A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A cell phone app that combines white noise, active game-based therapy, and counseling could help “rewire” the brain to provide relief from tinnitus symptoms, new research suggests. In a randomized controlled trial, results at 12 weeks showed patients with tinnitus reported clinically meaningful reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness after using a digital polytherapeutic app prototype that focuses on relief, relaxation, and attention-focused retraining. In addition, their improvements were significantly greater than for the control group, which received a common white noise app.

Researchers called the results “promising” for a condition that has no cure and few successful treatments. “What this therapy does is essentially rewire the brain in a way that de-emphasizes the sound of the tinnitus to a background noise that has no meaning or relevance to the listener,” lead author Grant Searchfield, PhD, associate professor of audiology at the University of Auckland, New Zealand, said in a press release.

The findings were published online in Frontiers in Neurology.
 

Worldwide problem

A recent study showed more than 740 million adults worldwide (nearly 15% of the population) have experienced at least one symptom of tinnitus – and about 120 million are severely affected. Tinnitus is the perception of a ringing, buzzing, whistling, or hissing noise in one or both ears when no external source of the sound is present. Often caused by damage to the auditory system, tinnitus can also be a symptom of a wide range of medical conditions and has been identified as a side effect of COVID-19 vaccination. In its most severe form, which is associated with hearing loss, tinnitus can also affect a patient’s mental, emotional, and social health.

For the current study, participants with tinnitus were randomly assigned to a popular app that uses white noise (control group, n = 30) or to the UpSilent app (n = 31). The UpSilent group received a smartphone app, Bluetooth bone conduction headphones, a Bluetooth neck pillow speaker for sleep, and written counseling materials. Participants in the control group received a widely available app called “White Noise” and in-ear wired headphones.
 

‘Quicker and more effective’

Both groups reported reductions in ratings of annoyance, inability to ignore, unpleasantness, and loudness at 12 weeks. But significantly more of the UpSilent group reported clinically meaningful improvement compared with the control group (65% vs. 43%, respectively; P = .049).

“Earlier trials have found white noise, goal-based counseling, goal-oriented games, and other technology-based therapies are effective for some people some of the time,” Dr. Searchfield said. “This is quicker and more effective, taking 12 weeks rather than 12 months for more individuals to gain some control,” he added.

The investigators noted that the study was not designed to determine which of the app’s functions of passive listening, active listening, or counseling contributed to symptom improvement.

The next step will be to refine the prototype and proceed to larger local and international trials with a view toward approval by the U.S. Food and Drug Administration, they reported.

The researchers hope the app will be clinically available in about 6 months.

The study was funded by Return on Science, Auckland UniServices. Dr. Searchfield is a founder and scientific officer for TrueSilence, a spinout company of the University of Auckland, and has a financial interest in TrueSilence. His coauthor has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.

To the Editor:

Dermatofibromas (also known as fibrous histiocytomas) are benign fibrous nodules that most often arise as solitary lesions on the lower extremities. Multiple eruptive dermatofibromas (MEDFs) are uncommon and have been defined as more than 15 in number¹ or 5 to 8 dermatofibromas appearing within 4 months.² They have been reported in association with a number of conditions of immune dysregulation such as systemic lupus erythematosus, Sjögren syndrome, HIV infection, and leukemia.³ Multiple eruptive dermatofibromas also have been described in patients with Down syndrome (DS).^4-7 We report a case of MEDFs in a patient with DS and review the literature on the association between MEDFs and DS.

A 38-year-old woman with DS, hidradenitis suppurativa, and hypothyroidism presented with multiple cutaneous lesions developing over the last year. The lesions continued to increase in number but were otherwise asymptomatic. Physical examination revealed approximately 20 rubbery, pink-tan papules measuring less than 1 cm in diameter that were scattered along the trunk (Figure, A), arms, and legs (Figure, B).

The patient had no known history of immunosuppression or rheumatologic disease and was otherwise healthy. Basic laboratory tests including a complete blood cell count and antinuclear antibody titer were within reference range. The lesions were clinically consistent with dermatofibromas, but due to their increasing number within a short period of time, a biopsy of a representative lesion was performed to confirm the diagnosis.

The exact incidence of MEDFs is unknown, but they are rare, with one review finding only 50 cases reported from 1960 to 2002.⁸ They are increasingly recognized as a sign of potential immune dysregulation. Approximately 56% to 70% of cases are seen in patients with an underlying disease state; 80% are immune mediated.^8,9 Interestingly, DS has long been associated with notable immune dysfunction,^10,11 with evidence suggesting that trisomy 21 may result in widespread changes in gene expression that can lead to interferon activation.¹²

A PubMed search of articles indexed for MEDLINE using the terms dermatofibroma and Down, dermatofibroma and Down syndrome, eruptive dermatofibroma and Down syndrome, and multiple dermatofibroma and Down syndrome revealed 6 cases of MEDFs in patients with DS that have been reported since 2005.^4-7 An additional report by Honda et al¹³ described a patient with DS who developed 7 dermatofibromas, but no time frame of development was specified. We reviewed the characteristics of 8 patients with DS with MEDFs, which included our patient (Table). The average age at time of presentation was 39 years (median age, 40 years). Six patients (75%) were female and 2 (25%) were male. Dermatofibromas were reported to appear over the course of months to years. Comorbidities included psoriatic arthritis (treated with methotrexate),⁶ thyroid disorders (ie, Graves disease),⁶ hypercholesterolemia,⁶ hidradenitis suppurativa, long-standing mild lymphopenia (1.4×10⁹/L [reference range, 1.5−4.0×10⁹/L]),⁴ and acute megakaryoblastic leukemia¹³ treated 15 years before the appearance of dermatofibromas.

Many dermatologic conditions have been reported at increased rates in individuals with DS, including seborrheic dermatitis, alopecia areata, syringomas, elastosis perforans serpiginosa, cutis marmorata, xerosis, and palmoplantar hyperkeratosis.^14,15 Although drawing conclusions about associations between MEDFs and DS is limited by our small sample size, we have reported this case and reviewed existing cases of MEDFs in DS to highlight a potential association that may be underrecognized or underreported. More evidence is needed to determine the strength of the association between MEDFs and DS, but dermatologists should be aware that MEDFs may be an additional skin finding associated with DS that is related to the syndrome’s immune dysregulation.

New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).

The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).

The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

New COVID-19 cases in children declined for a second consecutive week, even as emergency department visit rates started rising for those aged 12-15 years.

The 7-day average percentage of ED visits with diagnosed COVID, which had reached a post-Omicron high of 3.5% in late July for those aged 12-15, began to fall and was down to 3.0% on Aug. 12. That trend reversed, however, and the rate was up to 3.6% on Aug. 19, the last date for which data are available from the Centers for Disease Control and Prevention.

That change of COVID fortunes cannot yet be seen for all children. The 7-day average ED visit rate for those aged 0-11 years peaked at 6.8% during the last week of July and has continued to fall, dropping from 5.7% on Aug. 12 to 5.1% on Aug. 19. Children aged 16-17 years seem to be taking a middle path: Their ED-visit rate declined from late July into mid-August but held steady over the last week, according to the CDC’s COVID Data Tracker.

There is a hint of the same trend regarding new admissions among children aged 0-17 years. The national rate, which had declined in recent weeks, ticked up from 0.42 to 0.43 new admissions per 100,000 population over the last week of available data, the CDC said.
 

Weekly cases fall below 80,000

New cases in general were down by 8.5% from the previous week, dropping from 87,902 for the week of Aug. 5-11 to 79,525 for Aug. 12-18. That marked the second straight week with fewer cases after a 4-week period that saw weekly totals increase from almost 68,000 to nearly 97,000, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The AAP and CHA put the cumulative number of child COVID-19 cases at just under 14.4 million since the pandemic began, which represents 18.4% of cases among all ages. The CDC estimates that there have been almost 14.7 million cases in children aged 0-17 years, as well as 1,750 deaths, of which 14 were reported in the last week (Aug. 16-22).

The CDC age subgroups indicate that children aged 0-4 years have experienced fewer cases (2.9 million) than children aged 5-11 years (5.6 million cases) and 12-15 (3.0 million cases) but more deaths: 548 so far, versus 432 for 5- to 11-year-olds and 437 for 12- to 15-year-olds, the COVID Data Tracker shows. Those aged 0-4 make up 6% of the total U.S. population, compared with 8.7% and 5.1%, respectively, for the older children.

Most younger children still not vaccinated

Although it may not qualify as a big push to vaccinate children before the start of the new school year, first-time vaccinations did rise somewhat in late July and August for children aged 5-17 years. Among children younger than 5 years, though, initial doses of the vaccine fell during the second full week of August, especially in 2- to 4-year-olds, based on the CDC data.

Through almost 2 months of vaccine eligibility, 4.8% of children under age 5 have received at least one dose and 0.9% are fully vaccinated as of Aug. 17. The current rates are 37.8% (one dose) and 30.4% (completed) for those aged 5-11 and 70.5% and 60.3% for 12- to 17-year-olds.

Use of the epidermal growth-factor receptor inhibitor erlotinib led to about a 30% reduction in duodenal polyp burden after 6 months of once-weekly treatment for patients with familial adenomatous polyposis (FAP) in a phase 2 clinical trial.

“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.

FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.

“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.

“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.

In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.

However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.

This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.

The study was first published online in the journal Gut.

In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.

After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).

The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.

“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.

GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).

While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.

Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.

The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).

Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”

The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.

The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Use of the epidermal growth-factor receptor inhibitor erlotinib led to about a 30% reduction in duodenal polyp burden after 6 months of once-weekly treatment for patients with familial adenomatous polyposis (FAP) in a phase 2 clinical trial.

“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.

FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.

“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.

“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.

In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.

However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.

This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.

The study was first published online in the journal Gut.

In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.

After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).

The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.

“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.

GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).

While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.

Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.

The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).

Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”

The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.

The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Use of the epidermal growth-factor receptor inhibitor erlotinib led to about a 30% reduction in duodenal polyp burden after 6 months of once-weekly treatment for patients with familial adenomatous polyposis (FAP) in a phase 2 clinical trial.

“If existing data are confirmed and extended through future research, this strategy has the potential for substantial impact on clinical practice by decreasing, delaying, or augmenting endoscopic and surgical interventions as the mainstay for duodenal cancer prevention in this high-risk patient population,” the study team says.

FAP is a rare genetic condition that markedly raises the risk for colorectal polyps and cancer.

“The biological pathway that leads to the development of polyps and colon cancer in patients with FAP is the same biological pathway as patients in the general population,” study investigator Niloy Jewel Samadder, MD, with the Mayo Clinic, Rochester, Minn., said in a news release.

“Our trial looked at opportunities to use chemoprevention agents in patients with FAP to inhibit the development of precancerous polyps in the small bowel and colorectum,” Dr. Samadder explains.

In an earlier study, the researchers found that the combination of the COX-2 inhibitor sulindac (150 mg twice daily) and erlotinib (75 mg daily) reduced duodenal polyp burden.

However, the dual-drug strategy was associated with a relatively high adverse event (AE) rate, which may limit use of the combination for chemoprevention, as reported previously.

This phase 2 study tested whether erlotinib’s AE profile would be improved with a once-weekly dosing schedule while still reducing polyp burden.

The study was first published online in the journal Gut.

In the single-arm, multicenter study, 46 adults with FAP (mean age, 44 years; 48% women) self-administered 350 mg of erlotinib by mouth one time per week for 6 months. All but four participants completed the 6-month study.

After 6 months of weekly erlotinib, duodenal polyp burden was significantly reduced, with a mean percent reduction of 29.6% (95% confidence interval: –39.6% to –19.7%; P < .0001).

The benefit was observed in patients with either Spigelman 2 or Spigelman 3 duodenal polyp burden.

“Though only 12% of patients noted a decrease in Spigelman stage from 3 to 2 associated with therapy, the majority of patients (86%) had stable disease while on treatment,” the study team reports.

GI polyp number (a secondary outcome) was also decreased after 6 months of treatment with erlotinib (median decrease of 30.8%; P = .0256).

While once-weekly erlotinib was “generally” well tolerated, grade 2 or 3 AEs were reported in 72% of patients; two suffered grade 3 toxicity. Nonetheless, the AE rate was significantly more than the expected null hypothesis rate of 50%, the study team states.

Four patients withdrew from the study because of drug-induced AEs, which included grade 3 rash acneiform, grade 2 infections (hand, foot, and mouth disease), grade 1 fatigue, and grade 1 rash acneiform. No grade 4 AEs were reported.

The most common AE was an erlotinib-induced acneiform-like rash, which occurred in 56.5% of study patients. The rash was managed with topical cortisone and/or clindamycin. Additional erlotinib-induced AEs included oral mucositis (6.5%), diarrhea (50%), and nausea (26.1%).

Summing up, Dr. Samadder and colleagues note that FAP “portends a heritable, systemic predisposition to cancer, and the ultimate goal of cancer preventive intervention is to interrupt the development of neoplasia, need for surgery, and ultimately death from cancer, with an acceptable AE profile.”

The findings from this phase 2 trial support further study of erlotinib as “an effective, acceptable cancer preventive agent for FAP-associated gastrointestinal polyposis,” they conclude.

The study was sponsored by the National Cancer Institute. Dr. Samadder is a consultant for Janssen Research and Development, Recursion Pharmaceuticals, and Cancer Prevention Pharmaceuticals.

A version of this article first appeared on Medscape.com.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

Gender differences in patient satisfaction with medical care have been evaluated in multiple settings; however, studies specific to the unique population of women veterans with cancer are lacking. Women are reported to value privacy, psychosocial support, and communication to a higher degree compared with men.¹ Factors affecting satisfaction include the following: discomfort in sharing treatment rooms with the opposite gender, a desire for privacy with treatment and restroom use, anatomic or illness differences, and a personal history of abuse^.2-4 Regrettably, up to 1 in 3 women in the United States are victims of sexual trauma in their lifetimes, and up to 1 in 4 women in the military are victims of military sexual trauma. Incidence in both settings is suspected to be higher due to underreporting^.5,6

Chemotherapy treatment units are often uniquely designed as an open space, with several patients sharing a treatment area. The design reduces isolation and facilitates quick nurse-patient access during potentially toxic treatments known to have frequent adverse effects. Data suggest that nursing staff prefer open models to facilitate quick patient assessments and interventions as needed; however, patients and families prefer private treatment rooms, especially among women patients or those receiving longer infusions.⁷

The Veterans Health Administration (VHA) patient population is male predominant, comprised only of 10% female patients.8 Although the proportion of female patients in the VHA is expected to rise annually to about 16% by 2043, the low percentage of female veterans will persist for the foreseeable future.⁸ This low percentage of female veterans is reflected in the Veterans Affairs Portland Health Care System (VAPHCS) cancer patient population and in the use of the chemotherapy infusion unit, which is used for the ambulatory treatment of veterans undergoing cancer therapy.

The VHA has previously explored gender differences in health care, such as with cardiovascular disease, transgender care, and access to mental health.^9-11 However, to the best of our knowledge, no analysis has explored gender differences within the outpatient cancer treatment experience. Patient satisfaction with outpatient cancer care may be magnified in the VHA setting due to the uniquely unequal gender populations, shared treatment space design, and high incidence of sexual abuse among women veterans. Given this, we aimed to identify gender-related preferences in outpatient cancer care in our chemotherapy infusion unit.

In our study, we used the terms male and female to reflect statistical data from the literature or labeled data from the electronic health record (EHR); whereas the terms men and women were used to describe and encompass the cultural implications and context of gender.¹²

Methods

This study was designated as a quality improvement (QI) project by the VAPHCS research office and Institutional Review Board in accordance with VHA policies.

The VAPHCS outpatient chemotherapy infusion unit is designed with 6 rooms for chemotherapy administration. One room is a large open space with 6 chairs for patients. The other rooms are smaller with glass dividers between the rooms, and 3 chairs inside each for patients. There are 2 private bathrooms, each gender neutral. Direct patient care is provided by physicians, nurse practitioners (NPs), infusion unit nurses, and nurse coordinators. Men represent the majority of hematology and oncology physicians (13 of 20 total: 5 women fellow physicians and 2 women attending physicians), and 2 of 4 NPs. Women represent 10 of 12 infusion unit and cancer coordinator nurses. We used the VHA Computerized Patient Record System (CPRS) EHR, to create a list of veterans treated at the VAPHCS outpatient chemotherapy infusion unit for a 2-year period (January 1, 2018, to December 31, 2020).

Male and female patient lists were first generated based on CPRS categorization. We identified all female veterans treated in the ambulatory infusion unit during the study period. Male patients were then chosen at random, recording the most recent names for each year until a matched number per year compared with the female cohort was reached. Patients were recorded only once even though they had multiple infusion unit visits. Patients were excluded who were deceased, on hospice care, lost to follow-up, could not be reached by phone, refused to take the survey, had undeliverable email addresses, or lacked internet or email access.

After filing the appropriate request through the VAPHCS Institutional Review Board committee in January 2021, patient records were reviewed for demographics data, contact information, and infusion treatment history. The survey was then conducted over a 2-week period during January and February 2021. Each patient was invited by phone to complete a 25-question anonymous online survey. The survey questions were created from patient-relayed experiences, then modeled into survey questions in a format similar to other patient satisfaction questionnaires described in cancer care and gender differences.^2,13,14 The survey included self-identification of gender and was multiple choice for all except 2 questions, which allowed an open-ended response (Appendix). Only 1 answer per question was permitted. Only 1 survey link was sent to each veteran who gave permission for the survey. To protect anonymity for the small patient population, we excluded those identifying as gender nonbinary or transgender.

Statistical Analysis

Patient, disease, and treatment features are separated by male and female cohorts to reflect information from the EHR (Table 1). Survey percentages were calculated to reflect the affirmative response of the question asked (Table 2). Questions with answer options of not important, minimally important, important, or very important were calculated to reflect the sum of any importance in both cohorts. Questions with answer options of never, once, often, or every time were calculated to reflect any occurrence (sum of once, often, or every time) in both patient groups. Questions with answer options of strongly agree, somewhat agree, somewhat disagree, and strongly disagree were calculated to reflect any agreement (somewhat agree and strongly agree summed together) for both groups. Comparisons between cohorts were then conducted using a Fisher exact test. A Welch t test was used to calculate the significance of the continuous variable and overall ranking of the infusion unit experience between groups.

Results 

In 2020, 414 individual patients were treated at the VAPAHCS outpatient infusion unit. Of these, 23 (5.6%) were female, and 18 agreed to take the survey. After deceased and duplicate names from 2020 were removed, another 14 eligible 2019 female patients were invited and 6 agreed to participate; 6 eligible 2018 female patients were invited and 4 agreed to take the survey (Figure). Thirty female veterans were sent a survey link and 21 (70%) responses were collected. Twenty-one male 2020 patients were contacted and 18 agreed to take the survey. After removing duplicate names and deceased individuals, 17 of 21 eligible 2019 male patients and 4 of 6 eligible 2018 patients agreed to take the survey. Five additional male veterans declined the online-based survey method. In total, 39 male veterans were reached who agreed to have the survey link emailed, and 20 (51%) total responses were collected.

Most respondents answered all questions in the survey. The most frequently skipped questions included 3 questions that were contingent on a yes answer to a prior question, and 2 openended questions asking for a write-in response. Percentages for female and male respondents were adjusted for number of responses when applicable.

Thirteen (62%) female patients were aged < 65 years, while 18 (90%) of male patients were aged ≥ 65 years. Education beyond high school was reported in 20 female and 15 male respondents. Almost all treatment administered in the infusion unit was for cancer-directed treatment, with only 1 reporting a noncancer treatment (IV iron). The most common malignancy among female patients was breast cancer (n = 11, 52%); for male patients prostate cancer (n = 4, 20%) and hematologic malignancy (n = 4, 20%) were most common. Four (19%) female and 8 (40%) male respondents reported having a metastatic diagnosis. Overall patient satisfaction ranked high with an average score of 9.1 on a 10-point scale. The mean (SD) satisfaction score for female respondents was 1 point lower than that for men: 8.7 (2.2) vs 9.6 (0.6) in men (P = .11).

Eighteen (86%) women reported a history of sexual abuse or harassment compared with 2 (10%) men (P < .001). The sexual abuse assailant was a different gender for 17 of 18 female respondents and of the same gender for both male respondents. Of those with sexual abuse history, 4 women reported feeling uncomfortable around their assailant’s gender vs no men (P = .11), but this difference was not statistically significant. Six women (29%) and 2 (10%) men reported feeling uncomfortable during clinical examinations from comments made by the clinician or during treatment administration (P = .24). Six (29%) women and no men reported that they “felt uncomfortable in the infusion unit by other patients” (P = .02). Six (29%) women and no men reported feeling unable to “voice uncomfortable experiences” to the infusion unit clinician (P = .02).

Ten (48%) women and 6 (30%) men reported emotional support when receiving treatments provided by staff of the same gender (P = .34). Eight (38%) women and 4 (20%) men noted that access to treatment with the same gender was important (P = .31). Six (29%) women and 4 (20%) men indicated that access to a sex or gender-specific restroom was important (P = .72). No gender preferences were identified in the survey questions regarding importance of private treatment room access and level of emotional support when receiving treatment with others of the same malignancy. These relationships were not statistically significant.

In addition, 2 open-ended questions were asked. Seventeen women and 14 men responded. Contact the corresponding author for more information on the questions and responses.

Discussion

Overall patient satisfaction was high among the men and women veterans with cancer who received treatment in our outpatient infusion unit; however, notable gender differences existed. Three items in the survey revealed statistically significant differences in the patient experience between men and women veterans: history of sexual abuse or harassment, uncomfortable feelings among other patients, and discomfort in relaying uncomfortable feelings to a clinician. Other items in the survey did not reach statistical significance; however, we have included discussion of the findings as they may highlight important trends and be of clinical significance.

We suspect differences among genders in patient satisfaction to be related to the high incidence of sexual abuse or harassment history reported by women, much higher at 86% than the one-third to one-fourth incidence rates estimated by the existing literature for civilian or military sexual abuse in women.5,6 These high sexual abuse or harassment rates are present in a majority of women who receive cancer-directed treatment toward a gender-specific breast malignancy, surrounded predominantly among men in a shared treatment space. Together, these factors are likely key reasons behind the differences in satisfaction observed. This sentiment is expressed in our cohort, where one-fifth of women with a sexual abuse or harassment history continue to remain uncomfortable around men, and 29% of women reporting some uncomfortable feelings during their treatment experience compared with none of the men. Additionally, 6 (29%) women vs no men felt uncomfortable in reporting an uncomfortable experience with a clinician; this represents a significant barrier in providing care for these patients.

A key gender preference among women included access to shared treatment rooms with other women and that sharing a treatment space with other women resulted in feeling more emotional support during treatments. Access to gender-specific restrooms was also preferred by women more than men. Key findings in both genders were that about half of men and women valued access to a private treatment room and would derive more emotional support when surrounded by others with the same cancer.

Prior studies on gender and patient satisfaction in general medical care and cancer care have found women value privacy more than men.^1-3 Wessels and colleagues performed an analysis of 386 patients with cancer in Europe and found gender to be the strongest influence in patient preferences within cancer care. Specifically, the highest statically significant association in care preferences among women included privacy, support/counseling/rehabilitation access, and decreased wait times.2 These findings were most pronounced in those with breast cancer compared with other malignancy type and highlights that malignancy type and gender predominance impact care satisfaction.

Traditionally a shared treatment space design has been used in outpatient chemotherapy units, similar to the design of the VAPHCS. However, recent data report on the patient preference for a private treatment space, which was especially prominent among women and those receiving longer infusions.7 In another study that evaluated 225 patients with cancer preferences in sharing a treatment space with those of a different sexual orientation or gender identify, differences were found. Both men and women had a similar level of comfort in sharing a treatment room with someone of a different sexual orientation; however, more women reported discomfort in sharing a treatment space with a transgender woman compared with men who felt more comfortable sharing a space with a transgender man.4 We noted a gender preference may be present to explain the difference. Within our cohort, women valued access to treatment with other women and derived more emotional support when with other women; however, we did not inquire about feelings in sharing a treatment space among transgender individuals or differing sexual orientation.

Gender differences for privacy and in shared room preferences may result from the lasting impacts of prior sexual abuse or harassment. A history of sexual abuse negatively impacts later medical care access and use.15 Those veterans who experienced sexual abuse/harrassment reported higher feelings of lack of control, vulnerability, depression, and pursued less medical care.^15,16 Within cancer care, these feelings are most pronounced among women with gender-specific malignancies, such as gynecologic cancers or breast cancer. Treatment, screening, and physical examinations by clinicians who are of the same gender as the sexual abuse/harassment assailant can recreate traumatic feelings.^15,16

A majority of women (n = 18, 86%) in our cohort reported a history of sexual abuse or harassment and breast malignancy was the most common cancer among women. However women represent just 5.6% of the VAPHCS infusion unit treatment population. This combination of factors may explain the reasons for women veterans’ preference for privacy during treatments, access to gender-specific restrooms, and feeling more emotional support when surrounded by other women. Strategies to help patients with a history of abuse have been described and include discussions from the clinician asking about abuse history, allowing time for the patient to express fears with an examination or test, and training on how to deliver sensitive care for those with trauma.^17,18

Quality Improvement

Project In the VAPHCS infusion unit, several low-cost interventions have been undertaken as a result of our survey findings. We presented our survey data to the VAPHCS Cancer Committee, accredited through the national American College of Surgeons Commission on Cancer. The committee awarded support for a yearlong QI project, including a formal framework of quarterly multidisciplinary meetings to discuss project updates, challenges, and resources. The QI project centers on education to raise awareness of survey results as well as specific interventions for improvement.

Education efforts have been applied through multiple department-wide emails, in-person education to our chemotherapy unit staff, abstract submission to national oncology conferences, and grand rounds department presentations at VAPHCS and at other VHA-affiliated university programs. Additionally, education to clinicians with specific contact information for psychology and women’s health to support mental health, trauma, and sexual abuse histories has been given to each clinician who cares for veterans in the chemotherapy unit.

We also have implemented a mandatory cancer care navigation consultation for all women veterans who have a new cancer or infusion need. The cancer care navigator has received specialized training in sensitive history-taking and provides women veterans with a direct number to reach the cancer care navigation nurse. Cancer care navigation also provides a continuum of support and referral access for psychosocial needs as indicated between infusion or health care visits. Our hope is that these resources may help offset the sentiment reflected in our cohort of women feeling unable to voice concerns to a clinician.

Other interventions underway include offering designated scheduling time each week to women so they can receive infusions in an area with other women. This may help mitigate the finding that women veterans felt more uncomfortable around other patients during infusion treatments compared with how men felt in the chemotherapy unit. We also have implemented gender-specific restrooms labeled with a sign on each bathroom door so men and women can have access to a designated restroom. Offering private or semiprivate treatment rooms is currently limited by space and capacity; however, these may offer the greatest opportunity to improve patient satisfaction, especially among women veterans. Working with the support of the VAPHCS Cancer Committee, we aim to reevaluate the impact of the education and QI efforts on gender differences and patient satisfaction at completion of the 1-year award.

Limitations

Limitations to our study include the overall small sample size. This is due to the combination of the low number of women treated at VAPHCS and many with advanced cancer who, unfortunately, have a limited overall survival and hinders accrual of a larger sample size. Other limitations included age as a possible confounder in our findings, with women representing a younger demographic compared with men. We did not collect responses on duration of infusion time, which also may impact overall satisfaction and patient experience. We also acknowledge that biologic male or female sex may not correspond to a specific individual’s gender. Use of CPRS to obtain a matched number of male and female patients through random selection relied on labeled data from the EHR. This potentially may have excluded male patients who identify as another gender that would have been captured on the anonymous survey.

Conclusions

Our findings may have broad applications to other VHA facilities and other cancer-directed treatment centers where the patient demographic and open shared infusion unit design may be similar. The study also may serve as a model of survey design and implementation from which other centers may consider improving patient satisfaction. We hope these survey results and interventions can provide insight and be used to improve patient satisfaction among all cancer patients at infusion units serving veterans and nonveterans.

Acknowledgments

We are very thankful to our cancer patients who took the time to take the survey. We also are very grateful to the VHA infusion unit nurses, staff, nurse practitioners, and physicians who have embraced this project and welcomed any changes that may positively impact treatment of veterans. Also, thank you to Tia Kohs for statistical support and Sophie West for gender discussions. Last, we specifically thank Barbara, for her pursuit of better care for women and for all veterans.

Gender differences in patient satisfaction with medical care have been evaluated in multiple settings; however, studies specific to the unique population of women veterans with cancer are lacking. Women are reported to value privacy, psychosocial support, and communication to a higher degree compared with men.¹ Factors affecting satisfaction include the following: discomfort in sharing treatment rooms with the opposite gender, a desire for privacy with treatment and restroom use, anatomic or illness differences, and a personal history of abuse^.2-4 Regrettably, up to 1 in 3 women in the United States are victims of sexual trauma in their lifetimes, and up to 1 in 4 women in the military are victims of military sexual trauma. Incidence in both settings is suspected to be higher due to underreporting^.5,6

Chemotherapy treatment units are often uniquely designed as an open space, with several patients sharing a treatment area. The design reduces isolation and facilitates quick nurse-patient access during potentially toxic treatments known to have frequent adverse effects. Data suggest that nursing staff prefer open models to facilitate quick patient assessments and interventions as needed; however, patients and families prefer private treatment rooms, especially among women patients or those receiving longer infusions.⁷

The Veterans Health Administration (VHA) patient population is male predominant, comprised only of 10% female patients.8 Although the proportion of female patients in the VHA is expected to rise annually to about 16% by 2043, the low percentage of female veterans will persist for the foreseeable future.⁸ This low percentage of female veterans is reflected in the Veterans Affairs Portland Health Care System (VAPHCS) cancer patient population and in the use of the chemotherapy infusion unit, which is used for the ambulatory treatment of veterans undergoing cancer therapy.

The VHA has previously explored gender differences in health care, such as with cardiovascular disease, transgender care, and access to mental health.^9-11 However, to the best of our knowledge, no analysis has explored gender differences within the outpatient cancer treatment experience. Patient satisfaction with outpatient cancer care may be magnified in the VHA setting due to the uniquely unequal gender populations, shared treatment space design, and high incidence of sexual abuse among women veterans. Given this, we aimed to identify gender-related preferences in outpatient cancer care in our chemotherapy infusion unit.

In our study, we used the terms male and female to reflect statistical data from the literature or labeled data from the electronic health record (EHR); whereas the terms men and women were used to describe and encompass the cultural implications and context of gender.¹²

Methods

This study was designated as a quality improvement (QI) project by the VAPHCS research office and Institutional Review Board in accordance with VHA policies.

The VAPHCS outpatient chemotherapy infusion unit is designed with 6 rooms for chemotherapy administration. One room is a large open space with 6 chairs for patients. The other rooms are smaller with glass dividers between the rooms, and 3 chairs inside each for patients. There are 2 private bathrooms, each gender neutral. Direct patient care is provided by physicians, nurse practitioners (NPs), infusion unit nurses, and nurse coordinators. Men represent the majority of hematology and oncology physicians (13 of 20 total: 5 women fellow physicians and 2 women attending physicians), and 2 of 4 NPs. Women represent 10 of 12 infusion unit and cancer coordinator nurses. We used the VHA Computerized Patient Record System (CPRS) EHR, to create a list of veterans treated at the VAPHCS outpatient chemotherapy infusion unit for a 2-year period (January 1, 2018, to December 31, 2020).

Male and female patient lists were first generated based on CPRS categorization. We identified all female veterans treated in the ambulatory infusion unit during the study period. Male patients were then chosen at random, recording the most recent names for each year until a matched number per year compared with the female cohort was reached. Patients were recorded only once even though they had multiple infusion unit visits. Patients were excluded who were deceased, on hospice care, lost to follow-up, could not be reached by phone, refused to take the survey, had undeliverable email addresses, or lacked internet or email access.

After filing the appropriate request through the VAPHCS Institutional Review Board committee in January 2021, patient records were reviewed for demographics data, contact information, and infusion treatment history. The survey was then conducted over a 2-week period during January and February 2021. Each patient was invited by phone to complete a 25-question anonymous online survey. The survey questions were created from patient-relayed experiences, then modeled into survey questions in a format similar to other patient satisfaction questionnaires described in cancer care and gender differences.^2,13,14 The survey included self-identification of gender and was multiple choice for all except 2 questions, which allowed an open-ended response (Appendix). Only 1 answer per question was permitted. Only 1 survey link was sent to each veteran who gave permission for the survey. To protect anonymity for the small patient population, we excluded those identifying as gender nonbinary or transgender.

Statistical Analysis

Patient, disease, and treatment features are separated by male and female cohorts to reflect information from the EHR (Table 1). Survey percentages were calculated to reflect the affirmative response of the question asked (Table 2). Questions with answer options of not important, minimally important, important, or very important were calculated to reflect the sum of any importance in both cohorts. Questions with answer options of never, once, often, or every time were calculated to reflect any occurrence (sum of once, often, or every time) in both patient groups. Questions with answer options of strongly agree, somewhat agree, somewhat disagree, and strongly disagree were calculated to reflect any agreement (somewhat agree and strongly agree summed together) for both groups. Comparisons between cohorts were then conducted using a Fisher exact test. A Welch t test was used to calculate the significance of the continuous variable and overall ranking of the infusion unit experience between groups.

Results 

In 2020, 414 individual patients were treated at the VAPAHCS outpatient infusion unit. Of these, 23 (5.6%) were female, and 18 agreed to take the survey. After deceased and duplicate names from 2020 were removed, another 14 eligible 2019 female patients were invited and 6 agreed to participate; 6 eligible 2018 female patients were invited and 4 agreed to take the survey (Figure). Thirty female veterans were sent a survey link and 21 (70%) responses were collected. Twenty-one male 2020 patients were contacted and 18 agreed to take the survey. After removing duplicate names and deceased individuals, 17 of 21 eligible 2019 male patients and 4 of 6 eligible 2018 patients agreed to take the survey. Five additional male veterans declined the online-based survey method. In total, 39 male veterans were reached who agreed to have the survey link emailed, and 20 (51%) total responses were collected.

Most respondents answered all questions in the survey. The most frequently skipped questions included 3 questions that were contingent on a yes answer to a prior question, and 2 openended questions asking for a write-in response. Percentages for female and male respondents were adjusted for number of responses when applicable.

Thirteen (62%) female patients were aged < 65 years, while 18 (90%) of male patients were aged ≥ 65 years. Education beyond high school was reported in 20 female and 15 male respondents. Almost all treatment administered in the infusion unit was for cancer-directed treatment, with only 1 reporting a noncancer treatment (IV iron). The most common malignancy among female patients was breast cancer (n = 11, 52%); for male patients prostate cancer (n = 4, 20%) and hematologic malignancy (n = 4, 20%) were most common. Four (19%) female and 8 (40%) male respondents reported having a metastatic diagnosis. Overall patient satisfaction ranked high with an average score of 9.1 on a 10-point scale. The mean (SD) satisfaction score for female respondents was 1 point lower than that for men: 8.7 (2.2) vs 9.6 (0.6) in men (P = .11).

Eighteen (86%) women reported a history of sexual abuse or harassment compared with 2 (10%) men (P < .001). The sexual abuse assailant was a different gender for 17 of 18 female respondents and of the same gender for both male respondents. Of those with sexual abuse history, 4 women reported feeling uncomfortable around their assailant’s gender vs no men (P = .11), but this difference was not statistically significant. Six women (29%) and 2 (10%) men reported feeling uncomfortable during clinical examinations from comments made by the clinician or during treatment administration (P = .24). Six (29%) women and no men reported that they “felt uncomfortable in the infusion unit by other patients” (P = .02). Six (29%) women and no men reported feeling unable to “voice uncomfortable experiences” to the infusion unit clinician (P = .02).

Ten (48%) women and 6 (30%) men reported emotional support when receiving treatments provided by staff of the same gender (P = .34). Eight (38%) women and 4 (20%) men noted that access to treatment with the same gender was important (P = .31). Six (29%) women and 4 (20%) men indicated that access to a sex or gender-specific restroom was important (P = .72). No gender preferences were identified in the survey questions regarding importance of private treatment room access and level of emotional support when receiving treatment with others of the same malignancy. These relationships were not statistically significant.

In addition, 2 open-ended questions were asked. Seventeen women and 14 men responded. Contact the corresponding author for more information on the questions and responses.

Discussion

Overall patient satisfaction was high among the men and women veterans with cancer who received treatment in our outpatient infusion unit; however, notable gender differences existed. Three items in the survey revealed statistically significant differences in the patient experience between men and women veterans: history of sexual abuse or harassment, uncomfortable feelings among other patients, and discomfort in relaying uncomfortable feelings to a clinician. Other items in the survey did not reach statistical significance; however, we have included discussion of the findings as they may highlight important trends and be of clinical significance.

We suspect differences among genders in patient satisfaction to be related to the high incidence of sexual abuse or harassment history reported by women, much higher at 86% than the one-third to one-fourth incidence rates estimated by the existing literature for civilian or military sexual abuse in women.5,6 These high sexual abuse or harassment rates are present in a majority of women who receive cancer-directed treatment toward a gender-specific breast malignancy, surrounded predominantly among men in a shared treatment space. Together, these factors are likely key reasons behind the differences in satisfaction observed. This sentiment is expressed in our cohort, where one-fifth of women with a sexual abuse or harassment history continue to remain uncomfortable around men, and 29% of women reporting some uncomfortable feelings during their treatment experience compared with none of the men. Additionally, 6 (29%) women vs no men felt uncomfortable in reporting an uncomfortable experience with a clinician; this represents a significant barrier in providing care for these patients.

A key gender preference among women included access to shared treatment rooms with other women and that sharing a treatment space with other women resulted in feeling more emotional support during treatments. Access to gender-specific restrooms was also preferred by women more than men. Key findings in both genders were that about half of men and women valued access to a private treatment room and would derive more emotional support when surrounded by others with the same cancer.

Prior studies on gender and patient satisfaction in general medical care and cancer care have found women value privacy more than men.^1-3 Wessels and colleagues performed an analysis of 386 patients with cancer in Europe and found gender to be the strongest influence in patient preferences within cancer care. Specifically, the highest statically significant association in care preferences among women included privacy, support/counseling/rehabilitation access, and decreased wait times.2 These findings were most pronounced in those with breast cancer compared with other malignancy type and highlights that malignancy type and gender predominance impact care satisfaction.

Traditionally a shared treatment space design has been used in outpatient chemotherapy units, similar to the design of the VAPHCS. However, recent data report on the patient preference for a private treatment space, which was especially prominent among women and those receiving longer infusions.7 In another study that evaluated 225 patients with cancer preferences in sharing a treatment space with those of a different sexual orientation or gender identify, differences were found. Both men and women had a similar level of comfort in sharing a treatment room with someone of a different sexual orientation; however, more women reported discomfort in sharing a treatment space with a transgender woman compared with men who felt more comfortable sharing a space with a transgender man.4 We noted a gender preference may be present to explain the difference. Within our cohort, women valued access to treatment with other women and derived more emotional support when with other women; however, we did not inquire about feelings in sharing a treatment space among transgender individuals or differing sexual orientation.

Gender differences for privacy and in shared room preferences may result from the lasting impacts of prior sexual abuse or harassment. A history of sexual abuse negatively impacts later medical care access and use.15 Those veterans who experienced sexual abuse/harrassment reported higher feelings of lack of control, vulnerability, depression, and pursued less medical care.^15,16 Within cancer care, these feelings are most pronounced among women with gender-specific malignancies, such as gynecologic cancers or breast cancer. Treatment, screening, and physical examinations by clinicians who are of the same gender as the sexual abuse/harassment assailant can recreate traumatic feelings.^15,16

A majority of women (n = 18, 86%) in our cohort reported a history of sexual abuse or harassment and breast malignancy was the most common cancer among women. However women represent just 5.6% of the VAPHCS infusion unit treatment population. This combination of factors may explain the reasons for women veterans’ preference for privacy during treatments, access to gender-specific restrooms, and feeling more emotional support when surrounded by other women. Strategies to help patients with a history of abuse have been described and include discussions from the clinician asking about abuse history, allowing time for the patient to express fears with an examination or test, and training on how to deliver sensitive care for those with trauma.^17,18

Quality Improvement

Project In the VAPHCS infusion unit, several low-cost interventions have been undertaken as a result of our survey findings. We presented our survey data to the VAPHCS Cancer Committee, accredited through the national American College of Surgeons Commission on Cancer. The committee awarded support for a yearlong QI project, including a formal framework of quarterly multidisciplinary meetings to discuss project updates, challenges, and resources. The QI project centers on education to raise awareness of survey results as well as specific interventions for improvement.

Education efforts have been applied through multiple department-wide emails, in-person education to our chemotherapy unit staff, abstract submission to national oncology conferences, and grand rounds department presentations at VAPHCS and at other VHA-affiliated university programs. Additionally, education to clinicians with specific contact information for psychology and women’s health to support mental health, trauma, and sexual abuse histories has been given to each clinician who cares for veterans in the chemotherapy unit.

We also have implemented a mandatory cancer care navigation consultation for all women veterans who have a new cancer or infusion need. The cancer care navigator has received specialized training in sensitive history-taking and provides women veterans with a direct number to reach the cancer care navigation nurse. Cancer care navigation also provides a continuum of support and referral access for psychosocial needs as indicated between infusion or health care visits. Our hope is that these resources may help offset the sentiment reflected in our cohort of women feeling unable to voice concerns to a clinician.

Other interventions underway include offering designated scheduling time each week to women so they can receive infusions in an area with other women. This may help mitigate the finding that women veterans felt more uncomfortable around other patients during infusion treatments compared with how men felt in the chemotherapy unit. We also have implemented gender-specific restrooms labeled with a sign on each bathroom door so men and women can have access to a designated restroom. Offering private or semiprivate treatment rooms is currently limited by space and capacity; however, these may offer the greatest opportunity to improve patient satisfaction, especially among women veterans. Working with the support of the VAPHCS Cancer Committee, we aim to reevaluate the impact of the education and QI efforts on gender differences and patient satisfaction at completion of the 1-year award.

Limitations

Limitations to our study include the overall small sample size. This is due to the combination of the low number of women treated at VAPHCS and many with advanced cancer who, unfortunately, have a limited overall survival and hinders accrual of a larger sample size. Other limitations included age as a possible confounder in our findings, with women representing a younger demographic compared with men. We did not collect responses on duration of infusion time, which also may impact overall satisfaction and patient experience. We also acknowledge that biologic male or female sex may not correspond to a specific individual’s gender. Use of CPRS to obtain a matched number of male and female patients through random selection relied on labeled data from the EHR. This potentially may have excluded male patients who identify as another gender that would have been captured on the anonymous survey.

Conclusions

Our findings may have broad applications to other VHA facilities and other cancer-directed treatment centers where the patient demographic and open shared infusion unit design may be similar. The study also may serve as a model of survey design and implementation from which other centers may consider improving patient satisfaction. We hope these survey results and interventions can provide insight and be used to improve patient satisfaction among all cancer patients at infusion units serving veterans and nonveterans.

Acknowledgments

We are very thankful to our cancer patients who took the time to take the survey. We also are very grateful to the VHA infusion unit nurses, staff, nurse practitioners, and physicians who have embraced this project and welcomed any changes that may positively impact treatment of veterans. Also, thank you to Tia Kohs for statistical support and Sophie West for gender discussions. Last, we specifically thank Barbara, for her pursuit of better care for women and for all veterans.

Gender differences in patient satisfaction with medical care have been evaluated in multiple settings; however, studies specific to the unique population of women veterans with cancer are lacking. Women are reported to value privacy, psychosocial support, and communication to a higher degree compared with men.¹ Factors affecting satisfaction include the following: discomfort in sharing treatment rooms with the opposite gender, a desire for privacy with treatment and restroom use, anatomic or illness differences, and a personal history of abuse^.2-4 Regrettably, up to 1 in 3 women in the United States are victims of sexual trauma in their lifetimes, and up to 1 in 4 women in the military are victims of military sexual trauma. Incidence in both settings is suspected to be higher due to underreporting^.5,6

Chemotherapy treatment units are often uniquely designed as an open space, with several patients sharing a treatment area. The design reduces isolation and facilitates quick nurse-patient access during potentially toxic treatments known to have frequent adverse effects. Data suggest that nursing staff prefer open models to facilitate quick patient assessments and interventions as needed; however, patients and families prefer private treatment rooms, especially among women patients or those receiving longer infusions.⁷

The Veterans Health Administration (VHA) patient population is male predominant, comprised only of 10% female patients.8 Although the proportion of female patients in the VHA is expected to rise annually to about 16% by 2043, the low percentage of female veterans will persist for the foreseeable future.⁸ This low percentage of female veterans is reflected in the Veterans Affairs Portland Health Care System (VAPHCS) cancer patient population and in the use of the chemotherapy infusion unit, which is used for the ambulatory treatment of veterans undergoing cancer therapy.

The VHA has previously explored gender differences in health care, such as with cardiovascular disease, transgender care, and access to mental health.^9-11 However, to the best of our knowledge, no analysis has explored gender differences within the outpatient cancer treatment experience. Patient satisfaction with outpatient cancer care may be magnified in the VHA setting due to the uniquely unequal gender populations, shared treatment space design, and high incidence of sexual abuse among women veterans. Given this, we aimed to identify gender-related preferences in outpatient cancer care in our chemotherapy infusion unit.

In our study, we used the terms male and female to reflect statistical data from the literature or labeled data from the electronic health record (EHR); whereas the terms men and women were used to describe and encompass the cultural implications and context of gender.¹²

Methods

This study was designated as a quality improvement (QI) project by the VAPHCS research office and Institutional Review Board in accordance with VHA policies.

The VAPHCS outpatient chemotherapy infusion unit is designed with 6 rooms for chemotherapy administration. One room is a large open space with 6 chairs for patients. The other rooms are smaller with glass dividers between the rooms, and 3 chairs inside each for patients. There are 2 private bathrooms, each gender neutral. Direct patient care is provided by physicians, nurse practitioners (NPs), infusion unit nurses, and nurse coordinators. Men represent the majority of hematology and oncology physicians (13 of 20 total: 5 women fellow physicians and 2 women attending physicians), and 2 of 4 NPs. Women represent 10 of 12 infusion unit and cancer coordinator nurses. We used the VHA Computerized Patient Record System (CPRS) EHR, to create a list of veterans treated at the VAPHCS outpatient chemotherapy infusion unit for a 2-year period (January 1, 2018, to December 31, 2020).

Male and female patient lists were first generated based on CPRS categorization. We identified all female veterans treated in the ambulatory infusion unit during the study period. Male patients were then chosen at random, recording the most recent names for each year until a matched number per year compared with the female cohort was reached. Patients were recorded only once even though they had multiple infusion unit visits. Patients were excluded who were deceased, on hospice care, lost to follow-up, could not be reached by phone, refused to take the survey, had undeliverable email addresses, or lacked internet or email access.

After filing the appropriate request through the VAPHCS Institutional Review Board committee in January 2021, patient records were reviewed for demographics data, contact information, and infusion treatment history. The survey was then conducted over a 2-week period during January and February 2021. Each patient was invited by phone to complete a 25-question anonymous online survey. The survey questions were created from patient-relayed experiences, then modeled into survey questions in a format similar to other patient satisfaction questionnaires described in cancer care and gender differences.^2,13,14 The survey included self-identification of gender and was multiple choice for all except 2 questions, which allowed an open-ended response (Appendix). Only 1 answer per question was permitted. Only 1 survey link was sent to each veteran who gave permission for the survey. To protect anonymity for the small patient population, we excluded those identifying as gender nonbinary or transgender.

Statistical Analysis

Patient, disease, and treatment features are separated by male and female cohorts to reflect information from the EHR (Table 1). Survey percentages were calculated to reflect the affirmative response of the question asked (Table 2). Questions with answer options of not important, minimally important, important, or very important were calculated to reflect the sum of any importance in both cohorts. Questions with answer options of never, once, often, or every time were calculated to reflect any occurrence (sum of once, often, or every time) in both patient groups. Questions with answer options of strongly agree, somewhat agree, somewhat disagree, and strongly disagree were calculated to reflect any agreement (somewhat agree and strongly agree summed together) for both groups. Comparisons between cohorts were then conducted using a Fisher exact test. A Welch t test was used to calculate the significance of the continuous variable and overall ranking of the infusion unit experience between groups.

Results 

In 2020, 414 individual patients were treated at the VAPAHCS outpatient infusion unit. Of these, 23 (5.6%) were female, and 18 agreed to take the survey. After deceased and duplicate names from 2020 were removed, another 14 eligible 2019 female patients were invited and 6 agreed to participate; 6 eligible 2018 female patients were invited and 4 agreed to take the survey (Figure). Thirty female veterans were sent a survey link and 21 (70%) responses were collected. Twenty-one male 2020 patients were contacted and 18 agreed to take the survey. After removing duplicate names and deceased individuals, 17 of 21 eligible 2019 male patients and 4 of 6 eligible 2018 patients agreed to take the survey. Five additional male veterans declined the online-based survey method. In total, 39 male veterans were reached who agreed to have the survey link emailed, and 20 (51%) total responses were collected.

Most respondents answered all questions in the survey. The most frequently skipped questions included 3 questions that were contingent on a yes answer to a prior question, and 2 openended questions asking for a write-in response. Percentages for female and male respondents were adjusted for number of responses when applicable.

Thirteen (62%) female patients were aged < 65 years, while 18 (90%) of male patients were aged ≥ 65 years. Education beyond high school was reported in 20 female and 15 male respondents. Almost all treatment administered in the infusion unit was for cancer-directed treatment, with only 1 reporting a noncancer treatment (IV iron). The most common malignancy among female patients was breast cancer (n = 11, 52%); for male patients prostate cancer (n = 4, 20%) and hematologic malignancy (n = 4, 20%) were most common. Four (19%) female and 8 (40%) male respondents reported having a metastatic diagnosis. Overall patient satisfaction ranked high with an average score of 9.1 on a 10-point scale. The mean (SD) satisfaction score for female respondents was 1 point lower than that for men: 8.7 (2.2) vs 9.6 (0.6) in men (P = .11).

Eighteen (86%) women reported a history of sexual abuse or harassment compared with 2 (10%) men (P < .001). The sexual abuse assailant was a different gender for 17 of 18 female respondents and of the same gender for both male respondents. Of those with sexual abuse history, 4 women reported feeling uncomfortable around their assailant’s gender vs no men (P = .11), but this difference was not statistically significant. Six women (29%) and 2 (10%) men reported feeling uncomfortable during clinical examinations from comments made by the clinician or during treatment administration (P = .24). Six (29%) women and no men reported that they “felt uncomfortable in the infusion unit by other patients” (P = .02). Six (29%) women and no men reported feeling unable to “voice uncomfortable experiences” to the infusion unit clinician (P = .02).

Ten (48%) women and 6 (30%) men reported emotional support when receiving treatments provided by staff of the same gender (P = .34). Eight (38%) women and 4 (20%) men noted that access to treatment with the same gender was important (P = .31). Six (29%) women and 4 (20%) men indicated that access to a sex or gender-specific restroom was important (P = .72). No gender preferences were identified in the survey questions regarding importance of private treatment room access and level of emotional support when receiving treatment with others of the same malignancy. These relationships were not statistically significant.

In addition, 2 open-ended questions were asked. Seventeen women and 14 men responded. Contact the corresponding author for more information on the questions and responses.

Discussion

Overall patient satisfaction was high among the men and women veterans with cancer who received treatment in our outpatient infusion unit; however, notable gender differences existed. Three items in the survey revealed statistically significant differences in the patient experience between men and women veterans: history of sexual abuse or harassment, uncomfortable feelings among other patients, and discomfort in relaying uncomfortable feelings to a clinician. Other items in the survey did not reach statistical significance; however, we have included discussion of the findings as they may highlight important trends and be of clinical significance.

We suspect differences among genders in patient satisfaction to be related to the high incidence of sexual abuse or harassment history reported by women, much higher at 86% than the one-third to one-fourth incidence rates estimated by the existing literature for civilian or military sexual abuse in women.5,6 These high sexual abuse or harassment rates are present in a majority of women who receive cancer-directed treatment toward a gender-specific breast malignancy, surrounded predominantly among men in a shared treatment space. Together, these factors are likely key reasons behind the differences in satisfaction observed. This sentiment is expressed in our cohort, where one-fifth of women with a sexual abuse or harassment history continue to remain uncomfortable around men, and 29% of women reporting some uncomfortable feelings during their treatment experience compared with none of the men. Additionally, 6 (29%) women vs no men felt uncomfortable in reporting an uncomfortable experience with a clinician; this represents a significant barrier in providing care for these patients.

A key gender preference among women included access to shared treatment rooms with other women and that sharing a treatment space with other women resulted in feeling more emotional support during treatments. Access to gender-specific restrooms was also preferred by women more than men. Key findings in both genders were that about half of men and women valued access to a private treatment room and would derive more emotional support when surrounded by others with the same cancer.

Prior studies on gender and patient satisfaction in general medical care and cancer care have found women value privacy more than men.^1-3 Wessels and colleagues performed an analysis of 386 patients with cancer in Europe and found gender to be the strongest influence in patient preferences within cancer care. Specifically, the highest statically significant association in care preferences among women included privacy, support/counseling/rehabilitation access, and decreased wait times.2 These findings were most pronounced in those with breast cancer compared with other malignancy type and highlights that malignancy type and gender predominance impact care satisfaction.

Traditionally a shared treatment space design has been used in outpatient chemotherapy units, similar to the design of the VAPHCS. However, recent data report on the patient preference for a private treatment space, which was especially prominent among women and those receiving longer infusions.7 In another study that evaluated 225 patients with cancer preferences in sharing a treatment space with those of a different sexual orientation or gender identify, differences were found. Both men and women had a similar level of comfort in sharing a treatment room with someone of a different sexual orientation; however, more women reported discomfort in sharing a treatment space with a transgender woman compared with men who felt more comfortable sharing a space with a transgender man.4 We noted a gender preference may be present to explain the difference. Within our cohort, women valued access to treatment with other women and derived more emotional support when with other women; however, we did not inquire about feelings in sharing a treatment space among transgender individuals or differing sexual orientation.

Gender differences for privacy and in shared room preferences may result from the lasting impacts of prior sexual abuse or harassment. A history of sexual abuse negatively impacts later medical care access and use.15 Those veterans who experienced sexual abuse/harrassment reported higher feelings of lack of control, vulnerability, depression, and pursued less medical care.^15,16 Within cancer care, these feelings are most pronounced among women with gender-specific malignancies, such as gynecologic cancers or breast cancer. Treatment, screening, and physical examinations by clinicians who are of the same gender as the sexual abuse/harassment assailant can recreate traumatic feelings.^15,16

A majority of women (n = 18, 86%) in our cohort reported a history of sexual abuse or harassment and breast malignancy was the most common cancer among women. However women represent just 5.6% of the VAPHCS infusion unit treatment population. This combination of factors may explain the reasons for women veterans’ preference for privacy during treatments, access to gender-specific restrooms, and feeling more emotional support when surrounded by other women. Strategies to help patients with a history of abuse have been described and include discussions from the clinician asking about abuse history, allowing time for the patient to express fears with an examination or test, and training on how to deliver sensitive care for those with trauma.^17,18

Quality Improvement

Project In the VAPHCS infusion unit, several low-cost interventions have been undertaken as a result of our survey findings. We presented our survey data to the VAPHCS Cancer Committee, accredited through the national American College of Surgeons Commission on Cancer. The committee awarded support for a yearlong QI project, including a formal framework of quarterly multidisciplinary meetings to discuss project updates, challenges, and resources. The QI project centers on education to raise awareness of survey results as well as specific interventions for improvement.

Education efforts have been applied through multiple department-wide emails, in-person education to our chemotherapy unit staff, abstract submission to national oncology conferences, and grand rounds department presentations at VAPHCS and at other VHA-affiliated university programs. Additionally, education to clinicians with specific contact information for psychology and women’s health to support mental health, trauma, and sexual abuse histories has been given to each clinician who cares for veterans in the chemotherapy unit.

We also have implemented a mandatory cancer care navigation consultation for all women veterans who have a new cancer or infusion need. The cancer care navigator has received specialized training in sensitive history-taking and provides women veterans with a direct number to reach the cancer care navigation nurse. Cancer care navigation also provides a continuum of support and referral access for psychosocial needs as indicated between infusion or health care visits. Our hope is that these resources may help offset the sentiment reflected in our cohort of women feeling unable to voice concerns to a clinician.

Other interventions underway include offering designated scheduling time each week to women so they can receive infusions in an area with other women. This may help mitigate the finding that women veterans felt more uncomfortable around other patients during infusion treatments compared with how men felt in the chemotherapy unit. We also have implemented gender-specific restrooms labeled with a sign on each bathroom door so men and women can have access to a designated restroom. Offering private or semiprivate treatment rooms is currently limited by space and capacity; however, these may offer the greatest opportunity to improve patient satisfaction, especially among women veterans. Working with the support of the VAPHCS Cancer Committee, we aim to reevaluate the impact of the education and QI efforts on gender differences and patient satisfaction at completion of the 1-year award.

Limitations

Limitations to our study include the overall small sample size. This is due to the combination of the low number of women treated at VAPHCS and many with advanced cancer who, unfortunately, have a limited overall survival and hinders accrual of a larger sample size. Other limitations included age as a possible confounder in our findings, with women representing a younger demographic compared with men. We did not collect responses on duration of infusion time, which also may impact overall satisfaction and patient experience. We also acknowledge that biologic male or female sex may not correspond to a specific individual’s gender. Use of CPRS to obtain a matched number of male and female patients through random selection relied on labeled data from the EHR. This potentially may have excluded male patients who identify as another gender that would have been captured on the anonymous survey.

Conclusions

Our findings may have broad applications to other VHA facilities and other cancer-directed treatment centers where the patient demographic and open shared infusion unit design may be similar. The study also may serve as a model of survey design and implementation from which other centers may consider improving patient satisfaction. We hope these survey results and interventions can provide insight and be used to improve patient satisfaction among all cancer patients at infusion units serving veterans and nonveterans.

Acknowledgments

We are very thankful to our cancer patients who took the time to take the survey. We also are very grateful to the VHA infusion unit nurses, staff, nurse practitioners, and physicians who have embraced this project and welcomed any changes that may positively impact treatment of veterans. Also, thank you to Tia Kohs for statistical support and Sophie West for gender discussions. Last, we specifically thank Barbara, for her pursuit of better care for women and for all veterans.

The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The drive from Texas to the clinic in Albuquerque, N.M., took 10 hours. It was mid-April of this year. There wasn’t much to see along the mostly barren stretch, and there wasn’t much for Kailee DeSpain to do aside from think about where she was going and why.

Her husband was driving. She sensed his nervous glances toward the passenger seat where she sat struggling to quiet her thoughts.

No, she wasn’t having any pain, she told him. No, she wasn’t feeling like she did the last time or the two times before that.

This pregnancy was different. It was the first in which she feared for her own life. Her fetus – Finley – had triploidy, a rare chromosomal abnormality. Because of the condition, which affects 1%-3% of pregnancies, his heart, brain, and kidneys were not developing properly.

At 19 weeks, Finley was already struggling to draw breath from lungs squeezed inside an overcrowded chest cavity. Ms. DeSpain wanted nothing more than to carry Finley to term, hold him, meet him even for a moment before saying goodbye.

But his condition meant he would likely suffocate in utero well before that. And Ms. DeSpain knew that carrying him longer would likely raise her risk of bleeding and of her blood pressure increasing to dangerous highs.

“This could kill you,” her husband told her. “Do you realize you could die bringing a baby into this world who is not going to live? I don’t want to lose you.’”

Unlike her other pregnancies, the timing of this one and the decision she faced to end it put her health in even greater danger.
 

Imminent danger

On Sept. 1, 2021, a bill went into effect in Texas that banned abortions from as early as 6 weeks’ gestation. Texas Senate Bill 8 (SB8) became one of the most restrictive abortion laws in the country. It prohibited abortions whenever a fetal heartbeat, defined by lawmakers, could be detected on an ultrasound, often before many women knew they were pregnant.

The Texas abortion law was hardly the last word on the topic. Ms. DeSpain didn’t know it on her drive to New Mexico in April, but the U.S. Supreme Court was weeks away from overturning the landmark Roe v. Wade decision.

On June 24, the Supreme Court delivered its 6-3 ruling overturning Roe v. Wade, the 1973 case that granted women the right to abortion.

This decision set in motion “trigger laws” in some states – laws that essentially fully banned abortions. Those states included Ms. DeSpain’s home state of Texas, where abortion is now a felony except when the life of the mother is in peril.

However, legal definitions of what qualifies as “life-threatening” remain murky.

The law is unclear, says Lisa Harris, MD, PhD, professor in the department of obstetrics and gynecology at the University of Michigan, Ann Arbor. “What does the risk of death have to be, and how imminent must it be?” she asked in a recent editorial in the New England Journal of Medicine. Is 25% enough? 50%? Or does a woman have to be moments from dying?

“This whole thing makes me so angry,” says Shikha Jain, MD, a medical oncologist at University of Illinois Health, Chicago. “A patient may not be experiencing an emergency right now, but if we don’t take care of the situation, it may become an emergency in 2 hours or 2 days.”

Even before the Roe v. Wade decision, pregnancy had been a high-stakes endeavor for many women. In 2019, more than 750 women died from pregnancy-related events in the United States. In 2020, that number rose to 850. Each year dozens more suffer pregnancy-related events that require lifesaving interventions.

Now, in a post-Roe world, the number of maternal deaths will likely climb as more abortion bans take effect and fewer women have access to lifesaving care, experts say. A 2021 study that compared 2017 maternal mortality rates in states with different levels of abortion restrictions found that the rate of maternal mortality was almost two times higher in states that restricted abortion access compared with those that protected it – 28.5 per 100,000 women vs. 15.7.

Some women living in states with abortion bans won’t have the resources to cross state lines for care.

“This is just going to widen the health care disparities that are already so prevalent in this country,” Dr. Jain says.
 

Navigating a crossroads

Ms. DeSpain’s medical history reads like a checklist of pregnancy-related perils: chronic high blood pressure, persistent clotting problems, and a high risk of hemorrhage. She was also diagnosed with cervical cancer in 2020, which left her body more fragile.

Cardiovascular conditions, including hypertension and hemorrhage, are the leading causes of maternal mortality, responsible for more than one-third of pregnancy-related deaths. Preeclampsia, characterized by high blood pressure, accounts for more than 7% of maternal deaths in the United States. Although less common, genetic disorders, such as spinal muscular atrophy and triploidy, or cancer during pregnancy can put a mother and fetus at risk.

Cancer – which affects about 1 in 1,000 pregnant women and results in termination in as many as 28% of cases – brings sharp focus to the new dangers and complex decision-making patients and their doctors face as abortion bans take hold.

Before the Supreme Court decision, a pregnant woman with cancer was already facing great uncertainty. The decision to treat cancer during pregnancy involves “weighing the risk of exposing the fetus to medication vs. the risk to the mother’s untreated illness if you don’t expose the fetus to medication,” Elyce Cardonick, MD, an obstetrician at Cooper University Health Care, Camden, N.J., who specializes in high-risk pregnancies, told the National Cancer Institute.

Oncologists generally agree that it’s safe for pregnant women to receive chemotherapy during the second and third trimesters. But for women with aggressive cancers that are diagnosed in the first trimester, chemotherapy is dangerous. For women who need immunotherapy, the risks of treatment remain unclear.

In these cases, Alice S. Mims, MD, must broach the possibility of terminating the pregnancy.

“Cancer is a very urgent condition,” says Dr. Mims, a hematology specialist at the Ohio State University Comprehensive Cancer Center, Columbus, who sees patients who are pregnant. “These women may have other children at home, and they want to do their best to fight the disease so they can be around for their family long term.”

Now the changing legal landscape on abortion will put hundreds more pregnant women with cancer in danger. In a recent viewpoint article published in JAMA Oncology, Jordyn Silverstein and Katherine Van Loon, MD, MPH, estimate that during the next year, up to 420 pregnant women living in states with restricted abortion access will face threats to their cancer care and potentially their life.

“The repercussions of overturning Roe v. Wade – and the failure of the Supreme Court to provide any guidance on exceptions related to the life and health of the mother – are potentially catastrophic for a subset of women who face a life-threating diagnosis of [pregnancy-associated cancer],” they write.

The choice Ms. DeSpain faced after her cervical cancer diagnosis was different. She was not pregnant at the time, but she was at a crossroads.

Although it was caught early, the cancer was aggressive. Her oncologist recommended that she undergo a hysterectomy – the surgery that would give her the best chance for a cancer-free future. It would also mean she could no longer become pregnant.

With a less invasive procedure, on the other hand, she could still carry a child, but she would face a much greater chance that the cancer would come back.

At 27, Ms. DeSpain was not ready to close the pregnancy door. She opted for a surgery in which part of her cervix was removed, allowing her to try for another baby.

But she faced a ticking clock in the event her cancer returned.

If you want to have a baby, “try soon,” her doctor warned.
 

A dead end

After her cancer surgery and a third miscarriage, Ms. DeSpain and her husband were surprised and excited when in late 2021 she again became pregnant.

The first trimester seemed blissfully uneventful. As the weeks passed, Finley’s heart started to beat.

But the 16-week ultrasound signaled a turning point. The sonographer was too quiet.

“This is really bad, isn’t it?” Ms. DeSpain asked her sonographer.

The doctors told her he wouldn’t survive. Finley had no heart chambers. His heart couldn’t pump blood properly. He was missing one kidney, and his brain was split in the back. With almost no amniotic fluid, her doctor said he would likely die in utero, crushed to death without support from the protective liquid.

She fought for him anyway. She sought specialty care, followed bed rest orders, and traveled 3 hours to Houston to enroll in a clinical trial.

But every road was a dead end.

Ultimately, testing revealed Finley had triploidy, and all lines led to one point.

“There were too many things wrong, too much wrong for them to fix,” says Ms. DeSpain, recalling the news from her doctor in Houston. “I was in shock. My husband was just sitting with his hands flat on the table, staring at nothing, shaking a little bit.”

However, Finley still had a heartbeat, making an abortion after 6 weeks a felony in Texas. Even a compassionate induction was now out of the question unless her death was imminent.

Ms. DeSpain called the abortion clinic in Albuquerque and made an appointment. She would have to wait 2 weeks because of an influx of pregnant patients coming from Texas.

She welcomed the wait … just in case she changed her mind.

“At that point I wanted to carry him as far as I could,” she says.

For those 2 weeks, Ms. DeSpain remained on bed rest. She cried all day every day. She worried that Finley was experiencing pain.

Through this process, her doctor’s support helped keep her grounded.

“She cried with us in her office and said, ‘I wish that you didn’t have to go, but I think you’re doing the right thing, doing what keeps you safest,’ “ Ms. DeSpain recalls.

Ms. DeSpain declined to share the name of her doctor out of fear that even expressing compassion for a patient’s safety could put the physician in legal jeopardy and provoke harassment.

That fear is warranted. Some doctors will be forced to choose between doing what is legal – even though the law is vague – and doing what is right for patients, says law professor Jamie Abrams, who was recently diagnosed with breast cancer.

To live in a world where there’s talk of criminalizing doctors for taking care of their patients, where there’s “this national movement to position some women to be shunned and exiled for seeking care that’s right for them, their health, and might save their life is staggering and beyond comprehension,” says Ms. Abrams, professor of law at the American University Washington College of Law.

Ms. Abrams, who was diagnosed with hormone receptor–positive invasive breast cancer the same day she read the leaked Supreme Court draft on the decision to end of Roe v. Wade, said that “overnight, I became a person who would need an abortion if I became pregnant, because my treatment would compromise a healthy birth or delay necessary cancer care.” Ms. Abrams was also told she could no longer use hormonal contraception.

Dr. Harris’s advice to clinicians is to try to do what they feel is best for patients, including referring them to centers that have legal resources and protections regarding abortions.

Dr. Mims agrees and recommends that doctors reach out to those with more resources and legal backing for support. “I would advise doctors in [states with restrictive laws] to familiarize themselves with available resources and organizations taking action to deal with questionable cases,” Dr. Mims says.
 

‘Baby killers work here’

Following her 10-hour drive to Albuquerque, Ms. DeSpain encountered lines of protesters at the clinic. They were holding signs that said, “Abortion is murder,” and “Baby killers work here.”

“Please don’t kill your baby – we have resources for you,” a woman screeched through a megaphone as Ms. DeSpain, nearly 20 weeks’ pregnant, stepped out of the car to enter the clinic.

“I remember turning around, looking at her and making eye contact, and yelling back, ‘My baby has triploidy – he is dying! He is going to suffocate if I carry him full term. You don’t know what you’re talking about!’ “

A nurse held her hand during the procedure.

“He said, ‘You’re doing great, you’re okay,’ “ she recalls. She knew there was a chance that Finley’s face would be crushed by contractions during labor because of the lack of amniotic fluid, but she hoped not. Ms. DeSpain longed for a photo.

There was no photo to take home the next day, but Ms. DeSpain did receive Finley’s footprints, and his heartbeat – as captured by the specialty team in Houston – lives on in a stuffed giraffe.

His ashes arrived a few weeks later.

By then, the Supreme Court draft had been leaked. Ms. DeSpain knew her predicament in Texas would soon affect women across the United States and make any future pregnancy attempt for her even more risky.

The weeks and months that followed were a blur of grief, anger, and medical testing.

But she received some good news. A second triploidy pregnancy was extremely unlikely.

Several weeks later, Ms. DeSpain got more good news.

“I had a follow-up cancer appointment, and everything was completely clear,” she says.

She remains hopeful that she will be able to give birth, but her doctor cautioned that it’s no longer safe to become pregnant in Texas.

“I need you to understand that if you get pregnant and you have complications, we can’t intervene unless the baby doesn’t have a heartbeat, even if it would save your life,” Ms. DeSpain recalls her doctor saying.

If Texas remains a dangerous place to be pregnant, Ms. DeSpain and her husband will have to move.

For now, Ms. DeSpain wants people to know her story and to continue to fight for her right to govern her body.

In a public post to Facebook, she laid bare her pregnancy journey.

“No one should have to share a story like mine to justify abortion,” she wrote. “My choice is not yours to judge, and my rights are not yours to gleefully take away.”

Ms. Abrams, Ms. DeSpain, Dr. Harris, Dr. Jain, and Dr. Mims have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

More than half of patients with mild traumatic brain injury (TBI) and a negative head CT scan have not recovered completely 6 months after sustaining their injury, new data from the TRACK-TBI study shows.

“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.

“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.

The findings were published online in JAMA Network Open.

The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.

Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).

Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.

Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.

The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.

The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.

“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.

The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

In patients with moderate-to-severe atopic dermatitis, abrocitinib showed consistent treatment responses and no new safety issues, whether or not they had already been treated with the biologic dupilumab, an industry-sponsored study reports.

“In this post hoc analysis, both the efficacy and the safety profiles of abrocitinib were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy use,” lead author Melinda Gooderham, MD, medical director of the SKiN Centre for Dermatology, Peterborough, Ont., said during an oral presentation at the Society for Investigative Dermatology (SID) 2022 Annual Meeting.

“These results ... support the use of abrocitinib in patients who might have received biologic therapy prior,” she added.

“Prior biologic use did not reveal any new safety signals ... keeping in mind the key limitation of this analysis is that it was done post hoc,” she noted.

Guidelines for moderate-to-severe atopic dermatitis refractory to topical or systemic therapy include systemic immunosuppressants and dupilumab, a monoclonal antibody that inhibits interleukin-4 and interleukin-13 cytokine-induced responses, Dr. Gooderham said.

The Food and Drug Administration recently approved abrocitinib, an oral once-a-day Janus kinase 1 (JAK1) inhibitor, to treat the disease. The approval came with a boxed warning about increased risk for serious infections, mortality, malignancy, and lymphoproliferative disorders, major adverse cardiovascular events, thrombosis, and laboratory abnormalities.
 

Comparing the bio-experienced with the bio-naive

Dr. Gooderham and colleagues investigated whether patients who’d been treated with a biologic would respond to abrocitinib differently than patients who had not received prior biologic treatment.

Researchers pooled data from two phase 3 placebo-controlled trials of abrocitinib that led to approval and an earlier phase 2b study. They identified 67 patients previously treated with dupilumab and 867 patients who were bio-naive. They repeated their analysis using data from another phase 3 study of abrocitinib on 86 patients previously treated with dupilumab and 1,147 who were bio-naive. On average, the bio-experienced patients were in their mid-30s to early 40s, and the bio-naive group was several years younger.

In the pooled phase 2b and phase 3 JADE MONO-1 and JADE MONO-2 monotherapy trials, patients received once-daily abrocitinib 100 or 200 mg or placebo for 12 weeks. In the phase 3 JADE REGIMEN, which they analyzed separately, eligible patients were enrolled in a 12-week open-label run-in period during which they received an induction treatment of abrocitinib 200 mg once a day.

Researchers compared results of two assessments: the IGA (Investigator Global Assessment) and EASI-75 (Eczema Area and Severity Index, 75% or greater improvement from baseline).

• At week 12, IGA 0/1 dose-dependent response rates were similar in the pooled groups, regardless of whether they had received prior biologic therapy. With abrocitinib 200 mg, 43.5% of those with prior dupilumab therapy responded versus 41.4% of bio-naive patients; with abrocitinib 100 mg, 24.1% versus 26.7% responded. In JADE REGIMEN, corresponding response rates with abrocitinib 200 mg were 53.5% versus 66.9%, respectively.
• At week 12, EASI-75 responses were also comparable. In the pooled groups by dose, with abrocitinib 200 mg, EASI-75 response rates were 65.2% in patients with prior dupilumab therapy versus 62.4% in those without; at abrocitinib 100 mg, 34.5% versus 42.7% responded. Corresponding rates in JADE REGIMEN were 64.0% versus 76.4%, respectively.
• Treatment-emergent adverse event rates among patients with versus without prior biologic therapy were, respectively, 71.7% versus 69.9% (abrocitinib 200 mg + 100 mg groups) in the pooled population. Rates in JADE REGIMEN with abrocitinib 200 mg were, respectively, 66.3% versus 66.5%.
• Abrocitinib efficacy and safety were consistent in patients with moderate-to-severe atopic dermatitis, regardless of prior biologic therapy. Adverse events in the pooled monotherapy trials and in JADE REGIMEN included acne, atopic dermatitis, diarrhea, headache, nasopharyngitis, nausea, upper abdominal pain, and upper respiratory tract infection.

The authors acknowledge that the post hoc study design is a limitation and recommend confirming these findings in a large, long-term prospective study.
 

JAK inhibitors expand treatment options

The results will help doctors treat their patients, Jami L. Miller, MD, associate professor of dermatology and dermatology clinic medical director at Vanderbilt University Medical Center, Nashville, Tenn., told this news organization.

“Because JAK inhibitors have potentially more side effects than inhibitors of interleukin-4 and interleukin-13, in clinical practice most dermatologists are more likely to treat patients first with dupilumab or similar meds and step up to a JAK inhibitor if they do not respond,” she added in an email. 

“With more meds coming out to meet the needs of this population, this is an exciting time for patients with moderate-to-severe atopic dermatitis,” she commented.

Lindsay C. Strowd, MD, associate professor and vice chair of the department of dermatology at Wake Forest University, Winston-Salem, N.C., said JAK inhibitors are increasingly being studied and approved for use in various dermatologic diseases.

An oral JAK inhibitor (upadacitinib) is currently FDA approved for moderate-to-severe atopic dermatitis, and a topical JAK inhibitor (ruxolitinib) is also approved for use in atopic dermatitis, Dr. Strowd noted.

“The study results give providers important practical information,” added Dr. Strowd, who also was not involved with the study. “Those of us who care for patients with severe atopic dermatitis need to know how patients with prior biologic exposure will respond as newer agents come to market and the options for biologic use in atopic dermatitis continue to grow.”

The study was sponsored by Pfizer. All study authors have reported relevant financial relationships with, and several authors are employees of, Pfizer, the developer of abrocitinib. Dr. Strowd and Dr. Miller have reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Fecal and mucosal microbiota have been the focus of much research. A study by Hou and colleagues that showed distinct differences in the intestinal and fecal microbiomes of patients with constipation-predominant or diarrhea-predominant IBS, compared with healthy controls, highlights the importance of a balanced and diverse microbiome to maintain a healthy gut. The article notes specific genera of microbiota that were associated with intestinal pain. When microbiota diversity is limited, the incidence of IBS is increased. This reinforces the importance of promoting a healthy microbiome in all patients and appreciating the correlation of the microbiome with the development of IBS.

 Internet-based cognitive-behavioral therapy may make it easier for patients to obtain therapy services. Kim and colleagues have shown this to be a cost-effective and efficacious way to deliver care. This care improves the quality of life for patients with IBS and is an effective intervention that is readily available. During pandemic times, the forum of online care also provides a safe way to deliver therapy services without the burden of the patient needing to commute to clinic and potentially be exposed to infectious disease. Given the relationship between IBS and psychiatric diagnoses noted by Creed and colleagues, it seems important to extend the availability of therapeutic interventions to as many patients with IBS as possible.

Fecal and mucosal microbiota have been the focus of much research. A study by Hou and colleagues that showed distinct differences in the intestinal and fecal microbiomes of patients with constipation-predominant or diarrhea-predominant IBS, compared with healthy controls, highlights the importance of a balanced and diverse microbiome to maintain a healthy gut. The article notes specific genera of microbiota that were associated with intestinal pain. When microbiota diversity is limited, the incidence of IBS is increased. This reinforces the importance of promoting a healthy microbiome in all patients and appreciating the correlation of the microbiome with the development of IBS.

 Internet-based cognitive-behavioral therapy may make it easier for patients to obtain therapy services. Kim and colleagues have shown this to be a cost-effective and efficacious way to deliver care. This care improves the quality of life for patients with IBS and is an effective intervention that is readily available. During pandemic times, the forum of online care also provides a safe way to deliver therapy services without the burden of the patient needing to commute to clinic and potentially be exposed to infectious disease. Given the relationship between IBS and psychiatric diagnoses noted by Creed and colleagues, it seems important to extend the availability of therapeutic interventions to as many patients with IBS as possible.

Fecal and mucosal microbiota have been the focus of much research. A study by Hou and colleagues that showed distinct differences in the intestinal and fecal microbiomes of patients with constipation-predominant or diarrhea-predominant IBS, compared with healthy controls, highlights the importance of a balanced and diverse microbiome to maintain a healthy gut. The article notes specific genera of microbiota that were associated with intestinal pain. When microbiota diversity is limited, the incidence of IBS is increased. This reinforces the importance of promoting a healthy microbiome in all patients and appreciating the correlation of the microbiome with the development of IBS.

 Internet-based cognitive-behavioral therapy may make it easier for patients to obtain therapy services. Kim and colleagues have shown this to be a cost-effective and efficacious way to deliver care. This care improves the quality of life for patients with IBS and is an effective intervention that is readily available. During pandemic times, the forum of online care also provides a safe way to deliver therapy services without the burden of the patient needing to commute to clinic and potentially be exposed to infectious disease. Given the relationship between IBS and psychiatric diagnoses noted by Creed and colleagues, it seems important to extend the availability of therapeutic interventions to as many patients with IBS as possible.