“TRUST: How to build a support net for ObGyns affected by a medical error”

PATRICE M. WEISS, MD (JANUARY 2017)

Support for ObGyn versus “evidence” for attorney

While every clinician recognizes the need to support the practi- tioner involved in a significant medical error, I found it puzzling that Dr. Weiss’ article did not mention our constant after-the-event associate, the personal injury attorney. How are we to provide the needed relief for the practitioner’s emotional distress without handing ammunition to the plaintiff’s lawyer?

E. Darryl Barnes, MD
Mechanicsville, Virginia

Experienced being the second victim

As Dr. Weiss states in her article, patients and their families, the first victims, are not the only ones affected by medical errors. I was involved in a medication error on a labor and delivery unit more than 20 years ago, and I was the second victim. There were also countless others. You are correct when you state that physicians, and others in medicine, do not support colleagues who have experienced a medical error. I agree with Dr. Wu’s observation that lack of empathy by peers is distressing. Symptoms of depression, burnout, decreased quality of life, and feelings of distress, guilt, and shame can occur in the second victim. I hope more people will get on board to use The Joint Commission toolkit to assist health care organizations in developing a second-victim program.

Carol Permiceo, RN
Long Island, New York

Dr. Weiss responds

I thank Dr. Barnes for his comments. The purpose of this article was mainly to assist people in establishing institutional support systems for providers when medical errors occur. Often we are not aware of litigation until some time well after the event. The TRUST second-victim support program and other programs are for immediate first aid for the provider and the team. Concerning the plaintiff’s ammunition, please remember that the purpose of these support systems, whether immediate or ongoing, is to discuss the emotional impact of the case on the provider, not the clinical details of the case.

I appreciate Ms. Permiceo sharing her story. As you probably have figured out, my interest in this area stems from my own experiences with medical errors (one in particular) and unanticipated outcomes. I hope by talking about it and validating our feelings (we are only human, after all) others will suffer less and come forward.

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.

“TRUST: How to build a support net for ObGyns affected by a medical error”

PATRICE M. WEISS, MD (JANUARY 2017)

Support for ObGyn versus “evidence” for attorney

While every clinician recognizes the need to support the practi- tioner involved in a significant medical error, I found it puzzling that Dr. Weiss’ article did not mention our constant after-the-event associate, the personal injury attorney. How are we to provide the needed relief for the practitioner’s emotional distress without handing ammunition to the plaintiff’s lawyer?

E. Darryl Barnes, MD
Mechanicsville, Virginia

Experienced being the second victim

As Dr. Weiss states in her article, patients and their families, the first victims, are not the only ones affected by medical errors. I was involved in a medication error on a labor and delivery unit more than 20 years ago, and I was the second victim. There were also countless others. You are correct when you state that physicians, and others in medicine, do not support colleagues who have experienced a medical error. I agree with Dr. Wu’s observation that lack of empathy by peers is distressing. Symptoms of depression, burnout, decreased quality of life, and feelings of distress, guilt, and shame can occur in the second victim. I hope more people will get on board to use The Joint Commission toolkit to assist health care organizations in developing a second-victim program.

Carol Permiceo, RN
Long Island, New York

Dr. Weiss responds

I thank Dr. Barnes for his comments. The purpose of this article was mainly to assist people in establishing institutional support systems for providers when medical errors occur. Often we are not aware of litigation until some time well after the event. The TRUST second-victim support program and other programs are for immediate first aid for the provider and the team. Concerning the plaintiff’s ammunition, please remember that the purpose of these support systems, whether immediate or ongoing, is to discuss the emotional impact of the case on the provider, not the clinical details of the case.

I appreciate Ms. Permiceo sharing her story. As you probably have figured out, my interest in this area stems from my own experiences with medical errors (one in particular) and unanticipated outcomes. I hope by talking about it and validating our feelings (we are only human, after all) others will suffer less and come forward.

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.

“TRUST: How to build a support net for ObGyns affected by a medical error”

PATRICE M. WEISS, MD (JANUARY 2017)

Support for ObGyn versus “evidence” for attorney

While every clinician recognizes the need to support the practi- tioner involved in a significant medical error, I found it puzzling that Dr. Weiss’ article did not mention our constant after-the-event associate, the personal injury attorney. How are we to provide the needed relief for the practitioner’s emotional distress without handing ammunition to the plaintiff’s lawyer?

E. Darryl Barnes, MD
Mechanicsville, Virginia

Experienced being the second victim

As Dr. Weiss states in her article, patients and their families, the first victims, are not the only ones affected by medical errors. I was involved in a medication error on a labor and delivery unit more than 20 years ago, and I was the second victim. There were also countless others. You are correct when you state that physicians, and others in medicine, do not support colleagues who have experienced a medical error. I agree with Dr. Wu’s observation that lack of empathy by peers is distressing. Symptoms of depression, burnout, decreased quality of life, and feelings of distress, guilt, and shame can occur in the second victim. I hope more people will get on board to use The Joint Commission toolkit to assist health care organizations in developing a second-victim program.

Carol Permiceo, RN
Long Island, New York

Dr. Weiss responds

I thank Dr. Barnes for his comments. The purpose of this article was mainly to assist people in establishing institutional support systems for providers when medical errors occur. Often we are not aware of litigation until some time well after the event. The TRUST second-victim support program and other programs are for immediate first aid for the provider and the team. Concerning the plaintiff’s ammunition, please remember that the purpose of these support systems, whether immediate or ongoing, is to discuss the emotional impact of the case on the provider, not the clinical details of the case.

I appreciate Ms. Permiceo sharing her story. As you probably have figured out, my interest in this area stems from my own experiences with medical errors (one in particular) and unanticipated outcomes. I hope by talking about it and validating our feelings (we are only human, after all) others will suffer less and come forward.

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.

“MANAGEMENT OF WOUND COMPLICATIONS FOLLOWING OBSTETRIC ANAL SPHINCTER INJURY (OASIS)”

ROBERT L. BARBIERI, MD, AND JEANNINE M. MIRANNE, MD, MS (EDITORIAL; DECEMBER 2016)

Delivering clinician should be seated

Indeed, obstetric anal sphincter injuries (OASIS),¹ with their short- and long-term consequences, merit clinical attention, as spotlighted in Dr. Barbieri and Dr. Miranne’s article. An issue not discussed is the position of the obstetrician.

In our practice, we sit down to perform a vaginal delivery, as taught by Soranus of Ephesus.² We strive to be at the bedside sooner than when the nurse calls “she is crowning.” This allows communication with the woman, attending nurse, and support person(s), as well as for a brief review of recent estimated fetal weight, length of the second stage, position of the presenting part, degree of flexion, presence of caput, and other last-minute details. Sitting down in front of the outlet permits uninterrupted visual evaluation of the distention of the soft perineal tissues. All traditional maneuvers are performed comfortably from the sitting position: the vertex is controlled by hands-on, and a quick reach with the nonpredominant hand searches for a loop of cord or a small part procidentia to resolve it. The patient is coached either for the next bearing-down effort or to not push to allow for gradual, controlled delivery of the fetal shoulder girdle. We avoid use of the fetal head for traction and move to facilitate “shrugging” with reduction of the bisacromial to facilitate delivery.

In our experience, the sitting position is ideal to observe uninterruptedly the tension of the perineal body during vertex and shoulders delivery, without having to flex and rotate our back and neck in repeatedly nonergonomic positions.

If an obstetrician of above-average height stands for the delivery, the obstetric bed should be elevated to fit her or his reach. Should shoulder dystocia occur, an assistant will stand on a chair and hover over the maternal abdomen to provide suprapubic pressure (indeed, an indelible memory for any parturient and her family). From the sitting position, exploration of the birth canal and repair of any injury, if necessary, can be conducted without technical impediments.

These simple steps have provided our patients and ourselves with clinical and professional satisfaction with minimal OASIS events as shown by others.³ Ironically, if we successfully avoid perineal injuries, our young trainees may require simulation training to learn this tedious repair procedure. In our geographic practice area, a new “collaborative” expects the frequency of episiotomy to be less than 4.6%. Third- and 4th-degree spontaneous or procedure-related perineal injuries still are used to measure quality of care despite demonstrated reasons for this parameter to be a noncredible metric.

Federico G. Mariona, MD
Dearborn, Michigan

Dr. Barbieri responds

I agree with Dr. Mariona that in some cases the fetal head delivers without causing a 3rd- or 4th-degree laceration, but then the delivery of the posterior shoulder causes a severe perineal injury. Dr. Mariona’s clinical pearl is that the delivering clinician should be seated, carefully observe the delivery of the shoulders, and facilitate fetal shrugging by gently reducing the bisacromial diameter as the posterior shoulder transitions over the perineal body.

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.

“MANAGEMENT OF WOUND COMPLICATIONS FOLLOWING OBSTETRIC ANAL SPHINCTER INJURY (OASIS)”

ROBERT L. BARBIERI, MD, AND JEANNINE M. MIRANNE, MD, MS (EDITORIAL; DECEMBER 2016)

Delivering clinician should be seated

Indeed, obstetric anal sphincter injuries (OASIS),¹ with their short- and long-term consequences, merit clinical attention, as spotlighted in Dr. Barbieri and Dr. Miranne’s article. An issue not discussed is the position of the obstetrician.

In our practice, we sit down to perform a vaginal delivery, as taught by Soranus of Ephesus.² We strive to be at the bedside sooner than when the nurse calls “she is crowning.” This allows communication with the woman, attending nurse, and support person(s), as well as for a brief review of recent estimated fetal weight, length of the second stage, position of the presenting part, degree of flexion, presence of caput, and other last-minute details. Sitting down in front of the outlet permits uninterrupted visual evaluation of the distention of the soft perineal tissues. All traditional maneuvers are performed comfortably from the sitting position: the vertex is controlled by hands-on, and a quick reach with the nonpredominant hand searches for a loop of cord or a small part procidentia to resolve it. The patient is coached either for the next bearing-down effort or to not push to allow for gradual, controlled delivery of the fetal shoulder girdle. We avoid use of the fetal head for traction and move to facilitate “shrugging” with reduction of the bisacromial to facilitate delivery.

In our experience, the sitting position is ideal to observe uninterruptedly the tension of the perineal body during vertex and shoulders delivery, without having to flex and rotate our back and neck in repeatedly nonergonomic positions.

If an obstetrician of above-average height stands for the delivery, the obstetric bed should be elevated to fit her or his reach. Should shoulder dystocia occur, an assistant will stand on a chair and hover over the maternal abdomen to provide suprapubic pressure (indeed, an indelible memory for any parturient and her family). From the sitting position, exploration of the birth canal and repair of any injury, if necessary, can be conducted without technical impediments.

These simple steps have provided our patients and ourselves with clinical and professional satisfaction with minimal OASIS events as shown by others.³ Ironically, if we successfully avoid perineal injuries, our young trainees may require simulation training to learn this tedious repair procedure. In our geographic practice area, a new “collaborative” expects the frequency of episiotomy to be less than 4.6%. Third- and 4th-degree spontaneous or procedure-related perineal injuries still are used to measure quality of care despite demonstrated reasons for this parameter to be a noncredible metric.

Federico G. Mariona, MD
Dearborn, Michigan

Dr. Barbieri responds

I agree with Dr. Mariona that in some cases the fetal head delivers without causing a 3rd- or 4th-degree laceration, but then the delivery of the posterior shoulder causes a severe perineal injury. Dr. Mariona’s clinical pearl is that the delivering clinician should be seated, carefully observe the delivery of the shoulders, and facilitate fetal shrugging by gently reducing the bisacromial diameter as the posterior shoulder transitions over the perineal body.

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.

“MANAGEMENT OF WOUND COMPLICATIONS FOLLOWING OBSTETRIC ANAL SPHINCTER INJURY (OASIS)”

ROBERT L. BARBIERI, MD, AND JEANNINE M. MIRANNE, MD, MS (EDITORIAL; DECEMBER 2016)

Delivering clinician should be seated

Indeed, obstetric anal sphincter injuries (OASIS),¹ with their short- and long-term consequences, merit clinical attention, as spotlighted in Dr. Barbieri and Dr. Miranne’s article. An issue not discussed is the position of the obstetrician.

In our practice, we sit down to perform a vaginal delivery, as taught by Soranus of Ephesus.² We strive to be at the bedside sooner than when the nurse calls “she is crowning.” This allows communication with the woman, attending nurse, and support person(s), as well as for a brief review of recent estimated fetal weight, length of the second stage, position of the presenting part, degree of flexion, presence of caput, and other last-minute details. Sitting down in front of the outlet permits uninterrupted visual evaluation of the distention of the soft perineal tissues. All traditional maneuvers are performed comfortably from the sitting position: the vertex is controlled by hands-on, and a quick reach with the nonpredominant hand searches for a loop of cord or a small part procidentia to resolve it. The patient is coached either for the next bearing-down effort or to not push to allow for gradual, controlled delivery of the fetal shoulder girdle. We avoid use of the fetal head for traction and move to facilitate “shrugging” with reduction of the bisacromial to facilitate delivery.

In our experience, the sitting position is ideal to observe uninterruptedly the tension of the perineal body during vertex and shoulders delivery, without having to flex and rotate our back and neck in repeatedly nonergonomic positions.

If an obstetrician of above-average height stands for the delivery, the obstetric bed should be elevated to fit her or his reach. Should shoulder dystocia occur, an assistant will stand on a chair and hover over the maternal abdomen to provide suprapubic pressure (indeed, an indelible memory for any parturient and her family). From the sitting position, exploration of the birth canal and repair of any injury, if necessary, can be conducted without technical impediments.

These simple steps have provided our patients and ourselves with clinical and professional satisfaction with minimal OASIS events as shown by others.³ Ironically, if we successfully avoid perineal injuries, our young trainees may require simulation training to learn this tedious repair procedure. In our geographic practice area, a new “collaborative” expects the frequency of episiotomy to be less than 4.6%. Third- and 4th-degree spontaneous or procedure-related perineal injuries still are used to measure quality of care despite demonstrated reasons for this parameter to be a noncredible metric.

Federico G. Mariona, MD
Dearborn, Michigan

Dr. Barbieri responds

I agree with Dr. Mariona that in some cases the fetal head delivers without causing a 3rd- or 4th-degree laceration, but then the delivery of the posterior shoulder causes a severe perineal injury. Dr. Mariona’s clinical pearl is that the delivering clinician should be seated, carefully observe the delivery of the shoulders, and facilitate fetal shrugging by gently reducing the bisacromial diameter as the posterior shoulder transitions over the perineal body.

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.

“SHOULDER DYSTOCIA: TAKING THE FEAR OUT OF MANAGEMENT”

JOHN T. REPKE, MD, AND RONALD T. BURKMAN, MD (WEB EXCLUSIVE; APRIL 2016)

Montgomery maneuver for shoulder dystocia

In managing shoulder dystocia, my maneuver is to use my elbow to maximize mechanical advantage when applying suprapubic pressure to push the trapped shoulder down. It works well and is more efficient than having a nurse standing off to the side.

J.S. Montgomery, MD
Cypress, Texas

Dr. Barbieri responds

I thank Dr. Montgomery for sharing his maneuver for dislodging the trapped anterior shoulder by using his elbow to apply suprapubic pressure. There is vast knowledge and experience in our clinical community, and sharing insights is helpful to all our readers.

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.

“SHOULDER DYSTOCIA: TAKING THE FEAR OUT OF MANAGEMENT”

JOHN T. REPKE, MD, AND RONALD T. BURKMAN, MD (WEB EXCLUSIVE; APRIL 2016)

Montgomery maneuver for shoulder dystocia

In managing shoulder dystocia, my maneuver is to use my elbow to maximize mechanical advantage when applying suprapubic pressure to push the trapped shoulder down. It works well and is more efficient than having a nurse standing off to the side.

J.S. Montgomery, MD
Cypress, Texas

Dr. Barbieri responds

I thank Dr. Montgomery for sharing his maneuver for dislodging the trapped anterior shoulder by using his elbow to apply suprapubic pressure. There is vast knowledge and experience in our clinical community, and sharing insights is helpful to all our readers.

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.

“SHOULDER DYSTOCIA: TAKING THE FEAR OUT OF MANAGEMENT”

JOHN T. REPKE, MD, AND RONALD T. BURKMAN, MD (WEB EXCLUSIVE; APRIL 2016)

Montgomery maneuver for shoulder dystocia

In managing shoulder dystocia, my maneuver is to use my elbow to maximize mechanical advantage when applying suprapubic pressure to push the trapped shoulder down. It works well and is more efficient than having a nurse standing off to the side.

J.S. Montgomery, MD
Cypress, Texas

Dr. Barbieri responds

I thank Dr. Montgomery for sharing his maneuver for dislodging the trapped anterior shoulder by using his elbow to apply suprapubic pressure. There is vast knowledge and experience in our clinical community, and sharing insights is helpful to all our readers.

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.

“LONG-ACTING REVERSIBLE CONTRACEPTIVES AND ACNE IN ADOLESCENTS”

ROBERT L. BARBIERI, MD, AND ANDREA H. ROE, MD (EDITORIAL; JANUARY 2017)

Manage acne with spironolactone for women on LARC

Dr. Barbieri’s editorial with Dr. Roe addressed the very important theme of proactively talking about acne before a patient starts long-acting reversible contraception (LARC), especially when switching from a birth control pill that had controlled the acne to a levonorgestrel intrauterine device (LNG-IUD). It missed the mark, however, in not mentioning a very important presenting feature of adolescent polycystic ovary syndrome (PCOS)—cystic acne. I highly recommend obtaining baseline testosterone levels and using spironolactone, 50 to 200 mg daily, to treat acne while on LARC, especially an LNG-IUD. I learned this trick a few years ago from a Canadian endocrinologist.

John Lewis, MD

Waterbury, Connecticut

Dr. Barbieri responds

I thank Dr. Lewis for the important clinical pearl to use spironolactone to prevent and treat acne when inserting a progestin-releasing LARC in an adolescent or young woman. Spironolactone blocks testosterone action in the pilosebaceous unit, thereby decreasing sebum production and reducing acne activity. I frequently use spironolactone in my practice, especially for women with PCOS who have hirsutism and acne (see my editorial on page 8 of this issue). However, authors of a recent systematic review reported that there is minimal evidence from clinical trials to support the use of spironolactone to treat acne vulgaris.¹

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.

“LONG-ACTING REVERSIBLE CONTRACEPTIVES AND ACNE IN ADOLESCENTS”

ROBERT L. BARBIERI, MD, AND ANDREA H. ROE, MD (EDITORIAL; JANUARY 2017)

Manage acne with spironolactone for women on LARC

Dr. Barbieri’s editorial with Dr. Roe addressed the very important theme of proactively talking about acne before a patient starts long-acting reversible contraception (LARC), especially when switching from a birth control pill that had controlled the acne to a levonorgestrel intrauterine device (LNG-IUD). It missed the mark, however, in not mentioning a very important presenting feature of adolescent polycystic ovary syndrome (PCOS)—cystic acne. I highly recommend obtaining baseline testosterone levels and using spironolactone, 50 to 200 mg daily, to treat acne while on LARC, especially an LNG-IUD. I learned this trick a few years ago from a Canadian endocrinologist.

John Lewis, MD

Waterbury, Connecticut

Dr. Barbieri responds

I thank Dr. Lewis for the important clinical pearl to use spironolactone to prevent and treat acne when inserting a progestin-releasing LARC in an adolescent or young woman. Spironolactone blocks testosterone action in the pilosebaceous unit, thereby decreasing sebum production and reducing acne activity. I frequently use spironolactone in my practice, especially for women with PCOS who have hirsutism and acne (see my editorial on page 8 of this issue). However, authors of a recent systematic review reported that there is minimal evidence from clinical trials to support the use of spironolactone to treat acne vulgaris.¹

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.

“LONG-ACTING REVERSIBLE CONTRACEPTIVES AND ACNE IN ADOLESCENTS”

ROBERT L. BARBIERI, MD, AND ANDREA H. ROE, MD (EDITORIAL; JANUARY 2017)

Manage acne with spironolactone for women on LARC

Dr. Barbieri’s editorial with Dr. Roe addressed the very important theme of proactively talking about acne before a patient starts long-acting reversible contraception (LARC), especially when switching from a birth control pill that had controlled the acne to a levonorgestrel intrauterine device (LNG-IUD). It missed the mark, however, in not mentioning a very important presenting feature of adolescent polycystic ovary syndrome (PCOS)—cystic acne. I highly recommend obtaining baseline testosterone levels and using spironolactone, 50 to 200 mg daily, to treat acne while on LARC, especially an LNG-IUD. I learned this trick a few years ago from a Canadian endocrinologist.

John Lewis, MD

Waterbury, Connecticut

Dr. Barbieri responds

I thank Dr. Lewis for the important clinical pearl to use spironolactone to prevent and treat acne when inserting a progestin-releasing LARC in an adolescent or young woman. Spironolactone blocks testosterone action in the pilosebaceous unit, thereby decreasing sebum production and reducing acne activity. I frequently use spironolactone in my practice, especially for women with PCOS who have hirsutism and acne (see my editorial on page 8 of this issue). However, authors of a recent systematic review reported that there is minimal evidence from clinical trials to support the use of spironolactone to treat acne vulgaris.¹

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.

Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

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.

Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

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.

Forceful use of forceps, infant dies: $10.2M verdict

A woman in her mid-20s went to the hospital in labor. After several hours, fetal heart-rate (FHR) monitor results became nonreassuring. The ObGyn and the nurse in charge disagreed on the interpretation of the FHR monitor strips. The nurse went to her supervisor, who confronted the ObGyn 2 hours later, saying that fetal distress was a serious concern and necessitated the cessation of oxytocin. The ObGyn disagreed and ordered another nurse to increase the oxytocin dose.

Three hours later, when the FHR monitoring strips showed severe distress, the ObGyn decided to undertake an operative vaginal delivery. During a 17-minute period, the ObGyn unsuccessfully used forceps 3 times. On the second attempt, a cracking noise was heard. Then a cesarean delivery was ordered; the baby was born limp, lifeless, and unresponsive. She was found to have hypoxic ischemic encephalopathy, was removed from life support, and died.

PARENTS’ CLAIM:

Oxytocin should not have been continued when the baby was clearly in distress. The supervising nurse should have contacted her supervisor and continued up the chain of command until the ObGyn was forced to stop the oxytocin.

Physicians are prohibited from using their leg muscles when applying forceps; gentle action is critical. During one attempt, the ObGyn had his leg on the bed to increase the force with which he pulled on the forceps. The ObGyn’s reckless use of forceps caused a skull fracture to depress into the brain. The ObGyn also tried to turn the baby using forceps, which is outside the standard of care because of the risk of rotational injury. A mother’s pushing rarely causes such severe damage to the baby.

DEFENDANTS’ DEFENSE:

There was no negligence. The hypoxia was due to a hemorrhage. Natural forces of a long delivery caused the skull injury.

VERDICT:

A $10,200,575 Texas verdict was returned.

After long labor, baby has CP: $8.4M settlement

Early on March 20, a 30-year-old woman who weighed 300 lbs was admitted for delivery at 40 weeks’ gestation. Labor was induced with oxytocin. Within 30 minutes, FHR monitoring showed that the baby’s baseline began to climb, accelerations ceased, and late decelerations commenced. The oxytocin dose was steadily increased throughout the day. A nurse decided that the baby was not tolerating the contractions and discontinued oxytocin. The attending ObGyn ordered oxytocin be restarted after giving the baby a chance to recover. The mother requested a cesarean delivery, but the ObGyn refused, saying that he was concerned with the risk due to her excessive weight and prior heart surgery. When his shift ended, his partner took over.

On March 21, a nurse reported that the FHR had climbed to 160 bpm although labor had not progressed. The ObGyn ordered terbutaline to slow contractions but he did not examine the mother. An hour after terbutaline administration, the FHR showed a deceleration. An emergency cesarean delivery was performed. The baby, born severely depressed, was resuscitated. Magnetic resonance imaging performed at 23 days of life showed that the child had a hypoxic ischemic injury. She has cerebral palsy and is nonambulatory with significant cognitive deficits.

PARENTS’ CLAIM:

The care provided by 2 ObGyns, nursing staff, and hospital was negligent. A cesarean delivery should have been performed on March 20 when the nurse identified fetal distress. The nurses should have been more assertive in recommending cesarean delivery. The injury occurred 30 minutes prior to delivery and could have been prevented by an earlier cesarean delivery.

DEFENDANTS’ DEFENSE:

FHR strips on March 20 were not as nonreassuring as claimed and did not warrant cesarean delivery, which was performed when needed.

VERDICT:

An $8.4 million Wisconsin settlement was reached by mediation.

Eclamptic seizure, twins stillborn: $4.25M

A 29-year-old woman pregnant with twins had an eclamptic seizure at 33 4/7 weeks’ gestation. The babies were stillborn.

PARENTS’ CLAIM:

The ObGyn failed to properly treat the patient’s preeclampsia for more than 11 weeks. The seizure caused hypovolemic shock, tachycardia, and massive hemorrhaging and required an emergency hysterectomy and bilateral salpingo-oophorectomy. The patient has no children and has been rendered unable to conceive. She sought to apportion 60% of the settlement proceeds to her distress claim and 20% each to wrongful-death and survival claims. She also sought to bar the twins’ biological father from sharing in the recovery due to abandonment.

HOSPITAL'S DEFENSE:

The case was settled during the trial.

VERDICT:

The mother agreed to receive 65% of the wrongful-death and survival funds, with 35% going to the father. A Pennsylvania settlement of $4.25 million was reached.

Brachial plexus injury: $4.8M verdict

A woman gave birth with assistance from a midwife. During delivery, shoulder dystocia was encountered. The baby has a permanent brachial plexus injury.

PARENTS’ CLAIM:

The midwife mismanaged shoulder dystocia by applying excessive traction to the baby’s head. The ObGyn in charge of the mother’s care did not provide adequate supervision.

DEFENDANTS’ DEFENSE:

The hospital settled prior to trial. The midwife and ObGyn denied negligence during delivery and contended that the child’s injury occurred as a result of the natural forces of labor.

VERDICT:

The jury found the midwife 60% negligent and the ObGyn 40% negligent. A $4.82 million Florida verdict was returned.

What caused infant's death?

During prenatal care, a woman underwent weekly nonstress tests due to excessive amniotic fluid until the level returned to normal. Near the end of her pregnancy, the patient noticed a decrease in fetal movement and called her ObGyn group. She was told to perform a fetal kick count and go to the emergency department (ED) if the count was abnormal, but she fell asleep. In the morning, she presented to the ObGyns’ office and was sent to the hospital for emergency cesarean delivery, which was performed 2.5 hrs after her arrival. The infant was born in distress and died 8 hours later.

PARENTS’ CLAIM:

The ObGyns should have continued weekly tests even after the amniotic fluid level returned to normal. She should have been sent to the ED when she initially reported decreased fetal movement. Cesarean delivery should have been performed immediately upon her arrival at the hospital.

PHYSICIAN’S DEFENSE:

Further prenatal testing for amniotic fluid levels was unwarranted. Telephone advice to count fetal kicks was appropriate. The delay in performing a cesarean delivery was beyond the ObGyns’ control. The outcome would have been the same regardless of their actions.

VERDICT:

A Michigan defense verdict was returned.

Perineal laceration during vaginal delivery

During vaginal delivery, a 27-year-old woman suffered a 4th-degree perineal laceration. She developed a retrovaginal fistula and has permanent fecal incontinence.

PARENTS’ CLAIM:

The ObGyn’s care was negligent. She failed to perform a rectal examination to assess the severity of the perineal laceration. The laceration was improperly repaired, and, as a result, the patient developed a retrovaginal fistula that persisted for 6 months until it was surgically repaired. A divot in her anal canal causes fecal incontinence.

PHYSICIAN’S DEFENSE:

The ObGyn contended she correctly diagnosed and repaired a 3rd-degree laceration. The wound later broke down for unknown reasons.

VERDICT:

An Arizona defense verdict was returned.

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.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

MELBOURNE – A reduction in urinary protein creatinine ratio and normalization of inflammatory biomarkers early in treatment of lupus nephritis may predict response rates at 24 and 48 weeks, according to data from the AURION study presented at an international congress on systemic lupus erythematosus.

The AURION study was a single-arm exploratory study assessing the value of an early reduction in proteinuria in 10 patients with active lupus nephritis. The patients were treated with novel calcineurin inhibitor voclosporin (23.7 mg twice daily) in addition to usual care with mycophenolate mofetil and low-dose steroids. The treatment protocol also included a forced steroid taper from 0.5 g at day 0 to 2.5 mg from week 12.

The 48-week study examined the biomarkers of a 25% reduction in urinary protein creatinine ratio and normalization of inflammatory lupus biomarkers C3, C4, and anti–double stranded DNA at 8 weeks, and explored their relationship to remission rates at 24 and 48 weeks. Overall, by week 24, 70% of patients had achieved complete remission, and by week 48, 5 of 7 (71%) had achieved complete remission. Three patients dropped out of the study before week 48: one because of decreased estimated glomerular filtration rate, one because of a systemic lupus erythematosus flare, and one at the discretion of an investigator.

All patients showed a 25% reduction in urinary protein creatinine ratio at week 8, with a mean decrease of 61% by week 24. Researchers also saw a 22% increase in mean C3 levels and a 58% increase in mean C4 from baseline to week 24. There was also a decrease in anti–double stranded DNA.

When researchers examined the specificity and sensitivities of these biomarkers at week 8 in predicting renal response at weeks 24 and 48, they found that a 25% reduction in urinary protein creatinine ratio had a good sensitivity (71% and 75% at 24 and 48 weeks, respectively), but low specificity (33% and 24%).

In contrast, normalization of C4 and C3 by week 8 both showed a specificity of 100% by week 24 and 75% by week 48, but a sensitivity of 29% for week 24 and 25% for week 48.

Normalization of anti–double stranded DNA had a sensitivity of 57% at week 24 and 50% at week 48, and a specificity of 100% at week 24 and 50% at week 48.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Researchers from The Cancer Genome Atlas (TCGA) Research Network analyzed 178 primary cervical cancers, and found > 70% had genomic alteration in 1 or both of 2 important cell signaling pathways. They also found that a subset of tumors showed no evidence of HPV infection.

“This aspect of the research is one of the most intriguing findings to come out of the TCGA program, which has been looking at more than 30 tumor types over the past decade,” said Jean-Claude Zenklusen, PhD, director of the TCGA program office.

The researchers found several instances of amplification of genes that code for known immune targets, which may predict responsiveness to immunotherapy. They also identified several novel mutated genes. Particularly interesting, the researchers say, was the identification of a unique set of 8 cervical cancers that showed molecular similarities to endometrial cancers; the cancers were mainly HPV negative. That finding “confirms that not all cervical cancers are related to HPV infection and that a small percentage of cervical tumors may be due to strictly genetic or other factors,” said Zenklusen.

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Daniel Gay

New research suggests assays used to screen donated blood for the Zika virus are more sensitive than assays used to help physicians diagnose Zika infection.

The study showed that donor screening assays could detect Zika virus RNA with greater sensitivity than diagnostic real-time polymerase chain reaction (RT-PCR) assays.

However, the evidence also indicated that increasing the volume of blood analyzed can increase the sensitivity of diagnostic assays.

This research was published in Transfusion in a special issue focusing on Zika and other transfusion-transmitted viruses.

The researchers compared 17 nucleic acid amplification technology assays used at 11 different labs. (Some of the 17 assays were actually the same assays used at different labs.)

One of the donor screening assays was the Procleix Zika virus assay, which was co-developed by Hologic, Inc. and Grifols Diagnostic Solutions, Inc. and used at Hologic.

The other donor screening assay was the cobas Zika test, which was developed by Roche Molecular Systems, Inc. and used in the company’s lab.

The RT-PCR diagnostic assays included the US Centers for Disease Control and Prevention’s (CDC) Singleplex (1087, 4481) and Trioplex assays—both low input (LI) and high input (HI)—which were used at the CDC labs in Puerto Rico (PR) and Fort Collins (FC).

Modified versions of the CDC’s assays were also used at the Blood Systems Research Institute (BSRI) in San Francisco, the University of California (UC) Davis, the Institut Louis Malarde (ILM) in French Polynesia, and 2 labs in Brazil—Fundação Pró-Sangue and Laboratório Richet.

The US Food and Drug Administration (FDA) used its own RT-PCR test, and the Etablissement Francais du Sang (EFS) in France used the Altona RealStar ZIKV RT-PCR assay.

Results

The various assays were used on plasma samples positive for 2 different strains of Zika virus—1 from Brazil and 1 from French Polynesia—as well as Zika-negative control samples.

The researchers found the donor screening assays provided comparable sensitivity and were more sensitive than each of the diagnostic RT-PCR assays.

So the team compared results with the 2 donor screening assays combined to results with the RT-PCR assays, which they grouped into 9 categories based on similar intended applications, methodologies, and results.

The 95% limit of detection (LOD₉₅) and 50% limit of detection (LOD₅₀) for the assays were as follows.

The researchers noted that the donor screening assays were about 10-fold to 100-fold more sensitive than the standard input RT-PCR assays.

However, the CDC’s assays were performed with low and high inputs of plasma. And increasing the sample input volume increased the limit of detection by 10-fold to 30-fold.

“The results of this study, that evaluated 17 Zika virus assays in 11 laboratories and documented excellent sensitivity of the 2 donor screening assays manufactured by Roche and Grifols, were critical to support the decision by the US Food and Drug Administration and blood industry to implement investigational screening of donors in Puerto Rico in April 2016 and the entire US by the end of 2016,” said study author Michael Busch, MD, PhD, of BSRI.

“Given the sensitivity of these assays, the FDA approved clinical trials using individual donation screening and rescinded earlier policies precluding transfusion of blood collected in Puerto Rico and deferral from donation by donors who had traveled to Zika risk countries throughout the US. This screening has detected over 350 infected blood donations in Puerto Rico and dozens of infected donations in the continental US.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Chad McNeeley

MARSEILLE—An investigational drug has successfully treated a severe case of transplant-associated thrombotic microangiopathy (TA-TMA), according to a presentation at the 43rd Annual Meeting of the European Society for Blood and Marrow Transplantation.

The drug is OMS721, a monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway of the complement system.

The patient received OMS721, which is being developed by Omeros Corporation, under a compassionate-use protocol.

Marco Zecca, MD, of the Fondazione IRCCS Policlinico San Matteo in Italy, and his colleagues provided details on this patient in a poster presented at the meeting (Physician Poster Abstracts-Day 1, abstract A437).

The female patient had undergone a hematopoietic stem cell transplant to treat Diamond‐Blackfan anemia. At age 14, she received a transplant from an HLA-compatible, unrelated donor.

Seven months later, she was diagnosed with TA-TMA. The patient was initially treated with eculizumab but had to stop taking the drug after she developed acute pulmonary edema.

She was then treated with plasma exchange but experienced a TA-TMA relapse at 11 months. The patient was again treated with eculizumab and again had to discontinue the drug after developing acute pulmonary edema.

The patient’s condition continued to worsen, and she soon required hemodialysis 3 times a week as well as daily platelet transfusions.

Dr Zecca requested OMS721 as compassionate-use treatment for the patient, and Omeros complied.

Two months after starting OMS721, the patient was able to discontinue hemodialysis and decrease her platelet transfusion requirements. She did not experience any adverse events related to OMS721.

Recently, the patient’s dose was tapered, but she developed a viral infection that reactivated her TA-TMA.

A return to the original dose of OMS721 was successful. Now, the patient no longer requires dialysis or transfusions.

“This patient had severe TMA that I believe would have caused her death,” Dr Zecca said. “Her positive response to OMS721 treatment, both initially and following her virus-induced relapse during tapering, was impressive.”

“The results of OMS721 treatment in this challenge-rechallenge scenario underscore the important effects of the drug. Since the poster was produced, her TMA has remained in remission, and we have been able to discontinue her platelet transfusions. Her rapid response has been heartening, and we all are grateful for this remarkable outcome.”

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.

Photo by Rhoda Baer

The National Comprehensive Cancer Network® (NCCN®) recently launched the NCCN Radiation Therapy Compendium™, which provides a single access point for NCCN recommendations pertaining to radiation therapy.

The compendium provides guidance on all radiation therapy modalities recommended within NCCN guidelines, including intensity modulated radiation therapy, intra-operative radiation therapy, stereotactic radiosurgery/stereotactic body radiotherapy/stereotactic ablative radiotherapy, image-guided radiotherapy, low dose-rate brachytherapy/high dose-rate brachytherapy, radioisotope, and particle therapy.

“As a single source for all radiation therapy recommendations within the NCCN guidelines, the compendium benefits patients with cancer by assisting providers and payers in making evidence-based treatment and coverage decisions,” said Robert W. Carlson, MD, chief executive officer of NCCN.

The NCCN Radiation Therapy Compendium™ includes recommendations for the following 24 cancer types:

Acute myeloid leukemia

Anal cancer

B-cell lymphomas

Bladder cancer

Breast cancer

Chronic lymphocytic leukemia/small lymphoblastic lymphoma

Colon cancer

Hepatobiliary cancers

Kidney cancer

Malignant pleural mesothelioma

Melanoma

Multiple myeloma

Neuroendocrine tumors

Non-small cell lung cancer

Occult primary cancer

Pancreatic adenocarcinoma

Penile cancer

Primary cutaneous B-cell lymphomas

Prostate cancer

Rectal cancer

Small cell lung cancer

Soft tissue sarcoma

T-cell lymphomas

Testicular cancer

NCCN said additional cancer types will be published on a rolling basis over the coming months.