User login
Cerclage in twin pregnancies reduces perinatal mortality in randomized trial
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
according to a randomized controlled trial. The trial, which was published in the American Journal of Obstetrics and Gynecology, included 30 patients at 8 centers. The investigators stopped the trial early because perinatal mortality occurred more often in the group that did not receive the intervention.
The research suggests that a combination of physical exam–indicated cerclage, indomethacin, and antibiotics decreased the incidence of spontaneous preterm birth and prolonged the period from diagnosis to delivery by an average of 5.6 weeks, compared with no cerclage.
“We’ve already incorporated this cerclage into our practice and have been able to offer this to pregnant mothers with twins with great success,” senior author Vincenzo Berghella, MD, said in a news release.
“These results have the potential to change practice and help many more women have healthy twin babies,” said Dr. Berghella, director of the division of maternal fetal medicine at Thomas Jefferson University in Philadelphia.
A shift in perspective
More research is needed to establish a standardized approach, but the trial should “open physicians’ perspectives to think about how, in selected cases and with the proper approach, cerclage can work well,” said Ozhan M. Turan, MD, PhD, director of the division of maternal and fetal medicine and director of fetal therapy and complex obstetric surgery at University of Maryland in Baltimore.
Although many physicians use cerclage for twin pregnancies in select situations, the practice is not well established. “If you look at the guidelines or books, mostly everyone thinks that doing a cerclage in twins is not a good idea,” Dr. Turan said in an interview.
In the present trial, the researchers controlled for many factors and carefully selected patients with no signs of preterm labor or infection. It is not simply a matter of saying, “Do the stitch,” he said. “But it is proven: if you select patients well and use the appropriate approach, then you could improve the outcome.”
The study is the first randomized controlled trial of physical exam–indicated cerclage focused on twins, according to its authors. It enrolled patients between July 2015 and July 2019. In the end, the researchers analyzed data from 30 pregnancies, rather than the originally intended 52. They stopped the trial after a data and safety monitoring board considered it “unethical to continue the study due to the considerable perinatal mortality in one of the arms ... and requested to unmask the arms of the study,” the researchers said.
Perinatal mortality occurred in 18% of neonates in the cerclage group (6 of 34), compared with 77% in the group without cerclage (20 of 26). All perinatal mortality cases were associated with delivery before 24 weeks.
“The small number of participants reflects how rare this condition is among all pregnancies,” first author Amanda Roman, MD, of the division of maternal fetal medicine at Thomas Jefferson University, Philadelphia, said in the news release. “But because women were randomized to treatment and nontreatment groups, the results are strong, as confirmed by the independent data and safety monitoring board.”
The researchers enrolled women with twin pregnancies and asymptomatic cervical dilation from 1 to 4 cm before 24 weeks. Exclusion criteria included monochorionic-monoamniotic pregnancy, selective fetal growth restriction, twin-twin transfusion syndrome, major fetal malformation, known genetic anomaly, placenta previa, signs of labor, or clinical chorioamnionitis.
In all, 17 women were randomized to cerclage and 13 to the no-cerclage group. Both groups had similar patient characteristics. About 93% of the twin gestations were diamniotic-dichorionic. Assisted reproductive technology was used by about 36% of the participants, and 20% had a history of singleton preterm birth. Four women assigned to cerclage did not undergo the procedure but were included in the intention-to-treat analysis. Two of the four patients had contraindications that occurred soon after randomization (rupture of amniotic membranes and vaginal bleeding), one had a friable cervix, and one declined cerclage after being randomized.
Spontaneous preterm birth before 34 weeks of gestation, the primary outcome, occurred in 12 of 17 women in the cerclage group and in all 13 women in the no-cerclage group (70% vs. 100%).
Trial to assess ultrasound indicated cerclage
“Expectant management with no cerclage is the current standard of care for these women,” Dr. Roman and coauthors wrote. “Despite small sample size, we were able to show a significant benefit to physical exam–indicated cerclage.”
Inability to place the cerclage in one patient due to friable cervix was the only intraoperative complication. “Larger cohorts in singleton pregnancies have informed a 10%-20% risk of intraoperative rupture of the membranes, cervical laceration, and bleeding during the procedure,” the researchers noted.
All women who received cerclage also received indomethacin and antibiotics, although these elements of management were not prespecified. Given the relatively small sample size, it is unclear what role factors such as indomethacin, which was administered to 82% of the cerclage group versus 31% of the no-cerclage group, and antibiotics may have played, said Dr. Turan.
Prospective studies may help clarify how the degree of cervical dilation, gestational age, use of progesterone, or surgical techniques may influence outcomes. In addition, the researchers are enrolling patients in another trial. That study aims to assess whether cerclage reduces the incidence of spontaneous preterm birth in asymptomatic women with twin gestations and cervical length of 15 mm or less diagnosed by transvaginal ultrasound between 16 and 24 weeks of gestation.
The study had no external financial support. The authors had no conflicts of interest. Dr. Turan said he had no relevant financial disclosures.
SOURCE: Roman A et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.047.
FROM THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY
Stillbirth incidence increases during COVID-19 pandemic
The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.
“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.
To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.
Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).
None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.
“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.
She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.
“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”
“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”
The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”
One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.
SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.
The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.
“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.
To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.
Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).
None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.
“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.
She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.
“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”
“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”
The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”
One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.
SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.
The incidence of stillbirth has increased since the COVID-19 pandemic began, according to a comparative study of pregnancy outcomes in a London hospital.
“The increase in stillbirths may have resulted from indirect effects such as reluctance to attend hospital when needed (e.g., with reduced fetal movements), fear of contracting infection, or not wanting to add to the National Health Service burden,” Asma Khalil, MD, of St George’s University of London and coauthors reported in JAMA.
To further assess reported changes in stillbirth and preterm delivery rates during the pandemic, the researchers began a retrospective study of pregnancy outcomes at St George’s University Hospital in London. They compared two periods: from Oct. 1, 2019, to Jan. 31, 2020 as the pre–COVID-19 period and from Feb. 1, 2020, to June 14, 2020 as the pandemic period. The median age of the mother at time of birth in both periods was 33 years. The prepandemic period had 1,681 births, and the pandemic period had 1,718 births.
Although there were found to be fewer nulliparous women and fewer women with hypertension in the pandemic period, the incidence of stillbirth in that period was significantly higher (n = 16 [9 per 1,000 births]) than in the prepandemic period (n = 4 [2 per 1,000 births]) (difference, 7 per 1,000 births; 95% confidence interval, 1.83-12.0; P = .01). The pandemic rate remained higher when late terminations for fetal abnormality were excluded (difference 6 per 1,000 births; 95% CI 1.54-10.1; P = .01).
None of the pregnant women who experienced stillbirth had COVID-19 symptoms, and none of the postmortems or placental exams indicated infection. There were no significant differences between the two periods in regard to births before 37 weeks’ gestation, births after 34 weeks’ gestation, neonatal unit admission, or cesarean delivery.
“It’s very important to highlight the effects of the pandemic on pregnant patients, even if they’re not infected with COVID-19,” Shannon Clark, MD, of the University of Texas Medical Branch in Galveston said in an interview.
She noted several COVID-related considerations that could have contributed to this increase: the reluctance of both low-risk and high-risk patients to enter a hospital setting during a pandemic, along with safety-centered changes made in antenatal services and care, which includes a reduced number of ultrasounds and screening exams.
“Checking a patient’s blood pressure, checking their weight changes, checking how the baby is growing,” she said. “They’re all simple things that just can’t be done via telemedicine.”
“We’ve thought a lot about the potential effects of getting COVID in pregnancy,” she added, “but it’s just as important to think about what might happen to those who don’t have it and are considered low risk otherwise.”
The study authors noted its limitations, including it being retrospective, analyzing a short time frame, and focusing on a single medical center. It also didn’t factor in the causes of the stillbirths, nor were the time periods precisely comparable, although they did add that “there is no seasonality to stillbirths in the UK.”
One doctor reported receiving grants outside of the submitted work. No other potential conflicts of interest were noted. Dr. Clark said she had no relevant financial disclosures.
SOURCE: Khalil A et al. JAMA. 2020 Jul. doi: 10.1001/jama.2020.12746.
FROM JAMA
Exposing hospital gowns
Bare bottoms, bare minimum
“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.1 Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”1-3
Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.8
Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”
It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.9 By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.9 Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.10
In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.9 In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.9 For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.
Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.11 One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).12-15
In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”15
The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.
Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”16 They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.16 Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”16 However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).1
Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!1-3
Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.
With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”17
Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”3
This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.
Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at clucas3@alumni.nd.edu. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.
References
1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.
2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.
3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.
4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.
5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.
6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.
7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.
8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.
9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.
10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.
11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.
12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.
13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.
14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.
15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.
16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.
17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.
Bare bottoms, bare minimum
Bare bottoms, bare minimum
“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.1 Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”1-3
Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.8
Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”
It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.9 By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.9 Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.10
In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.9 In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.9 For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.
Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.11 One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).12-15
In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”15
The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.
Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”16 They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.16 Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”16 However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).1
Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!1-3
Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.
With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”17
Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”3
This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.
Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at clucas3@alumni.nd.edu. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.
References
1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.
2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.
3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.
4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.
5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.
6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.
7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.
8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.
9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.
10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.
11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.
12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.
13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.
14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.
15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.
16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.
17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.
“Don’t let the gown get you down,” was the advice a 26-year-old gentleman with leukemia offered in a study investigating the psychosocial impact of hospital gowns on patients and providers.1 Patients were found to be resigned to their “uncomfortable,” “expos[ing],” “nightmare-[ish]” “uniform,” afraid to even ask to wear more dignifying attire for fear of seeming difficult to providers and potentially harming the therapeutic relationship; one 64-year-old woman with terminal cancer detailed, “I have my own pajamas at home, but I don’t bring them because you can’t wear them here … [wearing a gown] is really not fun, but hey, this is what [providers] have to do, so it’s what you have to do.”1-3
Research has consistently shown that patients are vulnerable to dehumanization and loss of identity in the hospital, often exacerbated by wearing the standard hospital gown.3-8 Case in point, a mixed-methods study revealed that hospital gowns may lead to an increased sense of exposure, discomfort, disempowerment, and embarrassment for patients during a period of potential vulnerability while undergoing medical intervention.8
Hospital gowns strip autonomy from individuals humbly coming to the hospital for help. The gown has become a linchpin of change, initiating the dehumanizing process of “person” to “patient.” One of the main problems with the hospital gown is its exposing nature, often made light of on the wards with the joke, “Do you know who invented the hospital gown?…See-more Hiney!” The joke continued in two Super Bowl LIII commercials for a large academic health care system and insurance provider in Pennsylvania, depicting a construction worker and businessman clad in hospital gowns, mooning their less-than-pleased coworkers, to inform patients of expanded insurance coverage, i.e., “completely covered.” Hospital gowns are also a source of comedic fodder on sitcoms, including “It’s Always Sunny in Philadelphia,” “Man with a Plan,” and “Carol’s Second Act.”
It is common knowledge that hospital gowns are flawed, but very little has been done to change them. Little is known about the origin of hospital gowns, and like their design, their history has many gaps. PubMed, Google, and Wikipedia yield no fruitful insight into the evolution of the hospital gown, and perhaps the best way to understand the hospital gown over time is to watch depictions of patients in television sitcoms, dramas, and movies, ranging from the days of black-and-white into the modern era, and view artistic depictions of hospitals across eras. Case in point, depictions of fourteenth century hospital wards in art show that all patients wore night shirts, under which they also wore some type of underclothing.9 By the end of the 1800s and beginning of the 1900s, pajamas for men became more common as hospital attire.9 Although it is not known who originally invented the traditional hospital gown, the original gown was designed around a century ago with an open back for use on patients admitted the night prior to surgery, who were sedated prior to transfer to the anesthetic room while half-asleep.10
In general, the most common reason that hospitals began to provide, require, or offer clothing to patients was to reduce infection and improve hygiene, as clothing can be ruined by leakage of bodily fluids from various examinations, treatments, and procedures.9 In addition, in certain settings, lifesaving measures require access to the naked body to allow equipment, like a defibrillator, to be connected to the patient; a gown can theoretically be removed quickly.9 For some reason along the way, the simple, open-backed “johnny” gown of the early 20th century became standard of care with minimal meaningful modifications in the last hundred years. One possible explanation for the persistence of the “johnny” gown is that in past eras of medicine, patients in gowns were expected to be bedbound for recovery, keeping their bare bottom under wraps, and this norm became the status quo. Today, ambulation is encouraged in patients as part of venous thromboembolism (VTE) prophylaxis but the gown design has fallen behind.
Modern medicine emphasizes, values, and even advertises evidence-based medicine, patient-centered care, and high-quality care, yet the hospital gown stands as a stark contrast to this pledge to move forward as beacons of change. Hospital gowns have fallen outside of the scope of evidence-based research.11 One may ask why the gown remains decades behind modern medicine, and it appears that this apathy stems from (1) accepting “medical tradition” and choosing to overlook the flaws of the current hospital gown, and (2) believing that changing the hospital gown would cost money, affronting an institution’s almighty bottom-line. Still, several institutions have attempted change, including Hackensack University Medical Center partnering with Cynthia Rowley and Nicole Miller (1999), Cleveland Clinic partnering with Diane von Furstenberg (2010), and Henry Ford Health System of Detroit’s “Model G” gown (2016).12-15
In spite of these efforts to revamp the hospital gown at academic medical centers, change has been neither long lasting nor widely disseminated. Traci Lamar, a professor at the North Carolina State University College of Textiles reasoned that, “There are number of pressures in the hospital environment that influence what they purchase and when they purchase. Cost management, inventory management, storage space. ... There’s more value coming with the apparel item if it also becomes something that replaces or enhances other equipment that’s used in the hospital environment. Like a gown that can also keep an eye on your blood pressure or measure your heart rate.”15
The hospital gown remains a poor attempt at proper attire for human beings, with the most similar evolutionary relative being a hairdresser’s cape. Taken a step further, functionally the hospital gown is most similar to a prison uniform. Although this may seem bold and sensational, one must stop and think about it, considering the parallels. When individuals are admitted to the hospital, they exchange their clothing for a hospital gown, so that they can be easily identified as a “patient” and remain safe in the hospital. When individuals are sentenced to prison, they exchange their clothing for a uniform, so that they can be easily identified as a “prisoner” and remain safe in jail. The problem is, more time, money, and effort has gone into designing prisoners’ garments, who expect a loss of autonomy, than designing patients’ garments, who should never expect a loss of autonomy.
Prison uniforms are designed with safety in mind, ensuring the absence of potential ligatures or improvised weapons. The United Nations even passed an amendment to its Standard Minimum Rules for the Treatment of Prisoners in 2015, prohibiting humiliating clothing and requiring every prisoner who is “not allowed to wear his or her own clothing” to “be provided with an outfit of clothing suitable for the climate and adequate to keep him or her in good health.”16 They also stipulated that prisoners’ clothing could not be degrading or humiliating and was mandated to “be clean and kept in proper condition”.16 Even more compelling, a physician was bequeathed the task of inspecting, and advising the prison director on “the suitability and cleanliness of the prisoners’ clothing and bedding.”16 However, there are no standard minimum rules for hospital patients’ clothing. Hospital gowns have been described as “threadbare,” “one-size-fits-none,” “stained,” and “drafty,” antithetical to both hygiene and the hospital climate – far from “proper condition” (See Figure 1).1
Where are the standard minimum rules for hospital gowns? Patients have admittedly wondered, “What happened to the person who wore this gown before I did?” or worse, “Who died in this gown?” Even more, the current hospital gown can unintentionally put a patient in harms’ way, posing a fall risk for patients with petite frames overwhelmed by the bulk of the gown and also inhibiting fast access to the chest for placement of defibrillation pads in a code. Ironically, prison uniforms have the main things patients have requested: bottoms, modesty, multiple sizes, and … color!1-3
Although jailhouse orange or stripes are unlikely to be high fashion in the hospital, it is important to consider that, through indifference about the current hospital gown, institutions are teaching that it is acceptable for patients to wear this dehumanizing garment analogous to a prison uniform, except less colorful and more exposing. The hospital gown has persisted under the myth of medical tradition, masking the fact that there is neither evidence for the current hospital gown design nor data to support its functional success for patients or providers.3,12,14 Silence speaks volumes, and patients are taught to expect and accept a loss of dignity without questioning this archaic aspect of medical culture. Patients, nurses, and physicians do not challenge the status quo because the hospital gown “is the way it has always been done.” Perceived added-cost and medical tradition have further perpetuated the current open-backed hospital gown because meaningful change would require money.
With that said, “double gowning,” the method hospitals have used to combat lunar eclipses in the hallways and provide a semblance of dignity to patients, is already costing hospitals more money, costs that can be reduced by creating an evidence-based, patient-guided, provider-approved design. As Mike Forbes, the product designer and licensing associate for the Model G gown, argued, “By using two, you’re purchasing two gowns because one doesn’t do the job, which costs money. … If you’re washing twice as many gowns as you need, you’re spending twice as much money as you need on laundry.”17
Thus, improvements can be made without breaking the bank and may even save hospitals money in the long run. For instance, a hospital administrator can order more colors or styles of hospital gowns and bottoms to give patients a choice of what they would prefer to wear: a small piece of autonomy in an environment where minimal autonomy exists. A physician or nurse can not only permit, but also encourage, a patient to wear his or her own attire within reason, for example, a loose-fitting t-shirt and sweatpants from home or pajama pants under a hospital gown. More complex solutions could include a community design contest for a medical center’s new hospital gown print, or even bolder, a community design contest for a medical center’s new inpatient attire. Above all, patients need to know that hospitals and providers care about what patients wear in the hospital. As a terminally ill patient suggested, “maybe all administrators and office staff should have to spend one day in a gown. …They advertise this: ‘We always put the patient first.’ Okay, so then I guess you have to put your money where your mouth is.”3
This new decade offers the opportunity to give patients a sense of dignity back and make concerted, evidence-based efforts towards meaningful and sustainable change in patient attire, be it purchasing more colorful and modest gown options in the present or total redesign in the future. The financial cost may seem burdensome, but the reward would be immensely bountiful. It is time to stop making hospital gown–clad patients’ exposed bottoms the butt of the joke, and the only way to change the punchline is to change the hospital gown. Patients deserve more than the bare minimum and a bare bottom, so hospitals must consider putting their money where their mouth is.
Dr. Lucas is based in the department of pediatrics, University of Pittsburgh Medical Center Children’s Hospital of Pittsburgh. She has a provisional utility patent pending for a novel patient gown. You can contact her at clucas3@alumni.nd.edu. Dr. Dellasega is based in the department of humanities, Penn State University, Hershey.
References
1. Lucas C et al. “Don’t let the gown get you down: How patients and providers perceive hospital gowns.” Abstract published at Hospital Medicine 2019, Mar 24-27, National Harbor, Md., Abstract 322.
2. Lucas C and Dellasega C. “You don’t have to be dying to do comfort measures: Patients’ and physicians’ perceptions of inpatient attire.” Abstract published at ACP Internal Medicine 2019, Apr 11-13, Philadelphia, Abstract.
3. Lucas C and Dellasega C. Finding common threads: How patients, physicians, and nurses perceive the patient gown. Patient Exp J. 2020;7(1):51-64.
4. Detsky A and Krumholtz H. Reducing the trauma of hospitalization. JAMA. 2014;311(21):2169-70.
5. Krumholz H. Post-hospital syndrome – an acquired, transient condition of generalized risk. N Engl J Med. 2013;368(2):100-2.
6. Wellbery C and Chan M. White coat, patient gown. Med Humanit. 2014;40(2):90-6.
7. McDonald E et al. Inpatient attire: An opportunity to improve the patient experience. JAMA Intern Med. 2014;174(11):1865-67.
8. Cogan N et al. Mixed methods study exploring the impact of the hospital gown on recovery and wellbeing: Implications for policy and practice. Lancet. 2019. doi: 10.1016/S0140-6736(19)32829-6.
9. Bergbom I, Pettersson M, and Mattsson E. Patient clothing – practical solution or means of imposing anonymity? J Hosp Med Manage. 2017;3(22):1-6.
10. Who invented the hospital gown? Interweave Healthcare. Accessed Mar 30, 2020.
11. Gordon L and Guttmann S. A user-centered approach to the redesign of the patient hospital gown. Fashion Practice. 2013;5(1):137-51. doi: 10.2752/175693813X13559997788961.
12. Limbong A. “Can a Patient Gown Makeover Move Hospitals to Embrace Change?” NPR. 2018 Feb 11. Accessed Mar 26, 2020.
13. Schiro A. “Patterns: Hospital Style.” New York Times. 1999 June 29. Accessed Mar 26, 2020.
14. Luthra S. “Hospital Gowns Get a Makeover.” The Atlantic. 2015 Apr 4. Accessed Mar 26, 2020.
15. Tien E. “Hospital Gowns Get a Life.” New York Times. 1998 Oct 18. Accessed Mar 26, 2020.
16. McCall-Smith K. United Nations Standard Minimum Rules for the Treatment of Prisoners (Nelson Mandela Rules). Int Leg Materials. 2016;55(6),1180-205.
17. Green C. “Updated hospital gowns a good investment, execs say, restore ‘dignity.’ ” Healthcare Finance. 2015 Aug 3. Accessed Apr 1, 2020.
Intraventricular methotrexate may improve survival for medulloblastoma subtypes
according to research published in the Journal of Clinical Oncology.
Investigators conducted a prospective trial of 87 children diagnosed with nonmetastatic medulloblastoma before the age of 4 years who were treated from 2001-2011.
At 5 years after diagnosis, the 42 DMB/MBEN patients had a 93% progression-free survival (PFS) rate, a 100% overall survival (OS) rate, and a 93% craniospinal irradiation (CSI)–free survival rate.
“Our results suggest that ... poor outcomes of patients treated with systemic chemotherapy alone can be improved by the addition of intraventricular [methotrexate],” wrote Martin Mynarek, MD, of the University Medical Center Hamburg-Eppendorf (Germany), and colleagues.
However, it was a different story for the 45 patients with classic medulloblastoma (CMB) or large-cell/anaplastic medulloblastoma (CLA), in which outcomes are historically worse. At 5 years, the PFS was 37%, the OS was 62%, and the CSI-free survival was 39% in these patients.
In 2006, the CMB and CLA patients started receiving local radiotherapy in addition to chemotherapy and intraventricular methotrexate, but the radiotherapy did not seem to help with their disease.
“Because data suggest no effects, or even adverse effects, of local radiotherapy, additional development of this approach does not seem justified,” the investigators wrote.
“Interestingly, almost all patients with CMB/LCA had distant or combined relapses after local radiotherapy,” they added. “One might speculate that local radiotherapy reduced disease burden of the primary tumor and subclinical metastasis in the posterior fossa, leading to a survival advantage of distant subclinical metastasis over local residues.”
Treatment details
The 87 patients were enrolled in the BIS4 arm of the HIT 2000 trial (NCT00303810), which was designed to test six protocols and identify the optimal approach for treating young patients with medulloblastoma, supratentorial primitive neuroectodermal tumor, or ependymoma.
Patients started “HIT-SKK” chemotherapy within 2-4 weeks of surgery. They received three cycles of intravenous cyclophosphamide, vincristine, methotrexate (followed by leucovorin rescue after 42 hours), carboplatin, and etoposide, with concomitant intraventricular methotrexate, for a duration of 6 months (Neuro Oncol. 2011 Jun;13[6]:669-79).
Among patients who achieved a complete remission, treatment was ended after two additional cycles of chemotherapy. For other patients, secondary surgery, radiotherapy, and consolidation chemotherapy were recommended.
Starting in 2006, DMB and MBEN patients without complete remissions, as well as those with CMB or LCA, received 54 Gy of focal radiotherapy to the tumor bed after the first three treatment cycles.
SHH-I vs. SHH-II DMB/MBEN
DNA methylation profiling was available for 50 of the 87 patients in this analysis, 28 of whom had infantile sonic hedgehog (SHH)–activated DMB/MBEN. Data from these 28 patients – and 71 patients in a validation cohort – revealed no significant difference in 5-year PFS or OS based on methylation subtype.
The 5-year PFS was 73% in SHH-I patients and 83% in SHH-II patients (P = .25). The 5-year OS was 88% and 97%, respectively (P = .099).
“This suggests that the higher risk of relapse in the less favorable [SHH-I subtype] can be abrogated by the addition of intraventricular [methotrexate] to systemic chemotherapy,” the investigators wrote.
The results suggest SHH-I patients “markedly benefit” from the addition of intraventricular chemotherapy, according to the authors of a related editorial, Giles Robinson, MD, and Amar Gajjar, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn.
“However, cross-trial comparison of PFS among the SHH-II subtype does not suggest that SHH-II patients derive the same benefit,” the editorialists wrote.
These data divide SHH medulloblastoma into SHH-I, which benefits from chemotherapy with intraventricular methotrexate, and SHH-II, which can be cured without intraventricular methotrexate, high-dose chemotherapy, or focal radiotherapy, according to the editorialists.
This new information might prompt investigation of a risk-adapted approach. SHH-II patients would receive a reduced-intensity regimen with systemic chemotherapy only, and SHH-I patients would receive systemic chemotherapy combined with intraventricular methotrexate. This could avoid exposing young children to “more intensive therapy than necessary,” according to the editorialists.
Non-WNT/non-SHH disease
Patients with non-WNT/non-SHH medulloblastoma (CMB or LCA) were divided into molecularly defined subtypes group 3 (n = 14) and group 4 (n = 6). The patients in group 3 had lower survival rates than patients in group 4. The 5-year PFS rate was 36% and 83%, respectively (P < .001 ). The 5-year OS rate was 49% and 100%, respectively (P < .001).
“This represents the third recent publication to describe a poor PFS for group 3, and it signals a desperate need for better therapy,” the editorialists wrote. As for the “encouraging” survival rate for group 4 patients, there were only six subjects, which makes this finding “worthy of follow-up but not actionable.”
Even so, the investigators noted that “although poor survival has been reported for non-SHH CMB/LCA in almost every series of patients treated with CSI-sparing approaches, again, use of intraventricular [methotrexate] might be associated with slightly higher PFS, compared with conventional chemotherapy alone.”
As expected, IQ was significantly lower in patients who received CSI salvage. The mean IQ was 74 in patients who received CSI and 90 in patients who did not (P = .012). Neurocognitive outcomes were poor in general among CMB/LCA survivors, “which was closely related to use of radiotherapy,” according to the investigators.
“It is important to recognize that these studies were not designed to define outcome on the basis of molecular subgroup or subtype and that the sample size in all these studies is small,” Dr. Robinson and Dr. Gajjar wrote. “Thus, caution should be used when basing any treatment recommendation on these results, and it is our strong-held opinion that any treatment change be done on a well-planned and well-monitored clinical trial.”
This research was supported by the German Childhood Cancer Foundation, Styrian Childhood Cancer Foundation, and other organizations. Dr. Mynarek and colleagues disclosed relationships with Medac, Novartis, Eli Lilly, Bayer, Roche, and numerous other companies. Dr. Robinson disclosed relationships with Eli Lilly, Genentech, and Novartis. Dr. Gajjar reported relationships with Genentech and Kazia Therapeutics.
SOURCE: Mynarek M et al. J Clin Oncol. 2020 Jun 20;38(18):2028-40.
according to research published in the Journal of Clinical Oncology.
Investigators conducted a prospective trial of 87 children diagnosed with nonmetastatic medulloblastoma before the age of 4 years who were treated from 2001-2011.
At 5 years after diagnosis, the 42 DMB/MBEN patients had a 93% progression-free survival (PFS) rate, a 100% overall survival (OS) rate, and a 93% craniospinal irradiation (CSI)–free survival rate.
“Our results suggest that ... poor outcomes of patients treated with systemic chemotherapy alone can be improved by the addition of intraventricular [methotrexate],” wrote Martin Mynarek, MD, of the University Medical Center Hamburg-Eppendorf (Germany), and colleagues.
However, it was a different story for the 45 patients with classic medulloblastoma (CMB) or large-cell/anaplastic medulloblastoma (CLA), in which outcomes are historically worse. At 5 years, the PFS was 37%, the OS was 62%, and the CSI-free survival was 39% in these patients.
In 2006, the CMB and CLA patients started receiving local radiotherapy in addition to chemotherapy and intraventricular methotrexate, but the radiotherapy did not seem to help with their disease.
“Because data suggest no effects, or even adverse effects, of local radiotherapy, additional development of this approach does not seem justified,” the investigators wrote.
“Interestingly, almost all patients with CMB/LCA had distant or combined relapses after local radiotherapy,” they added. “One might speculate that local radiotherapy reduced disease burden of the primary tumor and subclinical metastasis in the posterior fossa, leading to a survival advantage of distant subclinical metastasis over local residues.”
Treatment details
The 87 patients were enrolled in the BIS4 arm of the HIT 2000 trial (NCT00303810), which was designed to test six protocols and identify the optimal approach for treating young patients with medulloblastoma, supratentorial primitive neuroectodermal tumor, or ependymoma.
Patients started “HIT-SKK” chemotherapy within 2-4 weeks of surgery. They received three cycles of intravenous cyclophosphamide, vincristine, methotrexate (followed by leucovorin rescue after 42 hours), carboplatin, and etoposide, with concomitant intraventricular methotrexate, for a duration of 6 months (Neuro Oncol. 2011 Jun;13[6]:669-79).
Among patients who achieved a complete remission, treatment was ended after two additional cycles of chemotherapy. For other patients, secondary surgery, radiotherapy, and consolidation chemotherapy were recommended.
Starting in 2006, DMB and MBEN patients without complete remissions, as well as those with CMB or LCA, received 54 Gy of focal radiotherapy to the tumor bed after the first three treatment cycles.
SHH-I vs. SHH-II DMB/MBEN
DNA methylation profiling was available for 50 of the 87 patients in this analysis, 28 of whom had infantile sonic hedgehog (SHH)–activated DMB/MBEN. Data from these 28 patients – and 71 patients in a validation cohort – revealed no significant difference in 5-year PFS or OS based on methylation subtype.
The 5-year PFS was 73% in SHH-I patients and 83% in SHH-II patients (P = .25). The 5-year OS was 88% and 97%, respectively (P = .099).
“This suggests that the higher risk of relapse in the less favorable [SHH-I subtype] can be abrogated by the addition of intraventricular [methotrexate] to systemic chemotherapy,” the investigators wrote.
The results suggest SHH-I patients “markedly benefit” from the addition of intraventricular chemotherapy, according to the authors of a related editorial, Giles Robinson, MD, and Amar Gajjar, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn.
“However, cross-trial comparison of PFS among the SHH-II subtype does not suggest that SHH-II patients derive the same benefit,” the editorialists wrote.
These data divide SHH medulloblastoma into SHH-I, which benefits from chemotherapy with intraventricular methotrexate, and SHH-II, which can be cured without intraventricular methotrexate, high-dose chemotherapy, or focal radiotherapy, according to the editorialists.
This new information might prompt investigation of a risk-adapted approach. SHH-II patients would receive a reduced-intensity regimen with systemic chemotherapy only, and SHH-I patients would receive systemic chemotherapy combined with intraventricular methotrexate. This could avoid exposing young children to “more intensive therapy than necessary,” according to the editorialists.
Non-WNT/non-SHH disease
Patients with non-WNT/non-SHH medulloblastoma (CMB or LCA) were divided into molecularly defined subtypes group 3 (n = 14) and group 4 (n = 6). The patients in group 3 had lower survival rates than patients in group 4. The 5-year PFS rate was 36% and 83%, respectively (P < .001 ). The 5-year OS rate was 49% and 100%, respectively (P < .001).
“This represents the third recent publication to describe a poor PFS for group 3, and it signals a desperate need for better therapy,” the editorialists wrote. As for the “encouraging” survival rate for group 4 patients, there were only six subjects, which makes this finding “worthy of follow-up but not actionable.”
Even so, the investigators noted that “although poor survival has been reported for non-SHH CMB/LCA in almost every series of patients treated with CSI-sparing approaches, again, use of intraventricular [methotrexate] might be associated with slightly higher PFS, compared with conventional chemotherapy alone.”
As expected, IQ was significantly lower in patients who received CSI salvage. The mean IQ was 74 in patients who received CSI and 90 in patients who did not (P = .012). Neurocognitive outcomes were poor in general among CMB/LCA survivors, “which was closely related to use of radiotherapy,” according to the investigators.
“It is important to recognize that these studies were not designed to define outcome on the basis of molecular subgroup or subtype and that the sample size in all these studies is small,” Dr. Robinson and Dr. Gajjar wrote. “Thus, caution should be used when basing any treatment recommendation on these results, and it is our strong-held opinion that any treatment change be done on a well-planned and well-monitored clinical trial.”
This research was supported by the German Childhood Cancer Foundation, Styrian Childhood Cancer Foundation, and other organizations. Dr. Mynarek and colleagues disclosed relationships with Medac, Novartis, Eli Lilly, Bayer, Roche, and numerous other companies. Dr. Robinson disclosed relationships with Eli Lilly, Genentech, and Novartis. Dr. Gajjar reported relationships with Genentech and Kazia Therapeutics.
SOURCE: Mynarek M et al. J Clin Oncol. 2020 Jun 20;38(18):2028-40.
according to research published in the Journal of Clinical Oncology.
Investigators conducted a prospective trial of 87 children diagnosed with nonmetastatic medulloblastoma before the age of 4 years who were treated from 2001-2011.
At 5 years after diagnosis, the 42 DMB/MBEN patients had a 93% progression-free survival (PFS) rate, a 100% overall survival (OS) rate, and a 93% craniospinal irradiation (CSI)–free survival rate.
“Our results suggest that ... poor outcomes of patients treated with systemic chemotherapy alone can be improved by the addition of intraventricular [methotrexate],” wrote Martin Mynarek, MD, of the University Medical Center Hamburg-Eppendorf (Germany), and colleagues.
However, it was a different story for the 45 patients with classic medulloblastoma (CMB) or large-cell/anaplastic medulloblastoma (CLA), in which outcomes are historically worse. At 5 years, the PFS was 37%, the OS was 62%, and the CSI-free survival was 39% in these patients.
In 2006, the CMB and CLA patients started receiving local radiotherapy in addition to chemotherapy and intraventricular methotrexate, but the radiotherapy did not seem to help with their disease.
“Because data suggest no effects, or even adverse effects, of local radiotherapy, additional development of this approach does not seem justified,” the investigators wrote.
“Interestingly, almost all patients with CMB/LCA had distant or combined relapses after local radiotherapy,” they added. “One might speculate that local radiotherapy reduced disease burden of the primary tumor and subclinical metastasis in the posterior fossa, leading to a survival advantage of distant subclinical metastasis over local residues.”
Treatment details
The 87 patients were enrolled in the BIS4 arm of the HIT 2000 trial (NCT00303810), which was designed to test six protocols and identify the optimal approach for treating young patients with medulloblastoma, supratentorial primitive neuroectodermal tumor, or ependymoma.
Patients started “HIT-SKK” chemotherapy within 2-4 weeks of surgery. They received three cycles of intravenous cyclophosphamide, vincristine, methotrexate (followed by leucovorin rescue after 42 hours), carboplatin, and etoposide, with concomitant intraventricular methotrexate, for a duration of 6 months (Neuro Oncol. 2011 Jun;13[6]:669-79).
Among patients who achieved a complete remission, treatment was ended after two additional cycles of chemotherapy. For other patients, secondary surgery, radiotherapy, and consolidation chemotherapy were recommended.
Starting in 2006, DMB and MBEN patients without complete remissions, as well as those with CMB or LCA, received 54 Gy of focal radiotherapy to the tumor bed after the first three treatment cycles.
SHH-I vs. SHH-II DMB/MBEN
DNA methylation profiling was available for 50 of the 87 patients in this analysis, 28 of whom had infantile sonic hedgehog (SHH)–activated DMB/MBEN. Data from these 28 patients – and 71 patients in a validation cohort – revealed no significant difference in 5-year PFS or OS based on methylation subtype.
The 5-year PFS was 73% in SHH-I patients and 83% in SHH-II patients (P = .25). The 5-year OS was 88% and 97%, respectively (P = .099).
“This suggests that the higher risk of relapse in the less favorable [SHH-I subtype] can be abrogated by the addition of intraventricular [methotrexate] to systemic chemotherapy,” the investigators wrote.
The results suggest SHH-I patients “markedly benefit” from the addition of intraventricular chemotherapy, according to the authors of a related editorial, Giles Robinson, MD, and Amar Gajjar, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn.
“However, cross-trial comparison of PFS among the SHH-II subtype does not suggest that SHH-II patients derive the same benefit,” the editorialists wrote.
These data divide SHH medulloblastoma into SHH-I, which benefits from chemotherapy with intraventricular methotrexate, and SHH-II, which can be cured without intraventricular methotrexate, high-dose chemotherapy, or focal radiotherapy, according to the editorialists.
This new information might prompt investigation of a risk-adapted approach. SHH-II patients would receive a reduced-intensity regimen with systemic chemotherapy only, and SHH-I patients would receive systemic chemotherapy combined with intraventricular methotrexate. This could avoid exposing young children to “more intensive therapy than necessary,” according to the editorialists.
Non-WNT/non-SHH disease
Patients with non-WNT/non-SHH medulloblastoma (CMB or LCA) were divided into molecularly defined subtypes group 3 (n = 14) and group 4 (n = 6). The patients in group 3 had lower survival rates than patients in group 4. The 5-year PFS rate was 36% and 83%, respectively (P < .001 ). The 5-year OS rate was 49% and 100%, respectively (P < .001).
“This represents the third recent publication to describe a poor PFS for group 3, and it signals a desperate need for better therapy,” the editorialists wrote. As for the “encouraging” survival rate for group 4 patients, there were only six subjects, which makes this finding “worthy of follow-up but not actionable.”
Even so, the investigators noted that “although poor survival has been reported for non-SHH CMB/LCA in almost every series of patients treated with CSI-sparing approaches, again, use of intraventricular [methotrexate] might be associated with slightly higher PFS, compared with conventional chemotherapy alone.”
As expected, IQ was significantly lower in patients who received CSI salvage. The mean IQ was 74 in patients who received CSI and 90 in patients who did not (P = .012). Neurocognitive outcomes were poor in general among CMB/LCA survivors, “which was closely related to use of radiotherapy,” according to the investigators.
“It is important to recognize that these studies were not designed to define outcome on the basis of molecular subgroup or subtype and that the sample size in all these studies is small,” Dr. Robinson and Dr. Gajjar wrote. “Thus, caution should be used when basing any treatment recommendation on these results, and it is our strong-held opinion that any treatment change be done on a well-planned and well-monitored clinical trial.”
This research was supported by the German Childhood Cancer Foundation, Styrian Childhood Cancer Foundation, and other organizations. Dr. Mynarek and colleagues disclosed relationships with Medac, Novartis, Eli Lilly, Bayer, Roche, and numerous other companies. Dr. Robinson disclosed relationships with Eli Lilly, Genentech, and Novartis. Dr. Gajjar reported relationships with Genentech and Kazia Therapeutics.
SOURCE: Mynarek M et al. J Clin Oncol. 2020 Jun 20;38(18):2028-40.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
Rilzabrutinib shows positive results in phase 2b for pemphigus
accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.
Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.
The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.
The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.
Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.
Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.
Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.
Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.
SOURCE: Murrell DF. AAD 2020 LBCT.
accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.
Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.
The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.
The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.
Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.
Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.
Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.
Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.
SOURCE: Murrell DF. AAD 2020 LBCT.
accompanied by markedly reduced need for systemic corticosteroids in the phase 2b BELIEVE-PV trial, Dedee F. Murrell, MD, said at the virtual annual meeting of the American Academy of Dermatology.
Moreover, in sharp contrast to the standard first-line treatments for pemphigus – rituximab (Rituxan) and high-dose corticosteroids – the treatment-emergent adverse events that arose with 6 months of rilzabrutinib in BELIEVE-PV were uniformly mild to moderate and transient, added Dr. Murrell, professor of dermatology at the University of New South Wales and head of the department of dermatology at St. George University Hospital, Sydney.
The phase 2b BELIEVE-PV trial was a small, 24-week, open-label study that included six patients with newly diagnosed pemphigus and nine others with relapsing pemphigus. The primary endpoint was control of disease activity, defined as no new lesions appearing and established lesions beginning to heal. This was achieved in 9 of 15 patients (60%) at 4 weeks and in 13 patients by week 12. Meanwhile, the mean daily dose of prednisone fell from 21 mg at baseline to 6 mg at 24 weeks.
The mean score on the Pemphigus Disease Area Index (PDAI) dropped by 79% from a baseline of 15.5. Ten of 15 subjects improved to a PDAI of 0 or 1 – clear or almost clear skin – by week 24. The complete remission rate, defined as an absence of both new and established lesions while on no or a very low dose of prednisone, was 40% at week 24.
Treatment-emergent adverse events consisted of nausea in four patients, dizziness in two, and abdominal distension in two, all of which were grade 1 or 2.
Based upon these favorable results, the pivotal phase 3, double-blind, international PEGASUS trial is underway, led by Dr. Murrell. The trial will enroll 120 pemphigus patients, randomized to rilzabrutinib at 400 mg twice daily or placebo on top of background steroid tapering.
Rilzabrutinib is also in earlier-stage clinical trials for the treatment of immune thrombocytopenia.
Dr. Murrell reported serving as a consultant to Principia Biopharma, sponsor of the BELIEVE-PV and PEGASUS trials, and has received institutional research grants from numerous pharmaceutical companies.
SOURCE: Murrell DF. AAD 2020 LBCT.
FROM AAD 20
Early data support further study of ivosidenib in mIDH1 glioma
The median progression-free survival was 13.6 months for patients with nonenhancing tumors and 1.4 months for patients with enhancing tumors in a study of 66 adults with mIDH1 advanced glioma.
“On the basis of these data, additional clinical development of mIDH inhibitors for mIDH low-grade gliomas is warranted,” Ingo Mellinghoff, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues wrote in the Journal of Clinical Oncology.
“This is not a home run but is of interest to the community,” said Lawrence Recht, MD, of Stanford (Calif.) University, who was not involved in this study. “Other companies are also developing agents like this.”
Considering that the ivosidenib study “is uncontrolled, one cannot say for sure that this wasn’t just the natural history of the disease,” Dr. Recht continued. “This type of tumor can behave very indolently, and patients can survive years without treatment, so this is rather a short interval to make a long-time statement. I think the authors are a bit overenthusiastic.”
The authors tested ivosidenib in 66 adults with mIDH1 glioma – 35 with nonenhancing glioma and 31 with enhancing glioma. Tumors had recurred after, or did not respond to, initial surgery, radiation, or chemotherapy.
The patients’ median age was 41 years (range, 21-71 years), and 25 patients (37.9%) were women. The most common tumor type at screening was oligodendroglioma in 23 patients (34.8%).
Patients received ivosidenib at doses ranging from 100 mg twice a day to 900 mg once a day. A total of 50 patients received the phase 2 recommended dose – 500 mg once a day. There were no dose-limiting toxicities, and there was no maximum-tolerated dose.
Adverse events of grade 3 or higher occurred in 19.7% of patients and included headache, seizure, hyperglycemia, neutropenia, and hypophosphatemia. Grade 3 or higher treatment-related adverse events occurred in two patients.
A total of 30 patients with nonenhancing tumors (85.7%) and 14 with enhancing tumors (45.2%) had a best response of stable disease. There was one partial response in a nonenhancing patient on 500 mg/day. The rest of the subjects had a best response of progressive disease.
The median treatment duration was 18.4 months among patients with nonenhancing tumors and 1.9 months among those with enhancing tumors. Discontinuation was caused byo progression in all but one case.
Among patients with measurable disease, tumor measurements decreased from baseline in 22 nonenhancing tumors (66.7%) and in 9 enhancing tumors (33.3%).
“Despite the heterogeneous patient population in our trial, the nonrandomized design, and the lack of central pathology review, the data from our trial suggest that ivosidenib has greater activity against nonenhancing gliomas than against enhancing gliomas,” the investigators wrote. “This finding may seem surprising because the absence of contrast enhancement is typically associated with impaired drug delivery.
“We hypothesize that ivosidenib may be more effective in nonenhancing gliomas because these tumors represent an earlier disease stage with fewer genetic alterations, reminiscent of the greater antitumor activity of the BCR-ABL inhibitor imatinib in earlier stages of chronic myeloid leukemia,” the investigators wrote.
The team also noted that the median progression-free survival for patients with nonenhancing gliomas in the current study “compares favorably to that reported for temozolomide” in advanced mIDH1 low-grade glioma, which was approximately 7 months.
This research was funded by Agios Pharmaceuticals, the company developing ivosidenib. Dr. Mellinghoff receives travel compensation from and is an adviser to the company. Several other investigators are employees. Dr. Recht disclosed no conflicts of interest.
SOURCE: Mellinghoff I et al. J Clin Oncol. 2020 Jun 12. doi: 10.1200/JCO.19.03327
The median progression-free survival was 13.6 months for patients with nonenhancing tumors and 1.4 months for patients with enhancing tumors in a study of 66 adults with mIDH1 advanced glioma.
“On the basis of these data, additional clinical development of mIDH inhibitors for mIDH low-grade gliomas is warranted,” Ingo Mellinghoff, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues wrote in the Journal of Clinical Oncology.
“This is not a home run but is of interest to the community,” said Lawrence Recht, MD, of Stanford (Calif.) University, who was not involved in this study. “Other companies are also developing agents like this.”
Considering that the ivosidenib study “is uncontrolled, one cannot say for sure that this wasn’t just the natural history of the disease,” Dr. Recht continued. “This type of tumor can behave very indolently, and patients can survive years without treatment, so this is rather a short interval to make a long-time statement. I think the authors are a bit overenthusiastic.”
The authors tested ivosidenib in 66 adults with mIDH1 glioma – 35 with nonenhancing glioma and 31 with enhancing glioma. Tumors had recurred after, or did not respond to, initial surgery, radiation, or chemotherapy.
The patients’ median age was 41 years (range, 21-71 years), and 25 patients (37.9%) were women. The most common tumor type at screening was oligodendroglioma in 23 patients (34.8%).
Patients received ivosidenib at doses ranging from 100 mg twice a day to 900 mg once a day. A total of 50 patients received the phase 2 recommended dose – 500 mg once a day. There were no dose-limiting toxicities, and there was no maximum-tolerated dose.
Adverse events of grade 3 or higher occurred in 19.7% of patients and included headache, seizure, hyperglycemia, neutropenia, and hypophosphatemia. Grade 3 or higher treatment-related adverse events occurred in two patients.
A total of 30 patients with nonenhancing tumors (85.7%) and 14 with enhancing tumors (45.2%) had a best response of stable disease. There was one partial response in a nonenhancing patient on 500 mg/day. The rest of the subjects had a best response of progressive disease.
The median treatment duration was 18.4 months among patients with nonenhancing tumors and 1.9 months among those with enhancing tumors. Discontinuation was caused byo progression in all but one case.
Among patients with measurable disease, tumor measurements decreased from baseline in 22 nonenhancing tumors (66.7%) and in 9 enhancing tumors (33.3%).
“Despite the heterogeneous patient population in our trial, the nonrandomized design, and the lack of central pathology review, the data from our trial suggest that ivosidenib has greater activity against nonenhancing gliomas than against enhancing gliomas,” the investigators wrote. “This finding may seem surprising because the absence of contrast enhancement is typically associated with impaired drug delivery.
“We hypothesize that ivosidenib may be more effective in nonenhancing gliomas because these tumors represent an earlier disease stage with fewer genetic alterations, reminiscent of the greater antitumor activity of the BCR-ABL inhibitor imatinib in earlier stages of chronic myeloid leukemia,” the investigators wrote.
The team also noted that the median progression-free survival for patients with nonenhancing gliomas in the current study “compares favorably to that reported for temozolomide” in advanced mIDH1 low-grade glioma, which was approximately 7 months.
This research was funded by Agios Pharmaceuticals, the company developing ivosidenib. Dr. Mellinghoff receives travel compensation from and is an adviser to the company. Several other investigators are employees. Dr. Recht disclosed no conflicts of interest.
SOURCE: Mellinghoff I et al. J Clin Oncol. 2020 Jun 12. doi: 10.1200/JCO.19.03327
The median progression-free survival was 13.6 months for patients with nonenhancing tumors and 1.4 months for patients with enhancing tumors in a study of 66 adults with mIDH1 advanced glioma.
“On the basis of these data, additional clinical development of mIDH inhibitors for mIDH low-grade gliomas is warranted,” Ingo Mellinghoff, MD, of Memorial Sloan Kettering Cancer Center in New York, and colleagues wrote in the Journal of Clinical Oncology.
“This is not a home run but is of interest to the community,” said Lawrence Recht, MD, of Stanford (Calif.) University, who was not involved in this study. “Other companies are also developing agents like this.”
Considering that the ivosidenib study “is uncontrolled, one cannot say for sure that this wasn’t just the natural history of the disease,” Dr. Recht continued. “This type of tumor can behave very indolently, and patients can survive years without treatment, so this is rather a short interval to make a long-time statement. I think the authors are a bit overenthusiastic.”
The authors tested ivosidenib in 66 adults with mIDH1 glioma – 35 with nonenhancing glioma and 31 with enhancing glioma. Tumors had recurred after, or did not respond to, initial surgery, radiation, or chemotherapy.
The patients’ median age was 41 years (range, 21-71 years), and 25 patients (37.9%) were women. The most common tumor type at screening was oligodendroglioma in 23 patients (34.8%).
Patients received ivosidenib at doses ranging from 100 mg twice a day to 900 mg once a day. A total of 50 patients received the phase 2 recommended dose – 500 mg once a day. There were no dose-limiting toxicities, and there was no maximum-tolerated dose.
Adverse events of grade 3 or higher occurred in 19.7% of patients and included headache, seizure, hyperglycemia, neutropenia, and hypophosphatemia. Grade 3 or higher treatment-related adverse events occurred in two patients.
A total of 30 patients with nonenhancing tumors (85.7%) and 14 with enhancing tumors (45.2%) had a best response of stable disease. There was one partial response in a nonenhancing patient on 500 mg/day. The rest of the subjects had a best response of progressive disease.
The median treatment duration was 18.4 months among patients with nonenhancing tumors and 1.9 months among those with enhancing tumors. Discontinuation was caused byo progression in all but one case.
Among patients with measurable disease, tumor measurements decreased from baseline in 22 nonenhancing tumors (66.7%) and in 9 enhancing tumors (33.3%).
“Despite the heterogeneous patient population in our trial, the nonrandomized design, and the lack of central pathology review, the data from our trial suggest that ivosidenib has greater activity against nonenhancing gliomas than against enhancing gliomas,” the investigators wrote. “This finding may seem surprising because the absence of contrast enhancement is typically associated with impaired drug delivery.
“We hypothesize that ivosidenib may be more effective in nonenhancing gliomas because these tumors represent an earlier disease stage with fewer genetic alterations, reminiscent of the greater antitumor activity of the BCR-ABL inhibitor imatinib in earlier stages of chronic myeloid leukemia,” the investigators wrote.
The team also noted that the median progression-free survival for patients with nonenhancing gliomas in the current study “compares favorably to that reported for temozolomide” in advanced mIDH1 low-grade glioma, which was approximately 7 months.
This research was funded by Agios Pharmaceuticals, the company developing ivosidenib. Dr. Mellinghoff receives travel compensation from and is an adviser to the company. Several other investigators are employees. Dr. Recht disclosed no conflicts of interest.
SOURCE: Mellinghoff I et al. J Clin Oncol. 2020 Jun 12. doi: 10.1200/JCO.19.03327
FROM THE JOURNAL OF CLINICAL ONCOLOGY
One-week postsurgical interval for voiding trial increases pass rate
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
Women who underwent vaginal prolapse surgery and did not immediately have a successful voiding trial were seven times more likely to pass their second voiding trial if their follow-up was 7 days after surgery instead of 4 days, according to a study in the American Journal of Obstetrics and Gynecology.
“This information is useful for setting expectations and for counseling patients on when it might be best to repeat a voiding trial in those with transient incomplete bladder emptying on the day of surgery, especially for those who may not live close to their surgeon, or for those who have difficulty traveling to the office,” said Jeffrey S. Schachar, MD, of Wake Forest Baptist Health in Winston-Salem, N.C., and colleagues. “Despite a higher rate of initial unsuccessful office voiding trials, however, the early group did have significantly fewer days with an indwelling transurethral catheter, as well as total catheterization days,” including self-catheterization.
The researchers note that rates of temporary use of catheters after surgery vary widely, from 12% to 83%, likely because no consensus exists on how long to wait for voiding trials and what constitutes a successful trial.
“It is critical to identify patients with incomplete bladder emptying in order to prevent pain, myogenic and neurogenic damage, ureteral reflux and bladder overdistension that may further impair voiding function,” the authors wrote. “However, extending bladder drainage beyond the necessary recovery period may be associated with higher rates of urinary tract infection (UTI) and patient bother.”
To learn more about the best duration for postoperative catheter use, the researchers enrolled 102 patients before they underwent vaginal prolapse surgery at Wake Forest Baptist Health and Cleveland Clinic Florida from February 2017 to November 2019. The 29 patients with a successful voiding trial within 6 hours after surgery left the study, and 5 others were excluded for needing longer vaginal packing.
The voiding trial involved helping the patient stand to drain the bladder via the catheter, backfilling the bladder with 300 mL of saline solution through the catheter, removing the catheter to give women 1 hour to urinate, and then measuring the postvoid residual with a catheter or ultrasound. At least 100 mL postvoid residual was considered persistent incomplete bladder emptying.
The 60 remaining patients who did not pass the initial voiding trial and opted to remain in the study received a transurethral indwelling catheter and were randomly assigned to return for a second voiding trial either 2-4 days after surgery (depending on day of the week) or 7 days after surgery. The groups were demographically and clinically similar, with predominantly white postmenopausal, non-smoking women with stage II or III multicompartment pelvic organ prolapse.
Women without successful trials could continue with the transurethral catheter or give themselves intermittent catheterizations with a follow-up schedule determined by their surgeon. The researchers then tracked the women for 6 weeks to determine the rate of unsuccessful repeat voiding trials.
Among the women who returned 2-4 days post surgery, 23% had unsuccessful follow-up voiding trials, compared with 3% in the group returning 7 days after surgery (relative risk = 7; P = .02). The researchers calculated that one case of persistent postoperative incomplete bladder emptying was prevented for every five patients who used a catheter for 7 days after surgery.
Kevin A. Ault, MD, professor of obstetrics and gynecology at the University of Kansas Medical Center in Kansas City, said the study was well done, although the findings were unsurprising. He said the clinical implication is straightforward – to wait a week before doing a second voiding trial.
“I suspect these findings match the clinical experience of many surgeons. It is always good to see a well-done clinical trial on a topic,” Dr Ault said in an interview. “The most notable finding is how this impacts patient counseling. Gynecologists should tell their patients that it will take a week with a catheter when this problem arises.”
“The main limitation is whether this finding can be extrapolated to other gynecological surgeries, such as hysterectomy,” said Dr. Ault, who was not involved in the study. “Urinary retention is likely less common after that surgery, but it is still bothersome to patients.”
Dr. Schachar and associates also reported that patients in the earlier group “used significantly more morphine dose equivalents within 24 hours of the office voiding trial than the late-voiding trial group, which was expected given the proximity to surgery” (3 vs. 0.38; P = .005). However, new postoperative pain medication prescriptions and refills were similar in both groups.
Secondary endpoints included UTI rates, total days with a catheter, and patient experience of discomfort with the catheter. The two groups of women reported similar levels of catheter bother, but there was a nonsignificant difference in UTI rates: 23% in the earlier group, compared with 7% in the later group (P = .07).
The early-voiding trial group had an average 5 days with an indwelling transurethral catheter, compared with a significantly different 7 days in the later group (P = .0007). The early group also had fewer total days with an indwelling transurethral catheter and self-catheterization (6 days), compared with the late group (7 days; P = .0013). No patients had persistent incomplete bladder emptying after 17 days post surgery.
“Being able to adequately predict which patients are more likely to have unsuccessful postoperative voiding trials allows surgeons to better counsel their patients and may guide clinical decisions,” Dr. Schachar and associates said. They acknowledged, however, that their study’s biggest weakness is the small enrollment, which led to larger confidence intervals related to relative risk differences between the groups.
The study did not use external funding. Four of the investigators received grant, research funding, or honoraria from one or many medical device or pharmaceutical companies. The remaining researchers had no disclosures. Dr. Ault said he had no relevant financial disclosures.
SOURCE: Schachar JS et al. Am J Obstet Gynecol. 2020 Jun. doi: 10.1016/j.ajog.2020.06.001.
FROM AMERICAN JOURNAL OF OBSTETRICS & GYNECOLOGY
Bigotry and medical injustice
“We cannot teach people to withhold judgment; judgments are embedded in the way we view objects. I do not see a “tree”; I see a pleasant or an ugly tree. It is not possible without great, paralyzing effort to strip these small values we attach to matters. Likewise, it is not possible to hold a situation in one’s head without some element of bias” – Nassim Nicholas Taleb, MBA, PhD, “The Black Swan.”
Each morning I see the hungry ghosts congregate at the end of the alley behind my office waiting for their addiction clinic appointments (Maté G. “In the Realm of Hungry Ghosts, Close Encounters with Addiction” Berkeley, Calif.: North Atlantic Books, 2008). The fast food restaurant and the convenience store won’t let them linger, so there they sit on the curb in the saddest magpie’s row in the world. They have lip, nose, and eyebrow piercings, and lightning bolts tattooed up their cheeks. They all have backpacks, a few even rolling suitcases. They are opioid addicts, and almost all young, White adults. There they sit, once-innocent young girls, now worn and hardened, and vicious-looking young men, all with downcast empty eyes and miserable expressions. They are a frightening group marginalized by their addiction.
Opioid addiction became a national focus of attention with clarion calls for treatment, which resulted in legislative funding for treatment, restrictions on prescribing, and readily available Narcan. Physicians have greatly reduced their prescribing of narcotics and overdose death rates have dropped, but the drug crisis has not gone away, it has only been recently overshadowed by COVID-19.
The most ironic part of the current opioid epidemic and overdose deaths, and the other three bloodborne horsemen of death – endocarditis; hepatitis B, C, and D; and HIV – was that these scourges were affecting the Black community 40 years ago when, in my view, no one seemed to care. There was no addiction counseling, no treatment centers, and law enforcement would visit only with hopes of making a dealer’s arrest. Not until it became a White suburban issue, did this public health problem become recognized as something to act on. This is of course a result of racism, but there is a broader lesson here.
Humans may be naturally bigoted toward any marginalized or minority group. I recall working in the HIV clinic (before it was called HIV) in Dallas in the mid-1980s. The county refused to pay for zidovudine, which was very expensive at the time, and was sued to supply medication for a group marginalized by their sexual orientation. The AIDS epidemic was initially ignored, with the virus spreading to intravenous drug users and eventually to the broader population, which is when effective treatments became a priority.
Physicians and society should pay close attention to the ills of our marginalized communities. Because of isolation from health care, they are the medical canaries in the coal mine for all of us. Medical issues and infectious diseases identified there should be a priority and solutions sought and applied. This not only would benefit the marginalized group and ease their suffering, but would be salutary to society as a whole, because they surely will be coming everyone’s way.
COVID-19 highlights this. The working poor live in close quarters and most rely on crowded public transportation, and so a respiratory illness spreads rapidly in a population that cannot practically physically distance and probably cannot afford face masks, or alcohol hand gel.
As noted above, we have a persistent illegal drug epidemic. We also have a resurgence in venereal disease and tuberculosis, much of it drug resistant, which again is concentrated in our marginalized populations. Meanwhile, we have been cutting spending on public health, while we obviously need more resources devoted to public and community health.
When we step back and look, there are public health issues everywhere. We could eliminate 90% of cervical cancer and most of the oropharyngeal cancer with use of a very effective vaccine, but we struggle to get it paid for and to convince the public of its ultimate good.
Another example is in Ohio, where we raised the age to purchase tobacco to 21, which is laudable. But children of any age can still access tanning beds, which dramatically raises their lifetime risk of melanoma, often using a note from their “parents” that they write for each other on the car hood in the strip mall parking lot. This group of mostly young white women could also be considered a marginalized group despite their disposable income because of their belief in personal invincibility and false impressions of a tan conferring beauty and vitality repeated endlessly in their echo chamber of social media impressions.
Perhaps we should gauge the state of our public health by the health status of the most oppressed group of all, the incarcerated. Is it really possible that we don’t routinely test for and treat hepatitis C in many of our prisons? Is this indifference because the incarcerated are again a largely minority group and hepatitis C is spread by intravenous drug use?
Solutions and interventions for these problems range widely in cost, but all would eventually save the greater society money and alleviate great misery for those affected.
Perhaps we should be talking about the decriminalization of drug use. The drugs are already here and the consequences apparent, including overflowing prisons and out of control gun violence. This is a much thornier discussion, but seems at the root of many of our problems.
Bigotry is insidious and will take a long and continuing active effort to combat. As Dr. Taleb notes in the introductory quote, it requires a constant, tiring, deliberate mental effort to be mindful of one’s biases. As physicians, we have always been careful to try and treat all patients without bias, but this is not enough. We must become more insistent about the funding and application of public health measures.
Recognizing and treating the medical problems of our marginalized populations seems a doable first step while our greater society struggles with mental bias toward marginalized groups. Reducing the health burdens of these groups can only help them in their life struggles and will benefit all.
Someone once told me that the cold wind in the ghetto eventually blows out into the suburbs, and they were right. As physicians and a society, we should be insistent about correcting medical injustices beforehand. Let’s get started.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com
“We cannot teach people to withhold judgment; judgments are embedded in the way we view objects. I do not see a “tree”; I see a pleasant or an ugly tree. It is not possible without great, paralyzing effort to strip these small values we attach to matters. Likewise, it is not possible to hold a situation in one’s head without some element of bias” – Nassim Nicholas Taleb, MBA, PhD, “The Black Swan.”
Each morning I see the hungry ghosts congregate at the end of the alley behind my office waiting for their addiction clinic appointments (Maté G. “In the Realm of Hungry Ghosts, Close Encounters with Addiction” Berkeley, Calif.: North Atlantic Books, 2008). The fast food restaurant and the convenience store won’t let them linger, so there they sit on the curb in the saddest magpie’s row in the world. They have lip, nose, and eyebrow piercings, and lightning bolts tattooed up their cheeks. They all have backpacks, a few even rolling suitcases. They are opioid addicts, and almost all young, White adults. There they sit, once-innocent young girls, now worn and hardened, and vicious-looking young men, all with downcast empty eyes and miserable expressions. They are a frightening group marginalized by their addiction.
Opioid addiction became a national focus of attention with clarion calls for treatment, which resulted in legislative funding for treatment, restrictions on prescribing, and readily available Narcan. Physicians have greatly reduced their prescribing of narcotics and overdose death rates have dropped, but the drug crisis has not gone away, it has only been recently overshadowed by COVID-19.
The most ironic part of the current opioid epidemic and overdose deaths, and the other three bloodborne horsemen of death – endocarditis; hepatitis B, C, and D; and HIV – was that these scourges were affecting the Black community 40 years ago when, in my view, no one seemed to care. There was no addiction counseling, no treatment centers, and law enforcement would visit only with hopes of making a dealer’s arrest. Not until it became a White suburban issue, did this public health problem become recognized as something to act on. This is of course a result of racism, but there is a broader lesson here.
Humans may be naturally bigoted toward any marginalized or minority group. I recall working in the HIV clinic (before it was called HIV) in Dallas in the mid-1980s. The county refused to pay for zidovudine, which was very expensive at the time, and was sued to supply medication for a group marginalized by their sexual orientation. The AIDS epidemic was initially ignored, with the virus spreading to intravenous drug users and eventually to the broader population, which is when effective treatments became a priority.
Physicians and society should pay close attention to the ills of our marginalized communities. Because of isolation from health care, they are the medical canaries in the coal mine for all of us. Medical issues and infectious diseases identified there should be a priority and solutions sought and applied. This not only would benefit the marginalized group and ease their suffering, but would be salutary to society as a whole, because they surely will be coming everyone’s way.
COVID-19 highlights this. The working poor live in close quarters and most rely on crowded public transportation, and so a respiratory illness spreads rapidly in a population that cannot practically physically distance and probably cannot afford face masks, or alcohol hand gel.
As noted above, we have a persistent illegal drug epidemic. We also have a resurgence in venereal disease and tuberculosis, much of it drug resistant, which again is concentrated in our marginalized populations. Meanwhile, we have been cutting spending on public health, while we obviously need more resources devoted to public and community health.
When we step back and look, there are public health issues everywhere. We could eliminate 90% of cervical cancer and most of the oropharyngeal cancer with use of a very effective vaccine, but we struggle to get it paid for and to convince the public of its ultimate good.
Another example is in Ohio, where we raised the age to purchase tobacco to 21, which is laudable. But children of any age can still access tanning beds, which dramatically raises their lifetime risk of melanoma, often using a note from their “parents” that they write for each other on the car hood in the strip mall parking lot. This group of mostly young white women could also be considered a marginalized group despite their disposable income because of their belief in personal invincibility and false impressions of a tan conferring beauty and vitality repeated endlessly in their echo chamber of social media impressions.
Perhaps we should gauge the state of our public health by the health status of the most oppressed group of all, the incarcerated. Is it really possible that we don’t routinely test for and treat hepatitis C in many of our prisons? Is this indifference because the incarcerated are again a largely minority group and hepatitis C is spread by intravenous drug use?
Solutions and interventions for these problems range widely in cost, but all would eventually save the greater society money and alleviate great misery for those affected.
Perhaps we should be talking about the decriminalization of drug use. The drugs are already here and the consequences apparent, including overflowing prisons and out of control gun violence. This is a much thornier discussion, but seems at the root of many of our problems.
Bigotry is insidious and will take a long and continuing active effort to combat. As Dr. Taleb notes in the introductory quote, it requires a constant, tiring, deliberate mental effort to be mindful of one’s biases. As physicians, we have always been careful to try and treat all patients without bias, but this is not enough. We must become more insistent about the funding and application of public health measures.
Recognizing and treating the medical problems of our marginalized populations seems a doable first step while our greater society struggles with mental bias toward marginalized groups. Reducing the health burdens of these groups can only help them in their life struggles and will benefit all.
Someone once told me that the cold wind in the ghetto eventually blows out into the suburbs, and they were right. As physicians and a society, we should be insistent about correcting medical injustices beforehand. Let’s get started.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com
“We cannot teach people to withhold judgment; judgments are embedded in the way we view objects. I do not see a “tree”; I see a pleasant or an ugly tree. It is not possible without great, paralyzing effort to strip these small values we attach to matters. Likewise, it is not possible to hold a situation in one’s head without some element of bias” – Nassim Nicholas Taleb, MBA, PhD, “The Black Swan.”
Each morning I see the hungry ghosts congregate at the end of the alley behind my office waiting for their addiction clinic appointments (Maté G. “In the Realm of Hungry Ghosts, Close Encounters with Addiction” Berkeley, Calif.: North Atlantic Books, 2008). The fast food restaurant and the convenience store won’t let them linger, so there they sit on the curb in the saddest magpie’s row in the world. They have lip, nose, and eyebrow piercings, and lightning bolts tattooed up their cheeks. They all have backpacks, a few even rolling suitcases. They are opioid addicts, and almost all young, White adults. There they sit, once-innocent young girls, now worn and hardened, and vicious-looking young men, all with downcast empty eyes and miserable expressions. They are a frightening group marginalized by their addiction.
Opioid addiction became a national focus of attention with clarion calls for treatment, which resulted in legislative funding for treatment, restrictions on prescribing, and readily available Narcan. Physicians have greatly reduced their prescribing of narcotics and overdose death rates have dropped, but the drug crisis has not gone away, it has only been recently overshadowed by COVID-19.
The most ironic part of the current opioid epidemic and overdose deaths, and the other three bloodborne horsemen of death – endocarditis; hepatitis B, C, and D; and HIV – was that these scourges were affecting the Black community 40 years ago when, in my view, no one seemed to care. There was no addiction counseling, no treatment centers, and law enforcement would visit only with hopes of making a dealer’s arrest. Not until it became a White suburban issue, did this public health problem become recognized as something to act on. This is of course a result of racism, but there is a broader lesson here.
Humans may be naturally bigoted toward any marginalized or minority group. I recall working in the HIV clinic (before it was called HIV) in Dallas in the mid-1980s. The county refused to pay for zidovudine, which was very expensive at the time, and was sued to supply medication for a group marginalized by their sexual orientation. The AIDS epidemic was initially ignored, with the virus spreading to intravenous drug users and eventually to the broader population, which is when effective treatments became a priority.
Physicians and society should pay close attention to the ills of our marginalized communities. Because of isolation from health care, they are the medical canaries in the coal mine for all of us. Medical issues and infectious diseases identified there should be a priority and solutions sought and applied. This not only would benefit the marginalized group and ease their suffering, but would be salutary to society as a whole, because they surely will be coming everyone’s way.
COVID-19 highlights this. The working poor live in close quarters and most rely on crowded public transportation, and so a respiratory illness spreads rapidly in a population that cannot practically physically distance and probably cannot afford face masks, or alcohol hand gel.
As noted above, we have a persistent illegal drug epidemic. We also have a resurgence in venereal disease and tuberculosis, much of it drug resistant, which again is concentrated in our marginalized populations. Meanwhile, we have been cutting spending on public health, while we obviously need more resources devoted to public and community health.
When we step back and look, there are public health issues everywhere. We could eliminate 90% of cervical cancer and most of the oropharyngeal cancer with use of a very effective vaccine, but we struggle to get it paid for and to convince the public of its ultimate good.
Another example is in Ohio, where we raised the age to purchase tobacco to 21, which is laudable. But children of any age can still access tanning beds, which dramatically raises their lifetime risk of melanoma, often using a note from their “parents” that they write for each other on the car hood in the strip mall parking lot. This group of mostly young white women could also be considered a marginalized group despite their disposable income because of their belief in personal invincibility and false impressions of a tan conferring beauty and vitality repeated endlessly in their echo chamber of social media impressions.
Perhaps we should gauge the state of our public health by the health status of the most oppressed group of all, the incarcerated. Is it really possible that we don’t routinely test for and treat hepatitis C in many of our prisons? Is this indifference because the incarcerated are again a largely minority group and hepatitis C is spread by intravenous drug use?
Solutions and interventions for these problems range widely in cost, but all would eventually save the greater society money and alleviate great misery for those affected.
Perhaps we should be talking about the decriminalization of drug use. The drugs are already here and the consequences apparent, including overflowing prisons and out of control gun violence. This is a much thornier discussion, but seems at the root of many of our problems.
Bigotry is insidious and will take a long and continuing active effort to combat. As Dr. Taleb notes in the introductory quote, it requires a constant, tiring, deliberate mental effort to be mindful of one’s biases. As physicians, we have always been careful to try and treat all patients without bias, but this is not enough. We must become more insistent about the funding and application of public health measures.
Recognizing and treating the medical problems of our marginalized populations seems a doable first step while our greater society struggles with mental bias toward marginalized groups. Reducing the health burdens of these groups can only help them in their life struggles and will benefit all.
Someone once told me that the cold wind in the ghetto eventually blows out into the suburbs, and they were right. As physicians and a society, we should be insistent about correcting medical injustices beforehand. Let’s get started.
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com
More U.S. psychiatrists restricting practices to self-pay patients
A growing number of psychiatrists in the United States no longer accept insurance and will only see patients who can pay upfront, out-of-pocket for office visits, a new trends analysis shows.
Ivy Benjenk, BSN, MPH, and Jie Chen, PhD, from the University of Maryland, College Park, wrote that psychiatrists may be more likely than other specialties to adopt a self-pay-only model because of low insurance reimbursement rates, particularly for psychotherapy, as well as a demand for psychiatric services that outstrips supply.
There is a “limited supply” of psychiatrists in the United States and a “great deal of administrative hoops that go into accepting insurance for pretty minimal payment. So it makes some sense for psychiatrists to move entirely into the self-pay market,” Ms. Benjenk said in an interview.
The study was published online July 15 in JAMA Psychiatry.
Barrier to care
To explore patterns in self-payment for office-based psychiatric services and changes over time, the researchers analyzed data from 2007 to 2016 from the National Ambulatory Medical Care Survey, a nationally representative survey of physicians who were not federally employed, were office based, and were primarily engaged in direct patient care.
Of 15,790 psychiatrist visits, 3445 (21.8%) were self-paid by patients, compared with 4336 of 119,749 primary care clinician visits (3.6%).
Of the 750 psychiatrists in the sample, 146 (19.5%) were reimbursed predominantly by self-payment, compared with 69 of 4,294 primary care clinicians (1.6%).
The percentage of self-paid psychiatrist office visits has trended upward (from 18.5% in 2007-2009 to 26.7% in 2014-2016), whereas the percentage of self-paid primary care visits has trended downward (from 4.1% in 2007-2009 to 2.8% in 2014-2016).
The percentage of psychiatrists who work in predominantly self-pay practices has also trended upward (from 16.4% in 2007-2009 to 26.4% in 2014-2016), whereas the percentage of primary care clinicians who work in predominantly self-pay practices has not changed significantly (from 1.5% to 1.7%).
Psychiatrists who are reimbursed predominantly by self-payment were more likely to work in solo practices than group practices. Most self-pay psychiatry patients were White men.
Self-pay visits lasted longer than visits paid for by a third party (average duration, 38.3 min vs. 28.8 min; P < .001). Self-pay patients also made more visits to their psychiatrist than patients with third-party payers (mean, 18.3 visits vs. 9.4 visits in preceding 12 months; P < .001).
Ms. Benjenk and Dr. Chen wrote that self-pay psychiatry is a “hurdle many patients cannot surmount,” even if a portion of that payment is eventually paid by insurance.
“Either they have to pay out-of-pocket entirely or try to bill their insurance after the fact. It’s a lot of work to try to get an insurance company to pay for something after the fact. Ms. Benjenk said.
Ms. Benjenk believes that, with COVID-19 and a large shift to telepsychiatry, more psychiatrists might be interested in accepting insurance because they may be able to see more patients in a day.
“With telehealth, psychiatrists also can practice anywhere in their state, so that opens up a whole new pool of patients. And it’s cost saving; they don’t have to travel to an office, worry about office space or about no-shows, and there can be less lag time between appointments,” Ms. Benjenk said.
The study had no specific funding. Ms. Benjenk and Dr. Chen disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A growing number of psychiatrists in the United States no longer accept insurance and will only see patients who can pay upfront, out-of-pocket for office visits, a new trends analysis shows.
Ivy Benjenk, BSN, MPH, and Jie Chen, PhD, from the University of Maryland, College Park, wrote that psychiatrists may be more likely than other specialties to adopt a self-pay-only model because of low insurance reimbursement rates, particularly for psychotherapy, as well as a demand for psychiatric services that outstrips supply.
There is a “limited supply” of psychiatrists in the United States and a “great deal of administrative hoops that go into accepting insurance for pretty minimal payment. So it makes some sense for psychiatrists to move entirely into the self-pay market,” Ms. Benjenk said in an interview.
The study was published online July 15 in JAMA Psychiatry.
Barrier to care
To explore patterns in self-payment for office-based psychiatric services and changes over time, the researchers analyzed data from 2007 to 2016 from the National Ambulatory Medical Care Survey, a nationally representative survey of physicians who were not federally employed, were office based, and were primarily engaged in direct patient care.
Of 15,790 psychiatrist visits, 3445 (21.8%) were self-paid by patients, compared with 4336 of 119,749 primary care clinician visits (3.6%).
Of the 750 psychiatrists in the sample, 146 (19.5%) were reimbursed predominantly by self-payment, compared with 69 of 4,294 primary care clinicians (1.6%).
The percentage of self-paid psychiatrist office visits has trended upward (from 18.5% in 2007-2009 to 26.7% in 2014-2016), whereas the percentage of self-paid primary care visits has trended downward (from 4.1% in 2007-2009 to 2.8% in 2014-2016).
The percentage of psychiatrists who work in predominantly self-pay practices has also trended upward (from 16.4% in 2007-2009 to 26.4% in 2014-2016), whereas the percentage of primary care clinicians who work in predominantly self-pay practices has not changed significantly (from 1.5% to 1.7%).
Psychiatrists who are reimbursed predominantly by self-payment were more likely to work in solo practices than group practices. Most self-pay psychiatry patients were White men.
Self-pay visits lasted longer than visits paid for by a third party (average duration, 38.3 min vs. 28.8 min; P < .001). Self-pay patients also made more visits to their psychiatrist than patients with third-party payers (mean, 18.3 visits vs. 9.4 visits in preceding 12 months; P < .001).
Ms. Benjenk and Dr. Chen wrote that self-pay psychiatry is a “hurdle many patients cannot surmount,” even if a portion of that payment is eventually paid by insurance.
“Either they have to pay out-of-pocket entirely or try to bill their insurance after the fact. It’s a lot of work to try to get an insurance company to pay for something after the fact. Ms. Benjenk said.
Ms. Benjenk believes that, with COVID-19 and a large shift to telepsychiatry, more psychiatrists might be interested in accepting insurance because they may be able to see more patients in a day.
“With telehealth, psychiatrists also can practice anywhere in their state, so that opens up a whole new pool of patients. And it’s cost saving; they don’t have to travel to an office, worry about office space or about no-shows, and there can be less lag time between appointments,” Ms. Benjenk said.
The study had no specific funding. Ms. Benjenk and Dr. Chen disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
A growing number of psychiatrists in the United States no longer accept insurance and will only see patients who can pay upfront, out-of-pocket for office visits, a new trends analysis shows.
Ivy Benjenk, BSN, MPH, and Jie Chen, PhD, from the University of Maryland, College Park, wrote that psychiatrists may be more likely than other specialties to adopt a self-pay-only model because of low insurance reimbursement rates, particularly for psychotherapy, as well as a demand for psychiatric services that outstrips supply.
There is a “limited supply” of psychiatrists in the United States and a “great deal of administrative hoops that go into accepting insurance for pretty minimal payment. So it makes some sense for psychiatrists to move entirely into the self-pay market,” Ms. Benjenk said in an interview.
The study was published online July 15 in JAMA Psychiatry.
Barrier to care
To explore patterns in self-payment for office-based psychiatric services and changes over time, the researchers analyzed data from 2007 to 2016 from the National Ambulatory Medical Care Survey, a nationally representative survey of physicians who were not federally employed, were office based, and were primarily engaged in direct patient care.
Of 15,790 psychiatrist visits, 3445 (21.8%) were self-paid by patients, compared with 4336 of 119,749 primary care clinician visits (3.6%).
Of the 750 psychiatrists in the sample, 146 (19.5%) were reimbursed predominantly by self-payment, compared with 69 of 4,294 primary care clinicians (1.6%).
The percentage of self-paid psychiatrist office visits has trended upward (from 18.5% in 2007-2009 to 26.7% in 2014-2016), whereas the percentage of self-paid primary care visits has trended downward (from 4.1% in 2007-2009 to 2.8% in 2014-2016).
The percentage of psychiatrists who work in predominantly self-pay practices has also trended upward (from 16.4% in 2007-2009 to 26.4% in 2014-2016), whereas the percentage of primary care clinicians who work in predominantly self-pay practices has not changed significantly (from 1.5% to 1.7%).
Psychiatrists who are reimbursed predominantly by self-payment were more likely to work in solo practices than group practices. Most self-pay psychiatry patients were White men.
Self-pay visits lasted longer than visits paid for by a third party (average duration, 38.3 min vs. 28.8 min; P < .001). Self-pay patients also made more visits to their psychiatrist than patients with third-party payers (mean, 18.3 visits vs. 9.4 visits in preceding 12 months; P < .001).
Ms. Benjenk and Dr. Chen wrote that self-pay psychiatry is a “hurdle many patients cannot surmount,” even if a portion of that payment is eventually paid by insurance.
“Either they have to pay out-of-pocket entirely or try to bill their insurance after the fact. It’s a lot of work to try to get an insurance company to pay for something after the fact. Ms. Benjenk said.
Ms. Benjenk believes that, with COVID-19 and a large shift to telepsychiatry, more psychiatrists might be interested in accepting insurance because they may be able to see more patients in a day.
“With telehealth, psychiatrists also can practice anywhere in their state, so that opens up a whole new pool of patients. And it’s cost saving; they don’t have to travel to an office, worry about office space or about no-shows, and there can be less lag time between appointments,” Ms. Benjenk said.
The study had no specific funding. Ms. Benjenk and Dr. Chen disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Doctors say their COVID-19 protocol saves lives; others want proof
As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.
“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”
But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.
From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.
“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
Creating MATH+
MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.
When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.
Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.
Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.
In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.
“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.
The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”
Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
The basis for the protocol
The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.
They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.
“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.
Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.
Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”
“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”
The protocol authors push back against the necessity and feasibility of randomized control trials.
There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”
Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”
Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”
“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
Peer review
The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.
Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.
But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.
“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.
Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)
Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.
The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.
“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”
“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.
But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”
This article first appeared on Medscape.com.
As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.
“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”
But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.
From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.
“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
Creating MATH+
MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.
When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.
Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.
Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.
In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.
“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.
The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”
Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
The basis for the protocol
The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.
They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.
“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.
Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.
Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”
“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”
The protocol authors push back against the necessity and feasibility of randomized control trials.
There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”
Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”
Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”
“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
Peer review
The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.
Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.
But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.
“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.
Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)
Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.
The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.
“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”
“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.
But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”
This article first appeared on Medscape.com.
As COVID-19 cases mounted in Texas in late June, a local Houston news station shadowed Joseph Varon, MD, making rounds in the intensive care unit at United Memorial Medical Center in Houston. An unseen newscaster tells viewers that Varon credits his success against COVID-19 so far to an experimental and “controversial” drug protocol consisting of vitamins, steroids, and blood thinners.
“This is war. There’s no time to double-blind anything,” Varon tells the camera. “This is working. And if it’s working, I’m going to keep on doing it.”
But response to the protocol among other critical care physicians is mixed, with several physicians, in interviews with Medscape Medical News, urging caution because the benefits and relative risks of the combined medications have not been tested in randomized control trials.
From the earliest days of the pandemic, there’s been tension between the need for rigorous scientific study to understand a novel disease, which takes time, and the need to treat seriously ill patients immediately. Some treatments, like hydroxychloroquine, were promoted without randomized clinical trial data and then later were shown to be ineffective or even potentially harmful when tested.
“This pandemic has shown us there’s lots of ideas out there and they need to be tested and a theoretical basis is insufficient,” says Daniel Kaul, MD, a professor of infectious disease at the University of Michigan in Ann Arbor. The ups and downs with hydroxychloroquine offer a sobering example, he says. “I would argue we have an ethical obligation to do randomized controlled trials to see if our treatments work.”
Creating MATH+
MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” holds a place for additional therapies like vitamin D, zinc, and melatonin. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
Over a few weeks, the protocol evolved as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action, swapping in methylprednisolone and adding the anticoagulant heparin.
When Marik and colleagues created the protocol in early March, many healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients. The MATH+ physicians decided they needed to spread a different message, and began publicizing the protocol with a website and a small communications team.
Marik says they tried to get their protocol in front of healthcare organizations – including the WHO, the Centers for Disease Control and Prevention, and the National Institutes of Health – but received no response. Marik went on Newt Gingrich’s podcast to discuss the protocol in the hopes it would make its way to the White House.
Senator Ron Johnson of Wisconsin saw the protocol and invited Pierre Kory, MD, MPA, who practices in Johnson’s home state, to testify remotely in front of the Senate Homeland Security Committee. Kory is a pulmonary critical care specialist about to start a new job at Aurora St. Luke’s Medical Center in Milwaukee.
In his testimony, Kory shared his positive experience using the protocol to treat patients and expressed his dismay that national healthcare organizations came out against the use of corticosteroids for COVID-19 from the early days of the pandemic based on what he called a “tragic error in analysis of medical data.” Although an analysis by national organizations suggested corticosteroids might be dangerous in COVID-19 patients, one of his colleagues came to the opposite conclusion, he said. But these organizations advised supportive care only, and against steroids. “We think that is a fatal and tragic flaw,” Kory said.
“The problem with the protocol early on was that it was heresy,” says Kory, referring to the protocol’s inclusion of corticosteroids before official treatment guidelines. During the height of the pandemic in New York this spring, Kory spent 5 weeks working in the ICU at Mount Sinai Beth Israel in Manhattan. Seeing patients flounder on supportive care, Kory says he used MATH+ successfully during his time in New York, using escalating and pulse doses of corticosteroids to stabilize rapidly deteriorating patients.
The website’s home page initially included an invitation for visitors to donate money to support “getting word of this effective treatment protocol out to physicians and hospitals around the world.” After Medscape Medical News brought up the donation prompt in questions, the physicians decided to remove all calls for donations from the website and social media, communications representative Betsy Ashton said. “Critics are misinterpreting this as some kind of fund-raising operation, when that could hardly be the case,” Ashton said in an email. “They are horrified that anyone would impugn their motives.”
Donations paid for the website designer, webmaster, and her work, Ashton said, and the physicians now have donors who will support publicizing the protocol without online calls for donations. “We have no commercial or vested interest,” Marik said. “I’m not going to make a single cent out of this and it’s obviously very time-consuming.”
The basis for the protocol
The protocol is based on common sense, an understanding of scientific literature, and an understanding of COVID-19, Marik says. The website includes links to past research trials and observational studies examining ascorbic acid and thiamine in critically ill patients and early looks at anticoagulants in COVID-19 patients.
They chose methylprednisolone as their corticosteroid based on the expertise of group member G. Umberto Meduri, MD, professor of medicine at the University of Tennessee Health Science Center in Memphis, Tennessee, who had found the steroid effective in treating acute respiratory distress syndrome. On the MATH+ website, the physicians link to multiple observational studies posted on preprint servers in April and May that suggest methylprednisolone helped COVID-19 patients.
“What’s happened with time is all the elements have been validated by scientific studies, which makes this so cool,” says Marik. The RECOVERY Trial results in particular validated the push to use corticosteroids in COVID-19 patients, he says. But that study used a different steroid, dexamethasone, in much smaller doses than what MATH+ recommends. Revised guidance from the Infectious Diseases Society of America recommends dexamethasone for severely ill patients, but says methylprednisolone and prednisone can be used as substitutes at equivalent doses.
Marik and Kory say that mortality rates for COVID-19 patients at their respective hospitals decreased after they began using the protocol. The physicians have been collecting observational data on their patients, but have not yet published any, and do not plan to conduct a randomized trial.
Several physicians who were not involved in the creation of the protocol say the evidence the physicians cite is not robust enough to warrant the promotion of MATH+ and call for randomized controlled trials. Coming up with a protocol is fine, says Kaul, but “you have to do the hard work of doing a randomized control trial to determine if those drugs given in those combinations work or not.”
“When I looked at it, I thought it was actually not very evidence based,” says Michelle Gong, MD, chief of the Division of Critical Care Medicine at Montefiore Health System in New York City. “It is not something I would recommend for my doctors to do outside of a clinical trial.”
The protocol authors push back against the necessity and feasibility of randomized control trials.
There is no time for a randomized control trial right now, says Jose Iglesias, DO, associate professor at Hackensack Meridian School of Medicine at Seton Hall and critical care specialist at Community Medical Center and Jersey Shore University Medical Center in New Jersey. “Time is limited. We’re busy bedside clinicians taking care of patients, and patients who are dying.”
Marik argues there is not equipoise: It wouldn’t be ethical to randomize patients in a placebo group when the physicians are confident the steroids will help. And the protocol is personalized for each patient, making the standardization required for a randomized control trial incredibly difficult, he says. He also cites “the people who are unwilling to accept our results and just think it’s too good to be true.”
Hugh Cassiere, MD, director of critical care medicine at Northwell Health’s North Shore University Hospital in Manhasset, New York, said he finds it “very disturbing that this is being propagated.” In the context of a pandemic in which physicians from other specialties are helping out colleagues in ICUs and might follow the protocol uncritically, he worries, “this could potentially lead to harm.”
“I understand the intention; everybody wants to do something, these patients are so sick and the crisis so sharp that we all want to do something to make patients better,” Gong said. “But as physicians taking care of patients we need to make sure we separate the noise from the evidence.”
Peer review
The physicians who reviewed MATH+ for Medscape Medical News differed on which parts of the protocol they support and which parts they would change.
Dexamethasone should be the corticosteroid of choice over methylprednisolone, says Cassiere, because it has now been proven effective in the randomized RECOVERY Trial, which also tested dosing and a timetable for treatment.
But Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, thinks methylprednisolone may be effective, and that even higher doses over longer periods of time may stave off recurring pneumonia, based on his experience using the steroid to treat COVID-19 patients in New York.
“What I really like about this protocol is, these guys are very smart, they recommend the need to treat multiple different things at the same time,” says Parnia. COVID-19 is a complex condition, he notes: If physicians are only focused on solving one problem, like hypoxia, patients could still be dying from blood clots.
Despite general concerns about the protocol, Cassiere says he was excited about the inclusion of heparin. Given the extreme levels of clotting seen in COVID-19 patients, he would have included specific D-dimer levels to guide treatment and explored antiplatelet therapies like aspirin. Gong, however, cautioned that she had seen her patients on anticoagulants develop gastrointestinal bleeding, and reiterated the need for clinical evidence. (At least one clinical trial is currently testing the risks and benefits of heparin as an antithrombotic therapy for COVID-19 patients.)
Perhaps the most divisive part of the protocol is the inclusion of ascorbic acid. “That’s the civil war,” says Kory. “It’s the most polarizing medicine.” The authors of the MATH+ protocol were close colleagues before COVID-19 in part because of a mutual research interest in ascorbic acid, he says. Other physicians, including Cassiere, are extremely skeptical that ascorbic acid has any effect, citing recently published studies in the Journal of the American Medical Association that found ascorbic acid ineffective for treating sepsis.
The MATH+ creators say they are working on a literature review of the research behind the protocol, and they plan to write up the observational impacts of the protocol. Marik says he’s not optimistic about getting the findings published in a high-impact journal given the observational nature of the research; the relatively small number of patients treated at hospitals using the protocol (140 patients at Marik’s hospital in Virginia and 180 at Varon’s in Houston, according to Marik); and the vast number of COVID-19 papers being submitted to scientific journals right now.
“This is not a remedy with expensive designer drugs,” Marik said. “No one has any interest in treating patients with cheap, safe, readily available drugs.”
“I hope they’re right if they’re saying this combination of medicines dramatically decreases mortality,” says Taison Bell, MD, director of the medical intensive care unit and assistant professor of medicine at UVA Health in Charlottesville, Virginia.
But physicians have hurt patients in the past with medications they hoped would work, he says. “We have to make sure we’re balancing the risk and the harm with that benefit, and the only way to protect patients from those biases is by doing a randomized controlled trial.”
This article first appeared on Medscape.com.