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The influence of uterine fibroids on fertility in women planning to become pregnant
Q1: How do/can fibroids influence fertility?
When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.
It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.
We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has. But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.
There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.
Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?
One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.
It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.
What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.
Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.
Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?
I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.
We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.
The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.
For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.
I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.
There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.
Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?
The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.
For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.
Q1: How do/can fibroids influence fertility?
When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.
It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.
We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has. But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.
There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.
Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?
One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.
It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.
What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.
Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.
Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?
I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.
We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.
The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.
For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.
I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.
There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.
Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?
The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.
For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.
Q1: How do/can fibroids influence fertility?
When considering how uterine fibroids influence fertility, it's important to understand that uterine fibroids are very common. Uterine fibroids are the most common pelvic tumor in women, and they're non-cancerous tumors that are developed from the muscle cells of the uterus. The lifetime risk, before the age of 50, of a woman having fibroids varies by race and ethnicity, but in general, about 80% of Black women and 70% of Caucasian women will have at least one uterine fibroid diagnosed before the age of 50.
It's also important to understand when considering fertility that the prevalence of uterine fibroids increases as someone gets older. So uterine fibroids are much less common in younger women in their 20s as they are in women in their upper 30s and 40s. That's important to understand when looking at fertility because we also know that with age, fertility decreases. Thus, uterine fibroids also can impact fertility. There's also this age-related factor, which makes it difficult to really look at fibroids as far as being a causative agent for infertility.
We do know that approximately 10% of women with infertility will be diagnosed with uterine fibroids during their evaluation, and there's multiple ways that uterine fibroids impact fertility. In general, it's going to depend on the location of the uterine fibroids, the size and the bulk or the number of uterine fibroids that a woman has. But when we look at the ways that uterine fibroids can impact fertility, what they can do is they distort the uterine cavity. This is the most common for submucosal fibroids or fibroids that have a component that's present inside the uterine cavity. Fibroids that are submucosal or intramural fibroids are in the muscle of the uterus and have an intracavitary component. They're well-known to distort the uterine cavity and that can impact implantation of an embryo. There's also thought that it can impact an ongoing pregnancy.
There's speculation that uterine fibroids can impact the blood flow to a pregnancy as well and they may impact fertility. Depending on the size of the uterine fibroid, they may block the fallopian tubes. And so, if you have a uterine fibroid that's in the corner of the uterus, that could cause a tubal factor type of infertility where there's occlusion of the fallopian tube. But in general, the most concern we have for uterine fibroids is how those fibroids impact the uterine lining and implantation of an embryo, and it's thought that those are most likely due to submucosal fibroids, or some intramural fibroids that may be particularly large, or that have a component that's inside the cavity.
Q2. Several studies have attempted to clarify the influence of fibroids on fertility, however, there have been various, sometimes contradictory findings and a lack of well-designed trials. Why is this?
One of the challenges in counseling patients regarding uterine fibroids is that there's really a lack of high-quality studies assessing uterine fibroids and fertility. And we all know that the gold standard research study is a randomized control trial, as they provide the highest level of evidence, but those are very difficult to conduct especially for women with uterine fibroids, as many women will decline randomization.
It's difficult to design a study where there's one treatment that can be beneficial versus no treatment. That's one challenge. Because of that, the study designs that we've had to date have mostly been retrospective, and there's been some observational studies. But even those studies, unfortunately, are complicated by the fact that fibroids themselves are very heterogeneous. It's a very heterogeneous condition. There's a lot of difference between the size of the uterine fibroids, the location and the bulk of the fibroid, and then there's also going to be the issue with age. If you have a woman who's older with uterine fibroids, obviously her age is also going to impact her fertility. We know that women with uterine fibroids tend to be older and that also impacts fertility. So that's going to have an impact on any research as well.
What we do know from some of the research to date is that it's well-known that submucosal fibroids impair fertility, that's well established. We do know that subserosal fibroids or the fibroids on the surface of the uterus do not impact uterine fibroids. The question that really hasn't been answered because there hasn't been adequate research and there's just not enough data of high quality is, whether intramural fibroids or fibroids inside the uterine muscle, whether they impact fertility.
Many women who have intramural uterine fibroids are asymptomatic. They don't have symptoms at all. So, the question is whether a woman should undergo an invasive procedure to remove that fibroid and if it’s going to help or not? That's one of the questions that we just don't have enough adequate research on because there are some limitations in the literature.
Q3. What are the current treatments, both surgical and nonsurgical, for patients with fibroids who may want to become pregnant?
I think if there's a patient, a woman with uterine fibroids who's interested in fertility, she may be a patient who is diagnosed with symptomatic fibroids, who wants to preserve her fertility, or she may be a patient who's an infertility patient who during her fertility evaluation discovers she has fibroids. It is important to determine whether treatment is appropriate for that patient, and as we just discussed, there's not a lot of answers in the literature for some patients. I think the most important thing to do first before deciding on a treatment is to determine the best type of treatment. At Johns Hopkins, for many of our patients with uterine fibroids, they'll undergo a pelvic MRI because the pelvic MRI can provide the most detailed information regarding the size and exact location of the uterine fibroids.
We then have a multidisciplinary conference every two weeks where we review the MRIs with a group of minimally invasive surgeons, interventional radiologists, and fertility specialist where we can really decide the best treatment for the individual patient. In deciding on a patient, it's important to make the right decision and have the most information. So as far as treatments that are available, for women who are wanting to preserve their fertility or planning to get pregnant very soon, the most common options are going to be surgical.
The least invasive surgical treatment would be a hysteroscopic myomectomy where we would do a hysteroscopy and remove the uterine fibroids by either shaving the pieces of the submucosal fibroid or we can remove it with a hysteroscopic morcellator. There are various techniques. But for the submucosal fibroids that are inside the uterine cavity, hysteroscopic myomectomy is very minimally invasive. It's an outpatient procedure. It's very safe and it's something that we will typically offer to patients who have submucosal fibroids.
For patients who have symptomatic uterine fibroids and may have bulk symptoms, or have numerous uterine fibroids, we typically would recommend either a laparoscopic robotic-assisted myomectomy, sometimes just a laparoscopic myomectomy, or for women who have the most severe, a very large fibroid uterus, let's say greater than 20 centimeters, they may actually need to undergo an exploratory laparotomy or abdominal myomectomy. For patients who have symptomatic subserosal fibroids and large intramural fibroids that need to be removed, it really depends on the size, location, and bulk of the uterine fibroids. And that's where the pelvic MRI becomes very useful.
I would say that for the majority of my patients that have a large amount of fibroids, are still able to undergo a robotic-assisted laparoscopic hysterectomy which oftentimes can be an outpatient procedure just because we've had this improvement in technology with robotic and laparoscopic surgery. But surgery can be very beneficial as far as removing the bulk of the uterine fibroids. And so that is typically our treatments that we would recommend for those who want future fertility or who are imminently trying to get pregnant.
There are medical treatments as well or non-surgical treatments such as GnRH analogs that can shrink the size of the uterine fibroids. Unfortunately, the uterine fibroids are still there and typically will still impact fertility. So that's not something that we do often for those that are actively trying to get pregnant. The same for uterine artery embolization or uterine fibroids embolization. We will not recommend that for patients who want to have future fertility because the fibroids will still be in that location and they're typically in a location that's impairing fertility.
Q4. How long do patients have to wait after a fibroid treatment to try to get pregnant?
The length of time that a patient needs to wait after having fibroids removed for surgical treatment typically depends on the type of surgery the patient undergoes as well as the size of the fibroids and the extent of the surgery. For a patient who's undergoing a hysteroscopic myomectomy, they typically only must wait a month or two. Once they're assessed that there's no residual fibroid that's left, then they can try to conceive.
For patients who need to undergo abdominal myomectomy or laparoscopic myomectomy, those are much more extensive procedures. Typically, surgeons will recommend a patient wait three to six months to try to conceive. It's also important for the surgeon to discuss with the patient the extent of the myomectomy and whether that patient, when she does become pregnant, will require a c-section because typically if the uterine cavity is entered or if there are multiple incisions on the uterus during the myomectomy surgery, surgeons will recommend a c-section for that patient when she does become pregnant to decrease the risk of uterine rupture. And typically, that will be documented in the operative note, but the surgeon will also counsel the patient regarding this.
New data illustrate pandemic pivot to telehealth by patients, physicians
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.
Mortality-related risk factors for hospitalized patients with COVID-19
Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.
Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.
Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.
Disclosures: The study did not receive any funding. The authors declared no conflict of interests.
Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.
Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.
Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.
Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.
Disclosures: The study did not receive any funding. The authors declared no conflict of interests.
Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.
Key clinical point: A meta-analysis has identified 10 key risk factors for mortality in hospitalized patients with COVID-19.
Major finding: The significant mortality-related risk factors in hospitalized patients with COVID-19 included older age, male sex, smoking, obesity, cardiovascular disease, diabetes, hypertension, chronic obstructive pulmonary disease, acute kidney injury, and elevated D-dimer levels.
Study details: The data come from a meta-analysis of 42 studies involving 423,117 patients with COVID-19.
Disclosures: The study did not receive any funding. The authors declared no conflict of interests.
Source: Dessie ZG et al. BMC Infect Dis. 2021 Aug 21. doi: 10.1186/s12879-021-06536-3.
COVID-19: Antibody cocktail effective in preventing household transmission
Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.
Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).
Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).
Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.
Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.
Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.
Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).
Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).
Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.
Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.
Key clinical point: A single subcutaneous dose of the antibody cocktail REGEN-COV (casirivimab plus imdevimab) is effective in preventing symptomatic and asymptomatic infection in household contacts of COVID-19-positive individuals.
Major finding: The antibody cocktail group developed fewer symptomatic SARS-CoV-2 infections than the placebo group (relative risk reduction, 81.4%). The antibody cocktail effectively prevented symptomatic and asymptomatic infections overall (relative risk reduction, 66.4%).
Study details: In a randomized, double-blind, placebo-controlled trial, unaffected household members (age, 12 years or older) of individuals testing positive for SARS-CoV-2 received either the antibody cocktail (n=753) or placebo (n=752).
Disclosures: The study was funded by Regeneron Pharmaceuticals, F. Hoffmann-LaRoche, and the National Institutes of Health. Several authors were employees and/or stockholders of Regeneron Pharmaceuticals.
Source: O'Brien MP et al. N Engl J Med. 2021 Aug 4. doi: 10.1056/NEJMoa2109682.
Hospitalized COVID-19 patients with cardiometabolic risk do not benefit from dapagliflozin
Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.
Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.
Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).
Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.
Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.
Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.
Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).
Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.
Key clinical point: Dapagliflozin does not improve COVID-19 hospitalization outcomes for patients with cardiometabolic risk factors.
Major finding: Dapagliflozin vs placebo failed to meet the primary composite outcome of organ dysfunction or all-cause death (hazard ratio, 0.80; 95% confidence interval, 0.58-1.10). There was no difference in the rates of new/worsened organ dysfunction, deaths, or clinical improvement between the groups.
Study details: In the DARE-19 phase 3 trial, patients were randomly assigned to receive either dapagliflozin (n=625) or placebo (n=625).
Disclosures: The study was funded by AstraZeneca. R Esterline, J Oscarsson, SB Gasparyan, J Buenconsejo, AM Langkilde, and P Ambery are employees and stockholders of AstraZeneca. M Aboudara, E Akin, WKS Barroso, ADM Feitosa, CRH Filho, A Fonseca, K Gosch, RA Gordon, CP Jaeger, LN Maia, DDF Moia, JRL Soto, F Tang, SL Windsor, O Mukhtar, V Chopra, RVP Soares, V Garla, PE Leaes, FS Silveira, and M Pursley declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Kosiborod MN et al. Lancet Diabetes Endocrinol. 2021 Jul 21. doi: 10.1016/S2213-8587(21)00180-7.
Canakinumab fails to improve survival in hospitalized patients with severe COVID-19
Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.
Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).
Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).
Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.
Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.
Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.
Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).
Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).
Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.
Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.
Key clinical point: Canakinumab does not improve survival in hospitalized patients with severe COVID-19.
Major finding: There was no significant difference in survival without invasive mechanical ventilation between days 3 and 29 with canakinumab vs. placebo (88.8% vs. 85.7%; rate difference, 3.1 percentage points; 95% confidence interval [CI], −3.1 to 9.3). COVID-19 mortality also did not differ with canakinumab vs. placebo (4.9% vs 7.2%; rate difference, −2.3 percentage points; 95% CI, −6.7 to 2.2).
Study details: The data come from the randomized, double-blind, placebo-controlled phase 3 CAN-COVID trial (n=454).
Disclosures: The study was sponsored by Novartis Pharma AG, Basel, Switzerland. All authors received funding from Novartis during the conduct of the study. The authors also reported relationships with other pharmaceutical companies.
Source: Caricchio R et al. JAMA. 2021 Jul 20. doi: 10.1001/jama.2021.9508.
COVID-19: Inhaled budesonide may shorten recovery time
Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.
Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.
Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).
Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.
Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.
Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.
Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.
Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).
Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.
Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.
Key clinical point: Inhaled budesonide is associated with a shorter time to recovery but fails to reduce the risk for hospitalization or death in high-risk primary care patients with COVID-19.
Major finding: Budesonide vs usual care was associated with a shorter time to recovery (11.8 days vs 14.7 days). Budesonide was associated with a nonsignificant 2.0% reduction in hospitalization or death compared with usual care.
Study details: The data come from the PRINCIPLE trial, where 2,530 patients were randomly assigned to either inhaled budesonide (n=787), usual care alone (n=1,069), or usual care plus other interventions (n=674).
Disclosures: The study was funded by the National Institute of Health Research and United Kingdom Research Innovation. M Bafadhel, D Richards, BR Saville, N Berry, MA Detry, M Fitzgerald, S de Lusignan, MI Andersson, PJ Barnes, REK Russell, S Ramakrishnan, FDR Hobbs, and CC Butler reported relationships with pharmaceutical companies and/or research institutions. The remaining authors declared no conflict of interests.
Source: Yu LM et al. Lancet. 2021 Aug 10. doi: 10.1016/S0140-6736(21)01744-X.
COVID-19: Pulmonary embolism not tied to increased mortality risk
Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.
Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).
Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.
Disclosures: No funding information was available. The authors declared no conflict of interests.
Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.
Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.
Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).
Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.
Disclosures: No funding information was available. The authors declared no conflict of interests.
Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.
Key clinical point: Presence of pulmonary embolism (PE) is not associated with increased mortality in patients with COVID-19 risk.
Major finding: Risk factors for PE in patients with COVID-19 included male sex, mechanical ventilation, intensive care unit admission, and circulating D-dimer. Patients with PE did not have an increased risk for mortality compared with those without PE (odds ratio, 1.31; P = .25).
Study details: The data come from a meta-analysis of 16 cohort studies involving 5,826 patients with COVID-19.
Disclosures: No funding information was available. The authors declared no conflict of interests.
Source: Gómez CA et al. Sci Rep. 2021 Aug 6. doi: 10.1038/s41598-021-95512-7.
COVID-19: Early administration of plasma fails to prevent disease progression
Key clinical point: Administration of convalescent plasma within 7 days of symptom onset fails to prevent disease progression in acutely ill, high-risk patients with COVID-19.
Major finding: There was no difference between the convalescent plasma group and the placebo group in disease progression (30.0% vs 31.9%; risk difference, 1.9 percentage points; 95% credible interval, −6.0 to 9.8).
Study details: The multicenter, single-blind SIREN-C3PO trial included patients with COVID-19 (n=511) randomly assigned to receive either plasma or placebo in the emergency department.
Disclosures: The study was supported by the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Operation Warp Speed interagency program. D Beiser, A Burnett R Davenport, L Dumont, V Durkalski-Mauldin, N El Kassar, L Foster, C Greineder, N Haas, J Hah, A Kaplan, B Kea, F Korley, E Lowell, J McDyer, J Quinn, J Reynolds, R Silbergleit, C Van Huysen, and K Yadav declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Korley FK et al. N Engl J Med. 2021 Aug 18. doi: 10.1056/NEJMoa2103784.
Key clinical point: Administration of convalescent plasma within 7 days of symptom onset fails to prevent disease progression in acutely ill, high-risk patients with COVID-19.
Major finding: There was no difference between the convalescent plasma group and the placebo group in disease progression (30.0% vs 31.9%; risk difference, 1.9 percentage points; 95% credible interval, −6.0 to 9.8).
Study details: The multicenter, single-blind SIREN-C3PO trial included patients with COVID-19 (n=511) randomly assigned to receive either plasma or placebo in the emergency department.
Disclosures: The study was supported by the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Operation Warp Speed interagency program. D Beiser, A Burnett R Davenport, L Dumont, V Durkalski-Mauldin, N El Kassar, L Foster, C Greineder, N Haas, J Hah, A Kaplan, B Kea, F Korley, E Lowell, J McDyer, J Quinn, J Reynolds, R Silbergleit, C Van Huysen, and K Yadav declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Korley FK et al. N Engl J Med. 2021 Aug 18. doi: 10.1056/NEJMoa2103784.
Key clinical point: Administration of convalescent plasma within 7 days of symptom onset fails to prevent disease progression in acutely ill, high-risk patients with COVID-19.
Major finding: There was no difference between the convalescent plasma group and the placebo group in disease progression (30.0% vs 31.9%; risk difference, 1.9 percentage points; 95% credible interval, −6.0 to 9.8).
Study details: The multicenter, single-blind SIREN-C3PO trial included patients with COVID-19 (n=511) randomly assigned to receive either plasma or placebo in the emergency department.
Disclosures: The study was supported by the National Institutes of Health, the Biomedical Advanced Research and Development Authority, and the Operation Warp Speed interagency program. D Beiser, A Burnett R Davenport, L Dumont, V Durkalski-Mauldin, N El Kassar, L Foster, C Greineder, N Haas, J Hah, A Kaplan, B Kea, F Korley, E Lowell, J McDyer, J Quinn, J Reynolds, R Silbergleit, C Van Huysen, and K Yadav declared no conflict of interests. The remaining authors disclosed relationships with pharmaceutical companies and/or research institutions.
Source: Korley FK et al. N Engl J Med. 2021 Aug 18. doi: 10.1056/NEJMoa2103784.
Baricitinib plus standard of care may reduce mortality risk in hospitalized patients with COVID-19
Key clinical point: Addition of baricitinib to standard of care treatment may reduce 28-day mortality risk in patients hospitalized with COVID-19, but does not significantly reduce the frequency of disease progression.
Major finding: There was a 38.2% relative reduction in 28-day all-cause mortality risk with baricitinib vs placebo. There was no significant difference between the baricitinib and placebo groups in the primary composite endpoint of disease progression outcomes (odds ratio, 0.85; P = .18).
Study details: In a phase 3, double-blind trial, hospitalized patients with COVID-19 receiving standard of care were randomly assigned to either baricitinib (n=764) or placebo group (n=761).
Disclosures: The study was funded by Eli Lilly and Company. S de Bono, CE Kartman, V Krishnan, R Liao, MLB Piruzeli, A Cardose, S Chakladar, B Crowe, P Reis, X Zhang, and DH Adams are employees and shareholders of Eli Lilly and Company. RD Pellegrini declared no conflict of interests. Other authors reported relationships with pharmaceutical companies including Eli Lilly and Company.
Source: Marconi VC et al. Lancet Respir Med. 2021 Sep 1. doi: 10.1016/S2213-2600(21)00331-3.
Key clinical point: Addition of baricitinib to standard of care treatment may reduce 28-day mortality risk in patients hospitalized with COVID-19, but does not significantly reduce the frequency of disease progression.
Major finding: There was a 38.2% relative reduction in 28-day all-cause mortality risk with baricitinib vs placebo. There was no significant difference between the baricitinib and placebo groups in the primary composite endpoint of disease progression outcomes (odds ratio, 0.85; P = .18).
Study details: In a phase 3, double-blind trial, hospitalized patients with COVID-19 receiving standard of care were randomly assigned to either baricitinib (n=764) or placebo group (n=761).
Disclosures: The study was funded by Eli Lilly and Company. S de Bono, CE Kartman, V Krishnan, R Liao, MLB Piruzeli, A Cardose, S Chakladar, B Crowe, P Reis, X Zhang, and DH Adams are employees and shareholders of Eli Lilly and Company. RD Pellegrini declared no conflict of interests. Other authors reported relationships with pharmaceutical companies including Eli Lilly and Company.
Source: Marconi VC et al. Lancet Respir Med. 2021 Sep 1. doi: 10.1016/S2213-2600(21)00331-3.
Key clinical point: Addition of baricitinib to standard of care treatment may reduce 28-day mortality risk in patients hospitalized with COVID-19, but does not significantly reduce the frequency of disease progression.
Major finding: There was a 38.2% relative reduction in 28-day all-cause mortality risk with baricitinib vs placebo. There was no significant difference between the baricitinib and placebo groups in the primary composite endpoint of disease progression outcomes (odds ratio, 0.85; P = .18).
Study details: In a phase 3, double-blind trial, hospitalized patients with COVID-19 receiving standard of care were randomly assigned to either baricitinib (n=764) or placebo group (n=761).
Disclosures: The study was funded by Eli Lilly and Company. S de Bono, CE Kartman, V Krishnan, R Liao, MLB Piruzeli, A Cardose, S Chakladar, B Crowe, P Reis, X Zhang, and DH Adams are employees and shareholders of Eli Lilly and Company. RD Pellegrini declared no conflict of interests. Other authors reported relationships with pharmaceutical companies including Eli Lilly and Company.
Source: Marconi VC et al. Lancet Respir Med. 2021 Sep 1. doi: 10.1016/S2213-2600(21)00331-3.