Janelle Yates

Although US hospitals have been quick to embrace surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers.

The Johns Hopkins team, led by Martin A. Makary, MD, MPH, found that, among the 1 million or so robotic surgeries performed since 2000, only 245 complications—including 71 deaths—were reported to the US Food and Drug Administration (FDA).¹ When an adverse event or device malfunction occurs, hospitals are required to report these incidents to the manufacturer, which in turn is required to report them to the FDA—but this reporting doesn’t always happen.

“The number reported is very low for any complex technology used over a million times,” says Dr. Makary, associate professor of surgery at the Johns Hopkins University School of Medicine. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”

The use of the robot in surgery has skyrocketed. Between 2007 and 2011, for example, the number of procedures involving the robot increased by more than 400% in the United States and more than 300% internationally. At the end of 2011, there were 1,400 surgical robots installed in US hospitals, up from 800 just 4 years earlier.

Some incidents went unreported until the news media highlighted them
Dr. Makary and colleagues found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press, even though the incidents took place long before the media exposure. Dr. Makary says it’s likely that many other incidents go unreported, never to be captured by research like his or by the FDA.

“We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies,” he says. “But we have to evaluate new technology properly so we don’t over-adopt—or under-adopt—important advances that could benefit patients.”

How the study was conducted
Makary and colleagues reviewed the FDA adverse events database from January 1, 2000, to August 1, 2012. They also searched legal judgments and adverse events using LexisNexis to scan news media, and PACER to scan court records. The cases then were cross-referenced to see if they matched. The investigators found that eight cases were not appropriately reported to the FDA, five of which were never reported and two of which were reported only after a story about them appeared in the press.

Complication rate was highest for hysterectomy
When investigators reviewed complications that were reported, the procedures most commonly associated with death were:

• gynecologic (22 of the 71 deaths)
• urologic (15 deaths)
• cardiothoracic (12 deaths).

The cause of death was most often excessive bleeding. In cases where patients survived, hysterectomy by far had the most complications (43% of injuries).

A call for standardized reporting
Dr. Makary contends that standardized reporting is needed for all adverse events related to robotic devices. One rare complication that occurs, he says, is that a surgeon can accidentally cut the aorta because the surgeon cannot feel its firmness. For reporting purposes, however, it’s unclear whether such an event is surgeon error or device-related error.  The FDA currently collects only device-related errors.

Dr. Makary argues that errors such as inadvertent cutting of the aorta, although preventable with proper technique, should be tracked as device-related errors because they are more common with robotic surgery than with conventional surgery. Without better reporting standards, he says, these complications are less likely to be reported to the FDA at all. And if they go unreported, they cannot contribute to the understanding or identification of safety problems.

He suggests one solution: use of a database like the one maintained by the American College of Surgeons, in which independent nurses identify and track adverse events and complications of traditional operations.

Good information on robotic surgery is needed not only for research, but also to ensure that patients are fully informed about potential risks. Right now, Dr. Makary says, it’s too easy for a surgeon to claim that there are no additional risks related to robotic surgery because the evidence is nowhere to be found.

“Decisions should not be made based on the information in the FDA database,” he says. “We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot. We have all suspected the answer has not been zero. We still don’t really know what the true answer is.”

 

We want to hear from you! Tell us what you think.

Although US hospitals have been quick to embrace surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers.

The Johns Hopkins team, led by Martin A. Makary, MD, MPH, found that, among the 1 million or so robotic surgeries performed since 2000, only 245 complications—including 71 deaths—were reported to the US Food and Drug Administration (FDA).¹ When an adverse event or device malfunction occurs, hospitals are required to report these incidents to the manufacturer, which in turn is required to report them to the FDA—but this reporting doesn’t always happen.

“The number reported is very low for any complex technology used over a million times,” says Dr. Makary, associate professor of surgery at the Johns Hopkins University School of Medicine. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”

The use of the robot in surgery has skyrocketed. Between 2007 and 2011, for example, the number of procedures involving the robot increased by more than 400% in the United States and more than 300% internationally. At the end of 2011, there were 1,400 surgical robots installed in US hospitals, up from 800 just 4 years earlier.

Some incidents went unreported until the news media highlighted them
Dr. Makary and colleagues found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press, even though the incidents took place long before the media exposure. Dr. Makary says it’s likely that many other incidents go unreported, never to be captured by research like his or by the FDA.

“We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies,” he says. “But we have to evaluate new technology properly so we don’t over-adopt—or under-adopt—important advances that could benefit patients.”

How the study was conducted
Makary and colleagues reviewed the FDA adverse events database from January 1, 2000, to August 1, 2012. They also searched legal judgments and adverse events using LexisNexis to scan news media, and PACER to scan court records. The cases then were cross-referenced to see if they matched. The investigators found that eight cases were not appropriately reported to the FDA, five of which were never reported and two of which were reported only after a story about them appeared in the press.

Complication rate was highest for hysterectomy
When investigators reviewed complications that were reported, the procedures most commonly associated with death were:

• gynecologic (22 of the 71 deaths)
• urologic (15 deaths)
• cardiothoracic (12 deaths).

The cause of death was most often excessive bleeding. In cases where patients survived, hysterectomy by far had the most complications (43% of injuries).

A call for standardized reporting
Dr. Makary contends that standardized reporting is needed for all adverse events related to robotic devices. One rare complication that occurs, he says, is that a surgeon can accidentally cut the aorta because the surgeon cannot feel its firmness. For reporting purposes, however, it’s unclear whether such an event is surgeon error or device-related error.  The FDA currently collects only device-related errors.

Dr. Makary argues that errors such as inadvertent cutting of the aorta, although preventable with proper technique, should be tracked as device-related errors because they are more common with robotic surgery than with conventional surgery. Without better reporting standards, he says, these complications are less likely to be reported to the FDA at all. And if they go unreported, they cannot contribute to the understanding or identification of safety problems.

He suggests one solution: use of a database like the one maintained by the American College of Surgeons, in which independent nurses identify and track adverse events and complications of traditional operations.

Good information on robotic surgery is needed not only for research, but also to ensure that patients are fully informed about potential risks. Right now, Dr. Makary says, it’s too easy for a surgeon to claim that there are no additional risks related to robotic surgery because the evidence is nowhere to be found.

“Decisions should not be made based on the information in the FDA database,” he says. “We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot. We have all suspected the answer has not been zero. We still don’t really know what the true answer is.”

 

We want to hear from you! Tell us what you think.

Although US hospitals have been quick to embrace surgical robot technology over the past decade, a “slapdash” system of reporting complications paints an unclear picture of its safety, according to Johns Hopkins researchers.

The Johns Hopkins team, led by Martin A. Makary, MD, MPH, found that, among the 1 million or so robotic surgeries performed since 2000, only 245 complications—including 71 deaths—were reported to the US Food and Drug Administration (FDA).¹ When an adverse event or device malfunction occurs, hospitals are required to report these incidents to the manufacturer, which in turn is required to report them to the FDA—but this reporting doesn’t always happen.

“The number reported is very low for any complex technology used over a million times,” says Dr. Makary, associate professor of surgery at the Johns Hopkins University School of Medicine. “Doctors and patients can’t properly evaluate safety when we have a haphazard system of collecting data that is not independent and not transparent. There may be some complications specific to the use of this device, but we can only learn about them if we accurately track outcomes.”

The use of the robot in surgery has skyrocketed. Between 2007 and 2011, for example, the number of procedures involving the robot increased by more than 400% in the United States and more than 300% internationally. At the end of 2011, there were 1,400 surgical robots installed in US hospitals, up from 800 just 4 years earlier.

Some incidents went unreported until the news media highlighted them
Dr. Makary and colleagues found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press, even though the incidents took place long before the media exposure. Dr. Makary says it’s likely that many other incidents go unreported, never to be captured by research like his or by the FDA.

“We need innovation in medicine and, in this country, we are tremendously good at introducing new technologies,” he says. “But we have to evaluate new technology properly so we don’t over-adopt—or under-adopt—important advances that could benefit patients.”

How the study was conducted
Makary and colleagues reviewed the FDA adverse events database from January 1, 2000, to August 1, 2012. They also searched legal judgments and adverse events using LexisNexis to scan news media, and PACER to scan court records. The cases then were cross-referenced to see if they matched. The investigators found that eight cases were not appropriately reported to the FDA, five of which were never reported and two of which were reported only after a story about them appeared in the press.

Complication rate was highest for hysterectomy
When investigators reviewed complications that were reported, the procedures most commonly associated with death were:

• gynecologic (22 of the 71 deaths)
• urologic (15 deaths)
• cardiothoracic (12 deaths).

The cause of death was most often excessive bleeding. In cases where patients survived, hysterectomy by far had the most complications (43% of injuries).

A call for standardized reporting
Dr. Makary contends that standardized reporting is needed for all adverse events related to robotic devices. One rare complication that occurs, he says, is that a surgeon can accidentally cut the aorta because the surgeon cannot feel its firmness. For reporting purposes, however, it’s unclear whether such an event is surgeon error or device-related error.  The FDA currently collects only device-related errors.

Dr. Makary argues that errors such as inadvertent cutting of the aorta, although preventable with proper technique, should be tracked as device-related errors because they are more common with robotic surgery than with conventional surgery. Without better reporting standards, he says, these complications are less likely to be reported to the FDA at all. And if they go unreported, they cannot contribute to the understanding or identification of safety problems.

He suggests one solution: use of a database like the one maintained by the American College of Surgeons, in which independent nurses identify and track adverse events and complications of traditional operations.

Good information on robotic surgery is needed not only for research, but also to ensure that patients are fully informed about potential risks. Right now, Dr. Makary says, it’s too easy for a surgeon to claim that there are no additional risks related to robotic surgery because the evidence is nowhere to be found.

“Decisions should not be made based on the information in the FDA database,” he says. “We need to be able to give patients answers to their questions about safety and how much risk is associated with the robot. We have all suspected the answer has not been zero. We still don’t really know what the true answer is.”

 

We want to hear from you! Tell us what you think.

There may one day be another compelling reason for women to undergo the Pap test on a regular basis: It may be used to screen for endometrial and ovarian cancers.

That’s the conclusion of researchers who sought to determine whether the Pap test can be used to detect mutations present in rare tumor cells that are shed from endometrial and ovarian cancers and end up on the cervix.¹ They found that DNA from most endometrial and some ovarian cancers can be found in a standard liquid-based Pap specimen obtained during a routine pelvic exam.

Kinde and colleagues performed their study in four parts:

1. They established the somatic mutations that often are present in endometrial and ovarian cancers
2. They identified one or more mutations in each tumor from 46 women with these cancers
3. They determined whether these mutations could also be detected in Pap specimens from the same patients
4. They developed a technology—which they called the “PapGene test”—that could directly evaluate cells from Pap specimens to determine whether these mutations were present.

Using massively parallel sequencing, they identified these mutations in the DNA from liquid Pap specimens in 100% of women with endometrial cancers (24 of 24 cases) and 41% of women with ovarian cancers (9 of 22 cases).¹

Kinde and colleagues concluded that “PapGene testing has the capacity to increase the use of conventional cytology screening through the unambiguous detection of DNA from endometrial and ovarian carcinomas, and lays the foundation for a new generation of screening tests.”¹

In a summary accompanying the study, the editors of Science Translational Medicine noted that PapGene testing “is not yet ready for clinical use and will not serve as a foolproof method of diagnosing genital tract tumors, particularly ovarian cancer … Importantly, though, the new test has not misclassified any healthy woman as harboring a cancer, raising the possibility of its eventual use as a screening test for cancer. Even if this approach cannot identify every ovarian tumor, it may be able to detect more of them earlier and more accurately than is possible with existing methods.”¹

We want to hear from you. Tell us what you think.

There may one day be another compelling reason for women to undergo the Pap test on a regular basis: It may be used to screen for endometrial and ovarian cancers.

That’s the conclusion of researchers who sought to determine whether the Pap test can be used to detect mutations present in rare tumor cells that are shed from endometrial and ovarian cancers and end up on the cervix.¹ They found that DNA from most endometrial and some ovarian cancers can be found in a standard liquid-based Pap specimen obtained during a routine pelvic exam.

Kinde and colleagues performed their study in four parts:

1. They established the somatic mutations that often are present in endometrial and ovarian cancers
2. They identified one or more mutations in each tumor from 46 women with these cancers
3. They determined whether these mutations could also be detected in Pap specimens from the same patients
4. They developed a technology—which they called the “PapGene test”—that could directly evaluate cells from Pap specimens to determine whether these mutations were present.

Using massively parallel sequencing, they identified these mutations in the DNA from liquid Pap specimens in 100% of women with endometrial cancers (24 of 24 cases) and 41% of women with ovarian cancers (9 of 22 cases).¹

Kinde and colleagues concluded that “PapGene testing has the capacity to increase the use of conventional cytology screening through the unambiguous detection of DNA from endometrial and ovarian carcinomas, and lays the foundation for a new generation of screening tests.”¹

In a summary accompanying the study, the editors of Science Translational Medicine noted that PapGene testing “is not yet ready for clinical use and will not serve as a foolproof method of diagnosing genital tract tumors, particularly ovarian cancer … Importantly, though, the new test has not misclassified any healthy woman as harboring a cancer, raising the possibility of its eventual use as a screening test for cancer. Even if this approach cannot identify every ovarian tumor, it may be able to detect more of them earlier and more accurately than is possible with existing methods.”¹

We want to hear from you. Tell us what you think.

There may one day be another compelling reason for women to undergo the Pap test on a regular basis: It may be used to screen for endometrial and ovarian cancers.

That’s the conclusion of researchers who sought to determine whether the Pap test can be used to detect mutations present in rare tumor cells that are shed from endometrial and ovarian cancers and end up on the cervix.¹ They found that DNA from most endometrial and some ovarian cancers can be found in a standard liquid-based Pap specimen obtained during a routine pelvic exam.

Kinde and colleagues performed their study in four parts:

1. They established the somatic mutations that often are present in endometrial and ovarian cancers
2. They identified one or more mutations in each tumor from 46 women with these cancers
3. They determined whether these mutations could also be detected in Pap specimens from the same patients
4. They developed a technology—which they called the “PapGene test”—that could directly evaluate cells from Pap specimens to determine whether these mutations were present.

Using massively parallel sequencing, they identified these mutations in the DNA from liquid Pap specimens in 100% of women with endometrial cancers (24 of 24 cases) and 41% of women with ovarian cancers (9 of 22 cases).¹

Kinde and colleagues concluded that “PapGene testing has the capacity to increase the use of conventional cytology screening through the unambiguous detection of DNA from endometrial and ovarian carcinomas, and lays the foundation for a new generation of screening tests.”¹

In a summary accompanying the study, the editors of Science Translational Medicine noted that PapGene testing “is not yet ready for clinical use and will not serve as a foolproof method of diagnosing genital tract tumors, particularly ovarian cancer … Importantly, though, the new test has not misclassified any healthy woman as harboring a cancer, raising the possibility of its eventual use as a screening test for cancer. Even if this approach cannot identify every ovarian tumor, it may be able to detect more of them earlier and more accurately than is possible with existing methods.”¹

We want to hear from you. Tell us what you think.

Concerned by state and federal laws that force physicians to give or withhold specific information when counseling patients, as well as laws that mandate specific treatments, tests, and procedures, the American College of Obstetricians and Gynecologists (the College) and the American Congress of Obstetricians and Gynecologists (ACOG) issued a Statement of Policy opposing such interference.

The policy statement, issued in May 2013, opposes government interference with the patient-physician relationship without a substantial public health justification. The statement reads, in part:

Efforts to legislate elements of patient care and counseling can drive a wedge between a patient and her health-care provider, be that a physician, certified nurse-midwife, certified midwife, nurse practitioner, or physician assistant. Laws should not interfere with the ability of physicians to determine appropriate treatment options and have open, honest and confidential communications with their patients. Nor should laws interfere with the patient’s right to be counseled by a physician according to the best currently available medical evidence and the physician’s professional medical judgment. The College and ACOG strongly oppose any governmental interference that threatens communication between patients and their physicians or causes a physician to compromise his or her medical judgment about what information or treatment is in the best interest of the patient.¹

ACOG highlighted several examples of ill-advised laws that either interfere with physicians counseling their patients or that force patients to have unnecessary tests and procedures:

• laws that prohibit physicians from speaking to their patients about firearms and gun safety
• statutes that dictate a script about what must be communicated to women about breast density and cancer risk
• laws that require women to undergo unnecessary ultrasound imaging before an abortion.

“Given the relentless legislative assault on the patient-physician relationship that we’ve seen in the past few years—and unfortunately continue to see—we were compelled to issue a formal Statement of Policy,” said ACOG President Jeanne A. Conry, MD, PhD. “A disproportionate number of these types of laws are aimed at women’s reproductive rights and the physicians that provide women’s health-care services.”

We want to hear from you! Tell us what you think.

Concerned by state and federal laws that force physicians to give or withhold specific information when counseling patients, as well as laws that mandate specific treatments, tests, and procedures, the American College of Obstetricians and Gynecologists (the College) and the American Congress of Obstetricians and Gynecologists (ACOG) issued a Statement of Policy opposing such interference.

The policy statement, issued in May 2013, opposes government interference with the patient-physician relationship without a substantial public health justification. The statement reads, in part:

Efforts to legislate elements of patient care and counseling can drive a wedge between a patient and her health-care provider, be that a physician, certified nurse-midwife, certified midwife, nurse practitioner, or physician assistant. Laws should not interfere with the ability of physicians to determine appropriate treatment options and have open, honest and confidential communications with their patients. Nor should laws interfere with the patient’s right to be counseled by a physician according to the best currently available medical evidence and the physician’s professional medical judgment. The College and ACOG strongly oppose any governmental interference that threatens communication between patients and their physicians or causes a physician to compromise his or her medical judgment about what information or treatment is in the best interest of the patient.¹

ACOG highlighted several examples of ill-advised laws that either interfere with physicians counseling their patients or that force patients to have unnecessary tests and procedures:

• laws that prohibit physicians from speaking to their patients about firearms and gun safety
• statutes that dictate a script about what must be communicated to women about breast density and cancer risk
• laws that require women to undergo unnecessary ultrasound imaging before an abortion.

“Given the relentless legislative assault on the patient-physician relationship that we’ve seen in the past few years—and unfortunately continue to see—we were compelled to issue a formal Statement of Policy,” said ACOG President Jeanne A. Conry, MD, PhD. “A disproportionate number of these types of laws are aimed at women’s reproductive rights and the physicians that provide women’s health-care services.”

We want to hear from you! Tell us what you think.

Concerned by state and federal laws that force physicians to give or withhold specific information when counseling patients, as well as laws that mandate specific treatments, tests, and procedures, the American College of Obstetricians and Gynecologists (the College) and the American Congress of Obstetricians and Gynecologists (ACOG) issued a Statement of Policy opposing such interference.

The policy statement, issued in May 2013, opposes government interference with the patient-physician relationship without a substantial public health justification. The statement reads, in part:

Efforts to legislate elements of patient care and counseling can drive a wedge between a patient and her health-care provider, be that a physician, certified nurse-midwife, certified midwife, nurse practitioner, or physician assistant. Laws should not interfere with the ability of physicians to determine appropriate treatment options and have open, honest and confidential communications with their patients. Nor should laws interfere with the patient’s right to be counseled by a physician according to the best currently available medical evidence and the physician’s professional medical judgment. The College and ACOG strongly oppose any governmental interference that threatens communication between patients and their physicians or causes a physician to compromise his or her medical judgment about what information or treatment is in the best interest of the patient.¹

ACOG highlighted several examples of ill-advised laws that either interfere with physicians counseling their patients or that force patients to have unnecessary tests and procedures:

• laws that prohibit physicians from speaking to their patients about firearms and gun safety
• statutes that dictate a script about what must be communicated to women about breast density and cancer risk
• laws that require women to undergo unnecessary ultrasound imaging before an abortion.

“Given the relentless legislative assault on the patient-physician relationship that we’ve seen in the past few years—and unfortunately continue to see—we were compelled to issue a formal Statement of Policy,” said ACOG President Jeanne A. Conry, MD, PhD. “A disproportionate number of these types of laws are aimed at women’s reproductive rights and the physicians that provide women’s health-care services.”

We want to hear from you! Tell us what you think.

Women who undergo surgical treatment of endometriosis can lower their risk of ovarian cancer, according to data from Sweden.¹ Hormonal treatment of endometriosis does not lower the risk of ovarian cancer.

Earlier research revealed an increased risk of several cancers, including ovarian cancer, in women with endometriosis. Some found a protective effect against ovarian cancer with surgical intervention, such as hysterectomy or tubal ligation.

“Patients with endometriosis typically are treated with hormones or, in more severe cases, with surgery,” said lead author Dr. Anna-Sofia Melin from the Karolinska Institute and Karolinska University Hospital in Stockholm, Sweden. “We wanted to expand understanding of ovarian cancer risk in women with endometriosis who had some type of surgery or hormone therapy.”

Using the National Swedish Patient Register, the team identified women given a diagnosis of endometriosis between 1969 and 2007. They then used the National Swedish Cancer Register to link women who were given a diagnosis of epithelial ovarian cancer at least 1 year after a diagnosis of endometriosis. Information on hormonal and surgical treatments was taken from the medical records of 220 women who had both endometriosis and ovarian cancer and 416 who had only endometriosis.

Among women who underwent oophorectomy, the risk of ovarian cancer declined significantly (crude odds ratio [OR], 0.42; 95% confidence interval [CI], 0.28–0.62). Women who underwent radical surgical extirpation of all visible endometriosis also had a lower risk of ovarian cancer (OR, 0.37; 95% CI, 0.25–0.55).

“Our study suggests that surgical removal of an ovary and removal of visible endometriosis protects women from developing ovarian cancer at a later point,” said Dr. Melin. “For women with endometriosis, the role of hormonal treatment and future ovarian cancer risk remains unclear.”

We want to hear from you! Tell us what you think.

Women who undergo surgical treatment of endometriosis can lower their risk of ovarian cancer, according to data from Sweden.¹ Hormonal treatment of endometriosis does not lower the risk of ovarian cancer.

Earlier research revealed an increased risk of several cancers, including ovarian cancer, in women with endometriosis. Some found a protective effect against ovarian cancer with surgical intervention, such as hysterectomy or tubal ligation.

“Patients with endometriosis typically are treated with hormones or, in more severe cases, with surgery,” said lead author Dr. Anna-Sofia Melin from the Karolinska Institute and Karolinska University Hospital in Stockholm, Sweden. “We wanted to expand understanding of ovarian cancer risk in women with endometriosis who had some type of surgery or hormone therapy.”

Using the National Swedish Patient Register, the team identified women given a diagnosis of endometriosis between 1969 and 2007. They then used the National Swedish Cancer Register to link women who were given a diagnosis of epithelial ovarian cancer at least 1 year after a diagnosis of endometriosis. Information on hormonal and surgical treatments was taken from the medical records of 220 women who had both endometriosis and ovarian cancer and 416 who had only endometriosis.

Among women who underwent oophorectomy, the risk of ovarian cancer declined significantly (crude odds ratio [OR], 0.42; 95% confidence interval [CI], 0.28–0.62). Women who underwent radical surgical extirpation of all visible endometriosis also had a lower risk of ovarian cancer (OR, 0.37; 95% CI, 0.25–0.55).

“Our study suggests that surgical removal of an ovary and removal of visible endometriosis protects women from developing ovarian cancer at a later point,” said Dr. Melin. “For women with endometriosis, the role of hormonal treatment and future ovarian cancer risk remains unclear.”

We want to hear from you! Tell us what you think.

Women who undergo surgical treatment of endometriosis can lower their risk of ovarian cancer, according to data from Sweden.¹ Hormonal treatment of endometriosis does not lower the risk of ovarian cancer.

Earlier research revealed an increased risk of several cancers, including ovarian cancer, in women with endometriosis. Some found a protective effect against ovarian cancer with surgical intervention, such as hysterectomy or tubal ligation.

“Patients with endometriosis typically are treated with hormones or, in more severe cases, with surgery,” said lead author Dr. Anna-Sofia Melin from the Karolinska Institute and Karolinska University Hospital in Stockholm, Sweden. “We wanted to expand understanding of ovarian cancer risk in women with endometriosis who had some type of surgery or hormone therapy.”

Using the National Swedish Patient Register, the team identified women given a diagnosis of endometriosis between 1969 and 2007. They then used the National Swedish Cancer Register to link women who were given a diagnosis of epithelial ovarian cancer at least 1 year after a diagnosis of endometriosis. Information on hormonal and surgical treatments was taken from the medical records of 220 women who had both endometriosis and ovarian cancer and 416 who had only endometriosis.

Among women who underwent oophorectomy, the risk of ovarian cancer declined significantly (crude odds ratio [OR], 0.42; 95% confidence interval [CI], 0.28–0.62). Women who underwent radical surgical extirpation of all visible endometriosis also had a lower risk of ovarian cancer (OR, 0.37; 95% CI, 0.25–0.55).

“Our study suggests that surgical removal of an ovary and removal of visible endometriosis protects women from developing ovarian cancer at a later point,” said Dr. Melin. “For women with endometriosis, the role of hormonal treatment and future ovarian cancer risk remains unclear.”

We want to hear from you! Tell us what you think.

When Barbara S. Levy, MD, gave up her thriving private practice in Federal Way, Washington, last year to assume the newly created position of Vice President for Health Policy at the American College of Obstetricians and Gynecologists (ACOG), she set in motion a cascade of personal and professional changes.

On the personal front, besides the shift from clinical practice to health policy, the new post necessitated that she move from the West to the East Coast and endure temporary separation from her husband. But the opportunity to make a “real difference” in health policy made it worthwhile, she says.

On the professional front, the new position greatly broadened Dr. Levy’s opportunities to pursue a goal that has marked her entire career: doing “what’s best for our patients and their families.”

As Vice President for Health Policy, Dr. Levy:

• oversees ACOG’s legislative policy and regulatory affairs at the federal and state levels
• supervises ACOG’s Voluntary Review of Quality of Care, as well as the Safety Certification for Outpatient Practice Excellence for Women’s Health (SCOPE) program
• continues the College’s efforts on behalf of its Office of Global Women’s Health to promote national and international programs to improve women’s health worldwide.

“ACOG is doing so many exciting things in the global women’s health arena,” says Dr. Levy. “I am thrilled to be actively involved in these projects and to have the opportunity to expand ACOG’s leadership role in promoting quality health care for women.”

Another change necessitated by her post at ACOG: Dr. Levy has resigned her position on the OBG Management Board of Editors, a seat she has held since 1996.

In gratitude for her long tenure and the many milestones she helped bring about, the journal awarded her with lifetime achievement recognition at the 2013 ACOG annual clinical meeting for her service to OBG Management readers, women’s health, and the women of the United States.

A seasoned clinician who keeps the “big picture” in mind

Dr. Levy is not new to health policy. In addition to her private practice in Washington state, she helped design and served as medical director of the Women’s Health and Breast Center for the Franciscan Health System in Tacoma; she also served as medical director of women’s and children’s services for the health system. As a member of ACOG since 1984, Dr. Levy has served on several national committees and task forces. And she has worked hard as chair of the American Medical Association’s RVS Update Committee (RUC) to ensure that services in the women’s health arena are reimbursed as robustly as men’s healthcare services.

Dr. Levy has published or coauthored more than 65 studies and articles related to her main research interests, which include hysterectomy, endoscopic surgery, menopause and hormone therapy, osteoporosis, pelvic pain, surgical outcomes, female sexual function, and physician payment policy.

She is a member of the American Society for Reproductive Medicine and the American Urogynecologic Society and a past president of AAGL. She also has served as a consultant to and member of the US Food and Drug Administration’s ObGyn Devices Panel.

But it is her passion to enhance women’s health that drives her day to day.

“More and more of us are employed, and there are more rules than ever before,” she says. “When these rules limit our ability to provide the best care possible for our patients, we need to get a voice and do something about it.”

Choosing the rebel’s path

Dr. Levy graduated magna cum laude from Princeton University with a degree in psychology. She went on to earn her medical degree from the University of California, San Diego, followed by an internship and residency in obstetrics and gynecology at the University of Oregon Health Sciences Center (now the Oregon Health and Sciences University) in Portland.

Although Princeton graduates typically go on to medical school at Columbia or Yale, Dr. Levy made a very different choice.

“I’ve always been a rebel, so I didn’t want to follow the usual pathway,” she says.

At UC San Diego, Dr. Levy fell under the inspirational wing of Donna Brooks, MD, only the second female ObGyn in San Diego history.

“I was very lucky to have Donna as a mentor,” Dr. Levy says. “I would not have gone into obstetrics and gynecology without her.”

Two years into Dr. Levy’s residency at the University of Oregon, her husband’s career as a cardiac surgeon necessitated a move to the Seattle area. She finished her residency there, still under the auspices of the University of Oregon, with Leon Speroff, MD, as a mentor.

 

After residency, she was hired by the Mason Clinic in Seattle and began working with Glen E. Hayden, MD, and Richard Soderstrom, MD, who mentored her in vaginal surgery.

“It was a time when people coming out of residency went into practice with senior colleagues,” she explained. The senior physicians benefited from exposure to new ideas, and younger physicians gained from the senior physicians’ experience.

“In the end, under this arrangement, the patients benefited.”

Claiming a voice

Among the issues that concern Dr. Levy most are the rapid changes shaping medicine—not all of them beneficial.

“We’re spending too much money on health care and not getting value for what we’re spending,” she says. “It’s not sustainable.”

The move to ACOG provides her an opportunity to help frame how health care is delivered and, ultimately, to help slow the hemorrhage of healthcare dollars in unenriching ways.

“I couldn’t do that in a small practice,” she says. “In my view, the changes have to be geared around what’s best for the patient.”

She also strives to be a mentor to younger physicians, particularly women, in an era when red tape and time constraints significantly limit the altruism that was once the hallmark of the medical profession. She believes mentors remain important in medicine.

“Different people can help you at different times in your career,” she says, reflecting on her own experience and the doctors who shaped it.

“Senior physicians should take responsibility for guiding younger physicians when they come out of training,” she says. “They should graciously volunteer.”

Despite her many responsibilities, Dr. Levy finds time to connect with junior physicians. And despite her many accomplishments, she maintains a refreshing sense of modesty.

“I’m just an ordinary doc,” she says. “The only difference between me and everybody else out there is an intolerance when things aren’t right.”

“I speak out loudly.”

We want to hear from you! Tell us what you think.

When Barbara S. Levy, MD, gave up her thriving private practice in Federal Way, Washington, last year to assume the newly created position of Vice President for Health Policy at the American College of Obstetricians and Gynecologists (ACOG), she set in motion a cascade of personal and professional changes.

On the personal front, besides the shift from clinical practice to health policy, the new post necessitated that she move from the West to the East Coast and endure temporary separation from her husband. But the opportunity to make a “real difference” in health policy made it worthwhile, she says.

On the professional front, the new position greatly broadened Dr. Levy’s opportunities to pursue a goal that has marked her entire career: doing “what’s best for our patients and their families.”

As Vice President for Health Policy, Dr. Levy:

• oversees ACOG’s legislative policy and regulatory affairs at the federal and state levels
• supervises ACOG’s Voluntary Review of Quality of Care, as well as the Safety Certification for Outpatient Practice Excellence for Women’s Health (SCOPE) program
• continues the College’s efforts on behalf of its Office of Global Women’s Health to promote national and international programs to improve women’s health worldwide.

“ACOG is doing so many exciting things in the global women’s health arena,” says Dr. Levy. “I am thrilled to be actively involved in these projects and to have the opportunity to expand ACOG’s leadership role in promoting quality health care for women.”

Another change necessitated by her post at ACOG: Dr. Levy has resigned her position on the OBG Management Board of Editors, a seat she has held since 1996.

In gratitude for her long tenure and the many milestones she helped bring about, the journal awarded her with lifetime achievement recognition at the 2013 ACOG annual clinical meeting for her service to OBG Management readers, women’s health, and the women of the United States.

A seasoned clinician who keeps the “big picture” in mind

Dr. Levy is not new to health policy. In addition to her private practice in Washington state, she helped design and served as medical director of the Women’s Health and Breast Center for the Franciscan Health System in Tacoma; she also served as medical director of women’s and children’s services for the health system. As a member of ACOG since 1984, Dr. Levy has served on several national committees and task forces. And she has worked hard as chair of the American Medical Association’s RVS Update Committee (RUC) to ensure that services in the women’s health arena are reimbursed as robustly as men’s healthcare services.

Dr. Levy has published or coauthored more than 65 studies and articles related to her main research interests, which include hysterectomy, endoscopic surgery, menopause and hormone therapy, osteoporosis, pelvic pain, surgical outcomes, female sexual function, and physician payment policy.

She is a member of the American Society for Reproductive Medicine and the American Urogynecologic Society and a past president of AAGL. She also has served as a consultant to and member of the US Food and Drug Administration’s ObGyn Devices Panel.

But it is her passion to enhance women’s health that drives her day to day.

“More and more of us are employed, and there are more rules than ever before,” she says. “When these rules limit our ability to provide the best care possible for our patients, we need to get a voice and do something about it.”

Choosing the rebel’s path

Dr. Levy graduated magna cum laude from Princeton University with a degree in psychology. She went on to earn her medical degree from the University of California, San Diego, followed by an internship and residency in obstetrics and gynecology at the University of Oregon Health Sciences Center (now the Oregon Health and Sciences University) in Portland.

Although Princeton graduates typically go on to medical school at Columbia or Yale, Dr. Levy made a very different choice.

“I’ve always been a rebel, so I didn’t want to follow the usual pathway,” she says.

At UC San Diego, Dr. Levy fell under the inspirational wing of Donna Brooks, MD, only the second female ObGyn in San Diego history.

“I was very lucky to have Donna as a mentor,” Dr. Levy says. “I would not have gone into obstetrics and gynecology without her.”

Two years into Dr. Levy’s residency at the University of Oregon, her husband’s career as a cardiac surgeon necessitated a move to the Seattle area. She finished her residency there, still under the auspices of the University of Oregon, with Leon Speroff, MD, as a mentor.

 

After residency, she was hired by the Mason Clinic in Seattle and began working with Glen E. Hayden, MD, and Richard Soderstrom, MD, who mentored her in vaginal surgery.

“It was a time when people coming out of residency went into practice with senior colleagues,” she explained. The senior physicians benefited from exposure to new ideas, and younger physicians gained from the senior physicians’ experience.

“In the end, under this arrangement, the patients benefited.”

Claiming a voice

Among the issues that concern Dr. Levy most are the rapid changes shaping medicine—not all of them beneficial.

“We’re spending too much money on health care and not getting value for what we’re spending,” she says. “It’s not sustainable.”

The move to ACOG provides her an opportunity to help frame how health care is delivered and, ultimately, to help slow the hemorrhage of healthcare dollars in unenriching ways.

“I couldn’t do that in a small practice,” she says. “In my view, the changes have to be geared around what’s best for the patient.”

She also strives to be a mentor to younger physicians, particularly women, in an era when red tape and time constraints significantly limit the altruism that was once the hallmark of the medical profession. She believes mentors remain important in medicine.

“Different people can help you at different times in your career,” she says, reflecting on her own experience and the doctors who shaped it.

“Senior physicians should take responsibility for guiding younger physicians when they come out of training,” she says. “They should graciously volunteer.”

Despite her many responsibilities, Dr. Levy finds time to connect with junior physicians. And despite her many accomplishments, she maintains a refreshing sense of modesty.

“I’m just an ordinary doc,” she says. “The only difference between me and everybody else out there is an intolerance when things aren’t right.”

“I speak out loudly.”

We want to hear from you! Tell us what you think.

When Barbara S. Levy, MD, gave up her thriving private practice in Federal Way, Washington, last year to assume the newly created position of Vice President for Health Policy at the American College of Obstetricians and Gynecologists (ACOG), she set in motion a cascade of personal and professional changes.

On the personal front, besides the shift from clinical practice to health policy, the new post necessitated that she move from the West to the East Coast and endure temporary separation from her husband. But the opportunity to make a “real difference” in health policy made it worthwhile, she says.

On the professional front, the new position greatly broadened Dr. Levy’s opportunities to pursue a goal that has marked her entire career: doing “what’s best for our patients and their families.”

As Vice President for Health Policy, Dr. Levy:

• oversees ACOG’s legislative policy and regulatory affairs at the federal and state levels
• supervises ACOG’s Voluntary Review of Quality of Care, as well as the Safety Certification for Outpatient Practice Excellence for Women’s Health (SCOPE) program
• continues the College’s efforts on behalf of its Office of Global Women’s Health to promote national and international programs to improve women’s health worldwide.

“ACOG is doing so many exciting things in the global women’s health arena,” says Dr. Levy. “I am thrilled to be actively involved in these projects and to have the opportunity to expand ACOG’s leadership role in promoting quality health care for women.”

Another change necessitated by her post at ACOG: Dr. Levy has resigned her position on the OBG Management Board of Editors, a seat she has held since 1996.

In gratitude for her long tenure and the many milestones she helped bring about, the journal awarded her with lifetime achievement recognition at the 2013 ACOG annual clinical meeting for her service to OBG Management readers, women’s health, and the women of the United States.

A seasoned clinician who keeps the “big picture” in mind

Dr. Levy is not new to health policy. In addition to her private practice in Washington state, she helped design and served as medical director of the Women’s Health and Breast Center for the Franciscan Health System in Tacoma; she also served as medical director of women’s and children’s services for the health system. As a member of ACOG since 1984, Dr. Levy has served on several national committees and task forces. And she has worked hard as chair of the American Medical Association’s RVS Update Committee (RUC) to ensure that services in the women’s health arena are reimbursed as robustly as men’s healthcare services.

Dr. Levy has published or coauthored more than 65 studies and articles related to her main research interests, which include hysterectomy, endoscopic surgery, menopause and hormone therapy, osteoporosis, pelvic pain, surgical outcomes, female sexual function, and physician payment policy.

She is a member of the American Society for Reproductive Medicine and the American Urogynecologic Society and a past president of AAGL. She also has served as a consultant to and member of the US Food and Drug Administration’s ObGyn Devices Panel.

But it is her passion to enhance women’s health that drives her day to day.

“More and more of us are employed, and there are more rules than ever before,” she says. “When these rules limit our ability to provide the best care possible for our patients, we need to get a voice and do something about it.”

Choosing the rebel’s path

Dr. Levy graduated magna cum laude from Princeton University with a degree in psychology. She went on to earn her medical degree from the University of California, San Diego, followed by an internship and residency in obstetrics and gynecology at the University of Oregon Health Sciences Center (now the Oregon Health and Sciences University) in Portland.

Although Princeton graduates typically go on to medical school at Columbia or Yale, Dr. Levy made a very different choice.

“I’ve always been a rebel, so I didn’t want to follow the usual pathway,” she says.

At UC San Diego, Dr. Levy fell under the inspirational wing of Donna Brooks, MD, only the second female ObGyn in San Diego history.

“I was very lucky to have Donna as a mentor,” Dr. Levy says. “I would not have gone into obstetrics and gynecology without her.”

Two years into Dr. Levy’s residency at the University of Oregon, her husband’s career as a cardiac surgeon necessitated a move to the Seattle area. She finished her residency there, still under the auspices of the University of Oregon, with Leon Speroff, MD, as a mentor.

 

After residency, she was hired by the Mason Clinic in Seattle and began working with Glen E. Hayden, MD, and Richard Soderstrom, MD, who mentored her in vaginal surgery.

“It was a time when people coming out of residency went into practice with senior colleagues,” she explained. The senior physicians benefited from exposure to new ideas, and younger physicians gained from the senior physicians’ experience.

“In the end, under this arrangement, the patients benefited.”

Claiming a voice

Among the issues that concern Dr. Levy most are the rapid changes shaping medicine—not all of them beneficial.

“We’re spending too much money on health care and not getting value for what we’re spending,” she says. “It’s not sustainable.”

The move to ACOG provides her an opportunity to help frame how health care is delivered and, ultimately, to help slow the hemorrhage of healthcare dollars in unenriching ways.

“I couldn’t do that in a small practice,” she says. “In my view, the changes have to be geared around what’s best for the patient.”

She also strives to be a mentor to younger physicians, particularly women, in an era when red tape and time constraints significantly limit the altruism that was once the hallmark of the medical profession. She believes mentors remain important in medicine.

“Different people can help you at different times in your career,” she says, reflecting on her own experience and the doctors who shaped it.

“Senior physicians should take responsibility for guiding younger physicians when they come out of training,” she says. “They should graciously volunteer.”

Despite her many responsibilities, Dr. Levy finds time to connect with junior physicians. And despite her many accomplishments, she maintains a refreshing sense of modesty.

“I’m just an ordinary doc,” she says. “The only difference between me and everybody else out there is an intolerance when things aren’t right.”

“I speak out loudly.”

We want to hear from you! Tell us what you think.

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

We want to hear from you! Tell us what you think.

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

We want to hear from you! Tell us what you think.

A study of nearly 4,000 pairs of mothers and their children at the University of Bristol in England found no association between maternal vitamin D levels during pregnancy and the child’s bone health in later life.¹

And new guidelines from the US Preventive Services Task Force (USPSTF) recommend against supplementation of vitamin D in amounts up to 400 IU daily and calcium in amounts up to 1,000 mg daily for the primary prevention of fractures in noninstitutionalized postmenopausal women.²

Children of the 90s study is largest so far

In the largest observational study ever published on the effects of maternal vitamin D levels on children’s bone health—the Children of the 90s trial—Lawlor and colleagues assessed vitamin D levels in 3,960 pregnant women, recording data from all three trimesters. When the children of these women reached an average age of 9 years and 11 months, their bone-mineral density (BMD) was assessed using dual-energy x-ray absorptiometry (DXA). Investigators found no significant association between a mother’s vitamin D levels and her child’s BMD.¹

On average, the women’s vitamin D levels were lowest during the first trimester and increased as pregnancy progressed. As expected, levels were higher when measured during summer months and lower during winter months. And although nonwhite mothers and those who smoked during pregnancy tended to have lower vitamin D levels overall, this finding appeared to have no effect on their children’s bone health.

Earlier studies of the effects of maternal vitamin D levels on children’s bone health were inconclusive. This study by Lawlor and colleagues is more than 10 times larger than all previous studies combined.

“We believe that there is no strong evidence that pregnant women should receive vitamin D supplementation to prevent low [BMD] in their offspring, although we cannot comment on other possible effects of vitamin D in pregnant women,” said Dr. Debbie Lawlor, lead author of the study. “While excessive vitamin D intake can affect the body’s calcium balance and result in cardiac arrhythmias and muscle problems (both rare), as well as milder problems such as dry mouth and constipation, our study didn’t look at any other potential beneficial or adverse effects of vitamin D supplementation besides the association with children’s bone health.”¹

USPSTF mostly found a lack of evidence

The USPSTF commissioned two systematic evidence reviews and a meta-analysis of vitamin D supplementation with or without calcium to assess²:

• the effects of supplementation on bone health in community-dwelling adults
• the association between vitamin D and calcium levels and bone health
• any adverse effects of supplementation.

After reviewing the findings, the Task Force concluded that there is insufficient evidence to determine the true balance of benefits versus risks of supplementation of vitamin D in amounts greater than 400 IU daily and calcium in amounts greater than 1,000 mg daily among postmenopausal women in the community. It also recommended against daily supplementation with 400 IU or less of vitamin D and 1,000 mg or less of calcium in this population, as there is no evidence that this practice prevents bone fracture.

In other words, the USPSTF has no recommendation on doses of these supplements at amounts greater than 400 IU of vitamin D and 1,000 mg of calcium daily among postmenopausal women, and recommends against supplementation at lower amounts in the same population.

Both studies focused on a specific context

Both the USPSTF and Lawlor and colleagues emphasized that their investigations focused only on bone mineral density or the risk of fracture, and they acknowledged that there may be other benefits and risks of vitamin D supplementation in pregnancy—and of supplementation with vitamin D and calcium after menopause.^1,2

We want to hear from you! Tell us what you think.

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

We want to hear from you! Tell us what you think.

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

We want to hear from you! Tell us what you think.

When the Food and Drug Administration (FDA) approved Skyla, a 13.5-mg levonorgestrel-releasing intrauterine system (LNG-IUS), early this year, it increased the number of IUDs available in the United States by one-third. The new device joins the copper IUD (ParaGard) and the 52-mg LNG-IUS (Mirena) as options for women seeking long-acting intrauterine contraception. The new device and Mirena both are manufactured by Bayer HealthCare Pharmaceuticals.

Skyla releases 14 μg of levonorgestrel daily, an amount that decreases progressively to 5 μg/day after 3 years. The device comes packaged within a sterile inserter and is approved for 3 years of use.

Approval followed a multinational Phase 3 trial

The trial involved 1,432 women 18 to 35 years old, 556 (38.8%) of whom were nulliparous. The primary efficacy endpoint used to assess contraceptive reliability was the pregnancy rate, calculated as the Pearl Index (PI). The PI estimate for the first year of use, based on the five pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion, was 0.41, with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies and estimated by the Kaplan-Meier method, was 0.9 per 100 women or 0.9%, with a 95% upper confidence limit of 1.7%.¹

As a point of reference, the 12-month pregnancy rate for Mirena was ≤0.2%, and it was 0.5% over 5 years.² The one-year pregnancy rate for ParaGard is 0.6% with perfect use, 0.8% with typical use.³

Of the women using Skyla, 21.9% discontinued because of an adverse event. The most common adverse reactions (occurring in ≥10% of users) were:

• changes in bleeding patterns
  
• vulvovaginitis
  
• abdominal or pelvic pain
  
• acne or seborrhea
  
• ovarian cyst
  
• headache.¹
  

Family planning expert Mitchell Creinin, MD, professor and chair of obstetrics and gynecology at the University of California, Davis, does not see any cause for concern about adverse events.

“These adverse events include anything that occurs during study. For 20% of sexually active women to have at least one episode of vulvovaginitis over 3 years is not a problem”—nor is an occasional twinge of abdominal pain, he adds.

Insertion and removal

Skyla should be inserted during the first 7 days of the menstrual cycle or immediately after a first-trimester abortion. No back-up contraception is needed if it is inserted at these times.

Postpartum insertions should take place a minimum of 6 weeks after delivery or after a second-trimester abortion to allow for complete uterine involution.

Skyla should be removed after 3 years of use, preferably during the menstrual cycle to allow for immediate insertion of a new device or initiation of an alternate method of contraception.

Bleeding patterns may change during early use

During the first 3 to 6 months of use, women may experience irregular periods and an increase in the number of bleeding days. Women also may have frequent spotting or light bleeding. Some women may experience heavy bleeding during this interval. Over time, the number of bleeding and spotting days is likely to decline, and there is a small chance that periods may stop altogether. In clinical trials, 6% of Skyla users developed amenorrhea by the end of the first year.¹ By comparison, 20% of Mirena users developed amenorrhea by the end of the first year.²

The only IUD for nulliparas?

Although Skyla is the only IUD studied in a significant number of nulliparous women during Phase 3 studies, and its labeling states specifically that it is appropriate for use in this population, the other two IUDs are also safe for nulliparas.

“The label for ParaGard includes nulliparous and parous women,” notes Dr. Creinin. “The label for Mirena does not exclude nulliparous women, and there are huge numbers of studies about its use in teens and nulliparas. The only issue for Skyla is that the data presented to the FDA included nulliparous women, so the label reflects this fact.”

What’s the bottom line?

Skyla is an option for women who may desire a smaller IUD with a shorter duration of use. Although placement of Skyla is enhanced by a new inserter, compared with Mirena and ParaGard, Dr. Creinin notes that all IUD insertions, regardless of brand, are fairly straightforward. For example, a randomized trial by Gemzell-Danielsson and colleagues found that IUD insertion was “very difficult” in only 2 of 239 (0.8%) women receiving a prototype of Skyla and 4 of 254 (1.6%) women receiving Mirena.⁴

The cost of Skyla is approximately $650 (for 3 years of use) versus roughly $850 for Mirena and ParaGard (for 5 and 10 years of use, respectively).

 

In general, if a woman specifically requests a shorter duration of efficacy, then Skyla may be appropriate for her, although any IUD can be removed at any time if a patient decides to become pregnant.

We want to hear from you! Tell us what you think.

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

We want to hear from you! Tell us what you think.

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

We want to hear from you! Tell us what you think.

Robotically assisted hysterectomy for benign gynecologic disorders increased significantly between 2007 and 2010, according to a study published February 20, 2013, in JAMA.¹ However, compared with laparoscopic hysterectomy, the robotic procedure appears to offer little short-term benefit and is accompanied by substantially increased costs.

In the cohort study of 264,758 women who underwent hysterectomy at 441 hospitals across the United States, Wright and colleagues analyzed the use of robotically assisted hysterectomy in comparison with the abdominal and laparoscopic approaches. They also compared in-house complication rates between the three approaches.

Use of the robot for hysterectomy increased from 0.5% of all hysterectomies in 2007 to 9.5% in 2010, and laparoscopic hysterectomy increased from 24.3% to 30.5%. The rates of abdominal hysterectomy declined in hospitals, regardless of whether the robotic approach was available.

Complication rates were similar between robotically assisted hysterectomy and laparoscopic hysterectomy (5.5% vs 5.3%; relative risk [RR], 1.03; 95% confidence interval [CI], 0.86–1.24). The need for transfusion (1.4% for the robotic approach vs 1.8% for laparoscopy; RR, 0.80; 95% CI, 0.55–1.15) and the rate of discharge to a nursing facility (0.2% vs 0.3%, respectively; RR, 0.79; 95% CI, 0.35–1.76) were similar between the laparoscopic and robotically assisted approaches. However, the total cost of robotic hysterectomy was $2,189 more per case, compared with the laparoscopic approach (95% CI, $2,030–$2,389).

“Proponents of robotic surgery have argued that robotic technology allows women who otherwise would undergo laparotomy to have a minimally invasive procedure,” write Wright and colleagues. “However, there is little to support these claims, and because both laparoscopic and robotically assisted hysterectomy are associated with low complication rates, it is unclear what benefits robotically assisted hysterectomy offers.”

The investigators also point out that, unlike other procedures such as prostatectomy, for which robotic assistance is used more frequently than conventional laparoscopic approaches, laparoscopic hysterectomy is already widely available.

We want to hear from you! Tell us what you think.

One of the largest physician surveys ever conducted in the United States identified some disturbing trends in practice.¹ The comprehensive survey of 13,575 physicians, commissioned by the nonprofit Physicians Foundation, found that physicians are working fewer hours, seeing fewer patients, and limiting access to their practices as a response to significant changes to the medical practice environment.

If these patterns continue, as many as 44,250 full-time–equivalent physicians may leave the workforce over the next 4 years. The survey also found that, over the next 1 to 3 years, more than 50% of physicians will cut back on the number of patients they see, switch to part-time work or concierge medicine, retire, or take other steps likely to reduce patient access. And if 100,000 physicians transition from practice-owner to employed status over the next 4 years (eg, moving to a hospital setting), this shift will lead to 91 million fewer patient encounters.

“It is clear that the introduction of nearly 30 million new patients into the US health-care system through health-care reform, added to the already growing physician shortage, will have profound implications for patient access to medical care,” said Walker Ray, MD, vice president of the Physicians Foundation and chair of its Research Committee. “The rate of private practice physicians leaving the medical field, as well as changes in practice patterns that reduce the number of hours spent seeing and treating patients, is alarming. When these lost hours are added up, we get a much fuller and more ominous picture of the kind of access crisis that patients may soon face.”

More than half of physicians (52%) have limited the access of Medicare patients to their practices or are planning to do so, and one out of four physicians (26%) have already closed their practices to Medicaid patients, the survey reveals. Physicians cited rising operating costs, time constraints, and diminishing reimbursement as the primary reasons they are unable to accept additional Medicare and Medicaid patients.

Physician morale is flagging

An overwhelming 80% of physicians cited “patient relationships” as the most satisfying part of their job. Yet, 77% of respondents are pessimistic about the future of medicine. Eighty-two percent believe they have little ability to change the health-care system.

Among the variables cited as driving discontent:

• medicolegal risk and the pressure to practice defensively
  
• Medicare, Medicaid, and government regulations
  
• reimbursement issues
  
• uncertainty about the changes imposed by health reform.
  

These issues and others cited throughout the survey tend to distract from or interfere with the time physicians spend with patients, respondents said.

“The level of pessimism among America’s physicians is very troubling,” said Lou Goodman, PhD, president of the Physicians Foundation and chief executive officer (CEO) of the Texas Medical Association. “More than 84% of physicians feel that the medical profession is in decline, and nearly 58% are reluctant to recommend medicine as a career to their children. That means that we need to make significant changes to ensure that we preserve the patient-physician relationship and continue to have the brightest minds going into medicine.”

Other notable findings

• Sixty-nine percent of physicians cited defensive medicine as the No. 1 cost driver, and 65% cited the “aging population.” Older patients visit physicians three times as often as younger patients, on average. Other expense drivers cited were the cost of pharmaceuticals, advances in technology and treatment, and “social conditions.”
  
• Close to 92% of physicians are unsure where the health-care system will be or how they will fit into it 3 to 5 years from now.
  
• More than 62% of physicians said Accountable Care Organizations are either unlikely to increase the quality of health care and decrease costs, or that any quality/cost gains will not be worth the effort.
  
• Although almost 70% of physicians have implemented electronic medical records, 47.4% have significant concerns that these records pose a risk to patient privacy.
  

“The 13,000 plus physicians who participated in this landmark survey, which included nearly 8,000 open-ended responses, strongly demonstrates the overwhelming desire of America’s physicians to share their perspectives and concerns about the current state of medicine,” said Tim Norbeck, CEO of the Physicians Foundation.

We want to hear from you! Tell us what you think.

One of the largest physician surveys ever conducted in the United States identified some disturbing trends in practice.¹ The comprehensive survey of 13,575 physicians, commissioned by the nonprofit Physicians Foundation, found that physicians are working fewer hours, seeing fewer patients, and limiting access to their practices as a response to significant changes to the medical practice environment.

If these patterns continue, as many as 44,250 full-time–equivalent physicians may leave the workforce over the next 4 years. The survey also found that, over the next 1 to 3 years, more than 50% of physicians will cut back on the number of patients they see, switch to part-time work or concierge medicine, retire, or take other steps likely to reduce patient access. And if 100,000 physicians transition from practice-owner to employed status over the next 4 years (eg, moving to a hospital setting), this shift will lead to 91 million fewer patient encounters.

“It is clear that the introduction of nearly 30 million new patients into the US health-care system through health-care reform, added to the already growing physician shortage, will have profound implications for patient access to medical care,” said Walker Ray, MD, vice president of the Physicians Foundation and chair of its Research Committee. “The rate of private practice physicians leaving the medical field, as well as changes in practice patterns that reduce the number of hours spent seeing and treating patients, is alarming. When these lost hours are added up, we get a much fuller and more ominous picture of the kind of access crisis that patients may soon face.”

More than half of physicians (52%) have limited the access of Medicare patients to their practices or are planning to do so, and one out of four physicians (26%) have already closed their practices to Medicaid patients, the survey reveals. Physicians cited rising operating costs, time constraints, and diminishing reimbursement as the primary reasons they are unable to accept additional Medicare and Medicaid patients.

Physician morale is flagging

An overwhelming 80% of physicians cited “patient relationships” as the most satisfying part of their job. Yet, 77% of respondents are pessimistic about the future of medicine. Eighty-two percent believe they have little ability to change the health-care system.

Among the variables cited as driving discontent:

• medicolegal risk and the pressure to practice defensively
  
• Medicare, Medicaid, and government regulations
  
• reimbursement issues
  
• uncertainty about the changes imposed by health reform.
  

These issues and others cited throughout the survey tend to distract from or interfere with the time physicians spend with patients, respondents said.

“The level of pessimism among America’s physicians is very troubling,” said Lou Goodman, PhD, president of the Physicians Foundation and chief executive officer (CEO) of the Texas Medical Association. “More than 84% of physicians feel that the medical profession is in decline, and nearly 58% are reluctant to recommend medicine as a career to their children. That means that we need to make significant changes to ensure that we preserve the patient-physician relationship and continue to have the brightest minds going into medicine.”

Other notable findings

• Sixty-nine percent of physicians cited defensive medicine as the No. 1 cost driver, and 65% cited the “aging population.” Older patients visit physicians three times as often as younger patients, on average. Other expense drivers cited were the cost of pharmaceuticals, advances in technology and treatment, and “social conditions.”
  
• Close to 92% of physicians are unsure where the health-care system will be or how they will fit into it 3 to 5 years from now.
  
• More than 62% of physicians said Accountable Care Organizations are either unlikely to increase the quality of health care and decrease costs, or that any quality/cost gains will not be worth the effort.
  
• Although almost 70% of physicians have implemented electronic medical records, 47.4% have significant concerns that these records pose a risk to patient privacy.
  

“The 13,000 plus physicians who participated in this landmark survey, which included nearly 8,000 open-ended responses, strongly demonstrates the overwhelming desire of America’s physicians to share their perspectives and concerns about the current state of medicine,” said Tim Norbeck, CEO of the Physicians Foundation.

We want to hear from you! Tell us what you think.

One of the largest physician surveys ever conducted in the United States identified some disturbing trends in practice.¹ The comprehensive survey of 13,575 physicians, commissioned by the nonprofit Physicians Foundation, found that physicians are working fewer hours, seeing fewer patients, and limiting access to their practices as a response to significant changes to the medical practice environment.

If these patterns continue, as many as 44,250 full-time–equivalent physicians may leave the workforce over the next 4 years. The survey also found that, over the next 1 to 3 years, more than 50% of physicians will cut back on the number of patients they see, switch to part-time work or concierge medicine, retire, or take other steps likely to reduce patient access. And if 100,000 physicians transition from practice-owner to employed status over the next 4 years (eg, moving to a hospital setting), this shift will lead to 91 million fewer patient encounters.

“It is clear that the introduction of nearly 30 million new patients into the US health-care system through health-care reform, added to the already growing physician shortage, will have profound implications for patient access to medical care,” said Walker Ray, MD, vice president of the Physicians Foundation and chair of its Research Committee. “The rate of private practice physicians leaving the medical field, as well as changes in practice patterns that reduce the number of hours spent seeing and treating patients, is alarming. When these lost hours are added up, we get a much fuller and more ominous picture of the kind of access crisis that patients may soon face.”

More than half of physicians (52%) have limited the access of Medicare patients to their practices or are planning to do so, and one out of four physicians (26%) have already closed their practices to Medicaid patients, the survey reveals. Physicians cited rising operating costs, time constraints, and diminishing reimbursement as the primary reasons they are unable to accept additional Medicare and Medicaid patients.

Physician morale is flagging

An overwhelming 80% of physicians cited “patient relationships” as the most satisfying part of their job. Yet, 77% of respondents are pessimistic about the future of medicine. Eighty-two percent believe they have little ability to change the health-care system.

Among the variables cited as driving discontent:

• medicolegal risk and the pressure to practice defensively
  
• Medicare, Medicaid, and government regulations
  
• reimbursement issues
  
• uncertainty about the changes imposed by health reform.
  

These issues and others cited throughout the survey tend to distract from or interfere with the time physicians spend with patients, respondents said.

“The level of pessimism among America’s physicians is very troubling,” said Lou Goodman, PhD, president of the Physicians Foundation and chief executive officer (CEO) of the Texas Medical Association. “More than 84% of physicians feel that the medical profession is in decline, and nearly 58% are reluctant to recommend medicine as a career to their children. That means that we need to make significant changes to ensure that we preserve the patient-physician relationship and continue to have the brightest minds going into medicine.”

Other notable findings

• Sixty-nine percent of physicians cited defensive medicine as the No. 1 cost driver, and 65% cited the “aging population.” Older patients visit physicians three times as often as younger patients, on average. Other expense drivers cited were the cost of pharmaceuticals, advances in technology and treatment, and “social conditions.”
  
• Close to 92% of physicians are unsure where the health-care system will be or how they will fit into it 3 to 5 years from now.
  
• More than 62% of physicians said Accountable Care Organizations are either unlikely to increase the quality of health care and decrease costs, or that any quality/cost gains will not be worth the effort.
  
• Although almost 70% of physicians have implemented electronic medical records, 47.4% have significant concerns that these records pose a risk to patient privacy.
  

“The 13,000 plus physicians who participated in this landmark survey, which included nearly 8,000 open-ended responses, strongly demonstrates the overwhelming desire of America’s physicians to share their perspectives and concerns about the current state of medicine,” said Tim Norbeck, CEO of the Physicians Foundation.

We want to hear from you! Tell us what you think.