OBG Management

Mother has severe pain — uterine rupture: $9M settlement

At 37 weeks’ gestation, a woman went to the hospital with contractions and abdominal pain 2 weeks before her scheduled delivery. She had a previous cesarean delivery. When seen by hospital nurses, she was dilated to .5-cm and reported a pain score of 8/10. Fetal heart-rate (FHR) monitoring showed that the mother was having irregular contractions and that the baby had a reassuring heart-rate tracing. Her ObGyn, contacted by phone, prescribed a medication to stop the contractions. The patient’s pain score dropped to 0/10, and she was discharged.

She returned the next night after midnight with contractions and a pain score of 9/10, and she was admitted. The nurses spoke with the ObGyn via phone 6 times over the next 8 hours. He prescribed 3 pain medications but the patient’s pain was unresponsive. When the patient called her ObGyn, he told her an ultrasound would be performed and the baby would be delivered in the morning. FHR monitoring became nonreassuring at 8:00 am. The ObGyn ordered a cesarean delivery via phone at 8:05 am, and said he was leaving for the hospital. An on-call ObGyn began the cesarean delivery at 8:52 am and found a uterine rupture with the baby outside the uterus. The patient’s ObGyn arrived just after the incision was made. The infant was delivered at 8:54 am.

The baby was transferred to the neonatal intensive care unit (NICU) where he received therapeutic hypothermia. The parents were told that there was a 70% chance that the child would have cerebral palsy. The baby required a feeding tube and was hospitalized for 84 days. After discharge, he was moved to a long-term care facility. During his first year of life, he had pneumonia requiring hospitalization. Due to frequent aspiration of food and saliva into his airway, a tracheostomy was placed.

The child has hypoxic ischemic encephalopathy with severe brain damage, including spastic quadriplegic cerebral palsy. He is blind but can hear. He will need 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The ObGyn did not properly react to the mother’s reported severe pain. A cesarean delivery should have been performed when the mother first reported to the hospital or when she returned the following night.

PHYSICIAN'S DEFENSE: The defense was expected to argue at trial that the mother was not in labor because medication had stopped contractions; therefore it was reasonable to mature longer before delivery. The case settled during the trial.

VERDICT: A $9 million Michigan settlement was reached during mediation.

Baby dies at birth: $1.3M settlement

A 39-year-old woman was admitted to the hospital at 36 weeks’ gestation with regular contractions. Results of an ultrasound showed normal amniotic fluid and an anterior placental location. The patient’s membranes were artificially ruptured, and she received an epidural. The baby remained at plus-one station for more than 7 hours until delivery. Three attempts to rotate the baby over the course of labor failed. Variable decelerations were present on FHR monitoring throughout labor, and deep decelerations were noted within 2 hours of delivery. The ObGyn ordered cesarean delivery due to arrest of labor and fetal distress; delivery began 64 minutes after the decision. The baby’s head was deeply impacted in the pelvis and a Bandl’s ring was encountered. Several attempts were made to dislodge the fetal head. The fourth attempt, in conjunction with enlarging the hysterotomy, was successful. At birth, the baby was pale with no palpable pulse. A 17-minute resuscitation effort failed. An autopsy concluded that the cause of death was a subgaleal hemorrhage in the setting of acute and subacute placental pathology.

PARENT'S CLAIM: The ObGyn was negligent for not performing a cesarean delivery when the baby could not be rotated from a plus-one station and fetal distress was evident. The ObGyn never accessed the patient’s electronic medical records during the 8 hours of labor. An audit trail review revealed the editing and alleged purging of medical records.

PHYSICIAN'S CLAIM: The case was defended on the basis of the autopsy findings, alleging that the baby was compromised before labor and delivery. A pathology expert testified that blood loss from a subgaleal hemorrhage was not necessarily lethal and may occur spontaneously. However, the pathologist conceded that she failed to note complications that occurred during delivery and acknowledged that the autopsy did not document the bruising of the baby’s head, ear, neck, shoulder, and torso that was evident in autopsy photographs.

VERDICT: A $1.3 million Virginia settlement was reached.

Was tachycardic FHR ignored? $3M settlement

A 25-year-old woman with gestational diabetes was scheduled for induction of labor at 39 2/7 weeks’ gestation. When she presented for induction, artificial rupture of the membranes demonstrated clear fluid with no sign of fetal or maternal distress. Labor and delivery was managed by a certified nurse midwife (CNM) employed by an ObGyn group. Just prior to the CNM’s arrival, the FHR monitor tracings showed a series of decelerations; the CNM stopped the oxytocin. As labor progressed, the CNM reintroduced and increased the oxytocin dosage. The infant’s heart rate became tachycardic. The CNM documented a bloody show of vaginal fluid. After the mother began pushing, the FHR signal was lost on the external monitor and only the maternal pulse was detected. As the infant’s head crowned, the FHR monitor was reconnected; an FHR of 210 bpm was detected showing marked tachycardia.

After vaginal delivery, the child was limp and unresponsive. He had hypoxic ischemic encephalopathy and immediately began to have seizures. He was transferred to the NICU at another hospital where he stayed for 34 days. The infant was found to have spastic quadriplegic cerebral palsy, cortical visual impairment, a seizure disorder, right-sided torticollis, plagiocephaly, expressive language disorder, and dysphagia. He will require 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The CNM failed to consult an ObGyn to determine whether the patient needed an urgent cesarean delivery when FHR monitoring first indicated a worrisome fetal heart rate. The CNM improperly increased the dosage of oxytocin and did not remain at the mother’s bedside until she was fully dilated and began pushing. The CNM failed to rule out placental abruption or to communicate to the ObGyn that there was bloody show in vaginal fluid. The CNM interpreted the maternal heart rate as a reassuring fetal heart rate. When the monitor was reattached, the CNM failed to call for emergency assistance, despite signs of acute fetal distress. Testing ruled out any preexisting neurologic injury or congenital defect.

DEFENDANT'S DEFENSE: The CNM claimed that she delegated the heart monitoring to the labor nurse and relied on the nurse to report any irregularities. The case was settled during the trial.

VERDICT: A $3 million Virginia settlement was reached, which included $2.1M for the infant and $.9M for the mother.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Mother has severe pain — uterine rupture: $9M settlement

At 37 weeks’ gestation, a woman went to the hospital with contractions and abdominal pain 2 weeks before her scheduled delivery. She had a previous cesarean delivery. When seen by hospital nurses, she was dilated to .5-cm and reported a pain score of 8/10. Fetal heart-rate (FHR) monitoring showed that the mother was having irregular contractions and that the baby had a reassuring heart-rate tracing. Her ObGyn, contacted by phone, prescribed a medication to stop the contractions. The patient’s pain score dropped to 0/10, and she was discharged.

She returned the next night after midnight with contractions and a pain score of 9/10, and she was admitted. The nurses spoke with the ObGyn via phone 6 times over the next 8 hours. He prescribed 3 pain medications but the patient’s pain was unresponsive. When the patient called her ObGyn, he told her an ultrasound would be performed and the baby would be delivered in the morning. FHR monitoring became nonreassuring at 8:00 am. The ObGyn ordered a cesarean delivery via phone at 8:05 am, and said he was leaving for the hospital. An on-call ObGyn began the cesarean delivery at 8:52 am and found a uterine rupture with the baby outside the uterus. The patient’s ObGyn arrived just after the incision was made. The infant was delivered at 8:54 am.

The baby was transferred to the neonatal intensive care unit (NICU) where he received therapeutic hypothermia. The parents were told that there was a 70% chance that the child would have cerebral palsy. The baby required a feeding tube and was hospitalized for 84 days. After discharge, he was moved to a long-term care facility. During his first year of life, he had pneumonia requiring hospitalization. Due to frequent aspiration of food and saliva into his airway, a tracheostomy was placed.

The child has hypoxic ischemic encephalopathy with severe brain damage, including spastic quadriplegic cerebral palsy. He is blind but can hear. He will need 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The ObGyn did not properly react to the mother’s reported severe pain. A cesarean delivery should have been performed when the mother first reported to the hospital or when she returned the following night.

PHYSICIAN'S DEFENSE: The defense was expected to argue at trial that the mother was not in labor because medication had stopped contractions; therefore it was reasonable to mature longer before delivery. The case settled during the trial.

VERDICT: A $9 million Michigan settlement was reached during mediation.

Baby dies at birth: $1.3M settlement

A 39-year-old woman was admitted to the hospital at 36 weeks’ gestation with regular contractions. Results of an ultrasound showed normal amniotic fluid and an anterior placental location. The patient’s membranes were artificially ruptured, and she received an epidural. The baby remained at plus-one station for more than 7 hours until delivery. Three attempts to rotate the baby over the course of labor failed. Variable decelerations were present on FHR monitoring throughout labor, and deep decelerations were noted within 2 hours of delivery. The ObGyn ordered cesarean delivery due to arrest of labor and fetal distress; delivery began 64 minutes after the decision. The baby’s head was deeply impacted in the pelvis and a Bandl’s ring was encountered. Several attempts were made to dislodge the fetal head. The fourth attempt, in conjunction with enlarging the hysterotomy, was successful. At birth, the baby was pale with no palpable pulse. A 17-minute resuscitation effort failed. An autopsy concluded that the cause of death was a subgaleal hemorrhage in the setting of acute and subacute placental pathology.

PARENT'S CLAIM: The ObGyn was negligent for not performing a cesarean delivery when the baby could not be rotated from a plus-one station and fetal distress was evident. The ObGyn never accessed the patient’s electronic medical records during the 8 hours of labor. An audit trail review revealed the editing and alleged purging of medical records.

PHYSICIAN'S CLAIM: The case was defended on the basis of the autopsy findings, alleging that the baby was compromised before labor and delivery. A pathology expert testified that blood loss from a subgaleal hemorrhage was not necessarily lethal and may occur spontaneously. However, the pathologist conceded that she failed to note complications that occurred during delivery and acknowledged that the autopsy did not document the bruising of the baby’s head, ear, neck, shoulder, and torso that was evident in autopsy photographs.

VERDICT: A $1.3 million Virginia settlement was reached.

Was tachycardic FHR ignored? $3M settlement

A 25-year-old woman with gestational diabetes was scheduled for induction of labor at 39 2/7 weeks’ gestation. When she presented for induction, artificial rupture of the membranes demonstrated clear fluid with no sign of fetal or maternal distress. Labor and delivery was managed by a certified nurse midwife (CNM) employed by an ObGyn group. Just prior to the CNM’s arrival, the FHR monitor tracings showed a series of decelerations; the CNM stopped the oxytocin. As labor progressed, the CNM reintroduced and increased the oxytocin dosage. The infant’s heart rate became tachycardic. The CNM documented a bloody show of vaginal fluid. After the mother began pushing, the FHR signal was lost on the external monitor and only the maternal pulse was detected. As the infant’s head crowned, the FHR monitor was reconnected; an FHR of 210 bpm was detected showing marked tachycardia.

After vaginal delivery, the child was limp and unresponsive. He had hypoxic ischemic encephalopathy and immediately began to have seizures. He was transferred to the NICU at another hospital where he stayed for 34 days. The infant was found to have spastic quadriplegic cerebral palsy, cortical visual impairment, a seizure disorder, right-sided torticollis, plagiocephaly, expressive language disorder, and dysphagia. He will require 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The CNM failed to consult an ObGyn to determine whether the patient needed an urgent cesarean delivery when FHR monitoring first indicated a worrisome fetal heart rate. The CNM improperly increased the dosage of oxytocin and did not remain at the mother’s bedside until she was fully dilated and began pushing. The CNM failed to rule out placental abruption or to communicate to the ObGyn that there was bloody show in vaginal fluid. The CNM interpreted the maternal heart rate as a reassuring fetal heart rate. When the monitor was reattached, the CNM failed to call for emergency assistance, despite signs of acute fetal distress. Testing ruled out any preexisting neurologic injury or congenital defect.

DEFENDANT'S DEFENSE: The CNM claimed that she delegated the heart monitoring to the labor nurse and relied on the nurse to report any irregularities. The case was settled during the trial.

VERDICT: A $3 million Virginia settlement was reached, which included $2.1M for the infant and $.9M for the mother.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Mother has severe pain — uterine rupture: $9M settlement

At 37 weeks’ gestation, a woman went to the hospital with contractions and abdominal pain 2 weeks before her scheduled delivery. She had a previous cesarean delivery. When seen by hospital nurses, she was dilated to .5-cm and reported a pain score of 8/10. Fetal heart-rate (FHR) monitoring showed that the mother was having irregular contractions and that the baby had a reassuring heart-rate tracing. Her ObGyn, contacted by phone, prescribed a medication to stop the contractions. The patient’s pain score dropped to 0/10, and she was discharged.

She returned the next night after midnight with contractions and a pain score of 9/10, and she was admitted. The nurses spoke with the ObGyn via phone 6 times over the next 8 hours. He prescribed 3 pain medications but the patient’s pain was unresponsive. When the patient called her ObGyn, he told her an ultrasound would be performed and the baby would be delivered in the morning. FHR monitoring became nonreassuring at 8:00 am. The ObGyn ordered a cesarean delivery via phone at 8:05 am, and said he was leaving for the hospital. An on-call ObGyn began the cesarean delivery at 8:52 am and found a uterine rupture with the baby outside the uterus. The patient’s ObGyn arrived just after the incision was made. The infant was delivered at 8:54 am.

The baby was transferred to the neonatal intensive care unit (NICU) where he received therapeutic hypothermia. The parents were told that there was a 70% chance that the child would have cerebral palsy. The baby required a feeding tube and was hospitalized for 84 days. After discharge, he was moved to a long-term care facility. During his first year of life, he had pneumonia requiring hospitalization. Due to frequent aspiration of food and saliva into his airway, a tracheostomy was placed.

The child has hypoxic ischemic encephalopathy with severe brain damage, including spastic quadriplegic cerebral palsy. He is blind but can hear. He will need 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The ObGyn did not properly react to the mother’s reported severe pain. A cesarean delivery should have been performed when the mother first reported to the hospital or when she returned the following night.

PHYSICIAN'S DEFENSE: The defense was expected to argue at trial that the mother was not in labor because medication had stopped contractions; therefore it was reasonable to mature longer before delivery. The case settled during the trial.

VERDICT: A $9 million Michigan settlement was reached during mediation.

Baby dies at birth: $1.3M settlement

A 39-year-old woman was admitted to the hospital at 36 weeks’ gestation with regular contractions. Results of an ultrasound showed normal amniotic fluid and an anterior placental location. The patient’s membranes were artificially ruptured, and she received an epidural. The baby remained at plus-one station for more than 7 hours until delivery. Three attempts to rotate the baby over the course of labor failed. Variable decelerations were present on FHR monitoring throughout labor, and deep decelerations were noted within 2 hours of delivery. The ObGyn ordered cesarean delivery due to arrest of labor and fetal distress; delivery began 64 minutes after the decision. The baby’s head was deeply impacted in the pelvis and a Bandl’s ring was encountered. Several attempts were made to dislodge the fetal head. The fourth attempt, in conjunction with enlarging the hysterotomy, was successful. At birth, the baby was pale with no palpable pulse. A 17-minute resuscitation effort failed. An autopsy concluded that the cause of death was a subgaleal hemorrhage in the setting of acute and subacute placental pathology.

PARENT'S CLAIM: The ObGyn was negligent for not performing a cesarean delivery when the baby could not be rotated from a plus-one station and fetal distress was evident. The ObGyn never accessed the patient’s electronic medical records during the 8 hours of labor. An audit trail review revealed the editing and alleged purging of medical records.

PHYSICIAN'S CLAIM: The case was defended on the basis of the autopsy findings, alleging that the baby was compromised before labor and delivery. A pathology expert testified that blood loss from a subgaleal hemorrhage was not necessarily lethal and may occur spontaneously. However, the pathologist conceded that she failed to note complications that occurred during delivery and acknowledged that the autopsy did not document the bruising of the baby’s head, ear, neck, shoulder, and torso that was evident in autopsy photographs.

VERDICT: A $1.3 million Virginia settlement was reached.

Was tachycardic FHR ignored? $3M settlement

A 25-year-old woman with gestational diabetes was scheduled for induction of labor at 39 2/7 weeks’ gestation. When she presented for induction, artificial rupture of the membranes demonstrated clear fluid with no sign of fetal or maternal distress. Labor and delivery was managed by a certified nurse midwife (CNM) employed by an ObGyn group. Just prior to the CNM’s arrival, the FHR monitor tracings showed a series of decelerations; the CNM stopped the oxytocin. As labor progressed, the CNM reintroduced and increased the oxytocin dosage. The infant’s heart rate became tachycardic. The CNM documented a bloody show of vaginal fluid. After the mother began pushing, the FHR signal was lost on the external monitor and only the maternal pulse was detected. As the infant’s head crowned, the FHR monitor was reconnected; an FHR of 210 bpm was detected showing marked tachycardia.

After vaginal delivery, the child was limp and unresponsive. He had hypoxic ischemic encephalopathy and immediately began to have seizures. He was transferred to the NICU at another hospital where he stayed for 34 days. The infant was found to have spastic quadriplegic cerebral palsy, cortical visual impairment, a seizure disorder, right-sided torticollis, plagiocephaly, expressive language disorder, and dysphagia. He will require 24-hour nursing care for the rest of his life.

PARENT'S CLAIM: The CNM failed to consult an ObGyn to determine whether the patient needed an urgent cesarean delivery when FHR monitoring first indicated a worrisome fetal heart rate. The CNM improperly increased the dosage of oxytocin and did not remain at the mother’s bedside until she was fully dilated and began pushing. The CNM failed to rule out placental abruption or to communicate to the ObGyn that there was bloody show in vaginal fluid. The CNM interpreted the maternal heart rate as a reassuring fetal heart rate. When the monitor was reattached, the CNM failed to call for emergency assistance, despite signs of acute fetal distress. Testing ruled out any preexisting neurologic injury or congenital defect.

DEFENDANT'S DEFENSE: The CNM claimed that she delegated the heart monitoring to the labor nurse and relied on the nurse to report any irregularities. The case was settled during the trial.

VERDICT: A $3 million Virginia settlement was reached, which included $2.1M for the infant and $.9M for the mother.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Endometriosis surgery on a young woman: $483,351 award

A 17-year-old woman reported cramping and heavy bleeding during her menses. Her gynecologist suspected that the patient had endometriosis and recommended laparoscopic surgery with cauterization.

During surgery, the gynecologist found 2 metal staples in the patient’s pelvic region from a prior appendectomy. He continued with the surgery as planned, using monopolar cauterization to excise the endometriosis.

The following day, the patient sought emergency treatment for pain. Physicians discovered 2 perforations in her anterior rectum and performed an emergency colectomy. She spent 18 days in the hospital. When the colectomy was reversed 3 months later, she was hospitalized for 8 days and later developed a postoperative surgical site infection requiring IV antibiotics and weeks of wound care.

The patient was in the middle of her senior year of high school when she had the colectomy and could not return to normal activities. She was unable to graduate with her class and had to relinquish a college scholarship. As a result, she completed her senior year via homeschooling and graduated a year later.

PATIENT'S CLAIM: The gynecologist’s negligent use of the cautery device within millimeters of the staples caused the bowel injury and necessitated the colectomy. The electric current from the cautery device heated the staples, injuring the rectum, which became necrotic. While she had no long-term physical limitations, wearing the colostomy bag, missing her senior year, not being able to graduate with her class, and not being able to participate in typical senior year activities left her emotionally distressed.

PHYSICIAN'S DEFENSE: The staples were not found near the rectal injury. The injury was a known complication of cauterization, not a result of negligence.

VERDICT: A $588,351 California verdict was returned but was reduced to $483,351 because of the state cap on pain and suffering.

RELATED
Surgical excision of the most severe form of endometriosis

Sigmoid colon injury during hysterectomy

A 42-year-old woman had uterine fibroids that caused such heavy bleeding that she became anemic and required a transfusion. On June 26, she underwent laparoscopic-assisted supracervical hysterectomy performed by her primary ObGyn and an assisting ObGyn.

The next day, the patient developed pain and fever and her vital signs were unstable. The primary ObGyn called in a general surgeon. A CT scan showed a tear on the underside of the sigmoid colon. The general surgeon performed a laparotomy, resected the colon, and created a temporary colostomy. The colostomy reversal took place on September 25.

PATIENT'S CLAIM: The patient sued both ObGyns, alleging that they should have found the colon injury during surgery. The primary ObGyn settled before trial and the case continued against the assisting ObGyn. It was undisputed that one or both of the physicians caused the tear, but that was not the patient’s claim. The patient alleged that negligence occurred when the injury was not intraoperatively detected. Had the injury been found during surgery, a general surgeon could have performed a primary repair, saving the patient from further surgery and colostomy. The patient claimed mental anguish and embarrassment from the colostomy. Her abdomen is still tender and she has significant scarring.

PHYSICIAN'S CLAIM: There was no negligence. Nothing was unusual about the nature of the procedure, and nothing unusual was seen intraoperatively that would have led them to search for an injury. They performed adequate and appropriate exploration before closing. The linear tear on the underside of the sigmoid colon was very inconspicuous in size, shape, and location, and was away from the operative area. The injury likely occurred during manipulation of the sigmoid colon, which generally has to be retracted before the uterus can be removed. Even if the injury had been found intraoperatively, a general surgeon would have had to convert to laparoscopy to repair the colon.

VERDICT: After a settlement was reached with the primary gynecologist, a Texas defense verdict was returned for the assisting gynecologist.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Endometriosis surgery on a young woman: $483,351 award

A 17-year-old woman reported cramping and heavy bleeding during her menses. Her gynecologist suspected that the patient had endometriosis and recommended laparoscopic surgery with cauterization.

During surgery, the gynecologist found 2 metal staples in the patient’s pelvic region from a prior appendectomy. He continued with the surgery as planned, using monopolar cauterization to excise the endometriosis.

The following day, the patient sought emergency treatment for pain. Physicians discovered 2 perforations in her anterior rectum and performed an emergency colectomy. She spent 18 days in the hospital. When the colectomy was reversed 3 months later, she was hospitalized for 8 days and later developed a postoperative surgical site infection requiring IV antibiotics and weeks of wound care.

The patient was in the middle of her senior year of high school when she had the colectomy and could not return to normal activities. She was unable to graduate with her class and had to relinquish a college scholarship. As a result, she completed her senior year via homeschooling and graduated a year later.

PATIENT'S CLAIM: The gynecologist’s negligent use of the cautery device within millimeters of the staples caused the bowel injury and necessitated the colectomy. The electric current from the cautery device heated the staples, injuring the rectum, which became necrotic. While she had no long-term physical limitations, wearing the colostomy bag, missing her senior year, not being able to graduate with her class, and not being able to participate in typical senior year activities left her emotionally distressed.

PHYSICIAN'S DEFENSE: The staples were not found near the rectal injury. The injury was a known complication of cauterization, not a result of negligence.

VERDICT: A $588,351 California verdict was returned but was reduced to $483,351 because of the state cap on pain and suffering.

RELATED
Surgical excision of the most severe form of endometriosis

Sigmoid colon injury during hysterectomy

A 42-year-old woman had uterine fibroids that caused such heavy bleeding that she became anemic and required a transfusion. On June 26, she underwent laparoscopic-assisted supracervical hysterectomy performed by her primary ObGyn and an assisting ObGyn.

The next day, the patient developed pain and fever and her vital signs were unstable. The primary ObGyn called in a general surgeon. A CT scan showed a tear on the underside of the sigmoid colon. The general surgeon performed a laparotomy, resected the colon, and created a temporary colostomy. The colostomy reversal took place on September 25.

PATIENT'S CLAIM: The patient sued both ObGyns, alleging that they should have found the colon injury during surgery. The primary ObGyn settled before trial and the case continued against the assisting ObGyn. It was undisputed that one or both of the physicians caused the tear, but that was not the patient’s claim. The patient alleged that negligence occurred when the injury was not intraoperatively detected. Had the injury been found during surgery, a general surgeon could have performed a primary repair, saving the patient from further surgery and colostomy. The patient claimed mental anguish and embarrassment from the colostomy. Her abdomen is still tender and she has significant scarring.

PHYSICIAN'S CLAIM: There was no negligence. Nothing was unusual about the nature of the procedure, and nothing unusual was seen intraoperatively that would have led them to search for an injury. They performed adequate and appropriate exploration before closing. The linear tear on the underside of the sigmoid colon was very inconspicuous in size, shape, and location, and was away from the operative area. The injury likely occurred during manipulation of the sigmoid colon, which generally has to be retracted before the uterus can be removed. Even if the injury had been found intraoperatively, a general surgeon would have had to convert to laparoscopy to repair the colon.

VERDICT: After a settlement was reached with the primary gynecologist, a Texas defense verdict was returned for the assisting gynecologist.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Endometriosis surgery on a young woman: $483,351 award

A 17-year-old woman reported cramping and heavy bleeding during her menses. Her gynecologist suspected that the patient had endometriosis and recommended laparoscopic surgery with cauterization.

During surgery, the gynecologist found 2 metal staples in the patient’s pelvic region from a prior appendectomy. He continued with the surgery as planned, using monopolar cauterization to excise the endometriosis.

The following day, the patient sought emergency treatment for pain. Physicians discovered 2 perforations in her anterior rectum and performed an emergency colectomy. She spent 18 days in the hospital. When the colectomy was reversed 3 months later, she was hospitalized for 8 days and later developed a postoperative surgical site infection requiring IV antibiotics and weeks of wound care.

The patient was in the middle of her senior year of high school when she had the colectomy and could not return to normal activities. She was unable to graduate with her class and had to relinquish a college scholarship. As a result, she completed her senior year via homeschooling and graduated a year later.

PATIENT'S CLAIM: The gynecologist’s negligent use of the cautery device within millimeters of the staples caused the bowel injury and necessitated the colectomy. The electric current from the cautery device heated the staples, injuring the rectum, which became necrotic. While she had no long-term physical limitations, wearing the colostomy bag, missing her senior year, not being able to graduate with her class, and not being able to participate in typical senior year activities left her emotionally distressed.

PHYSICIAN'S DEFENSE: The staples were not found near the rectal injury. The injury was a known complication of cauterization, not a result of negligence.

VERDICT: A $588,351 California verdict was returned but was reduced to $483,351 because of the state cap on pain and suffering.

RELATED
Surgical excision of the most severe form of endometriosis

Sigmoid colon injury during hysterectomy

A 42-year-old woman had uterine fibroids that caused such heavy bleeding that she became anemic and required a transfusion. On June 26, she underwent laparoscopic-assisted supracervical hysterectomy performed by her primary ObGyn and an assisting ObGyn.

The next day, the patient developed pain and fever and her vital signs were unstable. The primary ObGyn called in a general surgeon. A CT scan showed a tear on the underside of the sigmoid colon. The general surgeon performed a laparotomy, resected the colon, and created a temporary colostomy. The colostomy reversal took place on September 25.

PATIENT'S CLAIM: The patient sued both ObGyns, alleging that they should have found the colon injury during surgery. The primary ObGyn settled before trial and the case continued against the assisting ObGyn. It was undisputed that one or both of the physicians caused the tear, but that was not the patient’s claim. The patient alleged that negligence occurred when the injury was not intraoperatively detected. Had the injury been found during surgery, a general surgeon could have performed a primary repair, saving the patient from further surgery and colostomy. The patient claimed mental anguish and embarrassment from the colostomy. Her abdomen is still tender and she has significant scarring.

PHYSICIAN'S CLAIM: There was no negligence. Nothing was unusual about the nature of the procedure, and nothing unusual was seen intraoperatively that would have led them to search for an injury. They performed adequate and appropriate exploration before closing. The linear tear on the underside of the sigmoid colon was very inconspicuous in size, shape, and location, and was away from the operative area. The injury likely occurred during manipulation of the sigmoid colon, which generally has to be retracted before the uterus can be removed. Even if the injury had been found intraoperatively, a general surgeon would have had to convert to laparoscopy to repair the colon.

VERDICT: After a settlement was reached with the primary gynecologist, a Texas defense verdict was returned for the assisting gynecologist.

These cases were selected by the editors of OBG Management from Medical Malpractice Verdicts, Settlements & Experts, with permission of the editor, Lewis Laska (www.verdictslaska.com). The information available to the editors about the cases presented here is sometimes incomplete. Moreover, the cases may or may not have merit. Nevertheless, these cases represent the types of clinical situations that typically result in litigation and are meant to illustrate nationwide variation in jury verdicts and awards.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Managing pain associated with prolapse and SUI surgery

A 46-year-old woman (G4P4) described 3 years of worsening symptoms related to recurrent stage-3 palpable uterine prolapse. She had associated symptomatic stress urinary incontinence. She had been treated for uterine prolapse 5 years ago with vaginal hysterectomy, bilateral salpingectomy, and high uterosacral-ligament suspension.

After consultation, the patient elected to undergo laparoscopic sacral colpopexy, a mid-urethral sling, and possible anterior and posterior colporrhaphy. Appropriate discussion about the risks and benefits of mesh was provided preoperatively. The surgical team judged her to be highly motivated; she wanted same-day outpatient surgery so that she could go home and then return to work. She had excellent support at home.

How would you counsel this patient about expected postoperative pain? Which medications would you administer to her preoperatively and perioperatively? Which ones would you prescribe for her to manage pain postoperatively?

Adverse impact of prescription opioids in the United States

Although fewer than 5% of the world’s population live in the United States, nearly 80% of the world’s opioids are written for them.¹ In 2012, 259 million prescriptions were written for opioids in the United States—more than enough to give every American adult their own bottle of pills.² Sadly, drug overdose is now a leading cause of accidental death in the United States, with 52,404 lethal drug overdoses in 2015. A startling statistic is that prescription opioid abuse is driving this epidemic, with 20,101 overdose deaths related to prescription pain relievers and 12,990 overdose deaths related to heroin in 2015.³

It is likely that there are multiple reasons prescribing of opioids is epidemic. Surgical pain is a common indication for opioid prescriptions; fewer than half of patients who undergo surgery report adequate postoperative pain relief.⁴ Recognition of these deficits in pain management has inspired national campaigns to improve patients’ experience with pain and aggressively address pain with drugs such as opioids.⁵

At the same time, marketing efforts by the pharmaceutical industry sought to reassure the medical community that patients would not become addicted to prescription opioid pain relievers if physical pain was the indication for such prescriptions. In response, health care providers began to prescribe opioids at a greater rate. As providers were encouraged to increase prescriptions, opioid medications began to be misused—and only then did it become clear that these medications are, in fact, highly addictive.⁶ Opioid abuse and overdose rates began to increase; in 2015, more than 33,000 Americans died because of an opioid overdose, including prescription opioids and heroin⁷ (FIGURE). In fact, although most people recognize the threat posed by illegal heroin, most of the 2 million who abused opioids in 2015 in the United States suffered from prescription abuse; only about a quarter, or about 600,000, abused heroin.⁸ In addition, more than 80% of people who abuse heroin initially abused prescription opioids.⁹

Read about medications and strategies for multimodal pain management.

Multimodal approach to pain management

The goals of postsurgical pain treatment are to relieve suffering, optimize bodily functioning after surgery, limit length of the stay, and optimize patient satisfaction. Pain-control regimens should consider the specific surgical procedure and the patient’s medical, psychological, and physical conditions; age; level of fear or anxiety; personal preference; and response to previous treatments.¹⁰

Optimally, postsurgical pain management starts well before the day of surgery. Employing such strategies as Enhanced Recovery after Surgery (ERAS) protocols does not necessarily mean providing the same care for every patient, every time. Rather, ERAS serves as a checklist to ensure that all applicable categories of pain medication and pain-control strategies are considered, selected, and dosed according to individual needs.¹¹ (See “Preoperative management of pain expectations.”)

Opioids

Opioids have been employed to treat pain for 700 years.¹² They are powerful pain relievers because they target central mechanisms involved in the perception of pain. Regrettably, because of their central action, opioids have many adverse effects in addition to being highly addictive.

Nonopioid alternatives

Expert consensus, including recommendations of the World Health Organization,¹¹ favors using nonopioids as first-line medications to address surgical pain. Nonopioid analgesic options are acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and adjuvant medications. In addition, nonanalgesic medications such as sedatives, sleep aids, and muscle relaxants can relieve postsurgical pain. Optimal use of these nonopioid medications can significantly reduce or eliminate the need for opioid medications to treat pain. Goals are to 1) reserve opioids for the most severe pain and 2) minimize the number of doses/pills of opioids required to control postsurgical pain.

Acetaminophen. At dosages of 325 to 1,000 mg orally every 4 to 6 hours, to a maximum dosage of 4,000 mg/d, acetaminophen can be used to treat mild pain and, in combination with other medications, moderate-to-severe pain. The drug also can be administered intravenously (IV), although use of the IV route is limited in many hospitals because of its significantly higher expense compared to the oral form.

The mechanism of action of acetaminophen is unique among pain relievers; it can therefore be used in combination with other pain relievers to more effectively treat pain with fewer concerns about medication-induced adverse effects or opioid overdose. However, keep in mind when considering combining analgesics, that acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription formulations, and that a combination of more than one acetaminophen-containing product can create the risk of overdose.

Acetaminophen should be used with caution in patients with liver disease. That being said, multiple trials have documented safe use in normal body weight adults who do not have hepatic disease, at dosages as high as 4,000 mg over a 24-hour period.¹³

NSAIDs. A combination of an NSAID and acetaminophen has been documented to reduce the amount of opioid medications required to treat postsurgical pain. In most circumstances, especially for minor surgery, acetaminophen and NSAIDS can be administered just before surgery starts. This preoperative treatment, called “preventive analgesia” or “preemptive analgesia,” has been demonstrated in multiple clinical trials to reduce postoperative pain.¹⁴

Adjuvant pain medications. Antidepressants, antiepileptic agents, and muscle relaxants—agents that have a primary indication for a condition (or conditions) other than pain and do not directly provide analgesia—have been used as adjuvant pain medications. When employed with traditional analgesics, they have been demonstrated to reduce postsurgical pain scores and the amount of opioids required. These medications need to be used cautiously because some are associated with serious sedation and vertigo (TABLE). Take caution when using adjuvant pain medications in patients older than 65 years; guidance on their use in older patients has been outlined by the American Geriatrics Society and other professional organizations.¹⁵

Case Continued

The patient was given the expectation that the 11-mm left lower-quadrant port site would likely be the most bothersome site of pain—a rating of 4 or 5 on a visual analogue scale of 1 to 10, on postoperative day 1, while standing. The other 3 (5-mm) laparoscopic ports, she was told, would, typically, be less bothersome. The patient was educated regarding the role of analgesics and adjuvant medications and cautioned not to exceed 4,000 mg of acetaminophen in any 24-hour period. She was told that gabapentin may make her feel sedated or dizzy, or both; she was encouraged to hold this medication if she found these adverse effects bothersome or limiting.

The following multimodal pain management was established.

Preoperatively, the patient was given:

• Acetaminophen 1.5 g orally (as a liquid, 45 mL of a suspension of 500 mg/15 mL liquid), 2 to 3 hours preoperatively; the surgical suite did not stock IV acetaminophen.
• Gabapentin 600 mg orally, with a sip of water, the morning of surgery.
• Celecoxib 100 mg orally, with a sip of water, the morning of surgery.

Prescriptions for home postoperative pain management were provided preoperatively:

• OTC acetaminophen 1,000 mg (as 2 500-mgtablets) taken as a scheduled dose every 8 hours for the first 48 hours postoperatively.
• Meloxicam 15 mg daily as the NSAID, taken as a scheduled dose once per day for the first 48 hours postoperatively, then as needed.
• Gabapentin 300 mg (in addition to the preoperative dose, above), taken as a scheduled dose every 8 hours for the first 48 hours postoperatively, then as needed.
• Oxycodone 5 mg (without acetaminophen) for breakthrough pain.

Intraoperatively:

• Meticulous attention was paid to patient positioning, to reduce the possibility of back and upper- and lower-extremity injury postoperatively.
• A corticosteroid (dexamethasone 8 mg IV) was administered to minimize postoperative nausea and vomiting and as an adjuvant medication for postoperative pain control.
• Careful attention was paid to limit residual CO₂ gas and intraoperative intra-abdominal pressures.
• All laparoscopic port sites were injected with 30 mL of 0.25% bupivacaine with epinephrine, extending to subcutaneous, fascial, and peritoneal layers.

Read about why a multimodal approach is best for postsurgical pain.

Why a multimodal plan to treat pain?

Pain following laparoscopy has been associated with many variables, including patient positioning, port size and placement, amount of port manipulation, and gas retention. After a laparoscopic surgical procedure, patients report pain in the abdomen, back, and shoulders.

Postsurgical pain has 3 components:

• Shoulder pain, thought to result from phrenic nerve irritation caused by lingering CO₂ in the abdominal cavity.
• Visceral pain, occurring secondary to stretching of the abdominal cavity.
• Somatic pain, caused by the surgical incision; of the 3 components to pain, somatic pain can have the least impact because laparoscopic incisions are small.

For our patient, prior to the incisions being made, she received local anesthesia intraoperatively to the laparoscopic port sites to include the subcutaneous, fascial, and peritoneal layers. Involving these layers allows for more of a block. An ultrasonography-guided transversus abdominis plane (TAP) block, if available, is highly effective at decreasing postoperative pain, but its efficacy is dependent on the anatomy and the skill of the physician (whether anesthesiologist, gynecologist, or surgeon) who is placing it.¹⁶

We used dexamethasone 8 mg IV, intraoperatively because this single dose has been shown to decrease the perception of pain postoperatively. Dexamethasone also has been shown to decrease consumption of oxycodone during the 24 hours after laparoscopic gynecologic surgery.¹⁷

CO₂ used to insufflate the patient’s abdomen can take as long as 2 days to fully resorb, resulting in increased pain. This discomfort has been described as delayed; the patient might not notice it until she goes home. In a study, 70% of patients had shoulder discomfort following laparoscopy 24 hours after their procedure.¹⁸ For this reason, we employed several techniques to reduce this effect:

• We reduced the intra-abdominal pressure limit to 10 mm Hg (from 15 mm Hg) once dissection was complete.
• At the end of the procedure, careful attention was paid to removing as much intra-abdominal gas as possible, including placing the patient in the Trendelenburg position and having the anesthesiologist induce a Valsalva maneuver. This action has been shown to significantly improve pain control compared to placebo intervention.¹⁹
• We used humidified CO₂, which has been demonstrated to reduce pain in laparoscopic surgery.²⁰

Preemptively, we provided this patient with acetaminophen, celecoxib, and gabapentin, which have been demonstrated to be effective in gynecologic patients to decrease the need for postoperative opioids.²¹ Also, our patient received counseling, with specific expectations for what to expect following the surgical procedure.

CASE Resolved

Our patient did exceptionally well following surgery. She used only one of the oxycodone pills and did not require unplanned interventions. She took gabapentin, acetaminophen, and meloxicam at their scheduled doses for 2 days. She continued to use meloxicam for 4 more days for mild abdominal pain, then discontinued all medications.She flushed her 9 unused oxycodone pills down the toilet. (See “A word about disposal of ‘excess’ opioids”²²) The patient returned to her administrative duties at work 2 weeks after the procedure and reported that she was “very satisfied” with her surgical experience.

In conclusion

Postoperative pain is a complex entity that must be considered to require individualized strategies and, possibly, multiple interventions. Optimally, thorough education, including pain management options, is provided to the patient prior to surgery. Given the current state of opioid abuse in the United States, all gynecologic surgeons should be familiar with multimodal pain therapy and how to employ nonmedical techniques to reduce postsurgical pain without relying solely on opioids. (See “Online resources for pain management”.)

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Managing pain associated with prolapse and SUI surgery

A 46-year-old woman (G4P4) described 3 years of worsening symptoms related to recurrent stage-3 palpable uterine prolapse. She had associated symptomatic stress urinary incontinence. She had been treated for uterine prolapse 5 years ago with vaginal hysterectomy, bilateral salpingectomy, and high uterosacral-ligament suspension.

After consultation, the patient elected to undergo laparoscopic sacral colpopexy, a mid-urethral sling, and possible anterior and posterior colporrhaphy. Appropriate discussion about the risks and benefits of mesh was provided preoperatively. The surgical team judged her to be highly motivated; she wanted same-day outpatient surgery so that she could go home and then return to work. She had excellent support at home.

How would you counsel this patient about expected postoperative pain? Which medications would you administer to her preoperatively and perioperatively? Which ones would you prescribe for her to manage pain postoperatively?

Adverse impact of prescription opioids in the United States

Although fewer than 5% of the world’s population live in the United States, nearly 80% of the world’s opioids are written for them.¹ In 2012, 259 million prescriptions were written for opioids in the United States—more than enough to give every American adult their own bottle of pills.² Sadly, drug overdose is now a leading cause of accidental death in the United States, with 52,404 lethal drug overdoses in 2015. A startling statistic is that prescription opioid abuse is driving this epidemic, with 20,101 overdose deaths related to prescription pain relievers and 12,990 overdose deaths related to heroin in 2015.³

It is likely that there are multiple reasons prescribing of opioids is epidemic. Surgical pain is a common indication for opioid prescriptions; fewer than half of patients who undergo surgery report adequate postoperative pain relief.⁴ Recognition of these deficits in pain management has inspired national campaigns to improve patients’ experience with pain and aggressively address pain with drugs such as opioids.⁵

At the same time, marketing efforts by the pharmaceutical industry sought to reassure the medical community that patients would not become addicted to prescription opioid pain relievers if physical pain was the indication for such prescriptions. In response, health care providers began to prescribe opioids at a greater rate. As providers were encouraged to increase prescriptions, opioid medications began to be misused—and only then did it become clear that these medications are, in fact, highly addictive.⁶ Opioid abuse and overdose rates began to increase; in 2015, more than 33,000 Americans died because of an opioid overdose, including prescription opioids and heroin⁷ (FIGURE). In fact, although most people recognize the threat posed by illegal heroin, most of the 2 million who abused opioids in 2015 in the United States suffered from prescription abuse; only about a quarter, or about 600,000, abused heroin.⁸ In addition, more than 80% of people who abuse heroin initially abused prescription opioids.⁹

Read about medications and strategies for multimodal pain management.

Multimodal approach to pain management

The goals of postsurgical pain treatment are to relieve suffering, optimize bodily functioning after surgery, limit length of the stay, and optimize patient satisfaction. Pain-control regimens should consider the specific surgical procedure and the patient’s medical, psychological, and physical conditions; age; level of fear or anxiety; personal preference; and response to previous treatments.¹⁰

Optimally, postsurgical pain management starts well before the day of surgery. Employing such strategies as Enhanced Recovery after Surgery (ERAS) protocols does not necessarily mean providing the same care for every patient, every time. Rather, ERAS serves as a checklist to ensure that all applicable categories of pain medication and pain-control strategies are considered, selected, and dosed according to individual needs.¹¹ (See “Preoperative management of pain expectations.”)

Opioids

Opioids have been employed to treat pain for 700 years.¹² They are powerful pain relievers because they target central mechanisms involved in the perception of pain. Regrettably, because of their central action, opioids have many adverse effects in addition to being highly addictive.

Nonopioid alternatives

Expert consensus, including recommendations of the World Health Organization,¹¹ favors using nonopioids as first-line medications to address surgical pain. Nonopioid analgesic options are acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and adjuvant medications. In addition, nonanalgesic medications such as sedatives, sleep aids, and muscle relaxants can relieve postsurgical pain. Optimal use of these nonopioid medications can significantly reduce or eliminate the need for opioid medications to treat pain. Goals are to 1) reserve opioids for the most severe pain and 2) minimize the number of doses/pills of opioids required to control postsurgical pain.

Acetaminophen. At dosages of 325 to 1,000 mg orally every 4 to 6 hours, to a maximum dosage of 4,000 mg/d, acetaminophen can be used to treat mild pain and, in combination with other medications, moderate-to-severe pain. The drug also can be administered intravenously (IV), although use of the IV route is limited in many hospitals because of its significantly higher expense compared to the oral form.

The mechanism of action of acetaminophen is unique among pain relievers; it can therefore be used in combination with other pain relievers to more effectively treat pain with fewer concerns about medication-induced adverse effects or opioid overdose. However, keep in mind when considering combining analgesics, that acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription formulations, and that a combination of more than one acetaminophen-containing product can create the risk of overdose.

Acetaminophen should be used with caution in patients with liver disease. That being said, multiple trials have documented safe use in normal body weight adults who do not have hepatic disease, at dosages as high as 4,000 mg over a 24-hour period.¹³

NSAIDs. A combination of an NSAID and acetaminophen has been documented to reduce the amount of opioid medications required to treat postsurgical pain. In most circumstances, especially for minor surgery, acetaminophen and NSAIDS can be administered just before surgery starts. This preoperative treatment, called “preventive analgesia” or “preemptive analgesia,” has been demonstrated in multiple clinical trials to reduce postoperative pain.¹⁴

Adjuvant pain medications. Antidepressants, antiepileptic agents, and muscle relaxants—agents that have a primary indication for a condition (or conditions) other than pain and do not directly provide analgesia—have been used as adjuvant pain medications. When employed with traditional analgesics, they have been demonstrated to reduce postsurgical pain scores and the amount of opioids required. These medications need to be used cautiously because some are associated with serious sedation and vertigo (TABLE). Take caution when using adjuvant pain medications in patients older than 65 years; guidance on their use in older patients has been outlined by the American Geriatrics Society and other professional organizations.¹⁵

Case Continued

The patient was given the expectation that the 11-mm left lower-quadrant port site would likely be the most bothersome site of pain—a rating of 4 or 5 on a visual analogue scale of 1 to 10, on postoperative day 1, while standing. The other 3 (5-mm) laparoscopic ports, she was told, would, typically, be less bothersome. The patient was educated regarding the role of analgesics and adjuvant medications and cautioned not to exceed 4,000 mg of acetaminophen in any 24-hour period. She was told that gabapentin may make her feel sedated or dizzy, or both; she was encouraged to hold this medication if she found these adverse effects bothersome or limiting.

The following multimodal pain management was established.

Preoperatively, the patient was given:

• Acetaminophen 1.5 g orally (as a liquid, 45 mL of a suspension of 500 mg/15 mL liquid), 2 to 3 hours preoperatively; the surgical suite did not stock IV acetaminophen.
• Gabapentin 600 mg orally, with a sip of water, the morning of surgery.
• Celecoxib 100 mg orally, with a sip of water, the morning of surgery.

Prescriptions for home postoperative pain management were provided preoperatively:

• OTC acetaminophen 1,000 mg (as 2 500-mgtablets) taken as a scheduled dose every 8 hours for the first 48 hours postoperatively.
• Meloxicam 15 mg daily as the NSAID, taken as a scheduled dose once per day for the first 48 hours postoperatively, then as needed.
• Gabapentin 300 mg (in addition to the preoperative dose, above), taken as a scheduled dose every 8 hours for the first 48 hours postoperatively, then as needed.
• Oxycodone 5 mg (without acetaminophen) for breakthrough pain.

Intraoperatively:

• Meticulous attention was paid to patient positioning, to reduce the possibility of back and upper- and lower-extremity injury postoperatively.
• A corticosteroid (dexamethasone 8 mg IV) was administered to minimize postoperative nausea and vomiting and as an adjuvant medication for postoperative pain control.
• Careful attention was paid to limit residual CO₂ gas and intraoperative intra-abdominal pressures.
• All laparoscopic port sites were injected with 30 mL of 0.25% bupivacaine with epinephrine, extending to subcutaneous, fascial, and peritoneal layers.

Read about why a multimodal approach is best for postsurgical pain.

Why a multimodal plan to treat pain?

Pain following laparoscopy has been associated with many variables, including patient positioning, port size and placement, amount of port manipulation, and gas retention. After a laparoscopic surgical procedure, patients report pain in the abdomen, back, and shoulders.

Postsurgical pain has 3 components:

• Shoulder pain, thought to result from phrenic nerve irritation caused by lingering CO₂ in the abdominal cavity.
• Visceral pain, occurring secondary to stretching of the abdominal cavity.
• Somatic pain, caused by the surgical incision; of the 3 components to pain, somatic pain can have the least impact because laparoscopic incisions are small.

For our patient, prior to the incisions being made, she received local anesthesia intraoperatively to the laparoscopic port sites to include the subcutaneous, fascial, and peritoneal layers. Involving these layers allows for more of a block. An ultrasonography-guided transversus abdominis plane (TAP) block, if available, is highly effective at decreasing postoperative pain, but its efficacy is dependent on the anatomy and the skill of the physician (whether anesthesiologist, gynecologist, or surgeon) who is placing it.¹⁶

We used dexamethasone 8 mg IV, intraoperatively because this single dose has been shown to decrease the perception of pain postoperatively. Dexamethasone also has been shown to decrease consumption of oxycodone during the 24 hours after laparoscopic gynecologic surgery.¹⁷

CO₂ used to insufflate the patient’s abdomen can take as long as 2 days to fully resorb, resulting in increased pain. This discomfort has been described as delayed; the patient might not notice it until she goes home. In a study, 70% of patients had shoulder discomfort following laparoscopy 24 hours after their procedure.¹⁸ For this reason, we employed several techniques to reduce this effect:

• We reduced the intra-abdominal pressure limit to 10 mm Hg (from 15 mm Hg) once dissection was complete.
• At the end of the procedure, careful attention was paid to removing as much intra-abdominal gas as possible, including placing the patient in the Trendelenburg position and having the anesthesiologist induce a Valsalva maneuver. This action has been shown to significantly improve pain control compared to placebo intervention.¹⁹
• We used humidified CO₂, which has been demonstrated to reduce pain in laparoscopic surgery.²⁰

Preemptively, we provided this patient with acetaminophen, celecoxib, and gabapentin, which have been demonstrated to be effective in gynecologic patients to decrease the need for postoperative opioids.²¹ Also, our patient received counseling, with specific expectations for what to expect following the surgical procedure.

CASE Resolved

Our patient did exceptionally well following surgery. She used only one of the oxycodone pills and did not require unplanned interventions. She took gabapentin, acetaminophen, and meloxicam at their scheduled doses for 2 days. She continued to use meloxicam for 4 more days for mild abdominal pain, then discontinued all medications.She flushed her 9 unused oxycodone pills down the toilet. (See “A word about disposal of ‘excess’ opioids”²²) The patient returned to her administrative duties at work 2 weeks after the procedure and reported that she was “very satisfied” with her surgical experience.

In conclusion

Postoperative pain is a complex entity that must be considered to require individualized strategies and, possibly, multiple interventions. Optimally, thorough education, including pain management options, is provided to the patient prior to surgery. Given the current state of opioid abuse in the United States, all gynecologic surgeons should be familiar with multimodal pain therapy and how to employ nonmedical techniques to reduce postsurgical pain without relying solely on opioids. (See “Online resources for pain management”.)

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

CASE Managing pain associated with prolapse and SUI surgery

A 46-year-old woman (G4P4) described 3 years of worsening symptoms related to recurrent stage-3 palpable uterine prolapse. She had associated symptomatic stress urinary incontinence. She had been treated for uterine prolapse 5 years ago with vaginal hysterectomy, bilateral salpingectomy, and high uterosacral-ligament suspension.

After consultation, the patient elected to undergo laparoscopic sacral colpopexy, a mid-urethral sling, and possible anterior and posterior colporrhaphy. Appropriate discussion about the risks and benefits of mesh was provided preoperatively. The surgical team judged her to be highly motivated; she wanted same-day outpatient surgery so that she could go home and then return to work. She had excellent support at home.

How would you counsel this patient about expected postoperative pain? Which medications would you administer to her preoperatively and perioperatively? Which ones would you prescribe for her to manage pain postoperatively?

Adverse impact of prescription opioids in the United States

Although fewer than 5% of the world’s population live in the United States, nearly 80% of the world’s opioids are written for them.¹ In 2012, 259 million prescriptions were written for opioids in the United States—more than enough to give every American adult their own bottle of pills.² Sadly, drug overdose is now a leading cause of accidental death in the United States, with 52,404 lethal drug overdoses in 2015. A startling statistic is that prescription opioid abuse is driving this epidemic, with 20,101 overdose deaths related to prescription pain relievers and 12,990 overdose deaths related to heroin in 2015.³

It is likely that there are multiple reasons prescribing of opioids is epidemic. Surgical pain is a common indication for opioid prescriptions; fewer than half of patients who undergo surgery report adequate postoperative pain relief.⁴ Recognition of these deficits in pain management has inspired national campaigns to improve patients’ experience with pain and aggressively address pain with drugs such as opioids.⁵

At the same time, marketing efforts by the pharmaceutical industry sought to reassure the medical community that patients would not become addicted to prescription opioid pain relievers if physical pain was the indication for such prescriptions. In response, health care providers began to prescribe opioids at a greater rate. As providers were encouraged to increase prescriptions, opioid medications began to be misused—and only then did it become clear that these medications are, in fact, highly addictive.⁶ Opioid abuse and overdose rates began to increase; in 2015, more than 33,000 Americans died because of an opioid overdose, including prescription opioids and heroin⁷ (FIGURE). In fact, although most people recognize the threat posed by illegal heroin, most of the 2 million who abused opioids in 2015 in the United States suffered from prescription abuse; only about a quarter, or about 600,000, abused heroin.⁸ In addition, more than 80% of people who abuse heroin initially abused prescription opioids.⁹

Read about medications and strategies for multimodal pain management.

Multimodal approach to pain management

The goals of postsurgical pain treatment are to relieve suffering, optimize bodily functioning after surgery, limit length of the stay, and optimize patient satisfaction. Pain-control regimens should consider the specific surgical procedure and the patient’s medical, psychological, and physical conditions; age; level of fear or anxiety; personal preference; and response to previous treatments.¹⁰

Optimally, postsurgical pain management starts well before the day of surgery. Employing such strategies as Enhanced Recovery after Surgery (ERAS) protocols does not necessarily mean providing the same care for every patient, every time. Rather, ERAS serves as a checklist to ensure that all applicable categories of pain medication and pain-control strategies are considered, selected, and dosed according to individual needs.¹¹ (See “Preoperative management of pain expectations.”)

Opioids

Opioids have been employed to treat pain for 700 years.¹² They are powerful pain relievers because they target central mechanisms involved in the perception of pain. Regrettably, because of their central action, opioids have many adverse effects in addition to being highly addictive.

Nonopioid alternatives

Expert consensus, including recommendations of the World Health Organization,¹¹ favors using nonopioids as first-line medications to address surgical pain. Nonopioid analgesic options are acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and adjuvant medications. In addition, nonanalgesic medications such as sedatives, sleep aids, and muscle relaxants can relieve postsurgical pain. Optimal use of these nonopioid medications can significantly reduce or eliminate the need for opioid medications to treat pain. Goals are to 1) reserve opioids for the most severe pain and 2) minimize the number of doses/pills of opioids required to control postsurgical pain.

Acetaminophen. At dosages of 325 to 1,000 mg orally every 4 to 6 hours, to a maximum dosage of 4,000 mg/d, acetaminophen can be used to treat mild pain and, in combination with other medications, moderate-to-severe pain. The drug also can be administered intravenously (IV), although use of the IV route is limited in many hospitals because of its significantly higher expense compared to the oral form.

The mechanism of action of acetaminophen is unique among pain relievers; it can therefore be used in combination with other pain relievers to more effectively treat pain with fewer concerns about medication-induced adverse effects or opioid overdose. However, keep in mind when considering combining analgesics, that acetaminophen is an active ingredient in hundreds of over-the-counter (OTC) and prescription formulations, and that a combination of more than one acetaminophen-containing product can create the risk of overdose.

Acetaminophen should be used with caution in patients with liver disease. That being said, multiple trials have documented safe use in normal body weight adults who do not have hepatic disease, at dosages as high as 4,000 mg over a 24-hour period.¹³

NSAIDs. A combination of an NSAID and acetaminophen has been documented to reduce the amount of opioid medications required to treat postsurgical pain. In most circumstances, especially for minor surgery, acetaminophen and NSAIDS can be administered just before surgery starts. This preoperative treatment, called “preventive analgesia” or “preemptive analgesia,” has been demonstrated in multiple clinical trials to reduce postoperative pain.¹⁴

Adjuvant pain medications. Antidepressants, antiepileptic agents, and muscle relaxants—agents that have a primary indication for a condition (or conditions) other than pain and do not directly provide analgesia—have been used as adjuvant pain medications. When employed with traditional analgesics, they have been demonstrated to reduce postsurgical pain scores and the amount of opioids required. These medications need to be used cautiously because some are associated with serious sedation and vertigo (TABLE). Take caution when using adjuvant pain medications in patients older than 65 years; guidance on their use in older patients has been outlined by the American Geriatrics Society and other professional organizations.¹⁵

Case Continued

The patient was given the expectation that the 11-mm left lower-quadrant port site would likely be the most bothersome site of pain—a rating of 4 or 5 on a visual analogue scale of 1 to 10, on postoperative day 1, while standing. The other 3 (5-mm) laparoscopic ports, she was told, would, typically, be less bothersome. The patient was educated regarding the role of analgesics and adjuvant medications and cautioned not to exceed 4,000 mg of acetaminophen in any 24-hour period. She was told that gabapentin may make her feel sedated or dizzy, or both; she was encouraged to hold this medication if she found these adverse effects bothersome or limiting.

The following multimodal pain management was established.

Preoperatively, the patient was given:

• Acetaminophen 1.5 g orally (as a liquid, 45 mL of a suspension of 500 mg/15 mL liquid), 2 to 3 hours preoperatively; the surgical suite did not stock IV acetaminophen.
• Gabapentin 600 mg orally, with a sip of water, the morning of surgery.
• Celecoxib 100 mg orally, with a sip of water, the morning of surgery.

Prescriptions for home postoperative pain management were provided preoperatively:

• OTC acetaminophen 1,000 mg (as 2 500-mgtablets) taken as a scheduled dose every 8 hours for the first 48 hours postoperatively.
• Meloxicam 15 mg daily as the NSAID, taken as a scheduled dose once per day for the first 48 hours postoperatively, then as needed.
• Gabapentin 300 mg (in addition to the preoperative dose, above), taken as a scheduled dose every 8 hours for the first 48 hours postoperatively, then as needed.
• Oxycodone 5 mg (without acetaminophen) for breakthrough pain.

Intraoperatively:

• Meticulous attention was paid to patient positioning, to reduce the possibility of back and upper- and lower-extremity injury postoperatively.
• A corticosteroid (dexamethasone 8 mg IV) was administered to minimize postoperative nausea and vomiting and as an adjuvant medication for postoperative pain control.
• Careful attention was paid to limit residual CO₂ gas and intraoperative intra-abdominal pressures.
• All laparoscopic port sites were injected with 30 mL of 0.25% bupivacaine with epinephrine, extending to subcutaneous, fascial, and peritoneal layers.

Read about why a multimodal approach is best for postsurgical pain.

Why a multimodal plan to treat pain?

Pain following laparoscopy has been associated with many variables, including patient positioning, port size and placement, amount of port manipulation, and gas retention. After a laparoscopic surgical procedure, patients report pain in the abdomen, back, and shoulders.

Postsurgical pain has 3 components:

• Shoulder pain, thought to result from phrenic nerve irritation caused by lingering CO₂ in the abdominal cavity.
• Visceral pain, occurring secondary to stretching of the abdominal cavity.
• Somatic pain, caused by the surgical incision; of the 3 components to pain, somatic pain can have the least impact because laparoscopic incisions are small.

For our patient, prior to the incisions being made, she received local anesthesia intraoperatively to the laparoscopic port sites to include the subcutaneous, fascial, and peritoneal layers. Involving these layers allows for more of a block. An ultrasonography-guided transversus abdominis plane (TAP) block, if available, is highly effective at decreasing postoperative pain, but its efficacy is dependent on the anatomy and the skill of the physician (whether anesthesiologist, gynecologist, or surgeon) who is placing it.¹⁶

We used dexamethasone 8 mg IV, intraoperatively because this single dose has been shown to decrease the perception of pain postoperatively. Dexamethasone also has been shown to decrease consumption of oxycodone during the 24 hours after laparoscopic gynecologic surgery.¹⁷

CO₂ used to insufflate the patient’s abdomen can take as long as 2 days to fully resorb, resulting in increased pain. This discomfort has been described as delayed; the patient might not notice it until she goes home. In a study, 70% of patients had shoulder discomfort following laparoscopy 24 hours after their procedure.¹⁸ For this reason, we employed several techniques to reduce this effect:

• We reduced the intra-abdominal pressure limit to 10 mm Hg (from 15 mm Hg) once dissection was complete.
• At the end of the procedure, careful attention was paid to removing as much intra-abdominal gas as possible, including placing the patient in the Trendelenburg position and having the anesthesiologist induce a Valsalva maneuver. This action has been shown to significantly improve pain control compared to placebo intervention.¹⁹
• We used humidified CO₂, which has been demonstrated to reduce pain in laparoscopic surgery.²⁰

Preemptively, we provided this patient with acetaminophen, celecoxib, and gabapentin, which have been demonstrated to be effective in gynecologic patients to decrease the need for postoperative opioids.²¹ Also, our patient received counseling, with specific expectations for what to expect following the surgical procedure.

CASE Resolved

Our patient did exceptionally well following surgery. She used only one of the oxycodone pills and did not require unplanned interventions. She took gabapentin, acetaminophen, and meloxicam at their scheduled doses for 2 days. She continued to use meloxicam for 4 more days for mild abdominal pain, then discontinued all medications.She flushed her 9 unused oxycodone pills down the toilet. (See “A word about disposal of ‘excess’ opioids”²²) The patient returned to her administrative duties at work 2 weeks after the procedure and reported that she was “very satisfied” with her surgical experience.

In conclusion

Postoperative pain is a complex entity that must be considered to require individualized strategies and, possibly, multiple interventions. Optimally, thorough education, including pain management options, is provided to the patient prior to surgery. Given the current state of opioid abuse in the United States, all gynecologic surgeons should be familiar with multimodal pain therapy and how to employ nonmedical techniques to reduce postsurgical pain without relying solely on opioids. (See “Online resources for pain management”.)

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

Clinicians always should consider endometriosis in the diagnostic work-up of an infertility patient. But the diagnosis of endometriosis is often difficult, and management is complex. In this Update, we summarize international consensus documents on endometriosis with the aim of enhancing clinicians’ ability to make evidence-based decisions. In addition, we explore the interesting results of a large hysterosalpingography trial in which 2 different contrast mediums were used. Finally, we urge all clinicians to adapt the new standardized lexicon of infertility and fertility care terms that comprise the recently revised international glossary.

Endometriosis and infertility: The knowns and unknowns

Johnson NP, Hummelshoj L, Adamson GD, et al; World Endometriosis Society Sao Paulo Consortium. World Endometriosis Society consensus on the classification of endometriosis. Hum Reprod. 2017;32(2):315-324.

Johnson NP, Hummelshoj L; World Endometriosis Society Montpellier Consortium. Consensus on current management of endometriosis. Hum Reprod. 2013;28(6):1552-1568.

Rogers PA, Adamson GD, Al-Jefout M, et al; WES/WERF Consortium for Research Priorities in Endometriosis. Research priorities for endometriosis. Reprod Sci. 2017;24(2):202-226.

Endometriosis is defined as "a disease characterized by the presence of endometrium-like epithelium and stroma outside the endometrium and myometrium. Intrapelvic endometriosis can be located superficially on the peritoneum (peritoneal endometriosis), can extend 5 mm or more beneath the peritoneum (deep endometriosis) or can be present as an ovarian endometriotic cyst (endometrioma)."¹ Always consider endometriosis in the infertile patient.

Although many professional societies and numerous Cochrane Database Systematic Reviews have provided guidelines on endometriosis, controversy and uncertainty remain. The World Endometriosis Society (WES) and the World Endometriosis Research Foundation (WERF), however, have now published several consensus documents that assess the global literature and professional organization guidelines in a structured, consensus-driven process.^2-4 These WES and WERF documents consolidate known information and can be used to inform the clinician in making evidence-linked diagnostic and treatment decisions. Recommendations offered in this discussion are based on those documents.

Establishing the diagnosis can be difficult

Diagnosis of endometriosis is often difficult and is delayed an average of 7 years from onset of symptoms. These include severe dysmenorrhea, deep dyspareunia, chronic pelvic pain, ovulation pain, cyclical or perimenstrual symptoms (bowel or bladder associated) with or without abnormal bleeding, chronic fatigue, and infertility. A major difficulty is that the predictive value of any one symptom or set of symptoms remains uncertain, as each of these symptoms can have other causes, and a significant proportion of affected women are asymptomatic.

For a definitive diagnosis of endometriosis, visual inspection of the pelvis at laparoscopy is the gold standard investigation, unless disease is visible in the vagina or elsewhere. Positive histology confirms the diagnosis of endometriosis; negative histology does not exclude it. Whether histology should be obtained if peritoneal disease alone is present is controversial: visual inspection usually is adequate, but histologic confirmation of at least one lesion is ideal. In cases of ovarian endometrioma (>4 cm in diameter) and in deeply infiltrating disease, histology should be obtained to identify endometriosis and to exclude rare instances of malignancy.

Compared with laparoscopy, transvaginal ultrasonography (TVUS) has no value in diagnosing peritoneal endometriosis, but it is a useful tool for both making and excluding the diagnosis of an ovarian endometrioma. TVUS may have a role in the diagnosis of disease involving the bladder or rectum.

At present, evidence is insufficient to indicate that magnetic resonance imaging (MRI) is useful for diagnosing or excluding endometriosis compared with laparoscopy. MRI should be reserved for when ultrasound results are equivocal in cases of rectovaginal or bladder endometriosis.

Serum cancer antigen 125 (CA 125) levels may be elevated in endometriosis. However, measuring serum CA 125 levels has no value as a diagnostic tool.

No fertility benefit with ovarian suppression

More than 2 dozen randomized controlled trials (RCTs) provide strong evidence that there is no fertility benefit from ovarian suppression. The drug costs and delayed time to pregnancy mean that ovarian suppression with oral contraceptives, other progestational agents, or gonadotropin-releasing hormone (GnRH) agonists before fertility treatment is not indicated, with the possible exception of using it prior to in vitro fertilization (IVF).

Ovarian suppression also has been suggested as beneficial in conjunction with surgery. However, at least 16 RCTs have failed to show fertility improvement when ovarian suppression is given either preoperatively or postoperatively. Again, the delay in attempting pregnancy, drug costs, and adverse effects render ovarian suppression not appropriate.

While ovarian suppression has not been shown to increase pregnancy rates, ovarian stimulation (OS) likely does, especially when combined with intrauterine insemination (IUI).⁵

Laparoscopy: Appropriate for selected patients

A major decision for clinicians and patients dealing with infertility is whether to perform a laparoscopy, both for diagnostic and for treatment reasons. Currently, data are insufficient to recommend laparoscopic surgery prior to OS/IUI unless there is a history of evidence of anatomic disease and/or the patient has sufficient pain to justify the physical, emotional, financial, and time costs of laparoscopy. Laparoscopy therefore can be considered as possibly appropriate in younger women (<37 years of age) with short duration of infertility (<4 years), normal male factor, normal or treatable uterus, normal or treatable ovulation disorder, and limited prior treatment.

It is important to consider what disease might be found and how much of an increase in fertility can be obtained by treatment, so that the number needed to treat (NNT) can be used as an estimate of the potential value of laparoscopy in a given patient. A patient also should have no contraindications to laparoscopy and accept 9 to 15 months of attempting pregnancy before undergoing IVF treatment.

When laparoscopy is performed for minimal to mild disease, the odds ratio for pregnancy is 1.66 with treatment. It is important to remove all visible disease without injuring healthy tissue. When disease is moderate to severe, there is often severe anatomic distortion and a very low background pregnancy rate. Numerous uncontrolled trials show benefit of operative laparoscopy, especially for invasive, adhesive, and cystic endometriosis. However, repeat surgery is rarely indicated. After surgery, the Endometriosis Fertility Index (EFI) can be used to determine prognosis and plan management (FIGURE  1).⁶ An easy-to-use electronic EFI calculator is available online at www.endometriosisefi.com.

Management of endometriomas

Endometriomas are often operated on because of pain. Initial pain relief occurs in 60% to 100% of patients, but cysts recur following stripping about 10% of the time, and drainage without stripping, about 20%. With recurrence, pain is present about 75% of the time.

Pregnancy rates following endometrioma treatment depend on patient age and the status of the pelvis following operative intervention. This can be determined from the EFI. Often, the dilemma with endometriomas is how aggressive to be in removing them. The principles involved are to remove all the cyst wall if possible, but absolutely to minimize ovarian tissue damage, because reduced ovarian reserve is a possible major negative consequence of ovarian surgery. 

Recommendations

While endometriosis is often a cause of infertility, often infertile patients do not have endometriosis. A careful history, physical examination, and ultrasonography, and possibly other imaging studies, are prerequisites to careful clinical judgment in diagnosing and treating infertile patients who might or do have endometriosis.

When pelvic pain is present, initially nonsteroidal anti-inflammatory drugs (NSAIDs), oral contraceptives (OCs), progestational agents, or an intrauterine device can be helpful. These ovarian suppression medications do not increase fertility, however, and should be stopped in any patient who desires to get pregnant.

When pelvic and male fertility factors appear reasonably normal (even if minimal or mild endometriosis is suspected), treatment with clomiphene 100 mg on cycle days 3 through 7 and IUI for 3 to 6 cycles is an effective first step. However, if the patient has persistent pain and/or infertility without other significant infertility factors, then diagnostic laparoscopy with intraoperative treatment of disease is indicated.

Surgery well performed is effective treatment for all stages of endometriosis and endometriomas, both for infertility and for pain. Repeat surgery, however, is rarely indicated because of limited results, so it is important to obtain the best possible result on the first surgery. Surgery is indicated for large endometriomas (>4 cm). Endometriosis has almost no effect on the IVF live birth rate unless ovarian reserve has been reduced by endometriomas or surgery, so endometriosis surgery should be performed by skilled and experienced surgeons.

Read about why oil-based contrast may be better than water-based contrast with HSG.

Oil-based contrast medium use in hysterosalpingography is associated with higher pregnancy rates compared with water-based contrast

Dreyer K, van Rijswijk J, Mijatovic V, et al. Oil-based or water-based contrast for hysterosalpingography in infertile women. N Engl J Med. 2017;376(21):2043-2052.

Hysterosalpingography (HSG) to assess tubal patency has been a mainstay of infertility diagnosis for decades. Some, but not all, studies also have suggested that pregnancy rates are higher after this tubal flushing procedure, especially if performed with oil contrast.^7,8 A recent multicenter, randomized, controlled trial by Dreyer and colleagues that compared ongoing pregnancy rates and other outcomes among women who had HSG with oil contrast versus with water contrast provides additional valuable information.⁹

Trial details

In this study, 1,294 infertile women in 27 academic, teaching and nonteaching hospitals were screened for trial eligibility; 1,119 women provided written informed consent. Of these, 557 women were randomly assigned to HSG with oil contrast and 562 to water contrast. The women had spontaneous menstrual cycles, had been attempting pregnancy for at least 1 year, and had indications for HSG.

Exclusion criteria were known endocrine disorders, fewer than 8 menstrual cycles per year, a high risk of tubal disease, iodine allergy, and a total motile sperm count after sperm wash of less than 3 million/mL in the male partner (or a total motile sperm count of less than 1 million/mL when an analysis after sperm wash was not performed).

Just prior to undergoing HSG, the women were randomly assigned to receive either oil contrast or water contrast medium. (The trial was not blinded to participants or caregivers.) HSG was performed according to local protocols using cervical vacuum cup, metal cannula (hysterophore), or balloon catheter and approximately 5 to 10 mL of contrast medium.

After HSG, couples received expectant management when the predicted likelihood of pregnancy within 12 months, based on the prognostic model of Hunault, was 30% or greater.¹⁰ IUI was offered for pregnancy likelihood less than 30%, mild male infertility, or failure after a period of expectant management. IUI with or without mild ovarian stimulation (2-3 follicles) with clomiphene or gonadotropins was initiated after a minimum of 2 months of expectant management after HSG.

The primary outcome measure was ongoing pregnancy, defined as a positive fetal heartbeat on ultrasonographic examination after 12 weeks of gestation, with the first day of the last menstrual cycle for the pregnancy within 6 months after randomization. Secondary outcome measures were clinical pregnancy, live birth, miscarriage, ectopic pregnancy, time to pregnancy, and pain scores after HSG. All data were analyzed according to intention-to-treat.

Pregnancy rates increased with oil-contrast HSG

The baseline characteristics of the 2 groups were similar. HSG showed bilateral tubal patency in 477 of 554 women (86.1%) in the oil contrast group and in 491 of 554 women (88.6%) who received the water contrast (rate ratio, 0.97; 95% confidence interval [CI], 0.93-1.02). Bilateral tubal occlusion occurred in 9 women in the oil group (1.6%) and in 13 in the water group (2.3%) (relative risk, 0.69; 95% CI, 0.30-1.61).

A total of 58.3% of the women assigned to oil contrast and 57.2% of those assigned to water contrast received expectant management. Similar percentages of women in the oil group and in the water group underwent IUI (39.7% and 41.0%, respectively), IVF or intracytoplasmic sperm injection (ICSI) (2.3% and 2.2%), laparoscopy (6.2% in each group), and hysteroscopy (4.4% and 4.2%).

Ongoing pregnancy occurred in 220 of 554 women (39.7%) in the oil contrast group and in 161 of 554 women (29.1%) in the water contrast group (rate ratio, 1.37; 95% CI, 1.16-1.61; P<.001). The median time to the onset of pregnancy in the oil group was 2.7 months (interquartile range, 1.5-4.7) (FIGURE 2), while in the water group it was 3.1 months (interquartile range, 1.6-4.8) (P = .44).

While the proportion of women getting pregnant with or without the different interventions was similar in both groups, the live birth rate was 38.8% in the oil group versus 28.1% in the water group (rate ratio, 1.38; 95% CI, 1.17-1.64; P<.001). Three of 554 women (0.5%) assigned to oil contrast and 4 of  554 women (0.7%) in the water contrast group had an adverse event during the trial period. Three women (1.4%), all in the oil group, delivered a child with a congenital anomaly.

Why this study is important

This is the largest and best methodologic study on this clinical issue. It showed higher pregnancy and live birth rates within 6 months of HSG performed with oil compared with water. Although the study was not blinded, the group similarities and objective outcomes support minimal bias. Importantly, these results can be generalized only to women with similar inclusion characteristics. 

It is unclear why oil HSG might enhance fertility. Suggested mechanisms include flushing of debris and/or mucous plugs or an effect on peritoneal macrophages or endometrial receptivity. Since HSG is minimally invasive and inexpensive, and the 10% increase in pregnancy rates corresponds to an NNT of 10, it is reasonable to consider, although formal cost-effectiveness data are lacking.

Concerns include the rare theoretical risk of intravasation with subsequent allergic  reaction or fat embolism. Three infants in the oil group and none in the water group had congenital anomalies. This is likely due to chance, since this rate is not higher than that in the general population and no other data suggest an increased risk. Comparison of these results with other new techniques, such as sonohysterography (saline infusion sonogram), awaits further studies.

Recommendation

HSG with oil contrast should be considered a potential therapeutic as well as diagnostic intervention in selected patients.

Read about new definitions of infertility terminology you should know.

Infertility glossary is newly updated

Zegers-Hochchild F, Adamson GD, Dyer S, et al. The International Glossary on Infertility and Fertility Care, 2017. Fertil Steril. 2017;108(3):393-406.

Terms and definitions used in infertility and fertility care frequently have had different meanings for different stakeholders, especially on a global basis. This can result in misunderstandings and inappropriate interpretation and comparison of published information and research. To help address these issues, international fertility organizations recently developed an updated glossary on infertilityterminology.

The consensus process for updating the glossary

The International Glossary on Infertility and Fertility Care, 2017, was recently published simultaneously in Fertility and Sterility and Human Reproduction. This is the second revision; the first glossary was published in 2006 and revised in 2009. This revision's 25 lead experts began work in 2014. Their teams of professionals interacted by electronic mail, at international and regional society meetings, and at 2 consultations held in Geneva, Switzerland. This glossary represents consensus agreement reached on 283 evidence-driven terms and definitions.

The work was led by the International Committee for Monitoring Assisted Reproductive Technologies in partnership with the American Society for Reproductive Medicine, European Society of Human Reproduction and Embryology, International Federation of Fertility Societies, March of Dimes, African Fertility Society, Groupe Inter-africain d'Etude de Recherche et d'Application sur la Fertilité, Asian Pacific Initiative on Reproduction, Middle East Fertility Society, Red Latinoamericana de Reproducción Asistida, and the International Federation of Gynecology and Obstetrics.

All together, 108 international professional experts (clinicians, basic scientists, epidemiologists, and social scientists), along with national and regional representatives of infertile persons, participated in the development of this evidence-base driven glossary. As such, these definitions now set the standard for international communication among clinicians, scientists, and policymakers.

Definition of infertility is broadened

The definitions take account of ethics, human rights, cultural sensitivities, ethnic minorities, and gender equality. For example, the first modification included broadening the concept of infertility to be an "impairment of individuals" in their capacity to reproduce, irrespective of whether the individual has a partner. (See “Broadened definition of infertility” below). Reproductive rights are individual human rights and do not depend on a relationship with another individual. The revised definition also reinforces the concept of infertility as a disease that can generate an impairment of function. 

New--and changed--definitions

Certain terms need to be consistent with those used currently internationally, for example, at which gestational age a miscarriage/abortion becomes a stillbirth.

Some terms are confusing, such as subfertility, which does not define a different or less severe fertility status than infertility, does not exist before infertility is diagnosed, and should not be confused with sterility, which is a permanent state of infertility. The term subfertility therefore is redundant and has been removed and replaced by infertility (See “Some terms with an important new definition” below).

In a different context, the term conception, and its derivatives such as conceiving or conceived, was removed because it cannot be described biologically during the process of reproduction. Instead, terms such as fertilization, implantation, pregnancy, and live birth should be used.

Important male terms also changed: oligospermia is a term for low semen volume that is now replaced by hypospermia to avoid confusion with oligozoospermia, which is low concentration of spermatozoa in the ejaculate below the lower reference limit. When reporting results, the reference criteria should be specified.

Lastly, owing to the lack of standardization in determining the burden of infertility, and to better ensure comparability of prevalence data published globally, this glossary includes definitions for terms frequently used in epidemiology and public health. Examples include voluntary and involuntary childlessness, primary and secondary infertility, fertility care, fecundity, and fecundability, among others. 

Getting the word out

The glossary has been approved by all of the participating organizations who are assisting in its distribution. It is being presented at national and international meetings and is used in The FIGO Fertility Toolbox (www.fertilitytool.com). It is hoped that all professionals and other stakeholders will begin to use its terminology globally to provide quality care and ensure consistency in registering specific fertility care interventions and more accurate reporting of their outcomes.

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures

ACOG’s role in developing quality measures

In October 2016, the Centers for Medicare and Medicaid Services released the final Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under this rule, the Merit-based Incentive Payment System (MIPS) was created, which was intended to drive “value” rather than “volume” in payment incentives. Measures are critical to defining value-based care. However, the law has limited or no impact on providers who do not care for Medicare patients.

Clinicians eligible to participate in MACRA must bill more than $90,000 a year in Medicare Part B allowed charges and provide care for more than 200 Medicare patients per year.⁶ This means that the MIPS largely overlooks ObGyns, as the bulk of our patients are insured either by private insurance or by Medicaid. However, maternity care spending is a significant part of both Medicaid and private insurers’ outlay, and both payers are actively considering using value-based financial models that will need to be fed by quality metrics. ACOG wants to be at the forefront of measure development for quality metrics that affect members and has committed resources to formation of a measure development team.

ACOG wants providers to be in control of how their practices are evaluated. For this reason, ACOG is focusing on measures that are based on clinical data entered by providers into an EHR at the point of care. At the same time, ACOG is cognizant of not increasing the documentation burden for providers. Understanding the quality of the data, as opposed to the quality of care, will be a fundamental task for the maternity care registry that ACOG is launching in 2018.

What can ObGyns do?

Quality measures are about more than just money. Public reporting of these measures on government and payer websites may influence public perception of a practice.⁷ The focus on patient-centered care means that patients have a voice in their care, financially as well as literally, so expect to see increased scrutiny of provider performance by patients as well as payers. One way to measure patient experience of treatments, symptoms, and quality of life is through patient-reported outcome measures (PROMs). Assessing PROMs in routine care ensures that information only the patient can provide is collected and analyzed, thus further enhancing the delivery of care and evaluating how that care is impacting the lives of your patients.

The transition from fee-for-service to a value-based system will not happen overnight, but it will happen. This transition—from being paid for the quantity of documentation to the quality of documentation—will require some change management, rethinking of workflows, and better documentation tools (such as apps instead of EHR customization).

Many in the medical profession are actively exploring these changes and new developments. These changes are too important to leave to administrators, coders, scribes, app developers, and policy makers. Someone in your practice, hospital, or health system is working on these issues today. Tomorrow, you need to be at the table. The voices of practicing ObGyns are critical as we work to address the current challenging environment in which we spend more per capita than any other nation with far inferior results. Measures that matter to us and to our patients will help us provide better and more cost-effective care that payers and patients value.⁸

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures

ACOG’s role in developing quality measures

In October 2016, the Centers for Medicare and Medicaid Services released the final Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Under this rule, the Merit-based Incentive Payment System (MIPS) was created, which was intended to drive “value” rather than “volume” in payment incentives. Measures are critical to defining value-based care. However, the law has limited or no impact on providers who do not care for Medicare patients.

Clinicians eligible to participate in MACRA must bill more than $90,000 a year in Medicare Part B allowed charges and provide care for more than 200 Medicare patients per year.⁶ This means that the MIPS largely overlooks ObGyns, as the bulk of our patients are insured either by private insurance or by Medicaid. However, maternity care spending is a significant part of both Medicaid and private insurers’ outlay, and both payers are actively considering using value-based financial models that will need to be fed by quality metrics. ACOG wants to be at the forefront of measure development for quality metrics that affect members and has committed resources to formation of a measure development team.

ACOG wants providers to be in control of how their practices are evaluated. For this reason, ACOG is focusing on measures that are based on clinical data entered by providers into an EHR at the point of care. At the same time, ACOG is cognizant of not increasing the documentation burden for providers. Understanding the quality of the data, as opposed to the quality of care, will be a fundamental task for the maternity care registry that ACOG is launching in 2018.

What can ObGyns do?

Quality measures are about more than just money. Public reporting of these measures on government and payer websites may influence public perception of a practice.⁷ The focus on patient-centered care means that patients have a voice in their care, financially as well as literally, so expect to see increased scrutiny of provider performance by patients as well as payers. One way to measure patient experience of treatments, symptoms, and quality of life is through patient-reported outcome measures (PROMs). Assessing PROMs in routine care ensures that information only the patient can provide is collected and analyzed, thus further enhancing the delivery of care and evaluating how that care is impacting the lives of your patients.

The transition from fee-for-service to a value-based system will not happen overnight, but it will happen. This transition—from being paid for the quantity of documentation to the quality of documentation—will require some change management, rethinking of workflows, and better documentation tools (such as apps instead of EHR customization).

Many in the medical profession are actively exploring these changes and new developments. These changes are too important to leave to administrators, coders, scribes, app developers, and policy makers. Someone in your practice, hospital, or health system is working on these issues today. Tomorrow, you need to be at the table. The voices of practicing ObGyns are critical as we work to address the current challenging environment in which we spend more per capita than any other nation with far inferior results. Measures that matter to us and to our patients will help us provide better and more cost-effective care that payers and patients value.⁸

Share your thoughts! Send your Letter to the Editor to [email protected]. Please include your name and the city and state in which you practice.

The future of health care is value-based care. If Value equals Quality divided by Cost, then a defined, validated way to measure Quality is paramount to that equation. (Fortunately, Cost comes with convenient measurement units called dollars.) Payers now are asking health care providers to shift from a fee-for-service to a value-based reimbursement structure to encourage providers to deliver the best care at the lowest cost. Providers who can embrace this data-driven paradigm will succeed in this new environment.

So how do we define high-quality care? What makes a good quality measure? How do you actually measure what happens in a clinical encounter that impacts health outcomes?

To answer these questions, organizations have constructed standardized clinical quality measures. Clinical quality measures facilitate value-based care by providing a metric on which to measure a patient’s quality of care. They can be used 1) to decrease the overuse, underuse, and misuse of health care services and 2) to measure patient engagement and satisfaction with care.

What are quality measures?

The Academy of Medicine (formerly named the Institute of Medicine) defines health care quality as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.”¹

Clearly defined components and terminology. From a quantitative standpoint, quality measures must have a clearly defined numerator and denominator and appropriate inclusions, exclusions, and exceptions. These components need to be expressed clearly in terms of publicly available terminologies, such as ICD (International Classification of Diseases) codes or SNOMED CT (Systematized Nomenclature of Medicine—Clinical Terms) terms. A measure that asks if “antihypertensive meds” have been given will not nearly be as specific as one that asks if “labetalol IV, or hydralazine IV, or nifedipine SL” has been administered. The decision to tie the data elements in a measure to administrative data, such as ICD codes, or to clinical data, such as SNOMED CT, also affects how these measures can be calculated.

Moving targets. The target of the measure also must carefully be considered. Quality measures can be used to evaluate care across the full range of health care settings—from individual providers, to care teams, to hospitals and hospital systems, to health plans. While some measures easily can be assigned to a specific provider, others are not as straightforward. For example, who gets assigned the cesarean delivery when a midwife turns the case over to an obstetrician?

Timeframe in outcomes measurement. The data infrastructure is currently set up to support measurement of immediate events, 30-day or 90-day episodes, and health insurance plan member years. Longer-term outcomes, such as over 5- and 10- year periods, are out of reach for most measures. To obtain an accurate view of the impact of medical interventions or disease conditions, however, it will be important to follow patients over time. For example, to know the failure rate of intrauterine systems, sterilization, or hormonal contraceptives, it is important to be able to track pregnancy occurrence during use of these methods for longer than 90 days. Failures can occur years after a method is initiated.

Another example is to create a performance measure focused on the overall improvement in quality of life and costs related to different treatments for abnormal uterine bleeding. How does the patient experience vary over time between treatment with hormonal contraception, endometrial ablation, or hysterectomy? Which option is most “valuable” over time when the patient experience and the cost are assessed for more than a 90-day episode? These important questions need to be answered as we maneuver into a value-based health system.

Risk adjustment. Quality measures also may need to be risk adjusted. The “My patients are sicker” refrain must be accounted for with full transparency and based on the best available data. Quality measures can be adjusted using an Observed/Expected factor, which helps to account for complicated cases.²

Clearly, social and behavioral determinants of health also play a role in these adjustments, but it can be more challenging to acquire the data elements needed for those types of adjustments. Including these data enables us to evaluate health disparities between populations, both demographically and socioeconomically.³ This is important for future development of minority inclusive quality measures. Some racial and ethnic minority populations have poorer health outcomes from preventable and treatable diseases. Evidence shows that these groups have differences in access to health care, quality of care, and health measures, including life expectancy and maternal mortality. Access to clinical data through quality measures allows for these health disparities to be brought into quantifiable perspective and assists in the development of future incentive programs to combat health inequalities and provide improved delivery of care.

Read about how to develop quality measures

Developing quality measures

Quality measures generally fall into 4 broad categories: structure, process, outcome, and patient experience (TABLE).^4,5 Quality measure development begins with an assessment of the evidence, which is usually derived from clinical guidelines that link a particular process, structure, or outcome with improved patient health or experience of care. For example, the American College of Obstetricians and Gynecologists (ACOG) has developed a clinical practice guideline for screening, diagnosing, and managing gestational diabetes. The guideline addresses drug therapies, such as insulin, and alternative treatments, such as nutrition therapy. Much like the process for creating the guideline itself, translating the guideline into a quality measure requires a thoughtful, transparent, and well-defined process.

Role of the quality measure steward. Coordinating the process of translating evidence-based guidelines into quality measures requires a measure steward. Measure stewards usually are government agencies, nonprofit organizations, and/or for-profit companies. During the development process, the steward usually reaches out to additional stakeholders for feedback and consensus. Development process steps include:

• evaluation of the evidence, including the clinical practice guideline(s)
• consensus on the best measurement approach (consider the feasibility of the measurement and how it will be collected)
• development of detailed measure specifications (that is, what will be measured and how)
• feedback on the specifications from stakeholders, including professional societies and patient advocates
• testing of the measure logic and clinical validity against clinical data
• final approval by the measure steward.

Endorsement of quality measures. After a quality measure is developed, it is often endorsed by government agencies, professional societies, and/or consumer groups. Endorsement is a consensus-based process in which stakeholders evaluate a proposed measure based on established standards. Generally, stakeholders include health care professionals, consumers, payers, hospitals, health plans, and government agencies.

Evaluation of quality measures includes these important considerations:

• Are the necessary data fields available in a typical electronic health record (EHR) system?
• What is the data quality for those data fields?
• Can the measure be calculated reliably across different data sets or EHRs?
• Does the measure address one of the National Academy of Medicine quality properties? According to the academy, quality in the context of clinical care can be defined in terms of properties of effectiveness, equity, safety, efficiency, patient centeredness, and timeliness.¹

Read about ACOG’s role in developing quality measures