OBG Management

In this prospective cohort study of women undergoing induction of labor of a singleton fetus at term (≥37 weeks), Clark and colleagues examined each patient chart for adherence to 6 clinical practices:

Defined requirements for fetal heart rate included at least 1 acceleration of 15 bpm x 15 seconds in 30 minutes, or adequate variability for 10 of the previous 30 minutes. There should have been no more than 1 late deceleration in the previous 30 minutes. And there should have been no more than 2 variable decelerations exceeding 60 seconds and decreasing more than 60 bpm from baseline in the previous 30 minutes.

Defined requirements for uterine activity included no more than 5 contractions in 10 minutes for any 20-minute interval. There should have been no 2 contractions longer than 120 seconds in duration. In addition, the uterus should have been soft upon palpation between contractions. If an intrauterine pressure catheter was in place, measurement in Montevideo units should have been less than 300 mm Hg, with baseline resting tone of less than 25 mm Hg.

Outcome measures included admission to a neonatal intensive care unit (NICU), 1- and 5-minute Apgar scores of less than 7, and primary cesarean delivery.

Study findings underscore value of a checklist
The study found that completion of a safety checklist every 30 minutes during labor was associated with a significantly reduced rate of NICU admission and cesarean delivery. When the clinician stopped or reduced oxytocin for failure to meet specific uterine activity requirements, the rate of NICU admission also was reduced, but there were no differences in other outcomes. When the clinician stopped or reduced oxytocin for a failure to meet specific fetal heart-rate requirements, the rate of NICU admission was significantly reduced, as was the rate of low Apgar scores at birth, but there was a significantly higher rate of cesarean delivery (26.6% vs 17.5%).

Strengths include size of the study
This is a large study in a population with demographics that likely reflect those of the general US population. The study size permitted detection of relatively small differences in outcome.

The data clearly support the conclusions that “electronic fetal heart-rate monitoring improves neonatal outcomes when unambiguous definitions of abnormal fetal heart rate and tachysystole are coupled with specific interventions” and that “utilization of a checklist for oxytocin monitoring is associated with improved neonatal outcomes.” However, data were conflicting regarding the impact of a standard oxytocin checklist on the rate of cesarean delivery.

What this evidence means for practice
Implementation of a conservative intrapartum checklist has been shown to improve specific measures of newborn outcome. Further study is needed to define the impact on the rate of cesarean delivery.
—David A. Miller, MD

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In this prospective cohort study of women undergoing induction of labor of a singleton fetus at term (≥37 weeks), Clark and colleagues examined each patient chart for adherence to 6 clinical practices:

Defined requirements for fetal heart rate included at least 1 acceleration of 15 bpm x 15 seconds in 30 minutes, or adequate variability for 10 of the previous 30 minutes. There should have been no more than 1 late deceleration in the previous 30 minutes. And there should have been no more than 2 variable decelerations exceeding 60 seconds and decreasing more than 60 bpm from baseline in the previous 30 minutes.

Defined requirements for uterine activity included no more than 5 contractions in 10 minutes for any 20-minute interval. There should have been no 2 contractions longer than 120 seconds in duration. In addition, the uterus should have been soft upon palpation between contractions. If an intrauterine pressure catheter was in place, measurement in Montevideo units should have been less than 300 mm Hg, with baseline resting tone of less than 25 mm Hg.

Outcome measures included admission to a neonatal intensive care unit (NICU), 1- and 5-minute Apgar scores of less than 7, and primary cesarean delivery.

Study findings underscore value of a checklist
The study found that completion of a safety checklist every 30 minutes during labor was associated with a significantly reduced rate of NICU admission and cesarean delivery. When the clinician stopped or reduced oxytocin for failure to meet specific uterine activity requirements, the rate of NICU admission also was reduced, but there were no differences in other outcomes. When the clinician stopped or reduced oxytocin for a failure to meet specific fetal heart-rate requirements, the rate of NICU admission was significantly reduced, as was the rate of low Apgar scores at birth, but there was a significantly higher rate of cesarean delivery (26.6% vs 17.5%).

Strengths include size of the study
This is a large study in a population with demographics that likely reflect those of the general US population. The study size permitted detection of relatively small differences in outcome.

The data clearly support the conclusions that “electronic fetal heart-rate monitoring improves neonatal outcomes when unambiguous definitions of abnormal fetal heart rate and tachysystole are coupled with specific interventions” and that “utilization of a checklist for oxytocin monitoring is associated with improved neonatal outcomes.” However, data were conflicting regarding the impact of a standard oxytocin checklist on the rate of cesarean delivery.

What this evidence means for practice
Implementation of a conservative intrapartum checklist has been shown to improve specific measures of newborn outcome. Further study is needed to define the impact on the rate of cesarean delivery.
—David A. Miller, MD

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

In this prospective cohort study of women undergoing induction of labor of a singleton fetus at term (≥37 weeks), Clark and colleagues examined each patient chart for adherence to 6 clinical practices:

Defined requirements for fetal heart rate included at least 1 acceleration of 15 bpm x 15 seconds in 30 minutes, or adequate variability for 10 of the previous 30 minutes. There should have been no more than 1 late deceleration in the previous 30 minutes. And there should have been no more than 2 variable decelerations exceeding 60 seconds and decreasing more than 60 bpm from baseline in the previous 30 minutes.

Defined requirements for uterine activity included no more than 5 contractions in 10 minutes for any 20-minute interval. There should have been no 2 contractions longer than 120 seconds in duration. In addition, the uterus should have been soft upon palpation between contractions. If an intrauterine pressure catheter was in place, measurement in Montevideo units should have been less than 300 mm Hg, with baseline resting tone of less than 25 mm Hg.

Outcome measures included admission to a neonatal intensive care unit (NICU), 1- and 5-minute Apgar scores of less than 7, and primary cesarean delivery.

Study findings underscore value of a checklist
The study found that completion of a safety checklist every 30 minutes during labor was associated with a significantly reduced rate of NICU admission and cesarean delivery. When the clinician stopped or reduced oxytocin for failure to meet specific uterine activity requirements, the rate of NICU admission also was reduced, but there were no differences in other outcomes. When the clinician stopped or reduced oxytocin for a failure to meet specific fetal heart-rate requirements, the rate of NICU admission was significantly reduced, as was the rate of low Apgar scores at birth, but there was a significantly higher rate of cesarean delivery (26.6% vs 17.5%).

Strengths include size of the study
This is a large study in a population with demographics that likely reflect those of the general US population. The study size permitted detection of relatively small differences in outcome.

The data clearly support the conclusions that “electronic fetal heart-rate monitoring improves neonatal outcomes when unambiguous definitions of abnormal fetal heart rate and tachysystole are coupled with specific interventions” and that “utilization of a checklist for oxytocin monitoring is associated with improved neonatal outcomes.” However, data were conflicting regarding the impact of a standard oxytocin checklist on the rate of cesarean delivery.

What this evidence means for practice
Implementation of a conservative intrapartum checklist has been shown to improve specific measures of newborn outcome. Further study is needed to define the impact on the rate of cesarean delivery.
—David A. Miller, MD

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

On October 1, 2014, the Centers for Medicare and Medicaid Services (CMS) and the National Correct Coding Initiative (NCCI) implemented a number of new coding pair edits that significantly restricted the types of surgical procedures that could be billed at the same time as vaginal hysterectomy. Most importantly, the new edits did not allow for combined anterior and posterior (AP) vaginal repair (57260) and apical vaginal suspensions (57282, 57283) to be separately billed and reimbursed when performed by the same surgeon and done in the same surgical session as a vaginal or laparoscopic hysterectomy. I initially reported on these changes in the January 2015 issue of OBG Management (“Recent NCCI edits have significantly impacted billing and reimbursement for vaginal hysterectomy”).

AUGS, ACOG, and others responded, and were heard
As a result of an intensive effort, the American Urogynecologic Society (AUGS), in conjunction with the American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Surgeons (SGS), and other professional societies, NCCI has agreed to change or modify a significant number of these pair edits.

As described in my earlier article, NCCI periodically reviews multiple surgical procedures performed in the same setting by a single surgeon to determine whether there is a significant overlap in services and therefore, in their opinion, redundant payment. Most significantly, CMS agreed with the argument made by the AUGS task force that it was inappropriate to bundle combined colporrhaphy with the various vaginal hysterectomy codes. These pair edits will no longer exist, and it is possible to bill separately for an AP repair performed in the same session as a vaginal hysterectomy—and expect additional payment for this procedure (subject to the multiple procedure reduction modifier -51).

Don’t miss out on reimbursement for your prior surgeries
It is important to recognize that this decision will be retroactive to October 1, 2014, which means that surgeons can resubmit charges for procedures performed between October 1, 2014, and March 31, 2015.

An exception to this rule is when the surgeon performs, and bills for, a vaginal hysterectomy code that includes enterocele repair, such as 58263. In these circumstances, the combined colporrhaphy remains bundled with the vaginal hysterectomy, unless a special modifier is used.

When can a modifier be used?
With regard to the majority of the other pair edits, CMS still contends that the edits are appropriate; however, they have modified the edits to allow for these procedures to be billed separately when the surgeon feels that substantial additional work has been performed. For example, CMS holds the position that all vaginal hysterectomies include some type of apical fixation to the surrounding tissues—such as fixation of the vaginal cuff at the time of closure to the distal uterosacral ligaments. However, it will allow for the additional billing for a more extensive vaginal apical suspension (such as a high uterosacral suspension or sacrospinous ligament suspension) as long as the surgeon documents the additional work performed and submits the claim using one of the NCCI-approved surgical modifiers. In this particular circumstance, the -59 modifier is the appropriate choice.

The AUGS task force also had objected to the bundling of a group of codes that, in the society’s opinion, were distinctly unrelated, such as a laparoscopic hysterectomy or vaginal hysterectomy combined with a sacral colpopexy performed through an open abdominal incision. CMS recognizes that these codes are used infrequently together and has therefore assumed that they may be billed in error. AUGS, however, has pointed out that, on occasion, a laparoscopic hysterectomy with an intended laparoscopic colpopexy may be converted to an open procedure due to a complication or technical difficulty, in which case the use of both codes would be appropriate.

The NCCI response was to keep the code pairs bundled but allow for billing with the -59 modifier.

We have cause for cheer, but bundling edits continue
Overall, these changes in pair edits represent a significant improvement in reimbursement for gynecologic surgeons, relative to the changes that went into effect on October 1. A more detailed explanation and list of the codes affected can be found on the AUGS Web site (http://www.augs.org). I emphasize again that these changes not only are in effect as of April 1, 2015, but also are retroactive to October 1, 2014.

Unfortunately, while AUGS and ACOG were advocating for these changes on behalf of gynecologists, NCCI recently has approved 6 additional pair edits that will go into effect on July 1. These changes specifically involve related procedures done at the time of vaginal hysterectomy with enterocele repair (58263, 58270 and 58294, 58292) and posterior vaginal repair (57250).

While these codes will be considered bundled on that date, NCCI will allow the use of the -59 modifier to override the bundle in clinically appropriate cases. The other code pairs affected are the 2 vaginal hysterectomy codes with colpourethropexy (58267, 58293) with anterior repair (57240). Again, these code pairs will be bundled, and it will require the use of a modifier to override this bundle.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

On October 1, 2014, the Centers for Medicare and Medicaid Services (CMS) and the National Correct Coding Initiative (NCCI) implemented a number of new coding pair edits that significantly restricted the types of surgical procedures that could be billed at the same time as vaginal hysterectomy. Most importantly, the new edits did not allow for combined anterior and posterior (AP) vaginal repair (57260) and apical vaginal suspensions (57282, 57283) to be separately billed and reimbursed when performed by the same surgeon and done in the same surgical session as a vaginal or laparoscopic hysterectomy. I initially reported on these changes in the January 2015 issue of OBG Management (“Recent NCCI edits have significantly impacted billing and reimbursement for vaginal hysterectomy”).

AUGS, ACOG, and others responded, and were heard
As a result of an intensive effort, the American Urogynecologic Society (AUGS), in conjunction with the American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Surgeons (SGS), and other professional societies, NCCI has agreed to change or modify a significant number of these pair edits.

As described in my earlier article, NCCI periodically reviews multiple surgical procedures performed in the same setting by a single surgeon to determine whether there is a significant overlap in services and therefore, in their opinion, redundant payment. Most significantly, CMS agreed with the argument made by the AUGS task force that it was inappropriate to bundle combined colporrhaphy with the various vaginal hysterectomy codes. These pair edits will no longer exist, and it is possible to bill separately for an AP repair performed in the same session as a vaginal hysterectomy—and expect additional payment for this procedure (subject to the multiple procedure reduction modifier -51).

Don’t miss out on reimbursement for your prior surgeries
It is important to recognize that this decision will be retroactive to October 1, 2014, which means that surgeons can resubmit charges for procedures performed between October 1, 2014, and March 31, 2015.

An exception to this rule is when the surgeon performs, and bills for, a vaginal hysterectomy code that includes enterocele repair, such as 58263. In these circumstances, the combined colporrhaphy remains bundled with the vaginal hysterectomy, unless a special modifier is used.

When can a modifier be used?
With regard to the majority of the other pair edits, CMS still contends that the edits are appropriate; however, they have modified the edits to allow for these procedures to be billed separately when the surgeon feels that substantial additional work has been performed. For example, CMS holds the position that all vaginal hysterectomies include some type of apical fixation to the surrounding tissues—such as fixation of the vaginal cuff at the time of closure to the distal uterosacral ligaments. However, it will allow for the additional billing for a more extensive vaginal apical suspension (such as a high uterosacral suspension or sacrospinous ligament suspension) as long as the surgeon documents the additional work performed and submits the claim using one of the NCCI-approved surgical modifiers. In this particular circumstance, the -59 modifier is the appropriate choice.

The AUGS task force also had objected to the bundling of a group of codes that, in the society’s opinion, were distinctly unrelated, such as a laparoscopic hysterectomy or vaginal hysterectomy combined with a sacral colpopexy performed through an open abdominal incision. CMS recognizes that these codes are used infrequently together and has therefore assumed that they may be billed in error. AUGS, however, has pointed out that, on occasion, a laparoscopic hysterectomy with an intended laparoscopic colpopexy may be converted to an open procedure due to a complication or technical difficulty, in which case the use of both codes would be appropriate.

The NCCI response was to keep the code pairs bundled but allow for billing with the -59 modifier.

We have cause for cheer, but bundling edits continue
Overall, these changes in pair edits represent a significant improvement in reimbursement for gynecologic surgeons, relative to the changes that went into effect on October 1. A more detailed explanation and list of the codes affected can be found on the AUGS Web site (http://www.augs.org). I emphasize again that these changes not only are in effect as of April 1, 2015, but also are retroactive to October 1, 2014.

Unfortunately, while AUGS and ACOG were advocating for these changes on behalf of gynecologists, NCCI recently has approved 6 additional pair edits that will go into effect on July 1. These changes specifically involve related procedures done at the time of vaginal hysterectomy with enterocele repair (58263, 58270 and 58294, 58292) and posterior vaginal repair (57250).

While these codes will be considered bundled on that date, NCCI will allow the use of the -59 modifier to override the bundle in clinically appropriate cases. The other code pairs affected are the 2 vaginal hysterectomy codes with colpourethropexy (58267, 58293) with anterior repair (57240). Again, these code pairs will be bundled, and it will require the use of a modifier to override this bundle.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

On October 1, 2014, the Centers for Medicare and Medicaid Services (CMS) and the National Correct Coding Initiative (NCCI) implemented a number of new coding pair edits that significantly restricted the types of surgical procedures that could be billed at the same time as vaginal hysterectomy. Most importantly, the new edits did not allow for combined anterior and posterior (AP) vaginal repair (57260) and apical vaginal suspensions (57282, 57283) to be separately billed and reimbursed when performed by the same surgeon and done in the same surgical session as a vaginal or laparoscopic hysterectomy. I initially reported on these changes in the January 2015 issue of OBG Management (“Recent NCCI edits have significantly impacted billing and reimbursement for vaginal hysterectomy”).

AUGS, ACOG, and others responded, and were heard
As a result of an intensive effort, the American Urogynecologic Society (AUGS), in conjunction with the American College of Obstetricians and Gynecologists (ACOG), the Society of Gynecologic Surgeons (SGS), and other professional societies, NCCI has agreed to change or modify a significant number of these pair edits.

As described in my earlier article, NCCI periodically reviews multiple surgical procedures performed in the same setting by a single surgeon to determine whether there is a significant overlap in services and therefore, in their opinion, redundant payment. Most significantly, CMS agreed with the argument made by the AUGS task force that it was inappropriate to bundle combined colporrhaphy with the various vaginal hysterectomy codes. These pair edits will no longer exist, and it is possible to bill separately for an AP repair performed in the same session as a vaginal hysterectomy—and expect additional payment for this procedure (subject to the multiple procedure reduction modifier -51).

Don’t miss out on reimbursement for your prior surgeries
It is important to recognize that this decision will be retroactive to October 1, 2014, which means that surgeons can resubmit charges for procedures performed between October 1, 2014, and March 31, 2015.

An exception to this rule is when the surgeon performs, and bills for, a vaginal hysterectomy code that includes enterocele repair, such as 58263. In these circumstances, the combined colporrhaphy remains bundled with the vaginal hysterectomy, unless a special modifier is used.

When can a modifier be used?
With regard to the majority of the other pair edits, CMS still contends that the edits are appropriate; however, they have modified the edits to allow for these procedures to be billed separately when the surgeon feels that substantial additional work has been performed. For example, CMS holds the position that all vaginal hysterectomies include some type of apical fixation to the surrounding tissues—such as fixation of the vaginal cuff at the time of closure to the distal uterosacral ligaments. However, it will allow for the additional billing for a more extensive vaginal apical suspension (such as a high uterosacral suspension or sacrospinous ligament suspension) as long as the surgeon documents the additional work performed and submits the claim using one of the NCCI-approved surgical modifiers. In this particular circumstance, the -59 modifier is the appropriate choice.

The AUGS task force also had objected to the bundling of a group of codes that, in the society’s opinion, were distinctly unrelated, such as a laparoscopic hysterectomy or vaginal hysterectomy combined with a sacral colpopexy performed through an open abdominal incision. CMS recognizes that these codes are used infrequently together and has therefore assumed that they may be billed in error. AUGS, however, has pointed out that, on occasion, a laparoscopic hysterectomy with an intended laparoscopic colpopexy may be converted to an open procedure due to a complication or technical difficulty, in which case the use of both codes would be appropriate.

The NCCI response was to keep the code pairs bundled but allow for billing with the -59 modifier.

We have cause for cheer, but bundling edits continue
Overall, these changes in pair edits represent a significant improvement in reimbursement for gynecologic surgeons, relative to the changes that went into effect on October 1. A more detailed explanation and list of the codes affected can be found on the AUGS Web site (http://www.augs.org). I emphasize again that these changes not only are in effect as of April 1, 2015, but also are retroactive to October 1, 2014.

Unfortunately, while AUGS and ACOG were advocating for these changes on behalf of gynecologists, NCCI recently has approved 6 additional pair edits that will go into effect on July 1. These changes specifically involve related procedures done at the time of vaginal hysterectomy with enterocele repair (58263, 58270 and 58294, 58292) and posterior vaginal repair (57250).

While these codes will be considered bundled on that date, NCCI will allow the use of the -59 modifier to override the bundle in clinically appropriate cases. The other code pairs affected are the 2 vaginal hysterectomy codes with colpourethropexy (58267, 58293) with anterior repair (57240). Again, these code pairs will be bundled, and it will require the use of a modifier to override this bundle.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“WHAT IS THE RISK THAT A PATIENT WILL HAVE AN OCCULT UTERINE CANCER AT MYOMECTOMY?”
ROBERT L. BARBIERI, MD (EXAMINING THE EVIDENCE; APRIL 2015)

More questions than answers?
The data presented by Wright and colleagues on the prevalence of underlying cancer in women who undergo myomectomy is disturbing and thought-provoking.

Are those in the 50-and-older age group who undergo myomectomy different from their same-aged peers with fibroids who do not undergo myomectomy? If so, why? If not, then with a 1 in 154 to 1 in 31 risk of occult malignancy, should not all women 50 years and older with fibroids undergo hysterectomy for this occult risk? This certainly has not been the standard of care for women 50 and older with asymptomatic fibroids. Thoughts?

In conclusion, it appears that power morcellation, or should I say the morcellation issue, has brought forth more questions than answers.
Richard L. Myers, MD
Jacksonville, Florida

Dr. Barbieri responds
I agree with Dr. Myers: Women aged 50 and older who have fibroids and undergo myomectomy must be clinically different than women of the same age who have fibroids but do not undergo myomectomy. It is likely that the women who undergo myomectomy have larger pelvic tumors or are more symptomatic than those who do not undergo myomectomy. I think this demonstrates that gynecologists are successfully identifying those women with a pelvic mass thought to be due to fibroids with the greatest risk of occult cancer and recommending that those women undergo surgery, while simultaneously recommending expectant management for those at lowest risk of an occult cancer.

“UPDATE ON MINIMALLY INVASIVE gynecologic SURGERY”
AMY L. GARCIA, MD (APRIL 2015)

Additional tips for in-office hysteroscopy
Thank you for the excellent coverage of hysteroscopy in the April issue. For me, patient trust is extremely important. Before I begin in-office hysteroscopy, I explain how the procedure is performed and answer all questions. I reassure the patient that, if it is too painful, I will stop and we will move to the operating room. I find music to be distracting to me as I am talking and constantly reassuring her.

In addition, I don’t perform the procedure when the patient is menstruating as it decreases visibility and I don’t want the intrauterine lidocaine to enter open vessels. It is helpful to perform this procedure shortly after menses and prior to ovulation to avoid instrumenting a pregnant uterus. Even if the menses is normal in timing and flow, a pregnancy test is still performed prior to the procedure. Doing it in this time period also can offer better visibility, as the endometrium is thinner.

I prescribe oral misoprostol the night before (400 mg, or 200 mg if she has undergone a cesarean delivery). The patient also is instructed to take ibuprofen 800 mg 1 hour prior to the procedure.

I continuously tell the patient what to expect. First, I perform a bimanual exam to determine the uterine position. Then local anesthesia placed on the anterior lip of the cervix prevents pain when placing the tenaculum. A paracervical block is performed and lidocaine jelly is placed in the cervix. Using an angiocatheter, I inject 4 mL of 2% lidocaine into the uterus and then wait 3 minutes.

It is important to only use the amount of fluid necessary to avoid overdistending the uterus. I take care to avoid touching the fundus, as this increases pain. I use a 4-mm 30˚ scope. I agree that the pain is dependent on physician expertise and procedure length.

If the cavity is clean, I perform a thorough endometrial biopsy that causes minimal pain because of the intrauterine lidocaine. I recently started doing in-office diagnostic hysteroscopy again. When I did it years ago without intrauterine lidocaine, it was unacceptably painful. I have performed 25 cases, all of which were successful, including on postmenopausal patients. All of the patients reported being highly satisfied and glad to have had the procedure performed in the office.
Ray Wertheim, MD
Fairfax, Virginia

Would you approve this candidate for uterus transplantation?

“UTERUS TRANSPLANTATION: MEDICAL BREAKTHROUGH OR SURGICAL FOLLY?”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2015)

Instant Poll
Dr. Barbieri presented 3 cases to readers in his recent editorial on uterus transplantation and asked, “Would you approve or disapprove of transplantation of the uterus in these cases?”

1. 23-year-old Army sergeant (G0) injured by improvised explosive device. To save her life, military surgeons removed her uterus, which had been lacerated in the explosion. She requested uterus transplantation to pursue a pregnancy. The Department of Defense has approved her request.
2. 30-year-old woman (G0) with congenital absence of the uterus who is a devout member of a religious community in which the tenets of faith prohibit gestational carriers. Rather than pursue adoption, she is seeking a uterus transplantation to pursue a pregnancy.
3. 35-year-old woman (G1P1) who had her uterus removed to treat cervical cancer. She has been disease-free for 3 years. She would like a uterus transplant to pursue a pregnancy.

READERS WEIGH IN:
Concentrate on saving lives
We should be concentrating our resources on saving lives rather than on satisfying the wishes of some very genuine people.

Where will it end? Let us not compare uterine transplant with kidney, heart, and lung transplants.
Ram A. Singh, MD
Oklahoma City, Oklahoma

No to 35-year-old patient
Assuming, as stated, that the women are healthy and psychosocially approved, to which I would add, they are fully informed on the preparation, medications, procedure, postoperative recovery, and potential complications,I would approve the first 2 cases and disapprove of the last. My reasoning for denying a uterus transplant to the 35-year-old woman is that, after she goes through the process of screening and evaluation, she will be an “elderly gravida,” which in itself has risks. I would also be concerned that all the family members fully understand the potential risks of her undertaking.
Helen T. Jackson, MD
Brookline, Massachusetts

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“WHAT IS THE RISK THAT A PATIENT WILL HAVE AN OCCULT UTERINE CANCER AT MYOMECTOMY?”
ROBERT L. BARBIERI, MD (EXAMINING THE EVIDENCE; APRIL 2015)

More questions than answers?
The data presented by Wright and colleagues on the prevalence of underlying cancer in women who undergo myomectomy is disturbing and thought-provoking.

Are those in the 50-and-older age group who undergo myomectomy different from their same-aged peers with fibroids who do not undergo myomectomy? If so, why? If not, then with a 1 in 154 to 1 in 31 risk of occult malignancy, should not all women 50 years and older with fibroids undergo hysterectomy for this occult risk? This certainly has not been the standard of care for women 50 and older with asymptomatic fibroids. Thoughts?

In conclusion, it appears that power morcellation, or should I say the morcellation issue, has brought forth more questions than answers.
Richard L. Myers, MD
Jacksonville, Florida

Dr. Barbieri responds
I agree with Dr. Myers: Women aged 50 and older who have fibroids and undergo myomectomy must be clinically different than women of the same age who have fibroids but do not undergo myomectomy. It is likely that the women who undergo myomectomy have larger pelvic tumors or are more symptomatic than those who do not undergo myomectomy. I think this demonstrates that gynecologists are successfully identifying those women with a pelvic mass thought to be due to fibroids with the greatest risk of occult cancer and recommending that those women undergo surgery, while simultaneously recommending expectant management for those at lowest risk of an occult cancer.

“UPDATE ON MINIMALLY INVASIVE gynecologic SURGERY”
AMY L. GARCIA, MD (APRIL 2015)

Additional tips for in-office hysteroscopy
Thank you for the excellent coverage of hysteroscopy in the April issue. For me, patient trust is extremely important. Before I begin in-office hysteroscopy, I explain how the procedure is performed and answer all questions. I reassure the patient that, if it is too painful, I will stop and we will move to the operating room. I find music to be distracting to me as I am talking and constantly reassuring her.

In addition, I don’t perform the procedure when the patient is menstruating as it decreases visibility and I don’t want the intrauterine lidocaine to enter open vessels. It is helpful to perform this procedure shortly after menses and prior to ovulation to avoid instrumenting a pregnant uterus. Even if the menses is normal in timing and flow, a pregnancy test is still performed prior to the procedure. Doing it in this time period also can offer better visibility, as the endometrium is thinner.

I prescribe oral misoprostol the night before (400 mg, or 200 mg if she has undergone a cesarean delivery). The patient also is instructed to take ibuprofen 800 mg 1 hour prior to the procedure.

I continuously tell the patient what to expect. First, I perform a bimanual exam to determine the uterine position. Then local anesthesia placed on the anterior lip of the cervix prevents pain when placing the tenaculum. A paracervical block is performed and lidocaine jelly is placed in the cervix. Using an angiocatheter, I inject 4 mL of 2% lidocaine into the uterus and then wait 3 minutes.

It is important to only use the amount of fluid necessary to avoid overdistending the uterus. I take care to avoid touching the fundus, as this increases pain. I use a 4-mm 30˚ scope. I agree that the pain is dependent on physician expertise and procedure length.

If the cavity is clean, I perform a thorough endometrial biopsy that causes minimal pain because of the intrauterine lidocaine. I recently started doing in-office diagnostic hysteroscopy again. When I did it years ago without intrauterine lidocaine, it was unacceptably painful. I have performed 25 cases, all of which were successful, including on postmenopausal patients. All of the patients reported being highly satisfied and glad to have had the procedure performed in the office.
Ray Wertheim, MD
Fairfax, Virginia

Would you approve this candidate for uterus transplantation?

“UTERUS TRANSPLANTATION: MEDICAL BREAKTHROUGH OR SURGICAL FOLLY?”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2015)

Instant Poll
Dr. Barbieri presented 3 cases to readers in his recent editorial on uterus transplantation and asked, “Would you approve or disapprove of transplantation of the uterus in these cases?”

1. 23-year-old Army sergeant (G0) injured by improvised explosive device. To save her life, military surgeons removed her uterus, which had been lacerated in the explosion. She requested uterus transplantation to pursue a pregnancy. The Department of Defense has approved her request.
2. 30-year-old woman (G0) with congenital absence of the uterus who is a devout member of a religious community in which the tenets of faith prohibit gestational carriers. Rather than pursue adoption, she is seeking a uterus transplantation to pursue a pregnancy.
3. 35-year-old woman (G1P1) who had her uterus removed to treat cervical cancer. She has been disease-free for 3 years. She would like a uterus transplant to pursue a pregnancy.

READERS WEIGH IN:
Concentrate on saving lives
We should be concentrating our resources on saving lives rather than on satisfying the wishes of some very genuine people.

Where will it end? Let us not compare uterine transplant with kidney, heart, and lung transplants.
Ram A. Singh, MD
Oklahoma City, Oklahoma

No to 35-year-old patient
Assuming, as stated, that the women are healthy and psychosocially approved, to which I would add, they are fully informed on the preparation, medications, procedure, postoperative recovery, and potential complications,I would approve the first 2 cases and disapprove of the last. My reasoning for denying a uterus transplant to the 35-year-old woman is that, after she goes through the process of screening and evaluation, she will be an “elderly gravida,” which in itself has risks. I would also be concerned that all the family members fully understand the potential risks of her undertaking.
Helen T. Jackson, MD
Brookline, Massachusetts

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

“WHAT IS THE RISK THAT A PATIENT WILL HAVE AN OCCULT UTERINE CANCER AT MYOMECTOMY?”
ROBERT L. BARBIERI, MD (EXAMINING THE EVIDENCE; APRIL 2015)

More questions than answers?
The data presented by Wright and colleagues on the prevalence of underlying cancer in women who undergo myomectomy is disturbing and thought-provoking.

Are those in the 50-and-older age group who undergo myomectomy different from their same-aged peers with fibroids who do not undergo myomectomy? If so, why? If not, then with a 1 in 154 to 1 in 31 risk of occult malignancy, should not all women 50 years and older with fibroids undergo hysterectomy for this occult risk? This certainly has not been the standard of care for women 50 and older with asymptomatic fibroids. Thoughts?

In conclusion, it appears that power morcellation, or should I say the morcellation issue, has brought forth more questions than answers.
Richard L. Myers, MD
Jacksonville, Florida

Dr. Barbieri responds
I agree with Dr. Myers: Women aged 50 and older who have fibroids and undergo myomectomy must be clinically different than women of the same age who have fibroids but do not undergo myomectomy. It is likely that the women who undergo myomectomy have larger pelvic tumors or are more symptomatic than those who do not undergo myomectomy. I think this demonstrates that gynecologists are successfully identifying those women with a pelvic mass thought to be due to fibroids with the greatest risk of occult cancer and recommending that those women undergo surgery, while simultaneously recommending expectant management for those at lowest risk of an occult cancer.

“UPDATE ON MINIMALLY INVASIVE gynecologic SURGERY”
AMY L. GARCIA, MD (APRIL 2015)

Additional tips for in-office hysteroscopy
Thank you for the excellent coverage of hysteroscopy in the April issue. For me, patient trust is extremely important. Before I begin in-office hysteroscopy, I explain how the procedure is performed and answer all questions. I reassure the patient that, if it is too painful, I will stop and we will move to the operating room. I find music to be distracting to me as I am talking and constantly reassuring her.

In addition, I don’t perform the procedure when the patient is menstruating as it decreases visibility and I don’t want the intrauterine lidocaine to enter open vessels. It is helpful to perform this procedure shortly after menses and prior to ovulation to avoid instrumenting a pregnant uterus. Even if the menses is normal in timing and flow, a pregnancy test is still performed prior to the procedure. Doing it in this time period also can offer better visibility, as the endometrium is thinner.

I prescribe oral misoprostol the night before (400 mg, or 200 mg if she has undergone a cesarean delivery). The patient also is instructed to take ibuprofen 800 mg 1 hour prior to the procedure.

I continuously tell the patient what to expect. First, I perform a bimanual exam to determine the uterine position. Then local anesthesia placed on the anterior lip of the cervix prevents pain when placing the tenaculum. A paracervical block is performed and lidocaine jelly is placed in the cervix. Using an angiocatheter, I inject 4 mL of 2% lidocaine into the uterus and then wait 3 minutes.

It is important to only use the amount of fluid necessary to avoid overdistending the uterus. I take care to avoid touching the fundus, as this increases pain. I use a 4-mm 30˚ scope. I agree that the pain is dependent on physician expertise and procedure length.

If the cavity is clean, I perform a thorough endometrial biopsy that causes minimal pain because of the intrauterine lidocaine. I recently started doing in-office diagnostic hysteroscopy again. When I did it years ago without intrauterine lidocaine, it was unacceptably painful. I have performed 25 cases, all of which were successful, including on postmenopausal patients. All of the patients reported being highly satisfied and glad to have had the procedure performed in the office.
Ray Wertheim, MD
Fairfax, Virginia

Would you approve this candidate for uterus transplantation?

“UTERUS TRANSPLANTATION: MEDICAL BREAKTHROUGH OR SURGICAL FOLLY?”
ROBERT L. BARBIERI, MD (EDITORIAL; APRIL 2015)

Instant Poll
Dr. Barbieri presented 3 cases to readers in his recent editorial on uterus transplantation and asked, “Would you approve or disapprove of transplantation of the uterus in these cases?”

1. 23-year-old Army sergeant (G0) injured by improvised explosive device. To save her life, military surgeons removed her uterus, which had been lacerated in the explosion. She requested uterus transplantation to pursue a pregnancy. The Department of Defense has approved her request.
2. 30-year-old woman (G0) with congenital absence of the uterus who is a devout member of a religious community in which the tenets of faith prohibit gestational carriers. Rather than pursue adoption, she is seeking a uterus transplantation to pursue a pregnancy.
3. 35-year-old woman (G1P1) who had her uterus removed to treat cervical cancer. She has been disease-free for 3 years. She would like a uterus transplant to pursue a pregnancy.

READERS WEIGH IN:
Concentrate on saving lives
We should be concentrating our resources on saving lives rather than on satisfying the wishes of some very genuine people.

Where will it end? Let us not compare uterine transplant with kidney, heart, and lung transplants.
Ram A. Singh, MD
Oklahoma City, Oklahoma

No to 35-year-old patient
Assuming, as stated, that the women are healthy and psychosocially approved, to which I would add, they are fully informed on the preparation, medications, procedure, postoperative recovery, and potential complications,I would approve the first 2 cases and disapprove of the last. My reasoning for denying a uterus transplant to the 35-year-old woman is that, after she goes through the process of screening and evaluation, she will be an “elderly gravida,” which in itself has risks. I would also be concerned that all the family members fully understand the potential risks of her undertaking.
Helen T. Jackson, MD
Brookline, Massachusetts

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.

Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.

The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.

The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.

Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues¹ used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.

However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.

Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.

The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.

The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.

Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues¹ used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.

However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

The objective of this investigation by Pierson and colleagues was to determine if there was any significant difference between erythyromycin and azithromycin, used in combination with ampicillin, for prophylaxis in women with PPROM.

Details of the study
The authors conducted a retrospective study of 168 women at 24 to 34 weeks’ gestation. At the discretion of the attending physician, patients received either ampicillin plus erythromycin or ampicillin plus azithromycin as their prophylactic antibiotic regimen. Patients were excluded from the study if they had a cerclage, a multiple gestation, a history of amniocentesis or fetal surgery, a history of abdominal trauma, or if they had a fetus with a lethal anomaly.

The primary study end point was the duration of the latency period between rupture of membranes and onset of labor. The secondary outcomes were gestational age at delivery, adverse drug effects, neonatal birth weight, Apgar scores, and rates of neonatal death, respiratory distress syndrome, and sepsis.

The mean (SD) duration of the latent period was 9.4 (10.4) days in the azithromycin group and 9.6 (13.2) days in the erythromycin group (P = .4). There also were no significant differences in any of the secondary outcome measures. Accordingly, the authors concluded that azithromycin was an acceptable alternative to erythromycin in the prophylactic antibiotic regimen for patients with PPROM.

Several factors make azithromycin the favored PPROM prophylactic option
In the original Maternal-Fetal Medicine Network trial of prophylactic antibiotics for PPROM, Mercer and colleagues¹ used the combination regimen of ampicillin plus erythromycin. In this regimen, ampicillin primarily targets group B streptococci and Escherichia coli. Erythromycin specifically targets mycoplasma organisms, which can be part of the polymicrobial flora that causes chorioamnionitis. The drug also is effective against chlamydia.

However, erythromycin may cause troublesome gastrointestinal adverse effects, notably diarrhea, in some patients. Therefore, in recent years, several investigators have advocated use of azithromycin in lieu of erythromycin. Azithromycin has a similar spectrum of activity as erythromycin, but it has a more favorable pharmacokinetic profile. When given in a single oral dose of 1,000 mg, it has a half-life of 68 hours, compared with erythromycin’s half-life of 1.6 hours. Thus, it is much easier to administer. Moreover, it is usually much better tolerated than erythromycin and, now that generic versions of the drug are available, it is relatively inexpensive.

WHAT THIS EVIDENCE MEANS FOR PRACTICE
Although this study is retrospective (Level II evidence), it is the first to demonstrate that, from the perspective of clinical effectiveness, azithromycin is comparable to erythromycin when used in combination with ampicillin for prophylaxis in patients with PPROM. For the reasons outlined above, I strongly favor azithromycin in lieu of erythromycin.
At our center we administer the drug in a single 1,000-mg oral dose. If the patient cannot tolerate oral medication at the time of admission, the drug can be administered intravenously.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Although evidence-based medicine, or EBM, is not a new concept, the phrase is tossed about frequently in today’s culture of quality improvement initiatives and metrics. What does EBM really mean, however, and how do we ensure we are practicing it?

At its heart, EBM integrates 3 components:

• the individual clinician’s expertise
• the patient’s values and preferences
• the best external evidence to guide treatment decisions.

Because each clinician’s skillset and each patient’s issues and preferences may be quite varied, in this article we target the third piece—determining the best external evidence.

Our focus on EBM is not meant to negate the importance of the clinician’s expertise, which has been gained through years of practice. Indeed, without expertise, “practice risks becoming tyrannized by evidence.”¹ However, without current best evidence, “practice risks becoming rapidly out of date, to the detriment of patients.”¹ With the integration of evidence, expertise, and patient choice, EBM is not “cookbook” medicine, and it is not conducted only from armchairs and ivory towers. Rather, EBM is, or should be, at the frontline of clinical care.

EBM begins with a specific clinical question, such as “What is the best treatment option for my patient?” The answer can be honed with the “PICO” approach, which considers Population, Intervention, Comparators, and Outcomes of interest. Specifically, in a particular patient population (similar to your own patient), how does an intervention impact key outcomes?

For directly comparing intervention options, such as surgery A versus surgery B, a randomized controlled trial (RCT) is one of the best methods to address clinical questions (FIGURE).² Systematic reviews are more generalizable than single studies since they compare a range of relevant interventions across populations and settings. Evaluations of diagnostic test accuracy^3,4or analyses of risk factors or natural history are best addressed by other study designs, which also can provide important evidence, but will not be discussed in depth here.

In this article, we focus on the benefits of RCTs and systematic reviews, as well as when to exhibit caution, for instance when RCTs report “surrogate outcomes” or make analyses drawn from subgroups of the original population. In addition, we discuss the inability to adequately assess treatment harms (versus benefits) from available evidence as well as the practicalities of how to apply EBM to patients.

RCTs: The good, the bad, and the ugly
RCTs are prospective experiments with a predefined protocol in which patients are randomly allocated to groups where the only difference is the intervention (vs comparators). This design helps to minimize the effects of known and unknown confounders and selection bias.

Ideally, the group into which a study participant is allocated is concealed from the patient and from the caregiver, minimizing the risk that the randomization is broken and the treatment allocation is biased. (Frequently this is not possible, however, particularly for surgical interventions.) Similarly, ideally, the outcome assessors are blinded to the treatment whenever possible. This minimizes the risk of a patient’s outcome being consciously or unconsciously altered due to the outcome assessor’s beliefs about the effectiveness of the intervention.

The reported clinical or surrogate outcomes (which will be discussed in more depth on the next page) for an RCT may be objective or subjective. Preferably, outcomes are patient-centered—important from the patient’s perspective of benefits and harms. Examples of these types of outcomes include survival, function, symptoms, and health-related quality of life, as well as impact on work and family, convenience, and cost. Patients likely are less interested in estimated blood loss, surgical time, biochemistry results, and other clinical or surrogate outcomes.

There are disadvantages to RCTs. For instance, each study provides only a snapshot of the evidence on a given topic. One study rarely, if ever, provides a definitive conclusion. The study’s findings are subject to random error and to biases introduced by study design or analytic methods, and they will not be generalizable to all patients and settings. In addition, the study likely has evaluated only 1 or 2 specific interventions among a plethora of available options, and is unlikely to have analyzed all outcomes of interest.

It becomes your burden to assess whether a trial’s findings are applicable to an actual patient (known as “external validity”). Because an RCT must artificially constrain the underlying clinical questions into a testable research question, translation to the specific patient is often flawed. Perhaps the patient does not precisely fit the inclusion criteria of the trial, for instance, or the exact intervention tested is not fully reproducible. From a practicality perspective, an RCT is often immensely costly to execute, which may be reflected in relatively small numbers of patients and short-term duration of follow-up. These disadvantages limit the ability of RCTs to assess harms, rare events, and long-term outcomes.

Surrogate outcomes
Outcomes measured in a trial should be relevant, easy to interpret and diagnose, sensitive to treatment differences, and measurable within a reasonable period of time. However, these characteristics are not always achievable for important clinical outcomes in an RCT. Therefore, a surrogate outcome may take the place of the true clinical efficacy measurement.

For example, in studies of interventions for infertility in patients with polycystic ovary syndrome (PCOS), common surrogates to the “true” desired outcome of a healthy live birth may include ovulation, implantation, or pregnancy rates. These surrogate outcomes may correlate with live birth but clearly ignore other factors extrinsic and intrinsic to PCOS that affect the chance for a healthy term delivery; the possible increased risk for miscarriage in PCOS; and increased risks of other pregnancy complications, such as preeclampsia and gestational diabetes.

Similarly, many trials of oral contraceptives that aim to study the clinical endpoint of pulmonary embolism or venous thromboembolism, which are rare events, instead use the surrogates of results of coagulation tests or levels of sex hormone-binding globulin. Clearly, caution must be exercised when interpreting studies that use surrogate outcomes. As the clinician, you must recognize that a change in a biologic or physical measurement may not be clinically relevant. Some judgment is required about causal pathways: The less that is known about the causal pathway of a disease, the less confident one should be in any surrogate outcome.

Finally, clinicians also must recognize that a valid surrogate for one treatment may not be valid for another treatment or another population.⁵ For example, ovulation inhibition would be an appropriate surrogate endpoint for contraceptive efficacy for a method that reliably prevents ovulation; however, this would not be a good surrogate outcome to evaluate the progestin-only pill, which fails to inhibit ovulation completely and yet is highly effective in contraceptive trials.

Avoiding pitfalls with subgroup analyses
It is common, particularly in large RCTs, to evaluate treatment effects for a specific endpoint in a subgroup of patients included in the trial. The goal is to determine whether the findings of the larger study apply more or less to a specific patient (who may differ from the total population by some important characteristic, such as age, weight, parity, or menopausal or smoking status). The variability in study results when stratified by these patient factors is known as heterogeneity of treatment effect, which may be quantitative or qualitative.⁶

In the former, one treatment is always better than the other, although by varying degrees depending on the subgroup. (For example, a stronger effect could be seen in those aged 65 and younger than in those older than 65.) In the latter, the treatment fares better than the comparator in one subgroup but worse or no different for another subgroup. In either case, the appropriate statistical tool to identify heterogeneity of treatment effect is a test for interaction between the characteristic and the treatment effect, rather than claiming heterogeneity on the basis of separate tests of treatment effects within the different subpopulations.

One problem with dividing the original population into smaller subpopulations is that the number of participants decreases—thus there is less power, or less statistical strength, to identify a treatment effect. More accurately, there is a greater likelihood of a type II error (a false negative) when these small subpopulations have too few patients to demonstrate a clinical treatment effect that actually may exist.

False positives. Paradoxically, another problem with subgroup analyses is a greater chance for false positives due to the multiple statistical testing that is performed. The original study is rarely powered appropriately to do this (see “Error rates in subgroup analyses”). According to Wang and colleagues, “It is common practice to conduct a subgroup analysis for each of several (and often many) baseline characteristics, for each of several endpoints, or for both.”⁷ The more subgroup analyses performed, the more likely that differences found are due to chance only. Unfortunately, in unplanned post hoc analyses, the number of tests performed is often unreported; therefore, the error rates are unknown. There are statistical methods to try and correct for this “multiplicity” problem but, ideally, only a few key subgroup analyses are performed, and they are planned a priori in the original study design. In these cases, the study’s size can be adjusted accordingly. In most instances, findings from subgroup analyses, whether positive or negative, should be considered as “hypothesis generating” and interpreted with caution.

Systematic reviews: What, why, and how?
Systematic reviews aim to overcome the deficiencies of single studies in a comprehensive and unbiased manner. They critically evaluate, summarize, and, when possible, combine all available studies addressing a given topic. By comparing a range of relevant interventions across populations and settings, systematic reviews may be more generalizable than single studies. Meta-analysis, or quantitatively combining study results, increases sample size and usually provides more precise estimates of effect sizes than the single studies. Critical appraisal of the combined studies can highlight methodologic and other concerns about the body of evidence to assess the overall confidence in the included studies.

A systematic review, like a well-conducted RCT, has a protocol that lays out the scope of the review and defines a priori criteria and analytic plans—all with the goal of minimizing bias. It starts with a well-formulated research question, explicitly defining the PICO elements—population, interventions, comparators, outcomes—in addition to the setting and study designs of interest.⁸ Based on these eligibility criteria, several sources of evidence (such as electronic databases and reference lists) are searched to find all potentially eligible studies.

Typically, several thousand citations are found that must be matched against the eligibility criteria. Potentially eligible studies are then rescreened in full text to further scrutinize their eligibility. The goal is to be highly sensitive to avoid missing relevant studies—even at the time cost of screening many articles. The individual study designs (including the study eligibility criteria, interventions, outcomes, and analytic methods) and the results for all outcomes of interest are extracted from each study.

For most systematic reviews, researchers also will assess the quality, or risk of bias, of each study for each outcome.^9,10 Study data are summarized across all included studies, with study results meta-analyzed and reasons for heterogeneity across studies explored. Several consensus statements detail the proper methodology to conduct and report a systematic review.^11,12 Ultimately, the review’s conclusions are based on analyses of all available evidence. By contrast, narrative reviews typically  start with a conclusion and then select evidence to support that conclusion, and are therefore more likely to be biased.¹³

As noted, systematic reviews often include meta-analysis, which may allow an exploration of some reasons for study heterogeneity. The meta-analysis is usually presented graphically in a forest plot, which displays point estimates for each study with their associated 95% confidence intervals and a description of each study.¹⁴ In a forest plot, one can see the estimate and precision of each study, assess the heterogeneity of results across studies, and compare individual studies to each other and to the overall summary estimate.

Systematic reviews should be read as critically as primary studies. Some important questions you should consider are:

• Did the review address the populations, interventions, comparators, outcomes, and settings relevant to your practice?
• Have studies been included in a nonbiased manner, and is the described body of evidence likely to be complete?
• Did the study authors evaluate and summarize the underlying risks of bias of the studies?
• Did the researchers avoid combining studies that are too different from each other to allow a coherent interpretation of the summary results?
• Did the researchers attempt to explain how and why studies differed from one another?

Of note, systematic reviews and meta-analyses are subject to the same biases as all retrospective studies. Also, the systematic reviewers’ own biases—due to factors such as funding source, researchers’ agendas, or specialties—may subtly affect systematic reviews just as biases may affect an individual study. Furthermore, the confidence you have in a systematic review’s conclusions may be limited by the quality and generalizability of the underlying studies.

Assessing harms
You make the ultimate management decisions for your patient (though, of course, with her participation). The likely benefit of a specific treatment—determined in an experimental trial and refined further in a systematic review and meta-analysis—must be balanced with the risk of harms. RCTs usually do not provide the highest quality evidence of harms due to their limited sample sizes and short follow-up duration. Rather, large observational studies, case series, and case reports commonly provide these important details. Increasingly, patient registries are being created to prospectively follow patients and gather uniform safety data. By providing a true denominator, more accurate estimates of adverse event incidence are possible. However, the disadvantages of all of these modalities are 1) there usually are no comparators (that is, “How does the adverse event incidence for surgery A compare to that for surgery B?”) and 2) data usually are gleaned from medical records and not directly from patients.

As a result, these studies typically lack information on subjective harms, such as impaired sexual function. The reporting of treatment harms suffers from inconsistent and imprecise terminology, making it hard to reliably gather all reports of similar adverse events. Adverse event reporting in clinical trials is often driven by regulatory definitions and requirements instead of patient-centered definitions. In fact, there has been little work to date that assesses which adverse events or complications may be most relevant or important from the patient perspective.

Taken together, it is clear that the medical literature tends to emphasize treatment benefits (with robust methodologies and data to detect these benefits) but does not reliably or adequately assess harms. For rare events, risk estimates always will be imprecise. Nonetheless, better systematic reviews and today’s larger comparative effectiveness reviews strive to gather harms data from the multiple available sources described above.

Applying the evidence and your expertise to your patient
Now that you have identified the best valid and important evidence to support or refute a clinical decision (TABLE¹⁵), and have coupled this with your own expert knowledge and judgment in shared decision making with your patient, you must communicate to her the personalized information about outcomes, probabilities, and scientific uncertainties of her available treatment options.¹⁵ Patients, in turn, should be allowed to communicate their values and the relative importance they place on benefits and harms.¹⁶ This conversation, of course, is built on the foundation of a sound physician–patient relationship and is a part of every informed consent process.

Decision tools
Increasingly, decision-aid tools are being developed to support this process. These aids must express the helpful and harmful effects of a treatment, including alternative options, in statements that are valid and concise. Furthermore, they must be intelligible to both the clinician and patient and modifiable to the patient’s values and wishes.¹⁷ Two examples of counseling aids are the Gail model of breast cancer risk prediction¹⁸ and the Framingham Coronary Heart Disease Prediction Score.¹⁹ Web-based decision aids that can be accessed in real-time in busy clinical settings also are being developed for gynecology.²⁰

Never stop re-evaluating
The final piece of EBM is to “close the loop”—meaning to evaluate the effectiveness of applying the evidence in clinical practice. To do this, watch for clinical practice guidelines that are based on systematic reviews and the EBM approach and stay abreast of ACOG’s and other professional societies’ guideline statements. Ultimately, guidelines beget performance measures. Organizations such as the National Quality Forum are working to define these standards of performance measurement and seek feedback from individual clinicians to ensure measures are meaningful and accurate. By 2017, 9% of all Medicare payments are scheduled to be performance based.²¹

Conclusion
During the course of reading medical literature, stay attuned to comparative effectiveness research and recognize studies with active comparators that examine clinical questions that could impact your day-to-day practice and that can be applied to your patient population. While there is no such thing as a perfect research study, and it is rare that one trial can address any one clinician’s specific patients precisely, increasingly we are seeing better systematic reviews and meta-analyses. It is these studies that provide the high quality data for you to couple with your clinical expertise and your patients’ values and preferences to truly deliver evidence-based medicine.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Although evidence-based medicine, or EBM, is not a new concept, the phrase is tossed about frequently in today’s culture of quality improvement initiatives and metrics. What does EBM really mean, however, and how do we ensure we are practicing it?

At its heart, EBM integrates 3 components:

• the individual clinician’s expertise
• the patient’s values and preferences
• the best external evidence to guide treatment decisions.

Because each clinician’s skillset and each patient’s issues and preferences may be quite varied, in this article we target the third piece—determining the best external evidence.

Our focus on EBM is not meant to negate the importance of the clinician’s expertise, which has been gained through years of practice. Indeed, without expertise, “practice risks becoming tyrannized by evidence.”¹ However, without current best evidence, “practice risks becoming rapidly out of date, to the detriment of patients.”¹ With the integration of evidence, expertise, and patient choice, EBM is not “cookbook” medicine, and it is not conducted only from armchairs and ivory towers. Rather, EBM is, or should be, at the frontline of clinical care.

EBM begins with a specific clinical question, such as “What is the best treatment option for my patient?” The answer can be honed with the “PICO” approach, which considers Population, Intervention, Comparators, and Outcomes of interest. Specifically, in a particular patient population (similar to your own patient), how does an intervention impact key outcomes?

For directly comparing intervention options, such as surgery A versus surgery B, a randomized controlled trial (RCT) is one of the best methods to address clinical questions (FIGURE).² Systematic reviews are more generalizable than single studies since they compare a range of relevant interventions across populations and settings. Evaluations of diagnostic test accuracy^3,4or analyses of risk factors or natural history are best addressed by other study designs, which also can provide important evidence, but will not be discussed in depth here.

In this article, we focus on the benefits of RCTs and systematic reviews, as well as when to exhibit caution, for instance when RCTs report “surrogate outcomes” or make analyses drawn from subgroups of the original population. In addition, we discuss the inability to adequately assess treatment harms (versus benefits) from available evidence as well as the practicalities of how to apply EBM to patients.

RCTs: The good, the bad, and the ugly
RCTs are prospective experiments with a predefined protocol in which patients are randomly allocated to groups where the only difference is the intervention (vs comparators). This design helps to minimize the effects of known and unknown confounders and selection bias.

Ideally, the group into which a study participant is allocated is concealed from the patient and from the caregiver, minimizing the risk that the randomization is broken and the treatment allocation is biased. (Frequently this is not possible, however, particularly for surgical interventions.) Similarly, ideally, the outcome assessors are blinded to the treatment whenever possible. This minimizes the risk of a patient’s outcome being consciously or unconsciously altered due to the outcome assessor’s beliefs about the effectiveness of the intervention.

The reported clinical or surrogate outcomes (which will be discussed in more depth on the next page) for an RCT may be objective or subjective. Preferably, outcomes are patient-centered—important from the patient’s perspective of benefits and harms. Examples of these types of outcomes include survival, function, symptoms, and health-related quality of life, as well as impact on work and family, convenience, and cost. Patients likely are less interested in estimated blood loss, surgical time, biochemistry results, and other clinical or surrogate outcomes.

There are disadvantages to RCTs. For instance, each study provides only a snapshot of the evidence on a given topic. One study rarely, if ever, provides a definitive conclusion. The study’s findings are subject to random error and to biases introduced by study design or analytic methods, and they will not be generalizable to all patients and settings. In addition, the study likely has evaluated only 1 or 2 specific interventions among a plethora of available options, and is unlikely to have analyzed all outcomes of interest.

It becomes your burden to assess whether a trial’s findings are applicable to an actual patient (known as “external validity”). Because an RCT must artificially constrain the underlying clinical questions into a testable research question, translation to the specific patient is often flawed. Perhaps the patient does not precisely fit the inclusion criteria of the trial, for instance, or the exact intervention tested is not fully reproducible. From a practicality perspective, an RCT is often immensely costly to execute, which may be reflected in relatively small numbers of patients and short-term duration of follow-up. These disadvantages limit the ability of RCTs to assess harms, rare events, and long-term outcomes.

Surrogate outcomes
Outcomes measured in a trial should be relevant, easy to interpret and diagnose, sensitive to treatment differences, and measurable within a reasonable period of time. However, these characteristics are not always achievable for important clinical outcomes in an RCT. Therefore, a surrogate outcome may take the place of the true clinical efficacy measurement.

For example, in studies of interventions for infertility in patients with polycystic ovary syndrome (PCOS), common surrogates to the “true” desired outcome of a healthy live birth may include ovulation, implantation, or pregnancy rates. These surrogate outcomes may correlate with live birth but clearly ignore other factors extrinsic and intrinsic to PCOS that affect the chance for a healthy term delivery; the possible increased risk for miscarriage in PCOS; and increased risks of other pregnancy complications, such as preeclampsia and gestational diabetes.

Similarly, many trials of oral contraceptives that aim to study the clinical endpoint of pulmonary embolism or venous thromboembolism, which are rare events, instead use the surrogates of results of coagulation tests or levels of sex hormone-binding globulin. Clearly, caution must be exercised when interpreting studies that use surrogate outcomes. As the clinician, you must recognize that a change in a biologic or physical measurement may not be clinically relevant. Some judgment is required about causal pathways: The less that is known about the causal pathway of a disease, the less confident one should be in any surrogate outcome.

Finally, clinicians also must recognize that a valid surrogate for one treatment may not be valid for another treatment or another population.⁵ For example, ovulation inhibition would be an appropriate surrogate endpoint for contraceptive efficacy for a method that reliably prevents ovulation; however, this would not be a good surrogate outcome to evaluate the progestin-only pill, which fails to inhibit ovulation completely and yet is highly effective in contraceptive trials.

Avoiding pitfalls with subgroup analyses
It is common, particularly in large RCTs, to evaluate treatment effects for a specific endpoint in a subgroup of patients included in the trial. The goal is to determine whether the findings of the larger study apply more or less to a specific patient (who may differ from the total population by some important characteristic, such as age, weight, parity, or menopausal or smoking status). The variability in study results when stratified by these patient factors is known as heterogeneity of treatment effect, which may be quantitative or qualitative.⁶

In the former, one treatment is always better than the other, although by varying degrees depending on the subgroup. (For example, a stronger effect could be seen in those aged 65 and younger than in those older than 65.) In the latter, the treatment fares better than the comparator in one subgroup but worse or no different for another subgroup. In either case, the appropriate statistical tool to identify heterogeneity of treatment effect is a test for interaction between the characteristic and the treatment effect, rather than claiming heterogeneity on the basis of separate tests of treatment effects within the different subpopulations.

One problem with dividing the original population into smaller subpopulations is that the number of participants decreases—thus there is less power, or less statistical strength, to identify a treatment effect. More accurately, there is a greater likelihood of a type II error (a false negative) when these small subpopulations have too few patients to demonstrate a clinical treatment effect that actually may exist.

False positives. Paradoxically, another problem with subgroup analyses is a greater chance for false positives due to the multiple statistical testing that is performed. The original study is rarely powered appropriately to do this (see “Error rates in subgroup analyses”). According to Wang and colleagues, “It is common practice to conduct a subgroup analysis for each of several (and often many) baseline characteristics, for each of several endpoints, or for both.”⁷ The more subgroup analyses performed, the more likely that differences found are due to chance only. Unfortunately, in unplanned post hoc analyses, the number of tests performed is often unreported; therefore, the error rates are unknown. There are statistical methods to try and correct for this “multiplicity” problem but, ideally, only a few key subgroup analyses are performed, and they are planned a priori in the original study design. In these cases, the study’s size can be adjusted accordingly. In most instances, findings from subgroup analyses, whether positive or negative, should be considered as “hypothesis generating” and interpreted with caution.

Systematic reviews: What, why, and how?
Systematic reviews aim to overcome the deficiencies of single studies in a comprehensive and unbiased manner. They critically evaluate, summarize, and, when possible, combine all available studies addressing a given topic. By comparing a range of relevant interventions across populations and settings, systematic reviews may be more generalizable than single studies. Meta-analysis, or quantitatively combining study results, increases sample size and usually provides more precise estimates of effect sizes than the single studies. Critical appraisal of the combined studies can highlight methodologic and other concerns about the body of evidence to assess the overall confidence in the included studies.

A systematic review, like a well-conducted RCT, has a protocol that lays out the scope of the review and defines a priori criteria and analytic plans—all with the goal of minimizing bias. It starts with a well-formulated research question, explicitly defining the PICO elements—population, interventions, comparators, outcomes—in addition to the setting and study designs of interest.⁸ Based on these eligibility criteria, several sources of evidence (such as electronic databases and reference lists) are searched to find all potentially eligible studies.

Typically, several thousand citations are found that must be matched against the eligibility criteria. Potentially eligible studies are then rescreened in full text to further scrutinize their eligibility. The goal is to be highly sensitive to avoid missing relevant studies—even at the time cost of screening many articles. The individual study designs (including the study eligibility criteria, interventions, outcomes, and analytic methods) and the results for all outcomes of interest are extracted from each study.

For most systematic reviews, researchers also will assess the quality, or risk of bias, of each study for each outcome.^9,10 Study data are summarized across all included studies, with study results meta-analyzed and reasons for heterogeneity across studies explored. Several consensus statements detail the proper methodology to conduct and report a systematic review.^11,12 Ultimately, the review’s conclusions are based on analyses of all available evidence. By contrast, narrative reviews typically  start with a conclusion and then select evidence to support that conclusion, and are therefore more likely to be biased.¹³

As noted, systematic reviews often include meta-analysis, which may allow an exploration of some reasons for study heterogeneity. The meta-analysis is usually presented graphically in a forest plot, which displays point estimates for each study with their associated 95% confidence intervals and a description of each study.¹⁴ In a forest plot, one can see the estimate and precision of each study, assess the heterogeneity of results across studies, and compare individual studies to each other and to the overall summary estimate.

Systematic reviews should be read as critically as primary studies. Some important questions you should consider are:

• Did the review address the populations, interventions, comparators, outcomes, and settings relevant to your practice?
• Have studies been included in a nonbiased manner, and is the described body of evidence likely to be complete?
• Did the study authors evaluate and summarize the underlying risks of bias of the studies?
• Did the researchers avoid combining studies that are too different from each other to allow a coherent interpretation of the summary results?
• Did the researchers attempt to explain how and why studies differed from one another?

Of note, systematic reviews and meta-analyses are subject to the same biases as all retrospective studies. Also, the systematic reviewers’ own biases—due to factors such as funding source, researchers’ agendas, or specialties—may subtly affect systematic reviews just as biases may affect an individual study. Furthermore, the confidence you have in a systematic review’s conclusions may be limited by the quality and generalizability of the underlying studies.

Assessing harms
You make the ultimate management decisions for your patient (though, of course, with her participation). The likely benefit of a specific treatment—determined in an experimental trial and refined further in a systematic review and meta-analysis—must be balanced with the risk of harms. RCTs usually do not provide the highest quality evidence of harms due to their limited sample sizes and short follow-up duration. Rather, large observational studies, case series, and case reports commonly provide these important details. Increasingly, patient registries are being created to prospectively follow patients and gather uniform safety data. By providing a true denominator, more accurate estimates of adverse event incidence are possible. However, the disadvantages of all of these modalities are 1) there usually are no comparators (that is, “How does the adverse event incidence for surgery A compare to that for surgery B?”) and 2) data usually are gleaned from medical records and not directly from patients.

As a result, these studies typically lack information on subjective harms, such as impaired sexual function. The reporting of treatment harms suffers from inconsistent and imprecise terminology, making it hard to reliably gather all reports of similar adverse events. Adverse event reporting in clinical trials is often driven by regulatory definitions and requirements instead of patient-centered definitions. In fact, there has been little work to date that assesses which adverse events or complications may be most relevant or important from the patient perspective.

Taken together, it is clear that the medical literature tends to emphasize treatment benefits (with robust methodologies and data to detect these benefits) but does not reliably or adequately assess harms. For rare events, risk estimates always will be imprecise. Nonetheless, better systematic reviews and today’s larger comparative effectiveness reviews strive to gather harms data from the multiple available sources described above.

Applying the evidence and your expertise to your patient
Now that you have identified the best valid and important evidence to support or refute a clinical decision (TABLE¹⁵), and have coupled this with your own expert knowledge and judgment in shared decision making with your patient, you must communicate to her the personalized information about outcomes, probabilities, and scientific uncertainties of her available treatment options.¹⁵ Patients, in turn, should be allowed to communicate their values and the relative importance they place on benefits and harms.¹⁶ This conversation, of course, is built on the foundation of a sound physician–patient relationship and is a part of every informed consent process.

Decision tools
Increasingly, decision-aid tools are being developed to support this process. These aids must express the helpful and harmful effects of a treatment, including alternative options, in statements that are valid and concise. Furthermore, they must be intelligible to both the clinician and patient and modifiable to the patient’s values and wishes.¹⁷ Two examples of counseling aids are the Gail model of breast cancer risk prediction¹⁸ and the Framingham Coronary Heart Disease Prediction Score.¹⁹ Web-based decision aids that can be accessed in real-time in busy clinical settings also are being developed for gynecology.²⁰

Never stop re-evaluating
The final piece of EBM is to “close the loop”—meaning to evaluate the effectiveness of applying the evidence in clinical practice. To do this, watch for clinical practice guidelines that are based on systematic reviews and the EBM approach and stay abreast of ACOG’s and other professional societies’ guideline statements. Ultimately, guidelines beget performance measures. Organizations such as the National Quality Forum are working to define these standards of performance measurement and seek feedback from individual clinicians to ensure measures are meaningful and accurate. By 2017, 9% of all Medicare payments are scheduled to be performance based.²¹

Conclusion
During the course of reading medical literature, stay attuned to comparative effectiveness research and recognize studies with active comparators that examine clinical questions that could impact your day-to-day practice and that can be applied to your patient population. While there is no such thing as a perfect research study, and it is rare that one trial can address any one clinician’s specific patients precisely, increasingly we are seeing better systematic reviews and meta-analyses. It is these studies that provide the high quality data for you to couple with your clinical expertise and your patients’ values and preferences to truly deliver evidence-based medicine.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

Although evidence-based medicine, or EBM, is not a new concept, the phrase is tossed about frequently in today’s culture of quality improvement initiatives and metrics. What does EBM really mean, however, and how do we ensure we are practicing it?

At its heart, EBM integrates 3 components:

• the individual clinician’s expertise
• the patient’s values and preferences
• the best external evidence to guide treatment decisions.

Because each clinician’s skillset and each patient’s issues and preferences may be quite varied, in this article we target the third piece—determining the best external evidence.

Our focus on EBM is not meant to negate the importance of the clinician’s expertise, which has been gained through years of practice. Indeed, without expertise, “practice risks becoming tyrannized by evidence.”¹ However, without current best evidence, “practice risks becoming rapidly out of date, to the detriment of patients.”¹ With the integration of evidence, expertise, and patient choice, EBM is not “cookbook” medicine, and it is not conducted only from armchairs and ivory towers. Rather, EBM is, or should be, at the frontline of clinical care.

EBM begins with a specific clinical question, such as “What is the best treatment option for my patient?” The answer can be honed with the “PICO” approach, which considers Population, Intervention, Comparators, and Outcomes of interest. Specifically, in a particular patient population (similar to your own patient), how does an intervention impact key outcomes?

For directly comparing intervention options, such as surgery A versus surgery B, a randomized controlled trial (RCT) is one of the best methods to address clinical questions (FIGURE).² Systematic reviews are more generalizable than single studies since they compare a range of relevant interventions across populations and settings. Evaluations of diagnostic test accuracy^3,4or analyses of risk factors or natural history are best addressed by other study designs, which also can provide important evidence, but will not be discussed in depth here.

In this article, we focus on the benefits of RCTs and systematic reviews, as well as when to exhibit caution, for instance when RCTs report “surrogate outcomes” or make analyses drawn from subgroups of the original population. In addition, we discuss the inability to adequately assess treatment harms (versus benefits) from available evidence as well as the practicalities of how to apply EBM to patients.

RCTs: The good, the bad, and the ugly
RCTs are prospective experiments with a predefined protocol in which patients are randomly allocated to groups where the only difference is the intervention (vs comparators). This design helps to minimize the effects of known and unknown confounders and selection bias.

Ideally, the group into which a study participant is allocated is concealed from the patient and from the caregiver, minimizing the risk that the randomization is broken and the treatment allocation is biased. (Frequently this is not possible, however, particularly for surgical interventions.) Similarly, ideally, the outcome assessors are blinded to the treatment whenever possible. This minimizes the risk of a patient’s outcome being consciously or unconsciously altered due to the outcome assessor’s beliefs about the effectiveness of the intervention.

The reported clinical or surrogate outcomes (which will be discussed in more depth on the next page) for an RCT may be objective or subjective. Preferably, outcomes are patient-centered—important from the patient’s perspective of benefits and harms. Examples of these types of outcomes include survival, function, symptoms, and health-related quality of life, as well as impact on work and family, convenience, and cost. Patients likely are less interested in estimated blood loss, surgical time, biochemistry results, and other clinical or surrogate outcomes.

There are disadvantages to RCTs. For instance, each study provides only a snapshot of the evidence on a given topic. One study rarely, if ever, provides a definitive conclusion. The study’s findings are subject to random error and to biases introduced by study design or analytic methods, and they will not be generalizable to all patients and settings. In addition, the study likely has evaluated only 1 or 2 specific interventions among a plethora of available options, and is unlikely to have analyzed all outcomes of interest.

It becomes your burden to assess whether a trial’s findings are applicable to an actual patient (known as “external validity”). Because an RCT must artificially constrain the underlying clinical questions into a testable research question, translation to the specific patient is often flawed. Perhaps the patient does not precisely fit the inclusion criteria of the trial, for instance, or the exact intervention tested is not fully reproducible. From a practicality perspective, an RCT is often immensely costly to execute, which may be reflected in relatively small numbers of patients and short-term duration of follow-up. These disadvantages limit the ability of RCTs to assess harms, rare events, and long-term outcomes.

Surrogate outcomes
Outcomes measured in a trial should be relevant, easy to interpret and diagnose, sensitive to treatment differences, and measurable within a reasonable period of time. However, these characteristics are not always achievable for important clinical outcomes in an RCT. Therefore, a surrogate outcome may take the place of the true clinical efficacy measurement.

For example, in studies of interventions for infertility in patients with polycystic ovary syndrome (PCOS), common surrogates to the “true” desired outcome of a healthy live birth may include ovulation, implantation, or pregnancy rates. These surrogate outcomes may correlate with live birth but clearly ignore other factors extrinsic and intrinsic to PCOS that affect the chance for a healthy term delivery; the possible increased risk for miscarriage in PCOS; and increased risks of other pregnancy complications, such as preeclampsia and gestational diabetes.

Similarly, many trials of oral contraceptives that aim to study the clinical endpoint of pulmonary embolism or venous thromboembolism, which are rare events, instead use the surrogates of results of coagulation tests or levels of sex hormone-binding globulin. Clearly, caution must be exercised when interpreting studies that use surrogate outcomes. As the clinician, you must recognize that a change in a biologic or physical measurement may not be clinically relevant. Some judgment is required about causal pathways: The less that is known about the causal pathway of a disease, the less confident one should be in any surrogate outcome.

Finally, clinicians also must recognize that a valid surrogate for one treatment may not be valid for another treatment or another population.⁵ For example, ovulation inhibition would be an appropriate surrogate endpoint for contraceptive efficacy for a method that reliably prevents ovulation; however, this would not be a good surrogate outcome to evaluate the progestin-only pill, which fails to inhibit ovulation completely and yet is highly effective in contraceptive trials.

Avoiding pitfalls with subgroup analyses
It is common, particularly in large RCTs, to evaluate treatment effects for a specific endpoint in a subgroup of patients included in the trial. The goal is to determine whether the findings of the larger study apply more or less to a specific patient (who may differ from the total population by some important characteristic, such as age, weight, parity, or menopausal or smoking status). The variability in study results when stratified by these patient factors is known as heterogeneity of treatment effect, which may be quantitative or qualitative.⁶

In the former, one treatment is always better than the other, although by varying degrees depending on the subgroup. (For example, a stronger effect could be seen in those aged 65 and younger than in those older than 65.) In the latter, the treatment fares better than the comparator in one subgroup but worse or no different for another subgroup. In either case, the appropriate statistical tool to identify heterogeneity of treatment effect is a test for interaction between the characteristic and the treatment effect, rather than claiming heterogeneity on the basis of separate tests of treatment effects within the different subpopulations.

One problem with dividing the original population into smaller subpopulations is that the number of participants decreases—thus there is less power, or less statistical strength, to identify a treatment effect. More accurately, there is a greater likelihood of a type II error (a false negative) when these small subpopulations have too few patients to demonstrate a clinical treatment effect that actually may exist.

False positives. Paradoxically, another problem with subgroup analyses is a greater chance for false positives due to the multiple statistical testing that is performed. The original study is rarely powered appropriately to do this (see “Error rates in subgroup analyses”). According to Wang and colleagues, “It is common practice to conduct a subgroup analysis for each of several (and often many) baseline characteristics, for each of several endpoints, or for both.”⁷ The more subgroup analyses performed, the more likely that differences found are due to chance only. Unfortunately, in unplanned post hoc analyses, the number of tests performed is often unreported; therefore, the error rates are unknown. There are statistical methods to try and correct for this “multiplicity” problem but, ideally, only a few key subgroup analyses are performed, and they are planned a priori in the original study design. In these cases, the study’s size can be adjusted accordingly. In most instances, findings from subgroup analyses, whether positive or negative, should be considered as “hypothesis generating” and interpreted with caution.

Systematic reviews: What, why, and how?
Systematic reviews aim to overcome the deficiencies of single studies in a comprehensive and unbiased manner. They critically evaluate, summarize, and, when possible, combine all available studies addressing a given topic. By comparing a range of relevant interventions across populations and settings, systematic reviews may be more generalizable than single studies. Meta-analysis, or quantitatively combining study results, increases sample size and usually provides more precise estimates of effect sizes than the single studies. Critical appraisal of the combined studies can highlight methodologic and other concerns about the body of evidence to assess the overall confidence in the included studies.

A systematic review, like a well-conducted RCT, has a protocol that lays out the scope of the review and defines a priori criteria and analytic plans—all with the goal of minimizing bias. It starts with a well-formulated research question, explicitly defining the PICO elements—population, interventions, comparators, outcomes—in addition to the setting and study designs of interest.⁸ Based on these eligibility criteria, several sources of evidence (such as electronic databases and reference lists) are searched to find all potentially eligible studies.

Typically, several thousand citations are found that must be matched against the eligibility criteria. Potentially eligible studies are then rescreened in full text to further scrutinize their eligibility. The goal is to be highly sensitive to avoid missing relevant studies—even at the time cost of screening many articles. The individual study designs (including the study eligibility criteria, interventions, outcomes, and analytic methods) and the results for all outcomes of interest are extracted from each study.

For most systematic reviews, researchers also will assess the quality, or risk of bias, of each study for each outcome.^9,10 Study data are summarized across all included studies, with study results meta-analyzed and reasons for heterogeneity across studies explored. Several consensus statements detail the proper methodology to conduct and report a systematic review.^11,12 Ultimately, the review’s conclusions are based on analyses of all available evidence. By contrast, narrative reviews typically  start with a conclusion and then select evidence to support that conclusion, and are therefore more likely to be biased.¹³

As noted, systematic reviews often include meta-analysis, which may allow an exploration of some reasons for study heterogeneity. The meta-analysis is usually presented graphically in a forest plot, which displays point estimates for each study with their associated 95% confidence intervals and a description of each study.¹⁴ In a forest plot, one can see the estimate and precision of each study, assess the heterogeneity of results across studies, and compare individual studies to each other and to the overall summary estimate.

Systematic reviews should be read as critically as primary studies. Some important questions you should consider are:

• Did the review address the populations, interventions, comparators, outcomes, and settings relevant to your practice?
• Have studies been included in a nonbiased manner, and is the described body of evidence likely to be complete?
• Did the study authors evaluate and summarize the underlying risks of bias of the studies?
• Did the researchers avoid combining studies that are too different from each other to allow a coherent interpretation of the summary results?
• Did the researchers attempt to explain how and why studies differed from one another?

Of note, systematic reviews and meta-analyses are subject to the same biases as all retrospective studies. Also, the systematic reviewers’ own biases—due to factors such as funding source, researchers’ agendas, or specialties—may subtly affect systematic reviews just as biases may affect an individual study. Furthermore, the confidence you have in a systematic review’s conclusions may be limited by the quality and generalizability of the underlying studies.

Assessing harms
You make the ultimate management decisions for your patient (though, of course, with her participation). The likely benefit of a specific treatment—determined in an experimental trial and refined further in a systematic review and meta-analysis—must be balanced with the risk of harms. RCTs usually do not provide the highest quality evidence of harms due to their limited sample sizes and short follow-up duration. Rather, large observational studies, case series, and case reports commonly provide these important details. Increasingly, patient registries are being created to prospectively follow patients and gather uniform safety data. By providing a true denominator, more accurate estimates of adverse event incidence are possible. However, the disadvantages of all of these modalities are 1) there usually are no comparators (that is, “How does the adverse event incidence for surgery A compare to that for surgery B?”) and 2) data usually are gleaned from medical records and not directly from patients.

As a result, these studies typically lack information on subjective harms, such as impaired sexual function. The reporting of treatment harms suffers from inconsistent and imprecise terminology, making it hard to reliably gather all reports of similar adverse events. Adverse event reporting in clinical trials is often driven by regulatory definitions and requirements instead of patient-centered definitions. In fact, there has been little work to date that assesses which adverse events or complications may be most relevant or important from the patient perspective.

Taken together, it is clear that the medical literature tends to emphasize treatment benefits (with robust methodologies and data to detect these benefits) but does not reliably or adequately assess harms. For rare events, risk estimates always will be imprecise. Nonetheless, better systematic reviews and today’s larger comparative effectiveness reviews strive to gather harms data from the multiple available sources described above.

Applying the evidence and your expertise to your patient
Now that you have identified the best valid and important evidence to support or refute a clinical decision (TABLE¹⁵), and have coupled this with your own expert knowledge and judgment in shared decision making with your patient, you must communicate to her the personalized information about outcomes, probabilities, and scientific uncertainties of her available treatment options.¹⁵ Patients, in turn, should be allowed to communicate their values and the relative importance they place on benefits and harms.¹⁶ This conversation, of course, is built on the foundation of a sound physician–patient relationship and is a part of every informed consent process.

Decision tools
Increasingly, decision-aid tools are being developed to support this process. These aids must express the helpful and harmful effects of a treatment, including alternative options, in statements that are valid and concise. Furthermore, they must be intelligible to both the clinician and patient and modifiable to the patient’s values and wishes.¹⁷ Two examples of counseling aids are the Gail model of breast cancer risk prediction¹⁸ and the Framingham Coronary Heart Disease Prediction Score.¹⁹ Web-based decision aids that can be accessed in real-time in busy clinical settings also are being developed for gynecology.²⁰

Never stop re-evaluating
The final piece of EBM is to “close the loop”—meaning to evaluate the effectiveness of applying the evidence in clinical practice. To do this, watch for clinical practice guidelines that are based on systematic reviews and the EBM approach and stay abreast of ACOG’s and other professional societies’ guideline statements. Ultimately, guidelines beget performance measures. Organizations such as the National Quality Forum are working to define these standards of performance measurement and seek feedback from individual clinicians to ensure measures are meaningful and accurate. By 2017, 9% of all Medicare payments are scheduled to be performance based.²¹

Conclusion
During the course of reading medical literature, stay attuned to comparative effectiveness research and recognize studies with active comparators that examine clinical questions that could impact your day-to-day practice and that can be applied to your patient population. While there is no such thing as a perfect research study, and it is rare that one trial can address any one clinician’s specific patients precisely, increasingly we are seeing better systematic reviews and meta-analyses. It is these studies that provide the high quality data for you to couple with your clinical expertise and your patients’ values and preferences to truly deliver evidence-based medicine.

Share your thoughts! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:

• a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
• improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
• improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:

1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.

Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:

• a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
• improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
• improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:

1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.

Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.

An analysis of 882 obstetric claims closed between 2007 and 2014 highlighted 3 common patient allegations:

• a delay in treatment of fetal distress (22%). The term fetal distress remains a common allegation in malpractice claims. Cases in this category most often reflected a delay or failure to act in the face of Category II or III fetal heart-rate tracings.
• improper performance of vaginal delivery (20%). Almost half of the cases in this category involved brachial plexus injuries linked to shoulder dystocia. Patients alleged that improper maneuvers were used to resolve the dystocia. The remainder of cases in this category involved forceps and vacuum extraction deliveries.
• improper management of pregnancy (17%). Among the allegations were a failure to test for fetal abnormalities, failure to recognize complications of pregnancy, and failure to address abnormal findings.

Together, these 3 allegations accounted for 59% of claims. Other allegations included diagnosis-related claims, delay in delivery, improper performance of operative delivery, retained foreign bodies, and improper choice of delivery method.¹

The Obstetrics Closed Claims Study findings were released earlier this spring by the Napa, California−based Doctors Company, the nation’s largest physician-owned medical malpractice insurer.¹ Susan Mann, MD, a spokesperson for the company, provided expert commentary on the study at the 2015 Annual Clinical Meeting of the American College of Obstetricians and Gynecologists in San Francisco. (Listen to this accompanying audiocast featuring her comments.) Dr. Mann practices obstetrics and gynecology in Brookline, Massachusetts, and at Beth Israel Deaconess Medical Center in Boston. She is president of the QualBridge Institute, a consulting firm focused on issues of quality and safety.

Top 7 factors contributing to patient injury
The Doctors Company identified specific factors that contributed to patient injury in the closed claims:

1. Selection and management of therapy (34%). Among the issues here were decisions involving augmentation of labor, route of delivery, and the timing of interventions. This factor also related to medications—for example, a failure to order antibiotics for Group A and Group B strep, a failure to order Rho(D) immune globulin for Rh-negative mothers, and a failure to provide magnesium sulfate for women with eclampsia.
2. Patient-assessment issues (32%). The Doctors Company reviewers found that physicians frequently failed to consider information that was available, or overlooked abnormal findings.
3. Technical performance (18%). This factor involved problems associated with known risks of various procedures, such as postpartum hemorrhage and brachial plexus injuries. It also included poor technique.
4. Communication among providers (17%)
5. Patient factors (16%). These factors included a failure to comply with therapy or to show up for appointments.
6. Insufficient or lack of documentation (14%)
7. Communication between patient/family and provider (14%).

“Studying obstetrical medical malpractice claims sheds light on the wide array of problems that may arise during pregnancy and in labor and delivery,” the study authors conclude. “Many of these cases reflect unusual maternal or neonatal conditions that can be diagnosed only with vigilance. Examples include protein deficiencies, clotting abnormalities, placental abruptions, infections, and genetic abnormalities. More common conditions should be identified with close attention to vital signs, laboratory studies, changes to maternal and neonatal conditions, and patient complaints.”

“Obstetric departments must plan for clinical emergencies by developing and maintaining physician and staff competencies through mock drills and simulations that reduce the likelihood of injuries to mothers and their infants,” the study authors conclude.

Tips for reducing malpractice claims in obstetrics
The Obstetrics Closed Claim Study identified a number of “underlying vulnerabilities” that place patients at risk and increase liability for clinicians. The Doctors Company offers the following tips to help reduce these claims:
• Require periodic training and certification for physicians and nurses to maintain competency and facilitate conversations about fetal heart-rate (FHR) tracing interpretation. Both parties should use the same terminology when discussing the strips.
• Use technology that allows physicians to review FHR patterns from remote locations so that physicians and nurses are able to see the same information when discussing next steps.
• When operative vaginal delivery is attempted in the face of a Category III FHR tracing, a contingency team should be available for possible emergent cesarean delivery.
• Foster a culture in which caregivers feel comfortable speaking up if they have a concern. Ensure that the organization has a well-defined escalation guideline.

Share your thoughts on this article! Send your Letter to the Editor to rbarbieri@frontlinemedcom.com. Please include your name and the city and state in which you practice.