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NACMI: Clear benefit with PCI in STEMI COVID-19 patients
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).
Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).
“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.
The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.
Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.
NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.
The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.
Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.
The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.
COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).
They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.
Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.
Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).
But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).
Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.
“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”
Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.
During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.
“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”
Future topics of interest include ethnic and regional/country differences; time-to-treatment including chest pain onset-to-arrival; transfer, in-hospital, and no-culprit patients; changes over time during the pandemic; and eventually 1-year outcomes, Dr. Henry said.
Press briefing moderator Ajay Kirtane, MD, director of the cardiac catheterization labs at NewYork-Presbyterian/Columbia University Irving, New York, remarked that “a lot of times people will pooh-pooh observational data, but this is exactly the type of data that we need to try to be able to gather information about what our practices are, how they fit. And I think many of us around the world will see these data, and it will echo their own experience.”
The study was funded by the Society for Cardiovascular Angiography and Interventions and the Canadian Association of Interventional Cardiology. Dr. Henry has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
October 2020 Product News
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Express Scripts Covers Rhofade on the National Preferred Formulary
EPI Health, LLC, announces that Rhofade (oxymetazoline hydrochloride) cream 1% is now covered on the Express Scripts National Preferred Formulary, providing more access to this rosacea therapy. Rhofade is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. For more information, visit www.rhofade.com.
MC2 Therapeutics and EPI Health to Collaborate on Wynzora Cream
MC2 Therapeutics announces a Collaboration Agreement with EPI Health, LLC, on the commercialization of Wynzora cream (calcipotriene 0.005% and betamethasone dipropionate 0.064%) in the United States. Wynzora cream was approved by the US Food and Drug Administration in July 2020 for the topical treatment of plaque psoriasis in adults. MC2 Therapeutics retains full ownership of Wynzora cream under the Collaboration Agreement, and MC2 Therapeutics and EPI Health will utilize their combined resources to make Wynzora cream a leading patient-preferred topical treatment of psoriasis in the United States. EPI Health will utilize its commercial infrastructure to promote and sell Wynzora cream in return of a share of net sales. For more information, visit www.wynzora.com.
Positive Phase 3 Results for Tapinarof Cream for Plaque Psoriasis
Dermavant Sciences, Inc, reports positive results from PSOARING 1 (N=510) and PSOARING 2 (N=515), two identical, multicenter, randomized, vehicle-controlled, double-blind, parallel studies to evaluate the efficacy and safety of tapinarof cream 1% for the treatment of plaque psoriasis in adults. In both trials, tapinarof cream demonstrated highly statistically significant improvement in PASI 75 (psoriasis area and severity index) from baseline at week 12 (P<.0001). In addition, up to 80% of patients achieved a 1-grade or higher improvement in physician global assessment across both studies. Following completion and findings of the ongoing long-term extension study, Dermavant expects to file a New Drug Application with the US Food and Drug Administration in 2021. For more information, visit www.dermavant.com.
If you would like your product included in Product News, please email a press release to the Editorial Office at [email protected].
Caring for patients who experience stillbirth: Dos and don’ts
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
As a provider whose passion is helping women after stillbirth or neonatal loss, I get many transfers of women from their previous practice after a loss. Sometimes they transfer because they need a “fresh start,” but often, it is because they were let down by the practice – not by the medical care they received but by the emotional care and support and what was said or not said after the loss of the baby. A 2014 meta-analysis in the British Journal of Obstetrics and Gynaecology found that “Parents regarded contacts with health professionals as their central source of reassurance; but experiences often fell short of expectations.”1 I decided to conduct a survey via local and national support groups about what “loss parents” felt helpful or not helpful after the loss of a child. I purposely made these quotes the dominant part of this article, as I believe our patients are often our best teachers.
Inappropriate comments providers make
A very common theme among loss parents was how providers had made comments about how rare stillbirth is after it had just happened to them. Parents expressed that they felt this statistic kept them from getting the care that they needed prior to their loss and then they were told to not worry. Some example quotes include:
“ ‘This only happens to 1% of babies. Very rare.’ (It happened to our baby, and we have to live with this grief our whole lives. She is more than a statistic. She was our hopes, dreams, and future.)”
“I wish doctors didn’t wait to act based on statistics. There’s a lot of us in the 1% of unlikely occurrences.”
“For me, when my practice brushed off my feelings, I knew in my gut something was wrong. They said, ‘We need to wean you from worrying.’”
Another very common theme from parents included examples of helpful and not helpful care they received in the hospital.
Help parents make good memories
Many parents mentioned the importance of providing resources for after they go home. Most labor and delivery units have pregnancy loss services and have improved on the care they provide for loss families. One very common positive comment responded to the memories that nurses and providers helped them make after delivery. One parent said the following:
“While with baby and after loss, I think it’s really important to give ideas of what to do/experiences because the moments are so fleeting, and I needed someone to say, ‘You can dress him.’ ‘Let’s take pictures of his toes.’ ‘Save breast milk, etc.’”
“I appreciated the doctors and nurses who acknowledged my child, who looked at him and humanized him. One nurse even held him, which I still love her to this day for.”
“Explain things over, over, and over again, like you are explaining it to a child. I didn’t know what a cuddle cot was, and I didn’t use it because I didn’t understand.”
“Give suggestions and stress the importance of making memories. There are things I wish I did and now regret not doing. Taking pictures, handprints, lock of hair, giving the baby a bath.”
“For unknown losses give a full explanation of the autopsy and what it entails. Parents are making SO many decisions, and they need guidance.”
“Don’t shy away from it. It happened, and it is important to be human and compassionate. If you cannot do it, find someone else who can.”
“Ask to hold the baby and comment how beautiful the baby is. Treat the baby as if it were living.”
Don’t use the ‘silver lining’ theme
A common “don’t” in the hospital and postpartum is the “at least” and “silver lining” theme that is commonly expressed by providers. When I do my teaching sessions with a bereaved parents panel, we always stress that comforting words never begin with “at least.” We say a lot that there is no “silver lining” to a stillbirth. Dr. Brene Brown, in her TED talk on empathy, discussed that an empathic statement never starts with “at least.” However, this response is an all too common experience for women after stillbirth. Here are some examples from the Internet responses:
“‘The silver lining is you and your daughter have taught us so much.’ There is no silver lining, and her life was not for anyone’s easy path to learning lessons. She was wanted and loved.”
“What not to say: From a doctor, ‘You’re going to have lots more children.’ Anything along the lines of ‘at least you can get pregnant/have children’ is not OK.”
“As a teacher, ‘At least you are already a mother to your students.’ (I cannot even tell you how many times I’ve been told this. They already have mothers, and teaching a child 40 minutes once a week is not even close to being a mother to your own child.)”
“I felt it unhelpful for people to tell me how I should feel. I felt comments like ‘oh, you are young you can have another baby’ unhelpful.”
“Do not say, ‘you can have another, it wasn’t God’s plan, God wanted another angel, there is a reason for everything,’ etc.”
“The doctor who told me my baby was dead referred to him as a fetus. I was 38 weeks pregnant and did not refer to my baby as a fetus.”
Handling patient care after the loss
A huge portion of the response I received was regarding care from the practice where they delivered after the loss. These parents provided very important advice for any practice after a patient experiences a loss. Emotional support is vital for these patients. They also made it clear that topics such a medications and counseling should be frequently revisited.
“The care a patient receives after can really change their life – not physical care but emotional care. I truly believe I recovered well, and I am the person I am today because of my provider’s phone calls, suggestions for medications, support groups, and counseling. Don’t underestimate what simple phone calls can do. You don’t have to provide a solution or give advice, just listen.”
“Revisit conversations about medications. I have never taken anything in my entire life. In fact, I was very against it. Don’t be afraid to suggest medications time and time again if you think that it is the right plan. After 6 months, I said ‘yes’ to the medication, and it helped immensely.”
“My OB checking in with me constantly. Doctors offering compassionate and informative advice and encouragement. SUPPORT GROUPS. Star Legacy Foundation mentor!!! Klonopin! Psychologist!!”
“Also, I think it’s important for providers to continue to follow-up with patients even if they don’t seem receptive. Keep checking in. After losing your child you are in a fog. You don’t know quite what you need. But those calls, I promise you they mean something.”
When the patient returns to the office
The care received by a loss parent after returning to the office is challenging but so important. Some very careful steps can and must be made to help avoid emotionally harmful situations for the staff and patients. Offices need to make special accommodations and mark what happened clearly in the chart regarding the loss. When I have a mother coming in for a postpartum visit after a loss, I make sure she is the last patient of the day and try to bring her to our satellite offices where she can be the only patient there. Many parents made comments about carefully labeling what happened to the baby in the chart.
“Make sure it’s noted in the chart, and don’t AVOID talking about it. We like to have our baby brought up. Make sure staff knows the situation before entering the office so they don’t say something stupid (for example, ‘How is breast feeding going?’)”
“#1 don’t in my book: Not reading the patient’s chart and labels on it before seeing them if you’re not familiar with the patient. ... Nurses, techs and providers alike have assumed or asked “this is your first,” when clearly my chart lists “fetal death in utero.’”
“Many others have stated this, but having a BIG HUGE MASSIVE flag on our accounts and making sure ALL parts of the office are trained on this would be so incredibly helpful.”
“The nurse at my doctor’s office yesterday said, ‘Well, you’ve lost some weight since you were here last, so that’s good!’ My response was, ‘Well, losing a baby will do that.’”
“The follow-up appointment is awful. I went in heartbroken and angry and anxious. A phone call the day before acknowledging those feelings and reassuring me it was okay would have been nice.”
“At my first follow-up after my son died, I walked in, the receptionist pulled up my chart, saw I was there for my post-delivery appointment, and in the loudest, most cheery voice said, ‘Oooooooooh how’s he doing, how’s the baby?!’ It was awful telling her that he died, and I also felt terrible for all the pregnant woman in the waiting room who may have heard it.”
“When I was in emergency for a complication after birth, the only condolence a doctor from our previous practice gave was, ‘Well, that sucks’ (in regard to our daughter).”
Continuing care in the office
The care of women in the office immediately after loss and in years to come is a very important piece of the care they receive. In the same BJOG meta-analysis they found, “Parents frequently encountered professionals who were unaware of their history, through lack of access to/or reading of notes before a consultation. Dismissive attitudes to fears and concerns and insensitive and inappropriate comments sometimes resulted. These often remained with parents long after the event. In contrast, emotional wellbeing was enhanced when care providers demonstrated empathy, listened to concerns and committed to a collaborative and supportive relationship. Parents valued direct acknowledgment of the baby who had died, including using his or her name. Flexible antenatal care including extra appointments, routinely or on request, was also welcomed.”1 These findings were very similar to those reflected in the comments that I received.
“To the mother, there is no difference between a living baby and a stillborn baby. This stillborn baby is JUST AS MUCH a life to us. I’ve had four kids, and I can’t differentiate between how I feel about them.”
“Also, if staying with the same provider, ‘do’ ask what accommodations can be made moving forward. (For me I needed a different ultrasound tech and a different office for my ultrasounds in my subsequent pregnancies as I couldn’t go back there but wanted to stay with my same OB).”
“Don’t be afraid to ask about the child. I want people to know I like talking about my son, that he existed and how much love there was in his short but meaningful life.”
“Saying nothing is worse than saying you don’t know what to say and you are sorry.”
“Some moms love the rainbow baby term, and if they use it first, it’s fine to use it and encourage it and promote it. However, some moms do not like it because 1) they don’t like referring to their loss baby as a ‘storm.’ My baby was a BABY, and he was perfect and loved and I don’t like people referring to him as a storm. A storm is derogatory, [and] 2) the notion the subsequent baby makes everything okay is ridiculous. 3) Not everyone has another baby after a loss, so the ‘after every storm comes a rainbow’ phrase is stupid. It makes it seem like you can never be happy again unless you get a rainbow, and that is not true. 4) It’s a signal to the outside world that ‘everything’ is great and ok when in reality you can have grief, joy, sadness, happiness, pain, and hope all at the [same] time forever.”
Patients and their families who have lost their babies deserve our very best. No one grieves the same, and the differences in how our patients grieve must be respected. However, members of the loss community do have some common themes on responses that they appreciated or did not appreciate regarding their care. Most patients who deliver a stillborn baby or experience a neonatal death or pre-viable baby have had no time to prepare, and they are looking for our guidance and support. The more time we spend with them after diagnosis, during delivery, and after will be so appreciated. I hope some of these quotes ring true to many providers and that they either lead to attempts to change care or reinforce the amazing care providers are already providing. Being at our best when our patients are experiencing potentially the worst moments of their lives is our job as obstetrical providers. Our patients deserve the best care we can possibly provide. Hopefully, these suggestions from patients will help the care of future loss families.
Dr. Florescue is an ob.gyn. in private practice at Women Gynecology and Childbirth Associates in Rochester, N.Y. She delivers babies at Highland Hospital in Rochester. She has no relevant financial disclosures. Email her at [email protected].
Reference
1. BJOG. 2014 Jul; 121(8):943-50. doi: 10.1111/1471-0528.12656.
FDA issues new NSAIDs warning for second half of pregnancy
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.
Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.
The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.
Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.
Low-dose (81-mg) aspirin is excluded from this warning.
“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.
“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”
Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.
If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.
As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.
A version of this article originally appeared on Medscape.com.
Hospitalists and unit-based assignments
What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.
The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.
The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.
Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.
It is important that each team member is prepared prior to the rounds. The total time for the rounds is often tightly controlled, as a fundamental concern is that MDRs can take up too much time. Use of a checklist or whiteboard during the unit-based rounds can improve efficiency. Midday MDRs are another gem in patient care, where the team proactively addresses early barriers in patient care and discharge plans for the next day.
The 2020 State of Hospital Medicine report highlights utilization of unit-based rounding, including breakdowns based on employment model. In groups serving adults patients only, 43% of university/medical school practices utilized unit-based assignments versus 48% for hospital-employed HMGs and only 32% for HMGs employed by multistate management companies. In HMGs that served pediatric patients only, 27% utilized unit-based assignments.
Undoubtedly geographic rounding has its own challenges. The pros and cons and the feasibility needs to be determined by each HMG. It’s often best to conduct the unit-based rounds on a few units and then roll it out to all the floors.
An important prerequisite to establishing a unit-based model for rounding is a detailed data analysis of total number of patients in various units to ensure there is adequate staffing. It must be practical to localize providers to different units, and complexity of various units can differ. At Lahey Hospital and Medical Center in Burlington, Mass., an efficient unit-based model has been achieved with complex units typically assigned two providers. Units including oncology and the progressive care unit can be a challenge, because of higher intensity and patient turnover.
Each unit is tagged to another unit in the same geographical area; these units are designated “sister pods.” The intention of these units is to strike a balance and level off patient load when needed. This process helps with standardization of the work between the providers. A big challenge of the unit-based model is to understand that it’s not always feasible to maintain consistency in patient assignments. Some patients can get transferred to a different unit due to limited telemetry and specialty units. At Lahey the provider manages their own patient as “patient drift” happens, in an attempt to maintain continuity of care.
The ultimate goal of unit-based assignments is to improve quality, financial, and operational metrics for the organization and take a deeper dive into provider and staff satisfaction. The simplest benefit for a hospitalist is to reduce travel time while rounding.
Education and teaching opportunities during the daily MDRs are still debatable. Another big step in this area may be a “resident-centered MDR” with the dual goals of improving both quality of care and resident education by focusing on evidence-based medicine.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.
The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.
The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.
Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.
It is important that each team member is prepared prior to the rounds. The total time for the rounds is often tightly controlled, as a fundamental concern is that MDRs can take up too much time. Use of a checklist or whiteboard during the unit-based rounds can improve efficiency. Midday MDRs are another gem in patient care, where the team proactively addresses early barriers in patient care and discharge plans for the next day.
The 2020 State of Hospital Medicine report highlights utilization of unit-based rounding, including breakdowns based on employment model. In groups serving adults patients only, 43% of university/medical school practices utilized unit-based assignments versus 48% for hospital-employed HMGs and only 32% for HMGs employed by multistate management companies. In HMGs that served pediatric patients only, 27% utilized unit-based assignments.
Undoubtedly geographic rounding has its own challenges. The pros and cons and the feasibility needs to be determined by each HMG. It’s often best to conduct the unit-based rounds on a few units and then roll it out to all the floors.
An important prerequisite to establishing a unit-based model for rounding is a detailed data analysis of total number of patients in various units to ensure there is adequate staffing. It must be practical to localize providers to different units, and complexity of various units can differ. At Lahey Hospital and Medical Center in Burlington, Mass., an efficient unit-based model has been achieved with complex units typically assigned two providers. Units including oncology and the progressive care unit can be a challenge, because of higher intensity and patient turnover.
Each unit is tagged to another unit in the same geographical area; these units are designated “sister pods.” The intention of these units is to strike a balance and level off patient load when needed. This process helps with standardization of the work between the providers. A big challenge of the unit-based model is to understand that it’s not always feasible to maintain consistency in patient assignments. Some patients can get transferred to a different unit due to limited telemetry and specialty units. At Lahey the provider manages their own patient as “patient drift” happens, in an attempt to maintain continuity of care.
The ultimate goal of unit-based assignments is to improve quality, financial, and operational metrics for the organization and take a deeper dive into provider and staff satisfaction. The simplest benefit for a hospitalist is to reduce travel time while rounding.
Education and teaching opportunities during the daily MDRs are still debatable. Another big step in this area may be a “resident-centered MDR” with the dual goals of improving both quality of care and resident education by focusing on evidence-based medicine.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
What seems like a usual day to a seasoned hospitalist can be a daunting task for a new hospitalist. A routine day as a hospitalist begins with prerounding, organizing, familiarizing, and gathering data on the list of patients, and most importantly prioritizing the tasks for the day. I have experienced both traditional and unit-based rounding models, and the geographic (unit-based) rounding model stands out for me.
The push for geographic rounding comes from the need to achieve excellence in patient care, coordination with nursing staff, higher HCAHPS (Hospital Consumer Assessment of Healthcare Providers and Systems) scores, better provider satisfaction, and efficiency in work flow and in documentation. The goal is typically to use this well-established tool to provide quality care to acutely ill patients admitted to the hospital, creating an environment of improved communication with the staff. It’s a “patient-centered care” model – if the patient wants to see a physician, it’s quicker to get to the patient and provides more visibility for the physician. These encounters result in improved patient-provider relationships, which in turn influences HCAHPS scores. Proximity encourages empathy, better work flow, and productivity.
The American health care system is intense and complex, and effective hospital medicine groups (HMGs) strive to provide quality care. Performance of an effective HMG is often scored on a “balanced score card.” The “balanced score” evaluates performance on domains such as clinical quality and safety, financial stability, HCAHPS, and operational effectiveness (length of stay and readmission rates). In my experience, effective unit-based rounding positively influences all the measures of the balanced score card.
Multidisciplinary roundings (MDRs) provide a platform where “the team” meets every morning to discuss the daily plan of care, everyone gets on the same page, and unit-based assignments facilitate hospitalist participation in MDRs. MDRs typically are a collaborative effort between care team members, such as a case manager, nurse, and hospitalist, physical therapist, and pharmacist. Each team member provides a precise input. Team members feel accountable and are better prepared for the day. It’s easier to develop a rapport with your patient when the same organized, comprehensive plan of care gets communicated to the patient.
It is important that each team member is prepared prior to the rounds. The total time for the rounds is often tightly controlled, as a fundamental concern is that MDRs can take up too much time. Use of a checklist or whiteboard during the unit-based rounds can improve efficiency. Midday MDRs are another gem in patient care, where the team proactively addresses early barriers in patient care and discharge plans for the next day.
The 2020 State of Hospital Medicine report highlights utilization of unit-based rounding, including breakdowns based on employment model. In groups serving adults patients only, 43% of university/medical school practices utilized unit-based assignments versus 48% for hospital-employed HMGs and only 32% for HMGs employed by multistate management companies. In HMGs that served pediatric patients only, 27% utilized unit-based assignments.
Undoubtedly geographic rounding has its own challenges. The pros and cons and the feasibility needs to be determined by each HMG. It’s often best to conduct the unit-based rounds on a few units and then roll it out to all the floors.
An important prerequisite to establishing a unit-based model for rounding is a detailed data analysis of total number of patients in various units to ensure there is adequate staffing. It must be practical to localize providers to different units, and complexity of various units can differ. At Lahey Hospital and Medical Center in Burlington, Mass., an efficient unit-based model has been achieved with complex units typically assigned two providers. Units including oncology and the progressive care unit can be a challenge, because of higher intensity and patient turnover.
Each unit is tagged to another unit in the same geographical area; these units are designated “sister pods.” The intention of these units is to strike a balance and level off patient load when needed. This process helps with standardization of the work between the providers. A big challenge of the unit-based model is to understand that it’s not always feasible to maintain consistency in patient assignments. Some patients can get transferred to a different unit due to limited telemetry and specialty units. At Lahey the provider manages their own patient as “patient drift” happens, in an attempt to maintain continuity of care.
The ultimate goal of unit-based assignments is to improve quality, financial, and operational metrics for the organization and take a deeper dive into provider and staff satisfaction. The simplest benefit for a hospitalist is to reduce travel time while rounding.
Education and teaching opportunities during the daily MDRs are still debatable. Another big step in this area may be a “resident-centered MDR” with the dual goals of improving both quality of care and resident education by focusing on evidence-based medicine.
Dr. Puri is a hospitalist at Lahey Hospital and Medical Center in Burlington, Mass.
Four-week, 8-week CAB/RPV injections safe, effective in women
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
according to results from the ATLAS-2M study, presented at the HIV Glasgow 2020 Virtual Conference, held October 5-8. The women also reported high satisfaction with the regimen, compared with daily oral antiretroviral therapy.
Previously reported results had shown that the two-drug combination administered every 8 weeks (600 mg cabotegravir and 900 mg rilpivirine) was noninferior to injections every 4 weeks (400 mg cabotegravir and 600 mg rilpivirine) in adults with HIV during the open-label phase 3b ATLAS-2M trial. Further, the ATLAS and FLAIR phase 3 trials had shown the 4-week administration of the therapy to be noninferior to a daily oral three-drug antiretroviral therapy.
Paul Benn, MBBS, of ViiV Healthcare (which is seeking regulatory approval for CAB/RPV treatment), and his colleagues completed a planned subgroup analysis of women in the ATLAS-2M trial. The primary endpoint was the proportion of intention-to-treat participants with plasma HIV-1 RNA of at least 50 copies/mL with a noninferiority margin of 4% at 48 weeks. The secondary endpoint was the proportion of participants with HIV-1 RNA under 50 copies/mL with a noninferiority margin of 10%.
Among the 280 women enrolled, 137 were randomly assigned to receive injections every 8 weeks, and 143 to receive injections every 4 weeks. A majority of the women (56%) were White, the median age was 44 years, and just over half (53%) were treatment naive with cabotegravir and rilpivirine.
At 48 weeks, 3.6% of women in the 8-week group and 0% of women in the 4-week group had at least 50 copies/mL of HIV-1 RNA. In both arms, 91% of participants had HIV-1 RNA under 50 copies/mL. Plasma concentrations of cabotegravir and rilpivirine were similar between the women and the overall study population.
Confirmed virologic failure occurred in five women, all before week 24. Three of the women were subtype A/A1, and four of them had archived nonnucleoside reverse transcriptase inhibitor (NNRTI) resistance–associated mutations.
There were no significant differences in the safety profile between the groups; 99% of injection site reactions that occurred were mild to moderate and lasted a median 3-4 days. Fewer than 4% of participants discontinued because of adverse events – five women in the 8-week group and five women in the 4-week group. Four women cited injection site reactions as the reason for discontinuation.
Women not previously treated with CAB/RPV reported increased treatment satisfaction on the HIV Treatment Satisfaction Questionnaire, a score of 5.4 in the 8-week group and 3.9 in the 4-week group. Among those with prior CAB/RPV treatment, 88% preferred the 8-weekly injections, 8% preferred the 4-weekly injections, and 2% preferred oral dosing.
Long-acting CAB/RPV is an investigational formulation. In December 2019, the Food and Drug Administration denied approval to the formulation on the basis of manufacturing and chemistry concerns, according to a company press release.
This article first appeared on Medscape.com.
Social factors predicted peripartum depressive symptoms in Black women with HIV
Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.
Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.
In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.
Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
Social factors show significant impact
In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.
The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.
The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
Quantitative studies needed
Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.
The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.
“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.
Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.
Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.
In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.
Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
Social factors show significant impact
In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.
The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.
The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
Quantitative studies needed
Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.
The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.
“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.
Women with high-risk pregnancies because of chronic conditions are at increased risk for developing postpartum depression, and HIV may be one such risk. However, risk factors for women living with HIV, particularly Black women, have not been well studied, wrote Emmanuela Nneamaka Ojukwu of the University of Miami School of Nursing, and colleagues.
Data suggest that as many as half of cases of postpartum depression (PPD) begin before delivery, the researchers noted. “Therefore, for this study, the symptoms of both PND (prenatal depression) and PPD have been classified in what we have termed peripartum depressive symptoms (PDS),” and defined as depressive symptoms during pregnancy and within 1 year postpartum, they said.
In a study published in the Archives of Psychiatric Nursing, the researchers conducted a secondary analysis of 143 Black women living with HIV seen at specialty prenatal and women’s health clinics in Miami.
Overall, 81 women (57%) reported either perinatal or postpartum depressive symptoms, or both. “Some of the symptoms prevalent among women in our study included restlessness, depressed mood, apathy, guilt, hopelessness, and social isolation,” the researchers said.
Social factors show significant impact
In a multivariate analysis, low income, intimate partner violence, and childcare burden were significant predictors of PDS (P less than .05). Women who reported intimate partner violence or abuse were 6.5 times more likely to experience PDS than were women who did not report abuse, and women with a childcare burden involving two children were 4.6 times more likely to experience PDS than were women with no childcare burden or only one child needing child care.
The average age of the women studied was 29 years, and 59% were above the federal poverty level. Nearly two-thirds (62%) were Black and 38% were Haitian; 63% were unemployed, 62% had a high school diploma or less, and 59% received care through Medicaid.
The researchers assessed four categories of health: HIV-related, gynecologic, obstetric, and psychosocial. The average viral load among the patients was 22,359 copies/mL at baseline, and they averaged 2.5 medical comorbidities. The most common comorbid conditions were other sexually transmitted infections and blood disorders, followed by cardiovascular and metabolic conditions.
Quantitative studies needed
Larger quantitative studies of Black pregnant women living with HIV are needed to analyze social factors at multiple levels, the researchers said. “To address depression among Black women living with HIV, local and federal governments should enact measures that increase the family income and diminish the prevalence of [intimate partner violence] among these women,” they said.
The study findings were limited by several factors including retrospective design and use of self-reports, as well as the small sample size and lack of generalizability to women living with HIV of other races or from other regions, the researchers noted. However, the results reflect data from previous studies and support the value of early screening and referral to improve well being for Black women living with HIV, as well as the importance of comprehensive medical care, they said.
“Women should be counseled that postpartum physical and psychological changes (and the stresses and demands of caring for a new baby) may make [antiretroviral] adherence more difficult and that additional support may be needed during this period,” the researchers wrote.
The study received no outside funding. The researchers had no financial conflicts to disclose.
SOURCE: Ojukwu EN et al. Arch Psychiatr Nurs. 2020 May 22. doi: 10.1016/j.apnu.2020.05.004.
FROM ARCHIVES OF PSYCHIATRIC NURSING
New Americans: Considerations for culturally collaborative care
Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.
What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?
There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.1 In 2019, 30,000 refugees were resettled in the United States.2 In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.3 Given this information,
Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).4,5
Cultural framework model
One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,6,7 which initially was developed to be used within a family medicine clinic. It includes the following:
Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.
Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.
Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.
Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.
Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.
The following are tips to consider in the life-long process of becoming more culturally aware:
- Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
- Be aware of your own identity and what that may contribute to the clinical space.
- Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
- Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.
The case at hand
In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.
You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.
Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.
For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)
2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)
3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).
4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).
5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).
6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.
7. Paediatr Child Health. 2018 Feb;23(1):66-9.
Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.
What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?
There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.1 In 2019, 30,000 refugees were resettled in the United States.2 In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.3 Given this information,
Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).4,5
Cultural framework model
One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,6,7 which initially was developed to be used within a family medicine clinic. It includes the following:
Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.
Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.
Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.
Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.
Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.
The following are tips to consider in the life-long process of becoming more culturally aware:
- Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
- Be aware of your own identity and what that may contribute to the clinical space.
- Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
- Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.
The case at hand
In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.
You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.
Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.
For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)
2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)
3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).
4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).
5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).
6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.
7. Paediatr Child Health. 2018 Feb;23(1):66-9.
Adam is a 14-year-old who presents for “behavioral concerns” as recommended by his teacher. He is in the eighth grade and is struggling academically and socially. He has intermittent outbursts and poor engagement with other children, and often refuses to do schoolwork. He is seen in the outpatient primary care clinic, usually with his mother and two older siblings, one of whom typically translates for his Arabic-speaking mother. Adam is bilingual, although he prefers Arabic. It is difficult to understand the presenting concern as Adam states that he is doing well and is unsure why the teacher would have made such a report. Mother notes that she does not see these behaviors at home either.
What must we consider? Are there potential barriers, alternate ways to engage, and what role may culture have?
There are many things to consider in the above case, including language barriers, nuanced interactions, and cultural expectations and norms. To understand the scope, statistics reveal that the United States leads the world in its immigrant population with about 44.8 million foreign-born persons in 2018, which accounts for approximately 13.7% of the U.S. population.1 In 2019, 30,000 refugees were resettled in the United States.2 In 2017, immigrant children made up 27% (19.6 million) of U.S. children, of which second-generation children (born in the United States to immigrant parents) were the vast majority at 16.7 million.3 Given this information,
Culture is defined as a set of shared beliefs, norms, values, and behaviors exhibited by a group. Culture plays a role and impacts children in various ways throughout their development. Health care providers would benefit from aspiring to exude cultural humility – learning with and from patients and their families with openness, kindness, and a desire for collaboration. The provider also must consider a family’s history of migration as the response to migration may vary based on age, personal experiences, age at which migration occurred, language abilities, and amount of cultural engagement in the new country (i.e. acculturation).4,5
Cultural framework model
One example of a potential framework to use to engage within a cultural context includes the LEARN (Listen, Explain, Acknowledge, Recommend, Negotiate) model,6,7 which initially was developed to be used within a family medicine clinic. It includes the following:
Listen with sympathy and understanding to the patient’s perception of the problem. Try to understand their perspective of symptoms through considering their thoughts regarding etiology and treatment options.
Explain your perception of the problem. Have a dialogue about what you perceive is the likely cause based on a medical perspective.
Acknowledge and discuss the differences and similarities. Engage in open conversation while being cognizant that there may be similarities and differences in the perception you may have versus your patient’s perception. Try to find areas that can be engaged in and an alliance built upon, as well as respectfully and humbly addressing any concerns about potentially harmful patient understandings.
Recommend treatment. Present a treatment recommendation that considers both yours and the patient’s perspectives.
Negotiate agreement. Discuss, collaborate, and finalize a treatment plan that considers a biopsychosocial and spiritual/religious model of care that is patient-centered and personalized such that the main goal is optimal health and wellness for the patient/family.
The following are tips to consider in the life-long process of becoming more culturally aware:
- Be willing to learn with your patients and be thoughtful about your own feelings/thoughts/behaviors that may be positively or negatively impacting those interactions.
- Be aware of your own identity and what that may contribute to the clinical space.
- Recognize that you are not meant to know everything, but being open to the journey and learning process will go a long way.
- Try to shift the focus from paternalistic medicine to collaborative and patient-centered approaches.
The case at hand
In returning to our case and applying the LEARN model and cultural humility, we may be able to uncover more of the story. Adam is seen at a subsequent appointment, and you determine it best to obtain an in-person interpreter for this appointment. As you listen to the story, you learn that his father was killed early in Adam’s life, his mother has suffered from depression, and they moved here 3 years ago from a refugee camp, where most of their family continues to reside. He notes that at times he feels that he is back in that space and that he also feels frustrated. He is accustomed to doing well academically, but English has been difficult to learn.
You explain your understanding and acknowledge concerns for his past experiences playing a role, the importance of having community supports, and that learning a new language is challenging. You recommend that the school offer culturally appropriate interventions, trauma-informed assessments, and English-language opportunities. Adam and his mother note willingness to engage in this plan but would like to speak to their local religious leader as well.
Collaborating in a manner similar to this will likely build a therapeutic alliance between the patient, their family, and caretakers, thus leading to improved outcomes.
For further reading, consider AACAP Finding Mental Healthcare for Children of Immigrants and the American Academy of Pediatrics Providing Culturally Effective Care Toolkit.
Dr. Abdul-Karim, a child and adolescent psychiatrist, is assistant professor of psychiatry at the University of Vermont, Burlington. She said she had no relevant financial disclosures. Email her at [email protected].
References
1. “Key findings about U.S. immigrants.” Pew Research Center, Washington, D.C. (2020)
2. “Key facts about refugees to the U.S.” Pew Research Center, Washington, D.C. (2019)
3. “Immigrant Children.” Child Trends, Bethesda, MD (2018).
4. Kaplan & Sadock’s Synopsis of Psychiatry: Behavioral Sciences/Clinical Psychiatry, 11th ed. (Philadelphia: Lippincott Williams & Wilkins, 2015, pp. 139-45).
5. Lewis’sChild and Adolescent Psychiatry: A Comprehensive Textbook, 5th ed. (Philadelphia: Lippincott Williams & Wilkins, 2017, pp. 111-22).
6. Berlin EA, Fowkes WA Jr.A teaching framework for cross-cultural health care. Application in family practice. West J Med 1983;139(6):934-8.
7. Paediatr Child Health. 2018 Feb;23(1):66-9.
A teen presents with a severe, tender rash on the extremities
“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”
— Ophelia in Hamlet by William Shakespeare
The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.
The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.
Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.
The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.
Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.
The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.
In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
References
J Burn Care Res. 2018 Oct 23;39(6):1064-6.
Dermatitis. 2007 Mar;18(1):52-5.
BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.
“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”
— Ophelia in Hamlet by William Shakespeare
The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.
The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.
Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.
The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.
Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.
The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.
In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
References
J Burn Care Res. 2018 Oct 23;39(6):1064-6.
Dermatitis. 2007 Mar;18(1):52-5.
BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.
“There’s rue for you, and here’s some for me; we may call it herb of grace o’ Sundays. O, you must wear your rue with a difference.”
— Ophelia in Hamlet by William Shakespeare
The patient was admitted to the hospital for IV fluids, pain control, and observation. The following day she admitted using the leaves of a plant on the trail as a bug repellent, as one time was taught by her grandfather. She rubbed some of the leaves on the brother as well. The grandfather shared some pictures of the bushes, and the plant was identified as Ruta graveolens.
The blisters were deroofed, cleaned with saline, and wrapped with triamcinolone ointment and petrolatum. The patient was also started on a prednisone taper and received analgesics for the severe pain.
Ruta graveolens also known as common rue or herb of grace, is an ornamental plant from the Rutaceae family. This plant is also used as a medicinal herb, condiment, and as an insect repellent. If ingested in large doses, it can cause severe abdominal pain and vomiting. It also can be hepatotoxic.
The herb contains furocumarines, such as 8-methoxypsoralen and 5-methoxypsoralen and furoquinoline alkaloids. These chemicals when exposed to UVA radiation cause cell injury and inflammation of the skin. This is considered a phototoxic reaction of the skin, compared with allergic reactions, such as poison ivy dermatitis, which need a prior sensitization to the allergen for the T cells to be activated and cause injury in the skin. Other common plants and fruits that can cause phytophotodermatitis include citrus fruits, figs, carrots, celery, parsnips, parsley, and other wildflowers like hogweed.
Depending on the degree of injury, the patients can be treated with topical corticosteroids, petrolatum wraps, and pain control. In severe cases like our patient, systemic prednisone may help stop the progression of the lesions and help with the inflammation. Skin hyperpigmentation after the initial injury may take months to clear, and some patient can develop scars.
The differential diagnosis should include severe bullous contact dermatitis like exposure to urushiol in poison ivy; second- and third-degree burns; severe medications reactions such Stevens-Johnson syndrome or toxic epidermal necrolysis, and inmunobullous diseases such as bullous lupus erythematosus, pemphigus vulgaris, or bullous pemphigoid. If there is no history of exposure or there are any other systemic symptoms, consider performing a skin biopsy of one of the lesions.
In this patient’s case, the history of exposure and skin findings helped the dermatologist on call make the right diagnosis.
Dr. Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego. Email her at [email protected].
References
J Burn Care Res. 2018 Oct 23;39(6):1064-6.
Dermatitis. 2007 Mar;18(1):52-5.
BMJ Case Rep. 2015 Dec 23;2015:bcr2015213388.
She started taking lithium for depression and anxiety 3 weeks prior to her developing the rash. She denies taking any other medications, supplements, or recreational drugs.
She denied any prior history of photosensitivity, no history of mouth ulcers, joint pain, muscle weakness, hair loss, or any other symptoms.
Besides her brother, there are no other affected family members, and no history of immune bullous disorders or other skin conditions.
On physical exam, the girl appears in a lot of pain and is uncomfortable. The skin is red and hot, and there are tense bullae on the neck, arms, and legs. There are no ocular or mucosal lesions.
Substance in tears could be used for diabetes monitoring
Measuring glycated albumin (glycoalbumin, GA) in tears could be a future way for those with diabetes to monitor their blood sugar levels noninvasively.
In a 100-patient trial, levels of GA in tears were found to be strongly correlated (r = .722; P < .001) with those in the blood.
“GA levels in blood are widely measured in clinical practice in Japan,” said study investigator Masakazu Aihara, MD, PhD, in an interview.
“It’s a biomarker that reflects the 2-week average blood glucose level like fructosamine,” explained the researcher from the department of diabetes and metabolic diseases in the Graduate School of Medicine at the University of Tokyo.
This could make it a better biomarker for detecting earlier changes in blood glucose than glycated hemoglobin (HbA1c), which reflects changes in blood glucose over the preceding 2-3 months.
Prior studies had shown that glucose levels can be measured in tear samples and that tear glucose levels correlated with blood glucose levels, Dr. Aihara and fellow researchers observed in a poster presentation at the virtual annual meeting of the European Association for the Study of Diabetes.
“While looking for noninvasive diabetes-related markers, we found that tears contained albumin. Based on this fact, we thought that GA could be measured in tears,” Dr. Aihara explained.
Using tears to test for biomarkers is not a new idea – tears not only protect the eye, they contain a variety of large proteins, and their composition can change with disease. Indeed, researchers have been looking at their usefulness in helping find biomarkers for Parkinson’s disease and diabetic peripheral neuropathy.
During their study, Dr. Aihara and associates collected tear and blood samples at the same time. Tear samples were assessed using liquid chromatography (LC) and mass spectrometry (MS). An enzymic method was used to measure GA levels in blood. Several diagnosis assay kits for GA are sold in Japan, Dr. Aihara said, and at least one of these has U.S. Food and Drug Administration approval.
Multiple regression analysis revealed that the correlation between GA levels in tears and in blood was maintained even after adjustment for age, gender, nephropathy stage, and obesity (P < .001). The results obtained from the tests were thought unlikely to be affected by any changes in the concentration or dilution of tear samples.
“Since GA levels in blood are clinically used in all types of diabetes, GA levels in tears is also expected to be useful in all types of diabetes,” Dr. Aihara said, noting that the effects of receiving treatment on GA levels in tears is something that he would like to look at.
The team would also like to optimize how tear samples are collected and reduce the volume of tears that are required for analysis. At the moment tears are collected via a dropper and about 100 mcL of tear fluid is required for measurement.
“At present, it is difficult to measure for dry eye patients because sufficient tears cannot be collected, but if the required amount of tears decreases in the future, it may be indicated for dry eye patients,” Dr. Aihara noted.
Discussing further research plans, he added: “We would like to examine the conditions of LC-MS/MS so that the correlation coefficient with GA in blood can be improved.
“Since LC-MS/MS is a large equipment in the laboratory, I would like to develop a device that can measure at the clinic or at home in the future.”
The study was funded by a grant from the Japan Agency for Medical Research and Development. Dr. Aihara had no conflicts of interest.
SOURCE: Aihara M et al. EASD 2020, poster presentation 624.
Measuring glycated albumin (glycoalbumin, GA) in tears could be a future way for those with diabetes to monitor their blood sugar levels noninvasively.
In a 100-patient trial, levels of GA in tears were found to be strongly correlated (r = .722; P < .001) with those in the blood.
“GA levels in blood are widely measured in clinical practice in Japan,” said study investigator Masakazu Aihara, MD, PhD, in an interview.
“It’s a biomarker that reflects the 2-week average blood glucose level like fructosamine,” explained the researcher from the department of diabetes and metabolic diseases in the Graduate School of Medicine at the University of Tokyo.
This could make it a better biomarker for detecting earlier changes in blood glucose than glycated hemoglobin (HbA1c), which reflects changes in blood glucose over the preceding 2-3 months.
Prior studies had shown that glucose levels can be measured in tear samples and that tear glucose levels correlated with blood glucose levels, Dr. Aihara and fellow researchers observed in a poster presentation at the virtual annual meeting of the European Association for the Study of Diabetes.
“While looking for noninvasive diabetes-related markers, we found that tears contained albumin. Based on this fact, we thought that GA could be measured in tears,” Dr. Aihara explained.
Using tears to test for biomarkers is not a new idea – tears not only protect the eye, they contain a variety of large proteins, and their composition can change with disease. Indeed, researchers have been looking at their usefulness in helping find biomarkers for Parkinson’s disease and diabetic peripheral neuropathy.
During their study, Dr. Aihara and associates collected tear and blood samples at the same time. Tear samples were assessed using liquid chromatography (LC) and mass spectrometry (MS). An enzymic method was used to measure GA levels in blood. Several diagnosis assay kits for GA are sold in Japan, Dr. Aihara said, and at least one of these has U.S. Food and Drug Administration approval.
Multiple regression analysis revealed that the correlation between GA levels in tears and in blood was maintained even after adjustment for age, gender, nephropathy stage, and obesity (P < .001). The results obtained from the tests were thought unlikely to be affected by any changes in the concentration or dilution of tear samples.
“Since GA levels in blood are clinically used in all types of diabetes, GA levels in tears is also expected to be useful in all types of diabetes,” Dr. Aihara said, noting that the effects of receiving treatment on GA levels in tears is something that he would like to look at.
The team would also like to optimize how tear samples are collected and reduce the volume of tears that are required for analysis. At the moment tears are collected via a dropper and about 100 mcL of tear fluid is required for measurement.
“At present, it is difficult to measure for dry eye patients because sufficient tears cannot be collected, but if the required amount of tears decreases in the future, it may be indicated for dry eye patients,” Dr. Aihara noted.
Discussing further research plans, he added: “We would like to examine the conditions of LC-MS/MS so that the correlation coefficient with GA in blood can be improved.
“Since LC-MS/MS is a large equipment in the laboratory, I would like to develop a device that can measure at the clinic or at home in the future.”
The study was funded by a grant from the Japan Agency for Medical Research and Development. Dr. Aihara had no conflicts of interest.
SOURCE: Aihara M et al. EASD 2020, poster presentation 624.
Measuring glycated albumin (glycoalbumin, GA) in tears could be a future way for those with diabetes to monitor their blood sugar levels noninvasively.
In a 100-patient trial, levels of GA in tears were found to be strongly correlated (r = .722; P < .001) with those in the blood.
“GA levels in blood are widely measured in clinical practice in Japan,” said study investigator Masakazu Aihara, MD, PhD, in an interview.
“It’s a biomarker that reflects the 2-week average blood glucose level like fructosamine,” explained the researcher from the department of diabetes and metabolic diseases in the Graduate School of Medicine at the University of Tokyo.
This could make it a better biomarker for detecting earlier changes in blood glucose than glycated hemoglobin (HbA1c), which reflects changes in blood glucose over the preceding 2-3 months.
Prior studies had shown that glucose levels can be measured in tear samples and that tear glucose levels correlated with blood glucose levels, Dr. Aihara and fellow researchers observed in a poster presentation at the virtual annual meeting of the European Association for the Study of Diabetes.
“While looking for noninvasive diabetes-related markers, we found that tears contained albumin. Based on this fact, we thought that GA could be measured in tears,” Dr. Aihara explained.
Using tears to test for biomarkers is not a new idea – tears not only protect the eye, they contain a variety of large proteins, and their composition can change with disease. Indeed, researchers have been looking at their usefulness in helping find biomarkers for Parkinson’s disease and diabetic peripheral neuropathy.
During their study, Dr. Aihara and associates collected tear and blood samples at the same time. Tear samples were assessed using liquid chromatography (LC) and mass spectrometry (MS). An enzymic method was used to measure GA levels in blood. Several diagnosis assay kits for GA are sold in Japan, Dr. Aihara said, and at least one of these has U.S. Food and Drug Administration approval.
Multiple regression analysis revealed that the correlation between GA levels in tears and in blood was maintained even after adjustment for age, gender, nephropathy stage, and obesity (P < .001). The results obtained from the tests were thought unlikely to be affected by any changes in the concentration or dilution of tear samples.
“Since GA levels in blood are clinically used in all types of diabetes, GA levels in tears is also expected to be useful in all types of diabetes,” Dr. Aihara said, noting that the effects of receiving treatment on GA levels in tears is something that he would like to look at.
The team would also like to optimize how tear samples are collected and reduce the volume of tears that are required for analysis. At the moment tears are collected via a dropper and about 100 mcL of tear fluid is required for measurement.
“At present, it is difficult to measure for dry eye patients because sufficient tears cannot be collected, but if the required amount of tears decreases in the future, it may be indicated for dry eye patients,” Dr. Aihara noted.
Discussing further research plans, he added: “We would like to examine the conditions of LC-MS/MS so that the correlation coefficient with GA in blood can be improved.
“Since LC-MS/MS is a large equipment in the laboratory, I would like to develop a device that can measure at the clinic or at home in the future.”
The study was funded by a grant from the Japan Agency for Medical Research and Development. Dr. Aihara had no conflicts of interest.
SOURCE: Aihara M et al. EASD 2020, poster presentation 624.
FROM EASD 2020