Foscarnet-Induced Ulceration

Viral swabs were negative for herpes simplex virus. The diagnosis of foscarnet-induced ulceration was reached and the drug was discontinued. Symptomatic treatment with soap substitutes and lidocaine ointment was used.

Foscarnet is an antiviral agent used when resistance develops to first-line therapies.¹ It is a pyrophosphate analogue that inhibits viral DNA polymerase, thereby preventing viral replication. It is used in treating cytomegalovirus and herpes simplex virus, which are resistant to first-line therapies, or patients who develop hematologic toxicity from antivirals. The main side effects of foscarnet include nephrotoxicity, alteration of calcium homeostasis, and malaise. Genital ulceration is a known side effect of therapy, though it is rare and more commonly seen in uncircumcised males. Approximately 94% of the drug is excreted unchanged in the urine, which causes an irritant dermatitis that is more pronounced in males as the urine stays in the subpreputial area.¹

Vulval ulceration² and penile ulceration³ has been reported in AIDS patients treated with foscarnet. In these patients, the onset of ulceration is temporally related to foscarnet therapy, occurring at approximately day 7 to 24 of treatment and resolving after discontinuation of therapy.

Foscarnet-Induced Ulceration

Viral swabs were negative for herpes simplex virus. The diagnosis of foscarnet-induced ulceration was reached and the drug was discontinued. Symptomatic treatment with soap substitutes and lidocaine ointment was used.

Foscarnet is an antiviral agent used when resistance develops to first-line therapies.¹ It is a pyrophosphate analogue that inhibits viral DNA polymerase, thereby preventing viral replication. It is used in treating cytomegalovirus and herpes simplex virus, which are resistant to first-line therapies, or patients who develop hematologic toxicity from antivirals. The main side effects of foscarnet include nephrotoxicity, alteration of calcium homeostasis, and malaise. Genital ulceration is a known side effect of therapy, though it is rare and more commonly seen in uncircumcised males. Approximately 94% of the drug is excreted unchanged in the urine, which causes an irritant dermatitis that is more pronounced in males as the urine stays in the subpreputial area.¹

Vulval ulceration² and penile ulceration³ has been reported in AIDS patients treated with foscarnet. In these patients, the onset of ulceration is temporally related to foscarnet therapy, occurring at approximately day 7 to 24 of treatment and resolving after discontinuation of therapy.

Foscarnet-Induced Ulceration

Viral swabs were negative for herpes simplex virus. The diagnosis of foscarnet-induced ulceration was reached and the drug was discontinued. Symptomatic treatment with soap substitutes and lidocaine ointment was used.

Foscarnet is an antiviral agent used when resistance develops to first-line therapies.¹ It is a pyrophosphate analogue that inhibits viral DNA polymerase, thereby preventing viral replication. It is used in treating cytomegalovirus and herpes simplex virus, which are resistant to first-line therapies, or patients who develop hematologic toxicity from antivirals. The main side effects of foscarnet include nephrotoxicity, alteration of calcium homeostasis, and malaise. Genital ulceration is a known side effect of therapy, though it is rare and more commonly seen in uncircumcised males. Approximately 94% of the drug is excreted unchanged in the urine, which causes an irritant dermatitis that is more pronounced in males as the urine stays in the subpreputial area.¹

Vulval ulceration² and penile ulceration³ has been reported in AIDS patients treated with foscarnet. In these patients, the onset of ulceration is temporally related to foscarnet therapy, occurring at approximately day 7 to 24 of treatment and resolving after discontinuation of therapy.

The use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

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 use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

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 use of long-acting reversible contraceptive (LARC) methods has shown a steady increase in the United States. The major factors for increasing acceptance include high efficacy, ease of use, and an acceptable adverse effect profile. Since these methods require placement under the skin (implantable device) or into the uterus (intrauterine devices [IUDs]), unique management issues arise during their usage. Recently, the American College of Obstetricians and Gynecologists (ACOG) released a committee opinion addressing several of these clinical challenges—among them: pain with insertion, what to do when the IUD strings are not visualized, and the plan of action for a nonpalpable IUD or contraceptive implant.¹ In this article we present 7 cases, and successful management approaches, that reflect ACOG’s recent recommendations and our extensive clinical experience.

Read the first CHALLENGE: Pain with IUD insertion

CHALLENGE 1: Pain with IUD insertion

CASE First-time, nulliparous IUD user apprehensive about insertion pain

A 21-year-old woman (G0) presents for placement of a 52-mg levonorgestrel IUD for contraception and treatment of dysmenorrhea. Her medical and surgical histories are unremarkable. She has heard that IUD insertion “is more painful if you haven’t had a baby yet” and she asks what treatments are available to aid in pain relief.

What can you offer her?

A number of approaches have been used to reduce IUD insertion pain, including:

• placing lidocaine gel into or on the cervix
• lidocaine paracervical block
• preinsertion use of misoprostol or nonsteroidal anti-inflammatory drugs.

Authors of a recent Cochrane review² indicated that none of these approaches were particularly effective at reducing insertion pain for nulliparous women. Naproxen sodium 550 mg or tramadol 50 mg taken 1 hour prior to IUD insertion have been found to decrease IUD insertion pain in multiparous patients.³ Misoprostol, apart from being ineffective in reducing insertion pain, also requires use for a number of hours before insertion and can cause painful uterine cramping, upset stomach, and diarrhea.² Some studies do suggest that use of a paracervical block does reduce the pain associated with tenaculum placement but not the IUD insertion itself.

Related article:
Benefit of self-administered vaginal lidocaine gel in IUD placement
 

A reasonable pain management strategy for nulliparous patients. Given these data, there is not an evidence-based IUD insertion pain management strategy that can be used for the nulliparous case patient. A practical approach for nulliparous patients is to offer naproxen sodium or tramadol, which have been found to be beneficial in multiparous patients, to a nulliparous patient. Additionally, lidocaine gel applied to the cervix or tenaculum-site injection can be considered for tenaculum-associated pain, although it does not appear to help significantly with IUD insertion pain. Misoprostol should be avoided as it does not alleviate the pain of insertion and it can cause bothersome adverse effects.

Read CHALLENGE 2: IUD strings not visualized

CHALLENGE 2: IUD strings not visualized

CASE No strings palpated 6 weeks after postpartum IUD placement

A 26-year-old woman (G2P2) presents to your office for a postpartum visit 6 weeks after an uncomplicated cesarean delivery at term. She had requested that a 52-mg levonorgestrel IUD be placed at the time of delivery, and the delivery report describes an uneventful placement. The patient has not been able to feel the IUD strings using her fingers and you do not find them on examination. She does not remember the IUD falling out.

What are the next steps in her management?

Failure to palpate the IUD strings by the user or failure to visualize the strings is a fairly common occurrence. This is especially true when an IUD is placed immediatelypostpartum, as in this patient’s case.

When the strings cannot be palpated, it is important to exclude pregnancy and recommend a form of backup contraception, such as condoms and emergency contraception if appropriate, until evaluation can be completed.

Steps to locate a device. In the office setting, the strings often can be located by inserting a cytobrush into the endocervical canal to extract them. If that maneuver fails to locate them, an ultrasound should be completed to determine if the device is in the uterus. If the ultrasound does not detect the device in the uterus, obtain an anteroposterior (AP) x-ray encompassing the entire abdomen and pelvis. All IUDs used in the United States are radiopaque and will be observed on x-ray if present. If the IUD is identified, operative removal is indicated.

Related article:
How to identify and localize IUDs on ultrasound
 

Intraperitoneal location. If an IUD is found in this location, it is usually the result of a perforation that occurred at the time of insertion. In general, the device can be removed via laparoscopy. Occasionally, laparotomy is needed if there is significant pelvic infection, possible bowel perforation, or if there is an inability to locate the device at laparoscopy.⁴ The copper IUD is more inflammatory than the levonorgestrel IUDs.

Abdominal location. No matter the IUD type, operative removal of intra-abdominal IUDs should take place expeditiously after they are discovered.

In the case of expulsion. If the IUD is not seen on x-ray, expulsion is the likely cause. Expulsion tends to be more common among⁵:

• parous users
• those younger than age 20
• placements that immediately follow a delivery or second-trimester abortion.

Nulliparity and type of device are not associated with increased risk of expulsion.

Read CHALLENGE 3: Difficult IUD removal

CHALLENGE 3: Difficult IUD removal

CASE Strings not palpated in a patient with history of LEEP

A 37-year-old woman (G3P2) presents to your office for IUD removal. She underwent a loop electrosurgical excision procedure 2 years ago for cervical intraepithelial neoplasia (CIN) 2 and since then has not been able to feel the IUD strings. On pelvic examination, you do not palpate or visualize the IUD strings after speculum placement.

How can you achieve IUD removal for your patient?

When a patient requests that her IUD be removed, but the strings are not visible and the woman is not pregnant, employ ultrasonography to confirm the IUD remains intrauterine and to rule out expulsion or perforation.

Employ alligator forceps or an IUD hook. Once intrauterine position is confirmed, use an alligator forceps of suitable length and with a small diameter to extract the device (FIGURE 1). It is useful to utilize ultrasonography for guidance during the removal procedure. The alligator forceps will grasp both the IUD device itself and IUD strings well, so either can be targeted during removal.

A second useful tool for IUD removal is an IUD hook (FIGURE 2). In a similar way that a curette is used for endometrial sampling, IUD hooks can be used to drag the IUD from the uterus.

Anesthesia is not usually necessary for IUD removal with alligator forceps or an IUD hook, although it may be appropriate in select patients. Data are limited with regard to the utility of paracervical blocks in this situation.

Related article:
Surgical removal of malpositioned IUDs
 

Hysteroscopy is an option. If removal with an alligator forceps or IUD hook is unsuccessful, or if preferred by the clinician, hysteroscopic-guided removal is a management option. Hysteroscopic removal may be required if the IUD has become embedded in the uterine wall.

Read CHALLENGE 4: Nonfundal IUD location

CHALLENGE 4: Nonfundal IUD location

CASE Copper IUD found in lower uterine segment

A 31-year-old woman (G1P1) calls your office to report that she thinks her copper IUD strings are longer than before. Office examination confirms that the strings are noticeably longer than is typical. Pelvic ultrasonography shows the copper IUD in the lower uterine segment.

What is the appropriate course of action?

Occasionally, IUDs are noted to be located in the lower uterine segment (FIGURE 3) or cervix. With malposition, users may be experiencing cramping or abnormal bleeding.

Cervical malposition calls for removal. ACOG advises that, regardless of a patient’s presenting symptoms, clinicians should remove IUDs located in the cervix (ie, the stem below the internal os) due to an increased risk of pregnancy and address the woman’s contraceptive needs.

Related article:
STOP relying on 2D ultrasound for IUD localization
 

Lower-uterine-segment malposition man‑agement less clear. If the patient is symptomatic, remove the device and initiate some form of contraception. If the woman is asymptomatic, the woman should be given the option of having the device removed or left in place. The mechanisms of action of both the copper and levonorgestrel-releasing IUDs suggest that this lower location is unlikely to be associated with a significant decrease in efficacy.

Unfortunately, it is difficult to estimate the risk of pregnancy for a patient whose device is located in the lower uterine segment. Braaten and Goldberg discussed case-controlled data in their 2012 article that suggest malposition may be more important to the efficacy of copper IUDs than of levonorgestrel IUDs.^6,7 As unintended pregnancy is an important risk to avoid, ultimately, it is the woman’s decision as to whether she wants removal or continued IUD use.

Read CHALLENGE 5: Pregnancy in an IUD user

CHALLENGE 5: Pregnancy in an IUD user

CASE 3-year copper IUD user with positive pregnancy test

A 25-year-old woman (G3P2) presents to your office because of missed menses and a positive home pregnancy test. Her last menstrual period was 6 weeks ago. She has had a copper IUD in place for 3 years and can feel the strings herself. She has experienced light cramping but no bleeding. Office examination is notable for the IUD stem present at the external cervical os. While the pregnancy is unplanned, the patient desires that it continue.

Should you remove the IUD?

The pregnancy rate among IUD users is less than 1%—a rate that is equivalent to that experienced by women undergoing tubal sterilization. Although there is an overall low risk of pregnancy, a higher proportion of pregnancies among IUD users compared with nonusers are ectopic. Therefore, subsequent management of pregnancy in an IUD user needs to be determined by, using ultrasound, both the location of the pregnancy and whether the IUD is in place.

If an ectopic pregnancy is found, it may be managed medically or surgically with the IUD left in place if desired. If you find an intrauterine pregnancy that is undesired, the IUD can be removed at the time of a surgical abortion or before the initiation of a medical abortion.

If you fail to locate the IUD either before or after the abortion procedure, use an AP x-ray of the entire abdomen and pelvis to determine whether the IUD is in the peritoneal cavity or whether it was likely expelled prior to the pregnancy.

Related article:
In which clinical situations can the use of the 52-mg levonorgestrel-releasing IUD (Mirena) and the TCu380A copper-IUD (ParaGard) be extended?

With a desired pregnancy, if the strings are visible, remove the IUD with gentle traction. If the IUD is left in place, the risk of spontaneous abortion is significantly increased. If the strings are not seen, but the device was noted to be in the cervix by ultrasound, remove the device if the stem is below the internal cervical os. For IUDs that are located above the cervix, removal should not be attempted; counsel the patient about the increased risk of spontaneous abortion, infection, and preterm delivery.

Read CHALLENGE 6: Pregnancy in an implant user

CHALLENGE 6: Pregnancy in an implant user

CASE 3-week implant user with positive pregnancy test

Your 21-year-old patient who received a contraceptive implant 3 weeks earlier now pre‑sents with nausea and abdominal cramping. Her last menstrual period was 6 weeks ago. She has regular cycles that are 28 days in length. Results of urine pregnancy testing are positive. Prior to using the implant, the patient inconsistently used condoms.

How should you counsel your patient?

The rate of pregnancy among implant users is very low; it is estimated at 5 pregnancies per 10,000 implant users per year.⁸ As in this case, apparent “failures” of the contraceptive implant actually may represent placements that occurred before a very early pregnancy was recognized. Similar to IUDs, the proportion of pregnancies that are ectopic among implant users compared to nonusers may be higher.

With a pregnancy that is ectopic or that is intrauterine and undesired, the device may be left in and use continued after the pregnancy has been terminated. Although the effectiveness of medication abortion with pre-existing contraceptive implant in situ is not well known, researchers have demonstrated that medication abortion initiated at the same time as contraceptive implant insertion does not influence success of the medication abortion.⁹

Related article:
2016 Update on contraception

For women with desired intrauterine pregnancies, remove the device as soon as feasible and counsel the woman that there is no known teratogenic risk associated with the contraceptive implant.

Read CHALLENGE 7: Nonpalpable contraceptive implant

CHALLENGE 7: Nonpalpable contraceptive implant

CASE Patient requests device removal to attempt conception

A 30-year-old woman (G2P2) presents for contraceptive implant removal because she would like to have another child. The device was placed 30 months ago in the patient’s left arm. The insertion note in the patient’s medical record is unremarkable, and standard insertion technique was used. On physical examination, you cannot palpate the device.

What is your next course of action?

Nonpalpable implants, particularly if removal is desired, present a significant clinical challenge. Do not attempt removing a nonpalpable implant before trying to locate the device through past medical records or radiography. Records that describe the original insertion, particularly the location and type of device, are helpful.

Related article:
2015 Update on contraception
 

Appropriate imaging assistance. Ultrasonography with a high frequency linear array transducer (10 MHz or greater) may allow an experienced radiologist to identify the implant—including earlier versions without barium (Implanon) and later ones with barium (Nexplanon). Magnetic resonance imaging (MRI), computed tomography scan, or plain x-ray also can be used to detect a barium-containing device; MRI can be used to locate a non−barium-containing implant.

Carry out removal using ultrasonographic guidance. If a deep insertion is felt to be close to a neurovascular bundle, device removal should be carried out in an operating room by a surgeon familiar with the anatomy of the upper arm.

When an implant cannot be located despite radiography. This is an infrequent occurrence. Merck, the manufacturer of the etonorgestrel implant, provides advice and support in this circumstance. (Visit https://www.merckconnect.com/nexplanon/over view.html.)

Recently, published case reports detail episodes of implants inserted into the venous system with migration to the heart or lungs.¹⁰ While this phenomenon is considered rare, the manufacturer has recommended that insertion of the contraceptive implant avoid the sulcus between the biceps and triceps muscles.

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.

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

Surgical site infections are a major source of patient morbidity. They are also an important quality metric for surgeons and hospital systems, and are increasingly being linked to reimbursement.

They occur in approximately 2% of the 600,000 women undergoing hysterectomy in the United States each year. The U.S. Centers for Disease Control and Prevention defines surgical site infection (SSI) as an infection that occurs within 30 days of a procedure in the part of the body where the surgery took place. Most SSIs are superficial incisional, but they also include deep incisional or organ or space infections.

Classification

The incidence of SSI varies according to the classification of the wound, as defined by the National Academy of Sciences.¹ Most hysterectomies are classified as clean-contaminated wounds because they involve entry into the mucosa of the genitourinary tract. However, hysterectomy with contamination of bowel flora, or in the setting of acute infection (such as suppurative pelvic inflammatory disease) are considered a contaminated wound class, and are associated with even higher rates of SSI.

Risk factors

The risk factors associated with SSI are both modifiable and unmodifiable. Broadly speaking, they include increased risk to endogenous flora (e.g., wound classification), increased exposure to exogenous flora (e.g., inadequate protection of a wound from external pathogens), and impairment of the body’s immune mechanisms to prevent and overcome infection (e.g., hypothermia and hypoglycemia).

Unmodifiable risk factors include increasing age, a history of radiation exposure, vascular disease, and a history of prior SSIs. Modifiable risk factors include obesity, tobacco use, immunosuppressive medications, hypoalbuminemia, route of hysterectomy, hair removal, preoperative infections (such as bacterial vaginosis), surgical scrub, skin and vaginal preparation, antimicrobial prophylaxis (inappropriate choice or timing, inadequate dosing or redosing), operative time, blood transfusion, surgical skill, and operating room characteristics (ventilation, increased OR traffic, and sterilization of surgical equipment).

Antimicrobial prophylaxis

The CDC and the American College of Obstetricians and Gynecologists (ACOG) have provided clear guidelines regarding methods to reduce SSI in hysterectomy.^3,4 There is strong evidence for using antimicrobial prophylaxis for hysterectomy.

It is important that physicians confirm the validity of beta-lactam allergies with patients because there are higher rates of SSI with the use of non–beta-lactam regimens, even those endorsed by the CDC and ACOG.⁵

Antibiotics should be administered within 1 hour of skin incision, and ideally within 30 minutes. They should be discontinued within 24 hours. Dosing should be adjusted to weight, and antimicrobials should be redosed for long procedures (at intervals of two half-lives), and for increased blood loss.

Skin preparation

Hair removal should be avoided unless necessary for technical reasons. If it is required, it should be performed outside of the operative space using clippers, not razors. For patients colonized with methicillin-resistant S. aureus, there is supporting evidence for pretreatment with mupirocin ointment to the nares, and chlorhexidine showers for 5-10 days. Patients who have bacterial vaginosis should be treated before surgery to decrease the rate of vaginal cuff SSI.

Wound closure

Surgical technique and wound closure techniques also impact SSI. Minimally invasive and vaginal hysterectomy routes are preferred, as these are associated with the lowest rates of SSI. Antimicrobial-impregnated suture materials appear to be unnecessary. Surgeons should ensure that there is delicate handling of tissues and closure of dead spaces. If the subcutaneous fat space depth measures more than 2.5 cm, it should be reapproximated with a rapidly-absorbing suture material.

Use of electrosurgery versus a scalpel when creating the incision does not appear to influence infection rates, nor does use of staples versus subcuticular suture during closure.⁷

Using a dilute iodine lavage in the subcutaneous space, opening a sterile closing tray, and having surgeons change gloves prior to skin closure should be considered. The CDC recommends keeping the skin dressing in place for 24 hours postoperatively.

Other strategies

Hyperglycemia is associated with impaired neutrophil response, and therefore blood glucose should be controlled before surgery (hemoglobin A_1c levels of less than 7% preoperatively) and immediately postoperatively (less than 180 mg/dL within 18-24 hours after the end of anesthesia).

It is also important to minimize perioperative hypothermia (less than 35.5° F), as this also impairs the body’s immune response. Keeping operative room ambient temperatures higher, minimizing incision size, warming CO₂ gas in minimally invasive procedures, warming fluids, and using extrinsic body warmers can help achieve this.

Excessive blood loss should be minimized because blood transfusion is associated with impaired macrophage function and increased risk for SSI.

In addition to teamwide (including nonsurgeon) strict adherence to hand hygiene, OR personnel should avoid unnecessary operating room traffic. Hospital officials should ensure that the facility’s ventilator systems are well maintained and that there is care and maintenance of air handlers.

Many strategies can be employed perioperatively to decrease SSI rates for hysterectomy. We advocate for a protocol-based approach (known as “bundling” strategies) to achieve consistency of practice and to maximize surgeon and institutional improvements in SSI rates. This is similar to the approach outlined in a recent consensus statement from the Council on Patient Safety in Women’s Health Care.⁸

A comprehensive multidisciplinary approach throughout the perioperative period is necessary. It is imperative that good communication exist with patients regarding SSIs after hysterectomy and how patients, surgeons, and hospitals can together minimize the risks of SSIs.

References

1. Altemeier WA. “Manual on Control of Infection in Surgical Patients” (Philadelphia: Lippincott Williams & Wilkins, 1984).

2. Rev Infect Dis. 1991 Sep-Oct;13(Suppl 10):S821-41.

3. Infect Control Hosp Epidemiol. 2014 Jun;35(6):605-27.

4. Obstet Gynecol. 2009 May;113(5):1180-9.

5. Obstet Gynecol. 2016 Feb;127(2):321-9.

6. Am J Obstet Gynecol. 2005 Feb;192(2):422-5.

7. J Gastrointest Surg. 2016 Dec;20(12):2083-92.

8. Obstet Gynecol. 2016 Dec 7. doi: 10.1097/AOG.0000000000001751.

Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. Dr. Jackson-Moore is an associate professor in gynecologic oncology at UNC. They reported having no relevant financial disclosures.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

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.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

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.

An estimated 98,000 Americans die each year due to medical errors. This is an attention-grabbing statistic—from the year 2000.¹ A recent study (published in 2016) reported that medical errors are the third leading cause of death in the United States, ranking just behind heart disease and cancer.²

As expected, much has been done to reduce medical errors and improve patient safety as a result of these publications. Quality, safety, and outcomes are paramount, as evidenced by the Institute of Health Care Improvement’s “triple aim”: reduce cost of care, improve quality of care, and improve patient outcomes.³

While these 3 aims are of paramount importance, this article seeks to portray the “quadruple aim,” with an additional focus on physician well-being. Patients and their families (first victims) are not the only ones affected by medical errors. Clinicians are, too, and these effects can be devastating. Here I offer concrete strategies to support providers involved in medical errors, including tips on developing a formal support program. First, however, I describe the devastating effects medical errors can have on providers and the signs of a second victim.

Related article:
Medical errors: Caring for the second victim (you)

The scope of the problem

In 2000, it was Dr. Albert Wu’s publication in The British Medical Journal titled “Medical Error: The Second Victim” (the doctor who makes mistakes needs help too), that first addressed this important topic.⁴ In his article he shared a case of another house officer who missed signs of a pericardial tamponade and was judged incompetent by peers due to his mistake.

As physicians, we do not intrinsically support colleagues who have experienced a medical error. We all have taken, with pride and commitment, our Hippocratic Oath of “do no harm,” yet we are often held to standards of perfection by society, peers, and, above all, ourselves. Have technologic wonders and precise laboratory tests supplanted the adage “doctors are only human”? Dr. Wu also points out in this landmark essay his observation and dismay at the lack of empathy, sympathy, and compassion shown by peers when medical errors occur. All of these elements are needed for the healing of those involved to take place. If they are not provided, dysfunctional coping mechanisms ensue.⁴

Incidence of medical errors

Despite the Institute of Medicine report from 2000¹ and the recent study from Johns Hopkins,² determining the exact number of errors and incidents is not easy. Most data reporting is sparse. A prospective longitudinal study of perceived medical errors and resident distress estimated medical errors to be between 5% and 10% in hospitalized patients, but that it could be up to 50%.⁵ According to a 2005 study, approximately one-third of internal medicine residents report at least 1 major medical error during their 3 years of training, while 18% of multidisciplinary residents report an adverse event under their care in the previous week.⁶

Related article:
Medical errors: Meeting ethical obligations and reducing liability with proper communication

Who is at risk of becoming a second victim?

Any and all clinicians can become a second victim, and the state can be realized at varying points in the process of an experienced medical error. The circumstances of the initial error and the severity of the effect on the patient and/or the damaged physician−patient relationship can affect whether or not there is a second victim. A second victim also can emerge as a result of peers’ or colleagues’ comments and lack of empathy or support. Certainly a lawsuit can produce a second victim.⁷

How often do physicians become second victims?

The prevalence of second victims has a large variation in estimates. A 2006 study estimates a prevalence of 10.4%.⁸ In 2010, the estimate was 30%, and a prevalence of 43.3% was reported in 2000.^9,10 Regarding emotional distress within a year of a major adverse event, 30% of almost 900 providers reported these feelings.¹¹ Other studies note 50% of health care workers reported feelings consistent with those of a second victim.⁷

Next: What are the symptoms of a second victim?

The signs of, and long-lasting risks for, a second victim

Second victims are at risk for several well-documented symptoms, regardless of their stage of training, including⁶:

• depression (in fact, they have a 3-fold risk)
• decrease in overall quality of life
• increase in burnout
• increase in feelings of distress, guilt, and shame, which may be long lasting.

Health care providers as second victims also may experience shock and hopelessness, sleep disturbance, social avoidance, intrusive thoughts and nightmares, and poor memory and concentration. Interestingly, these emotions and reactions are indistinguishable from posttraumatic stress disorder. These continued symptoms can have short- and long-term implications for physicians, patients, and the health care organization.¹²

Next: How to support those affected by a medical error

How to support all of those affected by a medical error

Over the past decade or so, much attention has been paid to creating safer health systems, improving outcomes and patient satisfaction, and recognizing the needs of patients and families of first victims when medical errors occur. Much less has been done to acknowledge and address the needs of struggling clinicians.

Provide nurturing discussions and sympathy

Hospital systems do have embedded processes to review outcomes and medical errors, including, among others, peer review, quality improvement, morbidity and mortality review, and root cause analysis. Unfortunately, often a “name, blame, shame game” can result from the overall process, with certain individuals or groups of individuals singled out, and only worsen the incidence and effects of the second victim. Ideally, system processes for addressing medical errors should allow for an environment more focused on nurturing discussions to prevent error and recognize all the factors contributing to an error.

Of course in any outcome or error investigation, the goal is to identify what happened, what factors contributed to the incident, and what can be done to prevent future occurrences. The concern for the family as priority is understandable, as is the desire to prevent a lawsuit. The lack of attention and sympathy to the health care provider involved contributes to the second victim.⁷

It is all too easy to blame, even in a Just Culture. Deficiencies in sympathy and attention can occur without a system whose culture is focused on “name, blame, shame.” A Just Culture, as defined by the Institute for Healthcare Improvement, is one in which individuals come forward with a mistake without fear of punishment. Such a culture balances the need to learn from our mistakes and the need to have disciplinary action.¹³

David Marx, an outcomes engineer and author of “Whack a Mole: The Price We Pay for Expecting Perfection,” touts a Just Culture as one having the following sets of beliefs:

• recognition that professionals will make mistakes
• recognition that even professionals will develop unhealthy norms
• a fierce intolerance for reckless conduct.

He strongly asserts that human error be consoled while reckless behavior be punished.¹⁴ Punishing human error is a setup for the second victim.

Read on for tips to develop a coping program

Tips for developing a coping program

In 2009, Scott and colleagues described 6 stages of a second victim. These are:

• Stage 1: Chaos and event repair
• Stage 2: Intrusive thoughts, “what if”
• Stage 3: Restoring personal identity
• Stage 4: Enduring the inquisition
• Stage 5: Obtaining emotional first aid
• Stage 6: Moving on or dropping out; surviving and/or thriving

Throughout the stages, second victims look for support and share their experience of the medical error event, as well as their personal and professional impact of the error.¹⁵

A 2007 study that examined the emotional impact of medical errors on physicians revealed some startling data. A full 82% of physicians expressed interest in counseling to help cope with their distress. And 90% felt there was inadequate support at their hospitals or health care organizations for this distress.¹⁶

Use The Joint Commission’s toolkit

Unfortunately, there are only a few well-documented second-victim support programs in the United States, despite the growing evidence of the emotional distress that second victims experience. Many hospitals do not know how to develop or implement such a support system. Recognizing this challenge, The Joint Commission developed a toolkit to assist health care organizations in developing a second-victim program. The toolkit consists of 10 modules (TABLE) designed to assist organizations not only to implement a second-victim support process but also to customize it to their specific institutional culture. This toolkit can be downloaded for free or used online. Within the first year of its availability, over 6,000 people visited the website and there were more than 700 requests for a download.¹⁷

Follow forYOU’s example

An example and well-recognized second-victim support program is the “forYOU” team at the University of Missouri. The program is free to employees, confidential, and available 24-7. Its purpose is “providing care and support to our staff,” by helping members understand the phenomenon of the second victim and quickly returning members to a satisfying professional practice.¹⁸

The “forYOU” team was created in 2007 under the direction of the University of Missouri Health Care’s Office of Clinical Effectiveness with the goals of increasing institutional awareness, providing a second victim with a “safe zone,” and allowing for the expression of emotions and reactions in a confidential setting. Team members are multidisciplinary and include physicians, nurses, respiratory therapists, social workers, and chaplains. They strive to normalize the feelings and thoughts second victims experience after a stressful outcome or event. Team members are highly trained in second-victim responses and the stages of coping. The program has established institutional actions to each of the 6 stages (FIGURE).¹⁹

Read on to learn how peer mentors are crucial to a support program

Establish TRUST

At the Carilion Clinic in Roanoke, Virginia, we too have developed a second-victim support program for all of our employees: TRUST. In the beginning stages, we quickly reaffirmed the challenges in developing such a program.

Initial challenges you will face. First, education on what a second victim is needs to be recognized. The fact that not everyone experiences second-victim emotions needs to be validated. Administrators and staff must be convinced that needing support is not a sign of weakness. And the program must ensure confidentiality and recruit mentors. These are just a few of the obstacles we faced on our path to program realization. Our journey to develop our second-victim program was approximately 5 years and required participation, affirmation, and support from all levels of the organization.

Our program name embodies its inherent purpose and goals. TRUST stands for:

• Treatment that is just. Second victims deserve the right of a presumption that their intentions were good, and should be able to depend on organizational leaders for integrity, fairness, just treatment, and shared accountability for outcomes.
• Respect. Second victims deserve respect and common decency and should not be blamed and shamed for human fallibility.
• Understanding and compassion. Second victims need compassionate help to grieve and heal.
• Supportive care. Second victims are entitled to psychological and support services that are delivered in a professional and organized way.
• Transparency and opportunity to contribute. Second victims have a right to participate in the learning gathered from the event, to share important causal information with the organization, and to be provided with an opportunity to heal by contributing to the prevention of future events.

Employ peer mentors, who serve a vital role

We have identified the need to develop a more direct and active approach to the TRUST program’s recruitment and established a subcommittee to begin this process. We began by asking leaders to nominate potential peer mentors and spoke about the program and asked for volunteers at various hospital committees. Once we had most disciplines represented, leaders were asked to take an assessment for emotional intelligence.

Other than the initial training for the TRUST program, the time requirement for participation for peer mentors is likely less than an hour per month. The dedicated time certainly is dependent on how much support the second victim is requiring, however, and varies. We encourage the peer supporters to be aware of their time constraints and establish parameters for the relationship in a direct but supportive way.

Since the inception of the TRUST Team in September 2014, we have trained 12 peer mentors, 10 of whom currently still serve in that capacity. We have 3 additional peers awaiting training. To date, The TRUST team has supported 19 clinicians/staff, including 3 ACPs, 9 nurses, 6 physicians, and 1 other (pharmacist). Of those 10, 3 are still actively receiving support so closing data have yet to be collected. Of the 16 who have been closed, 6 were referred for ongoing support and 10 were able to return to baseline with TRUST Team Supports.

Related article:
Who is liable when a surgical error occurs?

Just surviving the medical error is not the goal

Medical errors are inevitable, and the effects on providers can be devastating. It is important that physicians and institutions are aware of the signs and symptoms of a second victim as well as provide support to them. Institutions must have a just culture in which all members of the health care team can come forward with medical errors without the fear of punishment. Ideally, these institutions also have a second-victim support system that identifies those who need assistance and assist all health care clinicians not only to survive the effects of medical errors but also to thrive after receiving the necessary support.

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.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

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.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

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.

Technology has changed--and continues to change--the practice of medicine. Health care providers access word processing programs, e-mail, and electronic medical records using desktop and laptop computers. Now, providers are accessing these same tools with handheld devices such as smartphones, tablets, and "phablets" (a class of mobile devices designed to combine the form of a smartphone and a tablet).

Critical to the popularity and functionality of handheld devices are mobile applications, also known as "apps." An app is a self-contained program or piece of software designed to run on handheld devices to perform a specific purpose. App overload and app inaccuracy, however, are major problems. Health care providers do not have the time to search through thousands of medical apps in app stores to find specialty-related apps that might be useful in their practice--or to check the accuracy of those apps.

Vetted apps for ObGyns

My team's research has focused on identifying apps for ObGyns to use in clinical practice.¹ In the process, we have developed the APPLICATIONS scoring system, which contains objective and subjective components to help differentiate among the accurate apps.² This new quarterly "App review" series in OBG Management will showcase recommended apps for the busy ObGyn in the hope of improving work efficiency and the provider-patient relationship.

First up: Apps for calculating the date of delivery. This first app review focuses on pregnancy wheels, or due date calculators. Calculator apps are preferred over other types of apps such as procedure/case documentation apps, as providers use smartphones at point of care to allow rapid decision making.³ Calculating the estimated date of delivery (EDD) and gestational age (GA) is an important, vital task for providers of obstetric care. In fact, new guidelines for calculating EDD were recently developed by the American College of Obstetricians and Gynecologists (ACOG), the American Institute of Ultrasound in Medicine (AIUM), and the Society for Maternal-Fetal Medicine (SMFM).⁴ Notably, pregnancy wheel apps are more accurate than paper wheels.5 My team checked the accuracy of the pregnancy wheel apps by applying strict criteria to ensure the correct EDD and GA and then scored them in a systematic, nonbiased, conflict-of-interest-free manner.²

Related article:
Elective induction of labor at 39 (vs 41) weeks: Caveats and considerations
 

The TABLE below lists the top 3 recommended pregnancy wheel or due date calculator apps vetted by our research. The apps are listed alphabetically, and details for each app are provided based on a shortened version of the APPLICATIONS scoring system, APPLI--app comprehensiveness, price, platform, literature use, and important special features.

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.

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

Results of a small study suggest a single dose of the hallucinogenic drug psilocybin, when combined with counseling, can significantly lessen psychological distress in cancer patients for months at a time.

The study showed that psychological counseling and a single dose of psilocybin brought relief from distress that lasted for more than 6 months in a majority of the subjects monitored.

This was based on clinical evaluation scores for anxiety and depression.

“Our results represent the strongest evidence to date of a clinical benefit from psilocybin therapy, with the potential to transform care for patients with cancer-related psychological distress,” said study author Stephen Ross, MD, of New York University School of Medicine in New York, New York.

“If larger clinical trials prove successful, then we could ultimately have available a safe, effective, and inexpensive medication—dispensed under strict control—to alleviate the distress that increases suicide rates among cancer patients.”

Dr Ross and his colleagues reported the results of their study in the Journal of Psychopharmacology alongside a related study and 11 accompanying editorials.

Dr Ross’s study included 29 patients with cancer-related anxiety and depression. Their mean age was 56, and 62% were female. Ninety percent were Caucasian, and 10% were classified as “other” race.

Patients had breast cancer (31%), reproductive cancers (28%), digestive cancers (17%), leukemia/lymphoma (14%), and other cancers (10%).

All patients had been diagnosed as suffering from serious psychological distress related to their disease.

Treatment

Half of the patients were randomly assigned to receive a 0.3 mg/kg dose of psilocybin, and half received a vitamin placebo (250 mg of niacin) known to produce a “rush” that mimics a hallucinogenic drug experience.

Approximately half way through the study’s monitoring period (after 7 weeks), all patients switched treatments. Those who initially received psilocybin took a single dose of niacin, and vice-versa. Neither patients nor researchers knew who had first received psilocybin or placebo.

All patients were provided with tailored counseling from a psychiatrist, psychologist, nurse, or social worker. And the patients were monitored for side effects and improvements in their mental state.

Safety

The researchers said there were no serious adverse events (AEs), either medical or psychiatric, that were attributed to psilocybin.

The most common medical AEs that were attributable to psilocybin were non-clinically significant elevations in blood pressure and heart rate (76%), headaches/migraines (28%), and nausea (14%).

The most common psychiatric AEs attributable to psilocybin were transient anxiety (17%) and transient psychotic-like symptoms (7%; 1 case of transient paranoid ideation and 1 case of transient thought disorder).
 
Efficacy

The researchers said that, prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression.

Specifically, patients who received psilocybin first had significant improvements in responses on the Hospital Anxiety and Depression Scale and the Beck Depression Inventory, when compared to patients who received niacin first.

The differences were significant 1 day after the patients’ first session and 7 weeks after the first session (P≤0.01 for all).

At the 6.5-month follow-up, 60% to 80% of participants continued with clinically significant reductions in depression or anxiety.

The researchers said a key finding of this study was that improvements in clinical evaluation scores for anxiety and depression lasted for the study’s extended monitoring period, which was 8 months for those who took psilocybin first.

Patients also reported post-psilocybin improvements in their quality of life, such as going out more, greater energy, getting along better with family members, and doing well at work. Some reported variations of spirituality, unusual peacefulness, and increased feelings of altruism.

“Our study showed that psilocybin facilitated experiences that drove reductions in psychological distress,” said study author Anthony Bossis, PhD, of New York University School of Medicine. “And if it’s true for cancer care, then it could apply to other stressful medical conditions.”

He cautioned that patients should not consume psilocybin on their own or without supervision from a physician and a trained counselor.

“Psilocybin therapy may not work for everyone,” he noted. “And some groups, such as people with schizophrenia, as well as adolescents, should not be treated with it.”

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

Results of a small study suggest a single dose of the hallucinogenic drug psilocybin, when combined with counseling, can significantly lessen psychological distress in cancer patients for months at a time.

The study showed that psychological counseling and a single dose of psilocybin brought relief from distress that lasted for more than 6 months in a majority of the subjects monitored.

This was based on clinical evaluation scores for anxiety and depression.

“Our results represent the strongest evidence to date of a clinical benefit from psilocybin therapy, with the potential to transform care for patients with cancer-related psychological distress,” said study author Stephen Ross, MD, of New York University School of Medicine in New York, New York.

“If larger clinical trials prove successful, then we could ultimately have available a safe, effective, and inexpensive medication—dispensed under strict control—to alleviate the distress that increases suicide rates among cancer patients.”

Dr Ross and his colleagues reported the results of their study in the Journal of Psychopharmacology alongside a related study and 11 accompanying editorials.

Dr Ross’s study included 29 patients with cancer-related anxiety and depression. Their mean age was 56, and 62% were female. Ninety percent were Caucasian, and 10% were classified as “other” race.

Patients had breast cancer (31%), reproductive cancers (28%), digestive cancers (17%), leukemia/lymphoma (14%), and other cancers (10%).

All patients had been diagnosed as suffering from serious psychological distress related to their disease.

Treatment

Half of the patients were randomly assigned to receive a 0.3 mg/kg dose of psilocybin, and half received a vitamin placebo (250 mg of niacin) known to produce a “rush” that mimics a hallucinogenic drug experience.

Approximately half way through the study’s monitoring period (after 7 weeks), all patients switched treatments. Those who initially received psilocybin took a single dose of niacin, and vice-versa. Neither patients nor researchers knew who had first received psilocybin or placebo.

All patients were provided with tailored counseling from a psychiatrist, psychologist, nurse, or social worker. And the patients were monitored for side effects and improvements in their mental state.

Safety

The researchers said there were no serious adverse events (AEs), either medical or psychiatric, that were attributed to psilocybin.

The most common medical AEs that were attributable to psilocybin were non-clinically significant elevations in blood pressure and heart rate (76%), headaches/migraines (28%), and nausea (14%).

The most common psychiatric AEs attributable to psilocybin were transient anxiety (17%) and transient psychotic-like symptoms (7%; 1 case of transient paranoid ideation and 1 case of transient thought disorder).
 
Efficacy

The researchers said that, prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression.

Specifically, patients who received psilocybin first had significant improvements in responses on the Hospital Anxiety and Depression Scale and the Beck Depression Inventory, when compared to patients who received niacin first.

The differences were significant 1 day after the patients’ first session and 7 weeks after the first session (P≤0.01 for all).

At the 6.5-month follow-up, 60% to 80% of participants continued with clinically significant reductions in depression or anxiety.

The researchers said a key finding of this study was that improvements in clinical evaluation scores for anxiety and depression lasted for the study’s extended monitoring period, which was 8 months for those who took psilocybin first.

Patients also reported post-psilocybin improvements in their quality of life, such as going out more, greater energy, getting along better with family members, and doing well at work. Some reported variations of spirituality, unusual peacefulness, and increased feelings of altruism.

“Our study showed that psilocybin facilitated experiences that drove reductions in psychological distress,” said study author Anthony Bossis, PhD, of New York University School of Medicine. “And if it’s true for cancer care, then it could apply to other stressful medical conditions.”

He cautioned that patients should not consume psilocybin on their own or without supervision from a physician and a trained counselor.

“Psilocybin therapy may not work for everyone,” he noted. “And some groups, such as people with schizophrenia, as well as adolescents, should not be treated with it.”

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

Results of a small study suggest a single dose of the hallucinogenic drug psilocybin, when combined with counseling, can significantly lessen psychological distress in cancer patients for months at a time.

The study showed that psychological counseling and a single dose of psilocybin brought relief from distress that lasted for more than 6 months in a majority of the subjects monitored.

This was based on clinical evaluation scores for anxiety and depression.

“Our results represent the strongest evidence to date of a clinical benefit from psilocybin therapy, with the potential to transform care for patients with cancer-related psychological distress,” said study author Stephen Ross, MD, of New York University School of Medicine in New York, New York.

“If larger clinical trials prove successful, then we could ultimately have available a safe, effective, and inexpensive medication—dispensed under strict control—to alleviate the distress that increases suicide rates among cancer patients.”

Dr Ross and his colleagues reported the results of their study in the Journal of Psychopharmacology alongside a related study and 11 accompanying editorials.

Dr Ross’s study included 29 patients with cancer-related anxiety and depression. Their mean age was 56, and 62% were female. Ninety percent were Caucasian, and 10% were classified as “other” race.

Patients had breast cancer (31%), reproductive cancers (28%), digestive cancers (17%), leukemia/lymphoma (14%), and other cancers (10%).

All patients had been diagnosed as suffering from serious psychological distress related to their disease.

Treatment

Half of the patients were randomly assigned to receive a 0.3 mg/kg dose of psilocybin, and half received a vitamin placebo (250 mg of niacin) known to produce a “rush” that mimics a hallucinogenic drug experience.

Approximately half way through the study’s monitoring period (after 7 weeks), all patients switched treatments. Those who initially received psilocybin took a single dose of niacin, and vice-versa. Neither patients nor researchers knew who had first received psilocybin or placebo.

All patients were provided with tailored counseling from a psychiatrist, psychologist, nurse, or social worker. And the patients were monitored for side effects and improvements in their mental state.

Safety

The researchers said there were no serious adverse events (AEs), either medical or psychiatric, that were attributed to psilocybin.

The most common medical AEs that were attributable to psilocybin were non-clinically significant elevations in blood pressure and heart rate (76%), headaches/migraines (28%), and nausea (14%).

The most common psychiatric AEs attributable to psilocybin were transient anxiety (17%) and transient psychotic-like symptoms (7%; 1 case of transient paranoid ideation and 1 case of transient thought disorder).
 
Efficacy

The researchers said that, prior to the crossover, psilocybin produced immediate, substantial, and sustained improvements in anxiety and depression.

Specifically, patients who received psilocybin first had significant improvements in responses on the Hospital Anxiety and Depression Scale and the Beck Depression Inventory, when compared to patients who received niacin first.

The differences were significant 1 day after the patients’ first session and 7 weeks after the first session (P≤0.01 for all).

At the 6.5-month follow-up, 60% to 80% of participants continued with clinically significant reductions in depression or anxiety.

The researchers said a key finding of this study was that improvements in clinical evaluation scores for anxiety and depression lasted for the study’s extended monitoring period, which was 8 months for those who took psilocybin first.

Patients also reported post-psilocybin improvements in their quality of life, such as going out more, greater energy, getting along better with family members, and doing well at work. Some reported variations of spirituality, unusual peacefulness, and increased feelings of altruism.

“Our study showed that psilocybin facilitated experiences that drove reductions in psychological distress,” said study author Anthony Bossis, PhD, of New York University School of Medicine. “And if it’s true for cancer care, then it could apply to other stressful medical conditions.”

He cautioned that patients should not consume psilocybin on their own or without supervision from a physician and a trained counselor.

“Psilocybin therapy may not work for everyone,” he noted. “And some groups, such as people with schizophrenia, as well as adolescents, should not be treated with it.”

Enterococcus bacteria
Photo courtesy of
Janice Carr/CDC

The quest to understand a prolonged infection in an infant with acute myeloid leukemia (AML) has led to the discovery of a mutation that allows bacteria to tolerate antibiotic therapy.

Researchers described this discovery in the journal mBio.

“These findings detail a ‘perfect storm’ for development of antibiotic tolerance by bacteria that already pose a clinical challenge,” said study author Jason Rosch, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The same conditions may be present in other patients with immune systems that have been compromised by chemotherapy or disease,” added co-author Joshua Wolf, MBBS, also of St. Jude.

The “perfect storm” involved a patient who was 6 weeks old when she was diagnosed with AML. The treatment wiped out her white blood cells, and, despite infection-control measures, she developed a bloodstream infection with vancomycin-resistant Enterococcus faecium (VRE).

The infection persisted for 26 days and only resolved after her immune system recovered. She then successfully completed AML treatment.

In-depth DNA sequencing of 22 VRE samples collected during the patient’s infection helped researchers link the prolonged infection to a point mutation in the relA gene of VRE.

The mutation inappropriately activated the stringent response pathway, which bacteria use to survive under stress and to tolerate antibiotics.

The mutation resulted in elevated levels of the signaling molecule alarmone, and this likely primed the bacteria to survive exposure to multiple antibiotics, the researchers said.

The team also noted that relA-mutant VRE was susceptible to the antibiotics linezolid and daptomycin in minimum inhibitory concentration testing and during planktonic growth.

However, when growing in biofilm, relA-mutant VRE could tolerate high doses of both antibiotics.

“This mutation has particular clinical significance because the antibiotics involved, linezolid and daptomycin, are the last line of defense against VRE infection,” Dr Wolf said.

Among the compounds in development for the treatment of bacterial biofilms is the experimental antibiotic ADEP-4. In this study, ADEP-4 killed relA-mutant and non-mutant VRE growing in biofilm in the lab.

“In the future, compounds like ADEP-4 may provide a new approach to resolving persistent infections,” Dr Wolf said.

Dr Rosch noted that evidence gleaned from tracking the evolution of VRE throughout the infection suggested the patient’s immune-compromised state was essential to survival of the mutant VRE.

Gene transcription was altered significantly in relA-mutant VRE and produced biofilms that were less robust and possibly unlikely to otherwise survive.

“The case expands our understanding of the role of the stringent response in susceptibility and tolerance to a wide range of antibiotics, especially in biofilms,” Dr Rosch said. “It also demonstrates that these mutations can develop and gain a foothold during a human infection.”

Enterococcus bacteria
Photo courtesy of
Janice Carr/CDC

The quest to understand a prolonged infection in an infant with acute myeloid leukemia (AML) has led to the discovery of a mutation that allows bacteria to tolerate antibiotic therapy.

Researchers described this discovery in the journal mBio.

“These findings detail a ‘perfect storm’ for development of antibiotic tolerance by bacteria that already pose a clinical challenge,” said study author Jason Rosch, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The same conditions may be present in other patients with immune systems that have been compromised by chemotherapy or disease,” added co-author Joshua Wolf, MBBS, also of St. Jude.

The “perfect storm” involved a patient who was 6 weeks old when she was diagnosed with AML. The treatment wiped out her white blood cells, and, despite infection-control measures, she developed a bloodstream infection with vancomycin-resistant Enterococcus faecium (VRE).

The infection persisted for 26 days and only resolved after her immune system recovered. She then successfully completed AML treatment.

In-depth DNA sequencing of 22 VRE samples collected during the patient’s infection helped researchers link the prolonged infection to a point mutation in the relA gene of VRE.

The mutation inappropriately activated the stringent response pathway, which bacteria use to survive under stress and to tolerate antibiotics.

The mutation resulted in elevated levels of the signaling molecule alarmone, and this likely primed the bacteria to survive exposure to multiple antibiotics, the researchers said.

The team also noted that relA-mutant VRE was susceptible to the antibiotics linezolid and daptomycin in minimum inhibitory concentration testing and during planktonic growth.

However, when growing in biofilm, relA-mutant VRE could tolerate high doses of both antibiotics.

“This mutation has particular clinical significance because the antibiotics involved, linezolid and daptomycin, are the last line of defense against VRE infection,” Dr Wolf said.

Among the compounds in development for the treatment of bacterial biofilms is the experimental antibiotic ADEP-4. In this study, ADEP-4 killed relA-mutant and non-mutant VRE growing in biofilm in the lab.

“In the future, compounds like ADEP-4 may provide a new approach to resolving persistent infections,” Dr Wolf said.

Dr Rosch noted that evidence gleaned from tracking the evolution of VRE throughout the infection suggested the patient’s immune-compromised state was essential to survival of the mutant VRE.

Gene transcription was altered significantly in relA-mutant VRE and produced biofilms that were less robust and possibly unlikely to otherwise survive.

“The case expands our understanding of the role of the stringent response in susceptibility and tolerance to a wide range of antibiotics, especially in biofilms,” Dr Rosch said. “It also demonstrates that these mutations can develop and gain a foothold during a human infection.”

Enterococcus bacteria
Photo courtesy of
Janice Carr/CDC

The quest to understand a prolonged infection in an infant with acute myeloid leukemia (AML) has led to the discovery of a mutation that allows bacteria to tolerate antibiotic therapy.

Researchers described this discovery in the journal mBio.

“These findings detail a ‘perfect storm’ for development of antibiotic tolerance by bacteria that already pose a clinical challenge,” said study author Jason Rosch, PhD, of St. Jude Children’s Research Hospital in Memphis, Tennessee.

“The same conditions may be present in other patients with immune systems that have been compromised by chemotherapy or disease,” added co-author Joshua Wolf, MBBS, also of St. Jude.

The “perfect storm” involved a patient who was 6 weeks old when she was diagnosed with AML. The treatment wiped out her white blood cells, and, despite infection-control measures, she developed a bloodstream infection with vancomycin-resistant Enterococcus faecium (VRE).

The infection persisted for 26 days and only resolved after her immune system recovered. She then successfully completed AML treatment.

In-depth DNA sequencing of 22 VRE samples collected during the patient’s infection helped researchers link the prolonged infection to a point mutation in the relA gene of VRE.

The mutation inappropriately activated the stringent response pathway, which bacteria use to survive under stress and to tolerate antibiotics.

The mutation resulted in elevated levels of the signaling molecule alarmone, and this likely primed the bacteria to survive exposure to multiple antibiotics, the researchers said.

The team also noted that relA-mutant VRE was susceptible to the antibiotics linezolid and daptomycin in minimum inhibitory concentration testing and during planktonic growth.

However, when growing in biofilm, relA-mutant VRE could tolerate high doses of both antibiotics.

“This mutation has particular clinical significance because the antibiotics involved, linezolid and daptomycin, are the last line of defense against VRE infection,” Dr Wolf said.

Among the compounds in development for the treatment of bacterial biofilms is the experimental antibiotic ADEP-4. In this study, ADEP-4 killed relA-mutant and non-mutant VRE growing in biofilm in the lab.

“In the future, compounds like ADEP-4 may provide a new approach to resolving persistent infections,” Dr Wolf said.

Dr Rosch noted that evidence gleaned from tracking the evolution of VRE throughout the infection suggested the patient’s immune-compromised state was essential to survival of the mutant VRE.

Gene transcription was altered significantly in relA-mutant VRE and produced biofilms that were less robust and possibly unlikely to otherwise survive.

“The case expands our understanding of the role of the stringent response in susceptibility and tolerance to a wide range of antibiotics, especially in biofilms,” Dr Rosch said. “It also demonstrates that these mutations can develop and gain a foothold during a human infection.”

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

One-time treatment with the hallucinogenic drug psilocybin may provide long-term relief of existential anxiety in patients with life-threatening cancers, according to a small study.

After receiving a single high dose of the drug, most of the patients studied reported decreases in depression and anxiety as well as increases in quality of life and optimism.

These improvements were sustained at 6 months of follow-up.

“The most interesting and remarkable finding is that a single dose of psilocybin, which lasts 4 to 6 hours, produced enduring decreases in depression and anxiety symptoms, and this may represent a fascinating new model for treating some psychiatric conditions,” said study author Roland Griffiths, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Dr Griffiths said this study grew out of a decade of research at Johns Hopkins on the effects of psilocybin in healthy volunteers, which showed that psilocybin can consistently produce positive changes in mood, behavior, and spirituality when administered to carefully screened and prepared participants.

The current study was designed to see if psilocybin could produce similar results in psychologically distressed cancer patients.

The results were published in the Journal of Psychopharmacology alongside a similar study and 11 accompanying editorials.

For their study, Dr Griffiths and his colleagues recruited 51 participants diagnosed with life-threatening cancers, most of which were recurrent or metastatic.

Types of cancer included breast (n=13), upper aerodigestive (n=7), gastrointestinal (n=4), genitourinary (n=18), and “other” cancers (n=1), as well as hematologic malignancies (n=8).

All participants had been given a formal psychiatric diagnosis, including an anxiety or depressive disorder.

Half of the participants were female, and they had an average age of 56. Ninety-two percent were white, 4% were black, and 2% were Asian.

Treatment

Each participant had 2 treatment sessions scheduled 5 weeks apart. In 1 session, they received a capsule containing a very low dose (1 or 3 mg per 70 kg) of psilocybin that was meant to act as a “control” because the dose was too low to produce effects.

In the other session, participants received a capsule with what is considered a moderate or high dose (22 or 30 mg per 70 kg).

To minimize expectancy effects, the participants and the staff members supervising the sessions were told that participants would receive psilocybin on both sessions, but they did not know that all participants would receive a high dose and a low dose.

Blood pressure and mood were monitored throughout the sessions.

Two monitors aided participants during each session, encouraging them to lie down, wear an eye mask, listen to music through headphones, and direct their attention on their inner experience. If anxiety or confusion arose, the monitors provided reassurance to the participants.

Participants, staff, and community observers rated participants’ moods, attitudes, and behaviors throughout the study.

The researchers assessed each participant via questionnaires and structured interviews before the first session, 7 hours after taking the psilocybin, 5 weeks after each session, and 6 months after the second session.

Adverse events

Thirty-four percent of participants had an episode of elevated systolic blood pressure (>160 mm Hg at 1 or more time-point) in the high-dose psilocybin session, and 17% of participants had such an episode in the low-dose session.

Thirteen percent and 2%, respectively, had an episode of elevated diastolic blood pressure (>100 mm Hg at 1 or more time-point). None of these episodes met criteria for medical intervention.

During the high-dose psilocybin session, 15% of patients experienced nausea or vomiting. There were no such events during the low-dose session.

Three participants reported mild to moderate headaches after the high-dose session.

Twenty-one percent of patients reported physical discomfort during the high-dose session, as did 8% of patients during the low-dose session.

Psychological discomfort occurred in 32% and 12% of participants, respectively. The researchers said there were no cases of hallucinogen persisting perception disorder or prolonged psychosis.

Efficacy outcomes

Most participants reported experiencing changes in visual perception, emotions, and thinking after taking high-dose psilocybin. They also reported experiences of psychological insight and profound, deeply meaningful experiences.

Six months after the final session of treatment, about 80% of participants continued to show clinically significant decreases in depressed mood and anxiety, according to clinician assessment.

According to the participants themselves, 83% had increases in well-being or life satisfaction at 6 months after treatment.

Sixty-seven percent of participants rated the experience as one of the top 5 meaningful experiences in their lives, and 70% rated the experience as one of their top 5 spiritually significant lifetime events.

“Before beginning the study, it wasn’t clear to me that this treatment would be helpful, since cancer patients may experience profound hopelessness in response to their diagnosis, which is often followed by multiple surgeries and prolonged chemotherapy,” Dr Griffiths said.

“I could imagine that cancer patients would receive psilocybin, look into the existential void, and come out even more fearful. However, the positive changes in attitudes, moods, and behavior that we documented in healthy volunteers were replicated in cancer patients.”

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

One-time treatment with the hallucinogenic drug psilocybin may provide long-term relief of existential anxiety in patients with life-threatening cancers, according to a small study.

After receiving a single high dose of the drug, most of the patients studied reported decreases in depression and anxiety as well as increases in quality of life and optimism.

These improvements were sustained at 6 months of follow-up.

“The most interesting and remarkable finding is that a single dose of psilocybin, which lasts 4 to 6 hours, produced enduring decreases in depression and anxiety symptoms, and this may represent a fascinating new model for treating some psychiatric conditions,” said study author Roland Griffiths, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Dr Griffiths said this study grew out of a decade of research at Johns Hopkins on the effects of psilocybin in healthy volunteers, which showed that psilocybin can consistently produce positive changes in mood, behavior, and spirituality when administered to carefully screened and prepared participants.

The current study was designed to see if psilocybin could produce similar results in psychologically distressed cancer patients.

The results were published in the Journal of Psychopharmacology alongside a similar study and 11 accompanying editorials.

For their study, Dr Griffiths and his colleagues recruited 51 participants diagnosed with life-threatening cancers, most of which were recurrent or metastatic.

Types of cancer included breast (n=13), upper aerodigestive (n=7), gastrointestinal (n=4), genitourinary (n=18), and “other” cancers (n=1), as well as hematologic malignancies (n=8).

All participants had been given a formal psychiatric diagnosis, including an anxiety or depressive disorder.

Half of the participants were female, and they had an average age of 56. Ninety-two percent were white, 4% were black, and 2% were Asian.

Treatment

Each participant had 2 treatment sessions scheduled 5 weeks apart. In 1 session, they received a capsule containing a very low dose (1 or 3 mg per 70 kg) of psilocybin that was meant to act as a “control” because the dose was too low to produce effects.

In the other session, participants received a capsule with what is considered a moderate or high dose (22 or 30 mg per 70 kg).

To minimize expectancy effects, the participants and the staff members supervising the sessions were told that participants would receive psilocybin on both sessions, but they did not know that all participants would receive a high dose and a low dose.

Blood pressure and mood were monitored throughout the sessions.

Two monitors aided participants during each session, encouraging them to lie down, wear an eye mask, listen to music through headphones, and direct their attention on their inner experience. If anxiety or confusion arose, the monitors provided reassurance to the participants.

Participants, staff, and community observers rated participants’ moods, attitudes, and behaviors throughout the study.

The researchers assessed each participant via questionnaires and structured interviews before the first session, 7 hours after taking the psilocybin, 5 weeks after each session, and 6 months after the second session.

Adverse events

Thirty-four percent of participants had an episode of elevated systolic blood pressure (>160 mm Hg at 1 or more time-point) in the high-dose psilocybin session, and 17% of participants had such an episode in the low-dose session.

Thirteen percent and 2%, respectively, had an episode of elevated diastolic blood pressure (>100 mm Hg at 1 or more time-point). None of these episodes met criteria for medical intervention.

During the high-dose psilocybin session, 15% of patients experienced nausea or vomiting. There were no such events during the low-dose session.

Three participants reported mild to moderate headaches after the high-dose session.

Twenty-one percent of patients reported physical discomfort during the high-dose session, as did 8% of patients during the low-dose session.

Psychological discomfort occurred in 32% and 12% of participants, respectively. The researchers said there were no cases of hallucinogen persisting perception disorder or prolonged psychosis.

Efficacy outcomes

Most participants reported experiencing changes in visual perception, emotions, and thinking after taking high-dose psilocybin. They also reported experiences of psychological insight and profound, deeply meaningful experiences.

Six months after the final session of treatment, about 80% of participants continued to show clinically significant decreases in depressed mood and anxiety, according to clinician assessment.

According to the participants themselves, 83% had increases in well-being or life satisfaction at 6 months after treatment.

Sixty-seven percent of participants rated the experience as one of the top 5 meaningful experiences in their lives, and 70% rated the experience as one of their top 5 spiritually significant lifetime events.

“Before beginning the study, it wasn’t clear to me that this treatment would be helpful, since cancer patients may experience profound hopelessness in response to their diagnosis, which is often followed by multiple surgeries and prolonged chemotherapy,” Dr Griffiths said.

“I could imagine that cancer patients would receive psilocybin, look into the existential void, and come out even more fearful. However, the positive changes in attitudes, moods, and behavior that we documented in healthy volunteers were replicated in cancer patients.”

Cancer patient receiving
chemotherapy
Photo by Rhoda Baer

One-time treatment with the hallucinogenic drug psilocybin may provide long-term relief of existential anxiety in patients with life-threatening cancers, according to a small study.

After receiving a single high dose of the drug, most of the patients studied reported decreases in depression and anxiety as well as increases in quality of life and optimism.

These improvements were sustained at 6 months of follow-up.

“The most interesting and remarkable finding is that a single dose of psilocybin, which lasts 4 to 6 hours, produced enduring decreases in depression and anxiety symptoms, and this may represent a fascinating new model for treating some psychiatric conditions,” said study author Roland Griffiths, PhD, of the Johns Hopkins University School of Medicine in Baltimore, Maryland.

Dr Griffiths said this study grew out of a decade of research at Johns Hopkins on the effects of psilocybin in healthy volunteers, which showed that psilocybin can consistently produce positive changes in mood, behavior, and spirituality when administered to carefully screened and prepared participants.

The current study was designed to see if psilocybin could produce similar results in psychologically distressed cancer patients.

The results were published in the Journal of Psychopharmacology alongside a similar study and 11 accompanying editorials.

For their study, Dr Griffiths and his colleagues recruited 51 participants diagnosed with life-threatening cancers, most of which were recurrent or metastatic.

Types of cancer included breast (n=13), upper aerodigestive (n=7), gastrointestinal (n=4), genitourinary (n=18), and “other” cancers (n=1), as well as hematologic malignancies (n=8).

All participants had been given a formal psychiatric diagnosis, including an anxiety or depressive disorder.

Half of the participants were female, and they had an average age of 56. Ninety-two percent were white, 4% were black, and 2% were Asian.

Treatment

Each participant had 2 treatment sessions scheduled 5 weeks apart. In 1 session, they received a capsule containing a very low dose (1 or 3 mg per 70 kg) of psilocybin that was meant to act as a “control” because the dose was too low to produce effects.

In the other session, participants received a capsule with what is considered a moderate or high dose (22 or 30 mg per 70 kg).

To minimize expectancy effects, the participants and the staff members supervising the sessions were told that participants would receive psilocybin on both sessions, but they did not know that all participants would receive a high dose and a low dose.

Blood pressure and mood were monitored throughout the sessions.

Two monitors aided participants during each session, encouraging them to lie down, wear an eye mask, listen to music through headphones, and direct their attention on their inner experience. If anxiety or confusion arose, the monitors provided reassurance to the participants.

Participants, staff, and community observers rated participants’ moods, attitudes, and behaviors throughout the study.

The researchers assessed each participant via questionnaires and structured interviews before the first session, 7 hours after taking the psilocybin, 5 weeks after each session, and 6 months after the second session.

Adverse events

Thirty-four percent of participants had an episode of elevated systolic blood pressure (>160 mm Hg at 1 or more time-point) in the high-dose psilocybin session, and 17% of participants had such an episode in the low-dose session.

Thirteen percent and 2%, respectively, had an episode of elevated diastolic blood pressure (>100 mm Hg at 1 or more time-point). None of these episodes met criteria for medical intervention.

During the high-dose psilocybin session, 15% of patients experienced nausea or vomiting. There were no such events during the low-dose session.

Three participants reported mild to moderate headaches after the high-dose session.

Twenty-one percent of patients reported physical discomfort during the high-dose session, as did 8% of patients during the low-dose session.

Psychological discomfort occurred in 32% and 12% of participants, respectively. The researchers said there were no cases of hallucinogen persisting perception disorder or prolonged psychosis.

Efficacy outcomes

Most participants reported experiencing changes in visual perception, emotions, and thinking after taking high-dose psilocybin. They also reported experiences of psychological insight and profound, deeply meaningful experiences.

Six months after the final session of treatment, about 80% of participants continued to show clinically significant decreases in depressed mood and anxiety, according to clinician assessment.

According to the participants themselves, 83% had increases in well-being or life satisfaction at 6 months after treatment.

Sixty-seven percent of participants rated the experience as one of the top 5 meaningful experiences in their lives, and 70% rated the experience as one of their top 5 spiritually significant lifetime events.

“Before beginning the study, it wasn’t clear to me that this treatment would be helpful, since cancer patients may experience profound hopelessness in response to their diagnosis, which is often followed by multiple surgeries and prolonged chemotherapy,” Dr Griffiths said.

“I could imagine that cancer patients would receive psilocybin, look into the existential void, and come out even more fearful. However, the positive changes in attitudes, moods, and behavior that we documented in healthy volunteers were replicated in cancer patients.”

Micrograph showing MDS

Preclinical research has revealed potential therapeutic targets for

myelodysplastic syndromes (MDS).

Investigators

found evidence to suggest that TRAF6, a toll-like receptor effector

with ubiquitin ligase activity, plays a key role in MDS.

So TRAF6 and

proteins regulated by TRAF6 may be therapeutic targets for MDS.

Daniel Starczynowski, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio, and his colleagues reported these findings in Nature Immunology.

The investigators first found that TRAF6 is overexpressed in hematopoietic stem/progenitor cells from MDS patients.

To more closely examine the role of TRAF6 in MDS, the team created mouse models in which the protein was overexpressed.

“We found that TRAF6 overexpression in mouse hematopoietic stem cells results in impaired blood cell formation and bone marrow failure,” Dr Starczynowski said.

Further investigation revealed that hnRNPA1, an RNA-binding protein and auxiliary splicing factor, is a substrate of TRAF6. And TRAF6 ubiquitination of hnRNPA1 regulates alternative splicing of Arhgap1.

This activates the GTP-binding Rho family protein Cdc42 and accounts for the defects observed in hematopoietic stem/progenitor cells that express TRAF6.

All of these proteins could be potential treatment targets for cases of MDS triggered by overexpression of TRAF6, according to Dr Starczynowski, who said future studies will test their therapeutic potential in mouse models of MDS.

“Based on our paper, a number of therapeutic approaches can be tested and directed against TRAF6 and other related proteins responsible for MDS,” he said.

Beyond the potential for new therapeutic approaches in MDS, this research revealed a new and critical immune-related function for TRAF6, according to the investigators.

TRAF6 regulates RNA isoform expression in response to various pathogens. In the context of the current study, TRAF6’s regulation of RNA isoform expression is important to the function of hematopoietic cells and reveals another dimension to how cells respond to infection, Dr Starczynowski said.

Micrograph showing MDS

Preclinical research has revealed potential therapeutic targets for

myelodysplastic syndromes (MDS).

Investigators

found evidence to suggest that TRAF6, a toll-like receptor effector

with ubiquitin ligase activity, plays a key role in MDS.

So TRAF6 and

proteins regulated by TRAF6 may be therapeutic targets for MDS.

Daniel Starczynowski, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio, and his colleagues reported these findings in Nature Immunology.

The investigators first found that TRAF6 is overexpressed in hematopoietic stem/progenitor cells from MDS patients.

To more closely examine the role of TRAF6 in MDS, the team created mouse models in which the protein was overexpressed.

“We found that TRAF6 overexpression in mouse hematopoietic stem cells results in impaired blood cell formation and bone marrow failure,” Dr Starczynowski said.

Further investigation revealed that hnRNPA1, an RNA-binding protein and auxiliary splicing factor, is a substrate of TRAF6. And TRAF6 ubiquitination of hnRNPA1 regulates alternative splicing of Arhgap1.

This activates the GTP-binding Rho family protein Cdc42 and accounts for the defects observed in hematopoietic stem/progenitor cells that express TRAF6.

All of these proteins could be potential treatment targets for cases of MDS triggered by overexpression of TRAF6, according to Dr Starczynowski, who said future studies will test their therapeutic potential in mouse models of MDS.

“Based on our paper, a number of therapeutic approaches can be tested and directed against TRAF6 and other related proteins responsible for MDS,” he said.

Beyond the potential for new therapeutic approaches in MDS, this research revealed a new and critical immune-related function for TRAF6, according to the investigators.

TRAF6 regulates RNA isoform expression in response to various pathogens. In the context of the current study, TRAF6’s regulation of RNA isoform expression is important to the function of hematopoietic cells and reveals another dimension to how cells respond to infection, Dr Starczynowski said.

Micrograph showing MDS

Preclinical research has revealed potential therapeutic targets for

myelodysplastic syndromes (MDS).

Investigators

found evidence to suggest that TRAF6, a toll-like receptor effector

with ubiquitin ligase activity, plays a key role in MDS.

So TRAF6 and

proteins regulated by TRAF6 may be therapeutic targets for MDS.

Daniel Starczynowski, PhD, of Cincinnati Children’s Hospital Medical Center in Ohio, and his colleagues reported these findings in Nature Immunology.

The investigators first found that TRAF6 is overexpressed in hematopoietic stem/progenitor cells from MDS patients.

To more closely examine the role of TRAF6 in MDS, the team created mouse models in which the protein was overexpressed.

“We found that TRAF6 overexpression in mouse hematopoietic stem cells results in impaired blood cell formation and bone marrow failure,” Dr Starczynowski said.

Further investigation revealed that hnRNPA1, an RNA-binding protein and auxiliary splicing factor, is a substrate of TRAF6. And TRAF6 ubiquitination of hnRNPA1 regulates alternative splicing of Arhgap1.

This activates the GTP-binding Rho family protein Cdc42 and accounts for the defects observed in hematopoietic stem/progenitor cells that express TRAF6.

All of these proteins could be potential treatment targets for cases of MDS triggered by overexpression of TRAF6, according to Dr Starczynowski, who said future studies will test their therapeutic potential in mouse models of MDS.

“Based on our paper, a number of therapeutic approaches can be tested and directed against TRAF6 and other related proteins responsible for MDS,” he said.

Beyond the potential for new therapeutic approaches in MDS, this research revealed a new and critical immune-related function for TRAF6, according to the investigators.

TRAF6 regulates RNA isoform expression in response to various pathogens. In the context of the current study, TRAF6’s regulation of RNA isoform expression is important to the function of hematopoietic cells and reveals another dimension to how cells respond to infection, Dr Starczynowski said.

A unicornuate uterus with a noncommunicating rudimentary horn is a rare mullerian duct anomaly (MDA). It often goes undiagnosed due to the absence of functional endometrium in the anomalous horn. However, when the rudimentary horn is lined with endometrium, obstructed menstrual flow can lead to severe cyclic pelvic pain, development of a pelvic mass, and endometriosis from retrograde menstruation. For these reasons, surgical resection is recommended for patients with this anomaly.

In this video the surgical patient is a 15-year-old adolescent with a 1-year history of progressive dysmenorrhea. Imaging studies revealed a noncommunicating cavitary right uterine horn and confirmed a normal urinary tract system.

We present a stepwise demonstration of our technique for surgical resection of a noncommunicating cavitary uterine horn and conclude that robotic surgery is a safe and feasible route for surgical management of this pathology.

I am pleased to bring you this video to kick off the New Year. We are delighted that our work won "Best Video on Robotic Technology" at the annual AAGL meeting in November 2016, and I hope that it is helpful to your practice.

Vidyard Video

 

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.

A unicornuate uterus with a noncommunicating rudimentary horn is a rare mullerian duct anomaly (MDA). It often goes undiagnosed due to the absence of functional endometrium in the anomalous horn. However, when the rudimentary horn is lined with endometrium, obstructed menstrual flow can lead to severe cyclic pelvic pain, development of a pelvic mass, and endometriosis from retrograde menstruation. For these reasons, surgical resection is recommended for patients with this anomaly.

In this video the surgical patient is a 15-year-old adolescent with a 1-year history of progressive dysmenorrhea. Imaging studies revealed a noncommunicating cavitary right uterine horn and confirmed a normal urinary tract system.

We present a stepwise demonstration of our technique for surgical resection of a noncommunicating cavitary uterine horn and conclude that robotic surgery is a safe and feasible route for surgical management of this pathology.

I am pleased to bring you this video to kick off the New Year. We are delighted that our work won "Best Video on Robotic Technology" at the annual AAGL meeting in November 2016, and I hope that it is helpful to your practice.

Vidyard Video

 

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.

A unicornuate uterus with a noncommunicating rudimentary horn is a rare mullerian duct anomaly (MDA). It often goes undiagnosed due to the absence of functional endometrium in the anomalous horn. However, when the rudimentary horn is lined with endometrium, obstructed menstrual flow can lead to severe cyclic pelvic pain, development of a pelvic mass, and endometriosis from retrograde menstruation. For these reasons, surgical resection is recommended for patients with this anomaly.

In this video the surgical patient is a 15-year-old adolescent with a 1-year history of progressive dysmenorrhea. Imaging studies revealed a noncommunicating cavitary right uterine horn and confirmed a normal urinary tract system.

We present a stepwise demonstration of our technique for surgical resection of a noncommunicating cavitary uterine horn and conclude that robotic surgery is a safe and feasible route for surgical management of this pathology.

I am pleased to bring you this video to kick off the New Year. We are delighted that our work won "Best Video on Robotic Technology" at the annual AAGL meeting in November 2016, and I hope that it is helpful to your practice.

Vidyard Video

 

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.