Ob.Gyn. News

According to the DSM-V, gender dysphoria in adolescents and adults “involves a difference between one’s experienced/expressed gender and assigned gender, and significant distress or problems functioning. It lasts at least 6 months,” and several other criteria must be met.¹ Many patients with gender dysphoria also identify as transgender. A “transition” or “transitioning” is a process by which individuals come to inhabit their gender identity.² A gender transition may take many forms, and only some people will choose to include medical assistance in their transition process. Although the scope of this article will not address these concerns, it should be noted that many people in the transgender and gender nonconforming community would object to the concepts of gender dysphoria and gender transition because they rely on a binary model of gender that may exclude individuals that see themselves as something other than “man or woman.”

sturti/Getty Images

There are both medical and surgical options for medical assistance in a gender transition. This article will focus on the surgical care of patients assigned female at birth who are seeking masculinizing surgical therapy. Many writers will discuss “gender-affirming” surgery, but we will use the term “gender-reaffirming” surgery because transgender patients have already affirmed their own genders and do not require surgery to inhabit this affirmation. Surgical options might include bilateral mastectomy, hysterectomy, bilateral salpingo-oophorectomy (BSO), metoidioplasty (surgical formation of a neophallus with existing genital tissue), or phalloplasty. There currently is no single surgical subspecialty that encompasses training in all forms of gender-reaffirming surgical therapies. In some areas of the country, centers of excellence have given rise to multidisciplinary teams that combine the skill sets of surgical subspecialists to provide a streamlined approach to gender-reaffirming surgery. Because of the scarcity of these integrated centers, most patients seeking gender-reaffirming surgeries will need to find individual subspecialists whose surgical training focuses on one area of the body. For example, patients seeking all possible surgical options may need a breast surgeon to perform their mastectomy, an ob.gyn. to perform their hysterectomy and BSO, a urologist to perform their metoidioplasty, and a plastic surgeon to perform their phalloplasty. In these scenarios, a general ob.gyn. may be consulted to perform a gender-reaffirming hysterectomy with BSO.

There are many reasons why transgender men might desire hysterectomy/BSO as part of their transition. Removal of the uterus and cervix eliminates concerns surrounding menstruation, pregnancy, and cervical cancer screening, all of which may add to their experience of gender dysphoria. Furthermore, removal of the ovaries may simplify long-term hormonal therapy with testosterone by eliminating the need for estrogen suppression. Lastly, a hysterectomy/BSO is a lower-risk and more cost-effective masculinizing surgery, compared with metoidioplasty or phalloplasty.

While the technical aspect of performing a hysterectomy/BSO certainly is within the scope of training for a general ob.gyn., there are several nuances of which providers should be aware when planning gender-reaffirming surgery for a transgender man. During the preoperative planning phase, it is of utmost importance to provide an environment of safety so that the focus of the preop visit is not clouded by communication mishaps between office staff and the patient. These barriers can be avoided by implementing office intake forms that give patients the opportunity to inform the health care team of their chosen name and personal pronouns upon registration for the visit.

A pelvic exam is commonly performed by ob.gyns. to determine surgical approach for a hysterectomy/BSO. When approaching transgender male patients for preoperative pelvic exams, it is important to be mindful of the fact that this type of exam may trigger gender dysphoria. While pelvic exams should be handled in sensitive fashion regardless of a patient’s gender identity, a patient who is a transgender man may benefit from some added steps in discussing the pelvic exam. One approach is to acknowledge that these exams/discussions may be especially triggering of gender dysphoria, and ask if the patient would prefer certain words to be used or not used in reference to their anatomy. As with any patient, the provider should explain the purpose of the examination and offer opportunities for the patient to have some control in the exam such as by assisting with insertion of the speculum or designating a “safe word” that would signal the provider to stop or pause the exam. In some cases, patients may not be able to tolerate the pelvic exam while awake because of the degree of gender dysphoria that the exam would induce. Providers might consider noninvasive imaging studies to help with surgical planning if they find they need more information before scheduling the operation, or they may offer a staged procedure with exam under anesthesia prior to the definitive surgery.

In conclusion, performing a gender-reaffirming hysterectomy/BSO requires thoughtful preparation to ensure a safe surgical environment for this vulnerable population. Care should be taken to plan the operation with a culturally sensitive approach.

Dr. Joyner is an assistant professor at Emory University, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital, both in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no relevant financial disclosures.

References

1. American Psychiatric Association. What is Gender Dysphoria? https://www.psychiatry.org/patients-families/gender-dysphoria/what-is-gender-dysphoria

2. UCSF Transgender Care. Transition Roadmap. https://transcare.ucsf.edu/transition-roadmap

According to the DSM-V, gender dysphoria in adolescents and adults “involves a difference between one’s experienced/expressed gender and assigned gender, and significant distress or problems functioning. It lasts at least 6 months,” and several other criteria must be met.¹ Many patients with gender dysphoria also identify as transgender. A “transition” or “transitioning” is a process by which individuals come to inhabit their gender identity.² A gender transition may take many forms, and only some people will choose to include medical assistance in their transition process. Although the scope of this article will not address these concerns, it should be noted that many people in the transgender and gender nonconforming community would object to the concepts of gender dysphoria and gender transition because they rely on a binary model of gender that may exclude individuals that see themselves as something other than “man or woman.”

sturti/Getty Images

There are both medical and surgical options for medical assistance in a gender transition. This article will focus on the surgical care of patients assigned female at birth who are seeking masculinizing surgical therapy. Many writers will discuss “gender-affirming” surgery, but we will use the term “gender-reaffirming” surgery because transgender patients have already affirmed their own genders and do not require surgery to inhabit this affirmation. Surgical options might include bilateral mastectomy, hysterectomy, bilateral salpingo-oophorectomy (BSO), metoidioplasty (surgical formation of a neophallus with existing genital tissue), or phalloplasty. There currently is no single surgical subspecialty that encompasses training in all forms of gender-reaffirming surgical therapies. In some areas of the country, centers of excellence have given rise to multidisciplinary teams that combine the skill sets of surgical subspecialists to provide a streamlined approach to gender-reaffirming surgery. Because of the scarcity of these integrated centers, most patients seeking gender-reaffirming surgeries will need to find individual subspecialists whose surgical training focuses on one area of the body. For example, patients seeking all possible surgical options may need a breast surgeon to perform their mastectomy, an ob.gyn. to perform their hysterectomy and BSO, a urologist to perform their metoidioplasty, and a plastic surgeon to perform their phalloplasty. In these scenarios, a general ob.gyn. may be consulted to perform a gender-reaffirming hysterectomy with BSO.

There are many reasons why transgender men might desire hysterectomy/BSO as part of their transition. Removal of the uterus and cervix eliminates concerns surrounding menstruation, pregnancy, and cervical cancer screening, all of which may add to their experience of gender dysphoria. Furthermore, removal of the ovaries may simplify long-term hormonal therapy with testosterone by eliminating the need for estrogen suppression. Lastly, a hysterectomy/BSO is a lower-risk and more cost-effective masculinizing surgery, compared with metoidioplasty or phalloplasty.

While the technical aspect of performing a hysterectomy/BSO certainly is within the scope of training for a general ob.gyn., there are several nuances of which providers should be aware when planning gender-reaffirming surgery for a transgender man. During the preoperative planning phase, it is of utmost importance to provide an environment of safety so that the focus of the preop visit is not clouded by communication mishaps between office staff and the patient. These barriers can be avoided by implementing office intake forms that give patients the opportunity to inform the health care team of their chosen name and personal pronouns upon registration for the visit.

A pelvic exam is commonly performed by ob.gyns. to determine surgical approach for a hysterectomy/BSO. When approaching transgender male patients for preoperative pelvic exams, it is important to be mindful of the fact that this type of exam may trigger gender dysphoria. While pelvic exams should be handled in sensitive fashion regardless of a patient’s gender identity, a patient who is a transgender man may benefit from some added steps in discussing the pelvic exam. One approach is to acknowledge that these exams/discussions may be especially triggering of gender dysphoria, and ask if the patient would prefer certain words to be used or not used in reference to their anatomy. As with any patient, the provider should explain the purpose of the examination and offer opportunities for the patient to have some control in the exam such as by assisting with insertion of the speculum or designating a “safe word” that would signal the provider to stop or pause the exam. In some cases, patients may not be able to tolerate the pelvic exam while awake because of the degree of gender dysphoria that the exam would induce. Providers might consider noninvasive imaging studies to help with surgical planning if they find they need more information before scheduling the operation, or they may offer a staged procedure with exam under anesthesia prior to the definitive surgery.

In conclusion, performing a gender-reaffirming hysterectomy/BSO requires thoughtful preparation to ensure a safe surgical environment for this vulnerable population. Care should be taken to plan the operation with a culturally sensitive approach.

Dr. Joyner is an assistant professor at Emory University, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital, both in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no relevant financial disclosures.

References

1. American Psychiatric Association. What is Gender Dysphoria? https://www.psychiatry.org/patients-families/gender-dysphoria/what-is-gender-dysphoria

2. UCSF Transgender Care. Transition Roadmap. https://transcare.ucsf.edu/transition-roadmap

According to the DSM-V, gender dysphoria in adolescents and adults “involves a difference between one’s experienced/expressed gender and assigned gender, and significant distress or problems functioning. It lasts at least 6 months,” and several other criteria must be met.¹ Many patients with gender dysphoria also identify as transgender. A “transition” or “transitioning” is a process by which individuals come to inhabit their gender identity.² A gender transition may take many forms, and only some people will choose to include medical assistance in their transition process. Although the scope of this article will not address these concerns, it should be noted that many people in the transgender and gender nonconforming community would object to the concepts of gender dysphoria and gender transition because they rely on a binary model of gender that may exclude individuals that see themselves as something other than “man or woman.”

sturti/Getty Images

There are both medical and surgical options for medical assistance in a gender transition. This article will focus on the surgical care of patients assigned female at birth who are seeking masculinizing surgical therapy. Many writers will discuss “gender-affirming” surgery, but we will use the term “gender-reaffirming” surgery because transgender patients have already affirmed their own genders and do not require surgery to inhabit this affirmation. Surgical options might include bilateral mastectomy, hysterectomy, bilateral salpingo-oophorectomy (BSO), metoidioplasty (surgical formation of a neophallus with existing genital tissue), or phalloplasty. There currently is no single surgical subspecialty that encompasses training in all forms of gender-reaffirming surgical therapies. In some areas of the country, centers of excellence have given rise to multidisciplinary teams that combine the skill sets of surgical subspecialists to provide a streamlined approach to gender-reaffirming surgery. Because of the scarcity of these integrated centers, most patients seeking gender-reaffirming surgeries will need to find individual subspecialists whose surgical training focuses on one area of the body. For example, patients seeking all possible surgical options may need a breast surgeon to perform their mastectomy, an ob.gyn. to perform their hysterectomy and BSO, a urologist to perform their metoidioplasty, and a plastic surgeon to perform their phalloplasty. In these scenarios, a general ob.gyn. may be consulted to perform a gender-reaffirming hysterectomy with BSO.

There are many reasons why transgender men might desire hysterectomy/BSO as part of their transition. Removal of the uterus and cervix eliminates concerns surrounding menstruation, pregnancy, and cervical cancer screening, all of which may add to their experience of gender dysphoria. Furthermore, removal of the ovaries may simplify long-term hormonal therapy with testosterone by eliminating the need for estrogen suppression. Lastly, a hysterectomy/BSO is a lower-risk and more cost-effective masculinizing surgery, compared with metoidioplasty or phalloplasty.

While the technical aspect of performing a hysterectomy/BSO certainly is within the scope of training for a general ob.gyn., there are several nuances of which providers should be aware when planning gender-reaffirming surgery for a transgender man. During the preoperative planning phase, it is of utmost importance to provide an environment of safety so that the focus of the preop visit is not clouded by communication mishaps between office staff and the patient. These barriers can be avoided by implementing office intake forms that give patients the opportunity to inform the health care team of their chosen name and personal pronouns upon registration for the visit.

A pelvic exam is commonly performed by ob.gyns. to determine surgical approach for a hysterectomy/BSO. When approaching transgender male patients for preoperative pelvic exams, it is important to be mindful of the fact that this type of exam may trigger gender dysphoria. While pelvic exams should be handled in sensitive fashion regardless of a patient’s gender identity, a patient who is a transgender man may benefit from some added steps in discussing the pelvic exam. One approach is to acknowledge that these exams/discussions may be especially triggering of gender dysphoria, and ask if the patient would prefer certain words to be used or not used in reference to their anatomy. As with any patient, the provider should explain the purpose of the examination and offer opportunities for the patient to have some control in the exam such as by assisting with insertion of the speculum or designating a “safe word” that would signal the provider to stop or pause the exam. In some cases, patients may not be able to tolerate the pelvic exam while awake because of the degree of gender dysphoria that the exam would induce. Providers might consider noninvasive imaging studies to help with surgical planning if they find they need more information before scheduling the operation, or they may offer a staged procedure with exam under anesthesia prior to the definitive surgery.

In conclusion, performing a gender-reaffirming hysterectomy/BSO requires thoughtful preparation to ensure a safe surgical environment for this vulnerable population. Care should be taken to plan the operation with a culturally sensitive approach.

Dr. Joyner is an assistant professor at Emory University, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital, both in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Joyner and Dr. Bahng reported no relevant financial disclosures.

References

1. American Psychiatric Association. What is Gender Dysphoria? https://www.psychiatry.org/patients-families/gender-dysphoria/what-is-gender-dysphoria

2. UCSF Transgender Care. Transition Roadmap. https://transcare.ucsf.edu/transition-roadmap

Molar pregnancy is an uncommon but serious condition that affects young women of reproductive age. The diagnosis and management of molar pregnancy is familiar to most gynecologists. However, in the days and weeks following evacuation of molar pregnancy, clinicians face a critical time period in which they must be vigilant for the development of postmolar gestational trophoblastic neoplasia (GTN). If recognized early and treated appropriately, it almost always can be cured; however, errors or delays in the management of this condition can have catastrophic consequences for patients, including decreasing the likelihood of cure. Here we will review some of the steps and actions that can be taken immediately following the diagnosis of a molar pregnancy to expeditiously identify postmolar GTN and ensure patients are appropriately prepared for further consultation and intervention.

Postmolar GTN includes the diagnoses of invasive mole and choriocarcinoma that contain highly atypical trophoblasts with the capacity for local invasion and metastasis. Typically, the diagnosis is made clinically and not distinguished with histology. While molar pregnancies are a benign condition, invasive moles and choriocarcinoma are malignant conditions in which the molar tissue infiltrates the uterine myometrium, vasculature, and frequently is associated with hematogenous spread with distant metastases. It is a highly chemosensitive disease, and cure with chemotherapy typically is achieved with the ability to preserve fertility if desired even in advanced stage disease.¹

After evacuation of a molar pregnancy, gynecologists should be on alert for the development of postmolar GTN if the following known risk factors are present: a history of a prior GTN diagnosis, complete mole on pathology (as opposed to partial mole), serum human chorionic gonadotropin (hCG) levels greater than 100,000 mIU/mL, age greater than 40 years, an enlarged uterus or large ovarian theca lutein cysts, and slow to normalize (more than 2 months) hCG. Symptoms for the development of postmolar GTN include persistent vaginal bleeding after evacuation, a persistently enlarged or enlarging uterine size, and adnexal masses. Ultimately, the diagnosis is made through plateaued or rising serum hCG assessments.² (See graphic.)

Following the evacuation of a molar pregnancy, hCG levels should be drawn at the same laboratory every 1-2 weeks until normalization and then three consecutive normal values. Once this has been achieved, hCG levels should be tested once at 3 months and again at 6 months. During this 6 month period, patients should use reliable contraception, ideally, and through oral contraceptive pills that suppress the secretion of pituitary hCG if not contraindicated. Should a woman become pregnant during this 6-month surveillance, it becomes impossible to rule out occult postmolar GTN.

Typically after evacuation of a molar pregnancy, there is rapid fall in hCG levels, but this does not occur when the molar pregnancy has become invasive or is associated with choriocarcinoma. In these cases, after an initial drop in hCG levels, there is an observed rise or plateau in levels (as defined in the accompanying table), and this establishes the diagnosis of postmolar GTN. It is common for hCG to fall in fits and starts, rather than have a smooth, consistent diminution, and this can be worrying for gynecologists; however, provided there is a consistent reduction in values in accordance with the stated definitions, observation can continue.

Another source of confusion and concern is an HCG level that fails to completely normalize during observation, yet reaches a very low level. If this is observed, clinicians should consider the diagnosis of quiescent hCG, pituitary hCG, or phantom hCG.³ These can be difficult to distinguish from postmolar GTN, and consultation with a gynecologic oncologist with experience in the diagnosis and management of these rare tumors is helpful to determine if the persistent low levels in hCG require intervention.

Once a clinician has observed a plateau or rise in hCG levels, a gynecologic examination should be performed because the lower genital tract is a common site for metastatic postmolar GTN. If during this evaluation, a suspicious lesion is identified (typically a blue-black, slightly raised, hemorrhagic-appearing lesion), it should not be biopsied, but rather assumed to be a metastatic site. The vasculature of metastatic sites is extremely fragile, and biopsy or disruption can result in catastrophic hemorrhage, even from very small lesions.

In addition to physical examination, several diagnostic studies should be performed which may expedite the triage and management of the case. A pelvic ultrasound should evaluate the endometrial cavity for a new viable pregnancy, and residual molar tissue; sometimes, myometrial invasion consistent with an invasive mole can be appreciated. Chest x-ray or CT scan should be ordered to evaluate for pulmonary metastatic lesions. Additionally, CT scans of the abdomen and pelvis should be ordered, and if lung metastases are present, brain imaging with either MRI or CT scan also should be obtained. These imaging studies will provide the necessary information to stage the GTN (as metastatic or not).

Treatment for postmolar GTN is determined based on further prognostic categorization (“high risk” or “low risk”) in accordance with the WHO classification, which is derived using several prognostic clinical variables including age, antecedent pregnancy, interval from index pregnancy, pretreatment hCG, largest tumor size, sites and number of metastases, and response to previous chemotherapy.⁴ These assignments are necessary to determine whether single-agent or multiagent chemotherapy should be prescribed.

Laboratory studies are helpful to obtain at this time and include metabolic panels (which can ensure that renal and hepatic function are within normal limits in anticipation of future chemotherapy), and complete blood count ,which can establish viable bone marrow function prior to chemotherapy.

Once postmolar GTN has been diagnosed, it is most appropriate to refer the patient to a gynecologic oncologist with experience in the treatment of these relatively rare malignancies. At that point, the patient will be formally staged, and offered treatment based on these staging results.

Among women with low-risk, nonmetastatic GTN who desire future fertility it is appropriate to offer a repeat dilation and curettage (D&C) procedure rather than immediately proceeding with chemotherapy. Approximately two-thirds of women with low risk disease can avoid chemotherapy with repeat curettage.⁵ Risk factors for needing chemotherapy after repeat D&C include the presence of trophoblastic disease in the pathology specimen and urinary hCG levels greater than 1,500 mIU/mL at the time of curettage. In my experience, many women appreciate this option to potentially avoid toxic chemotherapy.

For women with low-risk, nonmetastatic postmolar GTN who do not desire future fertility, and hope to avoid chemotherapy, hysterectomy also is a reasonable first option. This can be performed via either minimally invasive, laparotomy, or vaginal route. If performing a minimally invasive procedure in the setting of GTN, there should be caution or avoidance of use of a uterine manipulator because the uterine wall typically is soft and prone to perforation, and bleeding can be significant secondary to disruption of the tumor.

If repeat D&C or hysterectomy are adopted instead of chemotherapy, it is important that patients are very closely monitored post operatively to ensure normalization of their hCG levels (as described above). If it fails to normalize, restaging scans and examinations should be performed, and referral for the appropriate chemotherapy regimen should be initiated without delay.

Postmolar GTN is a serious condition that usually can be cured with chemotherapy or, if appropriate, surgery. Gynecologists should be vigilant for the development of postmolar GTN following evacuation of a molar pregnancy, and refer to a gynecologic oncologist when criteria are met to ensure that overtreatment is avoided and essential therapy is ensured.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2007 Aug;8(8):715-24.

2. J Natl Compr Canc Netw. 2019 Nov 1;17(11):1374-91.

3. Gynecol Oncol. 2009 Mar;112(3):663-72.

4. World Health Organ Tech Rep Ser. 1983;692:7-81.

5. Obstet Gynecol. 2016;128(3):535-42.

Molar pregnancy is an uncommon but serious condition that affects young women of reproductive age. The diagnosis and management of molar pregnancy is familiar to most gynecologists. However, in the days and weeks following evacuation of molar pregnancy, clinicians face a critical time period in which they must be vigilant for the development of postmolar gestational trophoblastic neoplasia (GTN). If recognized early and treated appropriately, it almost always can be cured; however, errors or delays in the management of this condition can have catastrophic consequences for patients, including decreasing the likelihood of cure. Here we will review some of the steps and actions that can be taken immediately following the diagnosis of a molar pregnancy to expeditiously identify postmolar GTN and ensure patients are appropriately prepared for further consultation and intervention.

Postmolar GTN includes the diagnoses of invasive mole and choriocarcinoma that contain highly atypical trophoblasts with the capacity for local invasion and metastasis. Typically, the diagnosis is made clinically and not distinguished with histology. While molar pregnancies are a benign condition, invasive moles and choriocarcinoma are malignant conditions in which the molar tissue infiltrates the uterine myometrium, vasculature, and frequently is associated with hematogenous spread with distant metastases. It is a highly chemosensitive disease, and cure with chemotherapy typically is achieved with the ability to preserve fertility if desired even in advanced stage disease.¹

After evacuation of a molar pregnancy, gynecologists should be on alert for the development of postmolar GTN if the following known risk factors are present: a history of a prior GTN diagnosis, complete mole on pathology (as opposed to partial mole), serum human chorionic gonadotropin (hCG) levels greater than 100,000 mIU/mL, age greater than 40 years, an enlarged uterus or large ovarian theca lutein cysts, and slow to normalize (more than 2 months) hCG. Symptoms for the development of postmolar GTN include persistent vaginal bleeding after evacuation, a persistently enlarged or enlarging uterine size, and adnexal masses. Ultimately, the diagnosis is made through plateaued or rising serum hCG assessments.² (See graphic.)

Following the evacuation of a molar pregnancy, hCG levels should be drawn at the same laboratory every 1-2 weeks until normalization and then three consecutive normal values. Once this has been achieved, hCG levels should be tested once at 3 months and again at 6 months. During this 6 month period, patients should use reliable contraception, ideally, and through oral contraceptive pills that suppress the secretion of pituitary hCG if not contraindicated. Should a woman become pregnant during this 6-month surveillance, it becomes impossible to rule out occult postmolar GTN.

Typically after evacuation of a molar pregnancy, there is rapid fall in hCG levels, but this does not occur when the molar pregnancy has become invasive or is associated with choriocarcinoma. In these cases, after an initial drop in hCG levels, there is an observed rise or plateau in levels (as defined in the accompanying table), and this establishes the diagnosis of postmolar GTN. It is common for hCG to fall in fits and starts, rather than have a smooth, consistent diminution, and this can be worrying for gynecologists; however, provided there is a consistent reduction in values in accordance with the stated definitions, observation can continue.

Another source of confusion and concern is an HCG level that fails to completely normalize during observation, yet reaches a very low level. If this is observed, clinicians should consider the diagnosis of quiescent hCG, pituitary hCG, or phantom hCG.³ These can be difficult to distinguish from postmolar GTN, and consultation with a gynecologic oncologist with experience in the diagnosis and management of these rare tumors is helpful to determine if the persistent low levels in hCG require intervention.

Once a clinician has observed a plateau or rise in hCG levels, a gynecologic examination should be performed because the lower genital tract is a common site for metastatic postmolar GTN. If during this evaluation, a suspicious lesion is identified (typically a blue-black, slightly raised, hemorrhagic-appearing lesion), it should not be biopsied, but rather assumed to be a metastatic site. The vasculature of metastatic sites is extremely fragile, and biopsy or disruption can result in catastrophic hemorrhage, even from very small lesions.

In addition to physical examination, several diagnostic studies should be performed which may expedite the triage and management of the case. A pelvic ultrasound should evaluate the endometrial cavity for a new viable pregnancy, and residual molar tissue; sometimes, myometrial invasion consistent with an invasive mole can be appreciated. Chest x-ray or CT scan should be ordered to evaluate for pulmonary metastatic lesions. Additionally, CT scans of the abdomen and pelvis should be ordered, and if lung metastases are present, brain imaging with either MRI or CT scan also should be obtained. These imaging studies will provide the necessary information to stage the GTN (as metastatic or not).

Treatment for postmolar GTN is determined based on further prognostic categorization (“high risk” or “low risk”) in accordance with the WHO classification, which is derived using several prognostic clinical variables including age, antecedent pregnancy, interval from index pregnancy, pretreatment hCG, largest tumor size, sites and number of metastases, and response to previous chemotherapy.⁴ These assignments are necessary to determine whether single-agent or multiagent chemotherapy should be prescribed.

Laboratory studies are helpful to obtain at this time and include metabolic panels (which can ensure that renal and hepatic function are within normal limits in anticipation of future chemotherapy), and complete blood count ,which can establish viable bone marrow function prior to chemotherapy.

Once postmolar GTN has been diagnosed, it is most appropriate to refer the patient to a gynecologic oncologist with experience in the treatment of these relatively rare malignancies. At that point, the patient will be formally staged, and offered treatment based on these staging results.

Among women with low-risk, nonmetastatic GTN who desire future fertility it is appropriate to offer a repeat dilation and curettage (D&C) procedure rather than immediately proceeding with chemotherapy. Approximately two-thirds of women with low risk disease can avoid chemotherapy with repeat curettage.⁵ Risk factors for needing chemotherapy after repeat D&C include the presence of trophoblastic disease in the pathology specimen and urinary hCG levels greater than 1,500 mIU/mL at the time of curettage. In my experience, many women appreciate this option to potentially avoid toxic chemotherapy.

For women with low-risk, nonmetastatic postmolar GTN who do not desire future fertility, and hope to avoid chemotherapy, hysterectomy also is a reasonable first option. This can be performed via either minimally invasive, laparotomy, or vaginal route. If performing a minimally invasive procedure in the setting of GTN, there should be caution or avoidance of use of a uterine manipulator because the uterine wall typically is soft and prone to perforation, and bleeding can be significant secondary to disruption of the tumor.

If repeat D&C or hysterectomy are adopted instead of chemotherapy, it is important that patients are very closely monitored post operatively to ensure normalization of their hCG levels (as described above). If it fails to normalize, restaging scans and examinations should be performed, and referral for the appropriate chemotherapy regimen should be initiated without delay.

Postmolar GTN is a serious condition that usually can be cured with chemotherapy or, if appropriate, surgery. Gynecologists should be vigilant for the development of postmolar GTN following evacuation of a molar pregnancy, and refer to a gynecologic oncologist when criteria are met to ensure that overtreatment is avoided and essential therapy is ensured.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2007 Aug;8(8):715-24.

2. J Natl Compr Canc Netw. 2019 Nov 1;17(11):1374-91.

3. Gynecol Oncol. 2009 Mar;112(3):663-72.

4. World Health Organ Tech Rep Ser. 1983;692:7-81.

5. Obstet Gynecol. 2016;128(3):535-42.

Molar pregnancy is an uncommon but serious condition that affects young women of reproductive age. The diagnosis and management of molar pregnancy is familiar to most gynecologists. However, in the days and weeks following evacuation of molar pregnancy, clinicians face a critical time period in which they must be vigilant for the development of postmolar gestational trophoblastic neoplasia (GTN). If recognized early and treated appropriately, it almost always can be cured; however, errors or delays in the management of this condition can have catastrophic consequences for patients, including decreasing the likelihood of cure. Here we will review some of the steps and actions that can be taken immediately following the diagnosis of a molar pregnancy to expeditiously identify postmolar GTN and ensure patients are appropriately prepared for further consultation and intervention.

Postmolar GTN includes the diagnoses of invasive mole and choriocarcinoma that contain highly atypical trophoblasts with the capacity for local invasion and metastasis. Typically, the diagnosis is made clinically and not distinguished with histology. While molar pregnancies are a benign condition, invasive moles and choriocarcinoma are malignant conditions in which the molar tissue infiltrates the uterine myometrium, vasculature, and frequently is associated with hematogenous spread with distant metastases. It is a highly chemosensitive disease, and cure with chemotherapy typically is achieved with the ability to preserve fertility if desired even in advanced stage disease.¹

After evacuation of a molar pregnancy, gynecologists should be on alert for the development of postmolar GTN if the following known risk factors are present: a history of a prior GTN diagnosis, complete mole on pathology (as opposed to partial mole), serum human chorionic gonadotropin (hCG) levels greater than 100,000 mIU/mL, age greater than 40 years, an enlarged uterus or large ovarian theca lutein cysts, and slow to normalize (more than 2 months) hCG. Symptoms for the development of postmolar GTN include persistent vaginal bleeding after evacuation, a persistently enlarged or enlarging uterine size, and adnexal masses. Ultimately, the diagnosis is made through plateaued or rising serum hCG assessments.² (See graphic.)

Following the evacuation of a molar pregnancy, hCG levels should be drawn at the same laboratory every 1-2 weeks until normalization and then three consecutive normal values. Once this has been achieved, hCG levels should be tested once at 3 months and again at 6 months. During this 6 month period, patients should use reliable contraception, ideally, and through oral contraceptive pills that suppress the secretion of pituitary hCG if not contraindicated. Should a woman become pregnant during this 6-month surveillance, it becomes impossible to rule out occult postmolar GTN.

Typically after evacuation of a molar pregnancy, there is rapid fall in hCG levels, but this does not occur when the molar pregnancy has become invasive or is associated with choriocarcinoma. In these cases, after an initial drop in hCG levels, there is an observed rise or plateau in levels (as defined in the accompanying table), and this establishes the diagnosis of postmolar GTN. It is common for hCG to fall in fits and starts, rather than have a smooth, consistent diminution, and this can be worrying for gynecologists; however, provided there is a consistent reduction in values in accordance with the stated definitions, observation can continue.

Another source of confusion and concern is an HCG level that fails to completely normalize during observation, yet reaches a very low level. If this is observed, clinicians should consider the diagnosis of quiescent hCG, pituitary hCG, or phantom hCG.³ These can be difficult to distinguish from postmolar GTN, and consultation with a gynecologic oncologist with experience in the diagnosis and management of these rare tumors is helpful to determine if the persistent low levels in hCG require intervention.

Once a clinician has observed a plateau or rise in hCG levels, a gynecologic examination should be performed because the lower genital tract is a common site for metastatic postmolar GTN. If during this evaluation, a suspicious lesion is identified (typically a blue-black, slightly raised, hemorrhagic-appearing lesion), it should not be biopsied, but rather assumed to be a metastatic site. The vasculature of metastatic sites is extremely fragile, and biopsy or disruption can result in catastrophic hemorrhage, even from very small lesions.

In addition to physical examination, several diagnostic studies should be performed which may expedite the triage and management of the case. A pelvic ultrasound should evaluate the endometrial cavity for a new viable pregnancy, and residual molar tissue; sometimes, myometrial invasion consistent with an invasive mole can be appreciated. Chest x-ray or CT scan should be ordered to evaluate for pulmonary metastatic lesions. Additionally, CT scans of the abdomen and pelvis should be ordered, and if lung metastases are present, brain imaging with either MRI or CT scan also should be obtained. These imaging studies will provide the necessary information to stage the GTN (as metastatic or not).

Treatment for postmolar GTN is determined based on further prognostic categorization (“high risk” or “low risk”) in accordance with the WHO classification, which is derived using several prognostic clinical variables including age, antecedent pregnancy, interval from index pregnancy, pretreatment hCG, largest tumor size, sites and number of metastases, and response to previous chemotherapy.⁴ These assignments are necessary to determine whether single-agent or multiagent chemotherapy should be prescribed.

Laboratory studies are helpful to obtain at this time and include metabolic panels (which can ensure that renal and hepatic function are within normal limits in anticipation of future chemotherapy), and complete blood count ,which can establish viable bone marrow function prior to chemotherapy.

Once postmolar GTN has been diagnosed, it is most appropriate to refer the patient to a gynecologic oncologist with experience in the treatment of these relatively rare malignancies. At that point, the patient will be formally staged, and offered treatment based on these staging results.

Among women with low-risk, nonmetastatic GTN who desire future fertility it is appropriate to offer a repeat dilation and curettage (D&C) procedure rather than immediately proceeding with chemotherapy. Approximately two-thirds of women with low risk disease can avoid chemotherapy with repeat curettage.⁵ Risk factors for needing chemotherapy after repeat D&C include the presence of trophoblastic disease in the pathology specimen and urinary hCG levels greater than 1,500 mIU/mL at the time of curettage. In my experience, many women appreciate this option to potentially avoid toxic chemotherapy.

For women with low-risk, nonmetastatic postmolar GTN who do not desire future fertility, and hope to avoid chemotherapy, hysterectomy also is a reasonable first option. This can be performed via either minimally invasive, laparotomy, or vaginal route. If performing a minimally invasive procedure in the setting of GTN, there should be caution or avoidance of use of a uterine manipulator because the uterine wall typically is soft and prone to perforation, and bleeding can be significant secondary to disruption of the tumor.

If repeat D&C or hysterectomy are adopted instead of chemotherapy, it is important that patients are very closely monitored post operatively to ensure normalization of their hCG levels (as described above). If it fails to normalize, restaging scans and examinations should be performed, and referral for the appropriate chemotherapy regimen should be initiated without delay.

Postmolar GTN is a serious condition that usually can be cured with chemotherapy or, if appropriate, surgery. Gynecologists should be vigilant for the development of postmolar GTN following evacuation of a molar pregnancy, and refer to a gynecologic oncologist when criteria are met to ensure that overtreatment is avoided and essential therapy is ensured.
 

Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She said she had no relevant financial disclosures. Email her at obnews@mdedge.com.

References

1. Lancet Oncol. 2007 Aug;8(8):715-24.

2. J Natl Compr Canc Netw. 2019 Nov 1;17(11):1374-91.

3. Gynecol Oncol. 2009 Mar;112(3):663-72.

4. World Health Organ Tech Rep Ser. 1983;692:7-81.

5. Obstet Gynecol. 2016;128(3):535-42.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A group of leading medical journal editors is seeking to improve the completeness and transparency of financial disclosure reporting with a proposed new disclosure form that puts more onus on readers to decide whether relationships and activities should influence how they view published papers.

The proposed changes are described in an editorial published simultaneously today in the Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, The Lancet, New England Journal of Medicine, and several other journals whose editors are members of the International Committee of Medical Journal Editors (ICMJE).

“While no approach to disclosure will be perfect or foolproof, we hope the changes we propose will help promote transparency and trust,” the editorial stated (Ann Intern Med. 2020 Jan 27. doi: 10.7326/M19-3933).

The ICMJE adopted its currently used electronic form – the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” – 10 years ago in an effort to create some uniformity amidst a patchwork of differing disclosure requirements for authors.

It’s not known how many journals outside of the ICMJE’s member journals routinely use the disclosure form, but the organization’s website houses an extensive list of journals whose editors or publishers have requested to be listed as following the ICMJE’s recommendations for editing, reporting, and publishing, including those concerning disclosures. The ICMJE does not “certify” journals. The full set of recommendations was updated in December 2019.

Most authors are committed to transparent reporting, but “opinions differ over which relationships or activities to report,” the editorial stated.

An author might choose to omit an item that others deem important because of a difference in opinion regarding “relevance,” confusion over definitions, or a simple oversight. Some authors may be “concerned that readers will interpret the listing of any item as a ‘potential conflict of interest’ as indicative of problematic influence and wrongdoing,” the editorial stated.

The revised form, like the current one, asks authors to disclose relationships and activities that are directly related to the reported work, as well as those that are topically related (within the broadly defined field addressed in the work). But unlike the current form, the new version provides a checklist of relationships and activities and asks authors to check ‘yes’ or ‘no’ for each one (and to name them when the answer is ‘yes’).

Items in the checklist include grants, payments/honoraria for lectures, patents issued or planned, stock/stock options, and leadership or fiduciary roles in committees, boards, or societies.

The proposed new form makes no mention of “potential conflicts of interest” or “relevancy,” per say. Authors aren’t asked to determine what might be interpreted as a potential conflict of interest, but instead are asked for a “complete listing” of what readers may find “pertinent” to their work.

“We’re trying to move away from calling everything a [potential] ‘conflict,’ ” Darren B. Taichman, MD, PhD, secretary of ICMJE and executive editor of the Annals of Internal Medicine, said in an interview. “We want to remove for authors the concern or stigma, if you will, that anything listed on a form implies that there is something wrong, because that’s just not true. … We want readers to decide what relationships are important as they interpret the work.”

Dr. Taichman said in the interview that the ICMJE’s updating of the form was more a function of “good housekeeping” and continuous appreciation of disclosure as an important issue, rather than any one specific issue, such as concern over a “relevancy” approach to disclosures.

The ICMJE is seeking feedback about its proposed form, which is available with a link for providing comments, at www.icmje.org.

Broader national efforts

Editors and others have been increasingly moving, however, toward asking for more complete disclosures where authors aren’t asked to judge “relevancy” and where readers can make decisions on their own. The American Society of Clinical Oncology, which produces the Journal of Clinical Oncology (JCO) as well as practice guidelines and continuing medical education programs, moved about 5 years ago to a system of general disclosure that asks physicians and others to disclose all financial interests and industry relationships, with no qualifiers.

Earlier in January 2020, the Accreditation Council for Continuing Medical Education issued proposed revisions to its Standards for Integrity and Independence in Accredited Continuing Education. These revisions, which are open for comment, require CME providers to collect disclosure information about all financial relationships of speakers and presenters. It’s up to the CME provider to then determine which relationships are relevant, according to the proposed document.

More change is on the way, as disclosure issues are being deliberated nationally in the wake of a highly publicized disclosure failure at Memorial Sloan Kettering Cancer Center in 2018. Chief medical officer José Baselga, MD, PhD, failed to report millions of dollars of industry payments and ownership interests in journal articles he wrote or cowrote over several years.

In February 2019, leaders from journals, academia, medical societies, and other institutions gathered in Washington for a closed-door meeting to hash out various disclosure related issues.

Hosted by the Association of American Medical Colleges and cosponsored by Memorial Sloan Kettering Cancer Center, ASCO, JAMA, and the Council of Medical Specialty Societies, the meeting led to a series of working groups that are creating additional recommendations “due out soon in 2020,” Heather Pierce, senior director of science policy and regulatory counsel for the AAMC, said in an interview.

Among the questions being discussed: What disclosures should be verified and who should do so? How can disclosures be made more complete and easier for researchers? And, “most importantly,” said Ms. Pierce, how can policy requirements across each of these sectors be aligned so that there’s more coordination and oversight – and with it, public trust?

Some critics of current disclosure policies have called for more reporting of compensation amounts, and Ms. Pierce said that this has been part of cross-sector discussions.

The ICMJE’s proposed form invites, but does not require, authors to indicate what payments were made to them or their institutions. “Part of this is due to the fact that it’s hard to define, let alone agree on, what’s an important amount,” Dr. Taichman said.

A push for registries

The ICMJE is also aiming to make the disclosure process more efficient for authors – and to eliminate inconsistent and incomplete disclosures – by accepting disclosures from web-based repositories, according to the editorial. Repositories allow authors to maintain an inventory of their relationships and activities and then create electronic disclosures that are tailored to the requirements of the ICMJE, medical societies, and other entities.

The AAMC-run repository, called Convey, is consistent with ICMJE reporting requirements and other criteria (e.g., there are no fees for individuals to enter, store, or export their data), but the development of other repositories may be helpful “for meeting regional, linguistic, and regulatory needs” of authors across the world, the editorial stated.

The Annals of Internal Medicine and the New England Journal of Medicine are both currently collecting disclosures through Convey. The platform was born from discussions that followed a 2009 Institute of Medicine report on conflicts of interest.

Signers of the ICMJE editorial include representatives of the National Library of Medicine and the World Association of Medical Editors, in addition to editors in chief and other leaders of the ICMJE member journals.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A Chinese man became ill from a novel coronavirus (2019-nCoV) 4 days after arriving in Vietnam to visit his 27-year-old son. Three days later the healthy young man was also stricken, according to a report published online Jan. 28 in the New England Journal of Medicine.

“This family cluster of 2019-nCoV infection that occurred outside China arouses concern regarding human-to-human transmission,” the authors wrote.

The father, age 65 years and with multiple comorbidities including hypertension, type 2 diabetes, coronary heart disease with stent placement, and lung cancer, flew to Hanoi with his wife on January 13; they traveled from the Wuchang district in Wuhan, China, where outbreaks of 2019-nCoV have been occurring.

On Jan. 17, the older man and his wife met their adult son in Ho Chi Minh City, Vietnam, and shared a hotel room with him for 3 days. The father developed a fever that same day and the son developed a dry cough, fever, diarrhea, and vomiting on Jan. 20. Both men went to a hospital ED on Jan. 22.

The authors say the timing of the son’s symptoms suggests the incubation period may have been 3 days or fewer.

Upon admission to the hospital, the father reported that he had not visited a “wet market” where live and dead animals are sold while he was in Wuhan. Throat swabs were positive for 2019-nCoV on real-time reverse-transcription–polymerase-chain-reaction assays.

The man was placed in isolation and “treated empirically with antiviral agents, broad-spectrum antibiotics, and supportive therapies,” wrote Lan T. Phan, PhD, from the Pasteur Institute Ho Chi Minh City and coauthors.

On admission, chest radiographs revealed an infiltrate in the upper lobe of his left lung; he developed worsening dyspnea with hypoxemia on Jan. 25 and required supplemental oxygen at 5 L/min by nasal cannula. Chest radiographs showed a progressive infiltrate and consolidation. His fever resolved on that day and he has progressively improved.

The man’s son had a fever of 39° C (102.2° F) when the two men arrived at the hospital on Jan. 22; hospital staff isolated the son, and chest radiographs and other laboratory tests were normal with the exception of an increased C-reactive protein level.

The son’s throat swab was positive for 2019-nCoV and he is believed to have been exposed from his father; however, the strains have not been ascertained.

“This family had traveled to four cities across Vietnam using various forms of transportation, including planes, trains, and taxis,” the authors wrote. A total of 28 close contacts were identified, none of whom have developed respiratory symptoms. The older man’s wife has been healthy as well.

The authors have disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

koakes@mdedge.com

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

koakes@mdedge.com

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.

Modafinil exposure during pregnancy was associated with an approximately tripled risk of congenital malformations in a large Danish registry-based study.

Modafinil (Provigil) is commonly prescribed to address daytime sleepiness in narcolepsy and multiple sclerosis. An interim postmarketing safety analysis showed increased rates of major malformation in modafinil-exposed pregnancies, so the manufacturer issued an alert advising health care professionals of this safety signal in June 2019, wrote Per Damkier, MD, PhD, corresponding author of a JAMA research letter reporting the Danish study results. The postmarketing study had shown a major malformation rate of about 15% in modafinil-exposed pregnancies, much higher than the 3% background rate.

Dr. Damkier and Anne Broe, MD, PhD, both of the department of clinical biochemistry and pharmacology at Odense (Denmark) University Hospital, compared outcomes for pregnant women who were prescribed modafinil at any point during the first trimester of pregnancy with those who were prescribed an active comparator, methylphenidate, as well as with those who had neither exposure. Methylphenidate is not associated with congenital malformations and is used for indications similar to modafinil.

Looking at all pregnancies for whom complete records existed in Danish health registries between 2004 and 2017, the investigators found 49 modafinil-exposed pregnancies, 963 methylphenidate-exposed pregnancies, and 828,644 pregnancies with neither exposure.

Six major congenital malformations occurred in the modafinil-exposed group for an absolute risk of 12%. Major malformations occurred in 43 (4.5%) of the methylphenidate-exposed group and 32,466 (3.9%) of the unexposed group.

Using the extensive data available in public registries, the authors were able to perform logistic regression to adjust for concomitant use of other psychotropic medication; comorbidities such as diabetes and hypertension; and demographic and anthropometric measures such as maternal age, smoking status, and body mass index.

After this statistical adjustment, the researchers found that modafinil exposure during the first trimester of pregnancy was associated with an odds ratio of 3.4 (95% confidence interval, 1.2-9.7) for major congenital malformation, compared with first-trimester methylphenidate exposure. Compared with the unexposed cohort, modafinil-exposed pregnancies had an adjusted odds ratio of 2.7 (95% CI, 1.1-6.9) for major congenital malformation.

A total of 13 (27%) women who took modafinil had multiple sclerosis, but the authors excluded women who’d received a prescription for the multiple sclerosis drug teriflunomide (Aubagio), a known teratogen. Sleep disorders were reported for 39% of modafinil users, compared with 4.5% of methylphenidate users. Rates of psychoactive drug use were 41% for the modafinil group and 30% for the methylphenidate group.

The authors acknowledged the possibility of residual confounders affecting their results, and of the statistical problems with the very small sample size of modafinil-exposed pregnancies. Also, actual medication use – rather than prescription redemption – wasn’t captured in the study.

The study was partially funded by the Novo Nordisk Foundation. The authors reported no conflicts of interest.

koakes@mdedge.com

SOURCE: Damkier P, Broe A. JAMA. 2020;323(4):374-6.

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

U.S. public health officials attempted to stymie concerns about the coronavirus during a press conference on Tuesday, emphasizing that most Americans are not in danger of contracting the illness and urging citizens not to take extreme measures in response to the low-risk virus.

“Right now, there is no spread of this virus in our communities here at home,” Centers for Disease Control and Prevention director Robert Redfield, MD, said during the Jan. 28 press conference. “This is why our current assessment is that the immediate health risk of this new virus to the general public is low in our nation. The coming days and weeks are likely to bring more confirmed cases here and around the world, including the possibility of some person-to-person spreading, but our goal of the ongoing U.S. public health response is to contain this outbreak and prevent sustained spread of the virus in our country.”

During the press conference, Department Health & Human Services Secretary Alex M. Azar II, reiterated there have been only five confirmed U.S. cases of the coronavirus thus far and all were associated with travel to Wuhan, China, where the virus first appeared. The number of confirmed cases in China, meanwhile, has risen to more than 4,500 with about 100 associated deaths.

U.S. health providers should be on the lookout for any patient who has traveled to China recently, particularly to Hubei province, and they should pay close attention to any relevant symptoms, Secretary Azar said during the press conference.

He defended the decision not to declare a public health emergency at this time, stressing that such a move is based on standards and requirements not yet met by the coronavirus.

“It’s important to remember where we are right now; we have five cases in the United States, each of those individuals with direct contact to Wuhan and no person-to-person transmission in the United States,” Secretary Azar said. “I won’t hesitate at all to invoke any authorities that I need to ensure that we’re taking all the steps to protect the American people, but I’ll do it when it’s appropriate under the standards that we have and the authorities that I need.”

In the meantime, a number of efforts are underway by U.S. agencies to assess the nation’s emergency preparedness stockpile, to assist American families in China with evacuation, and to pursue research into diagnostics and a potential vaccine for the virus, Secretary Azar said.

HHS.gov

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

A Washington Post article on depression after miscarriage is a reminder that, although couples can suffer deeply from such a loss, there still are ways to provide them with meaningful support (“After miscarriage, I was rocked by depression. Like many other women, I didn’t get follow-up care for this loss,” by Katie C. Reilly, Nov 30, 2019).

Carlo107/Getty Images

Psychiatrists who focus on reproductive psychiatry and collaborative care are trying to change the current therapeutic landscape and improve practitioner awareness and treatment. Ob.gyns. managing patients who have experienced reproductive loss, especially early-term loss, may not immediately refer couples to a therapist or psychiatrist, but we can change this. Practitioners who focus on reproductive health – both physical and mental – are trying to better understand such couples’ experiences, increase their access to care, develop preventative care strategies, and improve provider education.

At the outset, providers who treat patients who have experienced a perinatal loss must recognize that not all individuals will feel that a loss is tragic. Instead, patient reactions occur along a spectrum, and there is no “correct” way to process a loss. A couple’s reaction may depend on a variety of factors, including how late or early in pregnancy the loss occurs, whether the pregnancy is planned or unplanned, and what other psychosocial stressors, such as unstable housing, limited income, and few social supports, may exist. Not every patient experiencing grief, even profoundly, will shed tears; we need to be open to all potential reactions and be mindful when a person may need additional support.

According to the Washington Post article, even though 50% of miscarriages are due to chromosomal abnormalities, women still feel ultimately responsible for the loss. As a society we are bombarded with “experts” in the media telling us the best way, the right way, the healthiest way to live. This barrage of advice distorts our views of what it really means to be a good parent and subtly conveys the idea that mothers are solely responsible for any bad pregnancy outcomes. I remember being fearful of causing unintentional harm to my unborn baby during my own pregnancy. What if I accidentally ate something that would affect her development? Is exposure to second-hand smoke as I walk down the street harming her? How bad would it be if I just had one cup of coffee? My doubts caused quite a bit of distress for me, which is a mild form of the distress I see when counseling couples after their miscarriages.

The article’s author also expressed concern about the emotional sterility of the environment in which miscarriages usually occur: a hospital ED. EDs are designed to promote a level of detachment and to quell any stress for the clinicians so that they can calmly handle unexpected health crises. EDs are not primarily designed to provide patients with emotional support, nor should they be. However, we still can make some improvements to existing ED design to better address couples’ emotional needs. For example, some EDs have placed mental health clinicians on staff, others call patients post discharge to address concerns, and some EDs even provide patients access to mental health trauma teams. Such services are not found in all EDs, and even those that exist may just scratch the surface of what is needed, but they are a step in the right direction. Providing this level of auxiliary care directly from the ED increases patients’ ability to access mental health support in the place where miscarriages are most likely to be first diagnosed and managed.

The American College of Obstetricians and Gynecologists already is trying to fill in the missing pieces when it comes to identifying mood symptoms following miscarriage. One of the key recommendations from the May 2018 Committee Opinion on Redefining the Postpartum Visit is that every woman who has experienced a miscarriage, stillbirth, or neonatal death should receive follow-up care. Mental health is a suggested component of the postpartum care plan. Some outpatient ob.gyn. practices and inpatient units are using screening tools to identify postpartum depression. For example, the Edinburgh Postnatal Depression Scale can be utilized following a miscarriage to help providers identify symptoms of depression and anxiety.

However, advancements in screening practices are only the tip of the iceberg of helping patients following miscarriage. A major question is how do we provide treatment? The trend in psychiatry over the past decade has been toward collaborative care, models that embed psychiatrists and other mental health clinicians in ob.gyn. practices to help guide the diagnosis and treatment of mental health problems. Some psychiatrists practice a co-located model in which they see patients alongside their ob.gyn. colleagues, whereas other psychiatrists treat a larger number of patients by using chart reviews for medication management while relying on behavioral health care managers for counseling and monitoring. Using this model of mental health care, more patients have access to services that are provided in a location familiar to them.

Another step in the right direction is the October 2019 launch of The National Curriculum in Reproductive Psychiatry (NCRP), which provides free educational material for psychiatry faculty and residents to enhance education on topics related to reproductive psychiatry, including miscarriage, loss, and development of trauma disorders. NCRP aspires to develop educational materials for ob.gyn. residents.

In the past we may have missed the mark in recognizing and treating the trauma that prenatal loss can cause, but we are trying to improve our approaches. More and more couples are sharing their experiences and advocating for themselves and others, often creating change in medical practice, and doctors are starting to listen. As any clinician knows, changes to standards of care can take several years to disseminate into general practice, but this gap between knowledge and treatment is now in the forefront of our minds. I am hopeful that we will continue to make advances and provide better care to our patients who have endured the loss of a pregnancy.
 

Dr. Latorre is an assistant professor in the department of psychiatry at the University of Maryland School of Medicine. She has reported no relevant financial disclosures. Email her at obnews@mdedge.com.

With recent developments in many U.S. states regarding legalization of cannabis for medicinal or recreational use, there is an emerging need to better understand the risks or safety of its use during pregnancy and lactation. National survey data from 2007-2012 of more than 93,000 pregnant women suggest that around 7% of pregnant respondents reported any cannabis use in the last 2-12 months; of those, 16% reported daily or almost daily use. Among pregnant past-year users in the same survey, 70% perceived slight or no risk of harm from cannabis use 1-2 times a week in pregnancy.¹

Data from the Kaiser Northern California health plan involving more than 279,000 pregnancies followed during 2009-2016 suggest that there has been a significant upward trend in use of cannabis during pregnancy, from 4% to 7%, as reported by the mother and/or identified by routine urine screening. The highest prevalence in that study was seen among 18- to 24-year-old pregnant women, increasing from 13% to 22% over the 7-year study period. Importantly, more than 50% of cannabis users in the sample were identified by toxicology screening alone.^2,3 Common reasons given for use of cannabis in pregnancy include anxiety, pain, and nausea and vomiting of pregnancy.⁴

With respect to adverse perinatal outcomes, several case-control studies have examined risks for major birth defects with maternal self-report of cannabis use. Some have noted very modest increased risks for selected major birth defects (odds ratios less than 2); however, data still are very limited.^5,6

A number of prospective studies have addressed risks of preterm birth and growth restriction, accounting for mother’s concomitant tobacco use.^7-11 Some of these studies have suggested about a twofold to threefold increased risk for preterm delivery and an increased risk for reduced birth weight – particularly with heavier or regular cannabis use – but study findings have not been entirely consistent.

Given its psychoactive properties, there has been high interest in understanding whether there are any short- or long-term neurodevelopmental effects on children prenatally exposed to cannabis. These outcomes have been studied in two small older cohorts in the United States and Canada and one more recent cohort in the Netherlands.^12-15 Deficits in several measures of cognition and behavior were noted in follow-up of those children from birth to adulthood. However, it is unclear to what extent these findings may have been influenced by heredity, environment, or other factors.

There have been limitations in almost all studies published to date, including small sample sizes, no biomarker validation of maternal report of dose and gestational timing of cannabis use, and lack of detailed data on common coexposures, such as alcohol, tobacco, and other drugs. In addition, newer studies of pregnancy outcomes in women who use currently available cannabis products are needed, given the substantial increase in the potency of cannabis used today, compared with that of 20 years ago. For example, the tetrahydrocannabinol (THC) concentration in commonly cultivated marijuana plants has increased threefold from 4% to 12% between 1995 and 2014.¹⁶

There are very limited data on the presence of cannabis in breast milk and the potential effects of exposure to THC and other metabolites for breastfed infants. However, two recent studies have demonstrated there are low but measurable levels of some cannabis metabolites in breast milk.^17-18 Further work is needed to determine if these metabolites accumulate in milk and if at a given dose and age of the breastfed infant, there are any growth, neurodevelopmental, or other clinically important adverse effects.

Related questions, such as potential differences in the effects of exposure during pregnancy or lactation based on the route of administration (edible vs. inhaled) and the use of cannabidiol (CBD) products, have not been studied.

At the present time, the American College of Obstetricians and Gynecologists recommends that women who are pregnant or contemplating pregnancy be encouraged to discontinue marijuana use. With respect to lactation and breastfeeding, ACOG concludes there are insufficient data to evaluate the effects on infants, and in the absence of such data, marijuana use is discouraged. Similarly, the American Academy of Pediatrics recommends women of childbearing age abstain from marijuana use while pregnant or breastfeeding because of potential adverse consequences to the fetus, infant, or child.

In August 2019, the U.S. Surgeon General issued an advisory regarding potential harm to developing brains from the use of marijuana during pregnancy and lactation. The Food and Drug Administration issued a similar statement in October 2019 strongly advising against the use of CBD, THC, and marijuana in any form during pregnancy or while breastfeeding.
 

Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, president of the Organization of Teratology Information Specialists, and past president of the Teratology Society.

References

1. Am J Obstet Gynecol. 2015 Aug;213(2):201.e1-10.

2. JAMA. 2017 Dec 26;318(24):2490-1.

3. JAMA. 2017 Jan 10;317(2):207-9.

4. Complement Ther Clin Pract. 2009 Nov;15(4)242-6.

5. Paediatr Perinat Epidemiol. 2014 Sep; 28(5): 424-33.

6. J Toxicol Environ Health A. 2007 Jan;70(1):7-18.

7. Am J Obstet Gynecol. 1983 Aug 15;146(8):992-4.

8. Clin Perinatol. 1991 Mar;18(1):77-91.

9. Am J Epidemiol. 1986 Dec;124(6):986-93.

10. Pediatr Res. 2012 Feb;71(2):215-9.

11. Reprod Toxicol. 2016;62:77-86.

12. Neurotoxicol Teratol. 1987 Jan-Feb;9(1):1-7.

13. Neurotoxicol Teratol. 1994 Mar-Apr;16(2):169-75.

14. Biol Psychiatry. 2016 Jun 15;79(12):971-9.

15. Pharmacol Ther. 2018 Feb;182:133-51.

16. Biol Psychiatry. 2016 Apr 1;79(7):613-9.

17. Obstet Gynecol. 2018 May;131(5):783-8.

18. Pediatrics. 2018 Sep;142(3):e20181076.

With recent developments in many U.S. states regarding legalization of cannabis for medicinal or recreational use, there is an emerging need to better understand the risks or safety of its use during pregnancy and lactation. National survey data from 2007-2012 of more than 93,000 pregnant women suggest that around 7% of pregnant respondents reported any cannabis use in the last 2-12 months; of those, 16% reported daily or almost daily use. Among pregnant past-year users in the same survey, 70% perceived slight or no risk of harm from cannabis use 1-2 times a week in pregnancy.¹

Data from the Kaiser Northern California health plan involving more than 279,000 pregnancies followed during 2009-2016 suggest that there has been a significant upward trend in use of cannabis during pregnancy, from 4% to 7%, as reported by the mother and/or identified by routine urine screening. The highest prevalence in that study was seen among 18- to 24-year-old pregnant women, increasing from 13% to 22% over the 7-year study period. Importantly, more than 50% of cannabis users in the sample were identified by toxicology screening alone.^2,3 Common reasons given for use of cannabis in pregnancy include anxiety, pain, and nausea and vomiting of pregnancy.⁴

With respect to adverse perinatal outcomes, several case-control studies have examined risks for major birth defects with maternal self-report of cannabis use. Some have noted very modest increased risks for selected major birth defects (odds ratios less than 2); however, data still are very limited.^5,6

A number of prospective studies have addressed risks of preterm birth and growth restriction, accounting for mother’s concomitant tobacco use.^7-11 Some of these studies have suggested about a twofold to threefold increased risk for preterm delivery and an increased risk for reduced birth weight – particularly with heavier or regular cannabis use – but study findings have not been entirely consistent.

Given its psychoactive properties, there has been high interest in understanding whether there are any short- or long-term neurodevelopmental effects on children prenatally exposed to cannabis. These outcomes have been studied in two small older cohorts in the United States and Canada and one more recent cohort in the Netherlands.^12-15 Deficits in several measures of cognition and behavior were noted in follow-up of those children from birth to adulthood. However, it is unclear to what extent these findings may have been influenced by heredity, environment, or other factors.

There have been limitations in almost all studies published to date, including small sample sizes, no biomarker validation of maternal report of dose and gestational timing of cannabis use, and lack of detailed data on common coexposures, such as alcohol, tobacco, and other drugs. In addition, newer studies of pregnancy outcomes in women who use currently available cannabis products are needed, given the substantial increase in the potency of cannabis used today, compared with that of 20 years ago. For example, the tetrahydrocannabinol (THC) concentration in commonly cultivated marijuana plants has increased threefold from 4% to 12% between 1995 and 2014.¹⁶

There are very limited data on the presence of cannabis in breast milk and the potential effects of exposure to THC and other metabolites for breastfed infants. However, two recent studies have demonstrated there are low but measurable levels of some cannabis metabolites in breast milk.^17-18 Further work is needed to determine if these metabolites accumulate in milk and if at a given dose and age of the breastfed infant, there are any growth, neurodevelopmental, or other clinically important adverse effects.

Related questions, such as potential differences in the effects of exposure during pregnancy or lactation based on the route of administration (edible vs. inhaled) and the use of cannabidiol (CBD) products, have not been studied.

At the present time, the American College of Obstetricians and Gynecologists recommends that women who are pregnant or contemplating pregnancy be encouraged to discontinue marijuana use. With respect to lactation and breastfeeding, ACOG concludes there are insufficient data to evaluate the effects on infants, and in the absence of such data, marijuana use is discouraged. Similarly, the American Academy of Pediatrics recommends women of childbearing age abstain from marijuana use while pregnant or breastfeeding because of potential adverse consequences to the fetus, infant, or child.

In August 2019, the U.S. Surgeon General issued an advisory regarding potential harm to developing brains from the use of marijuana during pregnancy and lactation. The Food and Drug Administration issued a similar statement in October 2019 strongly advising against the use of CBD, THC, and marijuana in any form during pregnancy or while breastfeeding.
 

Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, president of the Organization of Teratology Information Specialists, and past president of the Teratology Society.

References

1. Am J Obstet Gynecol. 2015 Aug;213(2):201.e1-10.

2. JAMA. 2017 Dec 26;318(24):2490-1.

3. JAMA. 2017 Jan 10;317(2):207-9.

4. Complement Ther Clin Pract. 2009 Nov;15(4)242-6.

5. Paediatr Perinat Epidemiol. 2014 Sep; 28(5): 424-33.

6. J Toxicol Environ Health A. 2007 Jan;70(1):7-18.

7. Am J Obstet Gynecol. 1983 Aug 15;146(8):992-4.

8. Clin Perinatol. 1991 Mar;18(1):77-91.

9. Am J Epidemiol. 1986 Dec;124(6):986-93.

10. Pediatr Res. 2012 Feb;71(2):215-9.

11. Reprod Toxicol. 2016;62:77-86.

12. Neurotoxicol Teratol. 1987 Jan-Feb;9(1):1-7.

13. Neurotoxicol Teratol. 1994 Mar-Apr;16(2):169-75.

14. Biol Psychiatry. 2016 Jun 15;79(12):971-9.

15. Pharmacol Ther. 2018 Feb;182:133-51.

16. Biol Psychiatry. 2016 Apr 1;79(7):613-9.

17. Obstet Gynecol. 2018 May;131(5):783-8.

18. Pediatrics. 2018 Sep;142(3):e20181076.

With recent developments in many U.S. states regarding legalization of cannabis for medicinal or recreational use, there is an emerging need to better understand the risks or safety of its use during pregnancy and lactation. National survey data from 2007-2012 of more than 93,000 pregnant women suggest that around 7% of pregnant respondents reported any cannabis use in the last 2-12 months; of those, 16% reported daily or almost daily use. Among pregnant past-year users in the same survey, 70% perceived slight or no risk of harm from cannabis use 1-2 times a week in pregnancy.¹

Data from the Kaiser Northern California health plan involving more than 279,000 pregnancies followed during 2009-2016 suggest that there has been a significant upward trend in use of cannabis during pregnancy, from 4% to 7%, as reported by the mother and/or identified by routine urine screening. The highest prevalence in that study was seen among 18- to 24-year-old pregnant women, increasing from 13% to 22% over the 7-year study period. Importantly, more than 50% of cannabis users in the sample were identified by toxicology screening alone.^2,3 Common reasons given for use of cannabis in pregnancy include anxiety, pain, and nausea and vomiting of pregnancy.⁴

With respect to adverse perinatal outcomes, several case-control studies have examined risks for major birth defects with maternal self-report of cannabis use. Some have noted very modest increased risks for selected major birth defects (odds ratios less than 2); however, data still are very limited.^5,6

A number of prospective studies have addressed risks of preterm birth and growth restriction, accounting for mother’s concomitant tobacco use.^7-11 Some of these studies have suggested about a twofold to threefold increased risk for preterm delivery and an increased risk for reduced birth weight – particularly with heavier or regular cannabis use – but study findings have not been entirely consistent.

Given its psychoactive properties, there has been high interest in understanding whether there are any short- or long-term neurodevelopmental effects on children prenatally exposed to cannabis. These outcomes have been studied in two small older cohorts in the United States and Canada and one more recent cohort in the Netherlands.^12-15 Deficits in several measures of cognition and behavior were noted in follow-up of those children from birth to adulthood. However, it is unclear to what extent these findings may have been influenced by heredity, environment, or other factors.

There have been limitations in almost all studies published to date, including small sample sizes, no biomarker validation of maternal report of dose and gestational timing of cannabis use, and lack of detailed data on common coexposures, such as alcohol, tobacco, and other drugs. In addition, newer studies of pregnancy outcomes in women who use currently available cannabis products are needed, given the substantial increase in the potency of cannabis used today, compared with that of 20 years ago. For example, the tetrahydrocannabinol (THC) concentration in commonly cultivated marijuana plants has increased threefold from 4% to 12% between 1995 and 2014.¹⁶

There are very limited data on the presence of cannabis in breast milk and the potential effects of exposure to THC and other metabolites for breastfed infants. However, two recent studies have demonstrated there are low but measurable levels of some cannabis metabolites in breast milk.^17-18 Further work is needed to determine if these metabolites accumulate in milk and if at a given dose and age of the breastfed infant, there are any growth, neurodevelopmental, or other clinically important adverse effects.

Related questions, such as potential differences in the effects of exposure during pregnancy or lactation based on the route of administration (edible vs. inhaled) and the use of cannabidiol (CBD) products, have not been studied.

At the present time, the American College of Obstetricians and Gynecologists recommends that women who are pregnant or contemplating pregnancy be encouraged to discontinue marijuana use. With respect to lactation and breastfeeding, ACOG concludes there are insufficient data to evaluate the effects on infants, and in the absence of such data, marijuana use is discouraged. Similarly, the American Academy of Pediatrics recommends women of childbearing age abstain from marijuana use while pregnant or breastfeeding because of potential adverse consequences to the fetus, infant, or child.

In August 2019, the U.S. Surgeon General issued an advisory regarding potential harm to developing brains from the use of marijuana during pregnancy and lactation. The Food and Drug Administration issued a similar statement in October 2019 strongly advising against the use of CBD, THC, and marijuana in any form during pregnancy or while breastfeeding.
 

Dr. Chambers is professor of pediatrics and director of clinical research at Rady Children’s Hospital and associate director of the Clinical and Translational Research Institute at the University of California, San Diego. She is also director of MotherToBaby California, president of the Organization of Teratology Information Specialists, and past president of the Teratology Society.

References

1. Am J Obstet Gynecol. 2015 Aug;213(2):201.e1-10.

2. JAMA. 2017 Dec 26;318(24):2490-1.

3. JAMA. 2017 Jan 10;317(2):207-9.

4. Complement Ther Clin Pract. 2009 Nov;15(4)242-6.

5. Paediatr Perinat Epidemiol. 2014 Sep; 28(5): 424-33.

6. J Toxicol Environ Health A. 2007 Jan;70(1):7-18.

7. Am J Obstet Gynecol. 1983 Aug 15;146(8):992-4.

8. Clin Perinatol. 1991 Mar;18(1):77-91.

9. Am J Epidemiol. 1986 Dec;124(6):986-93.

10. Pediatr Res. 2012 Feb;71(2):215-9.

11. Reprod Toxicol. 2016;62:77-86.

12. Neurotoxicol Teratol. 1987 Jan-Feb;9(1):1-7.

13. Neurotoxicol Teratol. 1994 Mar-Apr;16(2):169-75.

14. Biol Psychiatry. 2016 Jun 15;79(12):971-9.

15. Pharmacol Ther. 2018 Feb;182:133-51.

16. Biol Psychiatry. 2016 Apr 1;79(7):613-9.

17. Obstet Gynecol. 2018 May;131(5):783-8.

18. Pediatrics. 2018 Sep;142(3):e20181076.

An ob.gyn. accused of being under the influence while on the job has prevailed in her defamation and fraud lawsuit against an Indiana hospital.

Jurors awarded Carmel, Ind.–based ob.gyn. Rebecca Denman, MD, $4.75 million in damages against St. Vincent Carmel Hospital and St. Vincent Carmel Medical Group on Jan. 16, 2020, after a 4-day trial in Indiana Commercial Court. Dr. Denman sued after the hospital and medical group took a series of actions in response to a nurse practitioner’s claim that Dr. Denman smelled of alcohol while on duty. The doctor’s lawsuit alleged the NP’s claim was unproven; that administrators failed to conduct a proper peer-review investigation; and that repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

Indianapolis attorney Kathleen DeLaney, who represented Dr. Denman in the case, said that her client was pleased with the verdict.

“Dr. Denman feels vindicated that a group of jurors spent 4 days listening to all the evidence and gave her a resounding victory,” she said in an interview.

Dr. Denman declined to comment for this story through her attorney.

In a statement, a spokesman for Ascension, the hospital’s parent company, said the hospital was disappointed by the verdict and that it was “exploring all options available to us, including appeal.” The spokesman declined to answer further questions about the case or its peer-review process.

The case stems from an NP’s claim that Dr. Denman’s breath smelled of alcohol during an evening shift on Dec. 11, 2017. Dr. Denman was not informed of the allegation on Dec. 11 and was not tested for alcohol at the time, according to Dr. Denman’s lawsuit. Under hospital policy, if a physician is suspected of being under the influence of alcohol at work, the employer must immediately assess the doctor, relieve the doctor of duty, and request the physician submit to immediate blood testing at an external facility.

The NP reported the allegation to her supervisor through an email on Dec. 12, 2017. The supervisor relayed the information to the hospital’s chief medical officer who met with other administrators and physicians to discuss the claim. During the discussions, a previous concern about Dr. Denman’s drinking was raised, according to deposition information included in court documents. In 2015, two physicians had suggested Dr. Denman consider an assistance program after expressing concerns that she was arriving late to work and missing partner meetings. At the time, Dr. Denman did not enter an assistance program, but she changed her drinking habits, began seeing a therapist, and started arriving on-time to work and to partner meetings, according to court documents. No other criticism or complaints regarding her drinking or workplace behavior had been reported since, according to court documents.

When confronted with the NP’s claim on Dec. 13, 2017, Dr. Denman denied consuming alcohol on Dec. 11, 2017, and questioned why the hospital’s substance abuse protocol was not followed.

St. Vincent Carmel Hospital conducted a preliminary review of the allegation through its peer-review process and turned the matter over to St. Vincent Medical Group for further review, according to court documents. St. Vincent Medical Group later informed Dr. Denman they had reviewed the allegation through its peer-review process and that she was suspended with partial pay until she underwent an evaluation for alcohol abuse through the Indiana State Medical Association, according to the lawsuit.

“They falsely misrepresented to her that peer review had been done,” Ms. DeLaney said in an interview. “In spite of that statement, they never offered her a hearing before a peer-review committee, they never shared with her the substance of any evidence they had against her, they never gave her an opportunity to respond to the allegations. In fact, she wasn’t interviewed at all until the deposition in the lawsuit.”

According to the Indiana Peer Review law, a health care provider under investigation is permitted to see any records accumulated by a peer-review committee pertaining to the provider’s personal practice, and the provider shall be offered the opportunity to appear before the peer-review committee with adequate representation to hear all charges and findings concerning the provider and to offer rebuttal information. The rebuttal shall be part of the record before any disclosure of the charges and before any findings can be made, according to the statute.

Dr. Denman was referred by the medical association to an addiction treatment center that evaluated Dr. Denman and diagnosed her with alcohol use disorder, according to the lawsuit. As a result of the report and as a condition of retaining her medical license, the medical association and St. Vincent Medical Group required Dr. Denman to enter a treatment program at the same addiction treatment center. Dr. Denman was also required to sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit.

“The actions had life-changing consequences,” Ms. DeLaney said. “As a result, she was required to sign a contract that mandates she do a breathalyzer test four times a day for the first year and then three times a day for 4 more years. She has to go for random drug screenings. For the first year, she had to go to four [Alcoholics Anonymous] meetings a week. Now that number has been reduced, but she’s on a 5-year monitoring contract because of all of this.”

Dr. Denman sued the hospital, the medical group, and the NP in July 2018 alleging fraud, defamation, tortuous interference with an employment relationship, and negligent misrepresentation. The NP was dismissed from the case shortly before trial.

In its response to the lawsuit, attorneys for St. Vincent wrote that Dr. Denman’s action was frivolous, vexatious, and executed in bad faith. The defendants requested that a judge dismiss the lawsuit, noting that they were entitled to immunity pursuant to Indiana state and federal laws, including protection by Indiana’s Peer Review statute. In October 2019, a judge denied the hospital’s request to dismiss the lawsuit and allowed the case to proceed.

In their verdict, jurors awarded Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

Dr. Denman remains employed by the medical group and must continue the conditions of her 5-year monitoring contract, Ms. DeLaney said. She hopes Dr. Denman’s case raises awareness about physicians’ due process rights.

“We hope that Dr. Denman’s case emboldens physicians to stand up for themselves in the face of false accusations and rushes to judgment,” she said. “We hope the verdict leads to fair, prompt, and unbiased investigations by hospital and medical practice administrators, which include due process for accused physicians.”

agallegos@mdedge.com

An ob.gyn. accused of being under the influence while on the job has prevailed in her defamation and fraud lawsuit against an Indiana hospital.

Jurors awarded Carmel, Ind.–based ob.gyn. Rebecca Denman, MD, $4.75 million in damages against St. Vincent Carmel Hospital and St. Vincent Carmel Medical Group on Jan. 16, 2020, after a 4-day trial in Indiana Commercial Court. Dr. Denman sued after the hospital and medical group took a series of actions in response to a nurse practitioner’s claim that Dr. Denman smelled of alcohol while on duty. The doctor’s lawsuit alleged the NP’s claim was unproven; that administrators failed to conduct a proper peer-review investigation; and that repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

Indianapolis attorney Kathleen DeLaney, who represented Dr. Denman in the case, said that her client was pleased with the verdict.

“Dr. Denman feels vindicated that a group of jurors spent 4 days listening to all the evidence and gave her a resounding victory,” she said in an interview.

Dr. Denman declined to comment for this story through her attorney.

In a statement, a spokesman for Ascension, the hospital’s parent company, said the hospital was disappointed by the verdict and that it was “exploring all options available to us, including appeal.” The spokesman declined to answer further questions about the case or its peer-review process.

The case stems from an NP’s claim that Dr. Denman’s breath smelled of alcohol during an evening shift on Dec. 11, 2017. Dr. Denman was not informed of the allegation on Dec. 11 and was not tested for alcohol at the time, according to Dr. Denman’s lawsuit. Under hospital policy, if a physician is suspected of being under the influence of alcohol at work, the employer must immediately assess the doctor, relieve the doctor of duty, and request the physician submit to immediate blood testing at an external facility.

The NP reported the allegation to her supervisor through an email on Dec. 12, 2017. The supervisor relayed the information to the hospital’s chief medical officer who met with other administrators and physicians to discuss the claim. During the discussions, a previous concern about Dr. Denman’s drinking was raised, according to deposition information included in court documents. In 2015, two physicians had suggested Dr. Denman consider an assistance program after expressing concerns that she was arriving late to work and missing partner meetings. At the time, Dr. Denman did not enter an assistance program, but she changed her drinking habits, began seeing a therapist, and started arriving on-time to work and to partner meetings, according to court documents. No other criticism or complaints regarding her drinking or workplace behavior had been reported since, according to court documents.

When confronted with the NP’s claim on Dec. 13, 2017, Dr. Denman denied consuming alcohol on Dec. 11, 2017, and questioned why the hospital’s substance abuse protocol was not followed.

St. Vincent Carmel Hospital conducted a preliminary review of the allegation through its peer-review process and turned the matter over to St. Vincent Medical Group for further review, according to court documents. St. Vincent Medical Group later informed Dr. Denman they had reviewed the allegation through its peer-review process and that she was suspended with partial pay until she underwent an evaluation for alcohol abuse through the Indiana State Medical Association, according to the lawsuit.

“They falsely misrepresented to her that peer review had been done,” Ms. DeLaney said in an interview. “In spite of that statement, they never offered her a hearing before a peer-review committee, they never shared with her the substance of any evidence they had against her, they never gave her an opportunity to respond to the allegations. In fact, she wasn’t interviewed at all until the deposition in the lawsuit.”

According to the Indiana Peer Review law, a health care provider under investigation is permitted to see any records accumulated by a peer-review committee pertaining to the provider’s personal practice, and the provider shall be offered the opportunity to appear before the peer-review committee with adequate representation to hear all charges and findings concerning the provider and to offer rebuttal information. The rebuttal shall be part of the record before any disclosure of the charges and before any findings can be made, according to the statute.

Dr. Denman was referred by the medical association to an addiction treatment center that evaluated Dr. Denman and diagnosed her with alcohol use disorder, according to the lawsuit. As a result of the report and as a condition of retaining her medical license, the medical association and St. Vincent Medical Group required Dr. Denman to enter a treatment program at the same addiction treatment center. Dr. Denman was also required to sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit.

“The actions had life-changing consequences,” Ms. DeLaney said. “As a result, she was required to sign a contract that mandates she do a breathalyzer test four times a day for the first year and then three times a day for 4 more years. She has to go for random drug screenings. For the first year, she had to go to four [Alcoholics Anonymous] meetings a week. Now that number has been reduced, but she’s on a 5-year monitoring contract because of all of this.”

Dr. Denman sued the hospital, the medical group, and the NP in July 2018 alleging fraud, defamation, tortuous interference with an employment relationship, and negligent misrepresentation. The NP was dismissed from the case shortly before trial.

In its response to the lawsuit, attorneys for St. Vincent wrote that Dr. Denman’s action was frivolous, vexatious, and executed in bad faith. The defendants requested that a judge dismiss the lawsuit, noting that they were entitled to immunity pursuant to Indiana state and federal laws, including protection by Indiana’s Peer Review statute. In October 2019, a judge denied the hospital’s request to dismiss the lawsuit and allowed the case to proceed.

In their verdict, jurors awarded Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

Dr. Denman remains employed by the medical group and must continue the conditions of her 5-year monitoring contract, Ms. DeLaney said. She hopes Dr. Denman’s case raises awareness about physicians’ due process rights.

“We hope that Dr. Denman’s case emboldens physicians to stand up for themselves in the face of false accusations and rushes to judgment,” she said. “We hope the verdict leads to fair, prompt, and unbiased investigations by hospital and medical practice administrators, which include due process for accused physicians.”

agallegos@mdedge.com

An ob.gyn. accused of being under the influence while on the job has prevailed in her defamation and fraud lawsuit against an Indiana hospital.

Jurors awarded Carmel, Ind.–based ob.gyn. Rebecca Denman, MD, $4.75 million in damages against St. Vincent Carmel Hospital and St. Vincent Carmel Medical Group on Jan. 16, 2020, after a 4-day trial in Indiana Commercial Court. Dr. Denman sued after the hospital and medical group took a series of actions in response to a nurse practitioner’s claim that Dr. Denman smelled of alcohol while on duty. The doctor’s lawsuit alleged the NP’s claim was unproven; that administrators failed to conduct a proper peer-review investigation; and that repercussions from the false allegation resulted in lost compensation, out-of-pocket expenses, emotional distress, and damage to her professional reputation.

Indianapolis attorney Kathleen DeLaney, who represented Dr. Denman in the case, said that her client was pleased with the verdict.

“Dr. Denman feels vindicated that a group of jurors spent 4 days listening to all the evidence and gave her a resounding victory,” she said in an interview.

Dr. Denman declined to comment for this story through her attorney.

In a statement, a spokesman for Ascension, the hospital’s parent company, said the hospital was disappointed by the verdict and that it was “exploring all options available to us, including appeal.” The spokesman declined to answer further questions about the case or its peer-review process.

The case stems from an NP’s claim that Dr. Denman’s breath smelled of alcohol during an evening shift on Dec. 11, 2017. Dr. Denman was not informed of the allegation on Dec. 11 and was not tested for alcohol at the time, according to Dr. Denman’s lawsuit. Under hospital policy, if a physician is suspected of being under the influence of alcohol at work, the employer must immediately assess the doctor, relieve the doctor of duty, and request the physician submit to immediate blood testing at an external facility.

The NP reported the allegation to her supervisor through an email on Dec. 12, 2017. The supervisor relayed the information to the hospital’s chief medical officer who met with other administrators and physicians to discuss the claim. During the discussions, a previous concern about Dr. Denman’s drinking was raised, according to deposition information included in court documents. In 2015, two physicians had suggested Dr. Denman consider an assistance program after expressing concerns that she was arriving late to work and missing partner meetings. At the time, Dr. Denman did not enter an assistance program, but she changed her drinking habits, began seeing a therapist, and started arriving on-time to work and to partner meetings, according to court documents. No other criticism or complaints regarding her drinking or workplace behavior had been reported since, according to court documents.

When confronted with the NP’s claim on Dec. 13, 2017, Dr. Denman denied consuming alcohol on Dec. 11, 2017, and questioned why the hospital’s substance abuse protocol was not followed.

St. Vincent Carmel Hospital conducted a preliminary review of the allegation through its peer-review process and turned the matter over to St. Vincent Medical Group for further review, according to court documents. St. Vincent Medical Group later informed Dr. Denman they had reviewed the allegation through its peer-review process and that she was suspended with partial pay until she underwent an evaluation for alcohol abuse through the Indiana State Medical Association, according to the lawsuit.

“They falsely misrepresented to her that peer review had been done,” Ms. DeLaney said in an interview. “In spite of that statement, they never offered her a hearing before a peer-review committee, they never shared with her the substance of any evidence they had against her, they never gave her an opportunity to respond to the allegations. In fact, she wasn’t interviewed at all until the deposition in the lawsuit.”

According to the Indiana Peer Review law, a health care provider under investigation is permitted to see any records accumulated by a peer-review committee pertaining to the provider’s personal practice, and the provider shall be offered the opportunity to appear before the peer-review committee with adequate representation to hear all charges and findings concerning the provider and to offer rebuttal information. The rebuttal shall be part of the record before any disclosure of the charges and before any findings can be made, according to the statute.

Dr. Denman was referred by the medical association to an addiction treatment center that evaluated Dr. Denman and diagnosed her with alcohol use disorder, according to the lawsuit. As a result of the report and as a condition of retaining her medical license, the medical association and St. Vincent Medical Group required Dr. Denman to enter a treatment program at the same addiction treatment center. Dr. Denman was also required to sign a 5-year monitoring contract with the Indiana State Medical Association as a condition of her employment, according to the lawsuit.

“The actions had life-changing consequences,” Ms. DeLaney said. “As a result, she was required to sign a contract that mandates she do a breathalyzer test four times a day for the first year and then three times a day for 4 more years. She has to go for random drug screenings. For the first year, she had to go to four [Alcoholics Anonymous] meetings a week. Now that number has been reduced, but she’s on a 5-year monitoring contract because of all of this.”

Dr. Denman sued the hospital, the medical group, and the NP in July 2018 alleging fraud, defamation, tortuous interference with an employment relationship, and negligent misrepresentation. The NP was dismissed from the case shortly before trial.

In its response to the lawsuit, attorneys for St. Vincent wrote that Dr. Denman’s action was frivolous, vexatious, and executed in bad faith. The defendants requested that a judge dismiss the lawsuit, noting that they were entitled to immunity pursuant to Indiana state and federal laws, including protection by Indiana’s Peer Review statute. In October 2019, a judge denied the hospital’s request to dismiss the lawsuit and allowed the case to proceed.

In their verdict, jurors awarded Dr. Denman $2 million for her defamation claims, $2 million for her claims of fraud and constructive fraud, $500,000 for her claim of tortious interference with an employment relationship, and $250,000 for her claim of negligent misrepresentation.

Dr. Denman remains employed by the medical group and must continue the conditions of her 5-year monitoring contract, Ms. DeLaney said. She hopes Dr. Denman’s case raises awareness about physicians’ due process rights.

“We hope that Dr. Denman’s case emboldens physicians to stand up for themselves in the face of false accusations and rushes to judgment,” she said. “We hope the verdict leads to fair, prompt, and unbiased investigations by hospital and medical practice administrators, which include due process for accused physicians.”

agallegos@mdedge.com

As the Wuhan coronavirus story unfolds, the most important thing for clinicians in the United States to do is ask patients who appear to have the flu if they, or someone they have been in contact with, recently returned from China, according to infectious disease experts.

China News Service/CC BY 3.0

“We are asking that of everyone with fever and respiratory symptoms who comes to our clinics, hospital, or emergency room. It’s a powerful screening tool,” said William Schaffner, MD, professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center, Nashville, Tenn.

In addition to fever, common signs of infection include cough, shortness of breath, and breathing difficulties. Some patients have had diarrhea, vomiting, and other gastrointestinal symptoms. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and death. The incubation period appears to be up to 2 weeks, according to the World Health Organization (WHO).

If patients exhibit symptoms and either they or a close contact has returned from China recently, take standard airborne precautions and send specimens – a serum sample, oral and nasal pharyngeal swabs, and lower respiratory tract specimens if available – to the local health department, which will forward them to the Centers for Disease Control and Prevention (CDC) for testing. Turnaround time is 24-48 hours.

Plan and rehearse

The first step to prepare is to use the CDC’s Interim Guidance for Healthcare Professionals to make a written plan specific to your practice to respond to a potential case. The plan must include notifying the local health department, the CDC liaison for testing, and tracking down patient contacts.

“It’s not good enough to just download CDC’s guidance; use it to make your own local plan and know what to do 24/7,” said Daniel Lucey, MD, an infectious disease expert at Georgetown University Medical Center, Washington, D.C.

“Know who is on call at the health department on weekends and nights,” he said. Know where the patient is going to be isolated; figure out what to do if there’s more than one, and tests come back positive. Have masks on hand, and rehearse the response. “Make a coronavirus team, and absolutely have the nurses involved,” as well as other providers who may come into contact with a case, he added.

Fatality rates

The focus right now is China. The outbreak has spread beyond Wuhan to other parts of the country, and there’s evidence of fourth-generation spread.

SARS: Lessons learned

In general, the world is much better equipped for coronavirus outbreaks than when SARS, in particular, emerged in 2003.

aotto@mdedge.com

This article was updated with new case numbers on 1/26/20.