower counts, Dr. Ramalingam explained.
The overall response rate (ORR) in those with baseline levels above the median (MHi, 11 patients) was 21.1% vs. 6.5% in those with levels below the median (MLo, 32 patients); median PFS was 4.7 vs. 2.7 months in the MHi and MLo groups, respectively, said Dr. Ramalingam of Winship Cancer Institute, Emory University, Atlanta.
ENCORE-601 included 76 subjects who received entinostat at a dose of 5 mg per week plus intravenous pembrolizumab at 200 mg every 3 weeks. The confirmed ORR with treatment in 72 efficacy-evaluable patients was 10%, with an additional 50% of patients having stable disease. The median duration of response was 8 months, and median PFS was 2.8 months.
Top-line results from the study, which was undertaken based in part on preclinical data showing synergy between the oral class 1-selective histone deacetylase inhibitor entinostat and anti-PD-1 inhibition, were presented at the 2018 World Conference on Lung Cancer, and the current findings represent secondary outcome measures involving analyses in pretreatment tumor samples from patients with sufficient RNA yield for analysis.
The data may provide a mechanistic basis for the responses seen with entinostat and pembrolizumab in ENCORE-601, Dr. Ramalingam said.
“Now we acknowledge that this is a relatively small dataset, and therefore further studies are warranted using these biomarkers to further understand whether they can be used as predictive biomarkers for treatment,” he said, noting that one such clinical trial is currently in the discussion phase.
The ENCORE-601 findings are important given that “with the movement of checkpoint inhibitors to the front-line setting, there is now an unmet need in the second-line [setting] where patients have already received a checkpoint inhibitor and have developed disease progression,” he noted, adding that “while chemotherapy remains central to this group of patients, development of novel agents is an unmet need.”
Dr. Ramalingam disclosed ties to AbbVie, Advaxis, Amgen, Astra Zeneca, Bristol-Myers Squibb, Genentech/Roche, Loxo, Merck, Nektar, Takeda, and Syndax.
SOURCE: Ramalingam S et al. AACR 2019, Abstract CT041.
ATLANTA – Combination entinostat and pembrolizumab showed promising activity in a phase 2 study of non–small cell lung cancer patients who progressed on or after anti-programmed death-ligand 1 (PD-L1) therapy, and new analyses have identified gene signatures associated with treatment response.
Gene set analysis in tumors from 43 of the patients – 4 responders and 39 nonresponders – who participated in the open-label ENCORE-601 study revealed that Myc gene signaling was enriched in responders vs. nonresponders, Suresh S. Ramalingam, MD, said at the annual meeting of the American Association for Cancer Research.
High Myc gene activity is known from previous studies to be associated with response to immune checkpoint inhibition, and this has been attributed to high PD-L1 expression, decrease in interferon signatures, and exclusion of lymphocytes, he noted.
“And we know from other publications that entinostat is known to decrease Myc activity,” he said. “Therefore, our putative hypothesis at this time – albeit on a small set of patients – is that for patients with baseline high Myc activity, when they have developed resistance to PD-1 or PD-L1 inhibition ... giving them entinostat drives down the Myc activity and results in a change in the tumor microenvironment to one where immune checkpoint inhibition could be rendered effective.”
Patients from ENCORE-601 also were evaluated by baseline circulating classical monocyte levels as prior findings showed improved overall survival and progression-free survival (PFS) in melanoma patients with higher vs. lower counts, Dr. Ramalingam explained.
The overall response rate (ORR) in those with baseline levels above the median (MHi, 11 patients) was 21.1% vs. 6.5% in those with levels below the median (MLo, 32 patients); median PFS was 4.7 vs. 2.7 months in the MHi and MLo groups, respectively, said Dr. Ramalingam of Winship Cancer Institute, Emory University, Atlanta.
ENCORE-601 included 76 subjects who received entinostat at a dose of 5 mg per week plus intravenous pembrolizumab at 200 mg every 3 weeks. The confirmed ORR with treatment in 72 efficacy-evaluable patients was 10%, with an additional 50% of patients having stable disease. The median duration of response was 8 months, and median PFS was 2.8 months.
Top-line results from the study, which was undertaken based in part on preclinical data showing synergy between the oral class 1-selective histone deacetylase inhibitor entinostat and anti-PD-1 inhibition, were presented at the 2018 World Conference on Lung Cancer, and the current findings represent secondary outcome measures involving analyses in pretreatment tumor samples from patients with sufficient RNA yield for analysis.
The data may provide a mechanistic basis for the responses seen with entinostat and pembrolizumab in ENCORE-601, Dr. Ramalingam said.
“Now we acknowledge that this is a relatively small dataset, and therefore further studies are warranted using these biomarkers to further understand whether they can be used as predictive biomarkers for treatment,” he said, noting that one such clinical trial is currently in the discussion phase.
The ENCORE-601 findings are important given that “with the movement of checkpoint inhibitors to the front-line setting, there is now an unmet need in the second-line [setting] where patients have already received a checkpoint inhibitor and have developed disease progression,” he noted, adding that “while chemotherapy remains central to this group of patients, development of novel agents is an unmet need.”
Dr. Ramalingam disclosed ties to AbbVie, Advaxis, Amgen, Astra Zeneca, Bristol-Myers Squibb, Genentech/Roche, Loxo, Merck, Nektar, Takeda, and Syndax.
SOURCE: Ramalingam S et al. AACR 2019, Abstract CT041.
ATLANTA – Combination entinostat and pembrolizumab showed promising activity in a phase 2 study of non–small cell lung cancer patients who progressed on or after anti-programmed death-ligand 1 (PD-L1) therapy, and new analyses have identified gene signatures associated with treatment response.
Gene set analysis in tumors from 43 of the patients – 4 responders and 39 nonresponders – who participated in the open-label ENCORE-601 study revealed that Myc gene signaling was enriched in responders vs. nonresponders, Suresh S. Ramalingam, MD, said at the annual meeting of the American Association for Cancer Research.
High Myc gene activity is known from previous studies to be associated with response to immune checkpoint inhibition, and this has been attributed to high PD-L1 expression, decrease in interferon signatures, and exclusion of lymphocytes, he noted.
“And we know from other publications that entinostat is known to decrease Myc activity,” he said. “Therefore, our putative hypothesis at this time – albeit on a small set of patients – is that for patients with baseline high Myc activity, when they have developed resistance to PD-1 or PD-L1 inhibition ... giving them entinostat drives down the Myc activity and results in a change in the tumor microenvironment to one where immune checkpoint inhibition could be rendered effective.”
Patients from ENCORE-601 also were evaluated by baseline circulating classical monocyte levels as prior findings showed improved overall survival and progression-free survival (PFS) in melanoma patients with higher vs. lower counts, Dr. Ramalingam explained.
The overall response rate (ORR) in those with baseline levels above the median (MHi, 11 patients) was 21.1% vs. 6.5% in those with levels below the median (MLo, 32 patients); median PFS was 4.7 vs. 2.7 months in the MHi and MLo groups, respectively, said Dr. Ramalingam of Winship Cancer Institute, Emory University, Atlanta.
ENCORE-601 included 76 subjects who received entinostat at a dose of 5 mg per week plus intravenous pembrolizumab at 200 mg every 3 weeks. The confirmed ORR with treatment in 72 efficacy-evaluable patients was 10%, with an additional 50% of patients having stable disease. The median duration of response was 8 months, and median PFS was 2.8 months.
Top-line results from the study, which was undertaken based in part on preclinical data showing synergy between the oral class 1-selective histone deacetylase inhibitor entinostat and anti-PD-1 inhibition, were presented at the 2018 World Conference on Lung Cancer, and the current findings represent secondary outcome measures involving analyses in pretreatment tumor samples from patients with sufficient RNA yield for analysis.
The data may provide a mechanistic basis for the responses seen with entinostat and pembrolizumab in ENCORE-601, Dr. Ramalingam said.
“Now we acknowledge that this is a relatively small dataset, and therefore further studies are warranted using these biomarkers to further understand whether they can be used as predictive biomarkers for treatment,” he said, noting that one such clinical trial is currently in the discussion phase.
The ENCORE-601 findings are important given that “with the movement of checkpoint inhibitors to the front-line setting, there is now an unmet need in the second-line [setting] where patients have already received a checkpoint inhibitor and have developed disease progression,” he noted, adding that “while chemotherapy remains central to this group of patients, development of novel agents is an unmet need.”
Dr. Ramalingam disclosed ties to AbbVie, Advaxis, Amgen, Astra Zeneca, Bristol-Myers Squibb, Genentech/Roche, Loxo, Merck, Nektar, Takeda, and Syndax.
SOURCE: Ramalingam S et al. AACR 2019, Abstract CT041.
REPORTING FROM AACR 2019
2019 Update on cervical disease
Cervical cancer rates remain low in the United States, with the incidence having plateaued for decades. And yet, in 2019, more than 13,000 US women will be diagnosed with cervical cancer.1 Globally, in 2018 almost 600,000 women were diagnosed with cervical cancer2; it is the fourth most frequent cancer in women. This is despite the fact that we have adequate primary and secondary prevention tools available to minimize—and almost eliminate—cervical cancer. We must continue to raise the bar for preventing, screening for, and managing this disease.
Human papillomavirus (HPV) vaccines provide a highly effective primary prevention strategy, but we need to improve our ability to identify and diagnose dysplastic lesions prior to the development of cervical cancer. Highly sensitive HPV testing and cytology is a powerful secondary prevention approach that enables us to assess a woman’s risk of having precancerous cells both now and in the near future. These modalities have been very successful in decreasing the incidence of cervical cancer in the United States and other areas with organized screening programs. In low- and middle-income countries, however, access to, availability of, and performance with these modalities is not optimal. Innovative strategies and new technologies are being evaluated to overcome these limitations.
Advances in radiation and surgical technology have enabled us to vastly improve cervical cancer treatment. Women with early-stage cervical cancer are candidates for surgical management, which frequently includes a radical hysterectomy and lymph node dissection. While these surgeries traditionally have been performed via an exploratory laparotomy, minimally invasive techniques (laparoscopic and robot-assisted surgical techniques) have decreased the morbidity with these surgeries. Notable new studies have shed light on the comparative effectiveness of minimally invasive technologies and have shown us that new is not always better.
The US Preventive Services Task Force (USPSTF) recently released its updated cervical cancer screening guidelines. The suggested approach to screening differs from previous recommendations. HPV testing as a primary test (that is, HPV testing alone or followed by cytology) takes the spotlight now, according to the analysis by the Task Force.
In this Update, we highlight important studies published in the past year that address these issues.
Continue to: New tech's potential to identify high-grade...
New tech's potential to identify high-grade cervical dysplasia may be a boon to low-resource settings
Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
When cervical screening tests like cytology and HPV testing show abnormal results, colposcopy often is recommended. The goal of colposcopy is to identify the areas that might harbor a high-grade precancerous lesion or worse. The gold standard in this case, however, is histology, not colposcopic impression, as many studies have shown that colposcopy without biopsies is limited and that performance is improved with more biopsies.3,4
Visual inspection with acetic acid (VIA) is an approach used often in low-resource settings where visual impression is the gold standard. However, as with colposcopy, a visual evaluation without histology does not perform well, and often women are overtreated. Many attempts have been made with new technologies to overcome the limitations of time, cost, and workforce required for cytology and histology services. New disruptive technologies may be able to surmount human limitations and improve on not only VIA but also the need for histology.
Novel technology uses images to develop algorithm with predictive ability
In a recent observational study, Hu and colleagues used images that were collected during a large population study in Guanacaste, Costa Rica.5 More than 9,000 women were followed for up to 7 years, and cervical photographs (cervigrams) were obtained. Well-annotated histopathology results were obtained for women with abnormal screening, and 279 women had a high-grade dysplastic lesion or cancer.
Cervigrams from women with high-grade lesions and matched controls were collected, and a deep learning-based algorithm using artificial intelligence technology was developed using 70% of the images. The remaining 30% of images were used as a validation set to test the algorithm's ability to "predict" high-grade dysplasia without knowing the final result.
Findings. Termed automated visual evaluation (AVE), this new technology demonstrated a very accurate ability to identify high-grade dysplasia or worse, with an area under the curve (AUC) of 0.91 from merely a cervicogram (FIGURE). This outperformed conventional Pap smears (AUC, 0.71), liquid-based cytology (AUC, 0.79) and, surprisingly, highly sensitive HPV testing (AUC, 0.82) in women in the prime of their screening ages (>25 years of age).
Colposcopy remains the gold standard for evaluating abnormal cervical cancer screening tests in the United States. But can we do better for our patients using new technologies like AVE? If validated in large-scale trials, AVE has the potential to revolutionize cervical cancer screening in low-resource settings where follow-up and adequate histology services are limited or nonexistent. Future large studies are necessary to evaluate the role of AVE alone versus in combination with other diagnostic testing (such as HPV testing) to detect cervical lesions globally.
Continue to: Data offer persuasive evidence...
Data offer persuasive evidence to abandon minimally invasive surgery in management of early-stage cervical cancer
Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
Over the past decade, gynecologic cancer surgery has shifted from what routinely were open procedures to the adoption of minimally invasive techniques. Recently, a large, well-designed prospective study and a large retrospective study both demonstrated worse outcomes with minimally invasive radical hysterectomy (MIRH) as compared with traditional open radical abdominal hysterectomy (RAH). These 2 landmark studies, initially presented at the Society of Gynecologic Oncology's 2018 annual meeting and later published in the New England Journal of Medicine, have really affected the gynecologic oncology community.
Shorter overall survival in women who had MIRH
Melamed and colleagues conducted a large, retrospective US-based study to evaluate all-cause mortality in women with cervical cancer who underwent MIRH compared with those who had RAH.6 The authors also sought to evaluate national trends in 4-year relative survival rates after minimally invasive surgery was adopted.
The study included 2,461 women who met the inclusion criteria; 49.8% (1,225) underwent MIRH procedures and, of those, 79.8% (978) had robot-assisted laparoscopy. Most women had stage IB1 tumors (88%), and most carcinomas were squamous cell (61%); 40.6% of tumors were less than 2 cm in size. There were no differences between the 2 groups with respect to rates of positive parametria, surgical margins, and lymph node involvement. Administration of adjuvant therapy, in those who qualified, was also similar between groups.
Results. At a median follow-up of 45 months, 94 deaths occurred in the minimally invasive group and 70 in the open surgery group. The risk of death at 4 years was 9.1% in the minimally invasive group versus 5.3% in the open surgery group, with a 65% higher risk of death from any cause, which was highly statistically significant.
Prospective trial showed MIRH was associated with lower survival rates
From 2008 to 2017, Ramirez and colleagues conducted a phase 3, multicenter, randomized controlled trial to prospectively establish the noninferiority of MIRH compared with RAH.7 The study included 631 women from 33 centers. The prespecified expected disease-free survival rate was 90% at 4.5 years.
To be included as a site, centers were required to submit details from 10 minimally invasive cases as well as 2 unedited videos for review by the trial management committee. In contrast to Melamed and colleagues' retrospective study, of the 319 procedures that were classified as minimally invasive, only 15.6% were robotically assisted. Similarly, most women had stage IB1 tumors (91.9%), and most were squamous cell carcinomas (67%). There were also no differences in the postoperative pathology findings or the need for adjuvant therapy administered between groups. The median follow-up was 2.5 years.
Results. At that time there were 27 recurrences in the MIRH group and 7 in the RAH group; there were also 19 deaths after MIRH and 3 after RAH. Disease-free survival at 4.5 years was 86% with MIRH versus 96.5% with RAH. Reported 3-year disease-free survival and overall survival were also significantily lower in the minimally invasive subgroup (91.2% vs 97.1%, 93.8% vs 99.0%, respectively).
Study limitations. Criticisms of this trial are that noninferiority could not be declared; in addition, the investigators were unable to complete enrollment secondary to early enrollment termination after the data and safety monitoring board raised survival concerns.
Many argue that subgroup analyses suggest a lower risk of poor outcomes in patients with smaller tumors (<2 cm); however, it is critical to note that this study was not powered to detect these differences.
The evidence is compelling and demonstrates potentially worse disease-related outcomes using MIRH when compared to traditional RAH with respect to cervical cancer recurrence, rates of death, and disease-free and overall survival. Several hypotheses have been proposed, and future research is needed to elucidate the differences in variables responsible for the outcomes demonstrated in these studies. Although there has been no ban on robot-assisted surgical devices or traditional minimally invasive techniques, the National Comprehensive Cancer Network has updated its recommendations to include careful counseling of patients who require a surgical approach for the management of early-stage cervical cancer.
Continue to: USPSTF updated guidance on cervical cancer screening...
USPSTF updated guidance on cervical cancer screening
Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
Past guidelines for cervical cancer screening have included testing for high-risk HPV (hrHPV) as a cotest with cytology or for triage of atypical squamous cells of undetermined significance (ASCUS) in women aged 30 to 65 years.8 The American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology, with other stakeholder organizations, issued interim guidance for primary HPV testing--that is, HPV test first and, in the case of non-16/18 hrHPV types, cytology as a triage. The most recent evidence report and systematic review by Melnikow and colleagues for the USPSTF offers an in-depth analysis of risks, benefits, harms, and value of cotesting and other management strategies.9
Focus on screening effectiveness
Large trials of cotesting were conducted in women aged 25 to 65.10-13 These studies all consistently showed that primary hrHPV screening led to a statistically significant increased detection of cervical intraepithelial neoplasia (CIN) 3+ in the initial round of screening, with a relative risk of detecting CIN 3+ ranging from 1.61 to 7.46 compared with cytology alone.
Four additional studies compared cotesting with conventional cytology for the detection of CIN 3+. None of these trials demonstrated a significantly higher detection rate of CIN 3+ with cotesting compared with conventional cytology testing alone. Notably, the studies reviewed were performed in European countries that had organized screening programs in place and a nationalized health care system. Thus, these data may not be as applicable to women in the United States, particularly to women who have limited health care access.
Risks of screening
In the same studies reviewed for screening effectiveness, the investigators found that overall, screening with hrHPV primary or cotesting was associated with more false-positive results and higher colposcopy rates. Women screened with hrHPV alone had a 7.9% referral rate to colposcopy, while those screened with cytology had a 2.8% referral rate to colposcopy. Similarly, the rate of biopsy was higher in the hrHPV-only group (3.2% vs 1.3%).
Overall, while cotesting might have some improvement in performance compared with hrHPV as a single modality, there might be risks of overreferral to colposcopy and overtreatment with additional cytology over hrHPV testing alone.
This evidence review also included an analysis of more potential harms. Very limited evidence suggests that positive hrHPV test results may be associated with greater psychological harm, including decreased sexual satisfaction, increased anxiety and distress, and worse feelings about sexual partners, than abnormal cytology results. These were assessed, however, 1 to 2 weeks after the test results were provided to the patients, and long-term assessment was not done.
New recommendations from the USPSTF
Based on these data, the USPSTF issued new recommendations regarding screening (TABLE).14 For women aged 21 to 29, cytology alone should be used for screening every 3 years. Women aged 30 to 65 can be screened with cytology alone every 3 years, with hrHPV testing alone every 5 years, or with cotesting every 5 years.
Primary screening with hrHPV is more effective in diagnosing a CIN 3+ than cytology alone. Cotesting with cytology and hrHPV testing appears to have limited performance improvement, with potential harm, compared with hrHPV testing alone in diagnosing CIN 3+. The Task Force recommendation is hrHPV testing alone or cotesting every 5 years.
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69:7-34.
- World Health Organization website. Cervical cancer. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/. Accessed April 17, 2019.
- Wentzensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy. J Clin Oncol. 2015;33:83-89.
- Gage JC, Hanson VW, Abbey K, et al. Number of cervical biopsies and sensitivity of colposcopy. Obstet Gynecol. 2006;108:264-272.
- Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Saslow D, Solomon D, Lawson HW, et al; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012;62:147-172.
- Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
- Canfell K, Caruana M, Gebski V, et al. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: results of the Compass pilot randomised trial. PLoS Med. 2017;14:e1002388. doi:10.1371/journal.pmed.1002388.
- Leinonen MK, Nieminen P, Lonnberg S, et al. Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland. BMJ. 2012;345:e7789.
- Ogilvie GS, van Niekerk D, Krajden M, et al. Effect of screening with primary cervical HPV testing vs cytology testing on high-grade cervical intraepithelial neoplasia at 48 months: the HPV FOCAL randomized clinical trial. JAMA. 2018;320:43-52.
- Ronco G, Fioprgi-Rossi P, Carozzi F, et al; New Technologies for Cervical Cancer screening (NTCC) Working Group. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol. 2010;11:249-257.
- US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
Jenna Z. Marcus, MD
Dr. Marcus is Assistant Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey.
Akiva P. Novetsky, MD, MS
Dr. Novetsky is Associate Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey, and Chief Quality Officer, Rutgers Cancer Institute of New Jersey, New Brunswick.
Mark H. Einstein, MD, MS
Dr. Einstein is Professor and Chair, Department of Obstetrics, Gynecology and Women’s Health, and Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, Newark, New Jersey.
Dr. Einstein has advised or participated in educational speaking activities, but he does not receive an honorarium from any companies. In specific cases, Rutgers has received payment for his time spent for these activities from Photocure, Papivax, Cynvec, Merck, Hologic, and PDS Biotechnology. If travel is required for meetings with industry, the company pays for Dr. Einstein’s travel expenses. Rutgers has received grant funding for research-related costs of clinical trials that Dr. Einstein has been the overall or local principal investigator within the past 12 months from J&J, Pfizer, and Inovio. Rutgers has received payment for Dr. Einstein’s time from Photocure, Papivax, Cynvec, and PDS Biotechnology.
Dr. Novetsky is the overall principal investigator of an investigator-initiated grant sponsored by Roche. His institution, Rutgers, has received funding for the clinical costs of this trial.
Dr. Marcus reports no financial relationships relevant to this article.
Jenna Z. Marcus, MD
Dr. Marcus is Assistant Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey.
Akiva P. Novetsky, MD, MS
Dr. Novetsky is Associate Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey, and Chief Quality Officer, Rutgers Cancer Institute of New Jersey, New Brunswick.
Mark H. Einstein, MD, MS
Dr. Einstein is Professor and Chair, Department of Obstetrics, Gynecology and Women’s Health, and Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, Newark, New Jersey.
Dr. Einstein has advised or participated in educational speaking activities, but he does not receive an honorarium from any companies. In specific cases, Rutgers has received payment for his time spent for these activities from Photocure, Papivax, Cynvec, Merck, Hologic, and PDS Biotechnology. If travel is required for meetings with industry, the company pays for Dr. Einstein’s travel expenses. Rutgers has received grant funding for research-related costs of clinical trials that Dr. Einstein has been the overall or local principal investigator within the past 12 months from J&J, Pfizer, and Inovio. Rutgers has received payment for Dr. Einstein’s time from Photocure, Papivax, Cynvec, and PDS Biotechnology.
Dr. Novetsky is the overall principal investigator of an investigator-initiated grant sponsored by Roche. His institution, Rutgers, has received funding for the clinical costs of this trial.
Dr. Marcus reports no financial relationships relevant to this article.
Jenna Z. Marcus, MD
Dr. Marcus is Assistant Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey.
Akiva P. Novetsky, MD, MS
Dr. Novetsky is Associate Professor, Department of Obstetrics, Gynecology and Women’s Health, Rutgers New Jersey Medical School, Newark, New Jersey, and Chief Quality Officer, Rutgers Cancer Institute of New Jersey, New Brunswick.
Mark H. Einstein, MD, MS
Dr. Einstein is Professor and Chair, Department of Obstetrics, Gynecology and Women’s Health, and Assistant Dean, Clinical Research Unit, Rutgers New Jersey Medical School, Newark, New Jersey.
Dr. Einstein has advised or participated in educational speaking activities, but he does not receive an honorarium from any companies. In specific cases, Rutgers has received payment for his time spent for these activities from Photocure, Papivax, Cynvec, Merck, Hologic, and PDS Biotechnology. If travel is required for meetings with industry, the company pays for Dr. Einstein’s travel expenses. Rutgers has received grant funding for research-related costs of clinical trials that Dr. Einstein has been the overall or local principal investigator within the past 12 months from J&J, Pfizer, and Inovio. Rutgers has received payment for Dr. Einstein’s time from Photocure, Papivax, Cynvec, and PDS Biotechnology.
Dr. Novetsky is the overall principal investigator of an investigator-initiated grant sponsored by Roche. His institution, Rutgers, has received funding for the clinical costs of this trial.
Dr. Marcus reports no financial relationships relevant to this article.
Cervical cancer rates remain low in the United States, with the incidence having plateaued for decades. And yet, in 2019, more than 13,000 US women will be diagnosed with cervical cancer.1 Globally, in 2018 almost 600,000 women were diagnosed with cervical cancer2; it is the fourth most frequent cancer in women. This is despite the fact that we have adequate primary and secondary prevention tools available to minimize—and almost eliminate—cervical cancer. We must continue to raise the bar for preventing, screening for, and managing this disease.
Human papillomavirus (HPV) vaccines provide a highly effective primary prevention strategy, but we need to improve our ability to identify and diagnose dysplastic lesions prior to the development of cervical cancer. Highly sensitive HPV testing and cytology is a powerful secondary prevention approach that enables us to assess a woman’s risk of having precancerous cells both now and in the near future. These modalities have been very successful in decreasing the incidence of cervical cancer in the United States and other areas with organized screening programs. In low- and middle-income countries, however, access to, availability of, and performance with these modalities is not optimal. Innovative strategies and new technologies are being evaluated to overcome these limitations.
Advances in radiation and surgical technology have enabled us to vastly improve cervical cancer treatment. Women with early-stage cervical cancer are candidates for surgical management, which frequently includes a radical hysterectomy and lymph node dissection. While these surgeries traditionally have been performed via an exploratory laparotomy, minimally invasive techniques (laparoscopic and robot-assisted surgical techniques) have decreased the morbidity with these surgeries. Notable new studies have shed light on the comparative effectiveness of minimally invasive technologies and have shown us that new is not always better.
The US Preventive Services Task Force (USPSTF) recently released its updated cervical cancer screening guidelines. The suggested approach to screening differs from previous recommendations. HPV testing as a primary test (that is, HPV testing alone or followed by cytology) takes the spotlight now, according to the analysis by the Task Force.
In this Update, we highlight important studies published in the past year that address these issues.
Continue to: New tech's potential to identify high-grade...
New tech's potential to identify high-grade cervical dysplasia may be a boon to low-resource settings
Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
When cervical screening tests like cytology and HPV testing show abnormal results, colposcopy often is recommended. The goal of colposcopy is to identify the areas that might harbor a high-grade precancerous lesion or worse. The gold standard in this case, however, is histology, not colposcopic impression, as many studies have shown that colposcopy without biopsies is limited and that performance is improved with more biopsies.3,4
Visual inspection with acetic acid (VIA) is an approach used often in low-resource settings where visual impression is the gold standard. However, as with colposcopy, a visual evaluation without histology does not perform well, and often women are overtreated. Many attempts have been made with new technologies to overcome the limitations of time, cost, and workforce required for cytology and histology services. New disruptive technologies may be able to surmount human limitations and improve on not only VIA but also the need for histology.
Novel technology uses images to develop algorithm with predictive ability
In a recent observational study, Hu and colleagues used images that were collected during a large population study in Guanacaste, Costa Rica.5 More than 9,000 women were followed for up to 7 years, and cervical photographs (cervigrams) were obtained. Well-annotated histopathology results were obtained for women with abnormal screening, and 279 women had a high-grade dysplastic lesion or cancer.
Cervigrams from women with high-grade lesions and matched controls were collected, and a deep learning-based algorithm using artificial intelligence technology was developed using 70% of the images. The remaining 30% of images were used as a validation set to test the algorithm's ability to "predict" high-grade dysplasia without knowing the final result.
Findings. Termed automated visual evaluation (AVE), this new technology demonstrated a very accurate ability to identify high-grade dysplasia or worse, with an area under the curve (AUC) of 0.91 from merely a cervicogram (FIGURE). This outperformed conventional Pap smears (AUC, 0.71), liquid-based cytology (AUC, 0.79) and, surprisingly, highly sensitive HPV testing (AUC, 0.82) in women in the prime of their screening ages (>25 years of age).
Colposcopy remains the gold standard for evaluating abnormal cervical cancer screening tests in the United States. But can we do better for our patients using new technologies like AVE? If validated in large-scale trials, AVE has the potential to revolutionize cervical cancer screening in low-resource settings where follow-up and adequate histology services are limited or nonexistent. Future large studies are necessary to evaluate the role of AVE alone versus in combination with other diagnostic testing (such as HPV testing) to detect cervical lesions globally.
Continue to: Data offer persuasive evidence...
Data offer persuasive evidence to abandon minimally invasive surgery in management of early-stage cervical cancer
Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
Over the past decade, gynecologic cancer surgery has shifted from what routinely were open procedures to the adoption of minimally invasive techniques. Recently, a large, well-designed prospective study and a large retrospective study both demonstrated worse outcomes with minimally invasive radical hysterectomy (MIRH) as compared with traditional open radical abdominal hysterectomy (RAH). These 2 landmark studies, initially presented at the Society of Gynecologic Oncology's 2018 annual meeting and later published in the New England Journal of Medicine, have really affected the gynecologic oncology community.
Shorter overall survival in women who had MIRH
Melamed and colleagues conducted a large, retrospective US-based study to evaluate all-cause mortality in women with cervical cancer who underwent MIRH compared with those who had RAH.6 The authors also sought to evaluate national trends in 4-year relative survival rates after minimally invasive surgery was adopted.
The study included 2,461 women who met the inclusion criteria; 49.8% (1,225) underwent MIRH procedures and, of those, 79.8% (978) had robot-assisted laparoscopy. Most women had stage IB1 tumors (88%), and most carcinomas were squamous cell (61%); 40.6% of tumors were less than 2 cm in size. There were no differences between the 2 groups with respect to rates of positive parametria, surgical margins, and lymph node involvement. Administration of adjuvant therapy, in those who qualified, was also similar between groups.
Results. At a median follow-up of 45 months, 94 deaths occurred in the minimally invasive group and 70 in the open surgery group. The risk of death at 4 years was 9.1% in the minimally invasive group versus 5.3% in the open surgery group, with a 65% higher risk of death from any cause, which was highly statistically significant.
Prospective trial showed MIRH was associated with lower survival rates
From 2008 to 2017, Ramirez and colleagues conducted a phase 3, multicenter, randomized controlled trial to prospectively establish the noninferiority of MIRH compared with RAH.7 The study included 631 women from 33 centers. The prespecified expected disease-free survival rate was 90% at 4.5 years.
To be included as a site, centers were required to submit details from 10 minimally invasive cases as well as 2 unedited videos for review by the trial management committee. In contrast to Melamed and colleagues' retrospective study, of the 319 procedures that were classified as minimally invasive, only 15.6% were robotically assisted. Similarly, most women had stage IB1 tumors (91.9%), and most were squamous cell carcinomas (67%). There were also no differences in the postoperative pathology findings or the need for adjuvant therapy administered between groups. The median follow-up was 2.5 years.
Results. At that time there were 27 recurrences in the MIRH group and 7 in the RAH group; there were also 19 deaths after MIRH and 3 after RAH. Disease-free survival at 4.5 years was 86% with MIRH versus 96.5% with RAH. Reported 3-year disease-free survival and overall survival were also significantily lower in the minimally invasive subgroup (91.2% vs 97.1%, 93.8% vs 99.0%, respectively).
Study limitations. Criticisms of this trial are that noninferiority could not be declared; in addition, the investigators were unable to complete enrollment secondary to early enrollment termination after the data and safety monitoring board raised survival concerns.
Many argue that subgroup analyses suggest a lower risk of poor outcomes in patients with smaller tumors (<2 cm); however, it is critical to note that this study was not powered to detect these differences.
The evidence is compelling and demonstrates potentially worse disease-related outcomes using MIRH when compared to traditional RAH with respect to cervical cancer recurrence, rates of death, and disease-free and overall survival. Several hypotheses have been proposed, and future research is needed to elucidate the differences in variables responsible for the outcomes demonstrated in these studies. Although there has been no ban on robot-assisted surgical devices or traditional minimally invasive techniques, the National Comprehensive Cancer Network has updated its recommendations to include careful counseling of patients who require a surgical approach for the management of early-stage cervical cancer.
Continue to: USPSTF updated guidance on cervical cancer screening...
USPSTF updated guidance on cervical cancer screening
Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
Past guidelines for cervical cancer screening have included testing for high-risk HPV (hrHPV) as a cotest with cytology or for triage of atypical squamous cells of undetermined significance (ASCUS) in women aged 30 to 65 years.8 The American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology, with other stakeholder organizations, issued interim guidance for primary HPV testing--that is, HPV test first and, in the case of non-16/18 hrHPV types, cytology as a triage. The most recent evidence report and systematic review by Melnikow and colleagues for the USPSTF offers an in-depth analysis of risks, benefits, harms, and value of cotesting and other management strategies.9
Focus on screening effectiveness
Large trials of cotesting were conducted in women aged 25 to 65.10-13 These studies all consistently showed that primary hrHPV screening led to a statistically significant increased detection of cervical intraepithelial neoplasia (CIN) 3+ in the initial round of screening, with a relative risk of detecting CIN 3+ ranging from 1.61 to 7.46 compared with cytology alone.
Four additional studies compared cotesting with conventional cytology for the detection of CIN 3+. None of these trials demonstrated a significantly higher detection rate of CIN 3+ with cotesting compared with conventional cytology testing alone. Notably, the studies reviewed were performed in European countries that had organized screening programs in place and a nationalized health care system. Thus, these data may not be as applicable to women in the United States, particularly to women who have limited health care access.
Risks of screening
In the same studies reviewed for screening effectiveness, the investigators found that overall, screening with hrHPV primary or cotesting was associated with more false-positive results and higher colposcopy rates. Women screened with hrHPV alone had a 7.9% referral rate to colposcopy, while those screened with cytology had a 2.8% referral rate to colposcopy. Similarly, the rate of biopsy was higher in the hrHPV-only group (3.2% vs 1.3%).
Overall, while cotesting might have some improvement in performance compared with hrHPV as a single modality, there might be risks of overreferral to colposcopy and overtreatment with additional cytology over hrHPV testing alone.
This evidence review also included an analysis of more potential harms. Very limited evidence suggests that positive hrHPV test results may be associated with greater psychological harm, including decreased sexual satisfaction, increased anxiety and distress, and worse feelings about sexual partners, than abnormal cytology results. These were assessed, however, 1 to 2 weeks after the test results were provided to the patients, and long-term assessment was not done.
New recommendations from the USPSTF
Based on these data, the USPSTF issued new recommendations regarding screening (TABLE).14 For women aged 21 to 29, cytology alone should be used for screening every 3 years. Women aged 30 to 65 can be screened with cytology alone every 3 years, with hrHPV testing alone every 5 years, or with cotesting every 5 years.
Primary screening with hrHPV is more effective in diagnosing a CIN 3+ than cytology alone. Cotesting with cytology and hrHPV testing appears to have limited performance improvement, with potential harm, compared with hrHPV testing alone in diagnosing CIN 3+. The Task Force recommendation is hrHPV testing alone or cotesting every 5 years.
Cervical cancer rates remain low in the United States, with the incidence having plateaued for decades. And yet, in 2019, more than 13,000 US women will be diagnosed with cervical cancer.1 Globally, in 2018 almost 600,000 women were diagnosed with cervical cancer2; it is the fourth most frequent cancer in women. This is despite the fact that we have adequate primary and secondary prevention tools available to minimize—and almost eliminate—cervical cancer. We must continue to raise the bar for preventing, screening for, and managing this disease.
Human papillomavirus (HPV) vaccines provide a highly effective primary prevention strategy, but we need to improve our ability to identify and diagnose dysplastic lesions prior to the development of cervical cancer. Highly sensitive HPV testing and cytology is a powerful secondary prevention approach that enables us to assess a woman’s risk of having precancerous cells both now and in the near future. These modalities have been very successful in decreasing the incidence of cervical cancer in the United States and other areas with organized screening programs. In low- and middle-income countries, however, access to, availability of, and performance with these modalities is not optimal. Innovative strategies and new technologies are being evaluated to overcome these limitations.
Advances in radiation and surgical technology have enabled us to vastly improve cervical cancer treatment. Women with early-stage cervical cancer are candidates for surgical management, which frequently includes a radical hysterectomy and lymph node dissection. While these surgeries traditionally have been performed via an exploratory laparotomy, minimally invasive techniques (laparoscopic and robot-assisted surgical techniques) have decreased the morbidity with these surgeries. Notable new studies have shed light on the comparative effectiveness of minimally invasive technologies and have shown us that new is not always better.
The US Preventive Services Task Force (USPSTF) recently released its updated cervical cancer screening guidelines. The suggested approach to screening differs from previous recommendations. HPV testing as a primary test (that is, HPV testing alone or followed by cytology) takes the spotlight now, according to the analysis by the Task Force.
In this Update, we highlight important studies published in the past year that address these issues.
Continue to: New tech's potential to identify high-grade...
New tech's potential to identify high-grade cervical dysplasia may be a boon to low-resource settings
Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
When cervical screening tests like cytology and HPV testing show abnormal results, colposcopy often is recommended. The goal of colposcopy is to identify the areas that might harbor a high-grade precancerous lesion or worse. The gold standard in this case, however, is histology, not colposcopic impression, as many studies have shown that colposcopy without biopsies is limited and that performance is improved with more biopsies.3,4
Visual inspection with acetic acid (VIA) is an approach used often in low-resource settings where visual impression is the gold standard. However, as with colposcopy, a visual evaluation without histology does not perform well, and often women are overtreated. Many attempts have been made with new technologies to overcome the limitations of time, cost, and workforce required for cytology and histology services. New disruptive technologies may be able to surmount human limitations and improve on not only VIA but also the need for histology.
Novel technology uses images to develop algorithm with predictive ability
In a recent observational study, Hu and colleagues used images that were collected during a large population study in Guanacaste, Costa Rica.5 More than 9,000 women were followed for up to 7 years, and cervical photographs (cervigrams) were obtained. Well-annotated histopathology results were obtained for women with abnormal screening, and 279 women had a high-grade dysplastic lesion or cancer.
Cervigrams from women with high-grade lesions and matched controls were collected, and a deep learning-based algorithm using artificial intelligence technology was developed using 70% of the images. The remaining 30% of images were used as a validation set to test the algorithm's ability to "predict" high-grade dysplasia without knowing the final result.
Findings. Termed automated visual evaluation (AVE), this new technology demonstrated a very accurate ability to identify high-grade dysplasia or worse, with an area under the curve (AUC) of 0.91 from merely a cervicogram (FIGURE). This outperformed conventional Pap smears (AUC, 0.71), liquid-based cytology (AUC, 0.79) and, surprisingly, highly sensitive HPV testing (AUC, 0.82) in women in the prime of their screening ages (>25 years of age).
Colposcopy remains the gold standard for evaluating abnormal cervical cancer screening tests in the United States. But can we do better for our patients using new technologies like AVE? If validated in large-scale trials, AVE has the potential to revolutionize cervical cancer screening in low-resource settings where follow-up and adequate histology services are limited or nonexistent. Future large studies are necessary to evaluate the role of AVE alone versus in combination with other diagnostic testing (such as HPV testing) to detect cervical lesions globally.
Continue to: Data offer persuasive evidence...
Data offer persuasive evidence to abandon minimally invasive surgery in management of early-stage cervical cancer
Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
Over the past decade, gynecologic cancer surgery has shifted from what routinely were open procedures to the adoption of minimally invasive techniques. Recently, a large, well-designed prospective study and a large retrospective study both demonstrated worse outcomes with minimally invasive radical hysterectomy (MIRH) as compared with traditional open radical abdominal hysterectomy (RAH). These 2 landmark studies, initially presented at the Society of Gynecologic Oncology's 2018 annual meeting and later published in the New England Journal of Medicine, have really affected the gynecologic oncology community.
Shorter overall survival in women who had MIRH
Melamed and colleagues conducted a large, retrospective US-based study to evaluate all-cause mortality in women with cervical cancer who underwent MIRH compared with those who had RAH.6 The authors also sought to evaluate national trends in 4-year relative survival rates after minimally invasive surgery was adopted.
The study included 2,461 women who met the inclusion criteria; 49.8% (1,225) underwent MIRH procedures and, of those, 79.8% (978) had robot-assisted laparoscopy. Most women had stage IB1 tumors (88%), and most carcinomas were squamous cell (61%); 40.6% of tumors were less than 2 cm in size. There were no differences between the 2 groups with respect to rates of positive parametria, surgical margins, and lymph node involvement. Administration of adjuvant therapy, in those who qualified, was also similar between groups.
Results. At a median follow-up of 45 months, 94 deaths occurred in the minimally invasive group and 70 in the open surgery group. The risk of death at 4 years was 9.1% in the minimally invasive group versus 5.3% in the open surgery group, with a 65% higher risk of death from any cause, which was highly statistically significant.
Prospective trial showed MIRH was associated with lower survival rates
From 2008 to 2017, Ramirez and colleagues conducted a phase 3, multicenter, randomized controlled trial to prospectively establish the noninferiority of MIRH compared with RAH.7 The study included 631 women from 33 centers. The prespecified expected disease-free survival rate was 90% at 4.5 years.
To be included as a site, centers were required to submit details from 10 minimally invasive cases as well as 2 unedited videos for review by the trial management committee. In contrast to Melamed and colleagues' retrospective study, of the 319 procedures that were classified as minimally invasive, only 15.6% were robotically assisted. Similarly, most women had stage IB1 tumors (91.9%), and most were squamous cell carcinomas (67%). There were also no differences in the postoperative pathology findings or the need for adjuvant therapy administered between groups. The median follow-up was 2.5 years.
Results. At that time there were 27 recurrences in the MIRH group and 7 in the RAH group; there were also 19 deaths after MIRH and 3 after RAH. Disease-free survival at 4.5 years was 86% with MIRH versus 96.5% with RAH. Reported 3-year disease-free survival and overall survival were also significantily lower in the minimally invasive subgroup (91.2% vs 97.1%, 93.8% vs 99.0%, respectively).
Study limitations. Criticisms of this trial are that noninferiority could not be declared; in addition, the investigators were unable to complete enrollment secondary to early enrollment termination after the data and safety monitoring board raised survival concerns.
Many argue that subgroup analyses suggest a lower risk of poor outcomes in patients with smaller tumors (<2 cm); however, it is critical to note that this study was not powered to detect these differences.
The evidence is compelling and demonstrates potentially worse disease-related outcomes using MIRH when compared to traditional RAH with respect to cervical cancer recurrence, rates of death, and disease-free and overall survival. Several hypotheses have been proposed, and future research is needed to elucidate the differences in variables responsible for the outcomes demonstrated in these studies. Although there has been no ban on robot-assisted surgical devices or traditional minimally invasive techniques, the National Comprehensive Cancer Network has updated its recommendations to include careful counseling of patients who require a surgical approach for the management of early-stage cervical cancer.
Continue to: USPSTF updated guidance on cervical cancer screening...
USPSTF updated guidance on cervical cancer screening
Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
Past guidelines for cervical cancer screening have included testing for high-risk HPV (hrHPV) as a cotest with cytology or for triage of atypical squamous cells of undetermined significance (ASCUS) in women aged 30 to 65 years.8 The American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology, with other stakeholder organizations, issued interim guidance for primary HPV testing--that is, HPV test first and, in the case of non-16/18 hrHPV types, cytology as a triage. The most recent evidence report and systematic review by Melnikow and colleagues for the USPSTF offers an in-depth analysis of risks, benefits, harms, and value of cotesting and other management strategies.9
Focus on screening effectiveness
Large trials of cotesting were conducted in women aged 25 to 65.10-13 These studies all consistently showed that primary hrHPV screening led to a statistically significant increased detection of cervical intraepithelial neoplasia (CIN) 3+ in the initial round of screening, with a relative risk of detecting CIN 3+ ranging from 1.61 to 7.46 compared with cytology alone.
Four additional studies compared cotesting with conventional cytology for the detection of CIN 3+. None of these trials demonstrated a significantly higher detection rate of CIN 3+ with cotesting compared with conventional cytology testing alone. Notably, the studies reviewed were performed in European countries that had organized screening programs in place and a nationalized health care system. Thus, these data may not be as applicable to women in the United States, particularly to women who have limited health care access.
Risks of screening
In the same studies reviewed for screening effectiveness, the investigators found that overall, screening with hrHPV primary or cotesting was associated with more false-positive results and higher colposcopy rates. Women screened with hrHPV alone had a 7.9% referral rate to colposcopy, while those screened with cytology had a 2.8% referral rate to colposcopy. Similarly, the rate of biopsy was higher in the hrHPV-only group (3.2% vs 1.3%).
Overall, while cotesting might have some improvement in performance compared with hrHPV as a single modality, there might be risks of overreferral to colposcopy and overtreatment with additional cytology over hrHPV testing alone.
This evidence review also included an analysis of more potential harms. Very limited evidence suggests that positive hrHPV test results may be associated with greater psychological harm, including decreased sexual satisfaction, increased anxiety and distress, and worse feelings about sexual partners, than abnormal cytology results. These were assessed, however, 1 to 2 weeks after the test results were provided to the patients, and long-term assessment was not done.
New recommendations from the USPSTF
Based on these data, the USPSTF issued new recommendations regarding screening (TABLE).14 For women aged 21 to 29, cytology alone should be used for screening every 3 years. Women aged 30 to 65 can be screened with cytology alone every 3 years, with hrHPV testing alone every 5 years, or with cotesting every 5 years.
Primary screening with hrHPV is more effective in diagnosing a CIN 3+ than cytology alone. Cotesting with cytology and hrHPV testing appears to have limited performance improvement, with potential harm, compared with hrHPV testing alone in diagnosing CIN 3+. The Task Force recommendation is hrHPV testing alone or cotesting every 5 years.
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69:7-34.
- World Health Organization website. Cervical cancer. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/. Accessed April 17, 2019.
- Wentzensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy. J Clin Oncol. 2015;33:83-89.
- Gage JC, Hanson VW, Abbey K, et al. Number of cervical biopsies and sensitivity of colposcopy. Obstet Gynecol. 2006;108:264-272.
- Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Saslow D, Solomon D, Lawson HW, et al; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012;62:147-172.
- Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
- Canfell K, Caruana M, Gebski V, et al. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: results of the Compass pilot randomised trial. PLoS Med. 2017;14:e1002388. doi:10.1371/journal.pmed.1002388.
- Leinonen MK, Nieminen P, Lonnberg S, et al. Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland. BMJ. 2012;345:e7789.
- Ogilvie GS, van Niekerk D, Krajden M, et al. Effect of screening with primary cervical HPV testing vs cytology testing on high-grade cervical intraepithelial neoplasia at 48 months: the HPV FOCAL randomized clinical trial. JAMA. 2018;320:43-52.
- Ronco G, Fioprgi-Rossi P, Carozzi F, et al; New Technologies for Cervical Cancer screening (NTCC) Working Group. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol. 2010;11:249-257.
- US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
- Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019;69:7-34.
- World Health Organization website. Cervical cancer. https://www.who.int/cancer/prevention/diagnosis-screening/cervical-cancer/en/. Accessed April 17, 2019.
- Wentzensen N, Walker JL, Gold MA, et al. Multiple biopsies and detection of cervical cancer precursors at colposcopy. J Clin Oncol. 2015;33:83-89.
- Gage JC, Hanson VW, Abbey K, et al. Number of cervical biopsies and sensitivity of colposcopy. Obstet Gynecol. 2006;108:264-272.
- Hu L, Bell D, Antani S, et al. An observational study of deep learning and automated evaluation of cervical images for cancer screening. J Natl Cancer Inst. 2019;doi:10.1093/jnci/djy225.
- Melamed A, Margul DJ, Chen L, et al. Survival after minimally invasive radical hysterectomy for early-stage cervical cancer. N Engl J Med. 2018;379:1905-1914.
- Ramirez PT, Frumovitz M, Pareja R, et al. Minimally invasive versus abdominal radical hysterectomy for cervical cancer. N Engl J Med. 2018;379:1895-1904.
- Saslow D, Solomon D, Lawson HW, et al; ACS-ASCCP-ASCP Cervical Cancer Guideline Committee. American Cancer Society, American Society for Colposcopy and Cervical Pathology, and American Society for Clinical Pathology screening guidelines for the prevention and early detection of cervical cancer. CA Cancer J Clin. 2012;62:147-172.
- Melnikow J, Henderson JT, Burda BU, et al. Screening for cervical cancer with high-risk human papillomavirus testing: updated evidence report and systematic review for the US Preventive Services Task Force. JAMA. 2018;320:687-705.
- Canfell K, Caruana M, Gebski V, et al. Cervical screening with primary HPV testing or cytology in a population of women in which those aged 33 years or younger had previously been offered HPV vaccination: results of the Compass pilot randomised trial. PLoS Med. 2017;14:e1002388. doi:10.1371/journal.pmed.1002388.
- Leinonen MK, Nieminen P, Lonnberg S, et al. Detection rates of precancerous and cancerous cervical lesions within one screening round of primary human papillomavirus DNA testing: prospective randomised trial in Finland. BMJ. 2012;345:e7789.
- Ogilvie GS, van Niekerk D, Krajden M, et al. Effect of screening with primary cervical HPV testing vs cytology testing on high-grade cervical intraepithelial neoplasia at 48 months: the HPV FOCAL randomized clinical trial. JAMA. 2018;320:43-52.
- Ronco G, Fioprgi-Rossi P, Carozzi F, et al; New Technologies for Cervical Cancer screening (NTCC) Working Group. Efficacy of human papillomavirus testing for the detection of invasive cervical cancers and cervical intraepithelial neoplasia: a randomised controlled trial. Lancet Oncol. 2010;11:249-257.
- US Preventive Services Task Force, Curry SJ, Krist AH, et al. Screening for cervical cancer: US Preventive Services Task Force recommendation statement. JAMA. 2018;320:674-686.
Cluster headache is associated with increased suicidality
Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.
Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
A prospective, multicenter study
Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.
The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
Suicidal ideation increased during the ictal phase
During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.
The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.
Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.
In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
Patients need a disease-modifying treatment
Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”
Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”
The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.
The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.
SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.
Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.
Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
A prospective, multicenter study
Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.
The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
Suicidal ideation increased during the ictal phase
During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.
The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.
Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.
In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
Patients need a disease-modifying treatment
Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”
Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”
The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.
The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.
SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.
Short- and long-term cluster headache disease burden, as well as depressive symptoms, contributes to suicidality, according to research published online Cephalalgia. Development of treatments that reduce the headache-related burden and prevent future bouts could reduce suicidality, said the researchers.
Although cluster headache has been called the “suicide headache,” few studies have examined suicidality in patients with cluster headache. Research by Rozen et al. found that the rate of suicidal attempt among patients was similar to that among the general population. The results have not been replicated, however, and the investigators did not examine whether suicidality varied according to the phases of the disorder.
A prospective, multicenter study
Mi Ji Lee, MD, PhD, clinical assistant professor of neurology at Samsung Medical Center in Seoul, South Korea, and colleagues conducted a prospective study to investigate the suicidality associated with cluster headache and the factors associated with increased suicidality in that disorder. The researchers enrolled 193 consecutive patients with cluster headache between September 2016 and August 2018 at 15 hospitals. They examined the patients and used the Patient Health Questionnaire–9 (PHQ-9) and the General Anxiety Disorder–7 item scale (GAD-7) screening tools. During the ictal and interictal phases, the researchers asked the patients whether they had had passive suicidal ideation, active suicidal ideation, suicidal planning, or suicidal attempt. Dr. Ji Lee and colleagues performed univariable and multivariable logistic regression analyses to evaluate the factors associated with high ictal suicidality, which was defined as two or more positive responses during the ictal phase. Participants were followed up during the between-bout phase.
The researchers excluded 18 patients from analysis because they were between bouts at enrollment. The mean age of the remaining 175 patients was 38.4 years. Mean age at onset was 29.9 years. About 85% of the patients were male. The diagnosis was definite cluster headache for 87.4% of the sample and probable cluster headache for 12.6%. In addition, 88% of the population had episodic cluster headache.
Suicidal ideation increased during the ictal phase
During the ictal phase, 64.2% of participants reported passive suicidal ideation, and 35.8% reported active suicidal ideation. Furthermore, 5.8% of patients had a suicidal plan, and 2.3% attempted suicide. In the interictal phase, 4.0% of patients reported passive suicidal ideation, and 3.5% reported active suicidal ideation. Interictal suicidal planning was reported by 2.9% of participants, and 1.2% of participants attempted suicide interictally. The results were similar between patients with definite and probable cluster headache.
The ictal phase increased the odds of passive suicidal ideation (odds ratio [OR], 42.46), active suicidal ideation (OR, 15.55), suicidal planning (OR, 2.06), and suicidal attempt (OR, 2.02), compared with the interictal phase. The differences in suicidal planning and suicidal attempt between the ictal and interictal phases, however, were not statistically significant.
Longer disease duration, higher attack intensity, higher Headache Impact Test–6 (HIT-6) score, GAD-7 score, and PHQ-9 score were associated with high ictal suicidality. Disease duration, HIT-6, and PHQ-9 remained significantly associated with high ictal suicidality in the multivariate analysis. Younger age at onset, longer disease duration, total number of lifetime bouts, and higher GAD-7 and PHQ-9 scores were significantly associated with interictal suicidality in the univariable analysis. The total number of lifetime bouts and the PHQ-9 scores remained significant in the multivariable analysis.
In all, 54 patients were followed up between bouts. None reported passive suicidal ideation, 1.9% reported active suicidal ideation, 1.9% reported suicidal planning, and none reported suicidal attempt. Compared with the between-bouts period, the ictal phase was associated with significantly higher odds of active suicidal ideation (OR, 37.32) and nonsignificantly increased suicidal planning (OR, 3.20).
Patients need a disease-modifying treatment
Taken together, the study results underscore the importance of proper management of cluster headache to reduce its burden, said the authors. “Given that greater headache-related impact was independently associated with ictal suicidality, an intensive treatment to reduce the headache-related impact might be beneficial to prevent suicide in cluster headache patients,” they said. In addition to reducing headache-related impact and headache intensity, “a disease-modifying treatment to prevent further bouts is warranted to decrease suicidality in cluster headache patients.”
Although patients with cluster headache had increased suicidality in the ictal and interictal phases, they had lower suicidality between bouts, compared with the general population. This result suggests that patients remain mentally healthy when the bouts are over, and that “a strategy to shorten the length of bout is warranted,” said Dr. Ji Lee and colleagues. Furthermore, the fact that suicidality did not differ significantly between patients with definite cluster headache and those with probable cluster headache “prompts clinicians for an increased identification and intensive treatment strategy for probable cluster headache.”
The current study is the first prospective investigation of suicidality in the various phases of cluster headache, according to the investigators. It nevertheless has several limitations. The prevalence of chronic cluster headache was low in the study population, and not all patients presented for follow-up during the period between bouts. In addition, the data were obtained from recall, and consequently may be less accurate than those gained from prospective recording. Finally, Dr. Ji Lee and colleagues did not gather information on personality disorders, insomnia, substance abuse, or addiction, even though these factors can influence suicidality in patients with chronic pain.
The investigators reported no conflicts of interest related to their research. The study was supported by a grant from the Korean Neurological Association.
SOURCE: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.
FROM CEPHALAGIA
Key clinical point: Cluster headache is associated with increased suicidality during attacks and within the active period.
Major finding: Cluster headache attacks increased the risk of active suicidal ideation (odds ratio, 15.55).
Study details: A prospective, multicenter study of 175 patients with cluster headache.
Disclosures: The study was supported by a grant from the Korean Neurological Association.
Source: Ji Lee M et al. Cephalalgia. 2019 Apr 24. doi: 10.1177/0333102419845660.
ASCO: Deintensified treatment in p16+ oropharyngeal cancer needs evaluation
Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).
“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.
The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.
After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.
“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.
At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.
The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.
More information on the provisional clinical opinion is available on the ASCO website.
ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.
SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.
Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).
“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.
The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.
After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.
“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.
At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.
The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.
More information on the provisional clinical opinion is available on the ASCO website.
ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.
SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.
Treatment deintensification for patients with p16+ oropharyngeal cancer (OPC) should occur only in the context of a clinical trial, according to a provisional clinical opinion released by the American Society of Clinical Oncology (ASCO).
“The hypothesis that deescalation of treatment intensity for patients with p16+ OPC can reduce long-term toxicity without compromising survival is compelling and necessitates careful study and the analysis of well-designed clinical trials before changing current treatment standards, wrote David J. Adelstein, MD, of Case Western Reserve University, Cleveland, along with his associates on the expert panel. Their report is in the Journal of Clinical Oncology.
The panel undertook a review of the literature for evidence pertaining to the treatment of patients with HPV-mediated p16+ OPC with radiation, transoral surgery, concomitant chemoradiotherapy, and chemotherapy, in addition to immunotherapy and targeted therapy. Both randomized and nonrandomized studies were included in the review, and expert consensus opinion was taken into consideration.
After the review, the panelists concluded that the presumption that deintensified treatment in patients with p16+ OPC can lower long-term adverse effects without impacting survival is still a hypothesis that warrants further testing. While early findings of deintensified treatment techniques show promise, current treatment recommendations have not changed, they said.
“The standard of care for the definitive nonoperative management of cisplatin-eligible patients with advanced disease is concurrent chemoradiation with high-dose cisplatin given every 3 weeks,” the panel wrote. “For patients undergoing initial surgical resection, adjuvant chemoradiation with concurrent high-dose cisplatin given every 3 weeks is recommended for patients with positive margins and/or extranodal tumor extension,” they added.
At present, they recommend that deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.
The panel acknowledged that establishing definitive recommendations for all possible clinical scenarios is challenging because of restrictive exclusion criteria in key clinical trials. As a result, the accuracy of outcome data may be limited to specific patient populations.
More information on the provisional clinical opinion is available on the ASCO website.
ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.
SOURCE: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: The hypothesis that deintensified treatment in patients with p16+ oropharyngeal cancer (OPC) can lower long-term adverse effects without impacting survival warrants further evaluation.
Major finding: Deintensified treatment for patients with p16+ OPC should occur only in the context of a clinical trial.
Study details: A provisional clinical opinion released by ASCO.
Disclosures: ASCO funded the study. The authors reported financial affiliations with AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, PDS Biotechnology, and several others.
Source: Adelstein DJ et al. J Clin Oncol. 2019 Apr 25. doi: 10.1200/JCO.19.00441.
Good news for ObGyns: Medical liability claims resulting in payment are decreasing!
Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.
The good news: Paid claims per 1,000 ObGyns have decreased greatly
In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1
The majority of claims result in no payment
In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.
In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3
Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing
In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1
Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.
Liability premiums are stable or decreasing
From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:
Create your own user feedback survey
Reform of the liability tort system
Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.
Medical factors contributing to a decrease in claims
In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.
In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:
- an elective induction bundle focused on the safe use of oxytocin
- an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
- an operative vaginal delivery bundle
- TeamSTEPPS teamwork training to improve the quality of communication
- best practices education with a focus on electronic fetal monitoring
- regular performance feedback to hospitals and clinicians
- implementation of a quality improvement collaboration to support implementation of the interventions.
During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.
Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9
Other health system interventions that may contribute to a reduction in claims include:
- systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
- rapid response systems to rescue hospital patients with worrisome vital signs11
- standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
- rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
- identification and referral of high-risk patients to tertiary centers14
- closed loop communication of critical imaging and laboratory results15
- universal insurance coverage for health care including contraception, obstetrics, and pediatric care.
Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.
- Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
- Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
- Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
- Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
- Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
- Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
- Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
- Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
- Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
- Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
- Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
- The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
- Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
- Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Robert L. Barbieri, MD
Editor in Chief, OBG Management
Chair, Obstetrics and Gynecology
Brigham and Women's Hospital, Boston, Massachusetts
Kate Macy Ladd Professor of Obstetrics,
Gynecology and Reproductive Biology
Harvard Medical School, Boston
Dr. Barbieri reports no financial relationships relevant to this article.
Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.
The good news: Paid claims per 1,000 ObGyns have decreased greatly
In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1
The majority of claims result in no payment
In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.
In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3
Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing
In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1
Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.
Liability premiums are stable or decreasing
From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:
Create your own user feedback survey
Reform of the liability tort system
Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.
Medical factors contributing to a decrease in claims
In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.
In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:
- an elective induction bundle focused on the safe use of oxytocin
- an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
- an operative vaginal delivery bundle
- TeamSTEPPS teamwork training to improve the quality of communication
- best practices education with a focus on electronic fetal monitoring
- regular performance feedback to hospitals and clinicians
- implementation of a quality improvement collaboration to support implementation of the interventions.
During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.
Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9
Other health system interventions that may contribute to a reduction in claims include:
- systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
- rapid response systems to rescue hospital patients with worrisome vital signs11
- standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
- rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
- identification and referral of high-risk patients to tertiary centers14
- closed loop communication of critical imaging and laboratory results15
- universal insurance coverage for health care including contraception, obstetrics, and pediatric care.
Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.
Medical professional liability claims (claims) are a major cause of worry and agony for physicians who are dedicated to optimizing the health of all their patients. Among physicians, those who practice neurosurgery, thoracic surgery, plastic surgery, and obstetrics and gynecology have the greatest rate of making a payment on a claim per year of practice.1 Physicians who practice psychiatry, pediatrics, pathology, and internal medicine have the lowest rate of making a payment on a claim. Among the physicians in high-risk specialties, greater than 90% will have a claim filed against them during their career.2 Although professional liability exposure reached a crisis during the 1980s and 1990s, recent data have shown a decrease in overall professional liability risk.
The good news: Paid claims per 1,000 ObGyns have decreased greatly
In a review of all paid claims reported to the National Practitioner Data Bank from 1992 to 2014, the annual rate of paid claims per 1,000 ObGyn physician-years was determined.1 For the time periods 1992–1996, 1997–2002, 2003–2008,and 2009–2014, the annual rate of paid claims per 1,000 ObGyn physician-years was 57.6, 51.5, 40.0, and 25.9, representing an astounding 55% decrease in paid claims from 1992 to 2014 (FIGURE).1
The majority of claims result in no payment
In a review of the experience of a nationwide professional liability insurer from 1991 to 2005, only 22% of claims resulted in a payment.2 In this study, for obstetrics and gynecology and gynecologic surgery, only 11% and 8% of claims, respectively, resulted in a payment.2 However, being named in a malpractice claim results in significant stress for a physician and requires a great deal of work and time to defend.
In another study using data from the Physician Insurer’s Association of America, among 10,915 claims closed from 2005 to 2014, 59.5% were dropped, withdrawn, or dismissed; 27.7% were settled; 2.5% were resolved using an alternative dispute resolution process; 1.8% were uncategorized; and 8.6% went to trial.3 Of the cases that went to trial, 87% resulted in a verdict for the physician and 13% resulted in a verdict for the plaintiff.3
Not as good news: Payments per claim and claims settling for a payment > $1 million are increasing
In the period 1992–1996, the average payment per paid claim in the field of obstetrics and gynecology was $387,186, rising to $447,034 in 2009–2014—a 16% increase.1 From 2004 to 2010, million dollar payments occurred in about 8% of cases of paid claims, but they represent 36% of the total of all paid claims.4 In the time periods 1992–1996 and 2009–2014, payments greater than $1 million occurred in 6% and 8% of paid claims, respectively.1
Claims settled for much more than $1 million are of great concern to physicians because the payment may exceed their policy limit, creating a complex legal problem that may take time to resolve. In some cases, where the award is greater than the insurance policy limit, aggressive plaintiff attorneys have obtained a lien on the defendant physician’s home pending settlement of the case. When a multimillion dollar payment is made to settle a professional liability claim, it can greatly influence physician practice and change hospital policies. Frequently, following a multimillion dollar payment a physician may decide to limit their practice to low-risk cases or retire from the practice of medicine.
Liability premiums are stable or decreasing
From 2014 to 2019, my ObGyn professional liability insurance premiums decreased by 18%. During the same time period, my colleagues who practice surgical gynecology (no obstetrics) had a premium decrease of 22%. Insurers use a complex algorithm to determine annual liability insurance premiums, and premiums for ObGyns may not have stabilized or decreased in all regions. Take this Instant Poll:
Create your own user feedback survey
Reform of the liability tort system
Litigation policies and practices that reduce liability risk reduce total medical liability losses. Policies that have helped to constrain medical liability risk include state constitutional amendments limiting payments for pain and suffering, caps on compensation to plaintiff attorneys, increased early resolution programs that compensate patients who experience an adverse event and no-fault conflict resolution programs.5 In 2003, Texas implemented a comprehensive package of tort reform laws. Experts believe the reforms decreased the financial burden of professional liability insurance6 and led to less defensive medical practices, reducing excessive use of imaging and laboratory tests.
Medical factors contributing to a decrease in claims
In 1999, the Institute of Medicine released the report, “To Err is Human,” which galvanized health care systems to deploy systems of care that reduce the rate of adverse patient outcomes.7 Over the past 20 years, health systems have implemented quality improvement programs in obstetrics and gynecology that have contributed to a reduction in the rate of adverse patient outcomes. This may have contributed to the decrease in the rate of paid claims.
In a quasi-experimental study performed in 13 health systems, 7 interventions were implemented with the goal of improving outcomes and reducing medical liability. The 7 interventions included8:
- an elective induction bundle focused on the safe use of oxytocin
- an augmentation bundle focused on early intervention for possible fetal metabolic acidosis
- an operative vaginal delivery bundle
- TeamSTEPPS teamwork training to improve the quality of communication
- best practices education with a focus on electronic fetal monitoring
- regular performance feedback to hospitals and clinicians
- implementation of a quality improvement collaboration to support implementation of the interventions.
During the two-year baseline period prior to the intervention there were 185,373 deliveries with 6.7 perinatal claims made per 10,000 deliveries and 1.3 claims paid per 10,000 deliveries. Following the intervention, the rate of claims made and claims paid per 10,000 deliveries decreased by 22% and 37%, respectively. In addition there was a marked decrease in claims over $1 million paid, greatly limiting total financial liability losses.
Experts with vast experience in obstetrics and obstetric liability litigation have identified 4 priority interventions that may improve outcomes and mitigate liability risk, including: 1) 24-hour in-house physician coverage of an obstetrics service, 2) a conservative approach to trial of labor after a prior cesarean delivery, 3) utilization of a comprehensive, standardized event note in cases of a shoulder dystocia, and 4) judicious use of oxytocin, misoprostol, and magnesium sulfate.9
Other health system interventions that may contribute to a reduction in claims include:
- systematic improvement in the quality of communication among physicians and nurses through the use of team training, preprocedure huddles, and time-out processes10
- rapid response systems to rescue hospital patients with worrisome vital signs11
- standardized responses to a worrisome category 2 or 3 fetal heart-rate tracing12
- rapid recognition, evaluation, and treatment of women with hemorrhage, severe hypertension, sepsis, and venous thromboembolism13
- identification and referral of high-risk patients to tertiary centers14
- closed loop communication of critical imaging and laboratory results15
- universal insurance coverage for health care including contraception, obstetrics, and pediatric care.
Medical liability risk is an important practice issue because it causes excessive use of imaging and laboratory tests and often traumatizes clinicians, which can result in burnout. In the 1980s and 1990s, medical liability litigation reached a crescendo and was a prominent concern among obstetrician-gynecologists. The good news is that, for ObGyns, liability risk has stabilized. Hopefully our resolute efforts to continuously improve the quality of care will result in a long-term reduction in medical liability risk.
- Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
- Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
- Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
- Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
- Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
- Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
- Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
- Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
- Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
- Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
- Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
- The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
- Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
- Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
- Schaffer AC, Jena AB, Seabury SA, et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992–2014. JAMA Intern Med. 2017;177:710-718.
- Jena AB, Seabury S, Lakdawalla D, et al. Malpractice risk according to physician specialty. N Engl J Med. 2011;365:629-636.
- Glaser LM, Alvi FA, Milad MP. Trends in malpractice claims for obstetric and gynecologic procedures, 2005 through 2014. Am J Obstet Gynecol. 2017;217:340.e1-e6.
- Bixenstine PJ, Shore AD, Mehtsun WT, et al. Catastrophic medical malpractice payouts in the United States. J Healthc Quality. 2014;36:43-53.
- Cardoso R, Zarin W, Nincic V, et al. Evaluative reports on medical malpractice policies in obstetrics: a rapid scoping review. Syst Rev. 2017;6:181.
- Stewart RM, Geoghegan K, Myers JG, et al. Malpractice risk and costs are significantly reduced after tort reform. J Am Coll Surg. 2011;212:463-467.
- Institute of Medicine Committee on Quality Health Care in America; Kohn LT, Corrigan JM, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academies Press; 2000.
- Riley W, Meredith LW, Price R, et al. Decreasing malpractice claims by reducing preventable perinatal harm. Health Serv Res. 2016;51(suppl 3):2453-2471.
- Clark SL, Belfort MA, Dildy GA, et al. Reducing obstetric litigation through alterations in practice patterns. Obstet Gynecol. 2008;112:1279-1283.
- Haynes AB, Weiser TG, Berry WR, et al; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360:491-499.
- Patel S, Gillon SA, Jones DA. Rapid response systems: recognition and rescue of the deteriorating hospital patient. Br J Hosp Med (Lond). 2017;78:143-148.
- Clark SL, Hamilton EF, Garite TJ, et al. The limits of electronic fetal heart rate monitoring in the prevention of neonatal metabolic acidemia. Am J Obstet Gynecol. 2017;216:163.e1-163.e6.
- The Council on Patient Safety in Women’s Healthcare website. www.safehealthcareforeverywoman.org. Accessed April 12, 2019.
- Zahn CM, Remick A, Catalano A, et al. Levels of maternal care verification pilot: translating guidance into practice. Obstet Gynecol. 2018;132:1401-1406.
- Zuccotti G, Maloney FL, Feblowitz J, et al. Reducing risk with clinical decision support: a study of closed malpractice claims. Appl Clin Inform. 2014;5:746-756.
CBO’s report on single-payer health care holds more questions than answers
Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.
A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.
“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.
The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.
“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”
The report comes as this once-lefty pipe dream becomes officially mainstream.
Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.
Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?
What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.
For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.
There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.
What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?
Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.
Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.
And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.
Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.
Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?
That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.
For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.
There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.
“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.
The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.
The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.
Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.
Yet again, though, the CBO said, whether that actually happens depends on the system’s design.
By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.
But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.
Even without clear answers, outlining those questions moves the ball, Liu said.
“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.
A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.
“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.
The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.
“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”
The report comes as this once-lefty pipe dream becomes officially mainstream.
Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.
Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?
What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.
For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.
There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.
What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?
Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.
Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.
And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.
Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.
Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?
That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.
For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.
There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.
“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.
The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.
The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.
Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.
Yet again, though, the CBO said, whether that actually happens depends on the system’s design.
By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.
But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.
Even without clear answers, outlining those questions moves the ball, Liu said.
“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.
Progressive Democrats have rallied around “Medicare-for-all,” a single-payer health plan popularized by Sen. Bernie Sanders (I-Vt.). Now, some of Washington’s official bean counters are trying to add a new framework around what it might look like. The picture they offer highlights just how complicated that shift might be.
A report released May 1 by the nonpartisan Congressional Budget Office outlined a laundry list of options and technicalities lawmakers would need to consider if they are serious about such a proposal.
“The conversation about single-payer is getting more in the weeds, more detailed, which is a good thing because it’s such a complicated issue,” said Jodi Liu, an associate policy researcher at the Rand Corp. who studies single-payer proposals.
The takeaway: There’s a lot left to be answered about the concepts of Medicare-for-all specifically and the category of single-payer more broadly before policymakers and voters can come close to understanding what it would mean in practice. The term “single-payer” generally refers to a system in which health care is paid for by a single public authority.
“Even single-payer systems around the globe vary from each other in many, many ways,” said John McDonough, a Harvard health policy professor who helped draft the Affordable Care Act. “There’s just so many aspects of it that differ from a Canada to a Sweden to a Taiwan – and those are all intensely consequential.”
The report comes as this once-lefty pipe dream becomes officially mainstream.
Medicare-for-all has been name-checked by Democrats running for president. On April 30, Democrats and Republicans alike put the proposal under the microscope at a House Rules Committee hearing. And that won’t be the last time that happens. House Ways and Means Committee Chairman Richard Neal (D-Mass.) said he, too, intends to hold a hearing on the issue this session. Meanwhile, Sanders’ latest Medicare-for-all bill, reintroduced in the Senate in April, and a similar House bill, have 14 and 108 cosponsors, respectively.
Let’s break down the most crucial issues raised by the CBO report – what single-payer might cover, why “what it would cost” isn’t easy to determine, and what it could mean for how Americans get their health care.
Medicare-for-all backers say the program would cover all medically necessary services. But what does that truly mean?
What may seem obvious – the notion of medical necessity – isn’t so easy to distill into policy rules. And different single-payer systems around the world handle the benefits question differently, the CBO noted.
For instance, Canada doesn’t cover prescription drugs, but the United Kingdom and Sweden do. Of those three, only Sweden fully covers long-term support services, according to the report.
There are two questions at the heart of it, said Robert Berenson, a health policy analyst at the Urban Institute, a left-leaning think tank.
What benefits would be covered? Would it include dental care or prescription drugs or vision, as Sanders’ bill would? And, how does one determine the discrete services included within those benefits categories?
Single-payer architects could look at existing standards, such as the so-called essential health benefits that govern Obamacare health plans, to determine what’s covered. They could be more generous by including long-term care, which isn’t currently covered by Medicare or most private insurance plans.
Even the two “Medicare-for-all” bills in Congress have slightly different takes. Though both provide for long-term support and services, they diverge on how to pay for it. Sanders’ bill covers only at-home long-term care and keeps Medicaid intact for services provided in institutions. The House bill by Rep. Pramila Jayapal (D-Wash.) covers both.
And there are questions about new medical treatments, and how to determine whether they provide added value. The CBO report suggested some kind of “cost-effectiveness criterion” could determine what the government is willing to cover. In practice, though, that standard could be difficult to develop and could fall victim to political lobbying or trigger contentious debate.
Separately from the CBO report, Mr. McDonough noted, controversial medical services could bring up different kinds of political baggage – whether this plan would cover abortion, for instance, likely would change the single-payer debate.
Next: Single-payer health care would probably require new taxes. Just what level of taxes, though, and who they would hit hardest remain open questions.
Notably, the CBO report avoids a question that critics frequently surface: How much would this cost? How would you pay for it?
That’s because there’s no uniform cost estimate for single-payer and no easy formula to apply.
For one thing, the price tag depends on what services are covered – something like long-term care would make the idea much more expensive.
There’s also the question of cost sharing. In some single-payer systems, people must pay a copay, meet a deductible, or pay a premium as part of the health plan. That would alleviate some need for new taxes.
“I don’t think you can put numbers on it until someone defines a benefit package and defines cost sharing,” Mr. Berenson said.
The current Medicare-for-all bills eschew cost sharing. Other health reform proposals would keep premiums intact to help foot some of the bill.
The CBO report suggests that new taxes would likely play a role in financing a new single-payer plan. But what kind of taxes – a payroll tax, an income tax, or a sales tax, for instance – has not yet been stipulated. And each would have different consequences.
The single-payer approach could bring down health expenses, or at least increase value. But how effectively it would do so – and its larger economic impact – would depend on other design choices.
Single-payer backers dismiss the “pay-for” questions because, the reasoning goes, this approach would save lots of money in other ways, ultimately making it a good deal.
Yet again, though, the CBO said, whether that actually happens depends on the system’s design.
By eliminating most private insurers, a single-payer system would likely slash hospitals’ administrative overhead. The government could then pay a rate that better reflects reduced hospital costs, according to the CBO report.
But, ultimately, the single-payer bottom line depends on what the system pays hospitals, doctors, and drug companies for different services and products. That answer also would inform other economic assessments – ascertaining, for instance, how single-payer affects a small town where the hospital is the main employer.
Even without clear answers, outlining those questions moves the ball, Liu said.
“This area is moving really fast,” she said. “To me, it seems like this is the beginning of a longer conversation.”
Kaiser Health News is a nonprofit national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation that is not affiliated with Kaiser Permanente.