Ob.Gyn. News

A study has shown for the first time that knowing BRCA1/2 mutation status before a breast cancer diagnosis was associated with better survival.

The study, conducted among Ashkenazi Jewish women in Israel, showed that among women who knew their carrier status before they developed breast cancer, diagnoses were made at an earlier disease stage and 5-year survival was improved compared to women who learned their carrier status only after their disease had been diagnosed.

The study was published online on July 9 in JAMA Oncology.

“I don’t want to belittle the complexities of knowing that you’re a carrier. But I think these results really show that knowledge is power,” first author Ephrat Levy-Lahad, MD, director of the medical genetics unit at Shaare Zedek Medical Center in Jerusalem, Israel, told Medscape Medical News.

Carrying a BRCA1/2 pathogenic mutation is associated with a 70% to 80% lifetime risk for breast cancer and about a 10% to 50% lifetime risk for ovarian cancer, depending on the specific mutation. Only about 10% of carriers will not develop either cancer during their lifetime.

The study provides support for genetic screening for pathogenic BRCA1/2 mutations, especially in high-risk populations, according to Levy-Lahad.

“For me, the results are part of a bigger picture.... I think we should be moving towards general population screening, certainly in high-risk populations like Ashkenazi Jews,” she said.

In Israel, that decision has already been made: a new policy, introduced in January 2020, offers testing for common BRCA1/2 mutations for all Ashkenazi Jewish women.

However, women in other countries may also benefit from testing, she argues. About half of BRCA1/2 carriers in a general population like that of the United States do not have a family history that would indicate a need for testing. That means many women who carry these mutations may not be taking advantage of recommended surveillance and prevention measures, she said.

But screening for BRCA1/2 mutations becomes more complicated when applied to more general populations, she acknowledged.

About 2.5% of women of Ashkenazi Jewish descent carry pathogenic mutations for BRCA1/2, compared to 0.5% in the general White population.

Also, screening in the Ashkenazi Jewish population is probably simpler than in the general population. Just three mutations are definitely known to cause disease and need to be tested for among Ashkenazi Jews. Screening in a larger population would require full sequencing of the gene. That increases the likelihood of finding variants of unknown significance (VUSs), which muddies the water. Knowledge is incomplete about whether some of these VUSs increase cancer risk, and physicians do not always know how to manage them in women who test positive.

Moreover, Israel has a national health system. Screening in a country without universal health insurance such as the United States raises questions about whether follow-up would be covered by insurance carriers for women who test positive.

Mehmet Copur, MD, an oncologist at Morrison Cancer Center in Hastings, Nebraska, questions how general population screening could be done in “real life.”

“These findings should be taken into consideration in the context of the patient population who would agree to genetic testing, who would agree to comply with the recommended guidelines for risk reduction, and who would have insurance coverage or resources to comply with the recommendations,” Copur told Medscape Medical News.

“If BRCA-positive patients did not or could not follow these recommendations, the results would different,” he added.

The most crucial component of screening for these mutations is genetic counselors, who are in short supply in the United States, according to Copur.

Another issue is that of cost. Genetic counseling is not always covered by insurance, especially for individuals who do not have a family history of BRCA-related cancers. Genetic testing is not cheap, and the costs of monitoring women who test positive could be prohibitive, especially in a healthcare system burdened by COVID-19.

“Whether our current healthcare system could bear the cost of such a change is up for debate. The screening itself may be feasible, but offering lifelong surveillance to every woman identified with mutations could present huge capacity issues,” Copur said. “Maybe in the future, the healthcare system can be ready for such an undertaking, but I don’t think we are there yet.”

Although she acknowledges the differences in risk between Ashkenazi Jews and the general population, Levy-Lahad thinks not having screening is like “throwing the baby out with the bath water.”

“Maybe we’re not ready for total general population screening, but I think we have to start thinking along those lines,” she said. “We have this incredible tool for cancer prevention, and we should really be using it, certainly in populations like Ashkenazi Jews.”

Researchers conducted a retrospective analysis that included 105 women diagnosed with breast cancer at Shaare Zedek Medical Center in Jerusalem between 2005 and 2016. Forty-two women knew they were carriers before their breast cancer diagnosis, and 63 learned of their carrier status only after diagnosis. Of the participants, 83% were Ashkenazi Jews. For both prediagnosis and postdiagnosis groups, the age at diagnosis was the same (50.4 years). For both groups, distributions of pathogenic mutations were similar. There were no significant differences in hormone receptor or ERBB2 status.

Among women who knew they were carriers before diagnosis, 80.9% (34/42) were diagnosed either with ductal carcinoma in situ or stage 1 disease. Only 9.5% (4/42) of these women were diagnosed with disease of stage 2 or higher.

In comparison, among women who learned their carrier status after diagnosis, 30% (19/63) had early-stage disease at diagnosis, and 52.4% (33/63) were diagnosed at stage 2 or higher (P < .001).

Compared to women who knew their carrier status before diagnosis, women who found out after diagnosis had 12 times higher odds of being diagnosed with disease of advanced clinical stage (P = .001) and eight times higher odds of being diagnosed with disease of advanced pathologic stage (P = .002).

A sentinel node biopsy was sufficient in 85.7% (36/42) of women who knew their carrier status before diagnosis; 7.2% (3/42) of these women needed a full lymph node dissection. In contrast, 3.2% (2/63) of women who learned their carrier status after diagnosis underwent sentinel node biopsy, and 34.9% (25/105) needed a full lymph node dissection (P < .001).

Among women who knew their carrier status before diagnosis, 54.8% (23/42) did not need chemotherapy at all, and none needed neoadjuvant chemotherapy. Only 4.8% (3/63) of women who learned their mutation status after diagnosis were able to forgo chemotherapy (P < .001); 22.2% (14/63) needed neoadjuvant therapy (P = .001).

These findings appeared to translate into better outcomes. Overall 5-year survival was significantly higher among women who knew their carrier status before diagnosis compared to women who found out afterward (94% [SE 4%] vs 78% [SE 5%]; P = .03). Only two of 42 women (4.8%) in the prediagnosis group died, compared to 16 of 63 (25.4%) in the postdiagnosis group.

Analyses that controlled for year at diagnosis showed that women who learned their carrier status before diagnosis had significantly lower risk for overall mortality compared with those who found out after diagnosis (hazard ratio [HR], 0.20; 95% CI, 0.04 – 0.93; P = .04). However, these results lost significance when controlled for age, socioeconomic index, family history, and gene variant (HR, 0.16; 95% CI, 0.02 – 1.4; P = .10).

Higher socioeconomic status (HR, 0.76; 95% CI, 0.6 – 0.97; P = .03), gene variant (BRCA2 vs BRCA1: HR, 0.15; 95% CI, 0.03 – 0.75; P = .02), and age at diagnosis (HR, 1.047; 95% CI, 1.003 – 1.093; P = .04) were all associated with overall mortality.

“I can’t infer causation, but we suspect that the reason for these results is the difference in follow-up,” Levy-Lahad said.

Most of the women (95.2%, 40/42) who knew their carrier status before diagnosis received their follow-up at the medical center’s high-risk carrier clinic. Twenty-seven of 42 (64.3%) of these women were diagnosed with breast MRI. By contrast, only 1.6% (1/63) of women who found out their carrier status after diagnosis were diagnosed with breast MRI. Breast MRI is not routinely used for breast cancer screening but can be more sensitive than mammography for detecting breast cancer.

The study was funded by the Breast Cancer Research Foundation and by a gift from Ellie and David Werber to ShaareZedek Medical Center.

Levy-Lahad received grants from the Breast Cancer Research Foundation and from the Israel Cancer Association during the conduct of the study and personal fees from AstraZeneca outside the submitted work. Copur has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study has shown for the first time that knowing BRCA1/2 mutation status before a breast cancer diagnosis was associated with better survival.

The study, conducted among Ashkenazi Jewish women in Israel, showed that among women who knew their carrier status before they developed breast cancer, diagnoses were made at an earlier disease stage and 5-year survival was improved compared to women who learned their carrier status only after their disease had been diagnosed.

The study was published online on July 9 in JAMA Oncology.

“I don’t want to belittle the complexities of knowing that you’re a carrier. But I think these results really show that knowledge is power,” first author Ephrat Levy-Lahad, MD, director of the medical genetics unit at Shaare Zedek Medical Center in Jerusalem, Israel, told Medscape Medical News.

Carrying a BRCA1/2 pathogenic mutation is associated with a 70% to 80% lifetime risk for breast cancer and about a 10% to 50% lifetime risk for ovarian cancer, depending on the specific mutation. Only about 10% of carriers will not develop either cancer during their lifetime.

The study provides support for genetic screening for pathogenic BRCA1/2 mutations, especially in high-risk populations, according to Levy-Lahad.

“For me, the results are part of a bigger picture.... I think we should be moving towards general population screening, certainly in high-risk populations like Ashkenazi Jews,” she said.

In Israel, that decision has already been made: a new policy, introduced in January 2020, offers testing for common BRCA1/2 mutations for all Ashkenazi Jewish women.

However, women in other countries may also benefit from testing, she argues. About half of BRCA1/2 carriers in a general population like that of the United States do not have a family history that would indicate a need for testing. That means many women who carry these mutations may not be taking advantage of recommended surveillance and prevention measures, she said.

But screening for BRCA1/2 mutations becomes more complicated when applied to more general populations, she acknowledged.

About 2.5% of women of Ashkenazi Jewish descent carry pathogenic mutations for BRCA1/2, compared to 0.5% in the general White population.

Also, screening in the Ashkenazi Jewish population is probably simpler than in the general population. Just three mutations are definitely known to cause disease and need to be tested for among Ashkenazi Jews. Screening in a larger population would require full sequencing of the gene. That increases the likelihood of finding variants of unknown significance (VUSs), which muddies the water. Knowledge is incomplete about whether some of these VUSs increase cancer risk, and physicians do not always know how to manage them in women who test positive.

Moreover, Israel has a national health system. Screening in a country without universal health insurance such as the United States raises questions about whether follow-up would be covered by insurance carriers for women who test positive.

Mehmet Copur, MD, an oncologist at Morrison Cancer Center in Hastings, Nebraska, questions how general population screening could be done in “real life.”

“These findings should be taken into consideration in the context of the patient population who would agree to genetic testing, who would agree to comply with the recommended guidelines for risk reduction, and who would have insurance coverage or resources to comply with the recommendations,” Copur told Medscape Medical News.

“If BRCA-positive patients did not or could not follow these recommendations, the results would different,” he added.

The most crucial component of screening for these mutations is genetic counselors, who are in short supply in the United States, according to Copur.

Another issue is that of cost. Genetic counseling is not always covered by insurance, especially for individuals who do not have a family history of BRCA-related cancers. Genetic testing is not cheap, and the costs of monitoring women who test positive could be prohibitive, especially in a healthcare system burdened by COVID-19.

“Whether our current healthcare system could bear the cost of such a change is up for debate. The screening itself may be feasible, but offering lifelong surveillance to every woman identified with mutations could present huge capacity issues,” Copur said. “Maybe in the future, the healthcare system can be ready for such an undertaking, but I don’t think we are there yet.”

Although she acknowledges the differences in risk between Ashkenazi Jews and the general population, Levy-Lahad thinks not having screening is like “throwing the baby out with the bath water.”

“Maybe we’re not ready for total general population screening, but I think we have to start thinking along those lines,” she said. “We have this incredible tool for cancer prevention, and we should really be using it, certainly in populations like Ashkenazi Jews.”

Researchers conducted a retrospective analysis that included 105 women diagnosed with breast cancer at Shaare Zedek Medical Center in Jerusalem between 2005 and 2016. Forty-two women knew they were carriers before their breast cancer diagnosis, and 63 learned of their carrier status only after diagnosis. Of the participants, 83% were Ashkenazi Jews. For both prediagnosis and postdiagnosis groups, the age at diagnosis was the same (50.4 years). For both groups, distributions of pathogenic mutations were similar. There were no significant differences in hormone receptor or ERBB2 status.

Among women who knew they were carriers before diagnosis, 80.9% (34/42) were diagnosed either with ductal carcinoma in situ or stage 1 disease. Only 9.5% (4/42) of these women were diagnosed with disease of stage 2 or higher.

In comparison, among women who learned their carrier status after diagnosis, 30% (19/63) had early-stage disease at diagnosis, and 52.4% (33/63) were diagnosed at stage 2 or higher (P < .001).

Compared to women who knew their carrier status before diagnosis, women who found out after diagnosis had 12 times higher odds of being diagnosed with disease of advanced clinical stage (P = .001) and eight times higher odds of being diagnosed with disease of advanced pathologic stage (P = .002).

A sentinel node biopsy was sufficient in 85.7% (36/42) of women who knew their carrier status before diagnosis; 7.2% (3/42) of these women needed a full lymph node dissection. In contrast, 3.2% (2/63) of women who learned their carrier status after diagnosis underwent sentinel node biopsy, and 34.9% (25/105) needed a full lymph node dissection (P < .001).

Among women who knew their carrier status before diagnosis, 54.8% (23/42) did not need chemotherapy at all, and none needed neoadjuvant chemotherapy. Only 4.8% (3/63) of women who learned their mutation status after diagnosis were able to forgo chemotherapy (P < .001); 22.2% (14/63) needed neoadjuvant therapy (P = .001).

These findings appeared to translate into better outcomes. Overall 5-year survival was significantly higher among women who knew their carrier status before diagnosis compared to women who found out afterward (94% [SE 4%] vs 78% [SE 5%]; P = .03). Only two of 42 women (4.8%) in the prediagnosis group died, compared to 16 of 63 (25.4%) in the postdiagnosis group.

Analyses that controlled for year at diagnosis showed that women who learned their carrier status before diagnosis had significantly lower risk for overall mortality compared with those who found out after diagnosis (hazard ratio [HR], 0.20; 95% CI, 0.04 – 0.93; P = .04). However, these results lost significance when controlled for age, socioeconomic index, family history, and gene variant (HR, 0.16; 95% CI, 0.02 – 1.4; P = .10).

Higher socioeconomic status (HR, 0.76; 95% CI, 0.6 – 0.97; P = .03), gene variant (BRCA2 vs BRCA1: HR, 0.15; 95% CI, 0.03 – 0.75; P = .02), and age at diagnosis (HR, 1.047; 95% CI, 1.003 – 1.093; P = .04) were all associated with overall mortality.

“I can’t infer causation, but we suspect that the reason for these results is the difference in follow-up,” Levy-Lahad said.

Most of the women (95.2%, 40/42) who knew their carrier status before diagnosis received their follow-up at the medical center’s high-risk carrier clinic. Twenty-seven of 42 (64.3%) of these women were diagnosed with breast MRI. By contrast, only 1.6% (1/63) of women who found out their carrier status after diagnosis were diagnosed with breast MRI. Breast MRI is not routinely used for breast cancer screening but can be more sensitive than mammography for detecting breast cancer.

The study was funded by the Breast Cancer Research Foundation and by a gift from Ellie and David Werber to ShaareZedek Medical Center.

Levy-Lahad received grants from the Breast Cancer Research Foundation and from the Israel Cancer Association during the conduct of the study and personal fees from AstraZeneca outside the submitted work. Copur has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

A study has shown for the first time that knowing BRCA1/2 mutation status before a breast cancer diagnosis was associated with better survival.

The study, conducted among Ashkenazi Jewish women in Israel, showed that among women who knew their carrier status before they developed breast cancer, diagnoses were made at an earlier disease stage and 5-year survival was improved compared to women who learned their carrier status only after their disease had been diagnosed.

The study was published online on July 9 in JAMA Oncology.

“I don’t want to belittle the complexities of knowing that you’re a carrier. But I think these results really show that knowledge is power,” first author Ephrat Levy-Lahad, MD, director of the medical genetics unit at Shaare Zedek Medical Center in Jerusalem, Israel, told Medscape Medical News.

Carrying a BRCA1/2 pathogenic mutation is associated with a 70% to 80% lifetime risk for breast cancer and about a 10% to 50% lifetime risk for ovarian cancer, depending on the specific mutation. Only about 10% of carriers will not develop either cancer during their lifetime.

The study provides support for genetic screening for pathogenic BRCA1/2 mutations, especially in high-risk populations, according to Levy-Lahad.

“For me, the results are part of a bigger picture.... I think we should be moving towards general population screening, certainly in high-risk populations like Ashkenazi Jews,” she said.

In Israel, that decision has already been made: a new policy, introduced in January 2020, offers testing for common BRCA1/2 mutations for all Ashkenazi Jewish women.

However, women in other countries may also benefit from testing, she argues. About half of BRCA1/2 carriers in a general population like that of the United States do not have a family history that would indicate a need for testing. That means many women who carry these mutations may not be taking advantage of recommended surveillance and prevention measures, she said.

But screening for BRCA1/2 mutations becomes more complicated when applied to more general populations, she acknowledged.

About 2.5% of women of Ashkenazi Jewish descent carry pathogenic mutations for BRCA1/2, compared to 0.5% in the general White population.

Also, screening in the Ashkenazi Jewish population is probably simpler than in the general population. Just three mutations are definitely known to cause disease and need to be tested for among Ashkenazi Jews. Screening in a larger population would require full sequencing of the gene. That increases the likelihood of finding variants of unknown significance (VUSs), which muddies the water. Knowledge is incomplete about whether some of these VUSs increase cancer risk, and physicians do not always know how to manage them in women who test positive.

Moreover, Israel has a national health system. Screening in a country without universal health insurance such as the United States raises questions about whether follow-up would be covered by insurance carriers for women who test positive.

Mehmet Copur, MD, an oncologist at Morrison Cancer Center in Hastings, Nebraska, questions how general population screening could be done in “real life.”

“These findings should be taken into consideration in the context of the patient population who would agree to genetic testing, who would agree to comply with the recommended guidelines for risk reduction, and who would have insurance coverage or resources to comply with the recommendations,” Copur told Medscape Medical News.

“If BRCA-positive patients did not or could not follow these recommendations, the results would different,” he added.

The most crucial component of screening for these mutations is genetic counselors, who are in short supply in the United States, according to Copur.

Another issue is that of cost. Genetic counseling is not always covered by insurance, especially for individuals who do not have a family history of BRCA-related cancers. Genetic testing is not cheap, and the costs of monitoring women who test positive could be prohibitive, especially in a healthcare system burdened by COVID-19.

“Whether our current healthcare system could bear the cost of such a change is up for debate. The screening itself may be feasible, but offering lifelong surveillance to every woman identified with mutations could present huge capacity issues,” Copur said. “Maybe in the future, the healthcare system can be ready for such an undertaking, but I don’t think we are there yet.”

Although she acknowledges the differences in risk between Ashkenazi Jews and the general population, Levy-Lahad thinks not having screening is like “throwing the baby out with the bath water.”

“Maybe we’re not ready for total general population screening, but I think we have to start thinking along those lines,” she said. “We have this incredible tool for cancer prevention, and we should really be using it, certainly in populations like Ashkenazi Jews.”

Researchers conducted a retrospective analysis that included 105 women diagnosed with breast cancer at Shaare Zedek Medical Center in Jerusalem between 2005 and 2016. Forty-two women knew they were carriers before their breast cancer diagnosis, and 63 learned of their carrier status only after diagnosis. Of the participants, 83% were Ashkenazi Jews. For both prediagnosis and postdiagnosis groups, the age at diagnosis was the same (50.4 years). For both groups, distributions of pathogenic mutations were similar. There were no significant differences in hormone receptor or ERBB2 status.

Among women who knew they were carriers before diagnosis, 80.9% (34/42) were diagnosed either with ductal carcinoma in situ or stage 1 disease. Only 9.5% (4/42) of these women were diagnosed with disease of stage 2 or higher.

In comparison, among women who learned their carrier status after diagnosis, 30% (19/63) had early-stage disease at diagnosis, and 52.4% (33/63) were diagnosed at stage 2 or higher (P < .001).

Compared to women who knew their carrier status before diagnosis, women who found out after diagnosis had 12 times higher odds of being diagnosed with disease of advanced clinical stage (P = .001) and eight times higher odds of being diagnosed with disease of advanced pathologic stage (P = .002).

A sentinel node biopsy was sufficient in 85.7% (36/42) of women who knew their carrier status before diagnosis; 7.2% (3/42) of these women needed a full lymph node dissection. In contrast, 3.2% (2/63) of women who learned their carrier status after diagnosis underwent sentinel node biopsy, and 34.9% (25/105) needed a full lymph node dissection (P < .001).

Among women who knew their carrier status before diagnosis, 54.8% (23/42) did not need chemotherapy at all, and none needed neoadjuvant chemotherapy. Only 4.8% (3/63) of women who learned their mutation status after diagnosis were able to forgo chemotherapy (P < .001); 22.2% (14/63) needed neoadjuvant therapy (P = .001).

These findings appeared to translate into better outcomes. Overall 5-year survival was significantly higher among women who knew their carrier status before diagnosis compared to women who found out afterward (94% [SE 4%] vs 78% [SE 5%]; P = .03). Only two of 42 women (4.8%) in the prediagnosis group died, compared to 16 of 63 (25.4%) in the postdiagnosis group.

Analyses that controlled for year at diagnosis showed that women who learned their carrier status before diagnosis had significantly lower risk for overall mortality compared with those who found out after diagnosis (hazard ratio [HR], 0.20; 95% CI, 0.04 – 0.93; P = .04). However, these results lost significance when controlled for age, socioeconomic index, family history, and gene variant (HR, 0.16; 95% CI, 0.02 – 1.4; P = .10).

Higher socioeconomic status (HR, 0.76; 95% CI, 0.6 – 0.97; P = .03), gene variant (BRCA2 vs BRCA1: HR, 0.15; 95% CI, 0.03 – 0.75; P = .02), and age at diagnosis (HR, 1.047; 95% CI, 1.003 – 1.093; P = .04) were all associated with overall mortality.

“I can’t infer causation, but we suspect that the reason for these results is the difference in follow-up,” Levy-Lahad said.

Most of the women (95.2%, 40/42) who knew their carrier status before diagnosis received their follow-up at the medical center’s high-risk carrier clinic. Twenty-seven of 42 (64.3%) of these women were diagnosed with breast MRI. By contrast, only 1.6% (1/63) of women who found out their carrier status after diagnosis were diagnosed with breast MRI. Breast MRI is not routinely used for breast cancer screening but can be more sensitive than mammography for detecting breast cancer.

The study was funded by the Breast Cancer Research Foundation and by a gift from Ellie and David Werber to ShaareZedek Medical Center.

Levy-Lahad received grants from the Breast Cancer Research Foundation and from the Israel Cancer Association during the conduct of the study and personal fees from AstraZeneca outside the submitted work. Copur has disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Bicycling has always been part of who I am because it offered me the freedom to explore as a preteen. As an adult I have always been a bicycle commuter and a very visible part of the community as I pedal around town to do my errands. But, I didn’t always wear a helmet ... because well, I just didn’t. I saw the helmet as a nuisance with very little benefit to myself. Eventually, when bike races required helmets I bought one just for the competitions. Until one day about 30 years ago when the mother of a child I was seeing in the office said, “Dr. Wilkoff, you know as an influential member of this community, particularly its children, you should be wearing a helmet.” My wife had been badgering me for years but this woman’s courage to speak up embarrassed me into changing my ways.

For some, maybe many, people, wearing a mask during the COVID-19 pandemic is a nuisance and an assault on their independence just as I viewed a bicycle helmet. Initially there was some information being circulated that any mask less robust than a N-95 had very little if any effect, either as protection or as way to decrease spread. I certainly had my doubts about the value of mask other than as a statement of solidarity. However, we are now learning that masks can serve an important role along with social distancing in a comprehensive community effort to minimize contagion.

In light of this new information, why are there are still people who won’t wear a mask? It may be that they are receiving their news filtered through a lens that discredits science. But, it is more likely the result of the same mindset that permeates the anti-vaccine faction that the common good is less important than personal freedom to follow their beliefs.

Do we have any tools at our disposal to increase the number of folks wearing masks? Based on our experience with attempts to convince those who are anti-vaccine, education will be ineffective in shifting the focus from personal freedom to a commitment to the welfare of the community at large. Shaming might be effective, but it runs the risk of igniting conflicts and further widening the gaps in our society. Some establishments have been effective in simply saying “no mask, no entry,” but this runs the same risk of creating friction depending on the community and the situation.

The ship may have already sailed on our best opportunity to achieve community compliance when the leaders of our national government have chosen to ignore their obligation to set an example by refusing to wear masks. I fear that the wedge has already been set and the widening of the gap between those who see their responsibility to the community at large and those who do not will continue to grow.

I am fortunate to live in a town whose residents look out for each other and have relied on local leaders to set an example in the absence of leadership on a national level.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Starting breast cancer screening in young adulthood has the potential to sharply reduce deaths from the disease among women who have received chest radiation for childhood cancer, a modeling study suggests.

Two strategies – annual mammography with MRI and annual MRI alone – at least halved breast cancer mortality when started at the ages of 25 or 30 years.

Jennifer M. Yeh, PhD, of Harvard Medical School in Boston and colleagues reported these results in the Annals of Internal Medicine.

When cost was also considered, 30 years emerged as the preferred starting age, dropping the incremental cost-effectiveness ratio (ICER) below the generally accepted threshold of $100,000 per quality-adjusted life-year gained.

“Our findings underscore the importance of making sure that young women previously treated with chest radiation are informed about their elevated breast cancer risk and the benefits of routine screening. Both primary care providers and oncologists who care for survivors should discuss breast cancer screening with these patients,” Dr. Yeh and colleagues wrote.

“Screening guidelines should emphasize the importance of MRI screening (with or without mammography) among survivors,” the authors recommended. “Our findings also highlight the importance of ensuring that survivors have access to health insurance coverage for MRI screening.”
 

Implications for awareness, coverage

“My hope is that, by showing the significantly decreased risk of death associated with early breast cancer screening, with harm-benefit ratios considerably lower than benchmarks for average-risk women, this study will help health insurance companies see the benefit in covering early screening for at-risk survivors,” commented Karen E. Effinger, MD, of Emory University, Atlanta, and the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta.

“In many survivors, the cost of current screening [as recommended by] guidelines is prohibitive,” added Dr. Effinger, who was not involved in the current study.

The main concern regarding the study’s findings is generalizability to the contemporary era, given the use of a cohort diagnosed and treated decades ago and changes in radiation techniques and dosing since then, she noted in an interview. This limitation was addressed in a sensitivity analysis that halved the women’s base-case lifetime risk of breast cancer and still netted similar results.

“However, it will take many years to determine the true risk reduction of our current treatment strategies,” Dr. Effinger acknowledged.

“It is crucial that we improve our education of both survivors and our colleagues who care for these survivors, especially in regard to risk of subsequent malignancies and the benefits of screening,” Dr. Effinger maintained. “While many people are aware of the risk of breast cancer associated with BRCA mutations, the increased risk in survivors of childhood cancer is not as recognized by nononcologists. This study reinforces that increasing this awareness can save lives.”

In educating their patients about preventive care, health care providers must strike “a fine balance between discussing the risks and benefits of screening without provoking significant anxiety,” she concluded. “It is important for survivors to establish care with a primary care provider in order to develop trust and receive the guidance they need to decrease the risk of early mortality.”
 

Study details

Dr. Yeh and colleagues developed models to compare outcomes with various screening strategies among women aged 20 years who had received chest radiotherapy for childhood cancer during 1970-1986. The women had been diagnosed with Hodgkin lymphoma (55%), Wilms tumor (12%), non-Hodgkin lymphoma (8%), and other cancers.

The investigators conducted their analysis using data from the Childhood Cancer Survivor Study and other published sources, a lifetime time horizon, and a payer perspective.

The team assessed three strategies: no screening; digital mammography with MRI screening starting at 25 years of age (the current Children’s Oncology Group recommendation), 30 years, or 35 years and continuing to 74 years of age; and MRI only starting at age 25, 30, or 35 years and continuing to age 74 years.

The main study results showed that, without screening, women who had received chest radiation for childhood cancer had a 10%-11% lifetime risk of breast cancer mortality across models.

Relative to no screening, starting at age 25 years, the largest share of deaths was averted with the strategy of annual mammography with MRI – 56.3%-71.2% – or with the strategy of annual MRI alone – 55.7%-62.0%.

These two strategies also yielded the most screening tests, as well as the most false-positive test results and benign biopsy results.

For women who started screening at age 25, there were 4,188-4,879 false-positive test results per 1,000 women for mammography plus MRI and 3,283-3,764 false-positive results per 1,000 women for MRI alone.

For women who started screening at age 25, there were 1,340-1,561 benign biopsy results per 1,000 women for mammography plus MRI and 1,248-1,430 benign results per 1,000 women for MRI alone.

After cost was factored in, beginning screening at age 30 emerged as the preferred strategy to achieve an ICER threshold of less than $100,000 per quality-adjusted life-year gained.

When started at 30 years of age, annual mammography with MRI averted 54.7%-68.8% of breast cancer deaths, with an ICER of $25,400-$113,200 per quality-adjusted life-year gained. Annual MRI alone averted 54.0%-60.0% of breast cancer deaths, with an ICER of $21,800-$50,580 per quality-adjusted life-year gained.

This research was supported by grants from the National Cancer Institute, American Cancer Society, and American Lebanese Syrian Associated Charities. The authors disclosed relationships with GE Healthcare and Biovector. Dr. Effinger disclosed no relevant conflicts of interest.

SOURCE: Yeh JM et al. Ann Intern Med. 2020 Jul 7. doi: 10.7326/M19-3481.

Starting breast cancer screening in young adulthood has the potential to sharply reduce deaths from the disease among women who have received chest radiation for childhood cancer, a modeling study suggests.

Two strategies – annual mammography with MRI and annual MRI alone – at least halved breast cancer mortality when started at the ages of 25 or 30 years.

Jennifer M. Yeh, PhD, of Harvard Medical School in Boston and colleagues reported these results in the Annals of Internal Medicine.

When cost was also considered, 30 years emerged as the preferred starting age, dropping the incremental cost-effectiveness ratio (ICER) below the generally accepted threshold of $100,000 per quality-adjusted life-year gained.

“Our findings underscore the importance of making sure that young women previously treated with chest radiation are informed about their elevated breast cancer risk and the benefits of routine screening. Both primary care providers and oncologists who care for survivors should discuss breast cancer screening with these patients,” Dr. Yeh and colleagues wrote.

“Screening guidelines should emphasize the importance of MRI screening (with or without mammography) among survivors,” the authors recommended. “Our findings also highlight the importance of ensuring that survivors have access to health insurance coverage for MRI screening.”
 

Implications for awareness, coverage

“My hope is that, by showing the significantly decreased risk of death associated with early breast cancer screening, with harm-benefit ratios considerably lower than benchmarks for average-risk women, this study will help health insurance companies see the benefit in covering early screening for at-risk survivors,” commented Karen E. Effinger, MD, of Emory University, Atlanta, and the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta.

“In many survivors, the cost of current screening [as recommended by] guidelines is prohibitive,” added Dr. Effinger, who was not involved in the current study.

The main concern regarding the study’s findings is generalizability to the contemporary era, given the use of a cohort diagnosed and treated decades ago and changes in radiation techniques and dosing since then, she noted in an interview. This limitation was addressed in a sensitivity analysis that halved the women’s base-case lifetime risk of breast cancer and still netted similar results.

“However, it will take many years to determine the true risk reduction of our current treatment strategies,” Dr. Effinger acknowledged.

“It is crucial that we improve our education of both survivors and our colleagues who care for these survivors, especially in regard to risk of subsequent malignancies and the benefits of screening,” Dr. Effinger maintained. “While many people are aware of the risk of breast cancer associated with BRCA mutations, the increased risk in survivors of childhood cancer is not as recognized by nononcologists. This study reinforces that increasing this awareness can save lives.”

In educating their patients about preventive care, health care providers must strike “a fine balance between discussing the risks and benefits of screening without provoking significant anxiety,” she concluded. “It is important for survivors to establish care with a primary care provider in order to develop trust and receive the guidance they need to decrease the risk of early mortality.”
 

Study details

Dr. Yeh and colleagues developed models to compare outcomes with various screening strategies among women aged 20 years who had received chest radiotherapy for childhood cancer during 1970-1986. The women had been diagnosed with Hodgkin lymphoma (55%), Wilms tumor (12%), non-Hodgkin lymphoma (8%), and other cancers.

The investigators conducted their analysis using data from the Childhood Cancer Survivor Study and other published sources, a lifetime time horizon, and a payer perspective.

The team assessed three strategies: no screening; digital mammography with MRI screening starting at 25 years of age (the current Children’s Oncology Group recommendation), 30 years, or 35 years and continuing to 74 years of age; and MRI only starting at age 25, 30, or 35 years and continuing to age 74 years.

The main study results showed that, without screening, women who had received chest radiation for childhood cancer had a 10%-11% lifetime risk of breast cancer mortality across models.

Relative to no screening, starting at age 25 years, the largest share of deaths was averted with the strategy of annual mammography with MRI – 56.3%-71.2% – or with the strategy of annual MRI alone – 55.7%-62.0%.

These two strategies also yielded the most screening tests, as well as the most false-positive test results and benign biopsy results.

For women who started screening at age 25, there were 4,188-4,879 false-positive test results per 1,000 women for mammography plus MRI and 3,283-3,764 false-positive results per 1,000 women for MRI alone.

For women who started screening at age 25, there were 1,340-1,561 benign biopsy results per 1,000 women for mammography plus MRI and 1,248-1,430 benign results per 1,000 women for MRI alone.

After cost was factored in, beginning screening at age 30 emerged as the preferred strategy to achieve an ICER threshold of less than $100,000 per quality-adjusted life-year gained.

When started at 30 years of age, annual mammography with MRI averted 54.7%-68.8% of breast cancer deaths, with an ICER of $25,400-$113,200 per quality-adjusted life-year gained. Annual MRI alone averted 54.0%-60.0% of breast cancer deaths, with an ICER of $21,800-$50,580 per quality-adjusted life-year gained.

This research was supported by grants from the National Cancer Institute, American Cancer Society, and American Lebanese Syrian Associated Charities. The authors disclosed relationships with GE Healthcare and Biovector. Dr. Effinger disclosed no relevant conflicts of interest.

SOURCE: Yeh JM et al. Ann Intern Med. 2020 Jul 7. doi: 10.7326/M19-3481.

Starting breast cancer screening in young adulthood has the potential to sharply reduce deaths from the disease among women who have received chest radiation for childhood cancer, a modeling study suggests.

Two strategies – annual mammography with MRI and annual MRI alone – at least halved breast cancer mortality when started at the ages of 25 or 30 years.

Jennifer M. Yeh, PhD, of Harvard Medical School in Boston and colleagues reported these results in the Annals of Internal Medicine.

When cost was also considered, 30 years emerged as the preferred starting age, dropping the incremental cost-effectiveness ratio (ICER) below the generally accepted threshold of $100,000 per quality-adjusted life-year gained.

“Our findings underscore the importance of making sure that young women previously treated with chest radiation are informed about their elevated breast cancer risk and the benefits of routine screening. Both primary care providers and oncologists who care for survivors should discuss breast cancer screening with these patients,” Dr. Yeh and colleagues wrote.

“Screening guidelines should emphasize the importance of MRI screening (with or without mammography) among survivors,” the authors recommended. “Our findings also highlight the importance of ensuring that survivors have access to health insurance coverage for MRI screening.”
 

Implications for awareness, coverage

“My hope is that, by showing the significantly decreased risk of death associated with early breast cancer screening, with harm-benefit ratios considerably lower than benchmarks for average-risk women, this study will help health insurance companies see the benefit in covering early screening for at-risk survivors,” commented Karen E. Effinger, MD, of Emory University, Atlanta, and the Aflac Cancer & Blood Disorders Center at Children’s Healthcare of Atlanta.

“In many survivors, the cost of current screening [as recommended by] guidelines is prohibitive,” added Dr. Effinger, who was not involved in the current study.

The main concern regarding the study’s findings is generalizability to the contemporary era, given the use of a cohort diagnosed and treated decades ago and changes in radiation techniques and dosing since then, she noted in an interview. This limitation was addressed in a sensitivity analysis that halved the women’s base-case lifetime risk of breast cancer and still netted similar results.

“However, it will take many years to determine the true risk reduction of our current treatment strategies,” Dr. Effinger acknowledged.

“It is crucial that we improve our education of both survivors and our colleagues who care for these survivors, especially in regard to risk of subsequent malignancies and the benefits of screening,” Dr. Effinger maintained. “While many people are aware of the risk of breast cancer associated with BRCA mutations, the increased risk in survivors of childhood cancer is not as recognized by nononcologists. This study reinforces that increasing this awareness can save lives.”

In educating their patients about preventive care, health care providers must strike “a fine balance between discussing the risks and benefits of screening without provoking significant anxiety,” she concluded. “It is important for survivors to establish care with a primary care provider in order to develop trust and receive the guidance they need to decrease the risk of early mortality.”
 

Study details

Dr. Yeh and colleagues developed models to compare outcomes with various screening strategies among women aged 20 years who had received chest radiotherapy for childhood cancer during 1970-1986. The women had been diagnosed with Hodgkin lymphoma (55%), Wilms tumor (12%), non-Hodgkin lymphoma (8%), and other cancers.

The investigators conducted their analysis using data from the Childhood Cancer Survivor Study and other published sources, a lifetime time horizon, and a payer perspective.

The team assessed three strategies: no screening; digital mammography with MRI screening starting at 25 years of age (the current Children’s Oncology Group recommendation), 30 years, or 35 years and continuing to 74 years of age; and MRI only starting at age 25, 30, or 35 years and continuing to age 74 years.

The main study results showed that, without screening, women who had received chest radiation for childhood cancer had a 10%-11% lifetime risk of breast cancer mortality across models.

Relative to no screening, starting at age 25 years, the largest share of deaths was averted with the strategy of annual mammography with MRI – 56.3%-71.2% – or with the strategy of annual MRI alone – 55.7%-62.0%.

These two strategies also yielded the most screening tests, as well as the most false-positive test results and benign biopsy results.

For women who started screening at age 25, there were 4,188-4,879 false-positive test results per 1,000 women for mammography plus MRI and 3,283-3,764 false-positive results per 1,000 women for MRI alone.

For women who started screening at age 25, there were 1,340-1,561 benign biopsy results per 1,000 women for mammography plus MRI and 1,248-1,430 benign results per 1,000 women for MRI alone.

After cost was factored in, beginning screening at age 30 emerged as the preferred strategy to achieve an ICER threshold of less than $100,000 per quality-adjusted life-year gained.

When started at 30 years of age, annual mammography with MRI averted 54.7%-68.8% of breast cancer deaths, with an ICER of $25,400-$113,200 per quality-adjusted life-year gained. Annual MRI alone averted 54.0%-60.0% of breast cancer deaths, with an ICER of $21,800-$50,580 per quality-adjusted life-year gained.

This research was supported by grants from the National Cancer Institute, American Cancer Society, and American Lebanese Syrian Associated Charities. The authors disclosed relationships with GE Healthcare and Biovector. Dr. Effinger disclosed no relevant conflicts of interest.

SOURCE: Yeh JM et al. Ann Intern Med. 2020 Jul 7. doi: 10.7326/M19-3481.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone do not significantly improve pain control after vaginal apical prolapse repair, compared with placebo, according to a study.

In a randomized trial, patients generally reported mild postoperative pain and low dosages of narcotic use. “The majority reported that they returned to their baseline activity by 2 weeks after surgery, which should be reassuring to similar urogynecology patient populations,” said Lauren Giugale, MD.

Although many gynecologic surgeries increasingly are performed as outpatient procedures, patients may have inadequate pain control and persistently use narcotics after surgery. In an effort to reduce postoperative pain, doctors have tried preemptive analgesia with various local anesthetic techniques. These approaches have had mixed results, however, and there is “no consensus on the ideal local anesthetic technique to reduce postoperative pain after vaginal reconstructive surgery,” said Dr. Giugale, of the University of Pittsburgh.

To evaluate whether preoperative pelvic floor muscle injections and pudendal nerve blocks with bupivacaine and dexamethasone improve postoperative pain control after vaginal apical prolapse repairs, Dr. Giugale and colleagues conducted a three-arm, double-blind trial that included 75 patients. Patients received placebo (normal saline), bupivacaine alone, or bupivacaine combined with 4 mg of dexamethasone at four injection sites.

Dr. Giugale presented the study results at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

A range of procedures

Participants received bilateral levator ani muscle injections via a transobturator approach and pudendal nerve blocks via a transvaginal approach. They received the injections – 5 mL at each site – after the administration of general anesthesia but before the start of surgery. “Anecdotally, we have had good success” with the transobturator approach to treating chronic pelvic pain, which was part of the rationale for the trial, said Dr. Giugale.

The study included women 18 years or older who were scheduled for a vaginal native tissue repair with apical support. Participants had to be able to tolerate general anesthesia with a standardized enhanced recovery after surgery (ERAS) protocol. The investigators excluded women undergoing mesh-augmented prolapse repairs or abdominal surgery and those with chronic pelvic pain or immunosuppression.

Each treatment arm had 25 patients. Patients had an average age of 69 years and an average body mass index of 27.5 kg/m². Most patients were white, and demographic variables did not significantly differ among the groups.

“The distribution of prolapse procedures was similar among study groups, with colpocleisis being the most common, followed by uterosacral ligament suspension, levator myorrhaphy, and sacrospinous ligament fixation,” said Dr. Giugale. Rates of concomitant hysterectomy were similar for each group.

Before surgery, patients completed pain, nausea, and activities assessments. At 6 hours after surgery, they completed pain and nausea assessments. During postoperative days 1 through 3, patients documented pain scores and analgesic use. One week after surgery, patients completed pain and activities assessments. And at postoperative weeks 2, 6, and 12, they completed additional activities assessments. The assessments included validated handouts that patients completed at home, and no additional office visits were required.

The numeric rating scale pain score on the day after surgery was the primary outcome, and the median pain score did not significantly differ among the groups (3.75 in the placebo group, 4 in the bupivacaine group, and 3 in the bupivacaine plus dexamethasone group). Between-group differences in pain scores at other time points also were not significant.

Activities assessments, nausea and vomiting scores, the percentage of patients with same-day discharge, urinary retention, postoperative narcotic use as measured by oral morphine equivalents, and adverse events also did not significantly differ among the groups.

“One week after surgery, 52% of women reported that they were at or better than their baseline preoperative activity level, which increased to 70% at 2 weeks, 84% at 6 weeks, and 94% at 12 weeks,” Dr. Giugale said.

In all, 57% of patients used narcotic medicine the day after surgery, which decreased to 44% on day 3. The dosage was low, with a median oral morphine equivalent of 5 mg of oxycodone or less per day, she said.

Early postoperative pain may be influenced by procedure type, according to an exploratory analysis. Through the first postoperative day, “there was a trend toward more pain with uterosacral ligament suspension,” Dr. Giugale said. By day 3, sacrospinous ligament fixation was associated with significantly more postoperative pain.
 

The role of ERAS protocols

The heterogeneity of surgical procedures among the treatment groups and the use of a predefined ERAS protocol may have confounded the results. In addition, the researchers did not measure patient satisfaction, and the findings may not apply to different patient populations, Dr. Giugale noted.

“As more and more gynecologic surgery patients have surgery under these enhanced recovery protocols, maybe additional preemptive local analgesia for vaginal reconstructive surgery is not all that beneficial,” she said. “Maybe we are getting enough benefit from the enhanced [recovery] protocols themselves.”

The investigators studied a novel idea – dual local therapy for pain in patients undergoing pelvic floor surgery – and described a novel transobturator technique for levator injection, commented Sunil Balgobin, MD, associate director of the female pelvic medicine and reconstructive surgery fellowship at University of Texas Southwestern Medical Center, Dallas.

“For the current opioid problem, development of alternative pain control strategies is extremely important to reduce narcotic use and improve patient outcomes,” Dr. Balgobin said. The study “addresses an important gap in the literature, is relevant to surgeons performing vaginal apical procedures, and aims to advance research in this area for the potential benefit of ... patients.”

Interpretation of the results for individual procedure types may be limited by the smaller sample sizes, he added.

The researchers and Dr. Balgobin had no relevant financial disclosures.

jremaly@mdedge.com

SOURCE: Giugale L et al. SGS 2020, Abstract 10.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

Laser treatment for lichen sclerosus was noninferior to steroid therapy after 6 months and may lead to better outcomes on various patient- and physician-reported measures, according to trial results presented at the virtual annual scientific meeting of the Society of Gynecologic Surgeons.

Patients with lichen sclerosus often present with itching, burning, and dysuria. Untreated, the vulvar dystrophy can cause architectural changes and is associated with an increased risk of vulvar malignancies.

Topical steroids are the standard treatment. To assess whether fractional CO₂ laser treatment is noninferior to clobetasol propionate at 6 months, Linda Burkett, MD, and colleagues conducted a randomized controlled trial. Dr. Burkett is affiliated with MedStar Washington Hospital Center and Georgetown University in Washington and UPMC Magee-Womens Hospital in Pittsburgh.

The researchers enrolled 52 postmenopausal women with biopsy-proven lichen sclerosus. Patients had to have significant symptoms reflected by a score of at least 21 on the Skindex-29.

Twenty-seven women were assigned to receive laser therapy, and 25 were assigned to receive steroids. One patient in the steroid arm was lost to follow-up. About half of the patients in each group had prior clobetasol propionate exposure.

Patients in the steroid arm were started on 0.05% clobetasol propionate used nightly for 4 weeks, then three times per week for 8 weeks, and then as needed. They had a phone call follow-up at 2 weeks to confirm compliance and an optional in-person appointment at 3 months.

Patients in the laser arm received three laser treatments 4-6 weeks apart.

At 6 months, all patients returned for repeat assessments. The primary outcome was the Skindex-29, a dermatologic questionnaire. Secondary outcomes included a patient visual analog scale of bothersome vulvar symptoms, a provider visual assessment score, the Vaginal Health Index, the Vulvovaginal Symptom Questionnaire, the Patient Global Impression of Improvement, and the Patient Global Impression of Satisfaction.

Average Skindex-29 scores from baseline to 6 months improved more in the laser treatment group, compared with the steroid group, for all health-related quality of life categories: overall, emotional, functional, and symptoms. “At 6 months across all scores, patients reported very little bother,” Dr. Burkett said.

Differences between the groups were statistically significant for all but the functional subscore.

Average scores on subjective secondary outcomes improved more in the laser treatment group, compared with the steroid treatment group. The between-group differences were statistically significant for irritation and the Vulvovaginal Symptom Questionnaire.

For provider-based scores, patients in the laser group had greater improvement on all measures except perianal involvement, relative to patients in the steroid group. In addition, fusion of the labia minora and phimosis worsened in the steroid group.

Differences between the groups were statistically significant for phimosis, erosion, and the Vaginal Health Index.

Significantly more patients in the laser group than in the steroid group were satisfied or very satisfied with the results at 6 months (81% vs. 41%). Patients in the laser group were more likely to report that they were better or much better (89% vs. 62%), though the difference was not statistically significant.

There were no major adverse events.

The trial – the first randomized controlled study of energy-based treatment for lichen sclerosus – was conducted at a single center, and treatment was not blinded, Dr. Burkett noted.

“The treatment effect was pretty significant in favor of laser therapy,” said Cecile A. Ferrando, MD, MPH, of the Center for Urogynecology and Pelvic Reconstructive Surgery at Cleveland Clinic, commenting on the research.

“Compliance issues with clobetasol aside,” the findings raise the question of whether laser therapy should be offered as first-line treatment, Dr. Ferrando said.

The study might have been more robust had it excluded patients with previous clobetasol propionate exposure, Dr. Ferrando added.

Dr. Burkett noted that future studies may incorporate multiple centers, histology measures, and sham laser treatments and include only women who have not previously received clobetasol propionate.

The researchers had no relevant financial disclosures. Dr. Ferrando disclosed authorship royalties from UpToDate.

jremaly@mdedge.com

SOURCE: Burkett L et al. SGS 2020, Abstract 09.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

A phase 1/2 trial of a vaccine against SARS-CoV-2 being developed by the University of Oxford has found that the vaccine is safe, causes few side effects, and induces strong immune responses.

The early stage results, published in The Lancet, found that the candidate vaccine, known as ChAdOx1 nCoV-19, provoked a T-cell response peaking 14 days after vaccination, and an antibody response within 28 days.

Andrew Pollard, chief investigator on the study, and professor of pediatric infection and immunity at Oxford University, described the results as “encouraging”. He told a briefing convened by the Science Media Centre on Monday that it was “a really important milestone on the path to the development of the vaccine”.

In the Commons, the Health Secretary, Matt Hancock, hailed the results for taking us “one step closer to finding a vaccine that can potentially save lives, all around the world”.

The trial, which has so far involved 1,077 healthy adults, caused minor side effects when compared with a control group given a meningitis vaccine. Fatigue and headache were the most commonly reported reactions.

However, there were no serious adverse events from the vaccine, the researchers said.
 

‘Still a long way to go’

Sarah Gilbert, lead researcher of the vaccine development program, and professor of vaccinology at Oxford, cautioned that there was still a long way to go before the team could confirm that the vaccine could protect against developing COVID-19.

“The difficulty that we have, and that all vaccine developers have in trying to make a vaccine against this particular virus, is that we don’t know how strong that immune response needs to be,” she said.

“So, we can’t say just by looking at immune responses whether this is going to protect people or not. And the only way we’re going to find out is by doing the large phase 3 trials and wait for people to be infected as part of that trial before we know if the vaccine can work.”

The authors noted some limitations to their findings. They said more research was needed to confirm their results in different groups of people – including older age groups, those with other health conditions, and in ethnically and geographically diverse populations.

A notable result of the trial was that participants given a second dose of the vaccine appeared to display a stronger immune response, a finding that had influenced plans to “look at two dose regimes as well as one dose regimes in the phase 3 trial”, Prof Adrian Hill, director of Oxford’s Jenner Institute, confirmed.

ChAdOx1 nCoV-19 is made from a weakened version of an adenovirus that causes infections in chimpanzees. The virus has been genetically modified so that it cannot grow in humans.

On Monday, the government announced that it had struck a deal with AstraZeneca for access to 100 million doses of the Oxford vaccine, in addition to millions of doses of other promising candidate vaccines.
 

Expert reaction to the findings

The Medical Research Council helped to fund the trial. Executive Chair Professor Fiona Watt commented: “It is truly remarkable how fast this vaccine has progressed, with our support, through early clinical trials, and it is very encouraging that it shows no safety concerns and evokes strong immune responses.

“There is a lot that we don’t yet know about immunity to the virus that causes COVID-19. However, it seems that both antibody and T cell immunity are important, and this vaccine triggers both responses. The much anticipated next milestone will be the results of the larger trials that are happening now to find out if the vaccine will protect people from the virus.”

Jonathan Ball, professor of molecular virology at the University of Nottingham, told the SMC: “The results of the Oxford chimp adenovirus vaccine candidate show that the vaccine is able to generate antibodies and T cells in humans and these persisted for several weeks. Whilst encouraging there is still a long way to go before we can herald the arrival of a successful coronavirus vaccine.

“It is unclear whether the levels of immunity can protect against infection – that’s what the larger ongoing phase III trials are designed to test. Nor do we know if this vaccine can protect those most vulnerable to severe COVID-19 disease.”

Stephen Evans, professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, commented: “For the vaccine to be really useful, we not only need the larger studies conducted where COVID-19 is still occurring at a high rate, but we need to be reasonably sure that the protection lasts for a considerable time.”

He said it was also vital that people older than 55 were included in later trials.

Richard Torbett, chief executive of the Association of the British Pharmaceutical Industry, said: “Developing a vaccine is an incredibly difficult challenge; the fact that there are multiple candidates in development is hopefully a sign that the hard work will ultimately pay off.

“But we must be patient. Proving that a vaccine is safe and effective is a long process and we could still be many months away.”

This article first appeared on Medscape.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

Every person who received Moderna’s COVID-19 vaccine, mRNA-1273, developed an immune response to the virus that causes it, the company says in a news release.

Researchers also reported some side effects in the 45 people in the phase I study, but no significant safety issues, the news release says.

The vaccine is among hundreds being tested worldwide in an effort to halt the pandemic that has killed nearly 600,000 worldwide.

A researcher testing the vaccine called the results encouraging but cautioned more study is needed. “Importantly, the vaccine resulted in a robust immune response,” Evan Anderson, MD, principal investigator for the trial at Emory University, says in a news release. Emory and Kaiser Permanente Washington Health Research Institute were the two sites for the study.

The company is already testing the vaccine in a larger group of people, known as a phase II trial. It plans to begin phase III trials in late July. Phase III trials involve testing the vaccine on an even larger group and are the final step before FDA approval.

The study results are published in The New England Journal of Medicine. The study was led by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health.

Moderna’s vaccine uses messenger RNA, also called mRNA. It carries the instruction for making the spike protein, a key protein on the surface of the virus that allows it to enter cells when a person is infected. After it’s injected, it goes to the immune cells and instructs them to make copies of the spike protein, acting as if the cells have been infected with the actual coronavirus. This allows other immune cells to develop immunity.

In the study, participants were divided into three groups of 15 people each. All groups received two vaccinations 28 days apart. Each group received a different strength of the vaccine – either 25, 100, or 250 micrograms.

Every person in the study developed antibodies that can block the infection. Most commonly reported side effects after the second vaccination in the 100-microgram group were fatigue, chills, headache, and muscle pains, ranging from mild to moderately severe.

The phase II study has 300 heathy adults ages 18-55, along with another 300 ages 55 and older

Moderna says it hopes to include about 30,000 participants at the 100-microgram dose level in the U.S. for the phase III trial. The estimated start date is July 27.

This article first appeared on WebMD.com.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

People with a body mass index of 30 kg/m² or above are at significantly increased risk for severe COVID-19, while a BMI of 35 and higher dramatically increases the risk for death, new research suggests.

The data, from nearly 500 patients hospitalized with COVID-19 in March and April 2020, were published in the European Journal of Endocrinology by Matteo Rottoli, MD, of the Alma Mater Studiorum, University of Bologna (Italy), and colleagues.

The data support the recent change by the Centers for Disease Control and Prevention to lower the cutoff for categorizing a person at increased risk from COVID-19 from a BMI of 40 down to 30. However, in the United Kingdom, the National Health Service still lists only a BMI of 40 or above as placing a person at “moderate risk (clinically vulnerable).”

“This finding calls for prevention and treatment strategies to reduce the risk of infection and hospitalization in patients with relevant degrees of obesity, supporting a revision of the BMI cutoff of 40 kg/m², which was proposed as an independent risk factor for an adverse outcome of COVID-19 in the ... guidelines for social distancing in the United Kingdom: It may be appropriate to include patients with BMI >30 among those at higher risk for COVID-19 severe progression,” the authors wrote.

The study included 482 adults admitted with confirmed COVID-19 to a single Italian hospital between March 1 and April 20, 2020. Of those, 41.9% had a BMI of less than 25 (normal weight), 36.5% had a BMI of 25-29.9 (overweight), and 21.6% had BMI of at least 30 (obese). Of the obese group, 20 (4.1%) had BMIs of at least 35, while 18 patients (3.7%) had BMIs of less than 20 (underweight).

Among those with obesity, 51.9% experienced respiratory failure, 36.4% were admitted to the ICU, 25% required mechanical ventilation, and 29.8% died within 30 days of symptom onset.

Patients with BMIs of at least 30 had significantly increased risks for respiratory failure (odds ratio, 2.48; P = .001), ICU admission (OR, 5.28; P < .001), and death (2.35, P = .017), compared with those with lower BMIs. Within the group classified as obese, the risks of respiratory failure and ICU admission were higher, with BMIs of 30-34.9 (OR, 2.32; P = .004 and OR, 4.96; P < .001, respectively) and for BMIs of at least 35 (OR, 3.24; P = .019 and OR, 6.58; P < .001, respectively).

The risk of death was significantly higher among patients with a BMI of at least 35 (OR, 12.1; P < .001).

Every 1-unit increase in BMI was significantly associated with all outcomes, but there was no significant difference in any outcome between the 25-29.9 BMI category and normal weight. In all models, the BMI cutoff for increased risk was 30.

The authors reported no disclosures.

SOURCE: Rottoli M et al. Eur J Endocrinol. 2020 Jul 1. doi: 10.1530/EJE-20-054.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.

The coronavirus pandemic has only highlighted the risks of childhood adversity. The burden of infection and mortality has been borne disproportionately by people of color and those with multiple chronic medical conditions (obesity, cardiovascular disease, diabetes, etc.). While viruses do not discriminate, they are more likely to infect those with higher risk of exposure and to kill those who are physiologically vulnerable.

And the pandemic increases the risk for adversity for today’s children and families. When children cannot attend school, financially vulnerable parents may have to choose between supervising them or feeding them. Families who suddenly are all in a small apartment together without school or other outside supports may be at higher risk for domestic violence and child abuse. Unemployment and financial uncertainty will increase the rates of substance abuse and depression amongst parents. And the serious illness or death of a parent will be a more common event for children in the year ahead. One of these risk factors may increase the likelihood of others.

Beyond the obvious need for substantial policy changes focused on housing, education, and health care, there are immediate and concrete strategies that can build resilience in children and their families. And resilience can build on itself, as children face subsequent challenges with the support of caring connected adults.

The critical first step is asking. Then listen calmly and supportively, normalizing for parents and children how common these experiences are. Explain how they affect health and well-being. Explain that adversity and its consequences are not their fault. Then educate them about what is in their control: the skills they can practice to buffer against the consequences of adversity and build resilience. They sound simple, but still require effort and work. And the pandemic has created some difficulty (social distancing) and opportunity (more family time, fewer school demands).
 

Sleep

Help parents establish and protect consistent, restful sleep for their children. They can set a consistent bedtime and a calm routine, with screens all off at least 30 minutes before sleep and reading before sleep. Restful sleep is physiologically and psychologically protective to everyone in a family.

Movement

Beyond directly improving physical health, establishing habits of exercise – especially outside – every day can effectively manage ongoing stress, build skills of self-regulation, and help with sleep.

Find out what parents and their children like to do together (walking the dog, shooting hoops, even dancing) and help them devise ways to create family routines around exercise.
 

Nutrition

Food should be a source of pleasure, but stress can make food into a source of comfort or escape. Help parents to create realistic ways to consistently offer healthy family meals and discourage unhealthy habits.

Even small changes like water instead of soda can help, and there are nutritional and emotional benefits to eating a healthy breakfast or dinner together as a family.
 

Connections

Nourishing social connections are protective. Help parents think about protecting time to spend with their children for talking, playing games, or even singing.

They should support their children’s connections to other caring adults, through community organizations (church, community centers, or sports), and they should know who their children’s reliable friends are. Parents will benefit from these supports for themselves, which in turn will benefit the full family.
 

Self-awareness

Activities that cultivate mindfulness are protective. Parents can simply ask how their children are feeling, physically or emotionally, and be able to bear it when it is uncomfortable. Work towards nonjudgmental awareness of how they are feeling. Learning what is relaxing or recharging for them (exercise, music, a hot bath, a good book, time with a friend) will protect against defaulting into maladaptive coping such as escape, numbing, or avoidance.

Of course, if you learn about symptoms that suggest PTSD, depression, or addiction, you should help your patient connect with effective treatment. The difficulty of referring to a mental health provider does not mean you should not try and bring as many people onto the team and into the orbit of the child and family at risk. It may be easier to access some therapy given the new availability of telemedicine visits across many more systems of care. Although the heaviest burdens of adversity are not being borne equally, the fact that adversity is currently a shared experience makes this a moment of promise.

Dr. Swick is physician in chief at Ohana, Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Dr. Swick and Dr. Jellinek had no relevant financial disclosures. Email them at pdnews@mdedge.com.

References
1. Am J Prev Med. 1998 May;14(4):245-58.
2. Ann Allergy Asthma Immunol. 2015;114: 379-84.
3. BMC Public Health. 2018. doi: 10.1186/s12889-018-5699-8.
4. Child Abuse Negl. 2011 Jun;35(6):408-13.
5. Community Dent Oral Epidemiol. 2015;43:193-9.
6. Community Dent Oral Epidemiol. 2018 Oct;46(5): 442-8.
7. Pediatrics 2016 Apr. doi: 10.1542/peds.2015-4016.
8. Matern Child Health J. 2016 Apr. doi: 10.1007/s10995-015-1915-7.
9. Acad Pediatr. 2017 May-Jun. doi: 10.1016/j.acap.2016.08.013.
10. Pediatrics. 2010 Apr. doi: 10.1542/peds.2009-0597.
 

This article was updated 7/27/2020.

We live in historic times. A worldwide pandemic is surging in the United States, with millions infected and the world’s highest death rate. Many of our hospitals are overwhelmed. Schools have been closed for months. Businesses are struggling, and unemployment is at record levels. The murder of George Floyd unleashed an outpouring of grief and rage over police brutality and structural racism.

Thinkstock

The value of knowing about these risk factors would seem self-evident; it would inform a patient’s health care from screening for cancer or heart disease, referral for mild depressive symptoms, and counseling about alcohol consumption. But this research did not lead to the establishment of routine screening for childhood adversity in primary care practices. There are multiple reasons for this, including growing pressure on physician time and discomfort with starting conversations about potentially traumatic material. But perhaps the greatest obstacle has been uncertainty about what to offer patients who screened in. What is the treatment for a high ACE score?

Even without treatments, we have learned much about childhood adversity since Dr. Anda and Dr. Felitti published their landmark study. Other more chronic adverse childhood experiences also contribute to adult health risk, such as poverty, homelessness, discrimination, community violence, parental chronic illness, or disability or placement in foster care. Having a high ACE score does not only affect health in adulthood. Children with an ACE score of 4 are 2 times as likely to have asthma^2,3 and allergies³, 2 times as likely to be obese⁴, 3 times as likely to have headaches³ and dental problems^5,6, 4 times as likely to have depression^7,8, 5 times as likely to have ADHD^8,9, 7 times as likely to have high rates of school absenteeism³ and aggression¹⁰, and over 30 times as likely to have learning or behavioral problems at school⁴. There is a growing body of knowledge about how chronic, severe stress in childhood affects can lead to pathological alterations in neuroendocrine and immune function. But this has not led to any concrete treatments that may be preventive or reparative.

Movement toward expanding screening nonetheless has accelerated. In California, Nadine Burke-Harris, MD, a pediatrician who studied ACEs and children’s health was named the state’s first Surgeon General in 2019 and spearheaded an effort to make screening for ACEs easier. Starting in 2020, MediCal will pay for annual screenings, and the state is offering training and resources on how to screen and what to do with the information to help patients and families.