Heidi Splete

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

A majority of primary care physicians recommended the human papillomavirus (HPV) vaccine to children aged 11-12 years and older, and about half of them used a presumptive style to recommend the vaccine, based on survey responses from 530 clinicians.

“Because of the crucial role of provider recommendation in parental decisions to vaccinate, a great deal of research and intervention efforts have been focused on improving provider communication regarding HPV vaccination,” Allison Kempe, MD, of the University of Colorado and Children’s Hospital Colorado, Aurora, and her colleagues wrote in Pediatrics.

“A presumptive style of initiating HPV vaccine discussions uses words that convey an assumption of vaccination and does not discuss the HPV vaccine in a different manner than other adolescent vaccines,” the authors explained. By contrast, “a conversational style engages parents in an open-ended discussion about the HPV vaccine without linguistic presupposition of vaccination.” Findings from multiple studies have shown that the presumptive approach is associated with higher acceptance of the HPV vaccine, compared with the conversational approach.

The researchers examined survey responses from a nationally representative sample of 302 pediatricians and 228 family physicians. Almost all clinicians in both specialties (99% of pediatricians, 90% of FPs) said they strongly recommended the HPV vaccine for girls aged 15 years and older. Strong recommendations for the HPV vaccine were lowest in both specialties for boys aged 11-12 years (83% of pediatricians, 66% of FPs).

Significantly more pediatricians than FPs reported using a presumptive style when discussing the HPV vaccine (65% vs. 42%, respectively; P <.0001). Overall, 40% of the survey respondents used standing orders for HPV vaccination and 42% had electronic alerts in patients’ medical records to prompt an HPV vaccine discussion.

The proportion of pediatricians who reported a vaccine refusal or deferral rate of 50% or higher for patients aged 11-12 years was 10% for girls and 23% for boys; among FPs, those percentages were 27% for girls and 36% for boys.

In multivariate analysis, the factors associated with a 50% or higher refusal or deferral rate among 11- to 12-year-olds were similar for both genders and included “not strongly recommending [the vaccine] to 11- to 12-year-old patients, not … always using a presumptive recommendation style, strongly agreeing that they encounter less resistance to HPV vaccination from patients aged 13 years versus patients aged 11 years, and anticipating an uncomfortable discussion when recommending to 11- to 12-year-old patients,” the researchers wrote.

More physicians in both specialties made stronger recommendations for HPV vaccination for patients aged 13 years and older than for those aged 11 and 12 years. However, physicians might overestimate parent and patient resistance to a strong recommendation for the HPV vaccine. A strong recommendation, “delivered in the same way as for other adolescent vaccines and on same day as other adolescent vaccines, may be key to increasing acceptance among parents of 11- to 12-year-old patients,” Dr. Kempe and associates said.

The current two-dose vaccine schedule also promoted complete vaccination, according to a majority of pediatricians and FPs.

The study findings were limited by several factors, including the use of self-reports and the potential lack of generalizability of the survey responses. The results, however, were strengthened by the large, nationally representative sample and suggest that the number of physicians who strongly recommend HPV vaccination to 11- and 12-year-olds has increased over the past 5 years, they said.

“Increased use of available communication training materials and applications, as well as further development of evidence-based messages for parents, may be helpful in improving the way HPV is introduced,” the investigators concluded.

The study was supported by the Centers for Disease Control and Prevention. The researchers reported that they had no financial conflicts.

SOURCE: Kempe A et al. Pediatrics. 2019 Sep 16. doi: 10.1542/peds.2019-1475.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.

Adolescent suicides can be prevented, and clinicians have a key role to play, Joan Asarnow, PhD, said in a webinar presented on World Suicide Prevention Day, Sept. 10, 2019, to raise awareness of the latest research in suicide prevention and risk factors.

AlexRaths/Thinkstock

“Primary care doctors are the most trusted doctors for our teenagers,” Dr. Asarnow said during a question-and-answer session. Primary care can be the first-line screening to identify risk factors for suicide, and a close link with primary care “can make a very big difference in helping kids get through tough times.”

Other studies have shown that when doctors and nurses are able to recognize suicidality and link to behavioral health when needed, suicide attempts and ideation are reduced. Strategies including dialectical behavioral therapy and cognitive-behavior therapy have demonstrated success in reducing self -harm, she noted.

Schools have a role in suicide prevention as well, said Dr. Asarnow of the University of California, Los Angeles, and editor of a special issue of the Journal of Child Psychology and Psychiatry on suicide and self-harm.

She cited data from the Saving and Empowering Young Lives in Europe (SEYLE) study, a longitudinal study of school-based suicide prevention interventions, in which suicide attempts were significantly lower among teens who were exposed to a school-based program (Youth Aware of Mental Health) than they were among controls.

Additional findings from the SEYLE study recently were published in the Journal of Child Psychology and Psychiatry (2019. doi: 10.1111/jcpp.13119).

The authors investigated the interaction of three interventions with a certain model of suicide risk. The three interventions were Youth Aware of Mental Health (YAM); Question, Persuade and Refer (QPR); and ProfScreen. The latter two are established interventions for use by teachers. In the study, 11,110 high school students from 10 countries in the European Union completed questionnaires to assess baseline feelings of being a burden to others and feelings of loneliness and isolation from family and peers. The questionnaires also assessed health risk behaviors, self-injury, suicide ideation, and suicide attempts (SA), which were factors in the model being investigated. The participants were randomized to one of the interventions or to a control group that received educational posters with information about mental health resources.

In a reassessment of 8,972 adolescents 12 months later, the interventions all significantly reduced the association between repeated suicide attempts and the baseline interaction of self-injury and suicide ideation, compared with the control group.

“Among each of the three intervention groups, [suicide ideation] at baseline did not increase the risk of self-injury to be associated with repeated [suicide attempt]” at follow-up, Shira Barzilay, PhD, of Tel Aviv University, and coauthors said.

In addition, the researchers’ model found that “belongingness to parents” predicted lower odds of SI after controlling for depression, anxiety, and internalizing symptoms, and this prediction was similar across the intervention and control groups, although good relations with peers and lack of feeling like a burden on others were not significantly associated with lower odds of SI.

The study findings were limited by several factors including the limits of the model to fully capture the measures of belongingness or burdensomeness, and the use of a 12-month follow-up, which was too long to examine certain patterns of SA, the researchers noted. However, the results suggest that interventions can help reduce risk behaviors or self-harm that could lead to suicide. Areas for further study include examining spikes in risk variables that might have preceded suicide attempts, elevated stress, or interpersonal conflicts.

“The implications for suicide prevention, in both community and clinical settings, are to monitor youth who may be engaged in risky behaviors regardless of [suicide ideation] presentation and provide them with mental health education,” Dr. Barzilay and coauthors concluded.

The ongoing mission, Dr. Asarnow said, is “to send messages of hope, and that there is help out there.”

This is particularly important in the United States and the United Kingdom because, while suicide rates in adolescents have declined in some countries, they have increased in others, notably the two countries aforementioned, Dennis Ougrin, MD, said at the webinar.

Males are more likely to commit suicide than females by a ratio of 3 or 4 to 1 in most Western countries, said Dr. Ougrin, a child and adolescent psychiatrist at South London and Maudsley National Health Service Foundation Trust, leading the Child and Adolescent Mental Health Services Enhanced Treatment Service.

Although hanging is the most common method for suicides in most countries, followed by poisoning, more than 50% of suicides in the United States are caused by firearms, he noted.

Risk factors for completed suicide include male sex, low social status, restricted educational achievement, parental mental disorder, individual mental disorder, family history of suicidal behavior, problems with interpersonal relationships, drug and alcohol misuse, and feelings of hopelessness, said Dr. Ougrin, citing data from a 2012 study published in the Lancet (2012 Jun 23. doi: 10.1016/S0140-6736[12]60322-5).

The webinar was sponsored by Wiley partnership with the World Federation of Science Journalists and the Association of Health Care Journalists. Dr. Asarnow and Dr. Ougrin had no financial conflicts to disclose. The SEYLE project is supported by the European Union through the Seventh Framework Program. Dr. Barzilay and coauthors of the SEYLE study had no financial conflicts to disclose.

Patients with psoriatic arthritis who participated in a tight control program for 48 weeks showed no clinical advantage over patients who received usual care when reviewed again 5 years after having gone back to standard rheumatology care outside of the study, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.

In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).

“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.

In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.

At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.

Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).

The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.

However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.

The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.

SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.

Patients with psoriatic arthritis who participated in a tight control program for 48 weeks showed no clinical advantage over patients who received usual care when reviewed again 5 years after having gone back to standard rheumatology care outside of the study, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.

In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).

“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.

In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.

At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.

Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).

The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.

However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.

The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.

SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.

Patients with psoriatic arthritis who participated in a tight control program for 48 weeks showed no clinical advantage over patients who received usual care when reviewed again 5 years after having gone back to standard rheumatology care outside of the study, based on data from 110 patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study.

In the original study, significantly more adults with psoriatic arthritis (PsA) who were randomized to a tight control, treat-to-target group achieved minimal disease activity criteria after 48 weeks, compared with a standard care group (40% vs. 25%).

“Following exit from this study, we hypothesized that this advantage would translate to a clinical advantage in the medium term,” wrote Laura C. Coates, MBChB, PhD, of the University of Oxford (England) and colleagues.

In a study published in Rheumatology, the researchers examined data from 54 patients in the tight control arm of TICOPA and 56 patients in the standard care arm.

At 5 years after the completion of the TICOPA study, 69% of patients in the tight control group and 76% of patients in the standard care group were considered to be in low disease activity. In addition, methotrexate use after 5 years was similar between the tight control and standard care groups (44% and 54%, respectively) and both groups had reduced methotrexate use since the study’s end.

Overall use of biologic drugs was similar between the tight control and standard care groups after 5 years (54% and 52%, respectively), although overall use of biologics was higher in the tight control group at the end of the original study, compared with the standard care group (33% vs. 9%).

The findings were limited by several factors, notably the lack of intention to continue treatment or observations beyond the end of the original TICOPA study, and the patients’ status at 5 years was based on routine clinician notes with no formal assessment of minimal disease activity or objective measure of disease status, the researchers noted.

However, “this result reflects clinical practice in routine rheumatology care,” and any benefit of early tight control on later disease activity could not be determined, they added.

The current study was funded by the National Institute for Health Research infrastructure at Leeds and Oxford (England). The original TICOPA study was funded by Arthritis Research UK (now called Versus Arthritis) and Pfizer. Some of the investigators disclosed financial relationships with companies that market drugs for PsA.

SOURCE: Coates LC et al. Rheumatology. 2019 Aug 31. doi: 10.1093/rheumatology/kez369.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

Approximately two-thirds of adults with uveitis achieved inflammation control after 6 months on either methotrexate or mycophenolate alongside a reduction in corticosteroid use in an international, multicenter, open-label, randomized trial.

“The findings of this trial have implications for clinical practice because they provide scientific justification that mycophenolate mofetil is not more effective than methotrexate as a corticosteroid-sparing immunosuppressive therapy for uveitis,” wrote S.R. Rathinam, MD, PhD, of Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Madurai, India, and colleagues.

Although corticosteroid therapy is the first-line treatment for uveitis, adverse effects limit long-term use. Mycophenolate mofetil and methotrexate are options for corticosteroid-sparing immunosuppressive therapy for uveitis, but their effectiveness has not been compared until the current study, they said.

In the First-line Antimetabolites as Steroid-sparing Treatment (FAST) trial published Sept. 10 in JAMA, the researchers randomized 216 adults with uveitis (a total of 407 eyes with uveitis) to 25 mg of weekly oral methotrexate or 1.5 g of twice-daily oral mycophenolate mofetil at nine referral eye care centers in India, the United States, Australia, Saudi Arabia, and Mexico; the investigators were masked to the treatment assignment.

Patients with treatment success continued taking their randomized medication for another 6 months. If treatment failed, patients switched to the other antimetabolite with another 6-month follow-up. Overall, 84%-93% in each group had bilateral uveitis. Forty-six patients (21%) had intermediate uveitis only or anterior uveitis and intermediate uveitis, and 170 patients (79%) had posterior uveitis or panuveitis. The median age of the patients was 36 years in the methotrexate group and 41 years in the mycophenolate group; other demographic characteristics were similar between the groups.

SOURCE: Rathinam SR et al. JAMA. 2019;322(10):936-45. doi: 10.1001/jama.2019.12618.

Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.

The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.

“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.

In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.

A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.

“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.

The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.

Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.

The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.

The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.

SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.

Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.

The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.

“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.

In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.

A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.

“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.

The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.

Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.

The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.

The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.

SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.

Immune dysregulation is a substantial feature of hidradenitis suppurativa in African American patients, according to data from 16 adults.

The etiology of hidradenitis suppurativa (HS) remains unknown, but neutrophils are prominent in affected areas of skin, wrote Angel S. Byrd, MD, PhD, of Johns Hopkins University, Baltimore, and colleagues.

“Among the several functions of neutrophils, these cells have the ability to form neutrophil extracellular traps (NETs) after exposure to certain microbes or sterile stimuli,” the researchers noted. These NETs are weblike structures that have been shown to activate several types of immune responses and promote inflammation.

In a study published in Science Translational Medicine, the researchers analyzed biospecimens from African American HS patients. They determined that NET structures were present in the lesional skin of HS patients, but not in control skin. Additionally, serum from HS patients did not properly degrade healthy control NETs in an in vitro examination.

A significant correlation (P less than .0001) occurred between the amount of NETs released in hidradenitis suppurativa lesions and hidradenitis suppurativa severity.

“Together, these results indicate that NET formation is enhanced in HS, both systemically and in lesional skin, in association with disease severity and that NET degradation mechanisms may be impaired in this disease,” the researchers wrote.

The researchers also found that total immunoglobulin G was significantly increased in the sera of HS patients, compared with that of healthy volunteers (P = .0011), and that enzymes involved in skin citrullination were elevated in the skin of HS patients, compared with controls’ skin.

Previous studies have shown that NETs can promote type I interferon (IFN) signatures in the blood of patients with autoimmune and chronic inflammatory conditions, and in this study, several type I IFN–regulated genes had increased expression in HS skin, including IFI44L, MX1, CXCL10, RSAD2, and IFI27.

The study findings were limited by the small sample size and homogenous population, the researchers noted. Future research should include “the role that neutrophil/type I IFN dysregulation plays in the clinical manifestations of the disease, and how these abnormalities in immune responses regulate other innate and adaptive immune cell types in HS,” which could affect the development of new treatments, they wrote.

The study was supported in part by the National Institutes of Health, the Johns Hopkins School of Medicine Physician Scientist Training Program, and the Danby Hidradenitis Suppurativa Foundation. Dr. Byrd disclosed participating in the Johns Hopkins Ethnic Skin Fellowship, which was supported in part by Valeant. Dr. Byrd also disclosed serving as a former investigator for Eli Lilly.

SOURCE: Byrd AS et al. Sci Transl Med. 2019 Sep 4. doi: 10.1126/scitranslmed.aav5908.

Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.

Dr. Cecil Fox/National Cancer Institute

SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.

Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.

Dr. Cecil Fox/National Cancer Institute

SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.

Medication to help prevent breast cancer is not recommended for women without increased risk, but could benefit women at increased risk for the disease, according to an update from the U.S. Preventive Services Task Force.

Dr. Cecil Fox/National Cancer Institute

SOURCEs: Owens DK et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.11885; Nelson HD et al. JAMA. 2019 Sept 3. doi: 10.1001/jama.2019.5780.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A community-based care model to control hypertension led by nonphysician health care workers significantly reduced cardiovascular disease risk over 12 months, data from a cluster-controlled randomized study has shown.

Hypertension remains the most common risk factor for cardiovascular disease, but fewer than 20% of individuals with hypertension have their blood pressure controlled, wrote Jon-David Schwalm, MD, of McMaster University in Hamilton, Ont., and colleagues. To help control hypertension in underserved populations, the researchers tested a care model involving nonphysician health workers (NPHWs), primary care physicians, and family members.

The HOPE4 study, presented at the annual congress of the European Society of Cardiology and published simultaneously in the Lancet, included 1,371 adults aged 50 years and older with new or poorly controlled hypertension from 30 communities in Colombia and Malaysia. Sixteen communities were randomized to usual care and 14 to an intervention. The intervention included community screening and treatment of cardiovascular disease risk factors by NPHWs, free medications recommended by NPHWs under physician supervision, and family support for treatment adherence.

After 12 months, the Framingham Risk Scores for 10-year cardiovascular disease risk were significantly lower in the intervention group, compared with the control group (–11.17% vs. –6.40%). In addition, the intervention group showed a significant 11.45 mm Hg greater reduction in systolic blood pressure and a significant 0.41 mmol/L reduction in LDL cholesterol, compared with controls (P less than .0001 for both measures).

Baseline characteristics were similar between the two groups. Approximately 74% of the participants had a history of poorly controlled hypertension, while the remaining patients had new hypertension diagnoses.

“NPHWs were found to be consistently accurate in their ability to identify cardiovascular risk (patient identified by NPHWs as having poorly controlled blood pressure and medication was indicated) and recommend appropriate therapies (antihypertensives and statin as per the study algorithm) when compared with the assessment by local primary care physicians,” the researchers wrote. The study shows how effectively NPHWs can help reduce cardiovascular disease risk at the community level with proper training, effective community outreach, and task sharing with physicians and family members, they noted.

The findings were limited by the inability to assess the safety of specific medications, but no differences in adverse events were reported between the intervention and control groups. Other limitations included the screening of controls for cardiovascular disease risk at baseline, which meant that controls may have modified their behavior as a result, the researchers noted. In addition, the study was not blinded and surrogate outcomes were used because of the short study duration and relatively small sample size, they said.

However, the results support the use of a comprehensive, NPHW-led model, and “the HOPE 4 strategy could help to attain the UN General Assembly Action Plan for a one-third reduction in premature mortality from cardiovascular disease” by 2030, the researchers concluded.

The study was supported by the Canadian Institutes of Health Research; Grand Challenges Canada; Ontario SPOR Support Unit and the Ontario Ministry of Health and Long-Term Care; Boehringer Ingelheim; Department of Management of Non-Communicable Diseases, World Health Organization; and the Population Health Research Institute. Lead author Dr. Schwalm and several coauthors disclosed grants to their institutions for this study from the Canadian Institutes of Health Research, Ontario Ministry of Health and Long-Term Care, Boehringer Ingelheim, and the Department of Management of Non-Communicable Diseases, WHO.

SOURCE: Schwalm J-D et al. Lancet. 2019 Sept 2. doi: http://dx.doi.org/10.1016/ S0140-6736(19)31949-X.

A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.

Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).

The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.

The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.

The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.

“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.

The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.

SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.

A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.

Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).

The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.

The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.

The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.

“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.

The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.

SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.

A history of using multiple conventional synthetic disease-modifying antirheumatic drugs (DMARDs) is a key predictor for poorer response to adalimumab therapy in rheumatoid arthritis patients, according to data from a pair of studies with a total of 274 patients.

Although patients with RA who have failed methotrexate or tumor necrosis factor inhibitor therapy respond less than methotrexate-naive patients, “it remains unknown if response to the first biologic DMARD, in particular a [tumor necrosis factor inhibitor], depends on disease duration or prior numbers of failed [conventional synthetic] DMARDs,” wrote Daniel Aletaha, MD, of the Medical University of Vienna and colleagues.

In a study published in Annals of the Rheumatic Diseases, the researchers reviewed data from two randomized, controlled trials of patients with RA. In the larger trial of 207 adults (known as DE019), past use of two or more conventional synthetic DMARDs was associated with less improvement in 28-joint Disease Activity Score using C-reactive protein (DAS28-CRP) after 24 weeks of adalimumab (Humira), compared with use of one or no DMARDs (–1.8 vs. –2.2, respectively). Similarly, disease activity and disability scores improved significantly less in patients who had used two or more DMARDs, compared with those who used one or no DMARDs, according to the Simplified Disease Activity Index (SDAI; –22.1 vs. –26.9) and the Health Assessment Questionnaire Disability Index (HAQ-DI; –0.43 vs. –0.64).

The researchers also examined the role of disease duration on treatment response. Overall, patients with disease duration greater than 10 years showed more improvement at 24 weeks than did those with disease duration less than 1 year, based on HAQ-DI scores (1.1 vs. 0.7), but final scores on the SDAI and DAS28-CRP were not significantly different between those with disease duration greater than 10 years and those with duration of less than 1 year. These results suggest that the impact of DMARDs holds true regardless of disease duration, the researchers noted.

The findings were similar with regard to number of prior conventional synthetic DMARDs and the effects of disease duration in the second trial of 67 patients, known as the ARMADA study.

The study findings were limited by several factors, including the post hoc analysis design, use of only adalimumab data, and the small number of patients in several subgroups, the researchers noted. However, the results support the need for more standardized treatment guidelines and suggest that RA patients who fail to respond to methotrexate soon after RA diagnosis may benefit most from adding adalimumab, they said.

“Furthermore, these findings should be considered in future trials when defining inclusion criteria not only by duration of disease but also by number of prior DMARDs,” they concluded.

The study was sponsored by AbbVie, which markets adalimumab. Dr. Aletaha disclosed grants and consulting fees from AbbVie, as well as other pharmaceutical companies. Four of the authors were current or former employees of AbbVie, and some other authors also reported financial relationships with the company.

SOURCE: Aletaha D et al. Ann Rheum Dis. 2019 Aug 21. doi: 10.1136/annrheumdis-2018-214918.

Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.

A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.

Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.

The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.

Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.

Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.

Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.

Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.

If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.

Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.

Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder. 

“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.* 


The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.

The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.

SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.

*This article was updated on 9/9/2019.

Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.

A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.

Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.

The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.

Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.

Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.

Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.

Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.

If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.

Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.

Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder. 

“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.* 


The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.

The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.

SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.

*This article was updated on 9/9/2019.

Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.

A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.

Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.

The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.

Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.

Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.

Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.

Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.

If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.

Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.

Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder. 

“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.* 


The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.

The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.

SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.

*This article was updated on 9/9/2019.

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.

The fracture risk assessment tool FRAX may underestimate fracture risk in women with diabetes when bone mineral density is included, according to data from 566 women aged 40-90 years.

©wildpixel/Thinkstock

In a study published in Bone Reports, Lelia L.F. de Abreu, MD, of Deakin University, Geelong, Australia, and colleagues investigated the accuracy of FRAX scores and the role of impaired fasting glucose (IFG) and bone mineral density (BMD) on fracture risk by comparing FRAX scores for 252 normoglycemic women, 247 women with IFG, and 67 women with diabetes.

When BMD was not included, women with diabetes had a higher median FRAX score for major osteoporotic fractures of the hip, clinical spine, forearm, and wrist than women without diabetes or women with IFG (7.1, 4.3, and 5.1, respectively). In the diabetes group, 11 major osteoporotic fractures were observed versus 5 predicted by FRAX. In the normoglycemic group, 28 fractures were observed versus 15 predicted, and in the IFG group 31 fractures were observed versus 16 predicted.

When BMD was included, major osteoporotic fractures and hip fractures also were underestimated in the diabetes group (11 observed vs. 4 observed; 6 observed vs. 1 predicted, respectively), but the difference in observed versus predicted fractures trended toward statistical significance but was not significant (P = .055; P = .52, respectively). FRAX with BMD increased the underestimation of major osteoporotic fractures in the normoglycemic and IFG groups (28 observed vs. 13 predicted; 31 observed vs. 13 predicted).

The study findings were limited by several factors including the inability to determine the impact of specific types of diabetes on fracture risk, lack of data on the duration of diabetes in study participants, the use of self-reports, and a relatively small and homogeneous sample size, the researchers noted.

However, the results support data from previous studies showing an increased fracture risk in diabetes patients regardless of BMD, and suggest that FRAX may be unreliable as a predictor of fractures in the diabetes population, they concluded.

The study was supported in part by the Victorian Health Promotion Foundation, National Health and Medical Research Council Australia, and the Geelong Region Medical Research Foundation. Two researchers were supported by university postgraduate rewards and one researcher was supported by a university postdoctoral research fellowship. The remaining coauthors reported no relevant financial conflicts.

SOURCE: de Abreu LLF et al. Bone Reports. 2019 Aug 13. doi: 10.1016/j.bonr.2019.100223.