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Tips and advice for Essure removal
Essure tubal microinserts were not designed to be removed. However, a small minority of women are requesting removal because of regret, complications, or the development of pelvic pain and other symptoms that may or may not be caused by the device.
Minimally invasive gynecologic surgeons have developed a variety of removal procedures and techniques for these women. There is general agreement that hysteroscopic removal is feasible only in the first 3 months following insertion of the device. After that, laparoscopic removal has become the norm. Small published reports and case series have documented the use of laparoscopic bilateral salpingectomy (BS) with and without hysterectomy, laparoscopic BS with cornuectomy, and laparoscopic salpingostomy, often followed by salpingectomy. There is not yet enough data to demonstrate that one method is superior to another, and we each have our own preferred approaches for preoperative imaging and removal.
Here is some of our advice on working with patients to assess the need for, and possible outcomes of, removal, as well as how to approach the surgery.
Counseling, assessment, and consent
Dr. Cohen: We have to be frank with our patients that symptoms may or may not improve following Essure removal. In a recently published case series of 52 women who underwent Essure removal at our institution, three-quarters of the patients reported near or total improvement in the quality of life. However, a relatively high number – roughly 30% – reported some ongoing symptoms (J Minim Invasive Gynecol. 2017 Jun 6. doi: 10:1016/j.jmig.2017.05.015).
The most common indication for Essure removal in this series was pelvic pain (96%), followed by abnormal uterine bleeding (35%) and patient-reported allergic reaction (21%). The indications were not mutually exclusive.
Importantly, could endometriosis or another underlying condition have developed since placement or worsened over time? Or, could her pelvic pain be worsened because of the cessation of hormonal contraception that coincided with Essure placement, rather than the device itself? For some women, Essure removal alone will not cure their symptoms.
In our cohort of 52 women, interestingly, 44% of those with pelvic pain had one or more concomitant or alternate causes of pain, including endometriosis, adenomyosis, and adhesions.
Dr. Levie: We can’t assume that Essure coils are at fault when patients present with pain and other symptoms, nor can we minimize complaints and concerns. We have to explore them.
It’s important that we inform women that pain may not be related to Essure microinserts. However, if, after thorough evaluation, the patient believes that the coils are the etiology of her pain and I cannot find another reason – or if she has regrets or is concerned about potential problems in the future – I am happy to remove them.
Dr. Yunker: In our case series of 29 women who underwent removal for the primary indication of pelvic pain, 88.5% reported significant relief at their postoperative visit (Contraception. 2016 Aug;94[2]:190-2). This, and other unpublished data, show that patients with gynecologic complaints specifically are the most likely to have resolution of symptoms, compared with those with more systemic or nongynecologic complaints.
Some patients have systemic symptoms that they feel are related and new since the device was placed. My counseling in these cases is that, while I do not have any physiologic evidence that the Essure coil is causing their symptoms, I’m hopeful that symptoms will improve with removal. If they do not, these patients must follow up with their primary care doctor for further work-up.
Device structure and use of imaging
Essure is a 4-cm long device (0.8 mm in diameter) with two parts: an inner coil made of stainless steel and PET fibers, the latter of which induces the fibrosis responsible for tubal occlusion, and an outer coil made of nitinol, a nickel titanium alloy.
Dr. Cohen: While the exact mechanism is unclear, it’s possible that the PET fibers may be drivers of the systemic inflammatory-type symptoms that some women report. Nickel allergies are also possible albeit uncommon. They appear to manifest as rash, urticaria, and other symptoms characteristic of contact allergic reactions.
The brittle nature of the outer coil makes a grasp-and-pull approach disadvantageous, unless you’re removing coils early on hysteroscopically. In general, one must avoid fracturing the outer coil, or parts of the device will be left behind. Pulling too hard may also cause the outer coil to unravel and expand to be quite long, which further increases the risk of fracture.
Hysterosalpingogram (HSG) and ultrasound are typically first-line options for looking at coil position. A diagnostic hysteroscopy may also help identify coils, and intraoperative fluoroscopy may be useful for either the hysteroscopic or laparoscopic approach, if there’s any question about portions of the device not being recovered.
Dr. Levie: Ultrasound is often sufficient for operative planning, but, if it does not detect devices in the cornual region, then further imaging may be warranted.
It’s important to be aware that some devices that appear to have correct placement on ultrasound or HSG may actually be partially tracking subserosally. In these cases, the distal portion of the device may have tracked through the mucosal layer and along the muscularis but below the serosa in the fallopian tube, causing pain. Imaging won’t be helpful in making this diagnosis. It will be identified laparoscopically.
Dr. Yunker: When patients have completed the 3-month HSG (to confirm occlusion of the Fallopian tubes post placement), I will review the images myself rather than relying on the report. Without an HSG – and, in many cases, even when I have it in hand – I will order a plain film x-ray of the abdomen and pelvis to look for coils. In almost all cases, I also order an ultrasound, which is helpful in assessing for ovarian and uterine conditions.
I’ve found plain film imaging to be valuable for identifying additional or misplaced Essure inserts. I have found up to four in one tube. In interpreting x-rays, one must appreciate that the outer coil is not radio-opaque (other than the tiny marker at the end) and will not show up. Occasionally we’ll add hysteroscopy to see how much of a coil is trailing into the uterus, but the ultrasound and x-ray are usually enough.
Some patients ask about postremoval imaging. I do not routinely do this, but I’m not opposed to it.
Surgical techniques
Dr. Cohen: I advise dissecting around each coil without cutting the outer portion and removing the coil intact, resecting all the way down to the interstitial portion of the tube, then proceeding with bilateral salpingectomy to ensure contraception.
If the patient’s symptoms are systemic and possibly reflective of PET fiber reactions, a wedge resection of the cornua may provide more peace of mind that PET fibers will not be left in situ. This procedure can be approached similarly to myomectomy, with the use of hemostatic agents such as misoprostol or vasopressin and suture closure in multiple layers.
If there are multiple coils present in the cavity, one option, to avoid having to pull them all out from the abdominal side, is to transect and remove the intracavity portion of the device hysteroscopically then dissect and remove the tubal/interstitial potion laparoscopically. As a general rule, I send all the removed tissue to pathology.
Dr. Levie: In general, I do a linear salpingostomy after using a uterine manipulator and a grasper to first identify the site of the distal portion of the device. One can usually feel where the tubes bend onto the device.
A bit proximal to where I visually and mentally mark the distal end of the device, I make a 2-3 cm incision over the device. With a fine-tip grasper, I can usually release the distal portion of the inner coil. Using two graspers over the inner and outer coils together and a hand-over-hand motion, I pull without excess traction in the access of the tubes, and the proximal portion will usually follow and deliver fairly simply. If the proximal portion breaks, I advise looking for it hysteroscopically and delivering it through the uterus.
Some surgeons have recommended hysteroscopy at the beginning of the procedure with cutting (using scissors) at the proximal end of the outer coil to avoid its getting caught in the cornua.
Most patients continue to want permanent sterilization, so we proceed with salpingectomy. Sometimes, given underlying pathologies, we’ll decide on laparoscopic or vaginal hysterectomy as well or bilateral salpingectomy without doing the salpingostomy. When hysterectomy is part of the surgery, we don’t need to worry at all about broken devices.
When the device is removed separately from the fallopian tube, one should inspect it afterward to ensure that all four markers of the device – the markers that are recommended by the manufacturer for radiologic confirmation of proper placement – have been delivered.
Dr. Yunker: When everything looks normal on the ultrasound – and when the coils on either HSG and/or plain film x-ray appear to be in the appropriate position in the tubes – then removal of the coils and tubes only is an option.
The closer the coil is to the fimbriae, the easier it is to come straight across the tube as you would in a regular salpingectomy without concern of breaking or cutting the coil. However, the closer the coil is the uterine side, the deeper you’ll need to dissect into the cornual region of the uterus. A cornual wedge resection may be necessary in order to remove the coil intact.
Our procedure has evolved over the years and we have moved away from salpingectomy as a means to dissect out the coils. With the theoretical risk of retained coil fragments and PET fibers, we prefer to remove the coils and tubes en bloc.
Dr. Cohen is director of research and the fellowship program director of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston. She reported that she has no financial disclosures. Dr. Levie is professor and associate chairman of the department of obstetrics and gynecology and women’s health and director of the minimally invasive surgery fellowship at Montefiore Medical Center, New York. Dr. Levie reported that he is an investigator in two studies involving Essure and sat on the Essure medical advisory board for Bayer but did not receive personal renumeration. Dr. Yunker is an assistant professor of obstetrics and gynecology at Vanderbilt University, Nashville. She reported that she is a consultant for Olympus.
Essure tubal microinserts were not designed to be removed. However, a small minority of women are requesting removal because of regret, complications, or the development of pelvic pain and other symptoms that may or may not be caused by the device.
Minimally invasive gynecologic surgeons have developed a variety of removal procedures and techniques for these women. There is general agreement that hysteroscopic removal is feasible only in the first 3 months following insertion of the device. After that, laparoscopic removal has become the norm. Small published reports and case series have documented the use of laparoscopic bilateral salpingectomy (BS) with and without hysterectomy, laparoscopic BS with cornuectomy, and laparoscopic salpingostomy, often followed by salpingectomy. There is not yet enough data to demonstrate that one method is superior to another, and we each have our own preferred approaches for preoperative imaging and removal.
Here is some of our advice on working with patients to assess the need for, and possible outcomes of, removal, as well as how to approach the surgery.
Counseling, assessment, and consent
Dr. Cohen: We have to be frank with our patients that symptoms may or may not improve following Essure removal. In a recently published case series of 52 women who underwent Essure removal at our institution, three-quarters of the patients reported near or total improvement in the quality of life. However, a relatively high number – roughly 30% – reported some ongoing symptoms (J Minim Invasive Gynecol. 2017 Jun 6. doi: 10:1016/j.jmig.2017.05.015).
The most common indication for Essure removal in this series was pelvic pain (96%), followed by abnormal uterine bleeding (35%) and patient-reported allergic reaction (21%). The indications were not mutually exclusive.
Importantly, could endometriosis or another underlying condition have developed since placement or worsened over time? Or, could her pelvic pain be worsened because of the cessation of hormonal contraception that coincided with Essure placement, rather than the device itself? For some women, Essure removal alone will not cure their symptoms.
In our cohort of 52 women, interestingly, 44% of those with pelvic pain had one or more concomitant or alternate causes of pain, including endometriosis, adenomyosis, and adhesions.
Dr. Levie: We can’t assume that Essure coils are at fault when patients present with pain and other symptoms, nor can we minimize complaints and concerns. We have to explore them.
It’s important that we inform women that pain may not be related to Essure microinserts. However, if, after thorough evaluation, the patient believes that the coils are the etiology of her pain and I cannot find another reason – or if she has regrets or is concerned about potential problems in the future – I am happy to remove them.
Dr. Yunker: In our case series of 29 women who underwent removal for the primary indication of pelvic pain, 88.5% reported significant relief at their postoperative visit (Contraception. 2016 Aug;94[2]:190-2). This, and other unpublished data, show that patients with gynecologic complaints specifically are the most likely to have resolution of symptoms, compared with those with more systemic or nongynecologic complaints.
Some patients have systemic symptoms that they feel are related and new since the device was placed. My counseling in these cases is that, while I do not have any physiologic evidence that the Essure coil is causing their symptoms, I’m hopeful that symptoms will improve with removal. If they do not, these patients must follow up with their primary care doctor for further work-up.
Device structure and use of imaging
Essure is a 4-cm long device (0.8 mm in diameter) with two parts: an inner coil made of stainless steel and PET fibers, the latter of which induces the fibrosis responsible for tubal occlusion, and an outer coil made of nitinol, a nickel titanium alloy.
Dr. Cohen: While the exact mechanism is unclear, it’s possible that the PET fibers may be drivers of the systemic inflammatory-type symptoms that some women report. Nickel allergies are also possible albeit uncommon. They appear to manifest as rash, urticaria, and other symptoms characteristic of contact allergic reactions.
The brittle nature of the outer coil makes a grasp-and-pull approach disadvantageous, unless you’re removing coils early on hysteroscopically. In general, one must avoid fracturing the outer coil, or parts of the device will be left behind. Pulling too hard may also cause the outer coil to unravel and expand to be quite long, which further increases the risk of fracture.
Hysterosalpingogram (HSG) and ultrasound are typically first-line options for looking at coil position. A diagnostic hysteroscopy may also help identify coils, and intraoperative fluoroscopy may be useful for either the hysteroscopic or laparoscopic approach, if there’s any question about portions of the device not being recovered.
Dr. Levie: Ultrasound is often sufficient for operative planning, but, if it does not detect devices in the cornual region, then further imaging may be warranted.
It’s important to be aware that some devices that appear to have correct placement on ultrasound or HSG may actually be partially tracking subserosally. In these cases, the distal portion of the device may have tracked through the mucosal layer and along the muscularis but below the serosa in the fallopian tube, causing pain. Imaging won’t be helpful in making this diagnosis. It will be identified laparoscopically.
Dr. Yunker: When patients have completed the 3-month HSG (to confirm occlusion of the Fallopian tubes post placement), I will review the images myself rather than relying on the report. Without an HSG – and, in many cases, even when I have it in hand – I will order a plain film x-ray of the abdomen and pelvis to look for coils. In almost all cases, I also order an ultrasound, which is helpful in assessing for ovarian and uterine conditions.
I’ve found plain film imaging to be valuable for identifying additional or misplaced Essure inserts. I have found up to four in one tube. In interpreting x-rays, one must appreciate that the outer coil is not radio-opaque (other than the tiny marker at the end) and will not show up. Occasionally we’ll add hysteroscopy to see how much of a coil is trailing into the uterus, but the ultrasound and x-ray are usually enough.
Some patients ask about postremoval imaging. I do not routinely do this, but I’m not opposed to it.
Surgical techniques
Dr. Cohen: I advise dissecting around each coil without cutting the outer portion and removing the coil intact, resecting all the way down to the interstitial portion of the tube, then proceeding with bilateral salpingectomy to ensure contraception.
If the patient’s symptoms are systemic and possibly reflective of PET fiber reactions, a wedge resection of the cornua may provide more peace of mind that PET fibers will not be left in situ. This procedure can be approached similarly to myomectomy, with the use of hemostatic agents such as misoprostol or vasopressin and suture closure in multiple layers.
If there are multiple coils present in the cavity, one option, to avoid having to pull them all out from the abdominal side, is to transect and remove the intracavity portion of the device hysteroscopically then dissect and remove the tubal/interstitial potion laparoscopically. As a general rule, I send all the removed tissue to pathology.
Dr. Levie: In general, I do a linear salpingostomy after using a uterine manipulator and a grasper to first identify the site of the distal portion of the device. One can usually feel where the tubes bend onto the device.
A bit proximal to where I visually and mentally mark the distal end of the device, I make a 2-3 cm incision over the device. With a fine-tip grasper, I can usually release the distal portion of the inner coil. Using two graspers over the inner and outer coils together and a hand-over-hand motion, I pull without excess traction in the access of the tubes, and the proximal portion will usually follow and deliver fairly simply. If the proximal portion breaks, I advise looking for it hysteroscopically and delivering it through the uterus.
Some surgeons have recommended hysteroscopy at the beginning of the procedure with cutting (using scissors) at the proximal end of the outer coil to avoid its getting caught in the cornua.
Most patients continue to want permanent sterilization, so we proceed with salpingectomy. Sometimes, given underlying pathologies, we’ll decide on laparoscopic or vaginal hysterectomy as well or bilateral salpingectomy without doing the salpingostomy. When hysterectomy is part of the surgery, we don’t need to worry at all about broken devices.
When the device is removed separately from the fallopian tube, one should inspect it afterward to ensure that all four markers of the device – the markers that are recommended by the manufacturer for radiologic confirmation of proper placement – have been delivered.
Dr. Yunker: When everything looks normal on the ultrasound – and when the coils on either HSG and/or plain film x-ray appear to be in the appropriate position in the tubes – then removal of the coils and tubes only is an option.
The closer the coil is to the fimbriae, the easier it is to come straight across the tube as you would in a regular salpingectomy without concern of breaking or cutting the coil. However, the closer the coil is the uterine side, the deeper you’ll need to dissect into the cornual region of the uterus. A cornual wedge resection may be necessary in order to remove the coil intact.
Our procedure has evolved over the years and we have moved away from salpingectomy as a means to dissect out the coils. With the theoretical risk of retained coil fragments and PET fibers, we prefer to remove the coils and tubes en bloc.
Dr. Cohen is director of research and the fellowship program director of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston. She reported that she has no financial disclosures. Dr. Levie is professor and associate chairman of the department of obstetrics and gynecology and women’s health and director of the minimally invasive surgery fellowship at Montefiore Medical Center, New York. Dr. Levie reported that he is an investigator in two studies involving Essure and sat on the Essure medical advisory board for Bayer but did not receive personal renumeration. Dr. Yunker is an assistant professor of obstetrics and gynecology at Vanderbilt University, Nashville. She reported that she is a consultant for Olympus.
Essure tubal microinserts were not designed to be removed. However, a small minority of women are requesting removal because of regret, complications, or the development of pelvic pain and other symptoms that may or may not be caused by the device.
Minimally invasive gynecologic surgeons have developed a variety of removal procedures and techniques for these women. There is general agreement that hysteroscopic removal is feasible only in the first 3 months following insertion of the device. After that, laparoscopic removal has become the norm. Small published reports and case series have documented the use of laparoscopic bilateral salpingectomy (BS) with and without hysterectomy, laparoscopic BS with cornuectomy, and laparoscopic salpingostomy, often followed by salpingectomy. There is not yet enough data to demonstrate that one method is superior to another, and we each have our own preferred approaches for preoperative imaging and removal.
Here is some of our advice on working with patients to assess the need for, and possible outcomes of, removal, as well as how to approach the surgery.
Counseling, assessment, and consent
Dr. Cohen: We have to be frank with our patients that symptoms may or may not improve following Essure removal. In a recently published case series of 52 women who underwent Essure removal at our institution, three-quarters of the patients reported near or total improvement in the quality of life. However, a relatively high number – roughly 30% – reported some ongoing symptoms (J Minim Invasive Gynecol. 2017 Jun 6. doi: 10:1016/j.jmig.2017.05.015).
The most common indication for Essure removal in this series was pelvic pain (96%), followed by abnormal uterine bleeding (35%) and patient-reported allergic reaction (21%). The indications were not mutually exclusive.
Importantly, could endometriosis or another underlying condition have developed since placement or worsened over time? Or, could her pelvic pain be worsened because of the cessation of hormonal contraception that coincided with Essure placement, rather than the device itself? For some women, Essure removal alone will not cure their symptoms.
In our cohort of 52 women, interestingly, 44% of those with pelvic pain had one or more concomitant or alternate causes of pain, including endometriosis, adenomyosis, and adhesions.
Dr. Levie: We can’t assume that Essure coils are at fault when patients present with pain and other symptoms, nor can we minimize complaints and concerns. We have to explore them.
It’s important that we inform women that pain may not be related to Essure microinserts. However, if, after thorough evaluation, the patient believes that the coils are the etiology of her pain and I cannot find another reason – or if she has regrets or is concerned about potential problems in the future – I am happy to remove them.
Dr. Yunker: In our case series of 29 women who underwent removal for the primary indication of pelvic pain, 88.5% reported significant relief at their postoperative visit (Contraception. 2016 Aug;94[2]:190-2). This, and other unpublished data, show that patients with gynecologic complaints specifically are the most likely to have resolution of symptoms, compared with those with more systemic or nongynecologic complaints.
Some patients have systemic symptoms that they feel are related and new since the device was placed. My counseling in these cases is that, while I do not have any physiologic evidence that the Essure coil is causing their symptoms, I’m hopeful that symptoms will improve with removal. If they do not, these patients must follow up with their primary care doctor for further work-up.
Device structure and use of imaging
Essure is a 4-cm long device (0.8 mm in diameter) with two parts: an inner coil made of stainless steel and PET fibers, the latter of which induces the fibrosis responsible for tubal occlusion, and an outer coil made of nitinol, a nickel titanium alloy.
Dr. Cohen: While the exact mechanism is unclear, it’s possible that the PET fibers may be drivers of the systemic inflammatory-type symptoms that some women report. Nickel allergies are also possible albeit uncommon. They appear to manifest as rash, urticaria, and other symptoms characteristic of contact allergic reactions.
The brittle nature of the outer coil makes a grasp-and-pull approach disadvantageous, unless you’re removing coils early on hysteroscopically. In general, one must avoid fracturing the outer coil, or parts of the device will be left behind. Pulling too hard may also cause the outer coil to unravel and expand to be quite long, which further increases the risk of fracture.
Hysterosalpingogram (HSG) and ultrasound are typically first-line options for looking at coil position. A diagnostic hysteroscopy may also help identify coils, and intraoperative fluoroscopy may be useful for either the hysteroscopic or laparoscopic approach, if there’s any question about portions of the device not being recovered.
Dr. Levie: Ultrasound is often sufficient for operative planning, but, if it does not detect devices in the cornual region, then further imaging may be warranted.
It’s important to be aware that some devices that appear to have correct placement on ultrasound or HSG may actually be partially tracking subserosally. In these cases, the distal portion of the device may have tracked through the mucosal layer and along the muscularis but below the serosa in the fallopian tube, causing pain. Imaging won’t be helpful in making this diagnosis. It will be identified laparoscopically.
Dr. Yunker: When patients have completed the 3-month HSG (to confirm occlusion of the Fallopian tubes post placement), I will review the images myself rather than relying on the report. Without an HSG – and, in many cases, even when I have it in hand – I will order a plain film x-ray of the abdomen and pelvis to look for coils. In almost all cases, I also order an ultrasound, which is helpful in assessing for ovarian and uterine conditions.
I’ve found plain film imaging to be valuable for identifying additional or misplaced Essure inserts. I have found up to four in one tube. In interpreting x-rays, one must appreciate that the outer coil is not radio-opaque (other than the tiny marker at the end) and will not show up. Occasionally we’ll add hysteroscopy to see how much of a coil is trailing into the uterus, but the ultrasound and x-ray are usually enough.
Some patients ask about postremoval imaging. I do not routinely do this, but I’m not opposed to it.
Surgical techniques
Dr. Cohen: I advise dissecting around each coil without cutting the outer portion and removing the coil intact, resecting all the way down to the interstitial portion of the tube, then proceeding with bilateral salpingectomy to ensure contraception.
If the patient’s symptoms are systemic and possibly reflective of PET fiber reactions, a wedge resection of the cornua may provide more peace of mind that PET fibers will not be left in situ. This procedure can be approached similarly to myomectomy, with the use of hemostatic agents such as misoprostol or vasopressin and suture closure in multiple layers.
If there are multiple coils present in the cavity, one option, to avoid having to pull them all out from the abdominal side, is to transect and remove the intracavity portion of the device hysteroscopically then dissect and remove the tubal/interstitial potion laparoscopically. As a general rule, I send all the removed tissue to pathology.
Dr. Levie: In general, I do a linear salpingostomy after using a uterine manipulator and a grasper to first identify the site of the distal portion of the device. One can usually feel where the tubes bend onto the device.
A bit proximal to where I visually and mentally mark the distal end of the device, I make a 2-3 cm incision over the device. With a fine-tip grasper, I can usually release the distal portion of the inner coil. Using two graspers over the inner and outer coils together and a hand-over-hand motion, I pull without excess traction in the access of the tubes, and the proximal portion will usually follow and deliver fairly simply. If the proximal portion breaks, I advise looking for it hysteroscopically and delivering it through the uterus.
Some surgeons have recommended hysteroscopy at the beginning of the procedure with cutting (using scissors) at the proximal end of the outer coil to avoid its getting caught in the cornua.
Most patients continue to want permanent sterilization, so we proceed with salpingectomy. Sometimes, given underlying pathologies, we’ll decide on laparoscopic or vaginal hysterectomy as well or bilateral salpingectomy without doing the salpingostomy. When hysterectomy is part of the surgery, we don’t need to worry at all about broken devices.
When the device is removed separately from the fallopian tube, one should inspect it afterward to ensure that all four markers of the device – the markers that are recommended by the manufacturer for radiologic confirmation of proper placement – have been delivered.
Dr. Yunker: When everything looks normal on the ultrasound – and when the coils on either HSG and/or plain film x-ray appear to be in the appropriate position in the tubes – then removal of the coils and tubes only is an option.
The closer the coil is to the fimbriae, the easier it is to come straight across the tube as you would in a regular salpingectomy without concern of breaking or cutting the coil. However, the closer the coil is the uterine side, the deeper you’ll need to dissect into the cornual region of the uterus. A cornual wedge resection may be necessary in order to remove the coil intact.
Our procedure has evolved over the years and we have moved away from salpingectomy as a means to dissect out the coils. With the theoretical risk of retained coil fragments and PET fibers, we prefer to remove the coils and tubes en bloc.
Dr. Cohen is director of research and the fellowship program director of minimally invasive gynecologic surgery at Brigham and Women’s Hospital, Boston. She reported that she has no financial disclosures. Dr. Levie is professor and associate chairman of the department of obstetrics and gynecology and women’s health and director of the minimally invasive surgery fellowship at Montefiore Medical Center, New York. Dr. Levie reported that he is an investigator in two studies involving Essure and sat on the Essure medical advisory board for Bayer but did not receive personal renumeration. Dr. Yunker is an assistant professor of obstetrics and gynecology at Vanderbilt University, Nashville. She reported that she is a consultant for Olympus.
So you want your Essure device removed ...
Despite recent negative lay press and a boxed safety warning from the Food and Drug Administration, Essure tubal microinserts continue to be a popular method of permanent contraception. It is imperative for patients to understand that this method of contraception cannot be reversed, and thereafter, the only method to achieve pregnancy would be via in vitro fertilization. Furthermore, preoperatively, patients must be counseled that placement of the Essure tubal microinserts may be associated with pelvic pain, abnormal bleeding, and even allergic reaction.
Even with our best effort to properly inform our patients as to the risks and benefits of permanent sterilization via Essure tubal microinserts, secondary to undesired side effects, patients desire their removal. This can be a challenging endeavor for the practitioner, especially if the women is not interested in hysterectomy.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago; director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column. He reported having no financial disclosures related to this column.
Despite recent negative lay press and a boxed safety warning from the Food and Drug Administration, Essure tubal microinserts continue to be a popular method of permanent contraception. It is imperative for patients to understand that this method of contraception cannot be reversed, and thereafter, the only method to achieve pregnancy would be via in vitro fertilization. Furthermore, preoperatively, patients must be counseled that placement of the Essure tubal microinserts may be associated with pelvic pain, abnormal bleeding, and even allergic reaction.
Even with our best effort to properly inform our patients as to the risks and benefits of permanent sterilization via Essure tubal microinserts, secondary to undesired side effects, patients desire their removal. This can be a challenging endeavor for the practitioner, especially if the women is not interested in hysterectomy.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago; director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column. He reported having no financial disclosures related to this column.
Despite recent negative lay press and a boxed safety warning from the Food and Drug Administration, Essure tubal microinserts continue to be a popular method of permanent contraception. It is imperative for patients to understand that this method of contraception cannot be reversed, and thereafter, the only method to achieve pregnancy would be via in vitro fertilization. Furthermore, preoperatively, patients must be counseled that placement of the Essure tubal microinserts may be associated with pelvic pain, abnormal bleeding, and even allergic reaction.
Even with our best effort to properly inform our patients as to the risks and benefits of permanent sterilization via Essure tubal microinserts, secondary to undesired side effects, patients desire their removal. This can be a challenging endeavor for the practitioner, especially if the women is not interested in hysterectomy.
Dr. Miller is clinical associate professor at the University of Illinois at Chicago and past president of the AAGL. He is a reproductive endocrinologist and minimally invasive gynecologic surgeon in metropolitan Chicago; director of minimally invasive gynecologic surgery at Advocate Lutheran General Hospital, Park Ridge, Ill.; and the medical editor of this column. He reported having no financial disclosures related to this column.
Evolving practice in perinatal psychopharmacology: Lessons learned
Over the last 2 decades, there has been a growing interest in establishing a rich evidence base for treatment of psychiatric illness in pregnancy and the postpartum period. It seems as if a week does not go by when we don’t find multiple publications in the scientific literature describing a new finding or confirmation or inconsistency with existing data – whether it is a small prospective cohort study or an elegant analysis of a large administrative database. The goals of these reports center on refining our knowledge of safe treatments for perinatal psychiatric disorders.
Despite these strides, my colleagues and I frequently see a divergence between recommendations in the literature and what is done clinically by those who treat women around reproductive associated psychiatric disturbance – premenstrual dysphoric disorder or psychiatric disorder during pregnancy and the postpartum period. In some cases, scientific evidence has not filtered into day to day practice and some physicians continue to follow practices that, while outdated, make intuitive sense. In other clinical situations, limited evidence is being applied too broadly or data are too sparse to clearly inform practice. Regardless of the reason, we frequently see patients in clinical situations in which we are forced to rethink the clinical rationale for advice they have received or the clinical path taken.
Here is a sample of the clinical scenarios in which we have seen inconsistencies between current practice and the best evidence in perinatal psychiatry or situations in which data are too sparse to inform the clearest clinical path.
1. Discontinuation of antidepressants proximate to conception
Despite multiple studies supporting the high risk for relapse of major depression in women on maintenance antidepressant therapy with a history of recurrent depressive illness, it is still quite common for clinicians to routinely advise women to stop antidepressants while planning a pregnancy or after documentation of a pregnancy, regardless of the severity of the underlying illness. This runs counter to data showing high rates of relapse in women who stop antidepressants proximate to conception, the safety of antidepressants in pregnancy, and the harm to the mother and fetus when depression during pregnancy is untreated.
2. Use of a lower dose of antidepressants during pregnancy
It makes intuitive sense to use the smallest dose of medicine like antidepressant during pregnancy. However, multiple studies show that, at least in nonpregnant patients, the dose that gets patients well is typically the dose that keeps them well. One of the quickest paths to relapse in depression is a reduction in the antidepressant dose after someone has gotten well. This is even more relevant in pregnant patients because pregnancy itself dilutes the plasma level of the antidepressant given the rapidly expanding plasma volume seen in pregnancy. One can debate whether clinicians should empirically increase the dose of antidepressant during pregnancy to sustain plasma level of medication, but lowering the dose of this medication proximate or during pregnancy makes little sense.
3. A switch to sertraline in pregnancy/post partum
Another scenario that my colleagues and I often see is a pregnant patient whose depression was previously well controlled with a particular antidepressant, but whose physician, once she decides to conceive or becomes pregnant, switched her to sertraline.
The idea, which has been around for a long time, is that sertraline is the safest antidepressant for pregnant women because it has robust reproductive safety data and has particularly modest amounts of medication (if detected at all) in the plasma of infants of mothers who breastfeed while using the medicine. While we certainly have more safety data on SSRIs that were manufactured earlier, as compared with antidepressants that became available later, we have now accumulated data that fails to demonstrate a clear signal for teratogenicity across many antidepressants manufactured over the last 2 decades. Identifying an antidepressant for a given patient to which she will respond can be a challenging course for the patient. Achieving euthymia and subsequently switching to sertraline or another medication may only put her at risk for recurrence of depression and its attendant morbidity.
4. A change to a Category B label drug
This is another example of switching a patient to a potentially less effective drug in a somewhat misguided effort at finding a treatment that is safer in pregnancy. While the Food and Drug Administration’s drug category label system was a step forward, or at least a well intentioned effort to give women and their clinicians clearer insight into the reproductive safety of a medication, ultimately, the incomplete nature of the information caused the agency to transition to a new system (see the Pregnancy Labeling and Lactation Rule). Switching a woman to a category B medicine with sparse reproductive safety data instead of a category C medicine, which may not be unsafe but has raised some concerns in animal models, is not a better choice. The new labeling system is a step forward.
5. Discontinuation of lithium during pregnancy
Like discontinuation of antidepressants, the discontinuation of lithium during attempts to conceive in a woman whose illness has been well controlled, is associated with a high risk of relapse. In earlier work, it was sometimes recommended that discontinuation of lithium be considered after a long period of wellness. We have learned over time that this can be a risky move. Even women with a remote history of bipolar disorder appear to be at high risk of relapse when a mood stabilizer is stopped. Exquisite response to medicine does not imply less severe illness. Women who have bipolar disorder who have sustained euthymia on lithium should consider maintaining the safest possible regimen before, during, and after pregnancy despite the known small teratogenic risk associated with fetal exposure to this agent.
6. Try supplements or alternative therapies
Out of a desire to avoid any medication with incomplete reproductive safety data, some women and clinicians make the intuitive leap that “alternative treatments” can mitigate relapse in pregnancy, and they stop pharmacological treatments and switch to supplements or alternative therapies, including acupuncture, massage, or light therapy. Unfortunately, data supporting this clinical maneuver are sparse. Frequently, we see women with past histories of severe depression who have stopped antidepressants and who have started supplements as a substitute and who then relapse. Then, they try to restore euthymia with antidepressants and psychotherapy, and the road to restoration of well-being can be long.
Data on efficacy of alternative therapies continues to evolve and is an exciting and important area of research. However, where these treatments are best employed in the algorithm for treating depression in pregnancy, or at other times, has yet to be adequately defined.
7. Stop breastfeeding or defer antidepressant treatment
Many women continue to be counseled to either stop breastfeeding while using antidepressants or to defer treatment with antidepressants if they wish to breastfeed. Not uncommonly, we see women who are suffering from postpartum depression and who are engaged in psychotherapy but who have deferred treatment with antidepressants despite residual depressive symptoms that impair functioning. Clinicians should keep in mind that data supporting evidence of toxicity in newborns of women using antidepressants while breastfeeding are extremely sparse. Unfortunately, some women with postpartum depression are deferring treatment because they were counseled that it is not compatible with their desire to breastfeed.
8. Use of non-benzodiazepine sedative-hypnotics
Insomnia is a common problem in pregnancy, especially when coupled with comorbid anxiety, and, increasingly, it is being treated with non-benzodiazepine sedative-hypnotics. Clinicians should keep in mind that a known small risk may be better than an unknown risk. If a pregnant woman has severe insomnia, she may benefit from a low dose of a benzodiazepine, such as lorazepam or clonazepam, as opposed to a medication such as zolpidem for which reproductive safety data are particularly limited.
9. Pumping and dumping breast milk
Many women are advised to set an alarm to “pump and dump” their breast milk to minimize their baby’s exposure to antidepressants during breastfeeding. Early literature to pump and dump breast milk at peak antidepressant concentration was of great analytic and theoretical interest but has scant clinical application. As an author of many of those early publications, I can say that we never intended for women to sacrifice precious sleep to dump breast milk with the idea that limiting exposure to trace amounts of antidepressants would have beneficial effects over the long term.
10. Failure to bring up contraception use
We continue to see a 50% unplanned pregnancy rate across sociodemographic groups in the United States. This is a critical statistic because it may affect how treatment is managed. Bringing up the topic of reliable contraception prior to pregnancy allows for planned pregnancy and affords us the time to discuss treatment options and the ability to plot a more thoughtful and safe clinical course. However, often, contraception is not discussed.
One of our goals as clinicians is to, first, do no harm and that continues to be a challenge because the data in perinatal psychiatry is still inconsistent in some areas and there are evidence gaps in others. Nevertheless, our task is to take the best available data along with the patient’s wishes and knowledge of her past clinical history and to then translate that into the best care for the individual.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.
Over the last 2 decades, there has been a growing interest in establishing a rich evidence base for treatment of psychiatric illness in pregnancy and the postpartum period. It seems as if a week does not go by when we don’t find multiple publications in the scientific literature describing a new finding or confirmation or inconsistency with existing data – whether it is a small prospective cohort study or an elegant analysis of a large administrative database. The goals of these reports center on refining our knowledge of safe treatments for perinatal psychiatric disorders.
Despite these strides, my colleagues and I frequently see a divergence between recommendations in the literature and what is done clinically by those who treat women around reproductive associated psychiatric disturbance – premenstrual dysphoric disorder or psychiatric disorder during pregnancy and the postpartum period. In some cases, scientific evidence has not filtered into day to day practice and some physicians continue to follow practices that, while outdated, make intuitive sense. In other clinical situations, limited evidence is being applied too broadly or data are too sparse to clearly inform practice. Regardless of the reason, we frequently see patients in clinical situations in which we are forced to rethink the clinical rationale for advice they have received or the clinical path taken.
Here is a sample of the clinical scenarios in which we have seen inconsistencies between current practice and the best evidence in perinatal psychiatry or situations in which data are too sparse to inform the clearest clinical path.
1. Discontinuation of antidepressants proximate to conception
Despite multiple studies supporting the high risk for relapse of major depression in women on maintenance antidepressant therapy with a history of recurrent depressive illness, it is still quite common for clinicians to routinely advise women to stop antidepressants while planning a pregnancy or after documentation of a pregnancy, regardless of the severity of the underlying illness. This runs counter to data showing high rates of relapse in women who stop antidepressants proximate to conception, the safety of antidepressants in pregnancy, and the harm to the mother and fetus when depression during pregnancy is untreated.
2. Use of a lower dose of antidepressants during pregnancy
It makes intuitive sense to use the smallest dose of medicine like antidepressant during pregnancy. However, multiple studies show that, at least in nonpregnant patients, the dose that gets patients well is typically the dose that keeps them well. One of the quickest paths to relapse in depression is a reduction in the antidepressant dose after someone has gotten well. This is even more relevant in pregnant patients because pregnancy itself dilutes the plasma level of the antidepressant given the rapidly expanding plasma volume seen in pregnancy. One can debate whether clinicians should empirically increase the dose of antidepressant during pregnancy to sustain plasma level of medication, but lowering the dose of this medication proximate or during pregnancy makes little sense.
3. A switch to sertraline in pregnancy/post partum
Another scenario that my colleagues and I often see is a pregnant patient whose depression was previously well controlled with a particular antidepressant, but whose physician, once she decides to conceive or becomes pregnant, switched her to sertraline.
The idea, which has been around for a long time, is that sertraline is the safest antidepressant for pregnant women because it has robust reproductive safety data and has particularly modest amounts of medication (if detected at all) in the plasma of infants of mothers who breastfeed while using the medicine. While we certainly have more safety data on SSRIs that were manufactured earlier, as compared with antidepressants that became available later, we have now accumulated data that fails to demonstrate a clear signal for teratogenicity across many antidepressants manufactured over the last 2 decades. Identifying an antidepressant for a given patient to which she will respond can be a challenging course for the patient. Achieving euthymia and subsequently switching to sertraline or another medication may only put her at risk for recurrence of depression and its attendant morbidity.
4. A change to a Category B label drug
This is another example of switching a patient to a potentially less effective drug in a somewhat misguided effort at finding a treatment that is safer in pregnancy. While the Food and Drug Administration’s drug category label system was a step forward, or at least a well intentioned effort to give women and their clinicians clearer insight into the reproductive safety of a medication, ultimately, the incomplete nature of the information caused the agency to transition to a new system (see the Pregnancy Labeling and Lactation Rule). Switching a woman to a category B medicine with sparse reproductive safety data instead of a category C medicine, which may not be unsafe but has raised some concerns in animal models, is not a better choice. The new labeling system is a step forward.
5. Discontinuation of lithium during pregnancy
Like discontinuation of antidepressants, the discontinuation of lithium during attempts to conceive in a woman whose illness has been well controlled, is associated with a high risk of relapse. In earlier work, it was sometimes recommended that discontinuation of lithium be considered after a long period of wellness. We have learned over time that this can be a risky move. Even women with a remote history of bipolar disorder appear to be at high risk of relapse when a mood stabilizer is stopped. Exquisite response to medicine does not imply less severe illness. Women who have bipolar disorder who have sustained euthymia on lithium should consider maintaining the safest possible regimen before, during, and after pregnancy despite the known small teratogenic risk associated with fetal exposure to this agent.
6. Try supplements or alternative therapies
Out of a desire to avoid any medication with incomplete reproductive safety data, some women and clinicians make the intuitive leap that “alternative treatments” can mitigate relapse in pregnancy, and they stop pharmacological treatments and switch to supplements or alternative therapies, including acupuncture, massage, or light therapy. Unfortunately, data supporting this clinical maneuver are sparse. Frequently, we see women with past histories of severe depression who have stopped antidepressants and who have started supplements as a substitute and who then relapse. Then, they try to restore euthymia with antidepressants and psychotherapy, and the road to restoration of well-being can be long.
Data on efficacy of alternative therapies continues to evolve and is an exciting and important area of research. However, where these treatments are best employed in the algorithm for treating depression in pregnancy, or at other times, has yet to be adequately defined.
7. Stop breastfeeding or defer antidepressant treatment
Many women continue to be counseled to either stop breastfeeding while using antidepressants or to defer treatment with antidepressants if they wish to breastfeed. Not uncommonly, we see women who are suffering from postpartum depression and who are engaged in psychotherapy but who have deferred treatment with antidepressants despite residual depressive symptoms that impair functioning. Clinicians should keep in mind that data supporting evidence of toxicity in newborns of women using antidepressants while breastfeeding are extremely sparse. Unfortunately, some women with postpartum depression are deferring treatment because they were counseled that it is not compatible with their desire to breastfeed.
8. Use of non-benzodiazepine sedative-hypnotics
Insomnia is a common problem in pregnancy, especially when coupled with comorbid anxiety, and, increasingly, it is being treated with non-benzodiazepine sedative-hypnotics. Clinicians should keep in mind that a known small risk may be better than an unknown risk. If a pregnant woman has severe insomnia, she may benefit from a low dose of a benzodiazepine, such as lorazepam or clonazepam, as opposed to a medication such as zolpidem for which reproductive safety data are particularly limited.
9. Pumping and dumping breast milk
Many women are advised to set an alarm to “pump and dump” their breast milk to minimize their baby’s exposure to antidepressants during breastfeeding. Early literature to pump and dump breast milk at peak antidepressant concentration was of great analytic and theoretical interest but has scant clinical application. As an author of many of those early publications, I can say that we never intended for women to sacrifice precious sleep to dump breast milk with the idea that limiting exposure to trace amounts of antidepressants would have beneficial effects over the long term.
10. Failure to bring up contraception use
We continue to see a 50% unplanned pregnancy rate across sociodemographic groups in the United States. This is a critical statistic because it may affect how treatment is managed. Bringing up the topic of reliable contraception prior to pregnancy allows for planned pregnancy and affords us the time to discuss treatment options and the ability to plot a more thoughtful and safe clinical course. However, often, contraception is not discussed.
One of our goals as clinicians is to, first, do no harm and that continues to be a challenge because the data in perinatal psychiatry is still inconsistent in some areas and there are evidence gaps in others. Nevertheless, our task is to take the best available data along with the patient’s wishes and knowledge of her past clinical history and to then translate that into the best care for the individual.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.
Over the last 2 decades, there has been a growing interest in establishing a rich evidence base for treatment of psychiatric illness in pregnancy and the postpartum period. It seems as if a week does not go by when we don’t find multiple publications in the scientific literature describing a new finding or confirmation or inconsistency with existing data – whether it is a small prospective cohort study or an elegant analysis of a large administrative database. The goals of these reports center on refining our knowledge of safe treatments for perinatal psychiatric disorders.
Despite these strides, my colleagues and I frequently see a divergence between recommendations in the literature and what is done clinically by those who treat women around reproductive associated psychiatric disturbance – premenstrual dysphoric disorder or psychiatric disorder during pregnancy and the postpartum period. In some cases, scientific evidence has not filtered into day to day practice and some physicians continue to follow practices that, while outdated, make intuitive sense. In other clinical situations, limited evidence is being applied too broadly or data are too sparse to clearly inform practice. Regardless of the reason, we frequently see patients in clinical situations in which we are forced to rethink the clinical rationale for advice they have received or the clinical path taken.
Here is a sample of the clinical scenarios in which we have seen inconsistencies between current practice and the best evidence in perinatal psychiatry or situations in which data are too sparse to inform the clearest clinical path.
1. Discontinuation of antidepressants proximate to conception
Despite multiple studies supporting the high risk for relapse of major depression in women on maintenance antidepressant therapy with a history of recurrent depressive illness, it is still quite common for clinicians to routinely advise women to stop antidepressants while planning a pregnancy or after documentation of a pregnancy, regardless of the severity of the underlying illness. This runs counter to data showing high rates of relapse in women who stop antidepressants proximate to conception, the safety of antidepressants in pregnancy, and the harm to the mother and fetus when depression during pregnancy is untreated.
2. Use of a lower dose of antidepressants during pregnancy
It makes intuitive sense to use the smallest dose of medicine like antidepressant during pregnancy. However, multiple studies show that, at least in nonpregnant patients, the dose that gets patients well is typically the dose that keeps them well. One of the quickest paths to relapse in depression is a reduction in the antidepressant dose after someone has gotten well. This is even more relevant in pregnant patients because pregnancy itself dilutes the plasma level of the antidepressant given the rapidly expanding plasma volume seen in pregnancy. One can debate whether clinicians should empirically increase the dose of antidepressant during pregnancy to sustain plasma level of medication, but lowering the dose of this medication proximate or during pregnancy makes little sense.
3. A switch to sertraline in pregnancy/post partum
Another scenario that my colleagues and I often see is a pregnant patient whose depression was previously well controlled with a particular antidepressant, but whose physician, once she decides to conceive or becomes pregnant, switched her to sertraline.
The idea, which has been around for a long time, is that sertraline is the safest antidepressant for pregnant women because it has robust reproductive safety data and has particularly modest amounts of medication (if detected at all) in the plasma of infants of mothers who breastfeed while using the medicine. While we certainly have more safety data on SSRIs that were manufactured earlier, as compared with antidepressants that became available later, we have now accumulated data that fails to demonstrate a clear signal for teratogenicity across many antidepressants manufactured over the last 2 decades. Identifying an antidepressant for a given patient to which she will respond can be a challenging course for the patient. Achieving euthymia and subsequently switching to sertraline or another medication may only put her at risk for recurrence of depression and its attendant morbidity.
4. A change to a Category B label drug
This is another example of switching a patient to a potentially less effective drug in a somewhat misguided effort at finding a treatment that is safer in pregnancy. While the Food and Drug Administration’s drug category label system was a step forward, or at least a well intentioned effort to give women and their clinicians clearer insight into the reproductive safety of a medication, ultimately, the incomplete nature of the information caused the agency to transition to a new system (see the Pregnancy Labeling and Lactation Rule). Switching a woman to a category B medicine with sparse reproductive safety data instead of a category C medicine, which may not be unsafe but has raised some concerns in animal models, is not a better choice. The new labeling system is a step forward.
5. Discontinuation of lithium during pregnancy
Like discontinuation of antidepressants, the discontinuation of lithium during attempts to conceive in a woman whose illness has been well controlled, is associated with a high risk of relapse. In earlier work, it was sometimes recommended that discontinuation of lithium be considered after a long period of wellness. We have learned over time that this can be a risky move. Even women with a remote history of bipolar disorder appear to be at high risk of relapse when a mood stabilizer is stopped. Exquisite response to medicine does not imply less severe illness. Women who have bipolar disorder who have sustained euthymia on lithium should consider maintaining the safest possible regimen before, during, and after pregnancy despite the known small teratogenic risk associated with fetal exposure to this agent.
6. Try supplements or alternative therapies
Out of a desire to avoid any medication with incomplete reproductive safety data, some women and clinicians make the intuitive leap that “alternative treatments” can mitigate relapse in pregnancy, and they stop pharmacological treatments and switch to supplements or alternative therapies, including acupuncture, massage, or light therapy. Unfortunately, data supporting this clinical maneuver are sparse. Frequently, we see women with past histories of severe depression who have stopped antidepressants and who have started supplements as a substitute and who then relapse. Then, they try to restore euthymia with antidepressants and psychotherapy, and the road to restoration of well-being can be long.
Data on efficacy of alternative therapies continues to evolve and is an exciting and important area of research. However, where these treatments are best employed in the algorithm for treating depression in pregnancy, or at other times, has yet to be adequately defined.
7. Stop breastfeeding or defer antidepressant treatment
Many women continue to be counseled to either stop breastfeeding while using antidepressants or to defer treatment with antidepressants if they wish to breastfeed. Not uncommonly, we see women who are suffering from postpartum depression and who are engaged in psychotherapy but who have deferred treatment with antidepressants despite residual depressive symptoms that impair functioning. Clinicians should keep in mind that data supporting evidence of toxicity in newborns of women using antidepressants while breastfeeding are extremely sparse. Unfortunately, some women with postpartum depression are deferring treatment because they were counseled that it is not compatible with their desire to breastfeed.
8. Use of non-benzodiazepine sedative-hypnotics
Insomnia is a common problem in pregnancy, especially when coupled with comorbid anxiety, and, increasingly, it is being treated with non-benzodiazepine sedative-hypnotics. Clinicians should keep in mind that a known small risk may be better than an unknown risk. If a pregnant woman has severe insomnia, she may benefit from a low dose of a benzodiazepine, such as lorazepam or clonazepam, as opposed to a medication such as zolpidem for which reproductive safety data are particularly limited.
9. Pumping and dumping breast milk
Many women are advised to set an alarm to “pump and dump” their breast milk to minimize their baby’s exposure to antidepressants during breastfeeding. Early literature to pump and dump breast milk at peak antidepressant concentration was of great analytic and theoretical interest but has scant clinical application. As an author of many of those early publications, I can say that we never intended for women to sacrifice precious sleep to dump breast milk with the idea that limiting exposure to trace amounts of antidepressants would have beneficial effects over the long term.
10. Failure to bring up contraception use
We continue to see a 50% unplanned pregnancy rate across sociodemographic groups in the United States. This is a critical statistic because it may affect how treatment is managed. Bringing up the topic of reliable contraception prior to pregnancy allows for planned pregnancy and affords us the time to discuss treatment options and the ability to plot a more thoughtful and safe clinical course. However, often, contraception is not discussed.
One of our goals as clinicians is to, first, do no harm and that continues to be a challenge because the data in perinatal psychiatry is still inconsistent in some areas and there are evidence gaps in others. Nevertheless, our task is to take the best available data along with the patient’s wishes and knowledge of her past clinical history and to then translate that into the best care for the individual.
Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications.
Understanding the human papillomavirus
Human papillomavirus (HPV) is the most prevalent sexually transmitted disease globally. It is causally related to the development of several malignancies, including cervical, anal, and oropharyngeal ones, because of its integration and dysregulation of the genome of infected cells. Fortunately, vaccination is available to prevent development of HPV-related diseases. Understanding this virus, its carcinogenic role, and the importance of prevention through vaccination are critically important for ob.gyns. This column reviews the fundamentals of HPV biology, epidemiology, and carcinogenesis.
Viral anatomy
HPV are members of the A genus of the family Papovaviridae. They contain between 7,800 and 7,900 base pairs. They are nonenveloped, double-stranded DNA viruses with a circular structure. The viral DNA is contained within an icosahedral capsid that measures 45 nm-55 nm. The HPV genome has three critical regions: the long control region, otherwise known as the upstream regulatory region; the early region; and the late region.1
Capsid proteins are similar between groups. Therefore, HPV are categorized into “types” and “subtypes” based on the extent of DNA similarity. There are more than 100 types of HPV in humans.2 The type of HPV is determined by the gene sequences of E6/E7 and L1 and must show more than 10% difference between types. The gene sequences between different subtypes differ by 2%-5%.
Epidemiology of HPV infection
HPV are widely distributed among mammalian species but are species specific. Their tissue affinity varies by type. HPV types 1, 2, and 4 cause common or plantar warts. HPV types 6 and 11 cause condyloma acuminata (genital warts) and low grade dysplasia. HPV types 16 and 18 – in addition to 31 and 52 – are of particular interest to oncologists because they are associated with lower genital tract high grade dysplasia and invasive carcinoma. Infection with HPV 16 is present in about half of invasive cervical cancers, with HPV type 18 present in 20% of cervical cancers. Adenocarcinomas of the cervix are more commonly associated with HPV 18. Anal cancer and oropharyngeal cancer are more commonly associated with HPV 16.3
HPV infections are acquired through cutaneous touching (including hand to genital) and HPV positivity is most commonly present within the first 10 years after sexual debut.4 However, most individuals who acquire HPV do so as a transient infection, which is cleared without sequelae. Those who fail to rapidly clear HPV infection, and in whom it becomes chronic, face an increasing risk of development of dysplasia and invasive carcinoma. The incidence of HPV infection increases again at menopause, but, for these older women, the new finding of HPV detection may be related to reactivation of an earlier infection rather than exclusively new exposure to the virus.5
Diagnosis and testing
HPV infection can be detected through DNA testing, RNA testing, and cellular markers.6
HPV DNA testing was the original form of testing offered. It improved the sensitivity over cytology alone in the detection of precursors to malignancy but had relatively poor specificity, resulting in a high false positive rate and unnecessary referral to colposcopy. The various tests approved by the Food and Drug Administration – Hybrid Capture 2 (HC2), Cervista, and Cobas 4800 – differ in the number and nature of HPV types that they detect.
HPV RNA testing has developed and involves measuring the expression of E6 and E7 RNA. This testing is FDA approved and has the potential to improve upon the specificity of DNA testing procedures by decreasing false positives.
Measurement of cellular markers is currently considered experimental/exploratory and is not yet FDA approved for diagnostic purposes in screening or confirmation of HPV infection or coexisting dysplasia. It involves measuring the downstream cellular targets (such as p16) of E6 or E7 activity.
The mechanism of carcinogenesis
The early region of the HPV genome is downstream from the upstream regulatory region. It codes for proteins involved in viral infection and replication. The two most important genes in the early region are E6 and E7. When integrated into the human genome of the lower genital tract cell, the viral genes E6 and E7 negatively interfere with cell cycle control and mechanisms to halt dysregulation.7
E6 and E7 are considered oncogenes because they cause loss of function of the critical tumor suppressor proteins p53 and the retinoblastoma protein. The p53 protein is typically responsible for controlling cell cycling through the G0/G1 to S phases. It involves stalling cellular mitosis in order to facilitate DNA repair mechanisms in the case of damaged cells, thereby preventing replication of DNA aberrations. The retinoblastoma protein also functions to inhibit cells that have acquired DNA damage from cycling and induces apoptosis in DNA damaged cells. When protein products of E6 and E7 negatively interact with these two tumor suppressor proteins they overcome the cell’s safeguard arrest response.
In the presence of other carcinogens, such as products of tobacco exposure, the increased DNA damage sustained by the genital tract cell is allowed to go relatively unchecked by the HPV coinfection, which has disabled tumor suppressor function. This facilitates immortality of the damaged cell, amplification of additional DNA mutations, and unchecked cellular growth and dysplastic transformation. E6 and E7 are strongly expressed in invasive genital tract lesions to support its important role in carcinogenesis.
HIV coinfection is another factor that promotes carcinogenesis following HPV infection because it inhibits clearance of the virus through T-cell mediated immunosuppression and directly enhances expression of E6 and E7 proteins in the HIV and HPV coinfected cell.8 For these reasons, HIV-positive women are less likely to clear HPV infection and more likely to develop high grade dysplasia or invasive carcinomas.
Prevention and vaccination
HPV vaccinations utilize virus-like particles (VLPs). These VLPs are capsid particles generated from the L1 region of the HPV DNA. The capsid proteins coded for by L1 are highly immunogenic. VLPs are recombinant proteins created in benign biologic systems (such as yeast) and contain no inner DNA core (effectively empty viral capsids) and therefore are not infectious. The L1 gene is incorporated into a plasmid, which is inserted into the nucleus of a eukaryotic cell. Transcription and translation of the L1 gene takes place, creating capsid proteins that self-assemble into VLPs. These VLPs are retrieved and inoculated into candidate patients to illicit an immune response.
Quadrivalent, nine-valent, and bivalent vaccines are available worldwide. However, only the nine-valent vaccine – protective against types 6, 11, 16, 18, 31, 33, 45, 52, and 58 – is available in the United States. This theoretically provides more comprehensive coverage against cervical cancer–causing HPV types, as 70% of cervical cancer is attributable to HPV 16 and 18, but an additional 20% is attributable to HPV 31, 33, 45, 52, and 58. This vaccine also provides protection against the HPV strains that cause genital warts and low-grade dysplastic changes.9
HPV, in most instances, is a transient virus with no sequelae. However, if not cleared from the cells of the lower genital tract, anus, or oropharynx it can result in the breakdown of cellular correction strategies and culminate in invasive carcinoma. Fortunately, highly effective and safe vaccinations are available and should be broadly prescribed.
Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.
References
1. Cancer Epidemiol Biomarkers Prev. 1995 Jun;4(4):415-28.
2. Gynecol Oncol. 2011 Apr;121(1):32-42.
3. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1611-22.
4. JAMA. 2007 Feb 28;297(8):813-9.
5. J Infect Dis. 2013; 207(2): 272-80.
6. J Natl Cancer Inst. 2011 Mar 2;103(5):368-83.
7. J Natl Cancer Inst. 2000 May 3;92(9):690-8.
8. Lancet. 2002 Jan 12;359(9301):108-13.
9. Obstet Gynecol 2017;129:e173–8.
Human papillomavirus (HPV) is the most prevalent sexually transmitted disease globally. It is causally related to the development of several malignancies, including cervical, anal, and oropharyngeal ones, because of its integration and dysregulation of the genome of infected cells. Fortunately, vaccination is available to prevent development of HPV-related diseases. Understanding this virus, its carcinogenic role, and the importance of prevention through vaccination are critically important for ob.gyns. This column reviews the fundamentals of HPV biology, epidemiology, and carcinogenesis.
Viral anatomy
HPV are members of the A genus of the family Papovaviridae. They contain between 7,800 and 7,900 base pairs. They are nonenveloped, double-stranded DNA viruses with a circular structure. The viral DNA is contained within an icosahedral capsid that measures 45 nm-55 nm. The HPV genome has three critical regions: the long control region, otherwise known as the upstream regulatory region; the early region; and the late region.1
Capsid proteins are similar between groups. Therefore, HPV are categorized into “types” and “subtypes” based on the extent of DNA similarity. There are more than 100 types of HPV in humans.2 The type of HPV is determined by the gene sequences of E6/E7 and L1 and must show more than 10% difference between types. The gene sequences between different subtypes differ by 2%-5%.
Epidemiology of HPV infection
HPV are widely distributed among mammalian species but are species specific. Their tissue affinity varies by type. HPV types 1, 2, and 4 cause common or plantar warts. HPV types 6 and 11 cause condyloma acuminata (genital warts) and low grade dysplasia. HPV types 16 and 18 – in addition to 31 and 52 – are of particular interest to oncologists because they are associated with lower genital tract high grade dysplasia and invasive carcinoma. Infection with HPV 16 is present in about half of invasive cervical cancers, with HPV type 18 present in 20% of cervical cancers. Adenocarcinomas of the cervix are more commonly associated with HPV 18. Anal cancer and oropharyngeal cancer are more commonly associated with HPV 16.3
HPV infections are acquired through cutaneous touching (including hand to genital) and HPV positivity is most commonly present within the first 10 years after sexual debut.4 However, most individuals who acquire HPV do so as a transient infection, which is cleared without sequelae. Those who fail to rapidly clear HPV infection, and in whom it becomes chronic, face an increasing risk of development of dysplasia and invasive carcinoma. The incidence of HPV infection increases again at menopause, but, for these older women, the new finding of HPV detection may be related to reactivation of an earlier infection rather than exclusively new exposure to the virus.5
Diagnosis and testing
HPV infection can be detected through DNA testing, RNA testing, and cellular markers.6
HPV DNA testing was the original form of testing offered. It improved the sensitivity over cytology alone in the detection of precursors to malignancy but had relatively poor specificity, resulting in a high false positive rate and unnecessary referral to colposcopy. The various tests approved by the Food and Drug Administration – Hybrid Capture 2 (HC2), Cervista, and Cobas 4800 – differ in the number and nature of HPV types that they detect.
HPV RNA testing has developed and involves measuring the expression of E6 and E7 RNA. This testing is FDA approved and has the potential to improve upon the specificity of DNA testing procedures by decreasing false positives.
Measurement of cellular markers is currently considered experimental/exploratory and is not yet FDA approved for diagnostic purposes in screening or confirmation of HPV infection or coexisting dysplasia. It involves measuring the downstream cellular targets (such as p16) of E6 or E7 activity.
The mechanism of carcinogenesis
The early region of the HPV genome is downstream from the upstream regulatory region. It codes for proteins involved in viral infection and replication. The two most important genes in the early region are E6 and E7. When integrated into the human genome of the lower genital tract cell, the viral genes E6 and E7 negatively interfere with cell cycle control and mechanisms to halt dysregulation.7
E6 and E7 are considered oncogenes because they cause loss of function of the critical tumor suppressor proteins p53 and the retinoblastoma protein. The p53 protein is typically responsible for controlling cell cycling through the G0/G1 to S phases. It involves stalling cellular mitosis in order to facilitate DNA repair mechanisms in the case of damaged cells, thereby preventing replication of DNA aberrations. The retinoblastoma protein also functions to inhibit cells that have acquired DNA damage from cycling and induces apoptosis in DNA damaged cells. When protein products of E6 and E7 negatively interact with these two tumor suppressor proteins they overcome the cell’s safeguard arrest response.
In the presence of other carcinogens, such as products of tobacco exposure, the increased DNA damage sustained by the genital tract cell is allowed to go relatively unchecked by the HPV coinfection, which has disabled tumor suppressor function. This facilitates immortality of the damaged cell, amplification of additional DNA mutations, and unchecked cellular growth and dysplastic transformation. E6 and E7 are strongly expressed in invasive genital tract lesions to support its important role in carcinogenesis.
HIV coinfection is another factor that promotes carcinogenesis following HPV infection because it inhibits clearance of the virus through T-cell mediated immunosuppression and directly enhances expression of E6 and E7 proteins in the HIV and HPV coinfected cell.8 For these reasons, HIV-positive women are less likely to clear HPV infection and more likely to develop high grade dysplasia or invasive carcinomas.
Prevention and vaccination
HPV vaccinations utilize virus-like particles (VLPs). These VLPs are capsid particles generated from the L1 region of the HPV DNA. The capsid proteins coded for by L1 are highly immunogenic. VLPs are recombinant proteins created in benign biologic systems (such as yeast) and contain no inner DNA core (effectively empty viral capsids) and therefore are not infectious. The L1 gene is incorporated into a plasmid, which is inserted into the nucleus of a eukaryotic cell. Transcription and translation of the L1 gene takes place, creating capsid proteins that self-assemble into VLPs. These VLPs are retrieved and inoculated into candidate patients to illicit an immune response.
Quadrivalent, nine-valent, and bivalent vaccines are available worldwide. However, only the nine-valent vaccine – protective against types 6, 11, 16, 18, 31, 33, 45, 52, and 58 – is available in the United States. This theoretically provides more comprehensive coverage against cervical cancer–causing HPV types, as 70% of cervical cancer is attributable to HPV 16 and 18, but an additional 20% is attributable to HPV 31, 33, 45, 52, and 58. This vaccine also provides protection against the HPV strains that cause genital warts and low-grade dysplastic changes.9
HPV, in most instances, is a transient virus with no sequelae. However, if not cleared from the cells of the lower genital tract, anus, or oropharynx it can result in the breakdown of cellular correction strategies and culminate in invasive carcinoma. Fortunately, highly effective and safe vaccinations are available and should be broadly prescribed.
Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.
References
1. Cancer Epidemiol Biomarkers Prev. 1995 Jun;4(4):415-28.
2. Gynecol Oncol. 2011 Apr;121(1):32-42.
3. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1611-22.
4. JAMA. 2007 Feb 28;297(8):813-9.
5. J Infect Dis. 2013; 207(2): 272-80.
6. J Natl Cancer Inst. 2011 Mar 2;103(5):368-83.
7. J Natl Cancer Inst. 2000 May 3;92(9):690-8.
8. Lancet. 2002 Jan 12;359(9301):108-13.
9. Obstet Gynecol 2017;129:e173–8.
Human papillomavirus (HPV) is the most prevalent sexually transmitted disease globally. It is causally related to the development of several malignancies, including cervical, anal, and oropharyngeal ones, because of its integration and dysregulation of the genome of infected cells. Fortunately, vaccination is available to prevent development of HPV-related diseases. Understanding this virus, its carcinogenic role, and the importance of prevention through vaccination are critically important for ob.gyns. This column reviews the fundamentals of HPV biology, epidemiology, and carcinogenesis.
Viral anatomy
HPV are members of the A genus of the family Papovaviridae. They contain between 7,800 and 7,900 base pairs. They are nonenveloped, double-stranded DNA viruses with a circular structure. The viral DNA is contained within an icosahedral capsid that measures 45 nm-55 nm. The HPV genome has three critical regions: the long control region, otherwise known as the upstream regulatory region; the early region; and the late region.1
Capsid proteins are similar between groups. Therefore, HPV are categorized into “types” and “subtypes” based on the extent of DNA similarity. There are more than 100 types of HPV in humans.2 The type of HPV is determined by the gene sequences of E6/E7 and L1 and must show more than 10% difference between types. The gene sequences between different subtypes differ by 2%-5%.
Epidemiology of HPV infection
HPV are widely distributed among mammalian species but are species specific. Their tissue affinity varies by type. HPV types 1, 2, and 4 cause common or plantar warts. HPV types 6 and 11 cause condyloma acuminata (genital warts) and low grade dysplasia. HPV types 16 and 18 – in addition to 31 and 52 – are of particular interest to oncologists because they are associated with lower genital tract high grade dysplasia and invasive carcinoma. Infection with HPV 16 is present in about half of invasive cervical cancers, with HPV type 18 present in 20% of cervical cancers. Adenocarcinomas of the cervix are more commonly associated with HPV 18. Anal cancer and oropharyngeal cancer are more commonly associated with HPV 16.3
HPV infections are acquired through cutaneous touching (including hand to genital) and HPV positivity is most commonly present within the first 10 years after sexual debut.4 However, most individuals who acquire HPV do so as a transient infection, which is cleared without sequelae. Those who fail to rapidly clear HPV infection, and in whom it becomes chronic, face an increasing risk of development of dysplasia and invasive carcinoma. The incidence of HPV infection increases again at menopause, but, for these older women, the new finding of HPV detection may be related to reactivation of an earlier infection rather than exclusively new exposure to the virus.5
Diagnosis and testing
HPV infection can be detected through DNA testing, RNA testing, and cellular markers.6
HPV DNA testing was the original form of testing offered. It improved the sensitivity over cytology alone in the detection of precursors to malignancy but had relatively poor specificity, resulting in a high false positive rate and unnecessary referral to colposcopy. The various tests approved by the Food and Drug Administration – Hybrid Capture 2 (HC2), Cervista, and Cobas 4800 – differ in the number and nature of HPV types that they detect.
HPV RNA testing has developed and involves measuring the expression of E6 and E7 RNA. This testing is FDA approved and has the potential to improve upon the specificity of DNA testing procedures by decreasing false positives.
Measurement of cellular markers is currently considered experimental/exploratory and is not yet FDA approved for diagnostic purposes in screening or confirmation of HPV infection or coexisting dysplasia. It involves measuring the downstream cellular targets (such as p16) of E6 or E7 activity.
The mechanism of carcinogenesis
The early region of the HPV genome is downstream from the upstream regulatory region. It codes for proteins involved in viral infection and replication. The two most important genes in the early region are E6 and E7. When integrated into the human genome of the lower genital tract cell, the viral genes E6 and E7 negatively interfere with cell cycle control and mechanisms to halt dysregulation.7
E6 and E7 are considered oncogenes because they cause loss of function of the critical tumor suppressor proteins p53 and the retinoblastoma protein. The p53 protein is typically responsible for controlling cell cycling through the G0/G1 to S phases. It involves stalling cellular mitosis in order to facilitate DNA repair mechanisms in the case of damaged cells, thereby preventing replication of DNA aberrations. The retinoblastoma protein also functions to inhibit cells that have acquired DNA damage from cycling and induces apoptosis in DNA damaged cells. When protein products of E6 and E7 negatively interact with these two tumor suppressor proteins they overcome the cell’s safeguard arrest response.
In the presence of other carcinogens, such as products of tobacco exposure, the increased DNA damage sustained by the genital tract cell is allowed to go relatively unchecked by the HPV coinfection, which has disabled tumor suppressor function. This facilitates immortality of the damaged cell, amplification of additional DNA mutations, and unchecked cellular growth and dysplastic transformation. E6 and E7 are strongly expressed in invasive genital tract lesions to support its important role in carcinogenesis.
HIV coinfection is another factor that promotes carcinogenesis following HPV infection because it inhibits clearance of the virus through T-cell mediated immunosuppression and directly enhances expression of E6 and E7 proteins in the HIV and HPV coinfected cell.8 For these reasons, HIV-positive women are less likely to clear HPV infection and more likely to develop high grade dysplasia or invasive carcinomas.
Prevention and vaccination
HPV vaccinations utilize virus-like particles (VLPs). These VLPs are capsid particles generated from the L1 region of the HPV DNA. The capsid proteins coded for by L1 are highly immunogenic. VLPs are recombinant proteins created in benign biologic systems (such as yeast) and contain no inner DNA core (effectively empty viral capsids) and therefore are not infectious. The L1 gene is incorporated into a plasmid, which is inserted into the nucleus of a eukaryotic cell. Transcription and translation of the L1 gene takes place, creating capsid proteins that self-assemble into VLPs. These VLPs are retrieved and inoculated into candidate patients to illicit an immune response.
Quadrivalent, nine-valent, and bivalent vaccines are available worldwide. However, only the nine-valent vaccine – protective against types 6, 11, 16, 18, 31, 33, 45, 52, and 58 – is available in the United States. This theoretically provides more comprehensive coverage against cervical cancer–causing HPV types, as 70% of cervical cancer is attributable to HPV 16 and 18, but an additional 20% is attributable to HPV 31, 33, 45, 52, and 58. This vaccine also provides protection against the HPV strains that cause genital warts and low-grade dysplastic changes.9
HPV, in most instances, is a transient virus with no sequelae. However, if not cleared from the cells of the lower genital tract, anus, or oropharynx it can result in the breakdown of cellular correction strategies and culminate in invasive carcinoma. Fortunately, highly effective and safe vaccinations are available and should be broadly prescribed.
Dr. Rossi is an assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She reported having no relevant financial disclosures.
References
1. Cancer Epidemiol Biomarkers Prev. 1995 Jun;4(4):415-28.
2. Gynecol Oncol. 2011 Apr;121(1):32-42.
3. Cancer Epidemiol Biomarkers Prev. 2008 Jul;17(7):1611-22.
4. JAMA. 2007 Feb 28;297(8):813-9.
5. J Infect Dis. 2013; 207(2): 272-80.
6. J Natl Cancer Inst. 2011 Mar 2;103(5):368-83.
7. J Natl Cancer Inst. 2000 May 3;92(9):690-8.
8. Lancet. 2002 Jan 12;359(9301):108-13.
9. Obstet Gynecol 2017;129:e173–8.
FDA clears use of reagents to detect hematopoietic neoplasia
The US Food and Drug Administration (FDA) has allowed marketing of the ClearLLab Reagent Panel, a combination of conjugated antibody cocktails designed to aid the detection of hematopoietic neoplasia.
This includes chronic and acute leukemias, non-Hodgkin lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms.
The ClearLLab reagents are intended for in vitro diagnostic use to identify various cell populations by immunophenotyping on an FC 500 flow cytometer.
The reagents are directed against B, T, and myeloid lineage antigens and intended to identify relevant leukocyte surface molecules.
ClearLLab provides 2 T-cell tubes, 2 B-cell tubes, and a myeloid tube, each consisting of pre-mixed 4- to 5-color cocktails. Together, this totals 18 markers as directly conjugated antibodies.
The reagents can be used with peripheral whole blood, bone marrow, and lymph node specimens.
The results obtained via testing with the ClearLLab reagents should be interpreted along with additional clinical and laboratory findings, according to Beckman Coulter, Inc., the company that will be marketing the reagents.
The FDA reviewed data for the ClearLLab reagents through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
The FDA’s clearance of the ClearLLab reagents was supported by a study designed to demonstrate the reagents’ performance, which was conducted on 279 samples at 4 independent clinical sites.
Results with the ClearLLab reagents were compared to results with alternative detection methods used at the sites.
The ClearLLab results aligned with the study sites’ final diagnosis 93.4% of the time and correctly detected abnormalities 84.2% of the time.
Along with its clearance of the ClearLLab reagents, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the reagents’ accuracy, reliability, and clinical relevance.
These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for the ClearLLab reagents and similar tools.
The special controls also describe the least burdensome regulatory pathway for future developers of similar diagnostic tests. 
The US Food and Drug Administration (FDA) has allowed marketing of the ClearLLab Reagent Panel, a combination of conjugated antibody cocktails designed to aid the detection of hematopoietic neoplasia.
This includes chronic and acute leukemias, non-Hodgkin lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms.
The ClearLLab reagents are intended for in vitro diagnostic use to identify various cell populations by immunophenotyping on an FC 500 flow cytometer.
The reagents are directed against B, T, and myeloid lineage antigens and intended to identify relevant leukocyte surface molecules.
ClearLLab provides 2 T-cell tubes, 2 B-cell tubes, and a myeloid tube, each consisting of pre-mixed 4- to 5-color cocktails. Together, this totals 18 markers as directly conjugated antibodies.
The reagents can be used with peripheral whole blood, bone marrow, and lymph node specimens.
The results obtained via testing with the ClearLLab reagents should be interpreted along with additional clinical and laboratory findings, according to Beckman Coulter, Inc., the company that will be marketing the reagents.
The FDA reviewed data for the ClearLLab reagents through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
The FDA’s clearance of the ClearLLab reagents was supported by a study designed to demonstrate the reagents’ performance, which was conducted on 279 samples at 4 independent clinical sites.
Results with the ClearLLab reagents were compared to results with alternative detection methods used at the sites.
The ClearLLab results aligned with the study sites’ final diagnosis 93.4% of the time and correctly detected abnormalities 84.2% of the time.
Along with its clearance of the ClearLLab reagents, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the reagents’ accuracy, reliability, and clinical relevance.
These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for the ClearLLab reagents and similar tools.
The special controls also describe the least burdensome regulatory pathway for future developers of similar diagnostic tests.
The US Food and Drug Administration (FDA) has allowed marketing of the ClearLLab Reagent Panel, a combination of conjugated antibody cocktails designed to aid the detection of hematopoietic neoplasia.
This includes chronic and acute leukemias, non-Hodgkin lymphoma, myeloma, myelodysplastic syndromes, and myeloproliferative neoplasms.
The ClearLLab reagents are intended for in vitro diagnostic use to identify various cell populations by immunophenotyping on an FC 500 flow cytometer.
The reagents are directed against B, T, and myeloid lineage antigens and intended to identify relevant leukocyte surface molecules.
ClearLLab provides 2 T-cell tubes, 2 B-cell tubes, and a myeloid tube, each consisting of pre-mixed 4- to 5-color cocktails. Together, this totals 18 markers as directly conjugated antibodies.
The reagents can be used with peripheral whole blood, bone marrow, and lymph node specimens.
The results obtained via testing with the ClearLLab reagents should be interpreted along with additional clinical and laboratory findings, according to Beckman Coulter, Inc., the company that will be marketing the reagents.
The FDA reviewed data for the ClearLLab reagents through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
The FDA’s clearance of the ClearLLab reagents was supported by a study designed to demonstrate the reagents’ performance, which was conducted on 279 samples at 4 independent clinical sites.
Results with the ClearLLab reagents were compared to results with alternative detection methods used at the sites.
The ClearLLab results aligned with the study sites’ final diagnosis 93.4% of the time and correctly detected abnormalities 84.2% of the time.
Along with its clearance of the ClearLLab reagents, the FDA is establishing criteria, called special controls, which clarify the agency’s expectations in assuring the reagents’ accuracy, reliability, and clinical relevance.
These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for the ClearLLab reagents and similar tools.
The special controls also describe the least burdensome regulatory pathway for future developers of similar diagnostic tests.
Study indicates parent-reported penicillin allergy in question
, according to David Vyles, DO, and his associates at the Medical College of Wisconsin, Milwaukee.
Because there is no process to safely and rapidly diagnose true penicillin allergy in a critical care setting, pediatric providers are reluctant to prescribe penicillin to children with a reported allergy. In this study, a three-tier penicillin testing process was used to evaluate the accuracy of a parent-reported penicillin allergy questionnaire in identifying children likely to be at low risk for penicillin allergy in an ED setting.
“Our results in the current study highlight that the high percentage of patients reporting a penicillin allergy to medical providers are likely inconsistent with true allergy,” concluded Dr. Vyles and his associates.
Read more at Pediatrics (2017. doi: 10.1542/peds.2017-0471).
, according to David Vyles, DO, and his associates at the Medical College of Wisconsin, Milwaukee.
Because there is no process to safely and rapidly diagnose true penicillin allergy in a critical care setting, pediatric providers are reluctant to prescribe penicillin to children with a reported allergy. In this study, a three-tier penicillin testing process was used to evaluate the accuracy of a parent-reported penicillin allergy questionnaire in identifying children likely to be at low risk for penicillin allergy in an ED setting.
“Our results in the current study highlight that the high percentage of patients reporting a penicillin allergy to medical providers are likely inconsistent with true allergy,” concluded Dr. Vyles and his associates.
Read more at Pediatrics (2017. doi: 10.1542/peds.2017-0471).
, according to David Vyles, DO, and his associates at the Medical College of Wisconsin, Milwaukee.
Because there is no process to safely and rapidly diagnose true penicillin allergy in a critical care setting, pediatric providers are reluctant to prescribe penicillin to children with a reported allergy. In this study, a three-tier penicillin testing process was used to evaluate the accuracy of a parent-reported penicillin allergy questionnaire in identifying children likely to be at low risk for penicillin allergy in an ED setting.
“Our results in the current study highlight that the high percentage of patients reporting a penicillin allergy to medical providers are likely inconsistent with true allergy,” concluded Dr. Vyles and his associates.
Read more at Pediatrics (2017. doi: 10.1542/peds.2017-0471).
FROM PEDIATRICS
Daily probiotics have no effect on infections causing child care absences
Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Any intervention that can prevent child care–associated illnesses can have economic and educational implications, as well as public health ones. However, in the Laursen et al. study, almost 47% of the infants enrolled were breastfed, as opposed to previous studies in which the children participating generally were over 1 year old.
Given the positive effects of breastfeeding in preventing infections and the high percentage of infants who were breastfed in this study, it may be harder to distinguish the effects of the probiotic supplement in the Laursen et al. study. Indirectly, this study suggests additional information on the relative value of a probiotic intervention, compared with breastfeeding and diet, is warranted, and perhaps there is another reason to encourage breastfeeding as long as possible.
Michael D. Cabana, MD, MPH, is a professor of pediatrics, epidemiology and biostatistics and a member of the faculty at the Philip R. Lee Institute for Health Policy Studies at the University of California, San Francisco. Daniel J. Merenstein, MD, is an associate professor of family medicine at Georgetown University, Washington. Pharmavite, Bayer, and Sanofi have provided Georgetown University with consulting funding. Both physicians, who commented in an editorial accompanying the article by Laursen et al. (Pediatrics. 2017. doi: 10.1542/peds.2017-1729), disclosed no financial relationships relevant to this article. Dr. Merenstein has been an expert witness for Proctor & Gamble while Dr. Cabana has served as a consultant for BioGaia, Nestle, Mead Johnson, and Wyeth.
Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
Results of a double-blind, placebo-controlled study do not support use of probiotics to prevent upper respiratory and gastrointestinal infections in children aged 8-14 months at enrollment, as the probiotics did not reduce infection-related child care absences.
In the study of 290 Danish infants randomly allocated to receive a placebo or a combination of Bifidobacterium animalis subsp lactis (BB-12) and Lactobacillus rhamnosus (LGG) in a dose of 109 colony-forming units of each daily for a 6-month intervention period, there were no differences in absences from child care between the two groups (1.14 days; 95% confidence interval, −0.55 to 2.82), reported Rikke Pilmann Laursen, MSc, and her associates at the University of Copenhagen (Pediatrics. 2017. doi: 10.1542/peds.2017-0735).
Infants were a mean 10 months old at baseline, and 47% were still breastfeeding. The mean age at breastfeeding discontinuation was 12 months.
In terms of the number of children with one or more episodes of an upper respiratory tract infection, the LGG and BB-12 vs. placebo odds ratio was 1.22 (95% CI, 0.74-2.00; P = .43). The number of children with one or more episodes of diarrhea in the LGG and BB-12 vs. placebo odds ratio was 1.42 (95% CI, 0.88-2.32; P = .15).
The effect of probiotics in preventing infections in preschool-aged children has been explored in several studies and recent reviews, suggesting an effect specifically on upper respiratory tract and GI infections in small children. This study diverges in that it examined the effect of a combination of probiotics on absences from child care related to those infections in infants aged 8-14 months at the time of enrollment, whereas previous studies focused on children older than 1 year.
This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
FROM PEDIATRICS
Key clinical point:
Major finding: Intention-to-treat analysis showed no difference between the probiotics and placebo study groups.
Data source: A randomized, double-blind, placebo-controlled study of 290 infants aged 8-14 months at enrollment.
Disclosures: This study was funded by Innovation Fund Denmark, the University of Copenhagen, and Chr Hansen A/S. Dr. Kim Fleischer Michaelsen and Dr. Christian Mølgaard received a grant from Chr Hansen for the current study. None of the other investigators had any relevant financial disclosures.
How Low Should You Go? Optimizing BP in CKD
Q) I hear providers quote different numbers for target blood pressure in kidney patients. Which are correct?
The answer to this question starts with the word “meta-analysis”—but don’t stop reading! We’ll get down to the basics quickly. Determining the goal blood pressure (BP) for patients with chronic kidney disease (CKD) comes down to three questions.
1. Does the patient have diabetes? The National Kidney Foundation states that the goal BP for a patient with type 2 diabetes, CKD, and urine albumin > 30 mg/dL is < 140/90 mm Hg.1 This is in line with the JNC-8 recommendations for patients with hypertension and CKD, which do not take urine albumin level into consideration.2 It is important to recognize that while many patients with CKD do not have diabetes, those who do have a worse prognosis.3
2. Is the patient African-American? A meta-analysis of nine randomized clinical trials found that lowering BP to < 130/80 mm Hg was linked to a slower decline in glomerular filtration rate (GFR) in non-African-American patients.3 But this BP was not beneficial for African-American patients; in fact, it actually caused a faster decline in GFR.3 Therefore, target BP for African-American patients should be < 140/90 mm Hg.
3. Does the patient have significant albuminuria? An additional subgroup analysis for patients with high levels of proteinuria (defined as > 1 g/d) yielded inconclusive results.3 Patients with proteinuria > 1 g/d tended to have a slower decline in GFR with intensive BP control.3 Proteinuria > 0.5 g/d was correlated with a slowed progression to end-stage renal disease with intensive BP control.3 Again, these were trends and not statistically significant. So, for patients with high levels of proteinuria, it will not hurt to achieve a BP < 130/80 mm Hg, but there is no statistically significant difference between BP < 130/80 mm Hg and BP < 140/90 mm Hg.
What, then, are the recommendations for an African-American patient with significant proteinuria? While not addressed directly in the analysis, the study results suggest that the goal should still be < 140/90 mm Hg, since the link between race and changes in GFR is statistically significant and the effects of proteinuria are not. Although the recommendations from this review are many, the main points are summarized in the Figure.—RC
Rebecca Clawson, MAT, PA-C
Instructor, PA Program, LSU Health Shreveport, Louisiana
1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD work group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Inter Suppl. 2013;3(1):1-150.
2. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520.
3. Tsai WC, Wu HY, Peng YS, et al. Association of intensive blood pressure control and kidney disease progression in nondiabetic patients with chronic kidney disease: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:792-799.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Clinician Reviews in partnership with
Renal Consult is edited by Jane S. Davis, CRNP, DNP, a member of the Clinician Reviews editorial board, who is a nurse practitioner in the Division of Nephrology at the University of Alabama at Birmingham and is the communications chairperson for the National Kidney Foundation’s Council of Advanced Practitioners (NKF-CAP); and Kim Zuber, PA-C, MSPS, DFAAPA, a semi-retired PA who works with the American Academy of Nephrology PAs and is a past chair of the NKF-CAP. This month’s responses were authored by Zorica Kauric-Klein, APRN-BC, PhD, who is an Assistant Clinical Professor in the College of Nursing at Wayne State University in Detroit, and Rebecca Clawson, MAT, PA-C, who is an Instructor in the PA Program at LSU Health Shreveport in Louisiana.
Q) I hear providers quote different numbers for target blood pressure in kidney patients. Which are correct?
The answer to this question starts with the word “meta-analysis”—but don’t stop reading! We’ll get down to the basics quickly. Determining the goal blood pressure (BP) for patients with chronic kidney disease (CKD) comes down to three questions.
1. Does the patient have diabetes? The National Kidney Foundation states that the goal BP for a patient with type 2 diabetes, CKD, and urine albumin > 30 mg/dL is < 140/90 mm Hg.1 This is in line with the JNC-8 recommendations for patients with hypertension and CKD, which do not take urine albumin level into consideration.2 It is important to recognize that while many patients with CKD do not have diabetes, those who do have a worse prognosis.3
2. Is the patient African-American? A meta-analysis of nine randomized clinical trials found that lowering BP to < 130/80 mm Hg was linked to a slower decline in glomerular filtration rate (GFR) in non-African-American patients.3 But this BP was not beneficial for African-American patients; in fact, it actually caused a faster decline in GFR.3 Therefore, target BP for African-American patients should be < 140/90 mm Hg.
3. Does the patient have significant albuminuria? An additional subgroup analysis for patients with high levels of proteinuria (defined as > 1 g/d) yielded inconclusive results.3 Patients with proteinuria > 1 g/d tended to have a slower decline in GFR with intensive BP control.3 Proteinuria > 0.5 g/d was correlated with a slowed progression to end-stage renal disease with intensive BP control.3 Again, these were trends and not statistically significant. So, for patients with high levels of proteinuria, it will not hurt to achieve a BP < 130/80 mm Hg, but there is no statistically significant difference between BP < 130/80 mm Hg and BP < 140/90 mm Hg.
What, then, are the recommendations for an African-American patient with significant proteinuria? While not addressed directly in the analysis, the study results suggest that the goal should still be < 140/90 mm Hg, since the link between race and changes in GFR is statistically significant and the effects of proteinuria are not. Although the recommendations from this review are many, the main points are summarized in the Figure.—RC
Rebecca Clawson, MAT, PA-C
Instructor, PA Program, LSU Health Shreveport, Louisiana
Q) I hear providers quote different numbers for target blood pressure in kidney patients. Which are correct?
The answer to this question starts with the word “meta-analysis”—but don’t stop reading! We’ll get down to the basics quickly. Determining the goal blood pressure (BP) for patients with chronic kidney disease (CKD) comes down to three questions.
1. Does the patient have diabetes? The National Kidney Foundation states that the goal BP for a patient with type 2 diabetes, CKD, and urine albumin > 30 mg/dL is < 140/90 mm Hg.1 This is in line with the JNC-8 recommendations for patients with hypertension and CKD, which do not take urine albumin level into consideration.2 It is important to recognize that while many patients with CKD do not have diabetes, those who do have a worse prognosis.3
2. Is the patient African-American? A meta-analysis of nine randomized clinical trials found that lowering BP to < 130/80 mm Hg was linked to a slower decline in glomerular filtration rate (GFR) in non-African-American patients.3 But this BP was not beneficial for African-American patients; in fact, it actually caused a faster decline in GFR.3 Therefore, target BP for African-American patients should be < 140/90 mm Hg.
3. Does the patient have significant albuminuria? An additional subgroup analysis for patients with high levels of proteinuria (defined as > 1 g/d) yielded inconclusive results.3 Patients with proteinuria > 1 g/d tended to have a slower decline in GFR with intensive BP control.3 Proteinuria > 0.5 g/d was correlated with a slowed progression to end-stage renal disease with intensive BP control.3 Again, these were trends and not statistically significant. So, for patients with high levels of proteinuria, it will not hurt to achieve a BP < 130/80 mm Hg, but there is no statistically significant difference between BP < 130/80 mm Hg and BP < 140/90 mm Hg.
What, then, are the recommendations for an African-American patient with significant proteinuria? While not addressed directly in the analysis, the study results suggest that the goal should still be < 140/90 mm Hg, since the link between race and changes in GFR is statistically significant and the effects of proteinuria are not. Although the recommendations from this review are many, the main points are summarized in the Figure.—RC
Rebecca Clawson, MAT, PA-C
Instructor, PA Program, LSU Health Shreveport, Louisiana
1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD work group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Inter Suppl. 2013;3(1):1-150.
2. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520.
3. Tsai WC, Wu HY, Peng YS, et al. Association of intensive blood pressure control and kidney disease progression in nondiabetic patients with chronic kidney disease: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:792-799.
1. Kidney Disease: Improving Global Outcomes (KDIGO) CKD work group. KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney Inter Suppl. 2013;3(1):1-150.
2. James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA. 2014;311(5):507-520.
3. Tsai WC, Wu HY, Peng YS, et al. Association of intensive blood pressure control and kidney disease progression in nondiabetic patients with chronic kidney disease: a systematic review and meta-analysis. JAMA Intern Med. 2017;177:792-799.
AHRQ identifies interventions, drugs that best target diabetic neuropathy
Contextual influences of trainee characteristics and daily workload on trainee learning preferences
We previously identified key domains of attending attributes for successful rounds1 and adapted them to represent the trainees’ perspective: Teaching Process (eg, sharing decision-making process, physical exam skills), Learning Environment (eg, being approachable, respectful), Role Modeling (eg, teaching by example, bedside manner), and Team Management (eg, efficiency, providing autonomy). Though all domains are necessary, the relative importance may change in response to external pressures. Inpatient service demands and time constraints fluctuate daily due to patient admissions and discharges, educational conference schedules, and concurrent outpatient clinic responsibilities.2–4 Furthermore, the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour rules placed greater time pressure on inpatient ward attending rounds.5 It is plausible that these pressures affect trainees’ needs and priorities during rounds.
Therefore, we sought to refine our understanding of the learners’ needs during ward rounds. Because we were interested in the contextual influences of trainee characteristics and workload on their preferences, we used the principles of ecological momentary assessment (EMA) to design a novel system to assess daily changes in trainee priorities and associated workload.
METHODS
Design, Participants, and Setting
In a prospective observational study, we assessed trainee priorities during inpatient rounds. Participants included third- and fourth-year medical students in the University of Alabama at Birmingham (UAB) School of Medicine (Birmingham campus) and residents in the Tinsley Harrison Internal Medicine Residency Training Program assigned to inpatient general medicine ward services from September 2010 to February 2011 (except from December 20, 2010, to January 3, 2011). Three training sites were included in this study: UAB Hospital (>1000-bed, university-based hospital), Birmingham Veterans Affairs Medical Center (300-bed), and Cooper Green Hospital (40-bed county hospital). Each site housed 4 or 5 general medicine ward teams, composed of 1–3 medical students (third or fourth year), 2 first-year residents, 1 upper level resident (postgraduate year 2–4), and 1 attending physician.
Trainees were recruited to participate via e-mail and verbal announcements during program conferences. Participation was voluntary and responses were confidential. As an incentive, the team submitting the highest number of cards per site each month received 1 free lunch. Institutional review boards of all 3 participating hospitals approved this study.
Assessment
Our original domains of attending rounds were derived from groupings and ratings of specific teaching characteristics by attending physicians, residents, and students.1 However, because our goal was to understand the learners’ perspective of successful ward rounds, we revised these domains by limiting the algorithm to data on groupings and ratings by residents and students only. This process resulted in the domains used in this study (Appendix).
We used EMA principles to create a novel system to assess daily variation in trainees’ prioritization of these domains and workload.6,7 EMA-derived assessment tools collect data frequently (several times per week, up to multiple times per day) to identify time-sensitive fluctuations. We designed a pocket-sized daily assessment card for trainees to complete each day after rounds (Figure 1). Trainees were asked to indicate the most important domain for successful ward rounds to them that day and provide individual characteristics (ie, sex and training level) and data on factors we hypothesized were related to perceived work load (ie, patient census, day of call cycle, and number of team members absent on rounds that day). We anticipated the Expectations domain would not be responsive to daily changes in workload because expectations are usually set once on the first day of the rotation, and thus we did not include this domain in our final assessment tool. Assessment cards and locked receptacles were kept in team workrooms for ease of accessibility; cards were collected twice monthly. All data were anonymous.
Analysis
Our unit of analysis was the EMA card. We examined associations between daily domain priority with respondent demographics and workload information using Pearson’s chi-squared analyses, adjusted for clustering effects by team. α was set at 0.05. All analyses were performed by using Stata 13.0 (Stata Statistical Software: Release 13; College Station, TX).
RESULTS
Sex and training level were associated with prioritization of teaching domains. Male trainees were more likely to choose Team Management (P = 0.01) or Teaching Process (P = 0.04) as their preferred domain. Medical students valued Teaching Process 42% of the time, compared with 23% for interns and 21% for upper level residents (P = 0.005). The opposite trend emerged for Team Management: as training level increased, the importance of Team Management increased (P < 0.001). There were no significant trends by training level for the Role Modeling and Learning Environment domains.
Domain priority was also associated with workload characteristics. On post-call days, Team Management (P < 0.001) was more likely to be selected as the most important domain, but on other days, Teaching Process (P = 0.005) was more often selected (Figure 2). Trainees also selected Team Management as the most important domain with an increasing number of team members absent (P = 0.001), and as the teams’ overall patient census increased (P < 0.001). The Learning Environment and Role Modeling domains’ importance did not vary by call-day or patient census.
DISCUSSION
We used a novel approach to assess contextual factors affecting trainee prioritization of 4 domains that contribute to successful inpatient internal medicine attending rounds. We found training level and workload demands were associated with prioritization of teaching domains. Prioritization of Teaching Process, exemplified by setting aside time to teach, demonstrating physical exam skills, and clear delineation of the attending’s thought process, was inversely associated with training level. On the days with highest workload, Team Management was most likely to be prioritized. Our findings suggest that attending physicians should consider adapting rounding style based on team members’ training levels and workload.
Prior work has described teaching and rounding styles, influences, and priorities in response to workload from the attending physician’s perspective,8–11 and our study extends these reports by providing the complementary perspective of trainees. On days with high workload, trainees prefer the Team Management domain, characterized by organized and efficient rounds, agreement on a clear and consistent plan of care, and being allowed independence and time during rounds to meet other responsibilities.1 These findings support an “empowerment style,” defined by Goldszmidt et al. as using integrated teaching and oversight strategies to support trainees’ progressive independence.9 Though some attending physicians report shifting to a more direct patient care style on days with a high patient census,9 our results suggest that learners instead prefer more independence, being empowered to perform more direct care. While there is an increasing pressure to heighten attending supervision due to concerns about patient safety, restricted work hours, and litigation,12 trainees value being part of the care process and being included as integral members of the care team, which may actually mitigate patient safety risks.8
Our results are consistent with prior studies, reporting that learners at different levels of training have different instructional needs: medical students seek more teaching, and senior residents sought an efficient leader.13,14 Taken together, these studies suggest that attending physicians should tailor rounds to the level of the trainee. For example, it may be beneficial for the attending physician to spend time outside of rounds with students to teach medical knowledge. During rounds, the entire group benefits most from modeling clinical reasoning, discussing new medical evidence, and demonstrating communication skills and leadership.
Our study has limitations. Though our study was performed before the 2011 ACGME duty hour restrictions,5 our results are likely of greater importance and relevance, as our findings ultimately highlight the competing demands of time vs duty. Also, while our study was performed at a single institution, potentially limiting generalizability, we included 3 types of training hospitals, a university, veterans and a county hospital, and found no differences between sites. Additionally, we collected over 1,000 cards over the course of 6 months, assessing rounds of over 50 different attending physicians, suggesting broader applicability. Our overall response rate was low, a typical signal for respondent bias, but because we collected daily assessments, standard interpretation of response rates referring to a one-time survey do not apply.15 We believe we achieved an adequate sample, as the majority of teams participated, the respondent demographics were proportional to the base population eligible to participate, and we received a similar number of cards on all months. Finally, although we were unable to account for clustering effects by individual respondents because response cards were anonymous, we adjusted for clustering effects by team.
Attending physicians may use our findings to adapt teaching techniques to appeal to specific training levels and to external pressures during teaching rounds. Focusing and investing time in teaching medical knowledge and clinical reasoning tailored to each level of learner is paramount on most days. However, days with a high workload may require emphasis on delegating clear, rational treatment plans, when learners are less receptive to traditional didactic methods.
Disclosure
An abstract based on the current analysis was presented at the Society of General Internal Medicine 34th Annual Meeting, April 2011, Phoenix, AZ. Dr. Brita Roy is supported by grant number K12HS023000 from the Agency for Healthcare Research and Quality. The authors have no conflicts to disclose. The opinions expressed in this article are those of the authors alone and do not reflect the views of the Department of Veterans Affairs or the Agency for Healthcare Research and Quality.
1. Roy B, Salanitro AH, Willett L, et al. Using cognitive mapping to identify attributes contributing to successful ward-attending rounds -- a resident and student perspective. J Gen Intern Med. 2010;25(S3):2. PubMed
2. Ben-Menachem T, Estrada C, Young MJ, et al. Balancing service and education: improving internal medicine residencies in the managed care era. Am J Med. 1996;100(2):224–229. PubMed
3. Drolet BC, Bishop KD. Unintended consequences of duty hours regulation. Acad Med. 2012;87(6):680. PubMed
4. Drolet BC, Spalluto LB, Fischer SA. Residents’ perspectives on ACGME regulation of supervision and duty hours--a national survey. N Engl J Med. 2010;363(23):e34. PubMed
5. Nasca TJ, Day SH, Amis ES, Jr. The new recommendations on duty hours from the ACGME Task Force. N Engl J Med. 2010;363(2):e3. PubMed
6. Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1–32. PubMed
7. Moskowitz DS, Young SN. Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology. J Psychiatry Neurosci. 2006;31(1):13–20. PubMed
8. Wingo MT, Halvorsen AJ, Beckman TJ, Johnson MG, Reed DA. Associations between attending physician workload, teaching effectiveness, and patient safety. J Hosp Med. 2016;11(3):169–173. PubMed
9. Goldszmidt M, Faden L, Dornan T, van Merriënboer J, Bordage G, Lingard L. Attending physician variability: a model of four supervisory styles. Acad Med. 2015;90(11):1541–1546. PubMed
10. Kennedy TJ, Lingard L, Baker GR, Kitchen L, Regehr G. Clinical oversight: conceptualizing the relationship between supervision and safety. J Gen Intern Med. 2007;22(8):1080–1085. PubMed
11. Irby DM. How attending physicians make instructional decisions when conducting teaching rounds. Acad Med. 1992;67(10):630–638. PubMed
12. Kennedy TJ, Regehr G, Baker GR, Lingard LA. Progressive independence in clinical training: a tradition worth defending? Acad Med. 2005;80(10):S106–S111. PubMed
13. Tariq M, Motiwala A, Ali SU, Riaz M, Awan S, Akhter J. The learners’ perspective on internal medicine ward rounds: a cross-sectional study. BMC Med Educ. 2010;10:53. PubMed
14. Certain LK, Guarino AJ, Greenwald JL. Effective multilevel teaching techniques on attending rounds: a pilot survey and systematic review of the literature. Med Teach. 2011;33(12):e644–e650. PubMed
15. Stone AA, Shiffman S. Capturing momentary, self-report data: A proposal for reporting guidelines. Ann Behav Med. 2002;24(3):236–243. PubMed
We previously identified key domains of attending attributes for successful rounds1 and adapted them to represent the trainees’ perspective: Teaching Process (eg, sharing decision-making process, physical exam skills), Learning Environment (eg, being approachable, respectful), Role Modeling (eg, teaching by example, bedside manner), and Team Management (eg, efficiency, providing autonomy). Though all domains are necessary, the relative importance may change in response to external pressures. Inpatient service demands and time constraints fluctuate daily due to patient admissions and discharges, educational conference schedules, and concurrent outpatient clinic responsibilities.2–4 Furthermore, the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour rules placed greater time pressure on inpatient ward attending rounds.5 It is plausible that these pressures affect trainees’ needs and priorities during rounds.
Therefore, we sought to refine our understanding of the learners’ needs during ward rounds. Because we were interested in the contextual influences of trainee characteristics and workload on their preferences, we used the principles of ecological momentary assessment (EMA) to design a novel system to assess daily changes in trainee priorities and associated workload.
METHODS
Design, Participants, and Setting
In a prospective observational study, we assessed trainee priorities during inpatient rounds. Participants included third- and fourth-year medical students in the University of Alabama at Birmingham (UAB) School of Medicine (Birmingham campus) and residents in the Tinsley Harrison Internal Medicine Residency Training Program assigned to inpatient general medicine ward services from September 2010 to February 2011 (except from December 20, 2010, to January 3, 2011). Three training sites were included in this study: UAB Hospital (>1000-bed, university-based hospital), Birmingham Veterans Affairs Medical Center (300-bed), and Cooper Green Hospital (40-bed county hospital). Each site housed 4 or 5 general medicine ward teams, composed of 1–3 medical students (third or fourth year), 2 first-year residents, 1 upper level resident (postgraduate year 2–4), and 1 attending physician.
Trainees were recruited to participate via e-mail and verbal announcements during program conferences. Participation was voluntary and responses were confidential. As an incentive, the team submitting the highest number of cards per site each month received 1 free lunch. Institutional review boards of all 3 participating hospitals approved this study.
Assessment
Our original domains of attending rounds were derived from groupings and ratings of specific teaching characteristics by attending physicians, residents, and students.1 However, because our goal was to understand the learners’ perspective of successful ward rounds, we revised these domains by limiting the algorithm to data on groupings and ratings by residents and students only. This process resulted in the domains used in this study (Appendix).
We used EMA principles to create a novel system to assess daily variation in trainees’ prioritization of these domains and workload.6,7 EMA-derived assessment tools collect data frequently (several times per week, up to multiple times per day) to identify time-sensitive fluctuations. We designed a pocket-sized daily assessment card for trainees to complete each day after rounds (Figure 1). Trainees were asked to indicate the most important domain for successful ward rounds to them that day and provide individual characteristics (ie, sex and training level) and data on factors we hypothesized were related to perceived work load (ie, patient census, day of call cycle, and number of team members absent on rounds that day). We anticipated the Expectations domain would not be responsive to daily changes in workload because expectations are usually set once on the first day of the rotation, and thus we did not include this domain in our final assessment tool. Assessment cards and locked receptacles were kept in team workrooms for ease of accessibility; cards were collected twice monthly. All data were anonymous.
Analysis
Our unit of analysis was the EMA card. We examined associations between daily domain priority with respondent demographics and workload information using Pearson’s chi-squared analyses, adjusted for clustering effects by team. α was set at 0.05. All analyses were performed by using Stata 13.0 (Stata Statistical Software: Release 13; College Station, TX).
RESULTS
Sex and training level were associated with prioritization of teaching domains. Male trainees were more likely to choose Team Management (P = 0.01) or Teaching Process (P = 0.04) as their preferred domain. Medical students valued Teaching Process 42% of the time, compared with 23% for interns and 21% for upper level residents (P = 0.005). The opposite trend emerged for Team Management: as training level increased, the importance of Team Management increased (P < 0.001). There were no significant trends by training level for the Role Modeling and Learning Environment domains.
Domain priority was also associated with workload characteristics. On post-call days, Team Management (P < 0.001) was more likely to be selected as the most important domain, but on other days, Teaching Process (P = 0.005) was more often selected (Figure 2). Trainees also selected Team Management as the most important domain with an increasing number of team members absent (P = 0.001), and as the teams’ overall patient census increased (P < 0.001). The Learning Environment and Role Modeling domains’ importance did not vary by call-day or patient census.
DISCUSSION
We used a novel approach to assess contextual factors affecting trainee prioritization of 4 domains that contribute to successful inpatient internal medicine attending rounds. We found training level and workload demands were associated with prioritization of teaching domains. Prioritization of Teaching Process, exemplified by setting aside time to teach, demonstrating physical exam skills, and clear delineation of the attending’s thought process, was inversely associated with training level. On the days with highest workload, Team Management was most likely to be prioritized. Our findings suggest that attending physicians should consider adapting rounding style based on team members’ training levels and workload.
Prior work has described teaching and rounding styles, influences, and priorities in response to workload from the attending physician’s perspective,8–11 and our study extends these reports by providing the complementary perspective of trainees. On days with high workload, trainees prefer the Team Management domain, characterized by organized and efficient rounds, agreement on a clear and consistent plan of care, and being allowed independence and time during rounds to meet other responsibilities.1 These findings support an “empowerment style,” defined by Goldszmidt et al. as using integrated teaching and oversight strategies to support trainees’ progressive independence.9 Though some attending physicians report shifting to a more direct patient care style on days with a high patient census,9 our results suggest that learners instead prefer more independence, being empowered to perform more direct care. While there is an increasing pressure to heighten attending supervision due to concerns about patient safety, restricted work hours, and litigation,12 trainees value being part of the care process and being included as integral members of the care team, which may actually mitigate patient safety risks.8
Our results are consistent with prior studies, reporting that learners at different levels of training have different instructional needs: medical students seek more teaching, and senior residents sought an efficient leader.13,14 Taken together, these studies suggest that attending physicians should tailor rounds to the level of the trainee. For example, it may be beneficial for the attending physician to spend time outside of rounds with students to teach medical knowledge. During rounds, the entire group benefits most from modeling clinical reasoning, discussing new medical evidence, and demonstrating communication skills and leadership.
Our study has limitations. Though our study was performed before the 2011 ACGME duty hour restrictions,5 our results are likely of greater importance and relevance, as our findings ultimately highlight the competing demands of time vs duty. Also, while our study was performed at a single institution, potentially limiting generalizability, we included 3 types of training hospitals, a university, veterans and a county hospital, and found no differences between sites. Additionally, we collected over 1,000 cards over the course of 6 months, assessing rounds of over 50 different attending physicians, suggesting broader applicability. Our overall response rate was low, a typical signal for respondent bias, but because we collected daily assessments, standard interpretation of response rates referring to a one-time survey do not apply.15 We believe we achieved an adequate sample, as the majority of teams participated, the respondent demographics were proportional to the base population eligible to participate, and we received a similar number of cards on all months. Finally, although we were unable to account for clustering effects by individual respondents because response cards were anonymous, we adjusted for clustering effects by team.
Attending physicians may use our findings to adapt teaching techniques to appeal to specific training levels and to external pressures during teaching rounds. Focusing and investing time in teaching medical knowledge and clinical reasoning tailored to each level of learner is paramount on most days. However, days with a high workload may require emphasis on delegating clear, rational treatment plans, when learners are less receptive to traditional didactic methods.
Disclosure
An abstract based on the current analysis was presented at the Society of General Internal Medicine 34th Annual Meeting, April 2011, Phoenix, AZ. Dr. Brita Roy is supported by grant number K12HS023000 from the Agency for Healthcare Research and Quality. The authors have no conflicts to disclose. The opinions expressed in this article are those of the authors alone and do not reflect the views of the Department of Veterans Affairs or the Agency for Healthcare Research and Quality.
We previously identified key domains of attending attributes for successful rounds1 and adapted them to represent the trainees’ perspective: Teaching Process (eg, sharing decision-making process, physical exam skills), Learning Environment (eg, being approachable, respectful), Role Modeling (eg, teaching by example, bedside manner), and Team Management (eg, efficiency, providing autonomy). Though all domains are necessary, the relative importance may change in response to external pressures. Inpatient service demands and time constraints fluctuate daily due to patient admissions and discharges, educational conference schedules, and concurrent outpatient clinic responsibilities.2–4 Furthermore, the 2011 Accreditation Council for Graduate Medical Education (ACGME) duty hour rules placed greater time pressure on inpatient ward attending rounds.5 It is plausible that these pressures affect trainees’ needs and priorities during rounds.
Therefore, we sought to refine our understanding of the learners’ needs during ward rounds. Because we were interested in the contextual influences of trainee characteristics and workload on their preferences, we used the principles of ecological momentary assessment (EMA) to design a novel system to assess daily changes in trainee priorities and associated workload.
METHODS
Design, Participants, and Setting
In a prospective observational study, we assessed trainee priorities during inpatient rounds. Participants included third- and fourth-year medical students in the University of Alabama at Birmingham (UAB) School of Medicine (Birmingham campus) and residents in the Tinsley Harrison Internal Medicine Residency Training Program assigned to inpatient general medicine ward services from September 2010 to February 2011 (except from December 20, 2010, to January 3, 2011). Three training sites were included in this study: UAB Hospital (>1000-bed, university-based hospital), Birmingham Veterans Affairs Medical Center (300-bed), and Cooper Green Hospital (40-bed county hospital). Each site housed 4 or 5 general medicine ward teams, composed of 1–3 medical students (third or fourth year), 2 first-year residents, 1 upper level resident (postgraduate year 2–4), and 1 attending physician.
Trainees were recruited to participate via e-mail and verbal announcements during program conferences. Participation was voluntary and responses were confidential. As an incentive, the team submitting the highest number of cards per site each month received 1 free lunch. Institutional review boards of all 3 participating hospitals approved this study.
Assessment
Our original domains of attending rounds were derived from groupings and ratings of specific teaching characteristics by attending physicians, residents, and students.1 However, because our goal was to understand the learners’ perspective of successful ward rounds, we revised these domains by limiting the algorithm to data on groupings and ratings by residents and students only. This process resulted in the domains used in this study (Appendix).
We used EMA principles to create a novel system to assess daily variation in trainees’ prioritization of these domains and workload.6,7 EMA-derived assessment tools collect data frequently (several times per week, up to multiple times per day) to identify time-sensitive fluctuations. We designed a pocket-sized daily assessment card for trainees to complete each day after rounds (Figure 1). Trainees were asked to indicate the most important domain for successful ward rounds to them that day and provide individual characteristics (ie, sex and training level) and data on factors we hypothesized were related to perceived work load (ie, patient census, day of call cycle, and number of team members absent on rounds that day). We anticipated the Expectations domain would not be responsive to daily changes in workload because expectations are usually set once on the first day of the rotation, and thus we did not include this domain in our final assessment tool. Assessment cards and locked receptacles were kept in team workrooms for ease of accessibility; cards were collected twice monthly. All data were anonymous.
Analysis
Our unit of analysis was the EMA card. We examined associations between daily domain priority with respondent demographics and workload information using Pearson’s chi-squared analyses, adjusted for clustering effects by team. α was set at 0.05. All analyses were performed by using Stata 13.0 (Stata Statistical Software: Release 13; College Station, TX).
RESULTS
Sex and training level were associated with prioritization of teaching domains. Male trainees were more likely to choose Team Management (P = 0.01) or Teaching Process (P = 0.04) as their preferred domain. Medical students valued Teaching Process 42% of the time, compared with 23% for interns and 21% for upper level residents (P = 0.005). The opposite trend emerged for Team Management: as training level increased, the importance of Team Management increased (P < 0.001). There were no significant trends by training level for the Role Modeling and Learning Environment domains.
Domain priority was also associated with workload characteristics. On post-call days, Team Management (P < 0.001) was more likely to be selected as the most important domain, but on other days, Teaching Process (P = 0.005) was more often selected (Figure 2). Trainees also selected Team Management as the most important domain with an increasing number of team members absent (P = 0.001), and as the teams’ overall patient census increased (P < 0.001). The Learning Environment and Role Modeling domains’ importance did not vary by call-day or patient census.
DISCUSSION
We used a novel approach to assess contextual factors affecting trainee prioritization of 4 domains that contribute to successful inpatient internal medicine attending rounds. We found training level and workload demands were associated with prioritization of teaching domains. Prioritization of Teaching Process, exemplified by setting aside time to teach, demonstrating physical exam skills, and clear delineation of the attending’s thought process, was inversely associated with training level. On the days with highest workload, Team Management was most likely to be prioritized. Our findings suggest that attending physicians should consider adapting rounding style based on team members’ training levels and workload.
Prior work has described teaching and rounding styles, influences, and priorities in response to workload from the attending physician’s perspective,8–11 and our study extends these reports by providing the complementary perspective of trainees. On days with high workload, trainees prefer the Team Management domain, characterized by organized and efficient rounds, agreement on a clear and consistent plan of care, and being allowed independence and time during rounds to meet other responsibilities.1 These findings support an “empowerment style,” defined by Goldszmidt et al. as using integrated teaching and oversight strategies to support trainees’ progressive independence.9 Though some attending physicians report shifting to a more direct patient care style on days with a high patient census,9 our results suggest that learners instead prefer more independence, being empowered to perform more direct care. While there is an increasing pressure to heighten attending supervision due to concerns about patient safety, restricted work hours, and litigation,12 trainees value being part of the care process and being included as integral members of the care team, which may actually mitigate patient safety risks.8
Our results are consistent with prior studies, reporting that learners at different levels of training have different instructional needs: medical students seek more teaching, and senior residents sought an efficient leader.13,14 Taken together, these studies suggest that attending physicians should tailor rounds to the level of the trainee. For example, it may be beneficial for the attending physician to spend time outside of rounds with students to teach medical knowledge. During rounds, the entire group benefits most from modeling clinical reasoning, discussing new medical evidence, and demonstrating communication skills and leadership.
Our study has limitations. Though our study was performed before the 2011 ACGME duty hour restrictions,5 our results are likely of greater importance and relevance, as our findings ultimately highlight the competing demands of time vs duty. Also, while our study was performed at a single institution, potentially limiting generalizability, we included 3 types of training hospitals, a university, veterans and a county hospital, and found no differences between sites. Additionally, we collected over 1,000 cards over the course of 6 months, assessing rounds of over 50 different attending physicians, suggesting broader applicability. Our overall response rate was low, a typical signal for respondent bias, but because we collected daily assessments, standard interpretation of response rates referring to a one-time survey do not apply.15 We believe we achieved an adequate sample, as the majority of teams participated, the respondent demographics were proportional to the base population eligible to participate, and we received a similar number of cards on all months. Finally, although we were unable to account for clustering effects by individual respondents because response cards were anonymous, we adjusted for clustering effects by team.
Attending physicians may use our findings to adapt teaching techniques to appeal to specific training levels and to external pressures during teaching rounds. Focusing and investing time in teaching medical knowledge and clinical reasoning tailored to each level of learner is paramount on most days. However, days with a high workload may require emphasis on delegating clear, rational treatment plans, when learners are less receptive to traditional didactic methods.
Disclosure
An abstract based on the current analysis was presented at the Society of General Internal Medicine 34th Annual Meeting, April 2011, Phoenix, AZ. Dr. Brita Roy is supported by grant number K12HS023000 from the Agency for Healthcare Research and Quality. The authors have no conflicts to disclose. The opinions expressed in this article are those of the authors alone and do not reflect the views of the Department of Veterans Affairs or the Agency for Healthcare Research and Quality.
1. Roy B, Salanitro AH, Willett L, et al. Using cognitive mapping to identify attributes contributing to successful ward-attending rounds -- a resident and student perspective. J Gen Intern Med. 2010;25(S3):2. PubMed
2. Ben-Menachem T, Estrada C, Young MJ, et al. Balancing service and education: improving internal medicine residencies in the managed care era. Am J Med. 1996;100(2):224–229. PubMed
3. Drolet BC, Bishop KD. Unintended consequences of duty hours regulation. Acad Med. 2012;87(6):680. PubMed
4. Drolet BC, Spalluto LB, Fischer SA. Residents’ perspectives on ACGME regulation of supervision and duty hours--a national survey. N Engl J Med. 2010;363(23):e34. PubMed
5. Nasca TJ, Day SH, Amis ES, Jr. The new recommendations on duty hours from the ACGME Task Force. N Engl J Med. 2010;363(2):e3. PubMed
6. Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1–32. PubMed
7. Moskowitz DS, Young SN. Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology. J Psychiatry Neurosci. 2006;31(1):13–20. PubMed
8. Wingo MT, Halvorsen AJ, Beckman TJ, Johnson MG, Reed DA. Associations between attending physician workload, teaching effectiveness, and patient safety. J Hosp Med. 2016;11(3):169–173. PubMed
9. Goldszmidt M, Faden L, Dornan T, van Merriënboer J, Bordage G, Lingard L. Attending physician variability: a model of four supervisory styles. Acad Med. 2015;90(11):1541–1546. PubMed
10. Kennedy TJ, Lingard L, Baker GR, Kitchen L, Regehr G. Clinical oversight: conceptualizing the relationship between supervision and safety. J Gen Intern Med. 2007;22(8):1080–1085. PubMed
11. Irby DM. How attending physicians make instructional decisions when conducting teaching rounds. Acad Med. 1992;67(10):630–638. PubMed
12. Kennedy TJ, Regehr G, Baker GR, Lingard LA. Progressive independence in clinical training: a tradition worth defending? Acad Med. 2005;80(10):S106–S111. PubMed
13. Tariq M, Motiwala A, Ali SU, Riaz M, Awan S, Akhter J. The learners’ perspective on internal medicine ward rounds: a cross-sectional study. BMC Med Educ. 2010;10:53. PubMed
14. Certain LK, Guarino AJ, Greenwald JL. Effective multilevel teaching techniques on attending rounds: a pilot survey and systematic review of the literature. Med Teach. 2011;33(12):e644–e650. PubMed
15. Stone AA, Shiffman S. Capturing momentary, self-report data: A proposal for reporting guidelines. Ann Behav Med. 2002;24(3):236–243. PubMed
1. Roy B, Salanitro AH, Willett L, et al. Using cognitive mapping to identify attributes contributing to successful ward-attending rounds -- a resident and student perspective. J Gen Intern Med. 2010;25(S3):2. PubMed
2. Ben-Menachem T, Estrada C, Young MJ, et al. Balancing service and education: improving internal medicine residencies in the managed care era. Am J Med. 1996;100(2):224–229. PubMed
3. Drolet BC, Bishop KD. Unintended consequences of duty hours regulation. Acad Med. 2012;87(6):680. PubMed
4. Drolet BC, Spalluto LB, Fischer SA. Residents’ perspectives on ACGME regulation of supervision and duty hours--a national survey. N Engl J Med. 2010;363(23):e34. PubMed
5. Nasca TJ, Day SH, Amis ES, Jr. The new recommendations on duty hours from the ACGME Task Force. N Engl J Med. 2010;363(2):e3. PubMed
6. Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1–32. PubMed
7. Moskowitz DS, Young SN. Ecological momentary assessment: what it is and why it is a method of the future in clinical psychopharmacology. J Psychiatry Neurosci. 2006;31(1):13–20. PubMed
8. Wingo MT, Halvorsen AJ, Beckman TJ, Johnson MG, Reed DA. Associations between attending physician workload, teaching effectiveness, and patient safety. J Hosp Med. 2016;11(3):169–173. PubMed
9. Goldszmidt M, Faden L, Dornan T, van Merriënboer J, Bordage G, Lingard L. Attending physician variability: a model of four supervisory styles. Acad Med. 2015;90(11):1541–1546. PubMed
10. Kennedy TJ, Lingard L, Baker GR, Kitchen L, Regehr G. Clinical oversight: conceptualizing the relationship between supervision and safety. J Gen Intern Med. 2007;22(8):1080–1085. PubMed
11. Irby DM. How attending physicians make instructional decisions when conducting teaching rounds. Acad Med. 1992;67(10):630–638. PubMed
12. Kennedy TJ, Regehr G, Baker GR, Lingard LA. Progressive independence in clinical training: a tradition worth defending? Acad Med. 2005;80(10):S106–S111. PubMed
13. Tariq M, Motiwala A, Ali SU, Riaz M, Awan S, Akhter J. The learners’ perspective on internal medicine ward rounds: a cross-sectional study. BMC Med Educ. 2010;10:53. PubMed
14. Certain LK, Guarino AJ, Greenwald JL. Effective multilevel teaching techniques on attending rounds: a pilot survey and systematic review of the literature. Med Teach. 2011;33(12):e644–e650. PubMed
15. Stone AA, Shiffman S. Capturing momentary, self-report data: A proposal for reporting guidelines. Ann Behav Med. 2002;24(3):236–243. PubMed
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