Females are the fastest growing population to seek care at the Veterans Health Administration (VHA).¹ Based on a 2014 study examining prevalence of military sexual trauma (MST), it is estimated that about one-third of females in the military screen positive for MST, and the rates are higher for younger veterans.² Military sexual trauma includes both rape and any sexual activity that occurred without consent; offensive sexual remarks or advances can also represent MST. The issue of MST, therefore, is an important one to address adequately, especially for female veterans who are screened through the VHA system.

Since 1992, the VHA has been required to provide services for MST, defined as “sexual harassment that is threatening in character or physical assault of a sexual nature that occurred while the victim was in the military.”³ Despite this mandate, it has taken many years for all VHA hospitals to adopt recommended screening tools to identify survivors of MST and give them proper resources. Only half of VHA hospitals adopted screening 6 years after the policy change.⁴ In addition, the environment in which the survivors receive MST care may trigger posttraumatic stress symptoms as many of the other patients seeking care at the VHA hospital resemble the perpetrators.⁵ Thus, up to half of females who report a history of MST do not receive care for their MST through the VHA.⁶

Having a history of MST significantly increases the risks of developing mental health disorders, including posttraumatic stress disorder (PTSD), major depressive disorder, generalized anxiety disorder, and suicidal ideation.² This group also has overall decreased quality of life (QOL). Female veterans have increased sexual dysfunction and dissatisfaction, which is heightened with a history of MST.⁷ Addressing MST requires treatment of all aspects of life affected by MST, such as mental health, sexual function, and QOL. The quality of treatment for MST through VHA hospitals deserves attention and likely still requires improvement with better incorporation of the patient’s perspective.

Qualitative research allows for incorporation of the patient’s perspective and is useful for exploring new ideas and themes.⁸ Current qualitative research using individual interviews of MST survivors focuses more on mental health treatment modalities through the VHA system and how resources are used within the system.^9,10 While it is important to understand the quantity of these resources, their quality also should be explored. Research has identified unique gender-specific concerns such as female-only mental health groups.¹⁰ However, there has been less focus on how to improve current therapies and the treatment modalities (regardless of whether it is a community service or at the VHA system) females find most helpful. There is a gap in understanding the patient’s perspective and assessment of current MST treatments as well as the unmet needs both within and outside of the VHA system. Therefore, the purpose of this study is 2-fold: (1) examine the utilization of VHA services for MST, as well as outside services, through focusgroup sessions; and (2) to offer specific recommendations for improving MST treatment for female veterans from the patient’s perspective.

Methods

After obtaining institutional review board approval (16-H192), females who screened positive for a history of MST, using the validated MST screening questionnaire, were recruited from the Women’s Continuity Clinic, Urology clinic, and via a research flyer placed within key locations at the New Mexico Veterans Affairs (VA) Health Care System (NMVAHCS).¹¹ Inclusion criteria were veterans aged > 18 years who could speak and understand English. Those who agreed to participate attended any 1 of 5 focus groups. Prior to initiation of the focus groups, the investigators generated a focus-group script, including specific questions or probes to explore treatment, unmet needs (such as other health conditions the veteran associated with MST that were not being addressed), and recommendations for care improvement.

Subjects granted consent privately prior to conduction of the focus group. Each participant completed a basic demographic (age, race, ethnicity) and clinical history (including pain conditions and therapy received for MST). These characteristics were evaluated with descriptive statistics, including means and frequencies.

The focus groups took place on the NM VAHCS Raymond G. Murphy VA Medical Center campus in a private conference room and were moderated by nonmedical research personnel experienced in focus-group moderation. Focus groups were recorded and transcribed. An iterative process was used with revisions to the script and probe questions as needed. Focus groups were planned for 2 hours but were allowed to continue at the participants’ discretion.

The de-identified transcripts were uploaded to the web-based qualitative engine Dedoose 6.2.21 software (Los Angeles, CA) and coded. Using grounded theory, the codes were grouped into themes and subsequently organized into emergent concepts.^8,12 Following constant comparative methodology, ideas were compared and combined between each focus group.^8,13 After completion of the focus groups, the generated ideas were organized and refined to create a conceptual framework that represented the collective ideas from the focus groups.

Results

Between January and June 2017, 5 focus groups with 17 participants were conducted; each session lasted about 3 hours. The average age was 52 ± 8.3 years, and were from a diverse racial and ethnic background. Most reported that > 20 years had passed since the first MST, and care-seeking for the first time was > 11 years after the trauma, although symptoms related to the MST most frequently began within 1 year of the trauma (Table 1). 

Preliminary Themes

The Trauma

Focus-group participants noted improved therapies offered by the VA but challenges obtaining health care:

“…because I’m really trying to deal with it and just be happy and get my joy back and deal with the isolation.”

“Another way that the memories affected me was barricading myself in my own house, starting from the front door.”

Male-Dominated VA

Participants also noted that, along with screening improving the system, dedicated female staff and service connection are important:

“The Womens Clinic is nice, and it’s nice to know that I can go there and I’m not having to discuss everything with men all over the place.”

“The other thing... that would be really good for survivors of MST, is help with disability.”

While the focus-group participants found dedicated women’s clinics helpful and providing improved care, the overall VA environment remains male-dominated:

“Because it’s really hard to relax and be vulnerable and be in your body and in your emotions if there‘s a bunch of penises around. When I saw these guys on the floor I’m like, I ain’t going in there.”

This male-dominated sense also incorporated a feeling of being misunderstood by a system that has traditionally cared for male veterans:

“People don‘t understand. They think, oh, you‘re overreacting, but they don’t know what it feels like to be inside.”

“I wouldn’t say they treat you like a second citizen, but it’s like almost every appointment I go to that’s not in the Women’s Clinic, the secretaries or whatever will be like ‘Oh, are you looking for somebody, or...’

Assumption Females Are Not Veterans

“There was an older gentleman behind me, they were like ‘Are you checking him in?’ I said, ‘I’m sure he’ll check himself in, but I’m checking myself in.’”

Participants also reported that there is an assumption that you’re not a veteran when you’re female:

“All of the care should be geared to be the same. And we know we need to recognize that men have their issues, and women will have their issues. But we don’t need to just say ‘all women have this issue, throw them over there.’”

Self-Doubt

“The world doesn’t validate rape, you asked for it, it was what you were wearing, it was what you said.”

Ongoing efforts to have female-only spaces, therapy groups, and support networks were encouraged by all 5 focus groups. These themes, provided the foundation for emergent concepts regarding patients’ perceptions of their treatment for MST: (1) Improvement has been slow but measurable; (2) VA cares more about male veterans; (3) The isolation from MST is pervasive; (4) It’s hard to navigate the VA system or any health care when you’re traumatized; and (5) Sexual assault leaves lasting self-doubt that providers need to address.

Isolation

Because there are barriers to seeking care the overarching method for coping with the effects of MST was isolation.

Overcoming the isolation was essential to seeking any care. Participants reported years of living alone, avoiding social situations and contexts, and difficulty with basic tasks because of the isolation.

“That the coping skills, that the isolation is a coping skill and all these things, and that I had to do that to survive.”

Lack of family and provider support and the VHA’s perceived focus on male veterans perpetuated this sense of isolation. Additionally, feeding the isolation were other maladaptive behaviors, such as alcoholism, weight gain, and anger.

“I was always an athlete until my MST, and I still find myself drinking whisky and wanting to smoke pot. It’s not that I want to, I guess it gives me a sense of relief, because my MST made me an alcoholic.”

Participants reported that successful treatment of MST must include treatment of other maladaptive behaviors and specific provider-behavior changes.

At times, providers contribute to female MST survivors’ feeling undervalued:

“I had an hour session and she kept looking at her watch and blowing me off, and I finally said, okay, I’m done, good-bye, after 45 minutes.”

Validation

Participants’ suggestions to improve MST treatment, including goal sharing, validation, knowledge, and support:

“They should have staff awareness groups, or focus groups to teach them the same thing that the patients are receiving as far as how to handle yourself, how to interact with others. Don’t bring your sh** from home into your job. You’re an employee, don’t take it personal.” (

Therapies for MST

A variety of modalities was recommended as helpful in coping with symptoms associated with MST. One female noted her therapy dog allowed her to get her first Papanicolaou (Pap) smear in years:

“Pelvic exams are like the seventh circle of hell. Like, God, you’d think I was being abducted by aliens or something. Last time, up here, they let me bring my little dog, which was extraordinarily helpful for me.”

For others, more traditional therapy such as prolonged exposure therapy or cognitive behavioral therapy, was helpful.

“After my prolonged exposure therapy; it saved my life. I’m not suicidal, and the only thing that’s really, really affected is sometimes I still have to sleep with a night light. Over 80% of the symptoms that I had and the problems that I had were alleviated with the therapy.”

Other veterans noted alternative therapies as beneficial for overcoming trauma:

“Yoga has really helped me with dealing with chronic pain and letting go of things that no longer serve me, and remembering about the inhale, the exhale, there’s a pause between the exhale and an inhale, where that’s where I make my choices, my thoughts, catch it, check it, change it, challenge my thoughts, that’s really, really helped me.”

From these concepts, and the specific suggestions female veterans provided for improvement in care, we developed a pictorial conceptual framework of the results. 

Discussion

This qualitative study of the quality of MST treatment with specific suggestions for improvement shows that the underlying force impacting health care in female survivors of MST is isolation. In turn, that isolation is perpetuated by personal beliefs, mental health, lack of support, and the VHA culture. While there was improvement in VHA care noted, female veterans offered many specific suggestions—simple ones that could be rapidly implemented—to enhance care. Many of these suggestions were targeted at provider-level behaviors such as validation, goal setting, knowledge (both about the military and about MST), and support.

Previous work showed that tangible (ie, words, being present) support rather than broad social support only generally helps reduces posttraumatic stress symptoms.¹⁵ These researchers found that tangible support moderated the relationship between number of lifetime traumas and PTSD. Schumm and colleagues also found that high social support predicted lower PTSD severity for inner-city women who experienced both child abuse and adult rape.¹⁶ A prior meta-analysis found social support was the strongest correlate of PTSD (effect size = 0.4).¹⁷

Our finding that female MST survivors desire verbal support from physicians may point to the inherent sense that validation helps healing, demonstrated by this meta-analysis. Importantly, the focus group participants did not specify the type of physician (psychiatrist, primary care provider, gynecologist, surgeon, etc) who needed to provide this support. Thus, we believe this suggestion is applicable to all physician interactions when the history of MST comes up. Physicians may be unaware of their profound impact in helping women recover from MST. This validation may also apply to survivors of other types of sexual trauma.

A second simple suggestion that arose from the focus groups was the need for broader options for MST therapy. Current data on the locations female veterans are treated for MST include specialty MST clinics, specialty PTSD clinics, psychosocial rehabilitation, and substance use disorder clinics, showing a wide range of settings.¹⁸ But female veterans are also asking for more services, including animal therapy, art therapy, yoga, and tai chi. While it may not be possible to offer every resource at every VHA facility, partnering with community services may help fulfill this veteran need. The advent of telehealth may also help address female veterans’ concerns about being surrounded by male patients and should be further explored.

The focus groups’ third suggestion for improvement in MST was better treatment for the health problems associated with sexual trauma, such as chronic pelvic pain, sexual dysfunction, and weight gain. It is important to note that the female veterans provided this list of associated health conditions from the broader facilitator question “What health problems do you think you have because of MST?” Females correctly identified common sequelae of sexual abuse, including pelvic pain and sexual dysfunction.^14,19 Weight gain and obesity have been associated with childhood sexual trauma and abuse, but they are not well studied in MST and may be worth further exploration.^20,21

Limitations

There are several inherent weaknesses in this study. The female veterans who agreed to participate in the focus group may not be representative of the entire population, particularly as survivors may be reluctant to talk about their MST experience. The participants in our focus groups were most commonly 2 decades past the MST and their experience with therapy may differ from that of women more recently traumatized and engaged in therapy. However, the fact that many of these females were still receiving some form of therapy 20 years after the traumatic event deserves attention.

Recall bias may have affected how female veterans described their experiences with MST treatment. We did not inquire about the timing of therapy and whether they sought VA care first, followed by community care, or vice versa. Finally, although the data were analyzed separately by 3 investigators, biases in data analysis may arise with qualitative methods.

Strengths of the study included the inherent patient-centered approach and ability to analyze data not readily extracted from patient records or validated questionnaires. Additionally, this qualitative approach allows for the discovery of patient-driven ideas and concerns. Our focus groups also contained a majority of minority females (including Hispanic and American Indian) populations that are frequently underrepresented in research.

Conclusion

Our data show there is still substantial room for improvement in the therapies and in the physician-level care for MST. While each treatment experience was unique, the collective agreement was that multimodal therapy was beneficial. However, the isolation that often comes from MST makes accessing care and treatment challenging. A crucial component to combating this isolation is provider validation and support for the female’s experience with MST. The simple act of hearing “I believe you” from the provider can make a huge impact on continuing to seek care and overcoming the consequences of MST.

Females are the fastest growing population to seek care at the Veterans Health Administration (VHA).¹ Based on a 2014 study examining prevalence of military sexual trauma (MST), it is estimated that about one-third of females in the military screen positive for MST, and the rates are higher for younger veterans.² Military sexual trauma includes both rape and any sexual activity that occurred without consent; offensive sexual remarks or advances can also represent MST. The issue of MST, therefore, is an important one to address adequately, especially for female veterans who are screened through the VHA system.

Since 1992, the VHA has been required to provide services for MST, defined as “sexual harassment that is threatening in character or physical assault of a sexual nature that occurred while the victim was in the military.”³ Despite this mandate, it has taken many years for all VHA hospitals to adopt recommended screening tools to identify survivors of MST and give them proper resources. Only half of VHA hospitals adopted screening 6 years after the policy change.⁴ In addition, the environment in which the survivors receive MST care may trigger posttraumatic stress symptoms as many of the other patients seeking care at the VHA hospital resemble the perpetrators.⁵ Thus, up to half of females who report a history of MST do not receive care for their MST through the VHA.⁶

Having a history of MST significantly increases the risks of developing mental health disorders, including posttraumatic stress disorder (PTSD), major depressive disorder, generalized anxiety disorder, and suicidal ideation.² This group also has overall decreased quality of life (QOL). Female veterans have increased sexual dysfunction and dissatisfaction, which is heightened with a history of MST.⁷ Addressing MST requires treatment of all aspects of life affected by MST, such as mental health, sexual function, and QOL. The quality of treatment for MST through VHA hospitals deserves attention and likely still requires improvement with better incorporation of the patient’s perspective.

Qualitative research allows for incorporation of the patient’s perspective and is useful for exploring new ideas and themes.⁸ Current qualitative research using individual interviews of MST survivors focuses more on mental health treatment modalities through the VHA system and how resources are used within the system.^9,10 While it is important to understand the quantity of these resources, their quality also should be explored. Research has identified unique gender-specific concerns such as female-only mental health groups.¹⁰ However, there has been less focus on how to improve current therapies and the treatment modalities (regardless of whether it is a community service or at the VHA system) females find most helpful. There is a gap in understanding the patient’s perspective and assessment of current MST treatments as well as the unmet needs both within and outside of the VHA system. Therefore, the purpose of this study is 2-fold: (1) examine the utilization of VHA services for MST, as well as outside services, through focusgroup sessions; and (2) to offer specific recommendations for improving MST treatment for female veterans from the patient’s perspective.

Methods

After obtaining institutional review board approval (16-H192), females who screened positive for a history of MST, using the validated MST screening questionnaire, were recruited from the Women’s Continuity Clinic, Urology clinic, and via a research flyer placed within key locations at the New Mexico Veterans Affairs (VA) Health Care System (NMVAHCS).¹¹ Inclusion criteria were veterans aged > 18 years who could speak and understand English. Those who agreed to participate attended any 1 of 5 focus groups. Prior to initiation of the focus groups, the investigators generated a focus-group script, including specific questions or probes to explore treatment, unmet needs (such as other health conditions the veteran associated with MST that were not being addressed), and recommendations for care improvement.

Subjects granted consent privately prior to conduction of the focus group. Each participant completed a basic demographic (age, race, ethnicity) and clinical history (including pain conditions and therapy received for MST). These characteristics were evaluated with descriptive statistics, including means and frequencies.

The focus groups took place on the NM VAHCS Raymond G. Murphy VA Medical Center campus in a private conference room and were moderated by nonmedical research personnel experienced in focus-group moderation. Focus groups were recorded and transcribed. An iterative process was used with revisions to the script and probe questions as needed. Focus groups were planned for 2 hours but were allowed to continue at the participants’ discretion.

The de-identified transcripts were uploaded to the web-based qualitative engine Dedoose 6.2.21 software (Los Angeles, CA) and coded. Using grounded theory, the codes were grouped into themes and subsequently organized into emergent concepts.^8,12 Following constant comparative methodology, ideas were compared and combined between each focus group.^8,13 After completion of the focus groups, the generated ideas were organized and refined to create a conceptual framework that represented the collective ideas from the focus groups.

Results

Between January and June 2017, 5 focus groups with 17 participants were conducted; each session lasted about 3 hours. The average age was 52 ± 8.3 years, and were from a diverse racial and ethnic background. Most reported that > 20 years had passed since the first MST, and care-seeking for the first time was > 11 years after the trauma, although symptoms related to the MST most frequently began within 1 year of the trauma (Table 1). 

Preliminary Themes

The Trauma

Focus-group participants noted improved therapies offered by the VA but challenges obtaining health care:

“…because I’m really trying to deal with it and just be happy and get my joy back and deal with the isolation.”

“Another way that the memories affected me was barricading myself in my own house, starting from the front door.”

Male-Dominated VA

Participants also noted that, along with screening improving the system, dedicated female staff and service connection are important:

“The Womens Clinic is nice, and it’s nice to know that I can go there and I’m not having to discuss everything with men all over the place.”

“The other thing... that would be really good for survivors of MST, is help with disability.”

While the focus-group participants found dedicated women’s clinics helpful and providing improved care, the overall VA environment remains male-dominated:

“Because it’s really hard to relax and be vulnerable and be in your body and in your emotions if there‘s a bunch of penises around. When I saw these guys on the floor I’m like, I ain’t going in there.”

This male-dominated sense also incorporated a feeling of being misunderstood by a system that has traditionally cared for male veterans:

“People don‘t understand. They think, oh, you‘re overreacting, but they don’t know what it feels like to be inside.”

“I wouldn’t say they treat you like a second citizen, but it’s like almost every appointment I go to that’s not in the Women’s Clinic, the secretaries or whatever will be like ‘Oh, are you looking for somebody, or...’

Assumption Females Are Not Veterans

“There was an older gentleman behind me, they were like ‘Are you checking him in?’ I said, ‘I’m sure he’ll check himself in, but I’m checking myself in.’”

Participants also reported that there is an assumption that you’re not a veteran when you’re female:

“All of the care should be geared to be the same. And we know we need to recognize that men have their issues, and women will have their issues. But we don’t need to just say ‘all women have this issue, throw them over there.’”

Self-Doubt

“The world doesn’t validate rape, you asked for it, it was what you were wearing, it was what you said.”

Ongoing efforts to have female-only spaces, therapy groups, and support networks were encouraged by all 5 focus groups. These themes, provided the foundation for emergent concepts regarding patients’ perceptions of their treatment for MST: (1) Improvement has been slow but measurable; (2) VA cares more about male veterans; (3) The isolation from MST is pervasive; (4) It’s hard to navigate the VA system or any health care when you’re traumatized; and (5) Sexual assault leaves lasting self-doubt that providers need to address.

Isolation

Because there are barriers to seeking care the overarching method for coping with the effects of MST was isolation.

Overcoming the isolation was essential to seeking any care. Participants reported years of living alone, avoiding social situations and contexts, and difficulty with basic tasks because of the isolation.

“That the coping skills, that the isolation is a coping skill and all these things, and that I had to do that to survive.”

Lack of family and provider support and the VHA’s perceived focus on male veterans perpetuated this sense of isolation. Additionally, feeding the isolation were other maladaptive behaviors, such as alcoholism, weight gain, and anger.

“I was always an athlete until my MST, and I still find myself drinking whisky and wanting to smoke pot. It’s not that I want to, I guess it gives me a sense of relief, because my MST made me an alcoholic.”

Participants reported that successful treatment of MST must include treatment of other maladaptive behaviors and specific provider-behavior changes.

At times, providers contribute to female MST survivors’ feeling undervalued:

“I had an hour session and she kept looking at her watch and blowing me off, and I finally said, okay, I’m done, good-bye, after 45 minutes.”

Validation

Participants’ suggestions to improve MST treatment, including goal sharing, validation, knowledge, and support:

“They should have staff awareness groups, or focus groups to teach them the same thing that the patients are receiving as far as how to handle yourself, how to interact with others. Don’t bring your sh** from home into your job. You’re an employee, don’t take it personal.” (

Therapies for MST

A variety of modalities was recommended as helpful in coping with symptoms associated with MST. One female noted her therapy dog allowed her to get her first Papanicolaou (Pap) smear in years:

“Pelvic exams are like the seventh circle of hell. Like, God, you’d think I was being abducted by aliens or something. Last time, up here, they let me bring my little dog, which was extraordinarily helpful for me.”

For others, more traditional therapy such as prolonged exposure therapy or cognitive behavioral therapy, was helpful.

“After my prolonged exposure therapy; it saved my life. I’m not suicidal, and the only thing that’s really, really affected is sometimes I still have to sleep with a night light. Over 80% of the symptoms that I had and the problems that I had were alleviated with the therapy.”

Other veterans noted alternative therapies as beneficial for overcoming trauma:

“Yoga has really helped me with dealing with chronic pain and letting go of things that no longer serve me, and remembering about the inhale, the exhale, there’s a pause between the exhale and an inhale, where that’s where I make my choices, my thoughts, catch it, check it, change it, challenge my thoughts, that’s really, really helped me.”

From these concepts, and the specific suggestions female veterans provided for improvement in care, we developed a pictorial conceptual framework of the results. 

Discussion

This qualitative study of the quality of MST treatment with specific suggestions for improvement shows that the underlying force impacting health care in female survivors of MST is isolation. In turn, that isolation is perpetuated by personal beliefs, mental health, lack of support, and the VHA culture. While there was improvement in VHA care noted, female veterans offered many specific suggestions—simple ones that could be rapidly implemented—to enhance care. Many of these suggestions were targeted at provider-level behaviors such as validation, goal setting, knowledge (both about the military and about MST), and support.

Previous work showed that tangible (ie, words, being present) support rather than broad social support only generally helps reduces posttraumatic stress symptoms.¹⁵ These researchers found that tangible support moderated the relationship between number of lifetime traumas and PTSD. Schumm and colleagues also found that high social support predicted lower PTSD severity for inner-city women who experienced both child abuse and adult rape.¹⁶ A prior meta-analysis found social support was the strongest correlate of PTSD (effect size = 0.4).¹⁷

Our finding that female MST survivors desire verbal support from physicians may point to the inherent sense that validation helps healing, demonstrated by this meta-analysis. Importantly, the focus group participants did not specify the type of physician (psychiatrist, primary care provider, gynecologist, surgeon, etc) who needed to provide this support. Thus, we believe this suggestion is applicable to all physician interactions when the history of MST comes up. Physicians may be unaware of their profound impact in helping women recover from MST. This validation may also apply to survivors of other types of sexual trauma.

A second simple suggestion that arose from the focus groups was the need for broader options for MST therapy. Current data on the locations female veterans are treated for MST include specialty MST clinics, specialty PTSD clinics, psychosocial rehabilitation, and substance use disorder clinics, showing a wide range of settings.¹⁸ But female veterans are also asking for more services, including animal therapy, art therapy, yoga, and tai chi. While it may not be possible to offer every resource at every VHA facility, partnering with community services may help fulfill this veteran need. The advent of telehealth may also help address female veterans’ concerns about being surrounded by male patients and should be further explored.

The focus groups’ third suggestion for improvement in MST was better treatment for the health problems associated with sexual trauma, such as chronic pelvic pain, sexual dysfunction, and weight gain. It is important to note that the female veterans provided this list of associated health conditions from the broader facilitator question “What health problems do you think you have because of MST?” Females correctly identified common sequelae of sexual abuse, including pelvic pain and sexual dysfunction.^14,19 Weight gain and obesity have been associated with childhood sexual trauma and abuse, but they are not well studied in MST and may be worth further exploration.^20,21

Limitations

There are several inherent weaknesses in this study. The female veterans who agreed to participate in the focus group may not be representative of the entire population, particularly as survivors may be reluctant to talk about their MST experience. The participants in our focus groups were most commonly 2 decades past the MST and their experience with therapy may differ from that of women more recently traumatized and engaged in therapy. However, the fact that many of these females were still receiving some form of therapy 20 years after the traumatic event deserves attention.

Recall bias may have affected how female veterans described their experiences with MST treatment. We did not inquire about the timing of therapy and whether they sought VA care first, followed by community care, or vice versa. Finally, although the data were analyzed separately by 3 investigators, biases in data analysis may arise with qualitative methods.

Strengths of the study included the inherent patient-centered approach and ability to analyze data not readily extracted from patient records or validated questionnaires. Additionally, this qualitative approach allows for the discovery of patient-driven ideas and concerns. Our focus groups also contained a majority of minority females (including Hispanic and American Indian) populations that are frequently underrepresented in research.

Conclusion

Our data show there is still substantial room for improvement in the therapies and in the physician-level care for MST. While each treatment experience was unique, the collective agreement was that multimodal therapy was beneficial. However, the isolation that often comes from MST makes accessing care and treatment challenging. A crucial component to combating this isolation is provider validation and support for the female’s experience with MST. The simple act of hearing “I believe you” from the provider can make a huge impact on continuing to seek care and overcoming the consequences of MST.

Females are the fastest growing population to seek care at the Veterans Health Administration (VHA).¹ Based on a 2014 study examining prevalence of military sexual trauma (MST), it is estimated that about one-third of females in the military screen positive for MST, and the rates are higher for younger veterans.² Military sexual trauma includes both rape and any sexual activity that occurred without consent; offensive sexual remarks or advances can also represent MST. The issue of MST, therefore, is an important one to address adequately, especially for female veterans who are screened through the VHA system.

Since 1992, the VHA has been required to provide services for MST, defined as “sexual harassment that is threatening in character or physical assault of a sexual nature that occurred while the victim was in the military.”³ Despite this mandate, it has taken many years for all VHA hospitals to adopt recommended screening tools to identify survivors of MST and give them proper resources. Only half of VHA hospitals adopted screening 6 years after the policy change.⁴ In addition, the environment in which the survivors receive MST care may trigger posttraumatic stress symptoms as many of the other patients seeking care at the VHA hospital resemble the perpetrators.⁵ Thus, up to half of females who report a history of MST do not receive care for their MST through the VHA.⁶

Having a history of MST significantly increases the risks of developing mental health disorders, including posttraumatic stress disorder (PTSD), major depressive disorder, generalized anxiety disorder, and suicidal ideation.² This group also has overall decreased quality of life (QOL). Female veterans have increased sexual dysfunction and dissatisfaction, which is heightened with a history of MST.⁷ Addressing MST requires treatment of all aspects of life affected by MST, such as mental health, sexual function, and QOL. The quality of treatment for MST through VHA hospitals deserves attention and likely still requires improvement with better incorporation of the patient’s perspective.

Qualitative research allows for incorporation of the patient’s perspective and is useful for exploring new ideas and themes.⁸ Current qualitative research using individual interviews of MST survivors focuses more on mental health treatment modalities through the VHA system and how resources are used within the system.^9,10 While it is important to understand the quantity of these resources, their quality also should be explored. Research has identified unique gender-specific concerns such as female-only mental health groups.¹⁰ However, there has been less focus on how to improve current therapies and the treatment modalities (regardless of whether it is a community service or at the VHA system) females find most helpful. There is a gap in understanding the patient’s perspective and assessment of current MST treatments as well as the unmet needs both within and outside of the VHA system. Therefore, the purpose of this study is 2-fold: (1) examine the utilization of VHA services for MST, as well as outside services, through focusgroup sessions; and (2) to offer specific recommendations for improving MST treatment for female veterans from the patient’s perspective.

Methods

After obtaining institutional review board approval (16-H192), females who screened positive for a history of MST, using the validated MST screening questionnaire, were recruited from the Women’s Continuity Clinic, Urology clinic, and via a research flyer placed within key locations at the New Mexico Veterans Affairs (VA) Health Care System (NMVAHCS).¹¹ Inclusion criteria were veterans aged > 18 years who could speak and understand English. Those who agreed to participate attended any 1 of 5 focus groups. Prior to initiation of the focus groups, the investigators generated a focus-group script, including specific questions or probes to explore treatment, unmet needs (such as other health conditions the veteran associated with MST that were not being addressed), and recommendations for care improvement.

Subjects granted consent privately prior to conduction of the focus group. Each participant completed a basic demographic (age, race, ethnicity) and clinical history (including pain conditions and therapy received for MST). These characteristics were evaluated with descriptive statistics, including means and frequencies.

The focus groups took place on the NM VAHCS Raymond G. Murphy VA Medical Center campus in a private conference room and were moderated by nonmedical research personnel experienced in focus-group moderation. Focus groups were recorded and transcribed. An iterative process was used with revisions to the script and probe questions as needed. Focus groups were planned for 2 hours but were allowed to continue at the participants’ discretion.

The de-identified transcripts were uploaded to the web-based qualitative engine Dedoose 6.2.21 software (Los Angeles, CA) and coded. Using grounded theory, the codes were grouped into themes and subsequently organized into emergent concepts.^8,12 Following constant comparative methodology, ideas were compared and combined between each focus group.^8,13 After completion of the focus groups, the generated ideas were organized and refined to create a conceptual framework that represented the collective ideas from the focus groups.

Results

Between January and June 2017, 5 focus groups with 17 participants were conducted; each session lasted about 3 hours. The average age was 52 ± 8.3 years, and were from a diverse racial and ethnic background. Most reported that > 20 years had passed since the first MST, and care-seeking for the first time was > 11 years after the trauma, although symptoms related to the MST most frequently began within 1 year of the trauma (Table 1). 

Preliminary Themes

The Trauma

Focus-group participants noted improved therapies offered by the VA but challenges obtaining health care:

“…because I’m really trying to deal with it and just be happy and get my joy back and deal with the isolation.”

“Another way that the memories affected me was barricading myself in my own house, starting from the front door.”

Male-Dominated VA

Participants also noted that, along with screening improving the system, dedicated female staff and service connection are important:

“The Womens Clinic is nice, and it’s nice to know that I can go there and I’m not having to discuss everything with men all over the place.”

“The other thing... that would be really good for survivors of MST, is help with disability.”

While the focus-group participants found dedicated women’s clinics helpful and providing improved care, the overall VA environment remains male-dominated:

“Because it’s really hard to relax and be vulnerable and be in your body and in your emotions if there‘s a bunch of penises around. When I saw these guys on the floor I’m like, I ain’t going in there.”

This male-dominated sense also incorporated a feeling of being misunderstood by a system that has traditionally cared for male veterans:

“People don‘t understand. They think, oh, you‘re overreacting, but they don’t know what it feels like to be inside.”

“I wouldn’t say they treat you like a second citizen, but it’s like almost every appointment I go to that’s not in the Women’s Clinic, the secretaries or whatever will be like ‘Oh, are you looking for somebody, or...’

Assumption Females Are Not Veterans

“There was an older gentleman behind me, they were like ‘Are you checking him in?’ I said, ‘I’m sure he’ll check himself in, but I’m checking myself in.’”

Participants also reported that there is an assumption that you’re not a veteran when you’re female:

“All of the care should be geared to be the same. And we know we need to recognize that men have their issues, and women will have their issues. But we don’t need to just say ‘all women have this issue, throw them over there.’”

Self-Doubt

“The world doesn’t validate rape, you asked for it, it was what you were wearing, it was what you said.”

Ongoing efforts to have female-only spaces, therapy groups, and support networks were encouraged by all 5 focus groups. These themes, provided the foundation for emergent concepts regarding patients’ perceptions of their treatment for MST: (1) Improvement has been slow but measurable; (2) VA cares more about male veterans; (3) The isolation from MST is pervasive; (4) It’s hard to navigate the VA system or any health care when you’re traumatized; and (5) Sexual assault leaves lasting self-doubt that providers need to address.

Isolation

Because there are barriers to seeking care the overarching method for coping with the effects of MST was isolation.

Overcoming the isolation was essential to seeking any care. Participants reported years of living alone, avoiding social situations and contexts, and difficulty with basic tasks because of the isolation.

“That the coping skills, that the isolation is a coping skill and all these things, and that I had to do that to survive.”

Lack of family and provider support and the VHA’s perceived focus on male veterans perpetuated this sense of isolation. Additionally, feeding the isolation were other maladaptive behaviors, such as alcoholism, weight gain, and anger.

“I was always an athlete until my MST, and I still find myself drinking whisky and wanting to smoke pot. It’s not that I want to, I guess it gives me a sense of relief, because my MST made me an alcoholic.”

Participants reported that successful treatment of MST must include treatment of other maladaptive behaviors and specific provider-behavior changes.

At times, providers contribute to female MST survivors’ feeling undervalued:

“I had an hour session and she kept looking at her watch and blowing me off, and I finally said, okay, I’m done, good-bye, after 45 minutes.”

Validation

Participants’ suggestions to improve MST treatment, including goal sharing, validation, knowledge, and support:

“They should have staff awareness groups, or focus groups to teach them the same thing that the patients are receiving as far as how to handle yourself, how to interact with others. Don’t bring your sh** from home into your job. You’re an employee, don’t take it personal.” (

Therapies for MST

A variety of modalities was recommended as helpful in coping with symptoms associated with MST. One female noted her therapy dog allowed her to get her first Papanicolaou (Pap) smear in years:

“Pelvic exams are like the seventh circle of hell. Like, God, you’d think I was being abducted by aliens or something. Last time, up here, they let me bring my little dog, which was extraordinarily helpful for me.”

For others, more traditional therapy such as prolonged exposure therapy or cognitive behavioral therapy, was helpful.

“After my prolonged exposure therapy; it saved my life. I’m not suicidal, and the only thing that’s really, really affected is sometimes I still have to sleep with a night light. Over 80% of the symptoms that I had and the problems that I had were alleviated with the therapy.”

Other veterans noted alternative therapies as beneficial for overcoming trauma:

“Yoga has really helped me with dealing with chronic pain and letting go of things that no longer serve me, and remembering about the inhale, the exhale, there’s a pause between the exhale and an inhale, where that’s where I make my choices, my thoughts, catch it, check it, change it, challenge my thoughts, that’s really, really helped me.”

From these concepts, and the specific suggestions female veterans provided for improvement in care, we developed a pictorial conceptual framework of the results. 

Discussion

This qualitative study of the quality of MST treatment with specific suggestions for improvement shows that the underlying force impacting health care in female survivors of MST is isolation. In turn, that isolation is perpetuated by personal beliefs, mental health, lack of support, and the VHA culture. While there was improvement in VHA care noted, female veterans offered many specific suggestions—simple ones that could be rapidly implemented—to enhance care. Many of these suggestions were targeted at provider-level behaviors such as validation, goal setting, knowledge (both about the military and about MST), and support.

Previous work showed that tangible (ie, words, being present) support rather than broad social support only generally helps reduces posttraumatic stress symptoms.¹⁵ These researchers found that tangible support moderated the relationship between number of lifetime traumas and PTSD. Schumm and colleagues also found that high social support predicted lower PTSD severity for inner-city women who experienced both child abuse and adult rape.¹⁶ A prior meta-analysis found social support was the strongest correlate of PTSD (effect size = 0.4).¹⁷

Our finding that female MST survivors desire verbal support from physicians may point to the inherent sense that validation helps healing, demonstrated by this meta-analysis. Importantly, the focus group participants did not specify the type of physician (psychiatrist, primary care provider, gynecologist, surgeon, etc) who needed to provide this support. Thus, we believe this suggestion is applicable to all physician interactions when the history of MST comes up. Physicians may be unaware of their profound impact in helping women recover from MST. This validation may also apply to survivors of other types of sexual trauma.

A second simple suggestion that arose from the focus groups was the need for broader options for MST therapy. Current data on the locations female veterans are treated for MST include specialty MST clinics, specialty PTSD clinics, psychosocial rehabilitation, and substance use disorder clinics, showing a wide range of settings.¹⁸ But female veterans are also asking for more services, including animal therapy, art therapy, yoga, and tai chi. While it may not be possible to offer every resource at every VHA facility, partnering with community services may help fulfill this veteran need. The advent of telehealth may also help address female veterans’ concerns about being surrounded by male patients and should be further explored.

The focus groups’ third suggestion for improvement in MST was better treatment for the health problems associated with sexual trauma, such as chronic pelvic pain, sexual dysfunction, and weight gain. It is important to note that the female veterans provided this list of associated health conditions from the broader facilitator question “What health problems do you think you have because of MST?” Females correctly identified common sequelae of sexual abuse, including pelvic pain and sexual dysfunction.^14,19 Weight gain and obesity have been associated with childhood sexual trauma and abuse, but they are not well studied in MST and may be worth further exploration.^20,21

Limitations

There are several inherent weaknesses in this study. The female veterans who agreed to participate in the focus group may not be representative of the entire population, particularly as survivors may be reluctant to talk about their MST experience. The participants in our focus groups were most commonly 2 decades past the MST and their experience with therapy may differ from that of women more recently traumatized and engaged in therapy. However, the fact that many of these females were still receiving some form of therapy 20 years after the traumatic event deserves attention.

Recall bias may have affected how female veterans described their experiences with MST treatment. We did not inquire about the timing of therapy and whether they sought VA care first, followed by community care, or vice versa. Finally, although the data were analyzed separately by 3 investigators, biases in data analysis may arise with qualitative methods.

Strengths of the study included the inherent patient-centered approach and ability to analyze data not readily extracted from patient records or validated questionnaires. Additionally, this qualitative approach allows for the discovery of patient-driven ideas and concerns. Our focus groups also contained a majority of minority females (including Hispanic and American Indian) populations that are frequently underrepresented in research.

Conclusion

Our data show there is still substantial room for improvement in the therapies and in the physician-level care for MST. While each treatment experience was unique, the collective agreement was that multimodal therapy was beneficial. However, the isolation that often comes from MST makes accessing care and treatment challenging. A crucial component to combating this isolation is provider validation and support for the female’s experience with MST. The simple act of hearing “I believe you” from the provider can make a huge impact on continuing to seek care and overcoming the consequences of MST.

Adverse events limited the dose intensity or schedule of chemotherapy when added to nivolumab in patients with treatment-naive advanced gastric cancer, according to results from a small, phase 2 trial.

Fully 95% of patients delayed or reduced the dose of chemotherapy because of adverse events. Serious (grade 3 or higher) treatment-related adverse events affected 15% of patients and 13% of patients stopped treatment because of adverse events, said Narikazu Boku, MD, PhD, of National Cancer Center Hospital in Tokyo, together with his associates. The findings were published in Annals of Oncology.

Nivolumab (Opdivo) is not approved for treating gastric cancer in the United States but is approved as third-line or later therapy in several other countries. In the phase 2 ATTRACTION-4 trial, 39 patients with previously untreated, unresectable, advanced, or recurrent gastric or gastroesophageal junction cancer received nivolumab (360 mg intravenously every 3 weeks), plus either S-1 (40 mg/m² orally twice daily for 14 days followed by 7 days off) or capecitabine (1000 mg/m² orally twice daily for 14 days followed by 7 days off), plus oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks).

For the regimen containing S-1, the most common serious adverse events requiring delays or reductions in chemotherapy were thrombocytopenia (57%), neutropenia (48%), and nausea (19%), followed by diarrhea, vomiting, abdominal pain, peripheral sensory neuropathy, and fatigue (14% each). For the regimen containing capecitabine, the most common of these adverse events were neutropenia (44%), decreased appetite (28%), and palmar-plantar erythrodysesthesia syndrome (22%), followed by nausea, vomiting, diarrhea, and peripheral sensory neuropathy (17% each). There were no treatment-related deaths.

Efficacy endpoints were secondary and limited by small sample size. Nonetheless, regardless of which of the two chemotherapy regimens patients received, about two-thirds had a complete or partial treatment response, which is “numerically higher” than that reported for either chemotherapy regimen alone, the researchers wrote. After a median follow-up of 13.2 months, median overall survival was not reached, while median progression-free survival was 9.7 months for the S-1-based regimen and 10.6 months for the capecitabine-based regimen. Antitumor response appeared to be unrelated to programmed death–ligand 1 status.

Based on the findings, both nivolumab-chemotherapy regimens have “manageable safety profile and clinically relevant antitumor profile,” Dr. Boku and his coinvestigators stated. The second part of ATTRACTION-4 has recruited a larger group of patients and should shed more light on efficacy.

Ono Pharmaceutical and Bristol-Myers Squibb funded the work. Dr. Boku reported financial ties to both companies and to AstraZeneca and Chugai Pharmaceutical.

SOURCE: Boku N et al. Ann Oncol. 2018 Dec 19. doi: 10.1093/annonc/mdy540.

Adverse events limited the dose intensity or schedule of chemotherapy when added to nivolumab in patients with treatment-naive advanced gastric cancer, according to results from a small, phase 2 trial.

Fully 95% of patients delayed or reduced the dose of chemotherapy because of adverse events. Serious (grade 3 or higher) treatment-related adverse events affected 15% of patients and 13% of patients stopped treatment because of adverse events, said Narikazu Boku, MD, PhD, of National Cancer Center Hospital in Tokyo, together with his associates. The findings were published in Annals of Oncology.

Nivolumab (Opdivo) is not approved for treating gastric cancer in the United States but is approved as third-line or later therapy in several other countries. In the phase 2 ATTRACTION-4 trial, 39 patients with previously untreated, unresectable, advanced, or recurrent gastric or gastroesophageal junction cancer received nivolumab (360 mg intravenously every 3 weeks), plus either S-1 (40 mg/m² orally twice daily for 14 days followed by 7 days off) or capecitabine (1000 mg/m² orally twice daily for 14 days followed by 7 days off), plus oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks).

For the regimen containing S-1, the most common serious adverse events requiring delays or reductions in chemotherapy were thrombocytopenia (57%), neutropenia (48%), and nausea (19%), followed by diarrhea, vomiting, abdominal pain, peripheral sensory neuropathy, and fatigue (14% each). For the regimen containing capecitabine, the most common of these adverse events were neutropenia (44%), decreased appetite (28%), and palmar-plantar erythrodysesthesia syndrome (22%), followed by nausea, vomiting, diarrhea, and peripheral sensory neuropathy (17% each). There were no treatment-related deaths.

Efficacy endpoints were secondary and limited by small sample size. Nonetheless, regardless of which of the two chemotherapy regimens patients received, about two-thirds had a complete or partial treatment response, which is “numerically higher” than that reported for either chemotherapy regimen alone, the researchers wrote. After a median follow-up of 13.2 months, median overall survival was not reached, while median progression-free survival was 9.7 months for the S-1-based regimen and 10.6 months for the capecitabine-based regimen. Antitumor response appeared to be unrelated to programmed death–ligand 1 status.

Based on the findings, both nivolumab-chemotherapy regimens have “manageable safety profile and clinically relevant antitumor profile,” Dr. Boku and his coinvestigators stated. The second part of ATTRACTION-4 has recruited a larger group of patients and should shed more light on efficacy.

Ono Pharmaceutical and Bristol-Myers Squibb funded the work. Dr. Boku reported financial ties to both companies and to AstraZeneca and Chugai Pharmaceutical.

SOURCE: Boku N et al. Ann Oncol. 2018 Dec 19. doi: 10.1093/annonc/mdy540.

Adverse events limited the dose intensity or schedule of chemotherapy when added to nivolumab in patients with treatment-naive advanced gastric cancer, according to results from a small, phase 2 trial.

Fully 95% of patients delayed or reduced the dose of chemotherapy because of adverse events. Serious (grade 3 or higher) treatment-related adverse events affected 15% of patients and 13% of patients stopped treatment because of adverse events, said Narikazu Boku, MD, PhD, of National Cancer Center Hospital in Tokyo, together with his associates. The findings were published in Annals of Oncology.

Nivolumab (Opdivo) is not approved for treating gastric cancer in the United States but is approved as third-line or later therapy in several other countries. In the phase 2 ATTRACTION-4 trial, 39 patients with previously untreated, unresectable, advanced, or recurrent gastric or gastroesophageal junction cancer received nivolumab (360 mg intravenously every 3 weeks), plus either S-1 (40 mg/m² orally twice daily for 14 days followed by 7 days off) or capecitabine (1000 mg/m² orally twice daily for 14 days followed by 7 days off), plus oxaliplatin (130 mg/m² intravenously on day 1 every 3 weeks).

For the regimen containing S-1, the most common serious adverse events requiring delays or reductions in chemotherapy were thrombocytopenia (57%), neutropenia (48%), and nausea (19%), followed by diarrhea, vomiting, abdominal pain, peripheral sensory neuropathy, and fatigue (14% each). For the regimen containing capecitabine, the most common of these adverse events were neutropenia (44%), decreased appetite (28%), and palmar-plantar erythrodysesthesia syndrome (22%), followed by nausea, vomiting, diarrhea, and peripheral sensory neuropathy (17% each). There were no treatment-related deaths.

Efficacy endpoints were secondary and limited by small sample size. Nonetheless, regardless of which of the two chemotherapy regimens patients received, about two-thirds had a complete or partial treatment response, which is “numerically higher” than that reported for either chemotherapy regimen alone, the researchers wrote. After a median follow-up of 13.2 months, median overall survival was not reached, while median progression-free survival was 9.7 months for the S-1-based regimen and 10.6 months for the capecitabine-based regimen. Antitumor response appeared to be unrelated to programmed death–ligand 1 status.

Based on the findings, both nivolumab-chemotherapy regimens have “manageable safety profile and clinically relevant antitumor profile,” Dr. Boku and his coinvestigators stated. The second part of ATTRACTION-4 has recruited a larger group of patients and should shed more light on efficacy.

Ono Pharmaceutical and Bristol-Myers Squibb funded the work. Dr. Boku reported financial ties to both companies and to AstraZeneca and Chugai Pharmaceutical.

SOURCE: Boku N et al. Ann Oncol. 2018 Dec 19. doi: 10.1093/annonc/mdy540.

NEW ORLEANS – The onset of pediatric refractory status epilepticus follows a circadian pattern, according to research presented at the annual meeting of the American Epilepsy Society. The number of episodes is greatest between 10 a.m. and 11 a.m. and smallest between 10 p.m. and 11 p.m.

“Our findings may inform the increase in preventive monitoring, such as video monitoring or seizure-tracking devices for patients,” said Justice Clark, MPH, a program coordinator at Boston Children’s Hospital. “They may also inform chronotherapeutic strategies.”

Research suggests that various types of seizures cluster at different times of the day. Data about the circadian distribution of status epilepticus, however, are limited.

Ms. Clark and colleagues conducted a prospective observational study at 25 hospitals in the United States and Canada from June 2011 to January 2018. Eligible participants were between ages 1 month and 21 years, had focal or generalized convulsive status epilepticus, and had failed to respond to one benzodiazepine and one nonbenzodiazepine antiseizure medication. For patients with more than one episode of refractory status epilepticus during the study, the researchers included only the first episode.

The investigators examined whether the temporal distribution of pediatric refractory status epilepticus onset followed a circadian pattern using a cosinor analysis with a 12-hour cycle. They used the midline-estimating statistic of rhythm (MESOR) technique to estimate the mean number of refractory status epilepticus episodes per hour if onset was evenly distributed. The amplitude in this analysis was the difference in number of episodes per hour between the MESOR and the peak or the MESOR and the trough.

Ms. Clark and her colleagues included 300 patients in their analysis, each of whom had one episode. Approximately 45% of participants were female. The population’s median age was 4.2 years, and the median duration of status epilepticus was 120 minutes.

The MESOR was 12.5 episodes per hour, and the amplitude was 2.4 episodes per hour, indicating that the distribution was not even over 24 hours. The peak number of onsets was between 10 a.m. and 11 a.m., and the trough was between 10 p.m. and 11 p.m.

A secondary analysis examined the circadian distribution of time to treatment with rescue medications. The distribution of time to treatment with the first benzodiazepine did not differ significantly from a uniform distribution. The time to treatment with the first nonbenzodiazepine antiseizure medication, however, was not uniformly distributed. The longest time to treatment occurred between 3 a.m. and 4 a.m., and the shortest time was between 3 p.m. and 4 p.m. “Although fewer refractory status epilepticus episodes occurred at night, the time to antiseizure medication administration was the longest [during that period]. Thus, nighttime refractory status epilepticus episodes may be at higher risk for delayed treatment,” said Ms. Clark. A limitation of this analysis is that it was influenced by outliers, she added.

The Pediatric Epilepsy Research Foundation and the Epilepsy Research Fund supported the study.

egreb@mdedge.com

SOURCE: Clark J et al. AES 2018. Abstract 3.426.

NEW ORLEANS – The onset of pediatric refractory status epilepticus follows a circadian pattern, according to research presented at the annual meeting of the American Epilepsy Society. The number of episodes is greatest between 10 a.m. and 11 a.m. and smallest between 10 p.m. and 11 p.m.

“Our findings may inform the increase in preventive monitoring, such as video monitoring or seizure-tracking devices for patients,” said Justice Clark, MPH, a program coordinator at Boston Children’s Hospital. “They may also inform chronotherapeutic strategies.”

Research suggests that various types of seizures cluster at different times of the day. Data about the circadian distribution of status epilepticus, however, are limited.

Ms. Clark and colleagues conducted a prospective observational study at 25 hospitals in the United States and Canada from June 2011 to January 2018. Eligible participants were between ages 1 month and 21 years, had focal or generalized convulsive status epilepticus, and had failed to respond to one benzodiazepine and one nonbenzodiazepine antiseizure medication. For patients with more than one episode of refractory status epilepticus during the study, the researchers included only the first episode.

The investigators examined whether the temporal distribution of pediatric refractory status epilepticus onset followed a circadian pattern using a cosinor analysis with a 12-hour cycle. They used the midline-estimating statistic of rhythm (MESOR) technique to estimate the mean number of refractory status epilepticus episodes per hour if onset was evenly distributed. The amplitude in this analysis was the difference in number of episodes per hour between the MESOR and the peak or the MESOR and the trough.

Ms. Clark and her colleagues included 300 patients in their analysis, each of whom had one episode. Approximately 45% of participants were female. The population’s median age was 4.2 years, and the median duration of status epilepticus was 120 minutes.

The MESOR was 12.5 episodes per hour, and the amplitude was 2.4 episodes per hour, indicating that the distribution was not even over 24 hours. The peak number of onsets was between 10 a.m. and 11 a.m., and the trough was between 10 p.m. and 11 p.m.

A secondary analysis examined the circadian distribution of time to treatment with rescue medications. The distribution of time to treatment with the first benzodiazepine did not differ significantly from a uniform distribution. The time to treatment with the first nonbenzodiazepine antiseizure medication, however, was not uniformly distributed. The longest time to treatment occurred between 3 a.m. and 4 a.m., and the shortest time was between 3 p.m. and 4 p.m. “Although fewer refractory status epilepticus episodes occurred at night, the time to antiseizure medication administration was the longest [during that period]. Thus, nighttime refractory status epilepticus episodes may be at higher risk for delayed treatment,” said Ms. Clark. A limitation of this analysis is that it was influenced by outliers, she added.

The Pediatric Epilepsy Research Foundation and the Epilepsy Research Fund supported the study.

egreb@mdedge.com

SOURCE: Clark J et al. AES 2018. Abstract 3.426.

NEW ORLEANS – The onset of pediatric refractory status epilepticus follows a circadian pattern, according to research presented at the annual meeting of the American Epilepsy Society. The number of episodes is greatest between 10 a.m. and 11 a.m. and smallest between 10 p.m. and 11 p.m.

“Our findings may inform the increase in preventive monitoring, such as video monitoring or seizure-tracking devices for patients,” said Justice Clark, MPH, a program coordinator at Boston Children’s Hospital. “They may also inform chronotherapeutic strategies.”

Research suggests that various types of seizures cluster at different times of the day. Data about the circadian distribution of status epilepticus, however, are limited.

Ms. Clark and colleagues conducted a prospective observational study at 25 hospitals in the United States and Canada from June 2011 to January 2018. Eligible participants were between ages 1 month and 21 years, had focal or generalized convulsive status epilepticus, and had failed to respond to one benzodiazepine and one nonbenzodiazepine antiseizure medication. For patients with more than one episode of refractory status epilepticus during the study, the researchers included only the first episode.

The investigators examined whether the temporal distribution of pediatric refractory status epilepticus onset followed a circadian pattern using a cosinor analysis with a 12-hour cycle. They used the midline-estimating statistic of rhythm (MESOR) technique to estimate the mean number of refractory status epilepticus episodes per hour if onset was evenly distributed. The amplitude in this analysis was the difference in number of episodes per hour between the MESOR and the peak or the MESOR and the trough.

Ms. Clark and her colleagues included 300 patients in their analysis, each of whom had one episode. Approximately 45% of participants were female. The population’s median age was 4.2 years, and the median duration of status epilepticus was 120 minutes.

The MESOR was 12.5 episodes per hour, and the amplitude was 2.4 episodes per hour, indicating that the distribution was not even over 24 hours. The peak number of onsets was between 10 a.m. and 11 a.m., and the trough was between 10 p.m. and 11 p.m.

A secondary analysis examined the circadian distribution of time to treatment with rescue medications. The distribution of time to treatment with the first benzodiazepine did not differ significantly from a uniform distribution. The time to treatment with the first nonbenzodiazepine antiseizure medication, however, was not uniformly distributed. The longest time to treatment occurred between 3 a.m. and 4 a.m., and the shortest time was between 3 p.m. and 4 p.m. “Although fewer refractory status epilepticus episodes occurred at night, the time to antiseizure medication administration was the longest [during that period]. Thus, nighttime refractory status epilepticus episodes may be at higher risk for delayed treatment,” said Ms. Clark. A limitation of this analysis is that it was influenced by outliers, she added.

The Pediatric Epilepsy Research Foundation and the Epilepsy Research Fund supported the study.

egreb@mdedge.com

SOURCE: Clark J et al. AES 2018. Abstract 3.426.

Emergency department visits in the United States climbed by 15% overall from 2006 to 2014. Over the same time period, ED visits by people with mental health issues soared by 44%, according to a report from the Agency for Health Care Research & Quality.

©Getty Images

“The extent to which ERs are now flooded with patients with mental illness is unprecedented,” David R. Rubinow, MD, chairman of the department of psychiatry at the University of North Carolina, Chapel Hill, said in an interview with CNN.

This overflow is “having a really destructive effect on health care delivery in general,” Dr. Rubinow said. “There are ERs now that are repeatedly on diversion – which means they can’t see any more patients – because there are so many patients with mental illness or behavioral problems [who] are populating the ER.”

Physicians such as Mark D. Pearlmutter, MD, are convinced that EDs have become the medical refuge for many people with mental illness. “We are the safety net,” said Dr. Pearlmutter, an emergency physician affiliated with Steward Health Care in Brighton, Mass. Dr. Pearlmutter said some patients he has seen in the ED often have dual diagnoses, such as “substance abuse and depression, for example.”

As a result of this situation, patients with psychiatric needs might not receive the care that they really need, and care might be delayed for patients with other life-threatening conditions. “The ER is not a great place if you’re a mental health patient; the cardiac patients get put in front of you, and you could end up being there for a really long time, said David Morris, PhD, a psychologist at the O’Donnell Brain Institute in Dallas.

One solution to the overcrowding issue might be to do a better job at integrating mental health into medical practice, Dr. Pearlmutter suggested. After all, increasingly, primary care physicians are providing mental health care.

Twists on New Year’s resolutions

Some people bring in each new year by shifting their perspectives – without making resolutions.

Tim Ferriss, an entrepreneur known for blogs and podcasts on work and life, engages in what he calls “past year reviews,” where accomplishments are tallied frequently throughout the year in terms of their positive or negative effect, with the latter being ruled out for the coming year. Over a few years, he hopes, the list of negatives will shrink and the positive items will increase, according to a post on the NBC News website.

Instead of making resolutions, Oprah Winfrey keeps a journal that is updated nightly with five things that spark gratitude. “I live in the present moment. I try to find the good that’s going on in any given situation,” Ms. Winfrey said in a 2017 interview. The practice has taught her to be careful in her personal wishes.

Melinda Gates starts the new year with a single word to provide guidance. Past examples include “gentle,” “spacious,” and, last year, “grace.” Her selections, she said, have helped her sharpen her focus on the really important aspects of her life.

“[Grace] even helped me find a beam of peace through the sadness of a friend’s funeral. When I was upset or distressed, I whispered to myself: ‘Grace.’ That’s the power of a well-chosen word of the year. It makes the year better – and it helps me be better, too, she wrote in a recent LinkedIn post.
 

20-somethings facing challenges

A recent article in the Guardian lamented a life that is not progressing as expected.

“I am 25 and a half, single, unable to pay my rent, and the closest thing I own to a car is a broken skateboard,” wrote Juliana Piskorz. “I’m in the throes of a quarter-life crisis.”

Ms. Piskorz, who said she suffers from anxiety attacks, said her experience of this crisis manifests itself by making her want to run away, start all over, or distract herself from reality.

She is not alone. According to LinkedIn, about three-quarters of people aged 25-33 share this kind of insecurity and doubt. Low self-esteem is an important culprit, according to James Arkell, MD, a psychiatrist affiliated with the Nightingale Hospital London. “Very often, 20-somethings I see here are beautiful, talented, and have the world on a plate, but they don’t like themselves and that’s got to be about society making them feel as if they have to keep up with these unrelenting standards.”

There are other reasons for millennial despair, Ms. Piskorz speculated.

“Our childhood visions for our lives ... are no longer realistic,” she wrote. “Due to unaffordable housing, less job security, and lower incomes, the traditional ‘markers’ of adulthood, such as owning a home, getting married, and having children, are being pushed back. This has left a vacuum between our teenage years and late 20s with many of us feeling we’re navigating a no man’s land with zero clue when we’ll reach the other side.”

Seeking optimism, Ms. Piskorz noted that, as a community, millennials share many positive characteristics that should serve them well.

“We are not afraid to talk about how we feel, although we should probably talk more,” she wrote. “We stand up for the causes that we think matter; we are not afraid to try new things, and we are not willing to live a life half lived.”

Apps monitor teen angst, depression

The smartphone, often seen as a tool that fuels angst, might be a resource that could identify teenagers in trouble.

According to an article in the Washington Post, research is underway on smartphone apps that can decipher the digital footprints left by users during their Internet ramblings.

“As teens scroll through Instagram or Snapchat, tap out texts, or watch YouTube videos, they also leave digital footprints that might offer clues to their psychological well-being,” wrote article author Lindsey Tanner, of the Associated Press. “Changes in typing speed, voice tone, word choice, and how often kids stay home could signal trouble.”

“We are tracking the equivalent of a heartbeat for the human brain,” said Alex Leow, MD, PhD, an app developer, and associate professor of psychiatry and bioengineering at the University of Illinois at Chicago.

The technology is not ready for deployment because of technical glitches and, more importantly, ethical issues concerning the recording and scrutiny of a user’s personal data being roadblocks. Still, with the permission of the user, mood-detecting apps might one day be a smartphone feature. “[Users] could withdraw permission at any time, said Nick B. Allen, PhD, a psychologist at the University of Oregon, Portland, who has helped create an app that is being tested on young people who have attempted suicide.

He said the biggest hurdle is figuring out “what’s the signal and what’s the noise – what is in this enormous amount of data that people accumulate on their phone that is indicative of a mental health crisis.”
 

Virtues of “intellectual humility”

Intellectual humility is neither a character flaw nor a sign of being a pushover.

Instead, wrote science reporter Brian Resnick in an article posted on Vox.com, “it’s a method of thinking. It’s about entertaining the possibility that you may be wrong and being open to learning from the experience of others. Intellectual humility is about being actively curious about your blind spots.”

In an effort to promote intellectual humility in psychology, two researchers, Tal Yarkoni, PhD, and Christopher F. Chabris, PhD, launched the Loss-of-Confidence project. The project is a safe space where researchers who doubt a previous finding in psychology can recalibrate. “I do think it’s a cultural issue that people are not willing to admit mistakes,” said Julia M. Rohrer, a PhD candidate and personality psychologist at the Max Planck Institute for Human Development in Berlin who joined the team in 2017. “Our broader goal is to gently nudge the whole scientific system and psychology toward a different culture where it’s okay, normalized, and expected for researchers to admit past mistakes and not get penalized for it.”

Put another way, the aim is to foster a culture where intellectually humble, honest, and curious people can thrive. For that to occur, “we all, even the smartest among us, need to better appreciate our cognitive blind spots,” Mr. Resnick wrote. “Our minds are more imperfect and imprecise than we’d often like to admit.”

In a recent paper, Ms. Rohrer and her associates said the Loss-of-Confidence project grew out of an online discussion in the wake of a post by Dana R. Carney, PhD, and associates on power poses. In that post, Dr. Carney explains why she changed her position on the value of power poses, concluding that the data gathered by her lab at the time leading to the power poses theory (Psychol Sci. 2010 Oct 21 [10]:1363-8) were real but flimsy. “My views have been updated to reflect the evidence,” she wrote. “As such, I do not believe that ‘power pose’ effects are real.”

In the Vox.com article, Mr. Resnick wrote that intellectual humility is needed for two reasons. “One is that our culture promotes and rewards overconfidence and arrogance. At the same time, when we are wrong – out of ignorance or error – and realize it, our culture doesn’t make it easy to admit it. Humbling moments too easily can turn into moments of humiliation.”

Emergency department visits in the United States climbed by 15% overall from 2006 to 2014. Over the same time period, ED visits by people with mental health issues soared by 44%, according to a report from the Agency for Health Care Research & Quality.

©Getty Images

“The extent to which ERs are now flooded with patients with mental illness is unprecedented,” David R. Rubinow, MD, chairman of the department of psychiatry at the University of North Carolina, Chapel Hill, said in an interview with CNN.

This overflow is “having a really destructive effect on health care delivery in general,” Dr. Rubinow said. “There are ERs now that are repeatedly on diversion – which means they can’t see any more patients – because there are so many patients with mental illness or behavioral problems [who] are populating the ER.”

Physicians such as Mark D. Pearlmutter, MD, are convinced that EDs have become the medical refuge for many people with mental illness. “We are the safety net,” said Dr. Pearlmutter, an emergency physician affiliated with Steward Health Care in Brighton, Mass. Dr. Pearlmutter said some patients he has seen in the ED often have dual diagnoses, such as “substance abuse and depression, for example.”

As a result of this situation, patients with psychiatric needs might not receive the care that they really need, and care might be delayed for patients with other life-threatening conditions. “The ER is not a great place if you’re a mental health patient; the cardiac patients get put in front of you, and you could end up being there for a really long time, said David Morris, PhD, a psychologist at the O’Donnell Brain Institute in Dallas.

One solution to the overcrowding issue might be to do a better job at integrating mental health into medical practice, Dr. Pearlmutter suggested. After all, increasingly, primary care physicians are providing mental health care.

Twists on New Year’s resolutions

Some people bring in each new year by shifting their perspectives – without making resolutions.

Tim Ferriss, an entrepreneur known for blogs and podcasts on work and life, engages in what he calls “past year reviews,” where accomplishments are tallied frequently throughout the year in terms of their positive or negative effect, with the latter being ruled out for the coming year. Over a few years, he hopes, the list of negatives will shrink and the positive items will increase, according to a post on the NBC News website.

Instead of making resolutions, Oprah Winfrey keeps a journal that is updated nightly with five things that spark gratitude. “I live in the present moment. I try to find the good that’s going on in any given situation,” Ms. Winfrey said in a 2017 interview. The practice has taught her to be careful in her personal wishes.

Melinda Gates starts the new year with a single word to provide guidance. Past examples include “gentle,” “spacious,” and, last year, “grace.” Her selections, she said, have helped her sharpen her focus on the really important aspects of her life.

“[Grace] even helped me find a beam of peace through the sadness of a friend’s funeral. When I was upset or distressed, I whispered to myself: ‘Grace.’ That’s the power of a well-chosen word of the year. It makes the year better – and it helps me be better, too, she wrote in a recent LinkedIn post.
 

20-somethings facing challenges

A recent article in the Guardian lamented a life that is not progressing as expected.

“I am 25 and a half, single, unable to pay my rent, and the closest thing I own to a car is a broken skateboard,” wrote Juliana Piskorz. “I’m in the throes of a quarter-life crisis.”

Ms. Piskorz, who said she suffers from anxiety attacks, said her experience of this crisis manifests itself by making her want to run away, start all over, or distract herself from reality.

She is not alone. According to LinkedIn, about three-quarters of people aged 25-33 share this kind of insecurity and doubt. Low self-esteem is an important culprit, according to James Arkell, MD, a psychiatrist affiliated with the Nightingale Hospital London. “Very often, 20-somethings I see here are beautiful, talented, and have the world on a plate, but they don’t like themselves and that’s got to be about society making them feel as if they have to keep up with these unrelenting standards.”

There are other reasons for millennial despair, Ms. Piskorz speculated.

“Our childhood visions for our lives ... are no longer realistic,” she wrote. “Due to unaffordable housing, less job security, and lower incomes, the traditional ‘markers’ of adulthood, such as owning a home, getting married, and having children, are being pushed back. This has left a vacuum between our teenage years and late 20s with many of us feeling we’re navigating a no man’s land with zero clue when we’ll reach the other side.”

Seeking optimism, Ms. Piskorz noted that, as a community, millennials share many positive characteristics that should serve them well.

“We are not afraid to talk about how we feel, although we should probably talk more,” she wrote. “We stand up for the causes that we think matter; we are not afraid to try new things, and we are not willing to live a life half lived.”

Apps monitor teen angst, depression

The smartphone, often seen as a tool that fuels angst, might be a resource that could identify teenagers in trouble.

According to an article in the Washington Post, research is underway on smartphone apps that can decipher the digital footprints left by users during their Internet ramblings.

“As teens scroll through Instagram or Snapchat, tap out texts, or watch YouTube videos, they also leave digital footprints that might offer clues to their psychological well-being,” wrote article author Lindsey Tanner, of the Associated Press. “Changes in typing speed, voice tone, word choice, and how often kids stay home could signal trouble.”

“We are tracking the equivalent of a heartbeat for the human brain,” said Alex Leow, MD, PhD, an app developer, and associate professor of psychiatry and bioengineering at the University of Illinois at Chicago.

The technology is not ready for deployment because of technical glitches and, more importantly, ethical issues concerning the recording and scrutiny of a user’s personal data being roadblocks. Still, with the permission of the user, mood-detecting apps might one day be a smartphone feature. “[Users] could withdraw permission at any time, said Nick B. Allen, PhD, a psychologist at the University of Oregon, Portland, who has helped create an app that is being tested on young people who have attempted suicide.

He said the biggest hurdle is figuring out “what’s the signal and what’s the noise – what is in this enormous amount of data that people accumulate on their phone that is indicative of a mental health crisis.”
 

Virtues of “intellectual humility”

Intellectual humility is neither a character flaw nor a sign of being a pushover.

Instead, wrote science reporter Brian Resnick in an article posted on Vox.com, “it’s a method of thinking. It’s about entertaining the possibility that you may be wrong and being open to learning from the experience of others. Intellectual humility is about being actively curious about your blind spots.”

In an effort to promote intellectual humility in psychology, two researchers, Tal Yarkoni, PhD, and Christopher F. Chabris, PhD, launched the Loss-of-Confidence project. The project is a safe space where researchers who doubt a previous finding in psychology can recalibrate. “I do think it’s a cultural issue that people are not willing to admit mistakes,” said Julia M. Rohrer, a PhD candidate and personality psychologist at the Max Planck Institute for Human Development in Berlin who joined the team in 2017. “Our broader goal is to gently nudge the whole scientific system and psychology toward a different culture where it’s okay, normalized, and expected for researchers to admit past mistakes and not get penalized for it.”

Put another way, the aim is to foster a culture where intellectually humble, honest, and curious people can thrive. For that to occur, “we all, even the smartest among us, need to better appreciate our cognitive blind spots,” Mr. Resnick wrote. “Our minds are more imperfect and imprecise than we’d often like to admit.”

In a recent paper, Ms. Rohrer and her associates said the Loss-of-Confidence project grew out of an online discussion in the wake of a post by Dana R. Carney, PhD, and associates on power poses. In that post, Dr. Carney explains why she changed her position on the value of power poses, concluding that the data gathered by her lab at the time leading to the power poses theory (Psychol Sci. 2010 Oct 21 [10]:1363-8) were real but flimsy. “My views have been updated to reflect the evidence,” she wrote. “As such, I do not believe that ‘power pose’ effects are real.”

In the Vox.com article, Mr. Resnick wrote that intellectual humility is needed for two reasons. “One is that our culture promotes and rewards overconfidence and arrogance. At the same time, when we are wrong – out of ignorance or error – and realize it, our culture doesn’t make it easy to admit it. Humbling moments too easily can turn into moments of humiliation.”

Emergency department visits in the United States climbed by 15% overall from 2006 to 2014. Over the same time period, ED visits by people with mental health issues soared by 44%, according to a report from the Agency for Health Care Research & Quality.

©Getty Images

“The extent to which ERs are now flooded with patients with mental illness is unprecedented,” David R. Rubinow, MD, chairman of the department of psychiatry at the University of North Carolina, Chapel Hill, said in an interview with CNN.

This overflow is “having a really destructive effect on health care delivery in general,” Dr. Rubinow said. “There are ERs now that are repeatedly on diversion – which means they can’t see any more patients – because there are so many patients with mental illness or behavioral problems [who] are populating the ER.”

Physicians such as Mark D. Pearlmutter, MD, are convinced that EDs have become the medical refuge for many people with mental illness. “We are the safety net,” said Dr. Pearlmutter, an emergency physician affiliated with Steward Health Care in Brighton, Mass. Dr. Pearlmutter said some patients he has seen in the ED often have dual diagnoses, such as “substance abuse and depression, for example.”

As a result of this situation, patients with psychiatric needs might not receive the care that they really need, and care might be delayed for patients with other life-threatening conditions. “The ER is not a great place if you’re a mental health patient; the cardiac patients get put in front of you, and you could end up being there for a really long time, said David Morris, PhD, a psychologist at the O’Donnell Brain Institute in Dallas.

One solution to the overcrowding issue might be to do a better job at integrating mental health into medical practice, Dr. Pearlmutter suggested. After all, increasingly, primary care physicians are providing mental health care.

Twists on New Year’s resolutions

Some people bring in each new year by shifting their perspectives – without making resolutions.

Tim Ferriss, an entrepreneur known for blogs and podcasts on work and life, engages in what he calls “past year reviews,” where accomplishments are tallied frequently throughout the year in terms of their positive or negative effect, with the latter being ruled out for the coming year. Over a few years, he hopes, the list of negatives will shrink and the positive items will increase, according to a post on the NBC News website.

Instead of making resolutions, Oprah Winfrey keeps a journal that is updated nightly with five things that spark gratitude. “I live in the present moment. I try to find the good that’s going on in any given situation,” Ms. Winfrey said in a 2017 interview. The practice has taught her to be careful in her personal wishes.

Melinda Gates starts the new year with a single word to provide guidance. Past examples include “gentle,” “spacious,” and, last year, “grace.” Her selections, she said, have helped her sharpen her focus on the really important aspects of her life.

“[Grace] even helped me find a beam of peace through the sadness of a friend’s funeral. When I was upset or distressed, I whispered to myself: ‘Grace.’ That’s the power of a well-chosen word of the year. It makes the year better – and it helps me be better, too, she wrote in a recent LinkedIn post.
 

20-somethings facing challenges

A recent article in the Guardian lamented a life that is not progressing as expected.

“I am 25 and a half, single, unable to pay my rent, and the closest thing I own to a car is a broken skateboard,” wrote Juliana Piskorz. “I’m in the throes of a quarter-life crisis.”

Ms. Piskorz, who said she suffers from anxiety attacks, said her experience of this crisis manifests itself by making her want to run away, start all over, or distract herself from reality.

She is not alone. According to LinkedIn, about three-quarters of people aged 25-33 share this kind of insecurity and doubt. Low self-esteem is an important culprit, according to James Arkell, MD, a psychiatrist affiliated with the Nightingale Hospital London. “Very often, 20-somethings I see here are beautiful, talented, and have the world on a plate, but they don’t like themselves and that’s got to be about society making them feel as if they have to keep up with these unrelenting standards.”

There are other reasons for millennial despair, Ms. Piskorz speculated.

“Our childhood visions for our lives ... are no longer realistic,” she wrote. “Due to unaffordable housing, less job security, and lower incomes, the traditional ‘markers’ of adulthood, such as owning a home, getting married, and having children, are being pushed back. This has left a vacuum between our teenage years and late 20s with many of us feeling we’re navigating a no man’s land with zero clue when we’ll reach the other side.”

Seeking optimism, Ms. Piskorz noted that, as a community, millennials share many positive characteristics that should serve them well.

“We are not afraid to talk about how we feel, although we should probably talk more,” she wrote. “We stand up for the causes that we think matter; we are not afraid to try new things, and we are not willing to live a life half lived.”

Apps monitor teen angst, depression

The smartphone, often seen as a tool that fuels angst, might be a resource that could identify teenagers in trouble.

According to an article in the Washington Post, research is underway on smartphone apps that can decipher the digital footprints left by users during their Internet ramblings.

“As teens scroll through Instagram or Snapchat, tap out texts, or watch YouTube videos, they also leave digital footprints that might offer clues to their psychological well-being,” wrote article author Lindsey Tanner, of the Associated Press. “Changes in typing speed, voice tone, word choice, and how often kids stay home could signal trouble.”

“We are tracking the equivalent of a heartbeat for the human brain,” said Alex Leow, MD, PhD, an app developer, and associate professor of psychiatry and bioengineering at the University of Illinois at Chicago.

The technology is not ready for deployment because of technical glitches and, more importantly, ethical issues concerning the recording and scrutiny of a user’s personal data being roadblocks. Still, with the permission of the user, mood-detecting apps might one day be a smartphone feature. “[Users] could withdraw permission at any time, said Nick B. Allen, PhD, a psychologist at the University of Oregon, Portland, who has helped create an app that is being tested on young people who have attempted suicide.

He said the biggest hurdle is figuring out “what’s the signal and what’s the noise – what is in this enormous amount of data that people accumulate on their phone that is indicative of a mental health crisis.”
 

Virtues of “intellectual humility”

Intellectual humility is neither a character flaw nor a sign of being a pushover.

Instead, wrote science reporter Brian Resnick in an article posted on Vox.com, “it’s a method of thinking. It’s about entertaining the possibility that you may be wrong and being open to learning from the experience of others. Intellectual humility is about being actively curious about your blind spots.”

In an effort to promote intellectual humility in psychology, two researchers, Tal Yarkoni, PhD, and Christopher F. Chabris, PhD, launched the Loss-of-Confidence project. The project is a safe space where researchers who doubt a previous finding in psychology can recalibrate. “I do think it’s a cultural issue that people are not willing to admit mistakes,” said Julia M. Rohrer, a PhD candidate and personality psychologist at the Max Planck Institute for Human Development in Berlin who joined the team in 2017. “Our broader goal is to gently nudge the whole scientific system and psychology toward a different culture where it’s okay, normalized, and expected for researchers to admit past mistakes and not get penalized for it.”

Put another way, the aim is to foster a culture where intellectually humble, honest, and curious people can thrive. For that to occur, “we all, even the smartest among us, need to better appreciate our cognitive blind spots,” Mr. Resnick wrote. “Our minds are more imperfect and imprecise than we’d often like to admit.”

In a recent paper, Ms. Rohrer and her associates said the Loss-of-Confidence project grew out of an online discussion in the wake of a post by Dana R. Carney, PhD, and associates on power poses. In that post, Dr. Carney explains why she changed her position on the value of power poses, concluding that the data gathered by her lab at the time leading to the power poses theory (Psychol Sci. 2010 Oct 21 [10]:1363-8) were real but flimsy. “My views have been updated to reflect the evidence,” she wrote. “As such, I do not believe that ‘power pose’ effects are real.”

In the Vox.com article, Mr. Resnick wrote that intellectual humility is needed for two reasons. “One is that our culture promotes and rewards overconfidence and arrogance. At the same time, when we are wrong – out of ignorance or error – and realize it, our culture doesn’t make it easy to admit it. Humbling moments too easily can turn into moments of humiliation.”

LOS ANGELES – In some individuals, reduced degradation of insulin by the liver is the cause of type 2 diabetes mellitus.

Doug Brunk/MDedge News

That’s a hypothesis that Richard N. Bergman, PhD, and his colleagues are testing in his lab at the Sports Spectacular Diabetes and Obesity Wellness and Research Center at Cedars-Sinai Medical Center, Los Angeles.

“More than 50% of insulin secreted into the portal vein is degraded by the liver and never enters the systemic circulation,” Dr. Bergman said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “We have found that if you make an animal insulin resistant with a high fat diet, they degrade less of the insulin. Why is that? They deliver a higher fraction of the insulin into the systemic circulation. One of the answers is that the liver is a gateway for insulin delivery to the systemic circulation.” In fact, when he and his colleagues tested a population of normal dogs, they found wide variability in the ability of the liver to take up and degrade insulin (Diabetes. 2018 67[8]:1495-503).

“It ranged from 20% to 70%; I didn’t believe these data,” said Dr. Bergman, who is also chair in diabetes research at Cedars-Sinai. “We had to redo the study and the same thing was true. There’s a wide variation in what fraction of insulin that enters the liver is degraded. That led to the idea that this could be true in humans.”

dbrunk@mdedge.com

LOS ANGELES – In some individuals, reduced degradation of insulin by the liver is the cause of type 2 diabetes mellitus.

Doug Brunk/MDedge News

That’s a hypothesis that Richard N. Bergman, PhD, and his colleagues are testing in his lab at the Sports Spectacular Diabetes and Obesity Wellness and Research Center at Cedars-Sinai Medical Center, Los Angeles.

“More than 50% of insulin secreted into the portal vein is degraded by the liver and never enters the systemic circulation,” Dr. Bergman said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “We have found that if you make an animal insulin resistant with a high fat diet, they degrade less of the insulin. Why is that? They deliver a higher fraction of the insulin into the systemic circulation. One of the answers is that the liver is a gateway for insulin delivery to the systemic circulation.” In fact, when he and his colleagues tested a population of normal dogs, they found wide variability in the ability of the liver to take up and degrade insulin (Diabetes. 2018 67[8]:1495-503).

“It ranged from 20% to 70%; I didn’t believe these data,” said Dr. Bergman, who is also chair in diabetes research at Cedars-Sinai. “We had to redo the study and the same thing was true. There’s a wide variation in what fraction of insulin that enters the liver is degraded. That led to the idea that this could be true in humans.”

dbrunk@mdedge.com

LOS ANGELES – In some individuals, reduced degradation of insulin by the liver is the cause of type 2 diabetes mellitus.

Doug Brunk/MDedge News

That’s a hypothesis that Richard N. Bergman, PhD, and his colleagues are testing in his lab at the Sports Spectacular Diabetes and Obesity Wellness and Research Center at Cedars-Sinai Medical Center, Los Angeles.

“More than 50% of insulin secreted into the portal vein is degraded by the liver and never enters the systemic circulation,” Dr. Bergman said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “We have found that if you make an animal insulin resistant with a high fat diet, they degrade less of the insulin. Why is that? They deliver a higher fraction of the insulin into the systemic circulation. One of the answers is that the liver is a gateway for insulin delivery to the systemic circulation.” In fact, when he and his colleagues tested a population of normal dogs, they found wide variability in the ability of the liver to take up and degrade insulin (Diabetes. 2018 67[8]:1495-503).

“It ranged from 20% to 70%; I didn’t believe these data,” said Dr. Bergman, who is also chair in diabetes research at Cedars-Sinai. “We had to redo the study and the same thing was true. There’s a wide variation in what fraction of insulin that enters the liver is degraded. That led to the idea that this could be true in humans.”

dbrunk@mdedge.com

Adiposity changes during adolescence are more strongly associated with ovarian cancer risk than changes in adiposity during adulthood, according to data from the Nurses’ Health Study.

Among the 133,526 women followed prospectively in the observational study, investigators documented 562 incident ovarian cancers in the first cohort (1980-2012) and 226 in the second cohort (1989-2013) during 32 years of follow-up. Body mass index (BMI) changes that occurred between age 10 and 18 years was strongly positively associated with ovarian cancer risk (hazard Ratio, 1.24; 95% confidence interval, 1.11-1.39; P = .0002), compared with a slight association with risk for BMI change after age 18 years (HR, 1.06; 95% CI, 0.99-1.14; P = .10), Tianyi Huang, ScD, of Harvard Medical School, Boston, and his associates reported in Annals of Oncology.

The association between adolescent BMI changes and ovarian cancer risk was stronger for premenopausal cases (HR, 2.41; 95% CI, 1.38-4.19; P = .002), compared with postmenopausal cases (HR, 1.31; 95% CI, 0.90-1.92; P = .16), and suggestively stronger for nonserous tumors versus serous ovarian tumors.

For BMI change between age 10 and 18 years, the HR for every 5 kg/m² increase was 1.35 (1.10, 1.65) for nonserous cancer and 1.08 (0.90, 1.28) for serous cancer (P = .10).

“This study provides additional evidence to support that maintaining a healthy weight throughout the life course may have moderate benefits on ovarian cancer prevention, particularly nonserous subtypes diagnosed during premenopausal years,” the authors wrote. “Further studies are needed to understand the specific mechanisms linking peripubertal adiposity and adult ovarian cancer risk.”

SOURCE: Huang T et al. Ann Oncol. 2018 Dec 21. doi: 10.1093/annonc/mdy546.

Adiposity changes during adolescence are more strongly associated with ovarian cancer risk than changes in adiposity during adulthood, according to data from the Nurses’ Health Study.

Among the 133,526 women followed prospectively in the observational study, investigators documented 562 incident ovarian cancers in the first cohort (1980-2012) and 226 in the second cohort (1989-2013) during 32 years of follow-up. Body mass index (BMI) changes that occurred between age 10 and 18 years was strongly positively associated with ovarian cancer risk (hazard Ratio, 1.24; 95% confidence interval, 1.11-1.39; P = .0002), compared with a slight association with risk for BMI change after age 18 years (HR, 1.06; 95% CI, 0.99-1.14; P = .10), Tianyi Huang, ScD, of Harvard Medical School, Boston, and his associates reported in Annals of Oncology.

The association between adolescent BMI changes and ovarian cancer risk was stronger for premenopausal cases (HR, 2.41; 95% CI, 1.38-4.19; P = .002), compared with postmenopausal cases (HR, 1.31; 95% CI, 0.90-1.92; P = .16), and suggestively stronger for nonserous tumors versus serous ovarian tumors.

For BMI change between age 10 and 18 years, the HR for every 5 kg/m² increase was 1.35 (1.10, 1.65) for nonserous cancer and 1.08 (0.90, 1.28) for serous cancer (P = .10).

“This study provides additional evidence to support that maintaining a healthy weight throughout the life course may have moderate benefits on ovarian cancer prevention, particularly nonserous subtypes diagnosed during premenopausal years,” the authors wrote. “Further studies are needed to understand the specific mechanisms linking peripubertal adiposity and adult ovarian cancer risk.”

SOURCE: Huang T et al. Ann Oncol. 2018 Dec 21. doi: 10.1093/annonc/mdy546.

Adiposity changes during adolescence are more strongly associated with ovarian cancer risk than changes in adiposity during adulthood, according to data from the Nurses’ Health Study.

Among the 133,526 women followed prospectively in the observational study, investigators documented 562 incident ovarian cancers in the first cohort (1980-2012) and 226 in the second cohort (1989-2013) during 32 years of follow-up. Body mass index (BMI) changes that occurred between age 10 and 18 years was strongly positively associated with ovarian cancer risk (hazard Ratio, 1.24; 95% confidence interval, 1.11-1.39; P = .0002), compared with a slight association with risk for BMI change after age 18 years (HR, 1.06; 95% CI, 0.99-1.14; P = .10), Tianyi Huang, ScD, of Harvard Medical School, Boston, and his associates reported in Annals of Oncology.

The association between adolescent BMI changes and ovarian cancer risk was stronger for premenopausal cases (HR, 2.41; 95% CI, 1.38-4.19; P = .002), compared with postmenopausal cases (HR, 1.31; 95% CI, 0.90-1.92; P = .16), and suggestively stronger for nonserous tumors versus serous ovarian tumors.

For BMI change between age 10 and 18 years, the HR for every 5 kg/m² increase was 1.35 (1.10, 1.65) for nonserous cancer and 1.08 (0.90, 1.28) for serous cancer (P = .10).

“This study provides additional evidence to support that maintaining a healthy weight throughout the life course may have moderate benefits on ovarian cancer prevention, particularly nonserous subtypes diagnosed during premenopausal years,” the authors wrote. “Further studies are needed to understand the specific mechanisms linking peripubertal adiposity and adult ovarian cancer risk.”

SOURCE: Huang T et al. Ann Oncol. 2018 Dec 21. doi: 10.1093/annonc/mdy546.

The FP recognized this as squamous cell carcinoma (SCC) of the penis.

The FP knew that a biopsy would be needed to confirm his clinical impression and obtained informed consent for a shave biopsy of a portion of the lesion. While the FP was taught in medical school to never use epinephrine on the penis, he realized that this was merely a myth (see “Biopsies for skin cancer detection: Dispelling the myths”). He injected 1% lidocaine with epinephrine into the lesion for anesthesia and to minimize bleeding during the shave biopsy. (See the Watch & Learn video on “Shave biopsy.”) The FP performed a shave biopsy of a small portion of the lesion farthest from the urethra.

Aluminum chloride was used to stop most of the bleeding, but since the penis is very vascular, some electrocoagulation was needed to stop all of the bleeding. The pathology came back as an invasive SCC. Due to the location of the lesion on the glans and around the urethra, the patient was referred to Urology.

A partial penectomy was performed and clear surgical margins were achieved. If the lesion had been on the shaft of the penis (rather than the glans penis), a Mohs surgeon would have attempted to save the whole penis with tissue sparing surgery.

‌

Photo courtesy of Jeff Meffert, MD, and text courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP recognized this as squamous cell carcinoma (SCC) of the penis.

The FP knew that a biopsy would be needed to confirm his clinical impression and obtained informed consent for a shave biopsy of a portion of the lesion. While the FP was taught in medical school to never use epinephrine on the penis, he realized that this was merely a myth (see “Biopsies for skin cancer detection: Dispelling the myths”). He injected 1% lidocaine with epinephrine into the lesion for anesthesia and to minimize bleeding during the shave biopsy. (See the Watch & Learn video on “Shave biopsy.”) The FP performed a shave biopsy of a small portion of the lesion farthest from the urethra.

Aluminum chloride was used to stop most of the bleeding, but since the penis is very vascular, some electrocoagulation was needed to stop all of the bleeding. The pathology came back as an invasive SCC. Due to the location of the lesion on the glans and around the urethra, the patient was referred to Urology.

A partial penectomy was performed and clear surgical margins were achieved. If the lesion had been on the shaft of the penis (rather than the glans penis), a Mohs surgeon would have attempted to save the whole penis with tissue sparing surgery.

‌

Photo courtesy of Jeff Meffert, MD, and text courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

The FP recognized this as squamous cell carcinoma (SCC) of the penis.

The FP knew that a biopsy would be needed to confirm his clinical impression and obtained informed consent for a shave biopsy of a portion of the lesion. While the FP was taught in medical school to never use epinephrine on the penis, he realized that this was merely a myth (see “Biopsies for skin cancer detection: Dispelling the myths”). He injected 1% lidocaine with epinephrine into the lesion for anesthesia and to minimize bleeding during the shave biopsy. (See the Watch & Learn video on “Shave biopsy.”) The FP performed a shave biopsy of a small portion of the lesion farthest from the urethra.

Aluminum chloride was used to stop most of the bleeding, but since the penis is very vascular, some electrocoagulation was needed to stop all of the bleeding. The pathology came back as an invasive SCC. Due to the location of the lesion on the glans and around the urethra, the patient was referred to Urology.

A partial penectomy was performed and clear surgical margins were achieved. If the lesion had been on the shaft of the penis (rather than the glans penis), a Mohs surgeon would have attempted to save the whole penis with tissue sparing surgery.

‌

Photo courtesy of Jeff Meffert, MD, and text courtesy of Richard P. Usatine, MD. This case was adapted from: Karnes J, Usatine R. Squamous cell carcinoma. In: Usatine R, Smith M, Mayeaux EJ, et al. Color Atlas of Family Medicine. 2nd ed. New York, NY: McGraw-Hill; 2013:999-1007.

To learn more about the newest 3rd edition of the Color Atlas and Synopsis of Family Medicine, see: https://www.amazon.com/Color-Atlas-Synopsis-Family-Medicine/dp/1259862046/

You can get the Color Atlas of Family Medicine app by clicking on this link: usatinemedia.com

Consider thinking outside the lower body for pelvic pain. Also today, treating obstructive sleep apnea with positive airway pressure decreased amyloid levels, spending on medical marketing increased by more than $12 billion over that past two decades, and one expert has advice on how you can get your work published.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Consider thinking outside the lower body for pelvic pain. Also today, treating obstructive sleep apnea with positive airway pressure decreased amyloid levels, spending on medical marketing increased by more than $12 billion over that past two decades, and one expert has advice on how you can get your work published.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Consider thinking outside the lower body for pelvic pain. Also today, treating obstructive sleep apnea with positive airway pressure decreased amyloid levels, spending on medical marketing increased by more than $12 billion over that past two decades, and one expert has advice on how you can get your work published.

Amazon Alexa

Apple Podcasts

Google Podcasts

Spotify
 

Transdermal hormone replacement therapy is associated with the lowest risk of venous thromboembolism, yet still is relatively underused compared to oral preparations, researchers say.

Alexander Raths/Fotolia

Writing in the BMJ, Yana Vinogradova, PhD, of the University of Nottingham (England) and her associates reported the results of two nested case-control studies of hormone replacement therapy (HRT) and venous thromboembolism (VTE) from Jan. 1998 to Feb. 2017 that altogether included 80,396 women aged 40-79 years with a primary diagnosis of VTE matched to 391,494 female controls.

Overall, 7% of the women with VTE had been exposed to HRT in the 90 days before the index date versus 5.5% of controls.

The greatest increase in risk of VTE, compared with no exposure, was seen with oral conjugated equine estrogen with medroxyprogesterone acetate, which was associated with a more than twofold increase in risk (odds ratio, 2.10; 95% confidence interval, 1.92-2.31; P less than .01).

However transdermal HRT use was not associated with any increase in risk, compared with no HRT exposure. The data even pointed to a slight decrease in risk, which the authors suggested may be the result of some residual confounding or indication bias.

Oral HRT generally was associated with a 58% increased risk of VTE, which amounted to a number needed to harm of 1,076 and nine extra cases of VTE per 10,000 women taking oral HRT.

Dr. Vinogradova and her colleagues noted that the vast majority of women in the study were being prescribed oral HRT for menopausal symptoms despite previous studies showing transdermal HRT has much lower risk.

“When women with menopausal symptoms already have an increased VTE risk because of comorbidities or obesity, these women and their doctors should give greater consideration to transdermal HRT,” they wrote.

Lubna Pal, MBBS, director of the menopause program and professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., commented in an interview, “These data are tremendously reassuring. The reported findings are: 1) reaffirm what we have already known , i.e. that advancing age, higher body mass index, and higher doses of exogenous systemic estrogen therapy are associated with increased risk for VTE; 2) offer greater granularity in risk for VTE with different formulations of estrogens and progestins and different regimens than understood thus far, 3) reaffirm that, unlike oral estrogen, transdermal estrogen formulations in doses commonly utilized in clinical practice are not associated with VTE risk, and 4) provide reassurance that the absolute risk, while exaggerated with oral estrogen or combination estrogen and progestin use, is nonetheless small as reflected in the number needed to harm with oral hormone therapy being 1,076, and the number of extra VTE cases attributable to oral HT being 9 per 10,000 woman years. 

“The authors are to be commended on this massive analytic undertaking that allows an improved understanding of HRT-related risk for VTE and offers meaningful guidance to the practitioner,” said Dr. Pal, who was not involved in the study.*

Estrogen-only preparations had a 40% higher risk and combined preparations had a 73% higher risk, compared with no exposure.

In estrogen-only preparations, the lowest risk was seen with estradiol, compared with conjugated equine estrogens or combined preparations.

The lowest risk of VTE among oral preparations was seen with estradiol plus dydrogesterone, which only showed a nonsignificant 18% increase in risk.

In an attempt to account for possible increased risk of VTE, the authors conducted a sensitivity analysis in a subgroup of women who had not previously used anticoagulants, but they found similar results to the main analysis.

“This sensitivity analysis indicates that most of the excluded women had probably used anticoagulants because of atrial fibrillation or hip replacement operations rather than an earlier unrecorded VTE,” they wrote.

One author declared directorship of a clinical software company, but no other conflicts of interest were declared. There was no external funding. Dr. Pal reported that she was a coinvestigator in the Kronos Early Estrogen Prevention Study and on an AMAG Pharmaceuticals advisory board and member of their speaker’s bureau. 

SOURCE: Vinogradova Y et al. BMJ. 2019 Jan 9. doi: 10.1136/bmj.k4810.

*This article was updated 1/11/19.
 

Transdermal hormone replacement therapy is associated with the lowest risk of venous thromboembolism, yet still is relatively underused compared to oral preparations, researchers say.

Alexander Raths/Fotolia

Writing in the BMJ, Yana Vinogradova, PhD, of the University of Nottingham (England) and her associates reported the results of two nested case-control studies of hormone replacement therapy (HRT) and venous thromboembolism (VTE) from Jan. 1998 to Feb. 2017 that altogether included 80,396 women aged 40-79 years with a primary diagnosis of VTE matched to 391,494 female controls.

Overall, 7% of the women with VTE had been exposed to HRT in the 90 days before the index date versus 5.5% of controls.

The greatest increase in risk of VTE, compared with no exposure, was seen with oral conjugated equine estrogen with medroxyprogesterone acetate, which was associated with a more than twofold increase in risk (odds ratio, 2.10; 95% confidence interval, 1.92-2.31; P less than .01).

However transdermal HRT use was not associated with any increase in risk, compared with no HRT exposure. The data even pointed to a slight decrease in risk, which the authors suggested may be the result of some residual confounding or indication bias.

Oral HRT generally was associated with a 58% increased risk of VTE, which amounted to a number needed to harm of 1,076 and nine extra cases of VTE per 10,000 women taking oral HRT.

Dr. Vinogradova and her colleagues noted that the vast majority of women in the study were being prescribed oral HRT for menopausal symptoms despite previous studies showing transdermal HRT has much lower risk.

“When women with menopausal symptoms already have an increased VTE risk because of comorbidities or obesity, these women and their doctors should give greater consideration to transdermal HRT,” they wrote.

Lubna Pal, MBBS, director of the menopause program and professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., commented in an interview, “These data are tremendously reassuring. The reported findings are: 1) reaffirm what we have already known , i.e. that advancing age, higher body mass index, and higher doses of exogenous systemic estrogen therapy are associated with increased risk for VTE; 2) offer greater granularity in risk for VTE with different formulations of estrogens and progestins and different regimens than understood thus far, 3) reaffirm that, unlike oral estrogen, transdermal estrogen formulations in doses commonly utilized in clinical practice are not associated with VTE risk, and 4) provide reassurance that the absolute risk, while exaggerated with oral estrogen or combination estrogen and progestin use, is nonetheless small as reflected in the number needed to harm with oral hormone therapy being 1,076, and the number of extra VTE cases attributable to oral HT being 9 per 10,000 woman years. 

“The authors are to be commended on this massive analytic undertaking that allows an improved understanding of HRT-related risk for VTE and offers meaningful guidance to the practitioner,” said Dr. Pal, who was not involved in the study.*

Estrogen-only preparations had a 40% higher risk and combined preparations had a 73% higher risk, compared with no exposure.

In estrogen-only preparations, the lowest risk was seen with estradiol, compared with conjugated equine estrogens or combined preparations.

The lowest risk of VTE among oral preparations was seen with estradiol plus dydrogesterone, which only showed a nonsignificant 18% increase in risk.

In an attempt to account for possible increased risk of VTE, the authors conducted a sensitivity analysis in a subgroup of women who had not previously used anticoagulants, but they found similar results to the main analysis.

“This sensitivity analysis indicates that most of the excluded women had probably used anticoagulants because of atrial fibrillation or hip replacement operations rather than an earlier unrecorded VTE,” they wrote.

One author declared directorship of a clinical software company, but no other conflicts of interest were declared. There was no external funding. Dr. Pal reported that she was a coinvestigator in the Kronos Early Estrogen Prevention Study and on an AMAG Pharmaceuticals advisory board and member of their speaker’s bureau. 

SOURCE: Vinogradova Y et al. BMJ. 2019 Jan 9. doi: 10.1136/bmj.k4810.

*This article was updated 1/11/19.
 

Transdermal hormone replacement therapy is associated with the lowest risk of venous thromboembolism, yet still is relatively underused compared to oral preparations, researchers say.

Alexander Raths/Fotolia

Writing in the BMJ, Yana Vinogradova, PhD, of the University of Nottingham (England) and her associates reported the results of two nested case-control studies of hormone replacement therapy (HRT) and venous thromboembolism (VTE) from Jan. 1998 to Feb. 2017 that altogether included 80,396 women aged 40-79 years with a primary diagnosis of VTE matched to 391,494 female controls.

Overall, 7% of the women with VTE had been exposed to HRT in the 90 days before the index date versus 5.5% of controls.

The greatest increase in risk of VTE, compared with no exposure, was seen with oral conjugated equine estrogen with medroxyprogesterone acetate, which was associated with a more than twofold increase in risk (odds ratio, 2.10; 95% confidence interval, 1.92-2.31; P less than .01).

However transdermal HRT use was not associated with any increase in risk, compared with no HRT exposure. The data even pointed to a slight decrease in risk, which the authors suggested may be the result of some residual confounding or indication bias.

Oral HRT generally was associated with a 58% increased risk of VTE, which amounted to a number needed to harm of 1,076 and nine extra cases of VTE per 10,000 women taking oral HRT.

Dr. Vinogradova and her colleagues noted that the vast majority of women in the study were being prescribed oral HRT for menopausal symptoms despite previous studies showing transdermal HRT has much lower risk.

“When women with menopausal symptoms already have an increased VTE risk because of comorbidities or obesity, these women and their doctors should give greater consideration to transdermal HRT,” they wrote.

Lubna Pal, MBBS, director of the menopause program and professor of obstetrics, gynecology, and reproductive sciences at Yale University, New Haven, Conn., commented in an interview, “These data are tremendously reassuring. The reported findings are: 1) reaffirm what we have already known , i.e. that advancing age, higher body mass index, and higher doses of exogenous systemic estrogen therapy are associated with increased risk for VTE; 2) offer greater granularity in risk for VTE with different formulations of estrogens and progestins and different regimens than understood thus far, 3) reaffirm that, unlike oral estrogen, transdermal estrogen formulations in doses commonly utilized in clinical practice are not associated with VTE risk, and 4) provide reassurance that the absolute risk, while exaggerated with oral estrogen or combination estrogen and progestin use, is nonetheless small as reflected in the number needed to harm with oral hormone therapy being 1,076, and the number of extra VTE cases attributable to oral HT being 9 per 10,000 woman years. 

“The authors are to be commended on this massive analytic undertaking that allows an improved understanding of HRT-related risk for VTE and offers meaningful guidance to the practitioner,” said Dr. Pal, who was not involved in the study.*

Estrogen-only preparations had a 40% higher risk and combined preparations had a 73% higher risk, compared with no exposure.

In estrogen-only preparations, the lowest risk was seen with estradiol, compared with conjugated equine estrogens or combined preparations.

The lowest risk of VTE among oral preparations was seen with estradiol plus dydrogesterone, which only showed a nonsignificant 18% increase in risk.

In an attempt to account for possible increased risk of VTE, the authors conducted a sensitivity analysis in a subgroup of women who had not previously used anticoagulants, but they found similar results to the main analysis.

“This sensitivity analysis indicates that most of the excluded women had probably used anticoagulants because of atrial fibrillation or hip replacement operations rather than an earlier unrecorded VTE,” they wrote.

One author declared directorship of a clinical software company, but no other conflicts of interest were declared. There was no external funding. Dr. Pal reported that she was a coinvestigator in the Kronos Early Estrogen Prevention Study and on an AMAG Pharmaceuticals advisory board and member of their speaker’s bureau. 

SOURCE: Vinogradova Y et al. BMJ. 2019 Jan 9. doi: 10.1136/bmj.k4810.

*This article was updated 1/11/19.
 

Torrent Pharmaceuticals is expanding its recall of losartan potassium tablets from 2 lots to 12 lots, according to a Safety Alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The recall was based on the discovery of N-nitrosodiethylamine (NDEA) above recommended levels in seven 100-mg lots of losartan, four 50-mg lots, and one 25-mg lot. NDEA is a naturally occurring substance that has been classified as a probable human carcinogen by the International Agency for Research on Cancer. Torrent Pharmaceuticals has not reported any adverse events related to the recall.

Losartan currently is indicated to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in type 2 diabetic patients. Patients who are taking losartan should continue to do so, as stopping treatment without an alternative could represent a greater health risk.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication,” the FDA said in the press release.

Find the full press release on the FDA website.

lfranki@mdedge.com

Torrent Pharmaceuticals is expanding its recall of losartan potassium tablets from 2 lots to 12 lots, according to a Safety Alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The recall was based on the discovery of N-nitrosodiethylamine (NDEA) above recommended levels in seven 100-mg lots of losartan, four 50-mg lots, and one 25-mg lot. NDEA is a naturally occurring substance that has been classified as a probable human carcinogen by the International Agency for Research on Cancer. Torrent Pharmaceuticals has not reported any adverse events related to the recall.

Losartan currently is indicated to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in type 2 diabetic patients. Patients who are taking losartan should continue to do so, as stopping treatment without an alternative could represent a greater health risk.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication,” the FDA said in the press release.

Find the full press release on the FDA website.

lfranki@mdedge.com

Torrent Pharmaceuticals is expanding its recall of losartan potassium tablets from 2 lots to 12 lots, according to a Safety Alert from the Food and Drug Administration.

Wikimedia Commons/FitzColinGerald/Creative Commons License

The recall was based on the discovery of N-nitrosodiethylamine (NDEA) above recommended levels in seven 100-mg lots of losartan, four 50-mg lots, and one 25-mg lot. NDEA is a naturally occurring substance that has been classified as a probable human carcinogen by the International Agency for Research on Cancer. Torrent Pharmaceuticals has not reported any adverse events related to the recall.

Losartan currently is indicated to treat hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in type 2 diabetic patients. Patients who are taking losartan should continue to do so, as stopping treatment without an alternative could represent a greater health risk.

“Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication,” the FDA said in the press release.

Find the full press release on the FDA website.

lfranki@mdedge.com