Expert Commentary

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

The uterus ruptured in a patient who had placenta previa. She required immediate intervention, but her private ObGyn was 25 minutes away. A laborist stepped in and performed C-section within 10 minutes, while the private physician was still en route.

“And our neonatologist said, had we had to wait the extra 5 or 10 minutes it took for that doc to arrive and get started, there would have been a much worse outcome for that baby because it had lost 40% of its blood volume,” says Deb Ohnoutka, administrative director of women’s and children’s services.

Not all interventions involving a laborist are as dramatic, but the laborist, or OB hospitalist, model—in which a hospital employs board-certified ObGyns for 24/7 coverage of labor and delivery—is gradually taking hold.

Because the model is new, there are no concrete data on exactly how many hospitals employ laborists or whether safety has improved as a result. To get an idea of how this model is faring, OBG Management interviewed a number of program administrators and laborists, whose comments are woven into this article. They describe diminishing pressures on community ObGyns, improved job satisfaction among laborists, greater patient safety, and other benefits.

Whence the inspiration?

It all started in 2003, when Louis Weinstein, MD, now chairman of obstetrics and gynecology at Jefferson Medical College in Philadelphia, penned an opinion piece for the American Journal of Obstetrics and Gynecology on the need for a new way of practicing obstetrics.¹ Weinstein cited some of the pressures assailing the profession.

“The desire to control one’s personal life, coupled with an apparent decrease in aggregate productivity and the increasing cost of professional liability insurance,” he wrote, “have the potential to lead to a decrease in the available obstetric work force within the next decade.”¹

Weinstein now says that, in fact, roughly “30% of physicians will stop working in the next 7 years. People say there’s a shortage of physicians, but it’s really a shortage of working physicians. It’s because of physician dissatisfaction.”

The solution?

Weinstein points to the success of the hospitalist model, which originated in 1996. He proposed a similar paradigm for obstetrics.

“I just sat down and worked out this thing called the laborist movement. When you look at the hospitalist model, their safety is way up” and job satisfaction is improved, he says, noting that he expects the laborist model to have a similar impact.

It took a while for Weinstein’s proposal to percolate through the specialty.

“I wrote about it in 2003 and for 2 years nobody even talked to me about it,” he says. It wasn’t until 2005 that the discussion began.

People began to acknowledge that a significant change in practice was needed to improve quality of care, increase safety for the patient and her fetus, and reduce medical negligence actions for hospitals.

“The way we practice obstetrics is insane,” says Weinstein. “People can’t work like they’re working.”

Life in the “old days”

Krista Wills, MD, lead physician of OB hospitalists at Presbyterian Hospital in Albuquerque, clearly recalls the days before the program started. Everyone was stretched a little too thin back then.

“The patient would be in triage until the doc could come by and evaluate her and send her out,” says Wills.

Depending on the physician’s location and office schedule, that wait could be several hours.

“If the mom came in in active labor and had not had any prenatal care, the doc whose name was on the ED [emergency department] call roster would be called and would have to come in and do the delivery,” Wills says. One of the problems with this system was that unassigned patients “who haven’t had any prenatal care in general tend to be high-risk patients, and for the community physicians it was just becoming an increasing burden. People did absorb it before, but it was something that creates not exactly friction but physician dissatisfaction.”

Presbyterian Hospital began its OB hospitalist program in January 2006. In general, its laborists have four main responsibilities:

• “We labor and deliver all the babies that come from high-risk mothers” that are cared for by a private group of perinatologists based at the hospital, says Wills. “We accept all the maternal transports from all over the state. The majority of these moms have had care in a small town in New Mexico—one of our regional facilities or just a small town—and the mom is either very sick and requires tertiary care or the baby is going to be born prematurely and needs a level III NICU.”
  
• “We take care of the unassigned patients who drop into the ED or OB triage area.”
  
• “We first-assist for a majority of the C-sections performed in the hospital.”
  
• “We are also a backup for our community doctors.” (“We’re not trying to take away their billings or anything like that,” Wills adds. “We just want to decrease our unattended delivery rate. And we just want to be able to get patients through triage more quickly.”)
  

Safety and continuity of care are among the benefits

At Middle Tennessee Medical Center in Murfreesboro, where the laborist program has been in effect for almost 20 months, the principal benefit has been increased safety—although that isn’t the only advantage.

“We’ve had three instances already since November of 2006 where we feel that there would have been a significant negative outcome either with a mother or a baby if we had not had a physician in house ready to go when that particular obstetrical emergency presented,” says Andy Brown, MD, vice president of medical affairs. “So we do feel that [the laborist program] provides a very good standard of care for the hospital.”

Overall, ObGyns in the community have been pleased with the program.

“It has actually allowed them to increase the size of their practices because they’re in much better control of what happens during the routine office hours,” says Brown. “They have better control over their office schedules.”

And the patients of those physicians?

“The vast majority of patients would be relieved to realize that there is someone there for an emergent situation,” Brown says.

Concurring with that observation is C. Brent Boles, MD. “We are very happy with the program,” he says. “I’m speaking with two hats on because I’m the medical director of the laborist program [at Middle Tennessee Medical Center], but I’m also a private physician.”

Boles confirms that a drive for ever-increasing safety was one of the concerns that prompted creation of the program.

“I wouldn’t say that it was the principal driving force, but it was certainly one of the top two or three reasons. Probably the consistency or continuity of care that is now easy to provide for the service call patients and the immediate coverage of in-house emergencies are the two major benefits to the community.”

Another benefit of the laborist model: It makes a trial of labor after C-section [vaginal birth after C-section (VBAC)] possible in hospitals that have 24/7 coverage. At Shawnee Mission Medical Center, the laborist program has greatly increased the number of VBACs.

“We had actually stopped laboring VBACs,” says Ohnoutka. “We mostly sectioned them.” Since the laborist program began, “we’ve seen a huge increase. There are some docs who really and truly believe in laboring VBACs and have hated not to be able to do it. So [the laborist program] has driven some volume here because other hospitals in our community aren’t doing it.”

At Monmouth Medical Center in Long Branch, New Jersey, a laborist program has been in place for a little over 2 years.

“It’s going very well in the sense that the solo practitioners that we have in the area really do appreciate it,” says Raksha Joshi, MD, chief medical officer and medical director of Monmouth Family Health Center. “It prevents disruption to their office practice as well as to their lifestyle.”

That does not mean the program is accepted wholeheartedly by every physician and patient, however.

“I think there may be some resistance from both sides in the sense that, traditionally, ObGyn has been a model where a patient has had a full ride,” says Joshi, “of demanding and expecting that her own physician will be the one to deliver her. That may be a bit of a barrier to overcome.”

Life as a laborist

From the point of view of the laborists themselves, the advantages of the job are many.

“I would say a lot less stress, a lot more free time,” says Kathryn Mills, MD, one of the laborists at Middle Tennessee Medical Center. “I have free time during the week if I’m not on a shift, so it’s great.”

Laura McMurray, MD, a laborist at Shawnee Mission Medical Center, is also enthusiastic.

“I love doing OB and this is the best of both worlds,” she says, “where you can do what you like to do—take care of patients—but you don’t have the call issues and the daily pressures of private practice. It allows you to have more time with your family and to be able to participate in a lot more of their activities.”

Krista Wills, MD, the head of the laborist program at Presbyterian Hospital in Albuquerque, is also a laborist herself. She is very happy with the job.

“I started practice in 1990,” she says. “At the time, a female ObGyn quit OB after roughly 10 years and went to GYN only. Her patient volume was built, her patients had aged with her, and now she could switch over to GYN.”

“If OB is truly your love but you need a more scheduled lifestyle, then being an OB hospitalist gives you that opportunity,” says Wills. “I love the OB part of ObGyn. I still get very excited for deliveries—it doesn’t matter if it’s two or three in the morning, I still get psyched with it.”

“We have no office; we have no overhead; our liability insurance is paid by the hospital. And it allows me to continue doing OB in a manner that doesn’t give me 60-hour workweeks and being up all day, then up all night, then up all day, which is really exhausting,” she adds.

If there is a downside, it is narrowing of the spectrum, says McMurray.

“You may not be doing the entire scope of what you might be doing in private practice in terms of GYN. You don’t really develop a relationship with the patient—a long-term relationship with the patient. I think that’s true of any type of emergency room, any situation in which you are doing more of a shift as opposed to being on call as a private practice sort of thing. But I don’t view those as negatives. Somebody might, but that’s part of how it’s set up.”

According to Boles, word of the advantages of working as a laborist is spreading among ObGyns as a whole.

“I get phone calls from physicians who are interested in finding out if we have any openings because they would love to close their private practice and walk away from the hassle.”

Does the laborist model pay for itself?

The answer depends on how you calculate its benefits.

“We don’t expect it to make a profit,” says Ohnoutka, “but we do hopefully expect it to get close to breaking even.”

“I think when you look at all the drivers, there are different ways to make that happen,” she says. “If a private doc consults, we can bill consultant fees. If we do a delivery for them, we can bill a delivery fee. But I think when you look at improved physician satisfaction and improved nursing satisfaction, when you look at decreasing liability because you have somebody here at all times, it will pay for itself in many other ways than just the bottom line.”

At Presbyterian Hospital, the case is more clear-cut.

“Our biggest thing is that we are able to increase the number of maternal transports that we are able to take from all over the state,” says Wills.

Because the NICU “traditionally is a profit-maker for hospitals because the babies are all insured or qualified for Medicaid, there is a downstream benefit: It helps out the women’s program overall, it helps out the children’s program overall, if you look at the bottom line,” she says.

At Middle Tennessee Medical Center, hospital administrators aren’t as concerned about the strict bottom line.

“With the goodwill in the local ObGyn community and with the standard of care that we are now able to provide for the community, I think that’s where the payoff comes in,” says Brown.

Will the model spread?

Louis Weinstein, MD, thinks it will. He predicts that, in 10 years, most hospitals with more than 2,000 deliveries a year will have a laborist program.

“Hospitals are offering $100 an hour for call and nobody will take them up on it,” he says. That makes a new model inevitable.

Like Weinstein, Boles sees lifestyle issues as a dominant force.

“Our three full-time laborists are very happy with their work schedule. When they’re working, they’re at the hospital. When it’s not their shift, they go away, they turn their beeper off, they don’t have to answer their cell phone, and they can go do whatever they want to do. So it’s a model that will become increasingly attractive for many, many people as the pressures on private practices increase.”

If the laborist model has significant warts, they have yet to reveal themselves, at least among the programs described here. It may be that the burden of business as usual has become so great that the model’s primary impact is relief. As it matures, areas in need of fine-tuning or overhaul should become apparent.

YES. In postmenopausal women treated for early-stage hormone receptor-positive breast cancer who have completed therapy with tamoxifen, treatment with the aromatase inhibitors letrozole or exemestane increased disease-free survival.

EXPERT COMMENTARY

Survival clearly improves in postmenopausal women with early-stage receptor-positive breast cancer who take tamoxifen or an aromatase inhibitor for 5 years after treatment. The risk of recurrence remains heightened, however, for many years after adjuvant endocrine therapy ends. These three studies explore the effects of extended hormonal adjuvant therapy in women who have completed tamoxifen therapy.

Canadian trial focused on letrozole

In the first trial, known as MA.17 and sponsored by the National Cancer Institute of Canada, more than 5,000 women who had taken tamoxifen for 5 years were randomized to letrozole or placebo. At a median follow-up of 30 months, letrozole significantly increased disease-free survival.

This study analyzed the risks and benefits of letrozole by age group:

• younger than 60 years
• 60 to 69 years
• 70 years and older.

After 4 years of letrozole, disease-free survival increased to a similar degree in all groups, but achieved statistical significance in the youngest group.

Compared with placebo, the youngest women experienced a lower incidence of vaginal bleeding and a greater incidence of arthralgias. Women in the 60-to-69-year group experienced more insomnia, hot flushes, arthralgias, and alopecia. In contrast, women 70 years or older had a side effect profile that was similar to that of the placebo group.

Both treated women and those randomized to placebo had a similar rate of diagnosis of new osteoporosis or fracture. One reason for this finding may be enhanced bone density from the 5 years of tamoxifen that preceded letrozole.

Letrozole is effective even long after tamoxifen therapy has ended

The study by Goss and colleagues explored the use of letrozole among women originally assigned to the placebo group in the MA.17 trial. After that trial was unblinded, roughly 66% of placebo-assigned women opted for open-label use of letrozole. The median time since completion of 5 years of tamoxifen therapy among these women was 2.8 years.

Although women who chose not to take letrozole had a lower baseline risk of disease recurrence, women who did choose letrozole had greater disease-free survival at a median follow-up of 5.3 years (hazard ratio, 0.39; P=.004), demonstrating that letrozole is effective even when it is not initiated for several years after discontinuation of tamoxifen.

Exemestane also improved survival

The National Surgical Adjuvant Breast and Bowel Project (NSABP), funded by the US National Cancer Institute, randomized postmenopausal women to exemestane or placebo. All women had receptor-positive breast cancer and had taken tamoxifen for 5 years. When the MA.17 trial was unblinded, accrual to the NSABP was halted, and all women randomized to placebo were offered exemestane. At a median follow-up of 30 months, disease-free survival improved marginally (P=.07) in the 560 women originally assigned to exemestane, compared with the 344 women originally randomized to placebo.

An editorial accompanying these studies describes trials still under way to assess the benefits and risks of aromatase inhibitors beyond 5 years of therapy.¹ The findings of those trials will help determine whether extended use is beneficial.

YES. In postmenopausal women treated for early-stage hormone receptor-positive breast cancer who have completed therapy with tamoxifen, treatment with the aromatase inhibitors letrozole or exemestane increased disease-free survival.

EXPERT COMMENTARY

Survival clearly improves in postmenopausal women with early-stage receptor-positive breast cancer who take tamoxifen or an aromatase inhibitor for 5 years after treatment. The risk of recurrence remains heightened, however, for many years after adjuvant endocrine therapy ends. These three studies explore the effects of extended hormonal adjuvant therapy in women who have completed tamoxifen therapy.

Canadian trial focused on letrozole

In the first trial, known as MA.17 and sponsored by the National Cancer Institute of Canada, more than 5,000 women who had taken tamoxifen for 5 years were randomized to letrozole or placebo. At a median follow-up of 30 months, letrozole significantly increased disease-free survival.

This study analyzed the risks and benefits of letrozole by age group:

• younger than 60 years
• 60 to 69 years
• 70 years and older.

After 4 years of letrozole, disease-free survival increased to a similar degree in all groups, but achieved statistical significance in the youngest group.

Compared with placebo, the youngest women experienced a lower incidence of vaginal bleeding and a greater incidence of arthralgias. Women in the 60-to-69-year group experienced more insomnia, hot flushes, arthralgias, and alopecia. In contrast, women 70 years or older had a side effect profile that was similar to that of the placebo group.

Both treated women and those randomized to placebo had a similar rate of diagnosis of new osteoporosis or fracture. One reason for this finding may be enhanced bone density from the 5 years of tamoxifen that preceded letrozole.

Letrozole is effective even long after tamoxifen therapy has ended

The study by Goss and colleagues explored the use of letrozole among women originally assigned to the placebo group in the MA.17 trial. After that trial was unblinded, roughly 66% of placebo-assigned women opted for open-label use of letrozole. The median time since completion of 5 years of tamoxifen therapy among these women was 2.8 years.

Although women who chose not to take letrozole had a lower baseline risk of disease recurrence, women who did choose letrozole had greater disease-free survival at a median follow-up of 5.3 years (hazard ratio, 0.39; P=.004), demonstrating that letrozole is effective even when it is not initiated for several years after discontinuation of tamoxifen.

Exemestane also improved survival

The National Surgical Adjuvant Breast and Bowel Project (NSABP), funded by the US National Cancer Institute, randomized postmenopausal women to exemestane or placebo. All women had receptor-positive breast cancer and had taken tamoxifen for 5 years. When the MA.17 trial was unblinded, accrual to the NSABP was halted, and all women randomized to placebo were offered exemestane. At a median follow-up of 30 months, disease-free survival improved marginally (P=.07) in the 560 women originally assigned to exemestane, compared with the 344 women originally randomized to placebo.

An editorial accompanying these studies describes trials still under way to assess the benefits and risks of aromatase inhibitors beyond 5 years of therapy.¹ The findings of those trials will help determine whether extended use is beneficial.

YES. In postmenopausal women treated for early-stage hormone receptor-positive breast cancer who have completed therapy with tamoxifen, treatment with the aromatase inhibitors letrozole or exemestane increased disease-free survival.

EXPERT COMMENTARY

Survival clearly improves in postmenopausal women with early-stage receptor-positive breast cancer who take tamoxifen or an aromatase inhibitor for 5 years after treatment. The risk of recurrence remains heightened, however, for many years after adjuvant endocrine therapy ends. These three studies explore the effects of extended hormonal adjuvant therapy in women who have completed tamoxifen therapy.

Canadian trial focused on letrozole

In the first trial, known as MA.17 and sponsored by the National Cancer Institute of Canada, more than 5,000 women who had taken tamoxifen for 5 years were randomized to letrozole or placebo. At a median follow-up of 30 months, letrozole significantly increased disease-free survival.

This study analyzed the risks and benefits of letrozole by age group:

• younger than 60 years
• 60 to 69 years
• 70 years and older.

After 4 years of letrozole, disease-free survival increased to a similar degree in all groups, but achieved statistical significance in the youngest group.

Compared with placebo, the youngest women experienced a lower incidence of vaginal bleeding and a greater incidence of arthralgias. Women in the 60-to-69-year group experienced more insomnia, hot flushes, arthralgias, and alopecia. In contrast, women 70 years or older had a side effect profile that was similar to that of the placebo group.

Both treated women and those randomized to placebo had a similar rate of diagnosis of new osteoporosis or fracture. One reason for this finding may be enhanced bone density from the 5 years of tamoxifen that preceded letrozole.

Letrozole is effective even long after tamoxifen therapy has ended

The study by Goss and colleagues explored the use of letrozole among women originally assigned to the placebo group in the MA.17 trial. After that trial was unblinded, roughly 66% of placebo-assigned women opted for open-label use of letrozole. The median time since completion of 5 years of tamoxifen therapy among these women was 2.8 years.

Although women who chose not to take letrozole had a lower baseline risk of disease recurrence, women who did choose letrozole had greater disease-free survival at a median follow-up of 5.3 years (hazard ratio, 0.39; P=.004), demonstrating that letrozole is effective even when it is not initiated for several years after discontinuation of tamoxifen.

Exemestane also improved survival

The National Surgical Adjuvant Breast and Bowel Project (NSABP), funded by the US National Cancer Institute, randomized postmenopausal women to exemestane or placebo. All women had receptor-positive breast cancer and had taken tamoxifen for 5 years. When the MA.17 trial was unblinded, accrual to the NSABP was halted, and all women randomized to placebo were offered exemestane. At a median follow-up of 30 months, disease-free survival improved marginally (P=.07) in the 560 women originally assigned to exemestane, compared with the 344 women originally randomized to placebo.

An editorial accompanying these studies describes trials still under way to assess the benefits and risks of aromatase inhibitors beyond 5 years of therapy.¹ The findings of those trials will help determine whether extended use is beneficial.

EXPERT COMMENTARY

Rowan and colleagues add to the data on the potential benefits of oral hypoglycemic agents, compared with insulin, in managing gestational diabetes. The presumption was that dietary treatment alone would not result in adequate glycemic control.

In the study, women assigned to metformin were given a starting dosage of 500 mg once or twice daily, which was then increased to a maximum daily dosage of 2,500 mg. According to the authors, women assigned to insulin were prescribed the drug “according to usual practice,” although that practice was never defined. In addition, if adequate glycemic control was not achieved in the metformin group, insulin was added.

Overall, 363 of the women who received metformin completed the study, with 195 receiving metformin alone and 168 ultimately receiving metformin plus insulin. In the other arm, 370 of the women assigned to insulin completed the study. Maternal baseline characteristics were the same for both groups, except that a statistically greater number of patients in the metformin group had had three or more pregnancy terminations or miscarriages.

The primary outcome of this study was a composite of various neonatal outcomes. Of the variables analyzed, significant differences were found only for prematurity (delivery

A variety of secondary outcomes were also analyzed, with no meaningful differences. The authors conclude that metformin with or without supplemental insulin is “effective and safe” for women with gestational diabetes. In the next sentence, however, they observe that “follow-up data are needed to establish long-term safety.”

EXPERT COMMENTARY

Rowan and colleagues add to the data on the potential benefits of oral hypoglycemic agents, compared with insulin, in managing gestational diabetes. The presumption was that dietary treatment alone would not result in adequate glycemic control.

In the study, women assigned to metformin were given a starting dosage of 500 mg once or twice daily, which was then increased to a maximum daily dosage of 2,500 mg. According to the authors, women assigned to insulin were prescribed the drug “according to usual practice,” although that practice was never defined. In addition, if adequate glycemic control was not achieved in the metformin group, insulin was added.

Overall, 363 of the women who received metformin completed the study, with 195 receiving metformin alone and 168 ultimately receiving metformin plus insulin. In the other arm, 370 of the women assigned to insulin completed the study. Maternal baseline characteristics were the same for both groups, except that a statistically greater number of patients in the metformin group had had three or more pregnancy terminations or miscarriages.

The primary outcome of this study was a composite of various neonatal outcomes. Of the variables analyzed, significant differences were found only for prematurity (delivery

A variety of secondary outcomes were also analyzed, with no meaningful differences. The authors conclude that metformin with or without supplemental insulin is “effective and safe” for women with gestational diabetes. In the next sentence, however, they observe that “follow-up data are needed to establish long-term safety.”

EXPERT COMMENTARY

Rowan and colleagues add to the data on the potential benefits of oral hypoglycemic agents, compared with insulin, in managing gestational diabetes. The presumption was that dietary treatment alone would not result in adequate glycemic control.

In the study, women assigned to metformin were given a starting dosage of 500 mg once or twice daily, which was then increased to a maximum daily dosage of 2,500 mg. According to the authors, women assigned to insulin were prescribed the drug “according to usual practice,” although that practice was never defined. In addition, if adequate glycemic control was not achieved in the metformin group, insulin was added.

Overall, 363 of the women who received metformin completed the study, with 195 receiving metformin alone and 168 ultimately receiving metformin plus insulin. In the other arm, 370 of the women assigned to insulin completed the study. Maternal baseline characteristics were the same for both groups, except that a statistically greater number of patients in the metformin group had had three or more pregnancy terminations or miscarriages.

The primary outcome of this study was a composite of various neonatal outcomes. Of the variables analyzed, significant differences were found only for prematurity (delivery

A variety of secondary outcomes were also analyzed, with no meaningful differences. The authors conclude that metformin with or without supplemental insulin is “effective and safe” for women with gestational diabetes. In the next sentence, however, they observe that “follow-up data are needed to establish long-term safety.”

EXPERT COMMENTARY

Conventional perinatal wisdom, since the inception of obstetric ultrasonography (US), has been that disordered growth in utero occurs only in the second half of pregnancy; growth in the first half of pregnancy is believed to be uniform, with little variation among individuals. This assumption of uniform growth at the beginning of gestation allows us to create growth curves for populations and generate estimates of gestational age for individual fetuses from their growth parameters. Utilization of US for dating has pushed the mean gestational age at delivery back a few days, tightened the distribution around the mean, and lowered the prevalence of postdatism.

In this new study, Thorsell and colleagues question conventional wisdom and introduce a new notion that disordered intrauterine growth may be present in the first half of pregnancy as early as the first trimester. Women whose US evaluation at 16–18 weeks moved their due date forward more than 6 days were at increased risk of intrauterine growth restriction, preterm birth, and preeclampsia. Those whose due date was moved forward more than 6 days as a result of US dating at 12–14 weeks were at increased risk of growth restriction, but not preterm birth or preeclampsia. The authors call for increased surveillance for growth restriction in pregnancies in which US evaluation changes dates.

Weaknesses of the study

These findings are intriguing, but take them with a grain of salt. “Intendedness” of conception can, of course, be a marker of higher social status and resources, thereby linking “unintendedness” to poor dates (dates that need to be adjusted by US) and poor pregnancy outcomes. To prove their point, Thorsell and associates would have to repeat the study in women using ovulation-prediction methods or assisted reproduction (which would be confounded by subfertility and its link to poor perinatal outcomes). Such a study would not be feasible, given that a sample size of more than 27,000 women was required to demonstrate very mild effects in this investigation (risk ratios from 1.1 to 1.5).

EXPERT COMMENTARY

Conventional perinatal wisdom, since the inception of obstetric ultrasonography (US), has been that disordered growth in utero occurs only in the second half of pregnancy; growth in the first half of pregnancy is believed to be uniform, with little variation among individuals. This assumption of uniform growth at the beginning of gestation allows us to create growth curves for populations and generate estimates of gestational age for individual fetuses from their growth parameters. Utilization of US for dating has pushed the mean gestational age at delivery back a few days, tightened the distribution around the mean, and lowered the prevalence of postdatism.

In this new study, Thorsell and colleagues question conventional wisdom and introduce a new notion that disordered intrauterine growth may be present in the first half of pregnancy as early as the first trimester. Women whose US evaluation at 16–18 weeks moved their due date forward more than 6 days were at increased risk of intrauterine growth restriction, preterm birth, and preeclampsia. Those whose due date was moved forward more than 6 days as a result of US dating at 12–14 weeks were at increased risk of growth restriction, but not preterm birth or preeclampsia. The authors call for increased surveillance for growth restriction in pregnancies in which US evaluation changes dates.

Weaknesses of the study

These findings are intriguing, but take them with a grain of salt. “Intendedness” of conception can, of course, be a marker of higher social status and resources, thereby linking “unintendedness” to poor dates (dates that need to be adjusted by US) and poor pregnancy outcomes. To prove their point, Thorsell and associates would have to repeat the study in women using ovulation-prediction methods or assisted reproduction (which would be confounded by subfertility and its link to poor perinatal outcomes). Such a study would not be feasible, given that a sample size of more than 27,000 women was required to demonstrate very mild effects in this investigation (risk ratios from 1.1 to 1.5).

EXPERT COMMENTARY

Conventional perinatal wisdom, since the inception of obstetric ultrasonography (US), has been that disordered growth in utero occurs only in the second half of pregnancy; growth in the first half of pregnancy is believed to be uniform, with little variation among individuals. This assumption of uniform growth at the beginning of gestation allows us to create growth curves for populations and generate estimates of gestational age for individual fetuses from their growth parameters. Utilization of US for dating has pushed the mean gestational age at delivery back a few days, tightened the distribution around the mean, and lowered the prevalence of postdatism.

In this new study, Thorsell and colleagues question conventional wisdom and introduce a new notion that disordered intrauterine growth may be present in the first half of pregnancy as early as the first trimester. Women whose US evaluation at 16–18 weeks moved their due date forward more than 6 days were at increased risk of intrauterine growth restriction, preterm birth, and preeclampsia. Those whose due date was moved forward more than 6 days as a result of US dating at 12–14 weeks were at increased risk of growth restriction, but not preterm birth or preeclampsia. The authors call for increased surveillance for growth restriction in pregnancies in which US evaluation changes dates.

Weaknesses of the study

These findings are intriguing, but take them with a grain of salt. “Intendedness” of conception can, of course, be a marker of higher social status and resources, thereby linking “unintendedness” to poor dates (dates that need to be adjusted by US) and poor pregnancy outcomes. To prove their point, Thorsell and associates would have to repeat the study in women using ovulation-prediction methods or assisted reproduction (which would be confounded by subfertility and its link to poor perinatal outcomes). Such a study would not be feasible, given that a sample size of more than 27,000 women was required to demonstrate very mild effects in this investigation (risk ratios from 1.1 to 1.5).

In this randomized, placebo-controlled trial by Oppegaard and colleagues, when 1,000 μg of vaginal misoprostol was self-administered by premenopausal women at least 12 hours before operative hysteroscopy, significant cervical ripening occurred, with increased cervical dilatation and less difficulty with dilatation, compared with women given placebo.

The drug was ineffective in postmenopausal women.

EXPERT COMMENTARY

Operative hysteroscopy is a common, minimally invasive procedure used to treat a number of gynecologic pathologies.¹ The procedure requires that the cervical canal be dilated enough to allow passage of the hysteroscope.

Misoprostol is a prostaglandin E₁ analog. It also is an effective cervical-ripening and labor-induction agent used during pregnancy in the second and third trimesters.^2,3 Earlier studies suggested that misoprostol may be promising as a cervical-ripening agent before hysteroscopy in premenopausal women, although further research is needed to determine the ideal dosage, route, and timing of administration.^1,4-6 Most of the studies demonstrating benefit with misoprostol before hysteroscopy have involved intravaginal dosages of 200 to 400 μg given 8 to 12 hours before the procedure.^1,4-6

Misoprostol enabled greater dilatation in more women

Oppegaard and colleagues found greater mean cervical dilatation with misoprostol in premenopausal women than with placebo (6.4±2.4 mm, compared with 4.8±2.2 mm), more women achieving at least 5-mm cervical dilatation (88% versus 65%), and fewer women being difficult to dilate for hysteroscopy (20% versus 32%). As in previous studies, they also found misoprostol to be an ineffective cervical-ripening agent in postmenopausal women.

Strengths of this study

Because this study was randomized and placebo-controlled, bias in the evaluation of outcomes was minimized. The sample size was based on a sequential trial design, which ensures adequate power to answer the question of interest using as few women as possible.

The medication was self-administered and therefore more convenient than physician administration. In addition, women were questioned afterward to determine the acceptability of the self-administered medication, and 83% of premenopausal subjects found self-administration fairly or completely acceptable.

Shortcomings

Oppegaard and colleagues recommend that 1,000 μg of vaginal misoprostol be offered to nulliparous premenopausal women before operative hysteroscopy, but they do not present data specific to nulliparous women.

Moreover, the use of 1,000 μg of misoprostol is higher than in most previous studies, and Oppegaard and colleagues do not compare different dosages. The use of a higher dosage (1,000 μg) may be expected to cause more side effects. Indeed, researchers found a higher incidence of vaginal bleeding with misoprostol, compared with placebo (21% versus 3%), and 42% of women receiving misoprostol experienced mild or moderate abdominal pain, with 7% reporting severe abdominal pain.

In this randomized, placebo-controlled trial by Oppegaard and colleagues, when 1,000 μg of vaginal misoprostol was self-administered by premenopausal women at least 12 hours before operative hysteroscopy, significant cervical ripening occurred, with increased cervical dilatation and less difficulty with dilatation, compared with women given placebo.

The drug was ineffective in postmenopausal women.

EXPERT COMMENTARY

Operative hysteroscopy is a common, minimally invasive procedure used to treat a number of gynecologic pathologies.¹ The procedure requires that the cervical canal be dilated enough to allow passage of the hysteroscope.

Misoprostol is a prostaglandin E₁ analog. It also is an effective cervical-ripening and labor-induction agent used during pregnancy in the second and third trimesters.^2,3 Earlier studies suggested that misoprostol may be promising as a cervical-ripening agent before hysteroscopy in premenopausal women, although further research is needed to determine the ideal dosage, route, and timing of administration.^1,4-6 Most of the studies demonstrating benefit with misoprostol before hysteroscopy have involved intravaginal dosages of 200 to 400 μg given 8 to 12 hours before the procedure.^1,4-6

Misoprostol enabled greater dilatation in more women

Oppegaard and colleagues found greater mean cervical dilatation with misoprostol in premenopausal women than with placebo (6.4±2.4 mm, compared with 4.8±2.2 mm), more women achieving at least 5-mm cervical dilatation (88% versus 65%), and fewer women being difficult to dilate for hysteroscopy (20% versus 32%). As in previous studies, they also found misoprostol to be an ineffective cervical-ripening agent in postmenopausal women.

Strengths of this study

Because this study was randomized and placebo-controlled, bias in the evaluation of outcomes was minimized. The sample size was based on a sequential trial design, which ensures adequate power to answer the question of interest using as few women as possible.

The medication was self-administered and therefore more convenient than physician administration. In addition, women were questioned afterward to determine the acceptability of the self-administered medication, and 83% of premenopausal subjects found self-administration fairly or completely acceptable.

Shortcomings

Oppegaard and colleagues recommend that 1,000 μg of vaginal misoprostol be offered to nulliparous premenopausal women before operative hysteroscopy, but they do not present data specific to nulliparous women.

Moreover, the use of 1,000 μg of misoprostol is higher than in most previous studies, and Oppegaard and colleagues do not compare different dosages. The use of a higher dosage (1,000 μg) may be expected to cause more side effects. Indeed, researchers found a higher incidence of vaginal bleeding with misoprostol, compared with placebo (21% versus 3%), and 42% of women receiving misoprostol experienced mild or moderate abdominal pain, with 7% reporting severe abdominal pain.

In this randomized, placebo-controlled trial by Oppegaard and colleagues, when 1,000 μg of vaginal misoprostol was self-administered by premenopausal women at least 12 hours before operative hysteroscopy, significant cervical ripening occurred, with increased cervical dilatation and less difficulty with dilatation, compared with women given placebo.

The drug was ineffective in postmenopausal women.

EXPERT COMMENTARY

Operative hysteroscopy is a common, minimally invasive procedure used to treat a number of gynecologic pathologies.¹ The procedure requires that the cervical canal be dilated enough to allow passage of the hysteroscope.

Misoprostol is a prostaglandin E₁ analog. It also is an effective cervical-ripening and labor-induction agent used during pregnancy in the second and third trimesters.^2,3 Earlier studies suggested that misoprostol may be promising as a cervical-ripening agent before hysteroscopy in premenopausal women, although further research is needed to determine the ideal dosage, route, and timing of administration.^1,4-6 Most of the studies demonstrating benefit with misoprostol before hysteroscopy have involved intravaginal dosages of 200 to 400 μg given 8 to 12 hours before the procedure.^1,4-6

Misoprostol enabled greater dilatation in more women

Oppegaard and colleagues found greater mean cervical dilatation with misoprostol in premenopausal women than with placebo (6.4±2.4 mm, compared with 4.8±2.2 mm), more women achieving at least 5-mm cervical dilatation (88% versus 65%), and fewer women being difficult to dilate for hysteroscopy (20% versus 32%). As in previous studies, they also found misoprostol to be an ineffective cervical-ripening agent in postmenopausal women.

Strengths of this study

Because this study was randomized and placebo-controlled, bias in the evaluation of outcomes was minimized. The sample size was based on a sequential trial design, which ensures adequate power to answer the question of interest using as few women as possible.

The medication was self-administered and therefore more convenient than physician administration. In addition, women were questioned afterward to determine the acceptability of the self-administered medication, and 83% of premenopausal subjects found self-administration fairly or completely acceptable.

Shortcomings

Oppegaard and colleagues recommend that 1,000 μg of vaginal misoprostol be offered to nulliparous premenopausal women before operative hysteroscopy, but they do not present data specific to nulliparous women.

Moreover, the use of 1,000 μg of misoprostol is higher than in most previous studies, and Oppegaard and colleagues do not compare different dosages. The use of a higher dosage (1,000 μg) may be expected to cause more side effects. Indeed, researchers found a higher incidence of vaginal bleeding with misoprostol, compared with placebo (21% versus 3%), and 42% of women receiving misoprostol experienced mild or moderate abdominal pain, with 7% reporting severe abdominal pain.

In this randomized trial, 338 women 18 to 45 years old who had acute uncomplicated urinary tract infection (UTI) were randomized to open-label treatment with nitrofurantoin (Macrobid), 100 mg twice daily for 5 days, or trimethoprim-sulfamethoxazole, one double-strength tablet twice daily for 3 days. Clinical cure 30 days after therapy was achieved in 84% of the women taking nitrofurantoin and in 79% of women taking trimethoprim-sulfamethoxazole.

EXPERT COMMENTARY

This study is important because UTI is routinely treated empirically. The usual drugs prescribed for uncomplicated UTI are TMP-SMX, extended-release ciprofloxacin (Cipro), or a first- or second-generation cephalosporin. Empiric use of fluoroquinolones such as ciprofloxacin has replaced trimethoprim-sulfamethoxazole in the treatment of uncomplicated cystitis. Such replacements are inappropriate for empiric therapy, and indiscriminate use of fluoroquinolones has led to increased resistance among Staphylococcus aureus organisms.

Nor has there been proper concern about the way antibiotics alter the endogenous bacteria of the body. Overuse of antibiotics such as the β-lactams (cephalosporin and expanded-spectrum penicillins), fluoroquinolones, and macrolides has added not only to the emergence of resistant bacteria strains but also to an increase in adverse events.

Resistance to TMP-SMX ranged from 12% to 21%

In this study, the authors isolated and identified bacteria responsible for infection, and the outcome reflects the national bacterial etiology in this age group (18 to 45 years). The number one bacterium isolated in the study was Escherichia coli (82%) as the sole uropathogen (TABLE). These data confirm that E coli remains the bacterium most likely to cause acute uncomplicated UTI.

The problem is that E coli has developed resistance to the antibiotics most commonly prescribed to treat this condition. In this study, 12% of the E coli isolates were resistant to trimethoprim-sulfamethoxazole. Even more alarming, 21% of non-E coli strains were resistant to trimethoprim-sulfamethoxazole. In contrast, 99.6% of E coli isolates and 90% of non-E coli isolates were sensitive to nitrofurantoin.

TABLE

Bacteria isolated from the study population (n=338)

Adverse effects did not deter use

In the trimethoprim-sulfamethoxazole group, 31% of women experienced adverse effects, as did 28% in the nitrofurantoin group. Side effects included those commonly seen with oral antibiotic therapy: nausea, diarrhea, headache, lightheadedness, and vaginal itching.

Adherence was good; only 1% of women taking trimethoprim-sulfamethoxazole and 2% of women taking nitrofurantoin discontinued the drug.

An advantage for women taking nitrofurantoin is that it is concentrated in the urine, with little uptake in tissue and other bodily fluids. Therefore, it has very little effect on the endogenous vaginal microflora and little chance of causing vaginitis.

Weaknesses of the study

This study was not blinded; therefore, clinical evaluation may have been biased.

The population involved in the study was rather homogenous—mostly white college students. A mix of races would have been more informative.

Another limitation is that the investigators chose cefotaxime (Claforan) as one of the comparative antibiotics in the microbiologic arm, but gave no reason for this choice. Cefotaxime is administered either intravenously or intramuscularly and therefore has questionable relevance to this study. The other antibiotics chosen in addition to the two study drugs were ciprofloxacin and amoxicillin-clavulanate—both commonly used to treat acute uncomplicated cystitis.

In this randomized trial, 338 women 18 to 45 years old who had acute uncomplicated urinary tract infection (UTI) were randomized to open-label treatment with nitrofurantoin (Macrobid), 100 mg twice daily for 5 days, or trimethoprim-sulfamethoxazole, one double-strength tablet twice daily for 3 days. Clinical cure 30 days after therapy was achieved in 84% of the women taking nitrofurantoin and in 79% of women taking trimethoprim-sulfamethoxazole.

EXPERT COMMENTARY

This study is important because UTI is routinely treated empirically. The usual drugs prescribed for uncomplicated UTI are TMP-SMX, extended-release ciprofloxacin (Cipro), or a first- or second-generation cephalosporin. Empiric use of fluoroquinolones such as ciprofloxacin has replaced trimethoprim-sulfamethoxazole in the treatment of uncomplicated cystitis. Such replacements are inappropriate for empiric therapy, and indiscriminate use of fluoroquinolones has led to increased resistance among Staphylococcus aureus organisms.

Nor has there been proper concern about the way antibiotics alter the endogenous bacteria of the body. Overuse of antibiotics such as the β-lactams (cephalosporin and expanded-spectrum penicillins), fluoroquinolones, and macrolides has added not only to the emergence of resistant bacteria strains but also to an increase in adverse events.

Resistance to TMP-SMX ranged from 12% to 21%

In this study, the authors isolated and identified bacteria responsible for infection, and the outcome reflects the national bacterial etiology in this age group (18 to 45 years). The number one bacterium isolated in the study was Escherichia coli (82%) as the sole uropathogen (TABLE). These data confirm that E coli remains the bacterium most likely to cause acute uncomplicated UTI.

The problem is that E coli has developed resistance to the antibiotics most commonly prescribed to treat this condition. In this study, 12% of the E coli isolates were resistant to trimethoprim-sulfamethoxazole. Even more alarming, 21% of non-E coli strains were resistant to trimethoprim-sulfamethoxazole. In contrast, 99.6% of E coli isolates and 90% of non-E coli isolates were sensitive to nitrofurantoin.

TABLE

Bacteria isolated from the study population (n=338)

Adverse effects did not deter use

In the trimethoprim-sulfamethoxazole group, 31% of women experienced adverse effects, as did 28% in the nitrofurantoin group. Side effects included those commonly seen with oral antibiotic therapy: nausea, diarrhea, headache, lightheadedness, and vaginal itching.

Adherence was good; only 1% of women taking trimethoprim-sulfamethoxazole and 2% of women taking nitrofurantoin discontinued the drug.

An advantage for women taking nitrofurantoin is that it is concentrated in the urine, with little uptake in tissue and other bodily fluids. Therefore, it has very little effect on the endogenous vaginal microflora and little chance of causing vaginitis.

Weaknesses of the study

This study was not blinded; therefore, clinical evaluation may have been biased.

The population involved in the study was rather homogenous—mostly white college students. A mix of races would have been more informative.

Another limitation is that the investigators chose cefotaxime (Claforan) as one of the comparative antibiotics in the microbiologic arm, but gave no reason for this choice. Cefotaxime is administered either intravenously or intramuscularly and therefore has questionable relevance to this study. The other antibiotics chosen in addition to the two study drugs were ciprofloxacin and amoxicillin-clavulanate—both commonly used to treat acute uncomplicated cystitis.

In this randomized trial, 338 women 18 to 45 years old who had acute uncomplicated urinary tract infection (UTI) were randomized to open-label treatment with nitrofurantoin (Macrobid), 100 mg twice daily for 5 days, or trimethoprim-sulfamethoxazole, one double-strength tablet twice daily for 3 days. Clinical cure 30 days after therapy was achieved in 84% of the women taking nitrofurantoin and in 79% of women taking trimethoprim-sulfamethoxazole.

EXPERT COMMENTARY

This study is important because UTI is routinely treated empirically. The usual drugs prescribed for uncomplicated UTI are TMP-SMX, extended-release ciprofloxacin (Cipro), or a first- or second-generation cephalosporin. Empiric use of fluoroquinolones such as ciprofloxacin has replaced trimethoprim-sulfamethoxazole in the treatment of uncomplicated cystitis. Such replacements are inappropriate for empiric therapy, and indiscriminate use of fluoroquinolones has led to increased resistance among Staphylococcus aureus organisms.

Nor has there been proper concern about the way antibiotics alter the endogenous bacteria of the body. Overuse of antibiotics such as the β-lactams (cephalosporin and expanded-spectrum penicillins), fluoroquinolones, and macrolides has added not only to the emergence of resistant bacteria strains but also to an increase in adverse events.

Resistance to TMP-SMX ranged from 12% to 21%

In this study, the authors isolated and identified bacteria responsible for infection, and the outcome reflects the national bacterial etiology in this age group (18 to 45 years). The number one bacterium isolated in the study was Escherichia coli (82%) as the sole uropathogen (TABLE). These data confirm that E coli remains the bacterium most likely to cause acute uncomplicated UTI.

The problem is that E coli has developed resistance to the antibiotics most commonly prescribed to treat this condition. In this study, 12% of the E coli isolates were resistant to trimethoprim-sulfamethoxazole. Even more alarming, 21% of non-E coli strains were resistant to trimethoprim-sulfamethoxazole. In contrast, 99.6% of E coli isolates and 90% of non-E coli isolates were sensitive to nitrofurantoin.

TABLE

Bacteria isolated from the study population (n=338)

Adverse effects did not deter use

In the trimethoprim-sulfamethoxazole group, 31% of women experienced adverse effects, as did 28% in the nitrofurantoin group. Side effects included those commonly seen with oral antibiotic therapy: nausea, diarrhea, headache, lightheadedness, and vaginal itching.

Adherence was good; only 1% of women taking trimethoprim-sulfamethoxazole and 2% of women taking nitrofurantoin discontinued the drug.

An advantage for women taking nitrofurantoin is that it is concentrated in the urine, with little uptake in tissue and other bodily fluids. Therefore, it has very little effect on the endogenous vaginal microflora and little chance of causing vaginitis.

Weaknesses of the study

This study was not blinded; therefore, clinical evaluation may have been biased.

The population involved in the study was rather homogenous—mostly white college students. A mix of races would have been more informative.

Another limitation is that the investigators chose cefotaxime (Claforan) as one of the comparative antibiotics in the microbiologic arm, but gave no reason for this choice. Cefotaxime is administered either intravenously or intramuscularly and therefore has questionable relevance to this study. The other antibiotics chosen in addition to the two study drugs were ciprofloxacin and amoxicillin-clavulanate—both commonly used to treat acute uncomplicated cystitis.

EXPERT COMMENTARY

BV is one of the most prevalent vaginal disorders, affecting 30% of women of reproductive age.¹ The syndrome is characterized by a relative lack of lactobacillus and increased anaerobes, Gardnerella vaginalis, Mobiluncus species, and Mycoplasma hominis. A strong and consistent association exists between BV during pregnancy and spontaneous preterm birth and amniotic fluid infection.^2,3

Data were collected with rigor and detail

In this meta-analysis, designed to update 2001 recommendations from the US Preventive Services Task Force, Nygren and colleagues augmented the earlier data with published English-language studies from Ovid Medline (2000 through September 2007) and Cochrane Library databases (through September 2007), reference lists, and expert suggestions. The authors are to be applauded for the rigor and detail with which they collected source data. They used these data to estimate the pooled effect of treatment of BV on preterm delivery (at

Heterogeneity of studies was a problem

It usually is difficult to pool studies because of major differences in study design, inclusion and exclusion criteria, diagnostic criteria, assessment of risk status, and treatment. This is particularly true in regard to studies of women at high risk for preterm birth. The authors acknowledge this heterogeneity and considered it in statistical analysis of the data, but the detection of significant benefit or harm for BV screening and treatment remained difficult.

More study is needed

More research certainly is needed to elucidate the relationship between vaginal flora and preterm birth among high-risk women. We currently lack the ability to identify particular subgroups of women with abnormal vaginal flora who are most likely to derive benefit from screening and treatment.

EXPERT COMMENTARY

BV is one of the most prevalent vaginal disorders, affecting 30% of women of reproductive age.¹ The syndrome is characterized by a relative lack of lactobacillus and increased anaerobes, Gardnerella vaginalis, Mobiluncus species, and Mycoplasma hominis. A strong and consistent association exists between BV during pregnancy and spontaneous preterm birth and amniotic fluid infection.^2,3

Data were collected with rigor and detail

In this meta-analysis, designed to update 2001 recommendations from the US Preventive Services Task Force, Nygren and colleagues augmented the earlier data with published English-language studies from Ovid Medline (2000 through September 2007) and Cochrane Library databases (through September 2007), reference lists, and expert suggestions. The authors are to be applauded for the rigor and detail with which they collected source data. They used these data to estimate the pooled effect of treatment of BV on preterm delivery (at

Heterogeneity of studies was a problem

It usually is difficult to pool studies because of major differences in study design, inclusion and exclusion criteria, diagnostic criteria, assessment of risk status, and treatment. This is particularly true in regard to studies of women at high risk for preterm birth. The authors acknowledge this heterogeneity and considered it in statistical analysis of the data, but the detection of significant benefit or harm for BV screening and treatment remained difficult.

More study is needed

More research certainly is needed to elucidate the relationship between vaginal flora and preterm birth among high-risk women. We currently lack the ability to identify particular subgroups of women with abnormal vaginal flora who are most likely to derive benefit from screening and treatment.

EXPERT COMMENTARY

BV is one of the most prevalent vaginal disorders, affecting 30% of women of reproductive age.¹ The syndrome is characterized by a relative lack of lactobacillus and increased anaerobes, Gardnerella vaginalis, Mobiluncus species, and Mycoplasma hominis. A strong and consistent association exists between BV during pregnancy and spontaneous preterm birth and amniotic fluid infection.^2,3

Data were collected with rigor and detail

In this meta-analysis, designed to update 2001 recommendations from the US Preventive Services Task Force, Nygren and colleagues augmented the earlier data with published English-language studies from Ovid Medline (2000 through September 2007) and Cochrane Library databases (through September 2007), reference lists, and expert suggestions. The authors are to be applauded for the rigor and detail with which they collected source data. They used these data to estimate the pooled effect of treatment of BV on preterm delivery (at

Heterogeneity of studies was a problem

It usually is difficult to pool studies because of major differences in study design, inclusion and exclusion criteria, diagnostic criteria, assessment of risk status, and treatment. This is particularly true in regard to studies of women at high risk for preterm birth. The authors acknowledge this heterogeneity and considered it in statistical analysis of the data, but the detection of significant benefit or harm for BV screening and treatment remained difficult.

More study is needed

More research certainly is needed to elucidate the relationship between vaginal flora and preterm birth among high-risk women. We currently lack the ability to identify particular subgroups of women with abnormal vaginal flora who are most likely to derive benefit from screening and treatment.

EXPERT COMMENTARY

In Summer 2002, the WHI randomized trial of CEE plus MPA was stopped after the WHI Writing Group concluded that data showed more risks than benefits from therapy. The risks included venous thromboembolism and stroke, cardiovascular disease, coronary heart disease, and invasive breast cancer, while benefits were reduced risk of fracture and colorectal cancer. In this latest update, WHI investigators report on outcomes 3 years after discontinuation of the study medication.

Risk–benefit ratio improved

In contrast to findings at the time that hormone therapy was discontinued in the WHI, no increased risk of thrombosis, coronary heart disease, or stroke was observed during the subsequent 3 years in women who had taken CEE plus MPA. Furthermore, neither a statistically significant increase in the risk of invasive breast cancer nor a lower risk of fracture or colorectal malignancy was observed after discontinuation.

The global risk index for the entire 8 years of follow-up (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.03–1.21), which was elevated at the time the trial was stopped, was noted to be 1.11 (95% CI, 0.99–1.27) during the 3 years after discontinuation. All-cause death rate was higher after discontinuation than during overall follow-up, although this difference was not statistically significant (HR, 1.15; 95% CI, 0.95–1.39 and HR, 1.04; 95% CI, 0.91–1.18, respectively).

Three years after the trial was discontinued, risk of any diagnosis of cancer was modestly higher than during active trial in women who had taken hormones (HR, 1.24; 95% CI, 1.04–1.48). An increased incidence of cancer in these women appeared to reflect a higher risk of a diagnosis of cancer other than ones prespecified as outcomes (especially lung).

EXPERT COMMENTARY

In Summer 2002, the WHI randomized trial of CEE plus MPA was stopped after the WHI Writing Group concluded that data showed more risks than benefits from therapy. The risks included venous thromboembolism and stroke, cardiovascular disease, coronary heart disease, and invasive breast cancer, while benefits were reduced risk of fracture and colorectal cancer. In this latest update, WHI investigators report on outcomes 3 years after discontinuation of the study medication.

Risk–benefit ratio improved

In contrast to findings at the time that hormone therapy was discontinued in the WHI, no increased risk of thrombosis, coronary heart disease, or stroke was observed during the subsequent 3 years in women who had taken CEE plus MPA. Furthermore, neither a statistically significant increase in the risk of invasive breast cancer nor a lower risk of fracture or colorectal malignancy was observed after discontinuation.

The global risk index for the entire 8 years of follow-up (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.03–1.21), which was elevated at the time the trial was stopped, was noted to be 1.11 (95% CI, 0.99–1.27) during the 3 years after discontinuation. All-cause death rate was higher after discontinuation than during overall follow-up, although this difference was not statistically significant (HR, 1.15; 95% CI, 0.95–1.39 and HR, 1.04; 95% CI, 0.91–1.18, respectively).

Three years after the trial was discontinued, risk of any diagnosis of cancer was modestly higher than during active trial in women who had taken hormones (HR, 1.24; 95% CI, 1.04–1.48). An increased incidence of cancer in these women appeared to reflect a higher risk of a diagnosis of cancer other than ones prespecified as outcomes (especially lung).

EXPERT COMMENTARY

In Summer 2002, the WHI randomized trial of CEE plus MPA was stopped after the WHI Writing Group concluded that data showed more risks than benefits from therapy. The risks included venous thromboembolism and stroke, cardiovascular disease, coronary heart disease, and invasive breast cancer, while benefits were reduced risk of fracture and colorectal cancer. In this latest update, WHI investigators report on outcomes 3 years after discontinuation of the study medication.

Risk–benefit ratio improved

In contrast to findings at the time that hormone therapy was discontinued in the WHI, no increased risk of thrombosis, coronary heart disease, or stroke was observed during the subsequent 3 years in women who had taken CEE plus MPA. Furthermore, neither a statistically significant increase in the risk of invasive breast cancer nor a lower risk of fracture or colorectal malignancy was observed after discontinuation.

The global risk index for the entire 8 years of follow-up (hazard ratio [HR], 1.12; 95% confidence interval [CI], 1.03–1.21), which was elevated at the time the trial was stopped, was noted to be 1.11 (95% CI, 0.99–1.27) during the 3 years after discontinuation. All-cause death rate was higher after discontinuation than during overall follow-up, although this difference was not statistically significant (HR, 1.15; 95% CI, 0.95–1.39 and HR, 1.04; 95% CI, 0.91–1.18, respectively).

Three years after the trial was discontinued, risk of any diagnosis of cancer was modestly higher than during active trial in women who had taken hormones (HR, 1.24; 95% CI, 1.04–1.48). An increased incidence of cancer in these women appeared to reflect a higher risk of a diagnosis of cancer other than ones prespecified as outcomes (especially lung).

Yes. This prospective cohort study from Sweden found a higher risk of invasive cervical cancer and vaginal cancer in women who had been treated for cervical intraepithelial neoplasia (CIN) 3. The study included all women in Sweden who were treated for severe dysplasia or cervical carcinoma in situ—equivalent to CIN 3—from 1958 to 2002, a total of 2,315,724 woman-years of follow-up. The standardized incidence ratio for invasive cervical cancer in women treated for CIN 3, compared with the general population, was 2.34 (95% confidence interval, 2.18–2.50). The relative risk of vaginal cancer also was high, exceeding 6. Women faced an even higher risk if they were older than 50 at treatment.

The risk of cancer decreased over time, but was still elevated 25 years after treatment.

EXPERT COMMENTARY

Newly updated consensus guidelines for posttreatment management of women with CIN 2,3 recommend human papillomavirus (HPV) testing at 6 to 12 months.¹ Surveillance using cytology or a combination of cytology and colposcopy at 6-month intervals also is acceptable. Women who have a positive test should undergo colposcopy and endocervical sampling. Women who have a negative HPV test or two consecutive negative Pap tests after treatment should be screened annually for at least 20 years. These recommendations were based on data that showed a higher incidence of recurrent disease and invasive cancer in women previously treated for high-grade dysplasia. This excellent study by Strander and associates confirms those recommendations.

Women who were treated from 1991 to 2000 had a risk of cancer and neoplasia almost twice as high as that of women treated from 1958 to 1970. Excision procedures became the main treatment for dysplasia after 1980 (replacing hysterectomy). Increased prevalence of HPV infection also may have a greater effect on women who have been treated for CIN than on the general population, who may be more immune competent.

In this study, it was not possible to link cervical or vaginal cancers with the specific method of treatment of CIN 3

Yes. This prospective cohort study from Sweden found a higher risk of invasive cervical cancer and vaginal cancer in women who had been treated for cervical intraepithelial neoplasia (CIN) 3. The study included all women in Sweden who were treated for severe dysplasia or cervical carcinoma in situ—equivalent to CIN 3—from 1958 to 2002, a total of 2,315,724 woman-years of follow-up. The standardized incidence ratio for invasive cervical cancer in women treated for CIN 3, compared with the general population, was 2.34 (95% confidence interval, 2.18–2.50). The relative risk of vaginal cancer also was high, exceeding 6. Women faced an even higher risk if they were older than 50 at treatment.

The risk of cancer decreased over time, but was still elevated 25 years after treatment.

EXPERT COMMENTARY

Newly updated consensus guidelines for posttreatment management of women with CIN 2,3 recommend human papillomavirus (HPV) testing at 6 to 12 months.¹ Surveillance using cytology or a combination of cytology and colposcopy at 6-month intervals also is acceptable. Women who have a positive test should undergo colposcopy and endocervical sampling. Women who have a negative HPV test or two consecutive negative Pap tests after treatment should be screened annually for at least 20 years. These recommendations were based on data that showed a higher incidence of recurrent disease and invasive cancer in women previously treated for high-grade dysplasia. This excellent study by Strander and associates confirms those recommendations.

Women who were treated from 1991 to 2000 had a risk of cancer and neoplasia almost twice as high as that of women treated from 1958 to 1970. Excision procedures became the main treatment for dysplasia after 1980 (replacing hysterectomy). Increased prevalence of HPV infection also may have a greater effect on women who have been treated for CIN than on the general population, who may be more immune competent.

In this study, it was not possible to link cervical or vaginal cancers with the specific method of treatment of CIN 3

Yes. This prospective cohort study from Sweden found a higher risk of invasive cervical cancer and vaginal cancer in women who had been treated for cervical intraepithelial neoplasia (CIN) 3. The study included all women in Sweden who were treated for severe dysplasia or cervical carcinoma in situ—equivalent to CIN 3—from 1958 to 2002, a total of 2,315,724 woman-years of follow-up. The standardized incidence ratio for invasive cervical cancer in women treated for CIN 3, compared with the general population, was 2.34 (95% confidence interval, 2.18–2.50). The relative risk of vaginal cancer also was high, exceeding 6. Women faced an even higher risk if they were older than 50 at treatment.

The risk of cancer decreased over time, but was still elevated 25 years after treatment.

EXPERT COMMENTARY

Newly updated consensus guidelines for posttreatment management of women with CIN 2,3 recommend human papillomavirus (HPV) testing at 6 to 12 months.¹ Surveillance using cytology or a combination of cytology and colposcopy at 6-month intervals also is acceptable. Women who have a positive test should undergo colposcopy and endocervical sampling. Women who have a negative HPV test or two consecutive negative Pap tests after treatment should be screened annually for at least 20 years. These recommendations were based on data that showed a higher incidence of recurrent disease and invasive cancer in women previously treated for high-grade dysplasia. This excellent study by Strander and associates confirms those recommendations.

Women who were treated from 1991 to 2000 had a risk of cancer and neoplasia almost twice as high as that of women treated from 1958 to 1970. Excision procedures became the main treatment for dysplasia after 1980 (replacing hysterectomy). Increased prevalence of HPV infection also may have a greater effect on women who have been treated for CIN than on the general population, who may be more immune competent.

In this study, it was not possible to link cervical or vaginal cancers with the specific method of treatment of CIN 3