Janelle Yates

Physician earnings as a whole have remained stagnant over the past 15 years, while the earnings of other health professionals have continued to rise, according to research published late in 2012.¹ For example, physician earnings increased 19.9% from 1987–1990 to 1996–2000 (95% confidence interval [CI], 15.2% to 24.5%). However, from 1996–2000 to 2006–2010, physician earnings decreased 1.6% (95% CI, –5.4% to 2.2%), and earnings for other health professionals continued to grow from 1996–2000 to 2006–2010, increasing 34.4% for pharmacists, for example (95% CI, 28.4% to 40.3%) ( TABLE ).

Earnings of health-care professionals from 1987–2010

Health-care professional	Median earnings
	1987–1990	1991–1995	1996–2000	2001–2005	2006–2010
Physicians (n = 6,258)	$143,963	$147,135	$166,773	$167,478	$157,751
Dentists (n = 1,640)	$105,511	$120,075	$132,029	$123,126	$129,795
Pharmacists (n = 1,745)	$70,341	$72,685	$76,616	$89,4321	$101,279
Registered nurses (n = 17,774)	$44,149	$48,181	$47,739	$52,944	$54,886
Physician assistants (n = 761)	$42,229	$37,201	$45,484	$49,127	$64,818
Health-care and insurance executives (n = 2,378)	$86,755	$88,282	$89,002	$94,543	$100,000
Adapted from Seabury et al1

Details of the study

Seabury and colleagues drew from the Current Population Survey—a nationally representative, monthly survey of approximately 60,000 households conducted by the Bureau of Labor Statistics and the Census Bureau—to gather data on occupation, number of hours worked, self-reported earnings, and other information. The survey had a high response rate (93.3%). Investigators focused on median earnings because “survey earnings were capped by the US Census to protect identities.” ¹ Among the occupations reported were:

• physician or surgeon
  
• dentist
  
• pharmacist
  
• registered nurse
  
• physician assistant
  
• health-care executive
  
• insurance executive.
  

Physician data were not broken down by specialty.

Analysis was limited to subjects older than 35 years because “the majority of physicians under this age are in training.”¹

The sample included 30,556 individuals who reported being a health professional. Of these, 6,258 were physicians (20.5%).

Why the stagnant earnings?

Seabury and colleagues hypothesize that the growth of managed care, cuts to Medicaid payments, poor growth to Medicare payments, and “bargaining” by insurance companies have contributed to the sluggish physician earnings since 1996–2000.

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

Physician earnings as a whole have remained stagnant over the past 15 years, while the earnings of other health professionals have continued to rise, according to research published late in 2012.¹ For example, physician earnings increased 19.9% from 1987–1990 to 1996–2000 (95% confidence interval [CI], 15.2% to 24.5%). However, from 1996–2000 to 2006–2010, physician earnings decreased 1.6% (95% CI, –5.4% to 2.2%), and earnings for other health professionals continued to grow from 1996–2000 to 2006–2010, increasing 34.4% for pharmacists, for example (95% CI, 28.4% to 40.3%) ( TABLE ).

Earnings of health-care professionals from 1987–2010

Health-care professional	Median earnings
	1987–1990	1991–1995	1996–2000	2001–2005	2006–2010
Physicians (n = 6,258)	$143,963	$147,135	$166,773	$167,478	$157,751
Dentists (n = 1,640)	$105,511	$120,075	$132,029	$123,126	$129,795
Pharmacists (n = 1,745)	$70,341	$72,685	$76,616	$89,4321	$101,279
Registered nurses (n = 17,774)	$44,149	$48,181	$47,739	$52,944	$54,886
Physician assistants (n = 761)	$42,229	$37,201	$45,484	$49,127	$64,818
Health-care and insurance executives (n = 2,378)	$86,755	$88,282	$89,002	$94,543	$100,000
Adapted from Seabury et al1

Details of the study

Seabury and colleagues drew from the Current Population Survey—a nationally representative, monthly survey of approximately 60,000 households conducted by the Bureau of Labor Statistics and the Census Bureau—to gather data on occupation, number of hours worked, self-reported earnings, and other information. The survey had a high response rate (93.3%). Investigators focused on median earnings because “survey earnings were capped by the US Census to protect identities.” ¹ Among the occupations reported were:

• physician or surgeon
  
• dentist
  
• pharmacist
  
• registered nurse
  
• physician assistant
  
• health-care executive
  
• insurance executive.
  

Physician data were not broken down by specialty.

Analysis was limited to subjects older than 35 years because “the majority of physicians under this age are in training.”¹

The sample included 30,556 individuals who reported being a health professional. Of these, 6,258 were physicians (20.5%).

Why the stagnant earnings?

Seabury and colleagues hypothesize that the growth of managed care, cuts to Medicaid payments, poor growth to Medicare payments, and “bargaining” by insurance companies have contributed to the sluggish physician earnings since 1996–2000.

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

Physician earnings as a whole have remained stagnant over the past 15 years, while the earnings of other health professionals have continued to rise, according to research published late in 2012.¹ For example, physician earnings increased 19.9% from 1987–1990 to 1996–2000 (95% confidence interval [CI], 15.2% to 24.5%). However, from 1996–2000 to 2006–2010, physician earnings decreased 1.6% (95% CI, –5.4% to 2.2%), and earnings for other health professionals continued to grow from 1996–2000 to 2006–2010, increasing 34.4% for pharmacists, for example (95% CI, 28.4% to 40.3%) ( TABLE ).

Earnings of health-care professionals from 1987–2010

Health-care professional	Median earnings
	1987–1990	1991–1995	1996–2000	2001–2005	2006–2010
Physicians (n = 6,258)	$143,963	$147,135	$166,773	$167,478	$157,751
Dentists (n = 1,640)	$105,511	$120,075	$132,029	$123,126	$129,795
Pharmacists (n = 1,745)	$70,341	$72,685	$76,616	$89,4321	$101,279
Registered nurses (n = 17,774)	$44,149	$48,181	$47,739	$52,944	$54,886
Physician assistants (n = 761)	$42,229	$37,201	$45,484	$49,127	$64,818
Health-care and insurance executives (n = 2,378)	$86,755	$88,282	$89,002	$94,543	$100,000
Adapted from Seabury et al1

Details of the study

Seabury and colleagues drew from the Current Population Survey—a nationally representative, monthly survey of approximately 60,000 households conducted by the Bureau of Labor Statistics and the Census Bureau—to gather data on occupation, number of hours worked, self-reported earnings, and other information. The survey had a high response rate (93.3%). Investigators focused on median earnings because “survey earnings were capped by the US Census to protect identities.” ¹ Among the occupations reported were:

• physician or surgeon
  
• dentist
  
• pharmacist
  
• registered nurse
  
• physician assistant
  
• health-care executive
  
• insurance executive.
  

Physician data were not broken down by specialty.

Analysis was limited to subjects older than 35 years because “the majority of physicians under this age are in training.”¹

The sample included 30,556 individuals who reported being a health professional. Of these, 6,258 were physicians (20.5%).

Why the stagnant earnings?

Seabury and colleagues hypothesize that the growth of managed care, cuts to Medicaid payments, poor growth to Medicare payments, and “bargaining” by insurance companies have contributed to the sluggish physician earnings since 1996–2000.

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

Women who have hormone-sensitive breast cancer and who have taken tamoxifen for 5 years as adjuvant therapy stand to benefit from an additional 5 years of the drug, according to preliminary findings from the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) trial.¹

Tamoxifen is widely used to treat estrogen-receptor–positive (ER-positive) breast cancer and is generally prescribed for 5 years of daily use once the cancer has been excised. The drug substantially reduces the breast cancer mortality rate not only while treatment continues, but throughout the first 15 years after diagnosis.

It was known that 5 years of tamoxifen are more effective than 2 years. Until now, however, it was unclear whether continuation beyond 5 years further reduces the 15-year breast cancer mortality rate.

Details of the trial

In the trial of 12,894 women, investigators randomly assigned those who had received tamoxifen for 5 years to another 5 years of therapy or to no additional therapy, regardless of ER status. For the analysis, however, they included only the 6,847 women known to have ER-positive disease. Of these women, 3,428 were randomly assigned to continue tamoxifen for another 5 years (10 years total), and 3,418 were allocated to stop the therapy immediately (5 years total).

Women who continued tamoxifen had a lower rate of recurrence and breast cancer mortality, but that benefit took several years to emerge. From the beginning of the ATLAS trial to year 15, the risk of recurrence was 21.4% among women who had continued tamoxifen to 10 years, and it was 25.1% among women who had only 5 years of therapy. Breast cancer mortality also declined significantly during years 5 to 15; it was 12.2% among women who continued tamoxifen to 10 years, and it was 15% among women who had only 5 years of therapy.

“Our results, taken together with results from previous trials of 5 years of tamoxifen versus none, suggest that 10 years of tamoxifen treatment can approximately halve breast cancer mortality during the second decade after diagnosis,” said Christina Davies, MBChB, lead investigator. “Good evidence now exists that 10 years of tamoxifen in ER- positive breast cancer produces substantial reductions in rates of recurrence and in breast cancer mortality, not only during the first decade, while treatment continues, but also during the second decade, long after it has ended.”

 

Side effects were more common among postmenopausal women

Although tamoxifen has some side effects, they had a relatively small net effect on survival. The most significant effect was an increased risk—among postmenopausal women—of endometrial cancer. However, the excess risk of dying of endometrial cancer by year 15 was only 0.2% (0.4% among women who continued tamoxifen to 10 years vs 0.2% in the control group).

Investigators found no evidence that tamoxifen increases the risk of stroke, despite the fact that the US Food and Drug Administration lists stroke as a possible side effect of the drug.

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

Women who have hormone-sensitive breast cancer and who have taken tamoxifen for 5 years as adjuvant therapy stand to benefit from an additional 5 years of the drug, according to preliminary findings from the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) trial.¹

Tamoxifen is widely used to treat estrogen-receptor–positive (ER-positive) breast cancer and is generally prescribed for 5 years of daily use once the cancer has been excised. The drug substantially reduces the breast cancer mortality rate not only while treatment continues, but throughout the first 15 years after diagnosis.

It was known that 5 years of tamoxifen are more effective than 2 years. Until now, however, it was unclear whether continuation beyond 5 years further reduces the 15-year breast cancer mortality rate.

Details of the trial

In the trial of 12,894 women, investigators randomly assigned those who had received tamoxifen for 5 years to another 5 years of therapy or to no additional therapy, regardless of ER status. For the analysis, however, they included only the 6,847 women known to have ER-positive disease. Of these women, 3,428 were randomly assigned to continue tamoxifen for another 5 years (10 years total), and 3,418 were allocated to stop the therapy immediately (5 years total).

Women who continued tamoxifen had a lower rate of recurrence and breast cancer mortality, but that benefit took several years to emerge. From the beginning of the ATLAS trial to year 15, the risk of recurrence was 21.4% among women who had continued tamoxifen to 10 years, and it was 25.1% among women who had only 5 years of therapy. Breast cancer mortality also declined significantly during years 5 to 15; it was 12.2% among women who continued tamoxifen to 10 years, and it was 15% among women who had only 5 years of therapy.

“Our results, taken together with results from previous trials of 5 years of tamoxifen versus none, suggest that 10 years of tamoxifen treatment can approximately halve breast cancer mortality during the second decade after diagnosis,” said Christina Davies, MBChB, lead investigator. “Good evidence now exists that 10 years of tamoxifen in ER- positive breast cancer produces substantial reductions in rates of recurrence and in breast cancer mortality, not only during the first decade, while treatment continues, but also during the second decade, long after it has ended.”

 

Side effects were more common among postmenopausal women

Although tamoxifen has some side effects, they had a relatively small net effect on survival. The most significant effect was an increased risk—among postmenopausal women—of endometrial cancer. However, the excess risk of dying of endometrial cancer by year 15 was only 0.2% (0.4% among women who continued tamoxifen to 10 years vs 0.2% in the control group).

Investigators found no evidence that tamoxifen increases the risk of stroke, despite the fact that the US Food and Drug Administration lists stroke as a possible side effect of the drug.

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

Women who have hormone-sensitive breast cancer and who have taken tamoxifen for 5 years as adjuvant therapy stand to benefit from an additional 5 years of the drug, according to preliminary findings from the Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) trial.¹

Tamoxifen is widely used to treat estrogen-receptor–positive (ER-positive) breast cancer and is generally prescribed for 5 years of daily use once the cancer has been excised. The drug substantially reduces the breast cancer mortality rate not only while treatment continues, but throughout the first 15 years after diagnosis.

It was known that 5 years of tamoxifen are more effective than 2 years. Until now, however, it was unclear whether continuation beyond 5 years further reduces the 15-year breast cancer mortality rate.

Details of the trial

In the trial of 12,894 women, investigators randomly assigned those who had received tamoxifen for 5 years to another 5 years of therapy or to no additional therapy, regardless of ER status. For the analysis, however, they included only the 6,847 women known to have ER-positive disease. Of these women, 3,428 were randomly assigned to continue tamoxifen for another 5 years (10 years total), and 3,418 were allocated to stop the therapy immediately (5 years total).

Women who continued tamoxifen had a lower rate of recurrence and breast cancer mortality, but that benefit took several years to emerge. From the beginning of the ATLAS trial to year 15, the risk of recurrence was 21.4% among women who had continued tamoxifen to 10 years, and it was 25.1% among women who had only 5 years of therapy. Breast cancer mortality also declined significantly during years 5 to 15; it was 12.2% among women who continued tamoxifen to 10 years, and it was 15% among women who had only 5 years of therapy.

“Our results, taken together with results from previous trials of 5 years of tamoxifen versus none, suggest that 10 years of tamoxifen treatment can approximately halve breast cancer mortality during the second decade after diagnosis,” said Christina Davies, MBChB, lead investigator. “Good evidence now exists that 10 years of tamoxifen in ER- positive breast cancer produces substantial reductions in rates of recurrence and in breast cancer mortality, not only during the first decade, while treatment continues, but also during the second decade, long after it has ended.”

 

Side effects were more common among postmenopausal women

Although tamoxifen has some side effects, they had a relatively small net effect on survival. The most significant effect was an increased risk—among postmenopausal women—of endometrial cancer. However, the excess risk of dying of endometrial cancer by year 15 was only 0.2% (0.4% among women who continued tamoxifen to 10 years vs 0.2% in the control group).

Investigators found no evidence that tamoxifen increases the risk of stroke, despite the fact that the US Food and Drug Administration lists stroke as a possible side effect of the drug.

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

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

 

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

Flaws in the US health-care system

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

 

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

 

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

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

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

 

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

Flaws in the US health-care system

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

 

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

 

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

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

Barbara S. Levy, MD, spent 29 years in private practice before accepting an appointment as vice president of health policy at the American College of Obstetricians and Gynecologists (ACOG). Those 29 years in private practice weren’t her only window onto the health-care arena, however. She has served as chair of the Resource Based Relative Value Scale Update Committee for the American Medical Association for 3 years; as medical director of Women’s and Children’s Services at Franciscan Health System in Tacoma, Washington; and as a long-time member of the OBG Management Board of Editors. As a result, she offers an informed and well-rounded perspective on the economics of surgical gynecology—the subject of a keynote address she delivered at the 2012 Pelvic Anatomy and Gynecologic Surgery (PAGS) symposium in December.

We sat down with Dr. Levy after her talk to explore some of the issues she raised—the focus of this Q&A. Dr. Levy also summarizes the high points of her talk in a video presentation available at obgmanagement.com.

OBG Management: What prompted you to leave private practice, move across country, and accept the post at ACOG?

Dr. Levy: I had spent the better part of 29 years complaining and feeling reasonably unhappy with what organized medicine was doing—or not doing—for ObGyns and our patients. I felt that the specialty was not really out there in front of the curve, driving the bus, so to speak, but was a victim of broader forces. So when I was given an opportunity to influence the way we approach health-care policy, to enable us to drive our own bus, I decided to take the challenge. I’m not sure I can make a difference, but I’m going to do everything possible to put us in control of our destiny. There are a lot of pitfalls out there, but I think that, given a commitment to doing what is right, we may be able to change the way we deliver health care in this country.

OBG Management: So what’s wrong with the way we deliver health care in the United States?

Dr. Levy: We are spending an inordinate amount of money. I’ve heard it referred to as an “investment,” but I’m not sure that word is accurate. It’s really an expenditure of trillions of dollars—as much as 17% of gross domestic product—but what are we getting in return? We’re not getting what we want or need. There is a lot of innovation out there, but what is it bringing us? Do we have better health care in this country, based on our per capita expenditure, than other developed nations have? The answer is “No.”

OBG Management: Why do you think that is?

Dr. Levy: If you look at the growth in Part B Medicare, and focus on where we’re spending the money, the culprits are pharmaceuticals, a huge increase in testing and imaging, and a sharp rise in office-based procedures. The complexity of services has also increased dramatically. Our population is aging, and obesity is epidemic and driving costs for management of diabetes, hypertension, and chronic heart disease, as well as joint replacements and back surgery. About 85% of Medicare dollars go to the care of 15% to 20% of the Medicare population. Yes, we’re reducing death rates from cardiovascular disease and cancer, but now we have a larger population of patients who have chronic, active disease.

OBG Management: Who’s responsible for this problem?

Dr. Levy: Our health-care systems have created this mess in many ways. We spend $98 billion annually on hospitalization for pregnancy and childbirth, but our mortality rate is increasing. We rank 50th in the world in maternal mortality despite a cesarean delivery rate over 30%, despite all the money that we’re spending—with maternal mortality higher here than in almost every European country, as well as several nations in Asia and the Middle East.¹

OBG Management: Why are we spending so much money?

Dr. Levy: We have become so fearful—of poor outcomes, of litigation, and our patients are coming to us with demands for tests and treatment that cost them little or nothing—that we intervene with tests and procedures that increase the cost of care without providing any true benefit in terms of outcome.

We’ve also made some poor choices. We’ve allowed ourselves to be the victims of legislation, of rule-making, because we don’t sit down and read the 1,300 or so pages in the Federal Register from the Centers for Medicare and Medicaid Services (CMS) on proposed rule-making every year. Things happen to us that we aren’t aware of. We have allowed ourselves to be drawn in by innovation, by testing, and by fear until we have begun to do things that may not have any real benefit for our patients.

 

Both physicians and hospitals have driven volume to increase reimbursement. And industry has been drawn into the mix because the medical field is the only one that’s expanding. We have become our own worst enemies. We have not stepped up to the plate to define quality and value, so now others are doing it—and they don’t necessarily use the same definitions we do. We have allowed our fears of liability and misperceptions about the value of procedures to drive our decisions. For example, when we perform robotic hysterectomy in a woman who is a great candidate for the vaginal approach, we quadruple the cost of the surgery. Consider that we perform roughly 500,000 hysterectomies every year, and you can see how costs mount rapidly.

Flaws in the US health-care system

OBG Management: What are some of the other problems afflicting the US health-care system?

Dr. Levy: There are tremendous disparities in quality and cost across the country. Why? How we spend money in health care is cultural. It’s influenced by what we become accustomed to, what our particular environment calls “standard.” Here’s an example: A man who is experiencing knee pain tries to make an appointment with an orthopedic surgeon, but when he telephones the physician’s office, he is told that he can’t make an appointment until he has an MRI. That’s cultural, not medically justified.

Patients also play a role. When the patient comes in with a ream of paper from the Internet, and she wants a CA 125 test because she thinks it’s somehow going to prevent ovarian cancer, we need to explain to her, in a way she can understand, that adding that testing is of no benefit and may actually cause harm. We need quick statements that can help defuse the demand for increased testing.

Role of the government

OBG Management: What role does the government play?

Dr. Levy: The Medicare Resource-Based Relative Value Scale (RBRVS) was enacted into law in 1992. Most payers now follow this scale to determine reimbursement, based on how many resources it requires to perform a service. Resources are defined in the law—we can’t change them. But the American Medical Association did convene the RBRVS Update Committee (RUC), of which I am the chair, to do the best we can to define for the federal government exactly how many of those resources are necessary for a particular intervention. For example, how much time does it really take to perform laparoscopic supracervical hysterectomy—and how does that compare with reading a computed tomography (CT) scan of the abdomen and pelvis or with performing a five-vessel bypass? How many office visits for hypertension does it take to equal an open-heart surgery and 90 days of care? That’s not an easy set of relative intensities to work through, but the RUC does do that and makes recommendations to CMS for the relative value units (RVUs) for the services we provide.

OBG Management: Is it time alone that determines the value of a service?

Dr. Levy: Physician work is defined as the time it takes to perform a procedure—but also as the intensity of that service as compared with other physician services.

There are also practice-expense RVUs, intended to address the cost of clinical staff, medical supplies, and equipment. Right now approximately 52% of reimbursement goes toward the practice-expense component, and less than 50% for the physician’s work.

In 1992, when the RBRVS was enacted, women’s health services were significantly undervalued because ObGyns did not form a large part of the Medicare fee schedule. Over the past 20 years, ACOG and the RUC have worked diligently to correct those initial inequities.

On the RUC, we believe that no physicians are paid at a level that is fair and appropriate, compared with a plumber or electrician. So the shift to a value-based system and away from the volume-based system may be beneficial to us.

Challenges ahead

OBG Management: What challenges do ObGyns face in attempting to overcome these problems?

Dr. Levy: The primary challenge is to face reality as it is—not as it was in the “good old days” or as we wish it to be. We need to become advocates for ourselves and our patients. Advocacy would support and promote our patients’ health-care rights and enhance community health. It would also foster policy initiatives that focus on availability, safety, and quality of care.

In our advocacy, we need to focus first on quality. If we don’t define quality ourselves, others are going to decide that quality is a constant and that the only thing that matters is cost, and they will shift all services to the lowest-cost providers. That is not the way we want things to go.

 

Some changes are already in play:

• Out-of-pocket costs for patients are increasing, motivating patients to become more discriminating
• Payment models will soon focus on “episodes of care,” with incentives for systems to reduce surgical volumes while preserving the patient’s quality of life
• Surgery will shift from low-volume surgeons to high-volume physicians who have demonstrated excellent outcomes. This is otherwise known as “value-based purchasing,” based on a model from Harvard Business School.²

Bundled payments will become the norm

OBG Management: Can you elaborate a bit on episodes of care?

Dr. Levy: By episode of care, I mean bundled payments. For example, pregnancy services where prenatal care, delivery, and postpartum care are bundled, or management of fibroids where the diagnosis, imaging, medical, and, potentially, surgical management could all be included in a single payment. All interventions in these periods would be grouped together and reimbursed at a set rate. As a result, the clinicians caring for the patient during these episodes have more of an incentive to reduce unnecessary costs. Are a first-trimester ultrasound scan and two second-trimester scans really necessary? Or might there be a less expensive way to ensure the same optimal outcome? Are the fibroids symptomatic or might observation be a more appropriate option for the patient?

OBG Management: Some people might assume you are prescribing “cookbook medicine” by urging a reduction in variations in care.

Dr. Levy: Not at all. I’m talking about reducing significant variations in outcomes, not processes. Physicians should remain free to treat the patient, using whatever approach they deem to be in her best interest. However, cost pressures mean that we will need to become more creative in keeping costs down without impairing outcomes.

OBG Management: What will happen if physicians don’t keep these cost pressures in mind?

Dr. Levy: People are already keeping score. CMS and payers are using ICD-9 diagnoses, married to the CPT code—the intervention, as well as the episode—and including the costs of things we may have no idea are being spent, such as pharmaceuticals, a return to the emergency room, and so on. We need to be aware of what other people are measuring. We need to understand what we are being measured on: patient satisfaction, quality of life, morbidity and mortality, and cost.

What can gynecologic surgeons do?

OBG Management: Here’s the million dollar question: What can gynecologic surgeons do about this problem?

Dr. Levy: We need to step up to the plate. We need to read the literature critically to focus on clinically meaningful outcomes. Although small differences in blood loss, analgesic use, or operating times may be statistically significant, they do not produce outcomes that are apparent and meaningful to our patients.

We also need to encourage comparative effectiveness research, which is essential to ensure the most clinically meaningful and cost-effective care.

Now that “DSH” payments—disproportional share, or the incremental amount of money that hospitals collected to reimburse them for care of the uninsured—are going away, hospitals are going to need to cut expenses 20% to 25% over the next 3 years to survive. You can bet they are going to change the way they look at you. Be prepared for them to limit the “toys” you are allowed to have, and other cuts.

OBG Management: Can you recommend specific steps?

Dr. Levy: Yes, we need to:

• think creatively to contain costs. A good book on this subject is Unaccountable: What Hospitals Won’t Tell You and How Transparency Can Revolutionize Health Care, by Marty Makary, MD.³
• track our own outcomes. Although it is irritating and time-consuming to enter data, it’s a little easier with electronic medical records. We need to document our own long-term outcomes. In fact, ACOG is working with the American Board of Obstetrics and Gynecology to look at ways we can create a structure for us to track our own outcomes as part of the maintenance of certification (MOC) process. When you track data, the Hawthorne effect comes into play: You get better at the activity you’re tracking, simply by writing it down.
• collaborate with others in our communities to improve public health issues such as obesity, smoking, and teenage access to contraception
• question and challenge preconceived notions and beliefs. We have a lot of them in surgery. For example, we tell patients not to lift after hysterectomy, not to have sex after hysteroscopic resection—but we have absolutely no data suggesting that these admonitions are helpful. Bowel prep is another example. Data have demonstrated that it not only does not benefit the patient, mechanical prep causes harm—but the randomized, controlled trials documenting this fact appear in the surgical literature, not the gynecologic literature. And guess how long it takes for us to incorporate definitive data like that into gynecologic practice? 17 years.
• get a seat at every table to participate in data definitions, acquisition, and dissemination to inform our daily clinical decisions
• participate in efforts to define and improve quality of care.

 

OBG Management: Any last comments?

Dr. Levy: I just want to emphasize how important it is that we take control of our destiny. If we are not at the table, we may be on the menu! But if we step up to the plate and approach these challenges the right way, we can become the premier surgical specialty.

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

In a Phase 3 trial of an investigational contraceptive patch—known for the time being as AG200-15, under development by Agile Therapeutics—women were more compliant with the patch than with an oral contraceptive (OC).¹ Over the first six cycles of the study, the percentage of cycles with perfect compliance was significantly higher among patch users than among women taking the pill (90.5% vs 78.8%; P <.001). In addition, compliance with the patch rose steadily over the first six cycles of the study, while compliance with the pill declined. Compliance was defined as no missed days of contraception in the cycle.

The AG200-15 patch is applied weekly and contains low-dose ethinyl estradiol in combination with levonorgestrel (LNG). The OC used in the study was Levlite (Berlex), a formulation containing 20 μg ethinyl estradiol and 0.1 mg LNG.

Data from the Phase 3 trial were presented at the annual meeting of the Association of Reproductive Health Professionals in late September. Findings were presented in a poster presentation by Andrew M. Kaunitz, MD, David F. Archer, MD, and Marie Foegh, MD, DrSc. Dr. Kaunitz is Associate Chair and Professor of Obstetrics and Gynecology at the University of Florida-Jacksonville and serves on the OBG Management Board of Editors. Dr. Archer is Director of the CONRAD Clinical Research Center and Professor of Obstetrics and Gynecology at Eastern Virginia Medical School. Dr. Foegh is Chief Medical Officer of Agile Therapeutics.

In the open-label, randomized, parallel-group, multicenter study, 1,328 women were treated for 1 year (13 cycles) with a patch (n = 998) or for six cycles with an OC, followed by seven cycles of the patch (n = 330). Women recorded their patch-application and pill-taking behavior in a diary.

The mean age of women in this study was 26.4 years; 60% were new users of hormonal contraception; 33% were obese; and 46% were non-Caucasian. Although there was no difference in the rate of compliance between obese and nonobese women using the patch or pill, compliance did vary by race and ethnicity, age, and education.

“Noncompliance among contraceptive users is an ongoing challenge,” Dr. Kaunitz said, “as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly, and we are encouraged to see that in this clinical trial, compliance was better with AG200-15 than with an oral contraceptive.”

Patch performed favorably in other measures, too

In a poster presentation at the 2012 annual clinical meeting of the American College of Obstetricians and Gynecologists,² Dr. Kaunitz and colleagues presented Phase 3 data on the efficacy, cycle control, and safety of AG200-15, compared with a low-dose OC.

Overall, 1,503 women were randomly assigned to the patch (n = 1,128) or to the OC (n = 375). The women in both groups had comparable age, racial and ethnic demographics, body mass index, and smoking status. A majority of women (60%) were new users of hormonal contraception; 14% had switched from another contraceptive.

The patch had contraceptive efficacy similar to that of the pill, among both obese and nonobese participants; there were no clinically meaningful differences in efficacy between groups. Cycle control was also similar between groups.

The patch was well tolerated, with a low rate of adverse effects. For example, four women (1.2%) in the OC group and 14 women in the patch group (1.3%) experienced a serious adverse event (SAE). One SAE (0.3%) in the OC group (liver problem) and three SAEs (0.3%) in the patch group (drug overdose with diphenhydramine, vomiting, and left subclavian venous thrombosis in a nonobese woman with risk factors) were thought to be possibly or probably related to the study drug.²

Agile recently filed a new drug application for AG200-15 with the US Food and Drug Administration and anticipates a response during the first quarter of 2013.

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

In a Phase 3 trial of an investigational contraceptive patch—known for the time being as AG200-15, under development by Agile Therapeutics—women were more compliant with the patch than with an oral contraceptive (OC).¹ Over the first six cycles of the study, the percentage of cycles with perfect compliance was significantly higher among patch users than among women taking the pill (90.5% vs 78.8%; P <.001). In addition, compliance with the patch rose steadily over the first six cycles of the study, while compliance with the pill declined. Compliance was defined as no missed days of contraception in the cycle.

The AG200-15 patch is applied weekly and contains low-dose ethinyl estradiol in combination with levonorgestrel (LNG). The OC used in the study was Levlite (Berlex), a formulation containing 20 μg ethinyl estradiol and 0.1 mg LNG.

Data from the Phase 3 trial were presented at the annual meeting of the Association of Reproductive Health Professionals in late September. Findings were presented in a poster presentation by Andrew M. Kaunitz, MD, David F. Archer, MD, and Marie Foegh, MD, DrSc. Dr. Kaunitz is Associate Chair and Professor of Obstetrics and Gynecology at the University of Florida-Jacksonville and serves on the OBG Management Board of Editors. Dr. Archer is Director of the CONRAD Clinical Research Center and Professor of Obstetrics and Gynecology at Eastern Virginia Medical School. Dr. Foegh is Chief Medical Officer of Agile Therapeutics.

In the open-label, randomized, parallel-group, multicenter study, 1,328 women were treated for 1 year (13 cycles) with a patch (n = 998) or for six cycles with an OC, followed by seven cycles of the patch (n = 330). Women recorded their patch-application and pill-taking behavior in a diary.

The mean age of women in this study was 26.4 years; 60% were new users of hormonal contraception; 33% were obese; and 46% were non-Caucasian. Although there was no difference in the rate of compliance between obese and nonobese women using the patch or pill, compliance did vary by race and ethnicity, age, and education.

“Noncompliance among contraceptive users is an ongoing challenge,” Dr. Kaunitz said, “as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly, and we are encouraged to see that in this clinical trial, compliance was better with AG200-15 than with an oral contraceptive.”

Patch performed favorably in other measures, too

In a poster presentation at the 2012 annual clinical meeting of the American College of Obstetricians and Gynecologists,² Dr. Kaunitz and colleagues presented Phase 3 data on the efficacy, cycle control, and safety of AG200-15, compared with a low-dose OC.

Overall, 1,503 women were randomly assigned to the patch (n = 1,128) or to the OC (n = 375). The women in both groups had comparable age, racial and ethnic demographics, body mass index, and smoking status. A majority of women (60%) were new users of hormonal contraception; 14% had switched from another contraceptive.

The patch had contraceptive efficacy similar to that of the pill, among both obese and nonobese participants; there were no clinically meaningful differences in efficacy between groups. Cycle control was also similar between groups.

The patch was well tolerated, with a low rate of adverse effects. For example, four women (1.2%) in the OC group and 14 women in the patch group (1.3%) experienced a serious adverse event (SAE). One SAE (0.3%) in the OC group (liver problem) and three SAEs (0.3%) in the patch group (drug overdose with diphenhydramine, vomiting, and left subclavian venous thrombosis in a nonobese woman with risk factors) were thought to be possibly or probably related to the study drug.²

Agile recently filed a new drug application for AG200-15 with the US Food and Drug Administration and anticipates a response during the first quarter of 2013.

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

In a Phase 3 trial of an investigational contraceptive patch—known for the time being as AG200-15, under development by Agile Therapeutics—women were more compliant with the patch than with an oral contraceptive (OC).¹ Over the first six cycles of the study, the percentage of cycles with perfect compliance was significantly higher among patch users than among women taking the pill (90.5% vs 78.8%; P <.001). In addition, compliance with the patch rose steadily over the first six cycles of the study, while compliance with the pill declined. Compliance was defined as no missed days of contraception in the cycle.

The AG200-15 patch is applied weekly and contains low-dose ethinyl estradiol in combination with levonorgestrel (LNG). The OC used in the study was Levlite (Berlex), a formulation containing 20 μg ethinyl estradiol and 0.1 mg LNG.

Data from the Phase 3 trial were presented at the annual meeting of the Association of Reproductive Health Professionals in late September. Findings were presented in a poster presentation by Andrew M. Kaunitz, MD, David F. Archer, MD, and Marie Foegh, MD, DrSc. Dr. Kaunitz is Associate Chair and Professor of Obstetrics and Gynecology at the University of Florida-Jacksonville and serves on the OBG Management Board of Editors. Dr. Archer is Director of the CONRAD Clinical Research Center and Professor of Obstetrics and Gynecology at Eastern Virginia Medical School. Dr. Foegh is Chief Medical Officer of Agile Therapeutics.

In the open-label, randomized, parallel-group, multicenter study, 1,328 women were treated for 1 year (13 cycles) with a patch (n = 998) or for six cycles with an OC, followed by seven cycles of the patch (n = 330). Women recorded their patch-application and pill-taking behavior in a diary.

The mean age of women in this study was 26.4 years; 60% were new users of hormonal contraception; 33% were obese; and 46% were non-Caucasian. Although there was no difference in the rate of compliance between obese and nonobese women using the patch or pill, compliance did vary by race and ethnicity, age, and education.

“Noncompliance among contraceptive users is an ongoing challenge,” Dr. Kaunitz said, “as the effectiveness of a contraceptive can decrease if it is not used correctly. The once-weekly regimen of AG200-15 is intended to be simple to use correctly, and we are encouraged to see that in this clinical trial, compliance was better with AG200-15 than with an oral contraceptive.”

Patch performed favorably in other measures, too

In a poster presentation at the 2012 annual clinical meeting of the American College of Obstetricians and Gynecologists,² Dr. Kaunitz and colleagues presented Phase 3 data on the efficacy, cycle control, and safety of AG200-15, compared with a low-dose OC.

Overall, 1,503 women were randomly assigned to the patch (n = 1,128) or to the OC (n = 375). The women in both groups had comparable age, racial and ethnic demographics, body mass index, and smoking status. A majority of women (60%) were new users of hormonal contraception; 14% had switched from another contraceptive.

The patch had contraceptive efficacy similar to that of the pill, among both obese and nonobese participants; there were no clinically meaningful differences in efficacy between groups. Cycle control was also similar between groups.

The patch was well tolerated, with a low rate of adverse effects. For example, four women (1.2%) in the OC group and 14 women in the patch group (1.3%) experienced a serious adverse event (SAE). One SAE (0.3%) in the OC group (liver problem) and three SAEs (0.3%) in the patch group (drug overdose with diphenhydramine, vomiting, and left subclavian venous thrombosis in a nonobese woman with risk factors) were thought to be possibly or probably related to the study drug.²

Agile recently filed a new drug application for AG200-15 with the US Food and Drug Administration and anticipates a response during the first quarter of 2013.

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

Analyses from the Cancer Genome Atlas (TCGA) have confirmed the existence of four primary subtypes of breast cancer, each with its own biology and survival outlooks, according to a study published in the journal Nature.¹

The standard molecular subtypes are:

• luminal A tumors
• luminal B tumors
• basal-like cancer, also known as triple-negative breast cancer because most of these tumors test negative for three receptors: estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2)
• HER2-enriched tumors.

In their analyses, funded by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), both part of the National Institutes of Health (NIH), researchers described new insights into the four subtypes based on a comprehensive characterization of samples from 825 breast cancer patients.

Most breast Ca cases involve luminal tumors

The milk ducts of the human breast, lined with luminal cells, are the most common origin of breast cancers. Malignancies that arise from these cells are fed by estrogen, spurring growth. Treatment for luminal cancers is fairly uniform, with good outcomes for many patients, though some respond poorly. Therefore, luminal cancers are divided into type A (responsive to treatment) and type B (not as responsive).

Researchers theorize that women with luminal A tumors may respond well to hormonal (estrogen-blocking) therapy, whereas those with luminal B tumors may require chemotherapy in addition to hormonal therapy.

In general, luminal subtypes of breast cancer tumors had the lowest overall mutation rate but the largest number of genes observed to be significantly mutated. This finding suggests that each of the genes identified as significantly mutated in the luminal subtypes is more likely to be important in fueling cancer progression.

Triple-negative breast cancers linked to serous ovarian cancer

One of the most dramatic discoveries of this analysis was the marked genomic similarities between the basal-like subtype and serous ovarian cancer. The mutation spectrum—or types and frequencies of genomic mutations—were largely the same in both cancer types. Further analyses identified several additional common genomic features, such as gene-mutation frequency, suggesting that diverse genomic aberrations can converge into a limited number of cancer subtypes.

Computational analyses suggest that basal-like breast cancer and serous ovarian cancer might both be susceptible to agents that inhibit blood vessel growth, cutting off the blood supply to the tumor, as well as to compounds that target DNA repair, which include chemotherapy drugs such as cisplatin.

“The molecular similarity of one of the principal subtypes of breast cancer to that found in ovarian cancer gives us additional leverage to compare treatments and outcomes across these two cancers,” said Harold Varmus, MD, NCI director.

Two types of HER2-positive tumors?

When researchers analyzed the genomic findings from tumors determined to be HER2-positive by standard cellular tests, they found that only half of the samples were actually HER2-enriched. The other half were characterized as luminal subtypes, suggesting that there are at least two types of clinically defined HER2-positive tumors.

Overall, the scale of the TCGA program allows researchers to perform the integrative analyses that detect these complex patterns of genomic changes and interactions. This close inspection of the cancer genome has led to a deeper understanding of the mutations essential for cancer progression, and several new mutations were identified in the study.

“The data generated by the TCGA program comprise a vast resource that investigators will be analyzing for years to come,” said Eric D. Green, MD, PhD, NHGRI director. “The resource of information about breast cancer genomes will undoubtedly fuel myriad discoveries by the cancer research community.”

So far, TCGA research has published analyses of ovarian serous adenocarcinoma, colorectal adenocarcinoma, lung squamous cell carcinoma, and glioblastoma multiforme.

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

Analyses from the Cancer Genome Atlas (TCGA) have confirmed the existence of four primary subtypes of breast cancer, each with its own biology and survival outlooks, according to a study published in the journal Nature.¹

The standard molecular subtypes are:

• luminal A tumors
• luminal B tumors
• basal-like cancer, also known as triple-negative breast cancer because most of these tumors test negative for three receptors: estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2)
• HER2-enriched tumors.

In their analyses, funded by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), both part of the National Institutes of Health (NIH), researchers described new insights into the four subtypes based on a comprehensive characterization of samples from 825 breast cancer patients.

Most breast Ca cases involve luminal tumors

The milk ducts of the human breast, lined with luminal cells, are the most common origin of breast cancers. Malignancies that arise from these cells are fed by estrogen, spurring growth. Treatment for luminal cancers is fairly uniform, with good outcomes for many patients, though some respond poorly. Therefore, luminal cancers are divided into type A (responsive to treatment) and type B (not as responsive).

Researchers theorize that women with luminal A tumors may respond well to hormonal (estrogen-blocking) therapy, whereas those with luminal B tumors may require chemotherapy in addition to hormonal therapy.

In general, luminal subtypes of breast cancer tumors had the lowest overall mutation rate but the largest number of genes observed to be significantly mutated. This finding suggests that each of the genes identified as significantly mutated in the luminal subtypes is more likely to be important in fueling cancer progression.

Triple-negative breast cancers linked to serous ovarian cancer

One of the most dramatic discoveries of this analysis was the marked genomic similarities between the basal-like subtype and serous ovarian cancer. The mutation spectrum—or types and frequencies of genomic mutations—were largely the same in both cancer types. Further analyses identified several additional common genomic features, such as gene-mutation frequency, suggesting that diverse genomic aberrations can converge into a limited number of cancer subtypes.

Computational analyses suggest that basal-like breast cancer and serous ovarian cancer might both be susceptible to agents that inhibit blood vessel growth, cutting off the blood supply to the tumor, as well as to compounds that target DNA repair, which include chemotherapy drugs such as cisplatin.

“The molecular similarity of one of the principal subtypes of breast cancer to that found in ovarian cancer gives us additional leverage to compare treatments and outcomes across these two cancers,” said Harold Varmus, MD, NCI director.

Two types of HER2-positive tumors?

When researchers analyzed the genomic findings from tumors determined to be HER2-positive by standard cellular tests, they found that only half of the samples were actually HER2-enriched. The other half were characterized as luminal subtypes, suggesting that there are at least two types of clinically defined HER2-positive tumors.

Overall, the scale of the TCGA program allows researchers to perform the integrative analyses that detect these complex patterns of genomic changes and interactions. This close inspection of the cancer genome has led to a deeper understanding of the mutations essential for cancer progression, and several new mutations were identified in the study.

“The data generated by the TCGA program comprise a vast resource that investigators will be analyzing for years to come,” said Eric D. Green, MD, PhD, NHGRI director. “The resource of information about breast cancer genomes will undoubtedly fuel myriad discoveries by the cancer research community.”

So far, TCGA research has published analyses of ovarian serous adenocarcinoma, colorectal adenocarcinoma, lung squamous cell carcinoma, and glioblastoma multiforme.

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

Analyses from the Cancer Genome Atlas (TCGA) have confirmed the existence of four primary subtypes of breast cancer, each with its own biology and survival outlooks, according to a study published in the journal Nature.¹

The standard molecular subtypes are:

• luminal A tumors
• luminal B tumors
• basal-like cancer, also known as triple-negative breast cancer because most of these tumors test negative for three receptors: estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2)
• HER2-enriched tumors.

In their analyses, funded by the National Cancer Institute (NCI) and the National Human Genome Research Institute (NHGRI), both part of the National Institutes of Health (NIH), researchers described new insights into the four subtypes based on a comprehensive characterization of samples from 825 breast cancer patients.

Most breast Ca cases involve luminal tumors

The milk ducts of the human breast, lined with luminal cells, are the most common origin of breast cancers. Malignancies that arise from these cells are fed by estrogen, spurring growth. Treatment for luminal cancers is fairly uniform, with good outcomes for many patients, though some respond poorly. Therefore, luminal cancers are divided into type A (responsive to treatment) and type B (not as responsive).

Researchers theorize that women with luminal A tumors may respond well to hormonal (estrogen-blocking) therapy, whereas those with luminal B tumors may require chemotherapy in addition to hormonal therapy.

In general, luminal subtypes of breast cancer tumors had the lowest overall mutation rate but the largest number of genes observed to be significantly mutated. This finding suggests that each of the genes identified as significantly mutated in the luminal subtypes is more likely to be important in fueling cancer progression.

Triple-negative breast cancers linked to serous ovarian cancer

One of the most dramatic discoveries of this analysis was the marked genomic similarities between the basal-like subtype and serous ovarian cancer. The mutation spectrum—or types and frequencies of genomic mutations—were largely the same in both cancer types. Further analyses identified several additional common genomic features, such as gene-mutation frequency, suggesting that diverse genomic aberrations can converge into a limited number of cancer subtypes.

Computational analyses suggest that basal-like breast cancer and serous ovarian cancer might both be susceptible to agents that inhibit blood vessel growth, cutting off the blood supply to the tumor, as well as to compounds that target DNA repair, which include chemotherapy drugs such as cisplatin.

“The molecular similarity of one of the principal subtypes of breast cancer to that found in ovarian cancer gives us additional leverage to compare treatments and outcomes across these two cancers,” said Harold Varmus, MD, NCI director.

Two types of HER2-positive tumors?

When researchers analyzed the genomic findings from tumors determined to be HER2-positive by standard cellular tests, they found that only half of the samples were actually HER2-enriched. The other half were characterized as luminal subtypes, suggesting that there are at least two types of clinically defined HER2-positive tumors.

Overall, the scale of the TCGA program allows researchers to perform the integrative analyses that detect these complex patterns of genomic changes and interactions. This close inspection of the cancer genome has led to a deeper understanding of the mutations essential for cancer progression, and several new mutations were identified in the study.

“The data generated by the TCGA program comprise a vast resource that investigators will be analyzing for years to come,” said Eric D. Green, MD, PhD, NHGRI director. “The resource of information about breast cancer genomes will undoubtedly fuel myriad discoveries by the cancer research community.”

So far, TCGA research has published analyses of ovarian serous adenocarcinoma, colorectal adenocarcinoma, lung squamous cell carcinoma, and glioblastoma multiforme.

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

A new survey confirms what many clinicians already know firsthand: Burnout is common among physicians in the United States. Almost half (45.8%) of a large sample of physicians (n = 7,288) reported at least one symptom of burnout, which included high emotional exhaustion (37.9%), a high level of depersonalization (29.4%), and a low sense of personal accomplishment (12.4%).¹

Compared with a sample of working US adults (n = 3,442), physicians were more likely to report symptoms of burnout (37.9% vs 27.8%) and to be dissatisfied with their work-life balance (40.2% vs 23.2%).

These findings are disturbing because, as the investigators noted in their report, “burnout may erode professionalism, influence quality of care, increase the risk for medical errors, and promote early retirement. Burnout also seems to have adverse personal consequences for physicians, including contributions to broken relationships, problematic alcohol use, and suicidal ideation.”¹

How ObGyns responded

Specialties reporting the highest level of burnout were emergency medicine, general internal medicine, neurology, and family medicine. Those with the lowest level of burnout were pathology, dermatology, general pediatrics, and preventive medicine.

The ObGyn specialty ranked near the top of the list in terms of burnout, with more than 45% of respondents reporting it. The specialty ranked near the bottom of the list (along with general surgery and general surgery subspecialties) in its level of satisfaction with work-life balance (just over 40%).

Some reasons for the high rate of burnout among ObGyns may be the need for extended call, low reimbursement for many procedures, and the high exposure to medicolegal risk among obstetricians.

Mitigating factors

When investigators analyzed data—adjusting for age, sex, relationship status, hours worked per week, and education—they found that burnout was less likely among physicians who were older and those who were married. The more hours worked per week, the greater the risk of burnout.

Education benefitted nonphysicians but tended to increase the likelihood of burnout among physicians. For example, compared with high school graduates, nonphysicians with higher levels of education had a lower risk of burnout (odds ratio [OR] for a bachelor’s degree, 0.80 [P = .048]; OR for a master’s degree, 0.71 [P = .01]; OR for a professional or doctoral degree other than an MD or DO degree, 0.64 [P = .04]). Among physicians, however, an MD or DO degree increased the risk of burnout (OR, 1.36; P <.001).

Data came from AMA Physician Masterfile

Investigators conducted their national survey of physicians in June 2011, with representation from all specialties. In addition, they surveyed a probability-based sample of the general US population for comparison.

The physician sample was compiled from data in the American Medical Association Physician Masterfile (PMF), “an almost complete record of all US physicians, independent of American Medical Association membership, that is primarily used for estimating the size of the physician workforce and for verifying professional credentials.”¹

A systemic problem

In commenting on their findings, the authors suggested:

• When considered with the mounting evidence that physician burnout adversely affects quality of care, these findings suggest a highly prevalent and systemic problem threatening the foundation of the US medical care system. The fact that almost 1 in 2 US physicians has symptoms of burnout implies that the origins of this problem are rooted in the environment and care delivery system rather than in the personal characteristics of a few susceptible individuals. Policy makers and health care organizations must address the problem of physician burnout for the sake of physicians and their patients.¹

ObGyn Louis Weinstein, MD, agrees that the problem is pervasive. Dr. Weinstein has written extensively about the problems of burnout and physician shortages.^2-4

“These issues were recognized in obstetrics and gynecology years ago, but nothing has been done to improve the situation by any of our professional organizations,” Dr. Weinstein says.

“The physician shortage is being addressed by an increase in the size of medical school classes and by the opening of several new medical schools,” Dr. Weinstein continues. “However, these strategies will not solve the epidemic of physician dissatisfaction. There is a very real shortage—which will continue to worsen—of working physicians, and new recruits to medicine will not be immune to the problems of burnout and dissatisfaction. The medical profession must recognize the need to develop and adopt newer models of practice (for example, the laborist model) that will improve physician well-being, decrease physician dissatisfaction, and markedly improve patient safety.”

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

A new survey confirms what many clinicians already know firsthand: Burnout is common among physicians in the United States. Almost half (45.8%) of a large sample of physicians (n = 7,288) reported at least one symptom of burnout, which included high emotional exhaustion (37.9%), a high level of depersonalization (29.4%), and a low sense of personal accomplishment (12.4%).¹

Compared with a sample of working US adults (n = 3,442), physicians were more likely to report symptoms of burnout (37.9% vs 27.8%) and to be dissatisfied with their work-life balance (40.2% vs 23.2%).

These findings are disturbing because, as the investigators noted in their report, “burnout may erode professionalism, influence quality of care, increase the risk for medical errors, and promote early retirement. Burnout also seems to have adverse personal consequences for physicians, including contributions to broken relationships, problematic alcohol use, and suicidal ideation.”¹

How ObGyns responded

Specialties reporting the highest level of burnout were emergency medicine, general internal medicine, neurology, and family medicine. Those with the lowest level of burnout were pathology, dermatology, general pediatrics, and preventive medicine.

The ObGyn specialty ranked near the top of the list in terms of burnout, with more than 45% of respondents reporting it. The specialty ranked near the bottom of the list (along with general surgery and general surgery subspecialties) in its level of satisfaction with work-life balance (just over 40%).

Some reasons for the high rate of burnout among ObGyns may be the need for extended call, low reimbursement for many procedures, and the high exposure to medicolegal risk among obstetricians.

Mitigating factors

When investigators analyzed data—adjusting for age, sex, relationship status, hours worked per week, and education—they found that burnout was less likely among physicians who were older and those who were married. The more hours worked per week, the greater the risk of burnout.

Education benefitted nonphysicians but tended to increase the likelihood of burnout among physicians. For example, compared with high school graduates, nonphysicians with higher levels of education had a lower risk of burnout (odds ratio [OR] for a bachelor’s degree, 0.80 [P = .048]; OR for a master’s degree, 0.71 [P = .01]; OR for a professional or doctoral degree other than an MD or DO degree, 0.64 [P = .04]). Among physicians, however, an MD or DO degree increased the risk of burnout (OR, 1.36; P <.001).

Data came from AMA Physician Masterfile

Investigators conducted their national survey of physicians in June 2011, with representation from all specialties. In addition, they surveyed a probability-based sample of the general US population for comparison.

The physician sample was compiled from data in the American Medical Association Physician Masterfile (PMF), “an almost complete record of all US physicians, independent of American Medical Association membership, that is primarily used for estimating the size of the physician workforce and for verifying professional credentials.”¹

A systemic problem

In commenting on their findings, the authors suggested:

• When considered with the mounting evidence that physician burnout adversely affects quality of care, these findings suggest a highly prevalent and systemic problem threatening the foundation of the US medical care system. The fact that almost 1 in 2 US physicians has symptoms of burnout implies that the origins of this problem are rooted in the environment and care delivery system rather than in the personal characteristics of a few susceptible individuals. Policy makers and health care organizations must address the problem of physician burnout for the sake of physicians and their patients.¹

ObGyn Louis Weinstein, MD, agrees that the problem is pervasive. Dr. Weinstein has written extensively about the problems of burnout and physician shortages.^2-4

“These issues were recognized in obstetrics and gynecology years ago, but nothing has been done to improve the situation by any of our professional organizations,” Dr. Weinstein says.

“The physician shortage is being addressed by an increase in the size of medical school classes and by the opening of several new medical schools,” Dr. Weinstein continues. “However, these strategies will not solve the epidemic of physician dissatisfaction. There is a very real shortage—which will continue to worsen—of working physicians, and new recruits to medicine will not be immune to the problems of burnout and dissatisfaction. The medical profession must recognize the need to develop and adopt newer models of practice (for example, the laborist model) that will improve physician well-being, decrease physician dissatisfaction, and markedly improve patient safety.”

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

A new survey confirms what many clinicians already know firsthand: Burnout is common among physicians in the United States. Almost half (45.8%) of a large sample of physicians (n = 7,288) reported at least one symptom of burnout, which included high emotional exhaustion (37.9%), a high level of depersonalization (29.4%), and a low sense of personal accomplishment (12.4%).¹

Compared with a sample of working US adults (n = 3,442), physicians were more likely to report symptoms of burnout (37.9% vs 27.8%) and to be dissatisfied with their work-life balance (40.2% vs 23.2%).

These findings are disturbing because, as the investigators noted in their report, “burnout may erode professionalism, influence quality of care, increase the risk for medical errors, and promote early retirement. Burnout also seems to have adverse personal consequences for physicians, including contributions to broken relationships, problematic alcohol use, and suicidal ideation.”¹

How ObGyns responded

Specialties reporting the highest level of burnout were emergency medicine, general internal medicine, neurology, and family medicine. Those with the lowest level of burnout were pathology, dermatology, general pediatrics, and preventive medicine.

The ObGyn specialty ranked near the top of the list in terms of burnout, with more than 45% of respondents reporting it. The specialty ranked near the bottom of the list (along with general surgery and general surgery subspecialties) in its level of satisfaction with work-life balance (just over 40%).

Some reasons for the high rate of burnout among ObGyns may be the need for extended call, low reimbursement for many procedures, and the high exposure to medicolegal risk among obstetricians.

Mitigating factors

When investigators analyzed data—adjusting for age, sex, relationship status, hours worked per week, and education—they found that burnout was less likely among physicians who were older and those who were married. The more hours worked per week, the greater the risk of burnout.

Education benefitted nonphysicians but tended to increase the likelihood of burnout among physicians. For example, compared with high school graduates, nonphysicians with higher levels of education had a lower risk of burnout (odds ratio [OR] for a bachelor’s degree, 0.80 [P = .048]; OR for a master’s degree, 0.71 [P = .01]; OR for a professional or doctoral degree other than an MD or DO degree, 0.64 [P = .04]). Among physicians, however, an MD or DO degree increased the risk of burnout (OR, 1.36; P <.001).

Data came from AMA Physician Masterfile

Investigators conducted their national survey of physicians in June 2011, with representation from all specialties. In addition, they surveyed a probability-based sample of the general US population for comparison.

The physician sample was compiled from data in the American Medical Association Physician Masterfile (PMF), “an almost complete record of all US physicians, independent of American Medical Association membership, that is primarily used for estimating the size of the physician workforce and for verifying professional credentials.”¹

A systemic problem

In commenting on their findings, the authors suggested:

• When considered with the mounting evidence that physician burnout adversely affects quality of care, these findings suggest a highly prevalent and systemic problem threatening the foundation of the US medical care system. The fact that almost 1 in 2 US physicians has symptoms of burnout implies that the origins of this problem are rooted in the environment and care delivery system rather than in the personal characteristics of a few susceptible individuals. Policy makers and health care organizations must address the problem of physician burnout for the sake of physicians and their patients.¹

ObGyn Louis Weinstein, MD, agrees that the problem is pervasive. Dr. Weinstein has written extensively about the problems of burnout and physician shortages.^2-4

“These issues were recognized in obstetrics and gynecology years ago, but nothing has been done to improve the situation by any of our professional organizations,” Dr. Weinstein says.

“The physician shortage is being addressed by an increase in the size of medical school classes and by the opening of several new medical schools,” Dr. Weinstein continues. “However, these strategies will not solve the epidemic of physician dissatisfaction. There is a very real shortage—which will continue to worsen—of working physicians, and new recruits to medicine will not be immune to the problems of burnout and dissatisfaction. The medical profession must recognize the need to develop and adopt newer models of practice (for example, the laborist model) that will improve physician well-being, decrease physician dissatisfaction, and markedly improve patient safety.”

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

HIV-infected women who have normal cervical cytology and who test negative for oncogenic types of human papillomavirus (HPV) have a 5-year risk of cervical precancer and cancer that is equivalent to the risk among women without HIV infection, according to a cohort study published in July in JAMA.¹

Howard D. Strickler, MD, MPH, of Albert Einstein College of Medicine of Yeshiva University, New York, and colleagues conducted the study to explore the 3- and 5-year risk of cervical precancer and cancer in 420 HIV-infected women and 279 women without HIV infection. Precancer and cancer were defined on the basis of cytology or histology:

• cytology: a high-grade squamous intraepithelial lesion (HSIL) or more severe finding
• histology: cervical intraepithelial neoplasia (CIN) grade 2 or higher.

Participants in the study underwent semiannual visits, including Pap testing and cervical biopsy, if indicated.

Two cases of HSIL or more severe cytology were observed during the 5 years of follow-up—one among HIV-infected women who had a CD4 cell count of at least 500 cells/μL and one among HIV-negative women. Overall, the cumulative incidence of HSIL or more severe cytology was 0.3% among HIV-infected women and 0.4% among HIV-negative women.

Based on a total of 15 cases, investigators determined that the cumulative incidence of CIN 2+ histology over 5 years was:

• 2% among HIV-infected women who had a CD4 cell count below 350 cells/μL
• 2% among HIV-infected women who had a CD4 cell count of 350 to 499 cells/μL
• 6% among HIV-infected women who had a CD4 cell count of 500 cells/μL or higher
• 5% in women without HIV infection.

When researchers combined the data among HIV-infected women, they found an overall 5-year cumulative incidence of CIN 2+ of 5%.

Screening intervals may one day be extended for HIV-infected women

These findings are important because cervical cancer screening guidelines for women who are not infected with HIV were recently updated to increase the co-testing interval from 3 to 5 years among women who have normal cytology and who test negative for oncogenic HPV. “Whether a 3-year or 5-year screening interval could be used in HIV-infected women who are cytologically normal and oncogenic HPV-negative is unknown,” wrote Strickler and colleagues as background to their study.

“The results of this prospective study suggest that HIV-infected women undergoing long-term clinical follow-up who are cytologically normal and oncogenic HPV-negative have a risk of cervical precancer similar to that in HIV-uninfected women through 5 years of follow-up. Additional observational studies or a randomized clinical trial may be necessary before clinical guideline committees consider whether to expand current recommendations regarding HPV co-testing to HIV-infected women. More broadly, the current investigation highlights the potential for a new era of molecular testing, including HPV as well as other biomarkers, to improve cervical cancer screening in HIV-infected women,” the investigators concluded.

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

HIV-infected women who have normal cervical cytology and who test negative for oncogenic types of human papillomavirus (HPV) have a 5-year risk of cervical precancer and cancer that is equivalent to the risk among women without HIV infection, according to a cohort study published in July in JAMA.¹

Howard D. Strickler, MD, MPH, of Albert Einstein College of Medicine of Yeshiva University, New York, and colleagues conducted the study to explore the 3- and 5-year risk of cervical precancer and cancer in 420 HIV-infected women and 279 women without HIV infection. Precancer and cancer were defined on the basis of cytology or histology:

• cytology: a high-grade squamous intraepithelial lesion (HSIL) or more severe finding
• histology: cervical intraepithelial neoplasia (CIN) grade 2 or higher.

Participants in the study underwent semiannual visits, including Pap testing and cervical biopsy, if indicated.

Two cases of HSIL or more severe cytology were observed during the 5 years of follow-up—one among HIV-infected women who had a CD4 cell count of at least 500 cells/μL and one among HIV-negative women. Overall, the cumulative incidence of HSIL or more severe cytology was 0.3% among HIV-infected women and 0.4% among HIV-negative women.

Based on a total of 15 cases, investigators determined that the cumulative incidence of CIN 2+ histology over 5 years was:

• 2% among HIV-infected women who had a CD4 cell count below 350 cells/μL
• 2% among HIV-infected women who had a CD4 cell count of 350 to 499 cells/μL
• 6% among HIV-infected women who had a CD4 cell count of 500 cells/μL or higher
• 5% in women without HIV infection.

When researchers combined the data among HIV-infected women, they found an overall 5-year cumulative incidence of CIN 2+ of 5%.

Screening intervals may one day be extended for HIV-infected women

These findings are important because cervical cancer screening guidelines for women who are not infected with HIV were recently updated to increase the co-testing interval from 3 to 5 years among women who have normal cytology and who test negative for oncogenic HPV. “Whether a 3-year or 5-year screening interval could be used in HIV-infected women who are cytologically normal and oncogenic HPV-negative is unknown,” wrote Strickler and colleagues as background to their study.

“The results of this prospective study suggest that HIV-infected women undergoing long-term clinical follow-up who are cytologically normal and oncogenic HPV-negative have a risk of cervical precancer similar to that in HIV-uninfected women through 5 years of follow-up. Additional observational studies or a randomized clinical trial may be necessary before clinical guideline committees consider whether to expand current recommendations regarding HPV co-testing to HIV-infected women. More broadly, the current investigation highlights the potential for a new era of molecular testing, including HPV as well as other biomarkers, to improve cervical cancer screening in HIV-infected women,” the investigators concluded.

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

HIV-infected women who have normal cervical cytology and who test negative for oncogenic types of human papillomavirus (HPV) have a 5-year risk of cervical precancer and cancer that is equivalent to the risk among women without HIV infection, according to a cohort study published in July in JAMA.¹

Howard D. Strickler, MD, MPH, of Albert Einstein College of Medicine of Yeshiva University, New York, and colleagues conducted the study to explore the 3- and 5-year risk of cervical precancer and cancer in 420 HIV-infected women and 279 women without HIV infection. Precancer and cancer were defined on the basis of cytology or histology:

• cytology: a high-grade squamous intraepithelial lesion (HSIL) or more severe finding
• histology: cervical intraepithelial neoplasia (CIN) grade 2 or higher.

Participants in the study underwent semiannual visits, including Pap testing and cervical biopsy, if indicated.

Two cases of HSIL or more severe cytology were observed during the 5 years of follow-up—one among HIV-infected women who had a CD4 cell count of at least 500 cells/μL and one among HIV-negative women. Overall, the cumulative incidence of HSIL or more severe cytology was 0.3% among HIV-infected women and 0.4% among HIV-negative women.

Based on a total of 15 cases, investigators determined that the cumulative incidence of CIN 2+ histology over 5 years was:

• 2% among HIV-infected women who had a CD4 cell count below 350 cells/μL
• 2% among HIV-infected women who had a CD4 cell count of 350 to 499 cells/μL
• 6% among HIV-infected women who had a CD4 cell count of 500 cells/μL or higher
• 5% in women without HIV infection.

When researchers combined the data among HIV-infected women, they found an overall 5-year cumulative incidence of CIN 2+ of 5%.

Screening intervals may one day be extended for HIV-infected women

These findings are important because cervical cancer screening guidelines for women who are not infected with HIV were recently updated to increase the co-testing interval from 3 to 5 years among women who have normal cytology and who test negative for oncogenic HPV. “Whether a 3-year or 5-year screening interval could be used in HIV-infected women who are cytologically normal and oncogenic HPV-negative is unknown,” wrote Strickler and colleagues as background to their study.

“The results of this prospective study suggest that HIV-infected women undergoing long-term clinical follow-up who are cytologically normal and oncogenic HPV-negative have a risk of cervical precancer similar to that in HIV-uninfected women through 5 years of follow-up. Additional observational studies or a randomized clinical trial may be necessary before clinical guideline committees consider whether to expand current recommendations regarding HPV co-testing to HIV-infected women. More broadly, the current investigation highlights the potential for a new era of molecular testing, including HPV as well as other biomarkers, to improve cervical cancer screening in HIV-infected women,” the investigators concluded.

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

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

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

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

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

Most ObGyns saw their income decline or remain flat from 2011 to 2012, according to a survey from Medscape. Thirty-five percent of ObGyns reported lower earnings than in the preceding year, and another 39% reported no change. Overall, the specialty earned 3% less than in the preceding year. For physicians as a whole, income also declined.

The survey was conducted in February 2012 among 24,216 US physicians across 25 specialties. It found that ObGyns earned a mean of $220,000—a slight decline from the previous year. About 26% of ObGyns reported an increase in earnings, however. For physicians as a whole, 34% reported an increase in earnings over the past year.

Top earners among the 25 specialties represented in the survey were radiologists and orthopedic surgeons (both earning a mean of $315,000), followed by cardiologists ($314,000), anesthesiologists ($309,000), and urologists ($309,000). The lowest income was reported by internists ($165,000), family physicians ($158,000), and pediatricians ($156,000).

Compensation for employed physicians comprised salary, any bonus, and profit-sharing contributions. For physicians in private practice, compensation consisted of earnings after the deduction of business expenses but before the payment of income tax. Compensation did not include income for nonclinical activities, such as speaking engagements and expert witness testimony.

Other findings

Men made more than women. Among physicians as a whole, male practitioners earned approximately 40% more than female practitioners. In the ObGyn specialty, however, the gap was narrower: Men earned approximately 12% more than women ($234,000 vs $206,000).

Some regions of the United States were more lucrative. The most profitable region of the United States for ObGyns was the Great Lakes region (Illinois, Indiana, Ohio, Michigan, Minnesota, and Wisconsin), with physicians there reporting a mean income of $245,000. Least profitable were the northeast and mid-Atlantic regions, with a mean income of $205,000 and $207,000, respectively.

ObGyns in private practice earned more. When income was broken down by practice setting, the single-specialty group was most profitable (mean income of $242,000), followed by health care organizations ($239,000), the multi-specialty group ($233,000), solo practice ($229,000), the hospital setting ($194,000), academia ($173,000), and outpatient clinic ($154,000).

Some paradigms remained on the margins. Only 1% of ObGyns reported working in a concierge practice, 3% required cash only, 3% were part of an accountable care organization, and 5% planned to join or form an accountable care organization over the coming year.

Most ObGyns would choose another specialty. Although most ObGyns (55%) reported that they would choose medicine again as a career, only 37% said they would choose the same specialty and 23% said they would choose the same practice setting.

For the full report, click here.

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

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

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

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

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

The latest estimate from the Centers for Disease Control and Prevention (CDC) points to a pervasive problem: Only 38% of sexually active young women were screened for C. trachomatis in the previous year. The CDC recommends annual screening for all sexually active women 25 years and younger, as well as for older women who have a risk factor for Chlamydia (i.e., a new sex partner or multiple sex partners). In addition, all pregnant women should be screened.¹

The 38% figure comes from a nationally representative estimate of Chlamydia screening among teenage girls and women 15 to 25 years old in the United States. Researchers collected the data as part of the 2006–2008 cycle of the National Survey of Family Growth, a nationally representative household survey.²

Testing was most common among African American women, those who had multiple sex partners, and those who received public insurance or who were uninsured. These are some of the groups at highest risk of infection with Chlamydia, the most commonly reported infectious disease in the United States, with an estimated 2.8 million infections occurring each year.¹

Young people are at greatest risk of infection because the cervix is not yet fully matured. Many cases go undetected because most people have few or no symptoms. Left untreated, Chlamydia can cause severe long-term health consequences, including chronic pelvic pain, potentially fatal ectopic pregnancy, and infertility.

“This new research makes it clear that we are missing too many opportunities to protect young women from health consequences that can last a lifetime,” said Kevin Fenton, MD, director of the CDC’s National Center for HIV/AIDS, Viral Hepatitis, STD and TB Prevention.

“Annual Chlamydia screening can protect young women’s reproductive health now and safeguard it for the future.”

Retesting after treatment is also urged

Besides annual screening of young women, the CDC recommends that anyone given a diagnosis of chlamydial infection be retested 3 months after initial treatment to ensure that the infection has cleared. However, additional data from the CDC show that the rate of retesting remains low, with many reinfections likely being missed.

Researchers examined data on more than 60,000 men and women who tested positive for Chlamydia between 2007 and 2009 at facilities participating in the CDC’s Infertility Prevention Project in New York, New Jersey, and the US Virgin Islands. They found that just 14% of men and 22% of women were retested within 30 to 180 days. Of those who were retested, 25% of men and 16% of women again tested positive for Chlamydia

“It is critical that health-care providers are not only aware of the importance of testing sexually active young women every year for Chlamydia infections, but also of retesting anyone who is diagnosed,” said Gail Bolan, MD, director of the CDC’s Division of STD Prevention. “Chlamydia can be easily treated and cured with antibiotics, and retesting plays a vital role in preventing serious future health consequences.”

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

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

Population	USPSTF	ACS/ASCCP/ASCP
<21 years	Do not screen, regardless of the age of sexual initiation and other risk factors
21–29 years	Screen with cytology every 3 years
30–65 years	Screen with cytology every 3 years (preferred) or with a combination of cytology and HPV testing every 5 years	Screen with a combination of cytology and HPV testing every 5 years (preferred) or cytology alone every 3 years
>65 years	Do not screen women who have had adequate prior screening and who are not otherwise at high risk of cervical cancer	Do not screen women who have evidence of adequate prior screening and no history of CIN 2+ within the past 20 years. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
After hysterectomy	Do not screen women who have undergone removal of the cervix and who have no history of CIN 2+ or cervical cancer	Do not screen for vaginal cancer in women who have undergone removal of the cervix and who have no history of CIN 2+. Evidence of adequate negative prior screening is not required. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
HPV-vaccinated	Continue screening, according to age and clinical history
USPSTF = US Preventive Services Task Force; ACS/ASCCP/ASCP = American Cancer Society/American Society for Colposcopy and Cervical Pathology/American Society of Clinical Pathology

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

 

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

 

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

 

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

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

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

Population	USPSTF	ACS/ASCCP/ASCP
<21 years	Do not screen, regardless of the age of sexual initiation and other risk factors
21–29 years	Screen with cytology every 3 years
30–65 years	Screen with cytology every 3 years (preferred) or with a combination of cytology and HPV testing every 5 years	Screen with a combination of cytology and HPV testing every 5 years (preferred) or cytology alone every 3 years
>65 years	Do not screen women who have had adequate prior screening and who are not otherwise at high risk of cervical cancer	Do not screen women who have evidence of adequate prior screening and no history of CIN 2+ within the past 20 years. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
After hysterectomy	Do not screen women who have undergone removal of the cervix and who have no history of CIN 2+ or cervical cancer	Do not screen for vaginal cancer in women who have undergone removal of the cervix and who have no history of CIN 2+. Evidence of adequate negative prior screening is not required. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
HPV-vaccinated	Continue screening, according to age and clinical history
USPSTF = US Preventive Services Task Force; ACS/ASCCP/ASCP = American Cancer Society/American Society for Colposcopy and Cervical Pathology/American Society of Clinical Pathology

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

 

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

 

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

 

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

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

New guidelines from multiple professional societies are in agreement: The cervical cancer screening interval should be extended in most women.^1,2

“Today, there is little evidence to support the annual screening of women at any age by any screening test, method, or modality,” say joint recommendations from the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology (ACS/ASCCP/ASCP).

The guideline emphasizes that point, going on to state: “Women at any age should not be screened annually by any screening method; rather, recommended screening intervals for women are based on age and clinical history.”²

Overview of the guidelines

In March 2012, the ACS/ASCCP/ASCP and the US Preventive Services Task Force (USPSTF) updated existing recommendations on the fine points of cervical cancer screening. Both sets of guidelines note that financial cost was not considered in formulating the recommendations. They also point out that the guidelines apply only to women who have a cervix. In addition, both sets of guidelines exclude women who have been identified as having a high-grade precancerous lesion or cervical cancer, women who were exposed in utero to diethylstilbestrol, and women who are immunocompromised (e.g., HIV-positive).

The recommendations are categorized according to the age of the patient and her clinical history (or lack thereof):

• Adolescents: No screening. “Adolescent cervical cancer prevention programs should focus on universal HPV vaccination, which is safe, highly efficacious, and, when used in adolescents before they become sexually active, highly effective and cost-effective,” notes ACS/ASCCP/ASCP.²
• Women 21 to 29 years old: Begin screening at age 21 and continue every 3 years until the age of 29 years. Routine testing for oncogenic human papillomavirus (HPV) strains is not recommended in this population.
• Women 30 to 65 years old: Cytology screening every 3 years or co-testing (cytology plus HPV testing) every 5 years. The 5-year co-testing interval is recommended by ACS/ASCCP/ASCP, whereas the USPSTF simply states: “Screening women ages 21 to 65 years every 3 years with cytology provides a reasonable balance between benefits and harms.” The USPSTF also notes that “HPV testing combined with cytology (co-testing) every 5 years in women ages 30 to 65 years offers a comparable balance of benefits and harms, and is therefore a reasonable alternative for women in this age group who would prefer to extend the screening interval.”
• Women over 65 years: Discontinue screening, provided the woman has undergone adequate screening in preceding years with negative results (TABLE).

Recommended cervical cancer screening under updated guidelines

Population	USPSTF	ACS/ASCCP/ASCP
<21 years	Do not screen, regardless of the age of sexual initiation and other risk factors
21–29 years	Screen with cytology every 3 years
30–65 years	Screen with cytology every 3 years (preferred) or with a combination of cytology and HPV testing every 5 years	Screen with a combination of cytology and HPV testing every 5 years (preferred) or cytology alone every 3 years
>65 years	Do not screen women who have had adequate prior screening and who are not otherwise at high risk of cervical cancer	Do not screen women who have evidence of adequate prior screening and no history of CIN 2+ within the past 20 years. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
After hysterectomy	Do not screen women who have undergone removal of the cervix and who have no history of CIN 2+ or cervical cancer	Do not screen for vaginal cancer in women who have undergone removal of the cervix and who have no history of CIN 2+. Evidence of adequate negative prior screening is not required. Do not resume screening for any reason, even if a woman reports having a new sexual partner.
HPV-vaccinated	Continue screening, according to age and clinical history
USPSTF = US Preventive Services Task Force; ACS/ASCCP/ASCP = American Cancer Society/American Society for Colposcopy and Cervical Pathology/American Society of Clinical Pathology

What to do about discordant co-test results

When a woman has atypical cells of undetermined significance (ASC-US) on cytology in combination with a negative HPV test, she should be managed the same way as women with normal screening results, says Andrew M. Kaunitz, MD, professor and associate chairman of obstetrics and gynecology at the University of Florida–Jacksonville. Dr. Kaunitz serves on the OBG Management Board of Editors.

“I anticipate that the greatest confusion over the new guidelines will center on the management of women who are found to be negative by cytology but positive on an HPV test,” he says. The ACS/ASCCP/ASCP guidelines offer two options for this population:

• Option 1: Repeat co-testing in 1 year. Women who are still HPV positive at the time of repeat co-testing, or who have low-grade squamous intraepithelial lesions (LSIL) or more severe findings on cytology, should undergo colposcopy and be managed according to ASCCP guidelines.³ Women who test HPV-negative and who have normal cytology or atypical squamous cells of undetermined significance (ASC-US) at the time of repeat co-testing should be returned to regular screening.
• Option 2: Immediate testing for HPV 16 and 18. Women who test positive for either of these viral types should undergo colposcopy. Women who test negative for both of these viral types should be co-tested in 12 months and managed according to Option 1.

 

“Women who have any other abnormality should be managed according to existing guidance from the ASCCP,” Dr. Kaunitz advises.³ “After spontaneous regression or appropriate treatment, women who have a history of cervical intraepithelial neoplasia (CIN) grade 2 or higher should continue routine screening for at least 20 years, even if this extends screening past the age of 65 years.”

Guidelines emphasize the harms of frequent screening

Both sets of guidelines mention the potential “harms” of screening. For example, the ACS/ASCCP/ASCP guidelines point out that most HPV infections and many cases of CIN 1 and CIN 2 are transient, unlikely to progress or develop into cancer.

“The potential harms associated with detecting these transient lesions include the anxiety associated with a ‘positive’ cancer screening test, potential stigmatization from the diagnosis of a sexually transmitted infection, discomfort from additional diagnostic and treatment procedures, bleeding from treatment, and, longer term, an increased risk of pregnancy complications such as preterm delivery due to treatment,” according to the guidelines. “Having a positive test at any point in one’s life may contribute to a perception of an increased risk of cancer, and a subsequent desire for more testing, further increasing the likelihood of another positive test.”²

The USPSTF takes this concern for potential harms a step further and emphasizes the possibility of “overtreatment” when HPV testing is used as part of a cervical cancer screening strategy: “Positive screening results are more common with strategies that include HPV testing than with strategies that use cytology alone. Therefore, the likelihood of prolonged surveillance and overtreatment may increase with strategies that incorporate HPV testing.”¹

However, the ACS/ASCCP/ASCP noted that screening models indicate that co-testing of women 30 years and older at 5-year intervals results in fewer colposcopies (thereby reducing harms) and carries “a similar or slightly lower cancer risk, compared with cytology alone performed at 3-year intervals.” That is because 5-year intervals reduce the number of screens in a woman’s lifetime, thereby detecting fewer transient HPV infections and low-grade cellular changes not destined to become cancer.

Reducing the number of colposcopies

The guidelines aim to reduce the number of women referred to colposcopy for cytologic abnormalities or HPV-positive results. In formulating the ACS/ASCCP/ASCP guidelines, the panel calculated the number of colposcopies associated with different screening intervals, noting that “screening every 3 years is associated with a lifetime prediction of about 760 colposcopies per 1,000 women, screening every 2 years with about 1,080 colposcopies per 1,000 women (a 40% increase vs screening every 3 years), and screening every year with about 2,000 per 1,000 women.”² However, the yield of high-grade CIN and cervical cancer identified during screening does not vary significantly between these intervals.

“The lifetime risk of cervical cancer in the United States in the absence of screening is projected to be approximately 31 to 33 cases in every 1,000 women,” says Tom Cox, MD, past president of ASCCP. Dr. Cox is an OBG Management contributing editor. “Screening with cytology alone every 3 years reduces this risk to 5 to 8 incident cancers per 1,000 women, and the risk drops slightly with screening every 2 years to 4 to 6 cases per 1,000 women. Annual screening further reduces this risk to about 3 cases per 1,000 women. The predicted lifetime risk of death due to cervical cancer associated with screening with cytology every 3 years, every 2 years, and annually is even lower: 0.05, 0.05, and 0.03 death per 1,000 women, respectively.”

“So there is a small reduction in the lifetime risk of cervical cancer with more frequent cytology screening,” Dr. Cox notes, “but the harms of more frequent screening were determined by both the USPSTF and the ACS/ASCCP/ASCP to far outweigh the benefit. Co-testing at 5-year intervals provides similar, or even lower, cancer risk than cytology at 3-year intervals, justifying the choice of a longer screening interval when co-testing is negative.”

Rethinking the annual exam

Many women schedule an appointment with their gynecologist each year for the express purpose of undergoing a Pap test. Now that the shortest recommended screening interval for cervical cancer is 3 years, will the annual gynecologic exam go the way of the dinosaurs?

“Absolutely,” says Neal M. Lonky, MD, MPH, clinical professor of obstetrics and gynecology at the University of California– Irvine and a member of the board of directors of Southern California Permanente Medical Group. Dr. Lonky is an OBG Management contributing editor.

“If there is no preventive health activity tied to an annual visit, I think insurers will support fewer visits, requiring less reimbursement for services, especially in HMO and PPO models. I envision more ‘virtual’ care—that is, visits that do not involve an examination, for purposes such as the dispensing of birth control pills. But I am hopeful that more education about the benefit of regular visits for other preventive measures would be possible.”

 

Dr. Kaunitz also believes the updated guidelines could have an impact on women’s health-care–seeking behavior.

“Many ObGyns may be concerned that longer screening intervals may translate into fewer patient visits. As we implement these new guidelines in our practices, our challenge as women’s health clinicians will include educating our patients not only that cervical cancer screening can be performed less frequently without placing them at risk, but also that well-woman visits and pelvic examinations provide health benefits above and beyond early detection of cervical cancer,” he says.

 

Dr. Cox sees things similarly: “We do have to keep in mind that screening in the United States is opportunistic, meaning that a majority of women do not receive reminders that it is time to schedule their next cervical screen. As a result, wider screening intervals could potentially result in less frequent screening than advised by the guidelines.”

“For some women who already get screened infrequently, co-testing has the advantage of providing a longer period of safety than that provided by cytology alone following a negative test,” Dr. Cox continues. “My only concern is that increasing the recommended screening interval to 3 years for cytology and 5 years for co-testing will undoubtedly result in some women getting screened even less frequently. A negative HPV test result has been shown to provide at least 6 years of prediction of low risk—and possibly longer—providing at least some buffer beyond the 5-year recommended interval for women who test negative on both cytology and an HPV test.”

A nod to the successes of cervical Ca screening

Cervical cancer was once the leading cause of cancer death in women in the United States. It now ranks 14^th.⁴

“The profound impact that annual Pap smears have had in reducing the incidence of and mortality from cervical cancer represents a triumph of preventive medicine,” says Dr. Kaunitz. “Over time, we have learned that beginning screening at age 21 and performing cytology less often than annually will not compromise outcomes.”

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