Gender imbalance seen in authorship of rheumatology guidelines

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Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Dr. Giovanni Adami of the University of Verona, Italy
Dr. Giovanni Adami

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”



Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

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Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Dr. Giovanni Adami of the University of Verona, Italy
Dr. Giovanni Adami

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”



Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

Less than one-third of first authors on rheumatology guidelines or recommendations are women, according to a research letter published in Annals of the Rheumatic Diseases.

Dr. Giovanni Adami of the University of Verona, Italy
Dr. Giovanni Adami

Giovanni Adami, MD, from the department of medicine at the University of Verona (Italy), and coauthors examined 366 English-language guidelines and recommendations published between 2004 and 2019 around the world.

They found that only 32% featured a female first author. However, they did observe a significant trend toward increasing female first authorship over the study period, with parity first being achieved for guidelines and recommendations published in 2017.

Male-dominated first authorship was seen almost across the disease subject matter. For RA, only 18.8% of the 96 guidelines or recommendations examined had a female first author, and of the 12 documents on polymyalgia rheumatica and giant cell arteritis, none featured a female first author.

Among the 73 guidelines and recommendations relating to psoriatic arthritis and spondyloarthritis, only 23.3% featured a female first author. However, three of the six documents on polymyositis and dermatomyositis had a female lead author, the only area where parity was achieved.

The authors noted the recent establishment of the EULAR Task Force on Gender Equity in Academic Rheumatology, which they said was an important first step toward gender equity in rheumatology guidelines authorship.

“Indeed, in the last 15 years we have witnessed an increase in female representativeness,” they wrote. “Notwithstanding, efforts should be made to improve the representation of female authors nationally and internationally.”



Commenting on the findings, rheumatologist Jean Liew, MD, said an interesting thing is that, in the United States at least, rheumatology is not a male-dominated field.

“Even though the practicing clinicians in rheumatology, most of them are women ... at the top of things it’s not as equitable as what it should be,” said Dr. Liew, acting instructor and senior fellow in the division of rheumatology at the University of Washington, Seattle.

Dr. Liew, who coauthored another study showing a significant gender gap in speakers at American College of Rheumatology meetings, said there was evidence suggesting men were more likely to be promoted, get grants, and get positive reviews, which made it harder for women to advance to senior research and leadership positions.

She noted that the ACR has been making a concerted effort to improve gender balance in the choice of speakers for meetings, but said that the problem of gender inequity in rheumatology required more widespread initiatives to address.

“It really takes people being aware of the problem and being good sponsors and promoting women who are qualified,” she said in an interview. “There should be more mentorship and sponsorship for women, otherwise this will never change.”

She also commented that pursuing research careers in rheumatology was difficult enough without the additional pressures of family life. “It’s years and years of sacrifice, it’s hard to get funding, which already makes it harder, especially for women with families who feel like they have to also be there at home.”

The study had no outside funding, and the authors declared no competing interests.

SOURCE: Adami G et al. Ann Rheum Dis. 2020 Feb 26. doi: 10.1136/annrheumdis-2020-217119.

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Vitamin D supplements in pregnancy boost bone health in offspring

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Mon, 02/24/2020 - 14:21

Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

Vitamin D pills spilling out of a bottle
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“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D3 (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D3.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm2 greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm2 higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

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Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

Vitamin D pills spilling out of a bottle
copyright Joss/Fotolia.com

“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D3 (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D3.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm2 greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm2 higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

Vitamin D supplementation during pregnancy is associated with higher bone mineral content in the offspring, even up to 6 years after birth, research suggests.

Vitamin D pills spilling out of a bottle
copyright Joss/Fotolia.com

“The well-established tracking of bone mineralization from early life throughout childhood and early adulthood is a key factor for the final peak bone mass gained and the subsequent risk of fractures and osteoporosis later in life,” wrote Nicklas Brustad, MD, of the Herlev and Gentofte Hospital at the University of Copenhagen, and coauthors. Their report is in JAMA Pediatrics.This was a secondary analysis of a prospective, double-blind, randomized controlled trial of high versus standard dose vitamin D supplementation in 623 pregnant Danish women and the outcomes in their 584 children. The women were randomized either to a daily dose of 2,400 IU vitamin D3 (cholecalciferol) or matching placebo capsules from 24 weeks’ gestation until 1 week after birth. All women were advised to maintain a daily intake of 400 IU of vitamin D3.

The children underwent anthropometric growth assessments regularly up to age 6 years, and underwent whole-body dual-energy radiograph absorptiometry (DXA) scanning at 3 years and 6 years.

At 3 years, children of mothers who received the vitamin D supplements showed significantly higher mean total-body-less-head (TBLH) bone mineral content (BMC) compared with those who received placebo (294 g vs. 289 g) and total-body BMC (526 g vs. 514 g), respectively, after adjustment for age, sex, height, and weight.

The difference in total-body BMC was particularly evident in children of mothers who had insufficient vitamin D levels at baseline, compared with those with sufficient vitamin D levels (538 g vs. 514 g). The study also saw higher head bone mineral density (BMD) in children of mothers with insufficient vitamin D at baseline who received supplementation.

At 6 years, there still were significant differences in BMC between the supplementation and placebo groups. Children in the vitamin D group had an 8-g greater TBLH BMC compared with those in the placebo group, and a 14-g higher total BMC.

Among the children of mothers with insufficient preintervention vitamin D, there was an 18-g higher mean total BMC and 0.0125 g/cm2 greater total BMD, compared with those with sufficient vitamin D at baseline.

Overall, the children of mothers who received high-dose vitamin D supplementation had a mean 8-g higher TBLH BMC, a mean 0.023 g/cm2 higher head BMD, and a mean 12-g higher total BMC.

Dr. Brustad and associates noted that the head could represent the most sensitive compartment for intervention, because 80% of bone mineralization of the skull occurs by the age of 3 years.

The study also showed a seasonal effect, such that mothers who gave birth in winter showed the greatest effects of vitamin D supplementation on head BMC.

There was a nonsignificant trend toward a lower fracture rate among children in the supplementation group, compared with the placebo group.

“We speculate that these intervention effects could be of importance for bone health and osteoporosis risk in adult life, which is supported by our likely underpowered post hoc analysis on fracture risk, suggesting an almost 40% reduced incidence of fractures of the larger bones in the high-dose vitamin D group,” the authors wrote.

Vitamin D supplementation did not appear to affect the children’s growth. At 6 years, there were no significant differences between the two groups in body mass index, height, weight, or waist, head, and thorax circumference.

Neonatologist Carol Wagner, MD, said in an interview that the study provided an absolute reason for vitamin D supplementation during pregnancy.

“At the very least, a study like this argues for much more than is recommended by the European nutrition group or the U.S. group,” said Dr. Wagner, professor of pediatrics at the Medical University of South Carolina, Charleston. “Here you have a therapy that costs literally pennies a day, and no one should be deficient.”

She also pointed out that the study was able to show significant effects on BMC despite the fact that there would have been considerable variation in postnatal vitamin D intake from breast milk or formula.

Cristina Palacios, PhD, an associate professor in the department of dietetics and nutrition at Florida International University, Miami, said that vitamin D deficiency is increasingly prevalent worldwide, and is associated with a return of rickets – the skeletal disorder caused by vitamin D deficiency – in children.

“If women are deficient during pregnancy, providing vitamin D supplementation in pregnancy may promote bone health in their offspring,” Dr. Palacios said in an interview. “Because vitamin D is such an important component of bone metabolism, this could prevent future rickets in these children.”

Dr. Palacios coauthored a recent Cochrane review that examined the safety of high-dose vitamin D supplementation in pregnancy, and said the analysis found no evidence of safety concerns.

The study was supported by The Lundbeck Foundation, the Ministry of Health, Danish Council for Strategic Research, and the Capital Region Research Foundation. The authors declared no conflicts of interest.

SOURCE: Brustad N et al. JAMA Pediatrics 2020 Feb 24. doi: 10.1001/jamapediatrics.2019.6083.

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Posttraumatic stress may persist up to 9 months after pregnancy loss

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Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

depression woman, alone
AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

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Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

depression woman, alone
AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

Women who have experienced early pregnancy loss may experience clinically significant posttraumatic stress, anxiety, and depression 9 months after the loss, new research suggests.

depression woman, alone
AkilinaWinner/Thinkstock

The outcomes of a prospective cohort study involving 737 women who had experienced miscarriage or ectopic pregnancy and 171 controls with healthy pregnancies were presented in a report in the American Journal of Obstetrics & Gynecology.

One month after their pregnancy loss, 29% of these women met the criteria for posttraumatic stress, 24% reported moderate to severe anxiety, and 11% reported moderate to severe depression. In comparison, just 13% of women in the control group met the criteria for anxiety, and 2% met the criteria for depression, which meant women who had experienced early pregnancy loss had a greater than twofold odds of anxiety and nearly fourfold (odds ratio, 3.88) greater odds of depression, reported Jessica Farren, PhD, of the Queen Charlotte’s and Chelsea Hospital, London, and coauthors.

The most common posttraumatic symptom, experienced by 91% of respondents with posttraumatic stress at 1 month after the pregnancy, was reexperiencing symptoms, while 60% experienced avoidance and hyperarousal symptoms. At 3 months after the loss, 50% of those with posttraumatic stress reported an interruption of their general satisfaction with life.

While the incidence of posttraumatic stress, anxiety, and depression decreased over time in the women who had early pregnancy loss, by the third month 21% still met the criteria for posttraumatic stress, and by 9 months, 18% still were experiencing posttraumatic stress. Similarly, moderate to severe anxiety was still present in 23% of women at 3 months and 17% at 9 months, and moderate to severe depression was still experienced by 8% of women at 3 months and 6% of women at 9 months.

Dr. Farren and coauthors wrote that, given the incidence of miscarriage and ectopic pregnancy in the population, the high proportion of women still experiencing posttraumatic stress, anxiety, and depression at 9 months pointed to a significant public health issue. “It is recognized that PTSD in other contexts can have a significant impact on work, social interaction, health care utilization, and risks in future pregnancies,” they wrote. “Work is needed to evaluate strategies to effectively identify and treat affected women with these specific psychopathologies.”

The investigators also looked at the differences in outcomes in women who experienced miscarriage, compared with those who experienced ectopic pregnancy.

Of the 363 women who had a miscarriage, 30% met criteria for posttraumatic stress at 1 month, 20% at 3 months, and 17% at 9 months. Moderate to severe anxiety was reported by 25% women at 1 month, 22% at 3 months, and 17% at 9 months. Moderate to severe depression was reported by 12% at 1 month, 7% at 3 months, and 5% at 9 months.

Of the 74 women who had an ectopic pregnancy, 23% met criteria for posttraumatic stress at 1 month, 28% at 3 months, and 21% at 9 months. Moderate to severe anxiety was reported by 21% at 1 month, 30% at 3 months, and 23% at 9 months. Moderate to severe depression was reported by 7% at 1 month, 12% at 3 months, and 11% at 9 months.

The authors noted that the incidence of posttraumatic stress, anxiety, and depression decreased more strongly over time in women who had experienced miscarriage, compared with those who experienced ectopic pregnancy, although they commented that the confidence intervals were wide.

One coauthor was supported by an Imperial Health Charity grant and another by the National Institute for Health Research Biomedical Research Centre. No conflicts of interest were declared.

SOURCE: Farren J et al. Amer J Obstet Gynecol. 2019 Dec 13. doi: 10.1016/j.ajog.2019.10.102.

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Barbers have role in encouraging diabetes screening in black men

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Tue, 05/03/2022 - 15:11

 

Shave and a haircut … and a blood glucose test? A study shows that barbershops owned by black proprietors can play a role in encouraging black men to get screened for diabetes.

In research letter published in the Jan. 27 edition of JAMA Internal Medicine, Marcela Osorio, BA, from New York University and coauthors wrote that black men with diabetes have disproportionately high rates of diabetes complications and lower survival rates. Their diagnosis is often delayed, particularly among men without regular primary health care.

African American barber shop
gisele/Getty Images


“In barbershops, which are places of trust among black men, community-based interventions have been successful in identifying and treating men with hypertension,” they wrote.

In this study, the researchers approached customers in eight barbershops in Brooklyn, in areas associated with a high prevalence of individuals with poor glycemic control, to encourage them to get tested for diabetes. All barbershops were owned by black individuals.

Around one-third of the 895 black men who were asked to participate in the study agreed to be screened, and 290 (32.4%) were successfully tested using point-of-care hemoglobin A1c testing.

The screening revealed that 9% of those tested had an HbA1c level of 6.5% or higher, and 16 of these individuals were obese. Three men had an HbA1c level of 7.5% or higher. The investigators noted that this prevalence of undiagnosed diabetes was much higher than the 3.6% estimated prevalence among New York City residents.

The highest HbA1c level recorded during testing was 7.8%, and 28.3% of those tested had a level between 5.7% and 6.4%, which meets the criteria for a diagnosis of prediabetes.

“We also found that barbers were important health advocates; although we do not have exact numbers, some customers (who initially declined testing) agreed after encouragement from their barber,” the authors wrote.

Of the 583 men who declined to participate, around one-quarter did so on the grounds that they already knew their health status or had been checked by their doctor, one-third (35.3%) said they were healthy or didn’t have the time or interest, or didn’t want to know the results. There were also 26 individuals who reported being scared of needles.

“Black men who live in urban areas of the United States may face socioeconomic barriers to good health, including poor food environments and difficulty in obtaining primary care,” the authors wrote. “Our findings suggest that community-based diabetes screening in barbershops owned by black individuals may play a role in the timely diagnosis of diabetes and may help to identify black men who need appropriate care for their newly diagnosed diabetes.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Two authors declared grants from the institute during the study, and one also reported grants from other research foundations outside the study.

SOURCE: Osorio M et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6867.

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Shave and a haircut … and a blood glucose test? A study shows that barbershops owned by black proprietors can play a role in encouraging black men to get screened for diabetes.

In research letter published in the Jan. 27 edition of JAMA Internal Medicine, Marcela Osorio, BA, from New York University and coauthors wrote that black men with diabetes have disproportionately high rates of diabetes complications and lower survival rates. Their diagnosis is often delayed, particularly among men without regular primary health care.

African American barber shop
gisele/Getty Images


“In barbershops, which are places of trust among black men, community-based interventions have been successful in identifying and treating men with hypertension,” they wrote.

In this study, the researchers approached customers in eight barbershops in Brooklyn, in areas associated with a high prevalence of individuals with poor glycemic control, to encourage them to get tested for diabetes. All barbershops were owned by black individuals.

Around one-third of the 895 black men who were asked to participate in the study agreed to be screened, and 290 (32.4%) were successfully tested using point-of-care hemoglobin A1c testing.

The screening revealed that 9% of those tested had an HbA1c level of 6.5% or higher, and 16 of these individuals were obese. Three men had an HbA1c level of 7.5% or higher. The investigators noted that this prevalence of undiagnosed diabetes was much higher than the 3.6% estimated prevalence among New York City residents.

The highest HbA1c level recorded during testing was 7.8%, and 28.3% of those tested had a level between 5.7% and 6.4%, which meets the criteria for a diagnosis of prediabetes.

“We also found that barbers were important health advocates; although we do not have exact numbers, some customers (who initially declined testing) agreed after encouragement from their barber,” the authors wrote.

Of the 583 men who declined to participate, around one-quarter did so on the grounds that they already knew their health status or had been checked by their doctor, one-third (35.3%) said they were healthy or didn’t have the time or interest, or didn’t want to know the results. There were also 26 individuals who reported being scared of needles.

“Black men who live in urban areas of the United States may face socioeconomic barriers to good health, including poor food environments and difficulty in obtaining primary care,” the authors wrote. “Our findings suggest that community-based diabetes screening in barbershops owned by black individuals may play a role in the timely diagnosis of diabetes and may help to identify black men who need appropriate care for their newly diagnosed diabetes.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Two authors declared grants from the institute during the study, and one also reported grants from other research foundations outside the study.

SOURCE: Osorio M et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6867.

 

Shave and a haircut … and a blood glucose test? A study shows that barbershops owned by black proprietors can play a role in encouraging black men to get screened for diabetes.

In research letter published in the Jan. 27 edition of JAMA Internal Medicine, Marcela Osorio, BA, from New York University and coauthors wrote that black men with diabetes have disproportionately high rates of diabetes complications and lower survival rates. Their diagnosis is often delayed, particularly among men without regular primary health care.

African American barber shop
gisele/Getty Images


“In barbershops, which are places of trust among black men, community-based interventions have been successful in identifying and treating men with hypertension,” they wrote.

In this study, the researchers approached customers in eight barbershops in Brooklyn, in areas associated with a high prevalence of individuals with poor glycemic control, to encourage them to get tested for diabetes. All barbershops were owned by black individuals.

Around one-third of the 895 black men who were asked to participate in the study agreed to be screened, and 290 (32.4%) were successfully tested using point-of-care hemoglobin A1c testing.

The screening revealed that 9% of those tested had an HbA1c level of 6.5% or higher, and 16 of these individuals were obese. Three men had an HbA1c level of 7.5% or higher. The investigators noted that this prevalence of undiagnosed diabetes was much higher than the 3.6% estimated prevalence among New York City residents.

The highest HbA1c level recorded during testing was 7.8%, and 28.3% of those tested had a level between 5.7% and 6.4%, which meets the criteria for a diagnosis of prediabetes.

“We also found that barbers were important health advocates; although we do not have exact numbers, some customers (who initially declined testing) agreed after encouragement from their barber,” the authors wrote.

Of the 583 men who declined to participate, around one-quarter did so on the grounds that they already knew their health status or had been checked by their doctor, one-third (35.3%) said they were healthy or didn’t have the time or interest, or didn’t want to know the results. There were also 26 individuals who reported being scared of needles.

“Black men who live in urban areas of the United States may face socioeconomic barriers to good health, including poor food environments and difficulty in obtaining primary care,” the authors wrote. “Our findings suggest that community-based diabetes screening in barbershops owned by black individuals may play a role in the timely diagnosis of diabetes and may help to identify black men who need appropriate care for their newly diagnosed diabetes.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Two authors declared grants from the institute during the study, and one also reported grants from other research foundations outside the study.

SOURCE: Osorio M et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6867.

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Key clinical point: Barbershops could offer a way to encourage diabetes screening among black men.

Major finding: HbA1c testing in barbershops identified a significant number of individuals with undiagnosed diabetes.

Study details: Study involving 895 black men attending eight barbershops in Brooklyn.

Disclosures: The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Two authors declared grants from the institute during the study, and one also reported grants from other research foundations outside the study.

Source: Osorio M et al. JAMA Intern Med. 2020 Jan 27. doi: 10.1001/jamainternmed.2019.6867.

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Apremilast more likely to succeed with moderate psoriatic arthritis activity

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Tue, 02/07/2023 - 16:50

 

Patients with moderate psoriatic arthritis disease activity are more likely to achieve remission or low disease activity with apremilast therapy than are those with high disease activity at baseline, new research suggests.

Dr. Philip J. Mease, University of Washington, Seattle
Dr. Philip J. Mease

A paper published in Arthritis Care & Research presents a pooled analysis of the PALACE 1-3 studies that included a total of 1,493 patients with active psoriatic arthritis whose disease had resisted treatment with tumor necrosis factor inhibitors or conventional disease-modifying antirheumatic drugs. Participants were randomized either to the oral phosphodiesterase 4 inhibitor apremilast (Otezla) 30 mg twice daily, 20 mg twice daily, or placebo for 24 weeks, after which all patients on placebo were rerandomized to one of the two apremilast doses until 52 weeks.

The analysis focused on 494 patients who were randomized to apremilast 30 mg twice daily at baseline.

At week 16, 40% patients with low disease activity at baseline had achieved remission on their clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score, compared with 7% of patients with moderate disease activity and 2.1% of patients with high disease activity. The cDAPSA score is calculated as a composite score including swollen and tender joint counts, patient’s assessment of pain, and patient’s global assessment of disease activity, with possible scores from 0 to 154. Based on patients’ cDAPSA score, the researchers defined remission as a score of 4 or less, low disease activity as more than 4 and up to 13, moderate disease activity as more than 13 and up to 27, and high disease activity as greater than 27.

Among patients with moderate disease activity, 29.8% achieved low disease activity by week 16; among patients with high disease activity at baseline, 11.5% achieved low disease activity, and 38.1% achieved moderate disease activity.

The study found that patients who had moderate disease activity at baseline and achieved either low disease activity or remission by week 16 had a 58.9%-88.5% probability of remaining at those treatment targets by week 52. Patients with high disease activity at baseline who achieved low disease activity or remission by week 16 had a 64.3%-77.4% probability of achieving treatment targets by week 52.

Overall, nearly twice as many patients who had moderate disease activity at baseline achieved their treatment targets when compared with those who began with high disease activity (46.9% vs. 24.9%).

Any patient who achieved at least a 30% improvement in cDAPSA score by week 16 had a 63% probability of achieving treatment targets by week 52.

First author Philip J. Mease, MD, from the Swedish Medical Center and the University of Washington, Seattle, and coauthors noted that the absence of treatment response by week 16 should point to the need for a treatment adjustment. “Taken together, these findings provide a framework of reference for the selection and monitoring of patients with the highest likelihood of achieving optimal treatment responses with apremilast in clinical practice,” they wrote.

The authors also commented that their study provided support for the use of clinical Disease Activity Index for Psoriatic Arthritis score to monitor patients treated with apremilast.

The study was sponsored by Celgene. Three authors were employees of Celgene at the time of the study, and nine authors declared a range of consultancies, grants, research, and other support from the pharmaceutical sector, including from Celgene.

SOURCE: Mease P et al. Arthritis Care Res. 2019 Jan 7. doi: 10.1002/acr.24134

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Patients with moderate psoriatic arthritis disease activity are more likely to achieve remission or low disease activity with apremilast therapy than are those with high disease activity at baseline, new research suggests.

Dr. Philip J. Mease, University of Washington, Seattle
Dr. Philip J. Mease

A paper published in Arthritis Care & Research presents a pooled analysis of the PALACE 1-3 studies that included a total of 1,493 patients with active psoriatic arthritis whose disease had resisted treatment with tumor necrosis factor inhibitors or conventional disease-modifying antirheumatic drugs. Participants were randomized either to the oral phosphodiesterase 4 inhibitor apremilast (Otezla) 30 mg twice daily, 20 mg twice daily, or placebo for 24 weeks, after which all patients on placebo were rerandomized to one of the two apremilast doses until 52 weeks.

The analysis focused on 494 patients who were randomized to apremilast 30 mg twice daily at baseline.

At week 16, 40% patients with low disease activity at baseline had achieved remission on their clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score, compared with 7% of patients with moderate disease activity and 2.1% of patients with high disease activity. The cDAPSA score is calculated as a composite score including swollen and tender joint counts, patient’s assessment of pain, and patient’s global assessment of disease activity, with possible scores from 0 to 154. Based on patients’ cDAPSA score, the researchers defined remission as a score of 4 or less, low disease activity as more than 4 and up to 13, moderate disease activity as more than 13 and up to 27, and high disease activity as greater than 27.

Among patients with moderate disease activity, 29.8% achieved low disease activity by week 16; among patients with high disease activity at baseline, 11.5% achieved low disease activity, and 38.1% achieved moderate disease activity.

The study found that patients who had moderate disease activity at baseline and achieved either low disease activity or remission by week 16 had a 58.9%-88.5% probability of remaining at those treatment targets by week 52. Patients with high disease activity at baseline who achieved low disease activity or remission by week 16 had a 64.3%-77.4% probability of achieving treatment targets by week 52.

Overall, nearly twice as many patients who had moderate disease activity at baseline achieved their treatment targets when compared with those who began with high disease activity (46.9% vs. 24.9%).

Any patient who achieved at least a 30% improvement in cDAPSA score by week 16 had a 63% probability of achieving treatment targets by week 52.

First author Philip J. Mease, MD, from the Swedish Medical Center and the University of Washington, Seattle, and coauthors noted that the absence of treatment response by week 16 should point to the need for a treatment adjustment. “Taken together, these findings provide a framework of reference for the selection and monitoring of patients with the highest likelihood of achieving optimal treatment responses with apremilast in clinical practice,” they wrote.

The authors also commented that their study provided support for the use of clinical Disease Activity Index for Psoriatic Arthritis score to monitor patients treated with apremilast.

The study was sponsored by Celgene. Three authors were employees of Celgene at the time of the study, and nine authors declared a range of consultancies, grants, research, and other support from the pharmaceutical sector, including from Celgene.

SOURCE: Mease P et al. Arthritis Care Res. 2019 Jan 7. doi: 10.1002/acr.24134

 

Patients with moderate psoriatic arthritis disease activity are more likely to achieve remission or low disease activity with apremilast therapy than are those with high disease activity at baseline, new research suggests.

Dr. Philip J. Mease, University of Washington, Seattle
Dr. Philip J. Mease

A paper published in Arthritis Care & Research presents a pooled analysis of the PALACE 1-3 studies that included a total of 1,493 patients with active psoriatic arthritis whose disease had resisted treatment with tumor necrosis factor inhibitors or conventional disease-modifying antirheumatic drugs. Participants were randomized either to the oral phosphodiesterase 4 inhibitor apremilast (Otezla) 30 mg twice daily, 20 mg twice daily, or placebo for 24 weeks, after which all patients on placebo were rerandomized to one of the two apremilast doses until 52 weeks.

The analysis focused on 494 patients who were randomized to apremilast 30 mg twice daily at baseline.

At week 16, 40% patients with low disease activity at baseline had achieved remission on their clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score, compared with 7% of patients with moderate disease activity and 2.1% of patients with high disease activity. The cDAPSA score is calculated as a composite score including swollen and tender joint counts, patient’s assessment of pain, and patient’s global assessment of disease activity, with possible scores from 0 to 154. Based on patients’ cDAPSA score, the researchers defined remission as a score of 4 or less, low disease activity as more than 4 and up to 13, moderate disease activity as more than 13 and up to 27, and high disease activity as greater than 27.

Among patients with moderate disease activity, 29.8% achieved low disease activity by week 16; among patients with high disease activity at baseline, 11.5% achieved low disease activity, and 38.1% achieved moderate disease activity.

The study found that patients who had moderate disease activity at baseline and achieved either low disease activity or remission by week 16 had a 58.9%-88.5% probability of remaining at those treatment targets by week 52. Patients with high disease activity at baseline who achieved low disease activity or remission by week 16 had a 64.3%-77.4% probability of achieving treatment targets by week 52.

Overall, nearly twice as many patients who had moderate disease activity at baseline achieved their treatment targets when compared with those who began with high disease activity (46.9% vs. 24.9%).

Any patient who achieved at least a 30% improvement in cDAPSA score by week 16 had a 63% probability of achieving treatment targets by week 52.

First author Philip J. Mease, MD, from the Swedish Medical Center and the University of Washington, Seattle, and coauthors noted that the absence of treatment response by week 16 should point to the need for a treatment adjustment. “Taken together, these findings provide a framework of reference for the selection and monitoring of patients with the highest likelihood of achieving optimal treatment responses with apremilast in clinical practice,” they wrote.

The authors also commented that their study provided support for the use of clinical Disease Activity Index for Psoriatic Arthritis score to monitor patients treated with apremilast.

The study was sponsored by Celgene. Three authors were employees of Celgene at the time of the study, and nine authors declared a range of consultancies, grants, research, and other support from the pharmaceutical sector, including from Celgene.

SOURCE: Mease P et al. Arthritis Care Res. 2019 Jan 7. doi: 10.1002/acr.24134

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Sleep problems linked to worsening PTSD in veterans

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Wed, 05/06/2020 - 12:46

Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

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Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

Insomnia is a common problem for veterans with PTSD, and the frequency of sleep problems is associated with increasing severity of PTSD, according to a study published in of the Journal of Traumatic Stress.

Raymond C. Rosen, PhD, of the New England Research Institutes, Watertown, Mass., and coauthors wrote that exploration of the relationship between PTSD and insomnia is complicated by the fact that it can be difficult to separate out disturbed sleep from other elements of PTSD, and because of the presence of other comorbidities in veterans, such as depression and traumatic brain injury.

The cohort study involved 1,643 veterans – roughly equal numbers of women and men – of Iraq and Afghanistan. Around two-thirds of the cohort had a diagnosis of PTSD. The participants completed a self-administered survey online or by mail, and were also assessed in a telephone interview, then followed up within 2-4 years.

While the prevalence of sleep problems was high across the cohort, the study found that 74% of participants with PTSD at baseline said they had experienced sleep difficulties for at least half of the previous 30 days, and one-third had been prescribed for a sedative-hypnotic drug in the past year.

In comparison, veterans without PTSD had fewer sleep problems and were prescribed significantly fewer sedative-hypnotic drugs.

The prevalence of sleep problems was similar in men and women with PTSD, although women had significantly higher rates of sedative-hypnotic prescriptions than men (40.4% vs. 35%, P = .006). A similar gender difference in prescription rates was seen in individuals without PTSD.

The study found that, although there was only a weak association between the severity of PTSD symptoms at baseline and the frequency of sleep problems at follow-up, there was a stronger association in reverse. Veterans with a higher frequency of sleep problems at baseline showed a significant increase in PTSD symptoms at follow-up.

The authors commented that this was in line with previous studies finding a similar effect of sleep disturbance on PTSD severity, both in military personnel and civilians.

“From a neurobiological perspective, it has been proposed that chronic sleep loss can lead to emotional dysregulation or heightened autonomic arousal, which in turn may be a risk factor for PTSD in trauma-exposed individuals,” they wrote. “It has also been proposed that prior sleep disturbance may attenuate the effects of extinction learning, leading to more enduring or severe symptoms in trauma-exposed individuals with concomitant sleep disorders.”

Given this association, the authors called for more attention to be given to identifying, diagnosing, and treating sleep disorders in veterans with and without PTSD.

The authors noted that they did not have access to polysomnographic data for participants, and were also unable to assess the prevalence, frequency, or intensity of nightmares in the cohort.

The study was supported by the Department of Defense. Conflict of interest disclosures were unavailable.

SOURCE: Rosen RC et al. J Trauma Stress. 2020;32:936-45.

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Ideal management of RA in pregnancy improves outcomes

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Thu, 01/16/2020 - 23:31

Women whose rheumatoid arthritis is carefully managed before and during pregnancy have a significantly lower risk of adverse pregnancy outcomes, including miscarriage or perinatal death, new research suggests.

Doctor and pregnant woman in consultation.
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A study published in Arthritis Care & Research presents the outcomes of a retrospective, observational study examining health care data from 443 first pregnancies in women with RA and 6,097 women without the disease.

First author Alessandra Bortoluzzi, MD, PhD, from the Rheumatology Unit at the University of Ferrara (Italy) and coauthors looked at seven diagnostic, therapeutic, and follow-up health care quality indicators during the prepregnancy and perinatal period. They included having at least one blood test in the 18 months before conception and during pregnancy, preconception musculoskeletal imaging, no exposure or wash-out from teratogenic drugs, and no exposure to biologic drugs between conception and delivery or end of pregnancy.

An ideal clinical pathway included at least one element from each of the diagnostic, therapeutic, and prenatal follow-up quality indicators.

Overall, women with RA had a significantly higher rate of thyroid diseases, adverse pregnancy outcomes, and miscarriage or perinatal death when compared with controls. However, those who followed the ideal clinical pathway for management of their disease during pregnancy had a 40% lower odds of adverse pregnancy outcomes (odds ratio, 0.60; 95% confidence interval, 0.39-0.94) and a 60% lower odds of miscarriage or perinatal death (OR, 0.40; 95% CI, 0.24-0.69) in comparison with women with RA who were not managed to the same standard. The researchers adjusted both comparisons for age, Charlson comorbidity index, and thyroid diseases.

Women with RA who met diagnostic, therapeutic, and prenatal follow-up quality indicators showed no significant differences from the general population in terms of the risk of adverse pregnancy outcomes, miscarriage, or perinatal death after adjusting for hypertension in addition to the same variables as before.

When researchers looked at some of the individual health care quality indicators, they found that testing for antiphospholipid (aPL) antibodies within 18 months of conception or pregnancy was associated with a 44% lower rate of adverse pregnancy outcomes. Similarly, antinuclear antibody or anti–extractable nuclear antigen antibody testing was associated with 36% lower odds of adverse pregnancy outcomes.



Dr. Bortoluzzi and her coauthors wrote that their findings pointed to the value of testing for aPL antibodies in women with RA who wish to get pregnant.

“In fact, despite the absence of formal recommendation or validated health care quality indicators focused on stratification of preconceptional obstetric risk in patients with RA, we started from the basic and universally accepted assumption that aPL antibodies are pathogenic autoantibodies and therefore recognized risk factors for adverse pregnancy outcome,” they wrote.

Women with RA who had either no exposure to methotrexate or leflunomide or who had a washout period from 6 months prior to conception had 72% lower odds of adverse pregnancy outcomes.

The authors also looked at the effects of drugs such as aspirin, glucocorticoids, and low-molecular-weight heparin that are used during pregnancy. They found that the relative risk of adverse pregnancy outcomes was 40% higher in women with RA who were taking glucocorticoids, compared with those with the disease but not taking that type of medication. However, low-molecular-weight heparin use was associated with an 80% lower relative risk of miscarriage or perinatal death in comparison with those not taking it. Researchers saw no significant effects of aspirin or conventional synthetic disease-modifying antirheumatic drugs on either adverse pregnancy outcomes or the risk of miscarriage or perinatal death.

“This reinforces the importance of adjustment of therapy for RA before conception and throughout pregnancy, because medication use could affect pregnancy course not only influencing maternal disease activity but also the gestational outcome,” the authors wrote. “Although this is a study conducted on administrative data, we can hypothesize that exposure to therapy represents a marker of high RA disease activity and severity. In our setting, it is possible that, the more active the disease, the greater the probability of being included in the ideal clinical pathway, but in any case, this resulted in a lower odds ratio of adverse pregnancy outcome and miscarriage/perinatal death.”

The study was supported by the Italian Society for Rheumatology. No conflicts of interest were declared.

SOURCE: Bortoluzzi A et al. Arthritis Care Res. 2020 Jan 8. doi: 10.1002/ACR.24116.

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Women whose rheumatoid arthritis is carefully managed before and during pregnancy have a significantly lower risk of adverse pregnancy outcomes, including miscarriage or perinatal death, new research suggests.

Doctor and pregnant woman in consultation.
zoranm/Getty Images

A study published in Arthritis Care & Research presents the outcomes of a retrospective, observational study examining health care data from 443 first pregnancies in women with RA and 6,097 women without the disease.

First author Alessandra Bortoluzzi, MD, PhD, from the Rheumatology Unit at the University of Ferrara (Italy) and coauthors looked at seven diagnostic, therapeutic, and follow-up health care quality indicators during the prepregnancy and perinatal period. They included having at least one blood test in the 18 months before conception and during pregnancy, preconception musculoskeletal imaging, no exposure or wash-out from teratogenic drugs, and no exposure to biologic drugs between conception and delivery or end of pregnancy.

An ideal clinical pathway included at least one element from each of the diagnostic, therapeutic, and prenatal follow-up quality indicators.

Overall, women with RA had a significantly higher rate of thyroid diseases, adverse pregnancy outcomes, and miscarriage or perinatal death when compared with controls. However, those who followed the ideal clinical pathway for management of their disease during pregnancy had a 40% lower odds of adverse pregnancy outcomes (odds ratio, 0.60; 95% confidence interval, 0.39-0.94) and a 60% lower odds of miscarriage or perinatal death (OR, 0.40; 95% CI, 0.24-0.69) in comparison with women with RA who were not managed to the same standard. The researchers adjusted both comparisons for age, Charlson comorbidity index, and thyroid diseases.

Women with RA who met diagnostic, therapeutic, and prenatal follow-up quality indicators showed no significant differences from the general population in terms of the risk of adverse pregnancy outcomes, miscarriage, or perinatal death after adjusting for hypertension in addition to the same variables as before.

When researchers looked at some of the individual health care quality indicators, they found that testing for antiphospholipid (aPL) antibodies within 18 months of conception or pregnancy was associated with a 44% lower rate of adverse pregnancy outcomes. Similarly, antinuclear antibody or anti–extractable nuclear antigen antibody testing was associated with 36% lower odds of adverse pregnancy outcomes.



Dr. Bortoluzzi and her coauthors wrote that their findings pointed to the value of testing for aPL antibodies in women with RA who wish to get pregnant.

“In fact, despite the absence of formal recommendation or validated health care quality indicators focused on stratification of preconceptional obstetric risk in patients with RA, we started from the basic and universally accepted assumption that aPL antibodies are pathogenic autoantibodies and therefore recognized risk factors for adverse pregnancy outcome,” they wrote.

Women with RA who had either no exposure to methotrexate or leflunomide or who had a washout period from 6 months prior to conception had 72% lower odds of adverse pregnancy outcomes.

The authors also looked at the effects of drugs such as aspirin, glucocorticoids, and low-molecular-weight heparin that are used during pregnancy. They found that the relative risk of adverse pregnancy outcomes was 40% higher in women with RA who were taking glucocorticoids, compared with those with the disease but not taking that type of medication. However, low-molecular-weight heparin use was associated with an 80% lower relative risk of miscarriage or perinatal death in comparison with those not taking it. Researchers saw no significant effects of aspirin or conventional synthetic disease-modifying antirheumatic drugs on either adverse pregnancy outcomes or the risk of miscarriage or perinatal death.

“This reinforces the importance of adjustment of therapy for RA before conception and throughout pregnancy, because medication use could affect pregnancy course not only influencing maternal disease activity but also the gestational outcome,” the authors wrote. “Although this is a study conducted on administrative data, we can hypothesize that exposure to therapy represents a marker of high RA disease activity and severity. In our setting, it is possible that, the more active the disease, the greater the probability of being included in the ideal clinical pathway, but in any case, this resulted in a lower odds ratio of adverse pregnancy outcome and miscarriage/perinatal death.”

The study was supported by the Italian Society for Rheumatology. No conflicts of interest were declared.

SOURCE: Bortoluzzi A et al. Arthritis Care Res. 2020 Jan 8. doi: 10.1002/ACR.24116.

Women whose rheumatoid arthritis is carefully managed before and during pregnancy have a significantly lower risk of adverse pregnancy outcomes, including miscarriage or perinatal death, new research suggests.

Doctor and pregnant woman in consultation.
zoranm/Getty Images

A study published in Arthritis Care & Research presents the outcomes of a retrospective, observational study examining health care data from 443 first pregnancies in women with RA and 6,097 women without the disease.

First author Alessandra Bortoluzzi, MD, PhD, from the Rheumatology Unit at the University of Ferrara (Italy) and coauthors looked at seven diagnostic, therapeutic, and follow-up health care quality indicators during the prepregnancy and perinatal period. They included having at least one blood test in the 18 months before conception and during pregnancy, preconception musculoskeletal imaging, no exposure or wash-out from teratogenic drugs, and no exposure to biologic drugs between conception and delivery or end of pregnancy.

An ideal clinical pathway included at least one element from each of the diagnostic, therapeutic, and prenatal follow-up quality indicators.

Overall, women with RA had a significantly higher rate of thyroid diseases, adverse pregnancy outcomes, and miscarriage or perinatal death when compared with controls. However, those who followed the ideal clinical pathway for management of their disease during pregnancy had a 40% lower odds of adverse pregnancy outcomes (odds ratio, 0.60; 95% confidence interval, 0.39-0.94) and a 60% lower odds of miscarriage or perinatal death (OR, 0.40; 95% CI, 0.24-0.69) in comparison with women with RA who were not managed to the same standard. The researchers adjusted both comparisons for age, Charlson comorbidity index, and thyroid diseases.

Women with RA who met diagnostic, therapeutic, and prenatal follow-up quality indicators showed no significant differences from the general population in terms of the risk of adverse pregnancy outcomes, miscarriage, or perinatal death after adjusting for hypertension in addition to the same variables as before.

When researchers looked at some of the individual health care quality indicators, they found that testing for antiphospholipid (aPL) antibodies within 18 months of conception or pregnancy was associated with a 44% lower rate of adverse pregnancy outcomes. Similarly, antinuclear antibody or anti–extractable nuclear antigen antibody testing was associated with 36% lower odds of adverse pregnancy outcomes.



Dr. Bortoluzzi and her coauthors wrote that their findings pointed to the value of testing for aPL antibodies in women with RA who wish to get pregnant.

“In fact, despite the absence of formal recommendation or validated health care quality indicators focused on stratification of preconceptional obstetric risk in patients with RA, we started from the basic and universally accepted assumption that aPL antibodies are pathogenic autoantibodies and therefore recognized risk factors for adverse pregnancy outcome,” they wrote.

Women with RA who had either no exposure to methotrexate or leflunomide or who had a washout period from 6 months prior to conception had 72% lower odds of adverse pregnancy outcomes.

The authors also looked at the effects of drugs such as aspirin, glucocorticoids, and low-molecular-weight heparin that are used during pregnancy. They found that the relative risk of adverse pregnancy outcomes was 40% higher in women with RA who were taking glucocorticoids, compared with those with the disease but not taking that type of medication. However, low-molecular-weight heparin use was associated with an 80% lower relative risk of miscarriage or perinatal death in comparison with those not taking it. Researchers saw no significant effects of aspirin or conventional synthetic disease-modifying antirheumatic drugs on either adverse pregnancy outcomes or the risk of miscarriage or perinatal death.

“This reinforces the importance of adjustment of therapy for RA before conception and throughout pregnancy, because medication use could affect pregnancy course not only influencing maternal disease activity but also the gestational outcome,” the authors wrote. “Although this is a study conducted on administrative data, we can hypothesize that exposure to therapy represents a marker of high RA disease activity and severity. In our setting, it is possible that, the more active the disease, the greater the probability of being included in the ideal clinical pathway, but in any case, this resulted in a lower odds ratio of adverse pregnancy outcome and miscarriage/perinatal death.”

The study was supported by the Italian Society for Rheumatology. No conflicts of interest were declared.

SOURCE: Bortoluzzi A et al. Arthritis Care Res. 2020 Jan 8. doi: 10.1002/ACR.24116.

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Key clinical point: Well-managed rheumatoid arthritis during preconception and pregnancy is associated with improved pregnancy outcomes.

Major finding: Women who adhered to an ideal clinical pathway for their RA had significantly lower risk of adverse pregnancy outcomes and miscarriage and/or perinatal death.

Study details: Retrospective, observational study of 443 first pregnancies in women with RA and 6,097 women without.

Disclosures: The study was supported by the Italian Society for Rheumatology. No conflicts of interest were declared.

Source: Bortoluzzi A et al. Arthritis Care Res. 2020 Jan 8. doi: 10.1002/ACR.24116.

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Vitamin D alone does not reduce fracture risk

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Thu, 01/09/2020 - 09:04

Vitamin D supplementation alone does not appear to reduce the risk of fracture, but a combination of vitamin D and calcium may, according to a systematic review and meta-analysis published in JAMA Network Open.

Pang Yao, PhD, from the Nuffield Department of Population Health at the University of Oxford (England) and coauthors wrote that, while randomized, controlled trials (RCTs) of vitamin D supplements – either alone or in combination with calcium supplementation – have found conflicting results, most only had limited power to detect differences in the risk of fracture.

Dr. Yao and associates performed a meta-analysis of 11 observational studies with 39,141 participants, 11 RCTs of vitamin D supplementation alone in 34,243 participants, and 6 RCTs of calcium plus vitamin D involving 49,282 participants.

The analysis of the observational studies revealed that each 10.0-ng/mL increase in blood 25-hydroxyvitamin D concentrations was associated with a 7% lower risk of any fracture. However the authors noted significant heterogeneity between individual studies.

The meta-analysis of the 11 trials of vitamin D alone found that supplementation was not associated with significant change in the risk for any fracture or for hip fracture. Even subgroup analyses looking at age, residential status, location, study design, daily supplementation, or duration of supplementation failed to find any effect. However, there was a median difference in blood 25-hydroxyvitamin D concentrations of 8.4 ng/mL with vitamin D supplementation.



In the meta-analysis of the six vitamin D plus calcium trials, there was a significant 6% reduction in the rate of any fracture and a 16% reduction in hip fracture rate with supplementation. Overall, there was a 1% reduction in the risk of any fracture for each 0.4-ng/mL difference in blood 25-hydroxyvitamin D concentration and 2% reduction in the risk of hip fracture.

However, the authors judged five of those six vitamin D plus calcium trials to be at high risk of bias, with two having open-label designs, although there was little heterogeneity among the studies. All the trials used either 800 or 400 IU/day of vitamin D and 1,200 or 800 mg/day of calcium, and the mean duration of treatment was 5.9 years.

Participants aged 80 years or older living in institutions showed greater reductions in the risk of any fracture with calcium plus vitamin D supplementation, compared with those younger than 80 years who were living in the community.

“In this systematic review and meta-analysis, the available evidence from completed RCTs provided no support for the effects of vitamin D alone on prevention of fracture, but most of these RCTs were constrained by methodological problems,” they wrote. “Meta-analyses of ongoing RCTs assessing the effects of higher daily doses of vitamin D on fracture risk are needed before making recommendations on the use of vitamin D for prevention of fracture.”

One author was supported by a Sino-British Fellowship Trust scholarship, and another received grants from the U.K. Medical Research Council. No conflicts of interest were declared.

SOURCE: Yao P et al. JAMA Netw Open. 2019. doi: 10.1001/jamanetworkopen.2019.17789.

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Vitamin D supplementation alone does not appear to reduce the risk of fracture, but a combination of vitamin D and calcium may, according to a systematic review and meta-analysis published in JAMA Network Open.

Pang Yao, PhD, from the Nuffield Department of Population Health at the University of Oxford (England) and coauthors wrote that, while randomized, controlled trials (RCTs) of vitamin D supplements – either alone or in combination with calcium supplementation – have found conflicting results, most only had limited power to detect differences in the risk of fracture.

Dr. Yao and associates performed a meta-analysis of 11 observational studies with 39,141 participants, 11 RCTs of vitamin D supplementation alone in 34,243 participants, and 6 RCTs of calcium plus vitamin D involving 49,282 participants.

The analysis of the observational studies revealed that each 10.0-ng/mL increase in blood 25-hydroxyvitamin D concentrations was associated with a 7% lower risk of any fracture. However the authors noted significant heterogeneity between individual studies.

The meta-analysis of the 11 trials of vitamin D alone found that supplementation was not associated with significant change in the risk for any fracture or for hip fracture. Even subgroup analyses looking at age, residential status, location, study design, daily supplementation, or duration of supplementation failed to find any effect. However, there was a median difference in blood 25-hydroxyvitamin D concentrations of 8.4 ng/mL with vitamin D supplementation.



In the meta-analysis of the six vitamin D plus calcium trials, there was a significant 6% reduction in the rate of any fracture and a 16% reduction in hip fracture rate with supplementation. Overall, there was a 1% reduction in the risk of any fracture for each 0.4-ng/mL difference in blood 25-hydroxyvitamin D concentration and 2% reduction in the risk of hip fracture.

However, the authors judged five of those six vitamin D plus calcium trials to be at high risk of bias, with two having open-label designs, although there was little heterogeneity among the studies. All the trials used either 800 or 400 IU/day of vitamin D and 1,200 or 800 mg/day of calcium, and the mean duration of treatment was 5.9 years.

Participants aged 80 years or older living in institutions showed greater reductions in the risk of any fracture with calcium plus vitamin D supplementation, compared with those younger than 80 years who were living in the community.

“In this systematic review and meta-analysis, the available evidence from completed RCTs provided no support for the effects of vitamin D alone on prevention of fracture, but most of these RCTs were constrained by methodological problems,” they wrote. “Meta-analyses of ongoing RCTs assessing the effects of higher daily doses of vitamin D on fracture risk are needed before making recommendations on the use of vitamin D for prevention of fracture.”

One author was supported by a Sino-British Fellowship Trust scholarship, and another received grants from the U.K. Medical Research Council. No conflicts of interest were declared.

SOURCE: Yao P et al. JAMA Netw Open. 2019. doi: 10.1001/jamanetworkopen.2019.17789.

Vitamin D supplementation alone does not appear to reduce the risk of fracture, but a combination of vitamin D and calcium may, according to a systematic review and meta-analysis published in JAMA Network Open.

Pang Yao, PhD, from the Nuffield Department of Population Health at the University of Oxford (England) and coauthors wrote that, while randomized, controlled trials (RCTs) of vitamin D supplements – either alone or in combination with calcium supplementation – have found conflicting results, most only had limited power to detect differences in the risk of fracture.

Dr. Yao and associates performed a meta-analysis of 11 observational studies with 39,141 participants, 11 RCTs of vitamin D supplementation alone in 34,243 participants, and 6 RCTs of calcium plus vitamin D involving 49,282 participants.

The analysis of the observational studies revealed that each 10.0-ng/mL increase in blood 25-hydroxyvitamin D concentrations was associated with a 7% lower risk of any fracture. However the authors noted significant heterogeneity between individual studies.

The meta-analysis of the 11 trials of vitamin D alone found that supplementation was not associated with significant change in the risk for any fracture or for hip fracture. Even subgroup analyses looking at age, residential status, location, study design, daily supplementation, or duration of supplementation failed to find any effect. However, there was a median difference in blood 25-hydroxyvitamin D concentrations of 8.4 ng/mL with vitamin D supplementation.



In the meta-analysis of the six vitamin D plus calcium trials, there was a significant 6% reduction in the rate of any fracture and a 16% reduction in hip fracture rate with supplementation. Overall, there was a 1% reduction in the risk of any fracture for each 0.4-ng/mL difference in blood 25-hydroxyvitamin D concentration and 2% reduction in the risk of hip fracture.

However, the authors judged five of those six vitamin D plus calcium trials to be at high risk of bias, with two having open-label designs, although there was little heterogeneity among the studies. All the trials used either 800 or 400 IU/day of vitamin D and 1,200 or 800 mg/day of calcium, and the mean duration of treatment was 5.9 years.

Participants aged 80 years or older living in institutions showed greater reductions in the risk of any fracture with calcium plus vitamin D supplementation, compared with those younger than 80 years who were living in the community.

“In this systematic review and meta-analysis, the available evidence from completed RCTs provided no support for the effects of vitamin D alone on prevention of fracture, but most of these RCTs were constrained by methodological problems,” they wrote. “Meta-analyses of ongoing RCTs assessing the effects of higher daily doses of vitamin D on fracture risk are needed before making recommendations on the use of vitamin D for prevention of fracture.”

One author was supported by a Sino-British Fellowship Trust scholarship, and another received grants from the U.K. Medical Research Council. No conflicts of interest were declared.

SOURCE: Yao P et al. JAMA Netw Open. 2019. doi: 10.1001/jamanetworkopen.2019.17789.

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Ultrasound improves specificity of psoriatic arthritis referrals

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The use of ultrasound in screening for psoriatic arthritis in patients with psoriasis could reduce the number of unnecessary referrals to rheumatologists, according to a research letter published in the British Journal of Dermatology.

ultrasound machine
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Up to one-third of patients with psoriasis have underlying psoriatic arthritis (PsA), but half of all patients with psoriasis experience nonspecific musculoskeletal complaints.

“Different screening tools have been developed for the dermatology practice to distinguish patients with a higher likelihood of having PsA; however, the low specificities of these tools limit their use in clinical practice,” wrote Dilek Solmaz, MD, and colleagues at the University of Ottawa.

In this prospective study, 51 patients with psoriasis were screened for referral to a rheumatologist using the Early Arthritis for Psoriatic Patients and Psoriasis Epidemiology Screening Tool questionnaires. They also underwent a limited ultrasound scanning of wrists, hands, feet, and the most painful joint, which was reviewed by experienced rheumatologists.

A dermatologist was asked to make a decision on referral based on the questionnaire data alone, then invited to revisit that decision after viewing the ultrasound results. When basing their decision on the questionnaires only, the dermatologist decided to refer 92% of patients to a rheumatologist. Of these patients, 40% were subsequently diagnosed with PsA, which represented a sensitivity of 95% but specificity of just 9%.



After reviewing the ultrasound data, the dermatologist revised their recommendations and only referred 43% of patients. Of these, 68% were later diagnosed with psoriatic arthritis. Among the patients who were not referred after the ultrasound review, five were diagnosed with PsA, but two had isolated axial involvement with no peripheral joint disease. Excluding these two cases, the sensitivity decreased to 88% but specificity increased to 77%.

“Screening tools in psoriasis that have high sensitivities usually have low specificities, which means a higher number of patients to be referred to rheumatology than needed,” the authors wrote. “Our study demonstrated that a musculoskeletal [ultrasound] based on a predefined protocol improves the referrals made to rheumatology.”

The authors did note that the ultrasounds were reviewed by experienced rheumatologists, so the results might not be generalizable to less-experienced sonographers without experience in musculoskeletal disorders.

The study was funded by AbbVie. One author declared receiving funding for a fellowship from UCB. Two authors declared honoraria and advisory consultancies with the pharmaceutical sector, including AbbVie.

SOURCE: Solmaz D et al. Br J Dermatol. 2019 Nov 28. doi: 10.1111/bjd.18515.

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The use of ultrasound in screening for psoriatic arthritis in patients with psoriasis could reduce the number of unnecessary referrals to rheumatologists, according to a research letter published in the British Journal of Dermatology.

ultrasound machine
Bogdanhoda/Thinkstock

Up to one-third of patients with psoriasis have underlying psoriatic arthritis (PsA), but half of all patients with psoriasis experience nonspecific musculoskeletal complaints.

“Different screening tools have been developed for the dermatology practice to distinguish patients with a higher likelihood of having PsA; however, the low specificities of these tools limit their use in clinical practice,” wrote Dilek Solmaz, MD, and colleagues at the University of Ottawa.

In this prospective study, 51 patients with psoriasis were screened for referral to a rheumatologist using the Early Arthritis for Psoriatic Patients and Psoriasis Epidemiology Screening Tool questionnaires. They also underwent a limited ultrasound scanning of wrists, hands, feet, and the most painful joint, which was reviewed by experienced rheumatologists.

A dermatologist was asked to make a decision on referral based on the questionnaire data alone, then invited to revisit that decision after viewing the ultrasound results. When basing their decision on the questionnaires only, the dermatologist decided to refer 92% of patients to a rheumatologist. Of these patients, 40% were subsequently diagnosed with PsA, which represented a sensitivity of 95% but specificity of just 9%.



After reviewing the ultrasound data, the dermatologist revised their recommendations and only referred 43% of patients. Of these, 68% were later diagnosed with psoriatic arthritis. Among the patients who were not referred after the ultrasound review, five were diagnosed with PsA, but two had isolated axial involvement with no peripheral joint disease. Excluding these two cases, the sensitivity decreased to 88% but specificity increased to 77%.

“Screening tools in psoriasis that have high sensitivities usually have low specificities, which means a higher number of patients to be referred to rheumatology than needed,” the authors wrote. “Our study demonstrated that a musculoskeletal [ultrasound] based on a predefined protocol improves the referrals made to rheumatology.”

The authors did note that the ultrasounds were reviewed by experienced rheumatologists, so the results might not be generalizable to less-experienced sonographers without experience in musculoskeletal disorders.

The study was funded by AbbVie. One author declared receiving funding for a fellowship from UCB. Two authors declared honoraria and advisory consultancies with the pharmaceutical sector, including AbbVie.

SOURCE: Solmaz D et al. Br J Dermatol. 2019 Nov 28. doi: 10.1111/bjd.18515.

The use of ultrasound in screening for psoriatic arthritis in patients with psoriasis could reduce the number of unnecessary referrals to rheumatologists, according to a research letter published in the British Journal of Dermatology.

ultrasound machine
Bogdanhoda/Thinkstock

Up to one-third of patients with psoriasis have underlying psoriatic arthritis (PsA), but half of all patients with psoriasis experience nonspecific musculoskeletal complaints.

“Different screening tools have been developed for the dermatology practice to distinguish patients with a higher likelihood of having PsA; however, the low specificities of these tools limit their use in clinical practice,” wrote Dilek Solmaz, MD, and colleagues at the University of Ottawa.

In this prospective study, 51 patients with psoriasis were screened for referral to a rheumatologist using the Early Arthritis for Psoriatic Patients and Psoriasis Epidemiology Screening Tool questionnaires. They also underwent a limited ultrasound scanning of wrists, hands, feet, and the most painful joint, which was reviewed by experienced rheumatologists.

A dermatologist was asked to make a decision on referral based on the questionnaire data alone, then invited to revisit that decision after viewing the ultrasound results. When basing their decision on the questionnaires only, the dermatologist decided to refer 92% of patients to a rheumatologist. Of these patients, 40% were subsequently diagnosed with PsA, which represented a sensitivity of 95% but specificity of just 9%.



After reviewing the ultrasound data, the dermatologist revised their recommendations and only referred 43% of patients. Of these, 68% were later diagnosed with psoriatic arthritis. Among the patients who were not referred after the ultrasound review, five were diagnosed with PsA, but two had isolated axial involvement with no peripheral joint disease. Excluding these two cases, the sensitivity decreased to 88% but specificity increased to 77%.

“Screening tools in psoriasis that have high sensitivities usually have low specificities, which means a higher number of patients to be referred to rheumatology than needed,” the authors wrote. “Our study demonstrated that a musculoskeletal [ultrasound] based on a predefined protocol improves the referrals made to rheumatology.”

The authors did note that the ultrasounds were reviewed by experienced rheumatologists, so the results might not be generalizable to less-experienced sonographers without experience in musculoskeletal disorders.

The study was funded by AbbVie. One author declared receiving funding for a fellowship from UCB. Two authors declared honoraria and advisory consultancies with the pharmaceutical sector, including AbbVie.

SOURCE: Solmaz D et al. Br J Dermatol. 2019 Nov 28. doi: 10.1111/bjd.18515.

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High-dose progesterone to reverse mifepristone held still 'experimental'

Study emphasizes the significance of scientific rigor
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Thu, 12/19/2019 - 14:45

A study of high-dose progesterone as a mifepristone antagonist to reverse medical abortion has been stopped early because of safety concerns, but the authors say mifepristone antagonization should not be considered impossible.

In Obstetrics & Gynecology, Mitchell D. Creinin, MD, of the University of California, Davis, and coauthors reported the outcomes of a double-blind, placebo-controlled trial investigating the efficacy and safety of high-dose oral progesterone as a mifepristone antagonist. The study intended to enroll more women at 44–63 days of gestation who were planning surgical abortion, but stopped enrolling after 12 patients because of hemorrhage concerns.

Women were given a 200-mg dose of oral mifepristone, then randomized to either 200 mg oral progesterone or placebo 24 hours later, taken twice daily for 3 days then once daily until their planned surgical abortion 14-16 days after enrollment.

The approved method of medical abortion in the United States involves a combination of mifepristone followed by the prostaglandin analogue misoprostol 24-48 hours later, a combination designed to improve efficacy of the treatment.

There have been reports of some patients changing their minds in between taking the mifepristone and the misoprostol. The fact that mifepristone binds strongly to the progesterone receptor has led to the idea that its action could be reversed with high-dose progesterone as an antagonist.

In this study, three women – two in the placebo group and one in the progesterone group – experienced severe bleeding requiring ambulance transport to the emergency department 2-3 days after taking the mifepristone.

The study found that four of the six patients in the progesterone group, and two of the six patients in the placebo group had continuing pregnancies at 2 weeks.

There were two patients – one in each group – who did not complete the study. One in the placebo group left after taking the mifepristone because of anxiety about bleeding, and had a suction aspiration. The second women completed two of the four doses of progesterone, then requested a suction aspiration.

Dr. Creinin and coauthors wrote that while the study ended early, they found that there were no significant differences in the side effects experienced by patients treated with progesterone, compared with those on placebo – apart from a worsening of some pregnancy symptoms such as vomiting and tiredness.

However, patients should be told of the risk of using mifepristone for medical abortion without using misoprostol, they said, as this was associated with severe hemorrhage even with progesterone treatment.

“Because of the potential dangers for patients who opt not to use misoprostol after mifepristone ingestion, any mifepristone antagonization treatment must be considered experimental,” Dr. Creinin and associates wrote.

The Society of Family Planning Research Fund supported the study. One author declared a consultancy with a laboratory providing medical consultation for clinicians regarding mifepristone, and a second author was an employee of Planned Parenthood. No other conflicts of interest were declared.

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I think that this study highlights the importance of scientific rigor approved by an institutional review board when we counsel and care for our patients. As ob.gyns., we have to remember the privilege that women entrust us with their health and well being. To a certain extent, we also care for their families within our scope of reproductive health. We practice based on the best evidence available and consider referral to another trusted provider when we feel that we cannot provide unbiased care. I also feel obligated to share my opinion that legislators should trust the scientific and clinical community to not only prioritize women and their health, but also avoid introducing legislation that infringes on medicine.

Dr. Catherine Cansino is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis.
Dr. Catherine Cansino
I applaud the investigators for the innovation of the study design and complying with their ethical duty to terminate the study early given safety concerns. I also appreciate the authors’ transparency in presenting outcomes for all subjects. Other case reports on this topic have presented only positive outcomes (i.e., continuing pregnancies/deliveries) which represent a fraction of the study population. Given the complicated outcomes experienced by some subjects in Dr. Creinin’s study, I am curious about the outcomes of the other subjects in previous case reports who didn’t have positive outcomes (i.e., those who did not have continuing pregnancies).

Catherine Cansino, MD, MPH, is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Creinin et al. article. Dr. Cansino is on the Ob.Gyn. News editorial advisory board.

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Body

 

I think that this study highlights the importance of scientific rigor approved by an institutional review board when we counsel and care for our patients. As ob.gyns., we have to remember the privilege that women entrust us with their health and well being. To a certain extent, we also care for their families within our scope of reproductive health. We practice based on the best evidence available and consider referral to another trusted provider when we feel that we cannot provide unbiased care. I also feel obligated to share my opinion that legislators should trust the scientific and clinical community to not only prioritize women and their health, but also avoid introducing legislation that infringes on medicine.

Dr. Catherine Cansino is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis.
Dr. Catherine Cansino
I applaud the investigators for the innovation of the study design and complying with their ethical duty to terminate the study early given safety concerns. I also appreciate the authors’ transparency in presenting outcomes for all subjects. Other case reports on this topic have presented only positive outcomes (i.e., continuing pregnancies/deliveries) which represent a fraction of the study population. Given the complicated outcomes experienced by some subjects in Dr. Creinin’s study, I am curious about the outcomes of the other subjects in previous case reports who didn’t have positive outcomes (i.e., those who did not have continuing pregnancies).

Catherine Cansino, MD, MPH, is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Creinin et al. article. Dr. Cansino is on the Ob.Gyn. News editorial advisory board.

Body

 

I think that this study highlights the importance of scientific rigor approved by an institutional review board when we counsel and care for our patients. As ob.gyns., we have to remember the privilege that women entrust us with their health and well being. To a certain extent, we also care for their families within our scope of reproductive health. We practice based on the best evidence available and consider referral to another trusted provider when we feel that we cannot provide unbiased care. I also feel obligated to share my opinion that legislators should trust the scientific and clinical community to not only prioritize women and their health, but also avoid introducing legislation that infringes on medicine.

Dr. Catherine Cansino is an associate clinical professor in the department of obstetrics and gynecology at the University of California, Davis.
Dr. Catherine Cansino
I applaud the investigators for the innovation of the study design and complying with their ethical duty to terminate the study early given safety concerns. I also appreciate the authors’ transparency in presenting outcomes for all subjects. Other case reports on this topic have presented only positive outcomes (i.e., continuing pregnancies/deliveries) which represent a fraction of the study population. Given the complicated outcomes experienced by some subjects in Dr. Creinin’s study, I am curious about the outcomes of the other subjects in previous case reports who didn’t have positive outcomes (i.e., those who did not have continuing pregnancies).

Catherine Cansino, MD, MPH, is associate clinical professor of obstetrics and gynecology at the University of California, Davis. She was asked to comment on the Creinin et al. article. Dr. Cansino is on the Ob.Gyn. News editorial advisory board.

Title
Study emphasizes the significance of scientific rigor
Study emphasizes the significance of scientific rigor

A study of high-dose progesterone as a mifepristone antagonist to reverse medical abortion has been stopped early because of safety concerns, but the authors say mifepristone antagonization should not be considered impossible.

In Obstetrics & Gynecology, Mitchell D. Creinin, MD, of the University of California, Davis, and coauthors reported the outcomes of a double-blind, placebo-controlled trial investigating the efficacy and safety of high-dose oral progesterone as a mifepristone antagonist. The study intended to enroll more women at 44–63 days of gestation who were planning surgical abortion, but stopped enrolling after 12 patients because of hemorrhage concerns.

Women were given a 200-mg dose of oral mifepristone, then randomized to either 200 mg oral progesterone or placebo 24 hours later, taken twice daily for 3 days then once daily until their planned surgical abortion 14-16 days after enrollment.

The approved method of medical abortion in the United States involves a combination of mifepristone followed by the prostaglandin analogue misoprostol 24-48 hours later, a combination designed to improve efficacy of the treatment.

There have been reports of some patients changing their minds in between taking the mifepristone and the misoprostol. The fact that mifepristone binds strongly to the progesterone receptor has led to the idea that its action could be reversed with high-dose progesterone as an antagonist.

In this study, three women – two in the placebo group and one in the progesterone group – experienced severe bleeding requiring ambulance transport to the emergency department 2-3 days after taking the mifepristone.

The study found that four of the six patients in the progesterone group, and two of the six patients in the placebo group had continuing pregnancies at 2 weeks.

There were two patients – one in each group – who did not complete the study. One in the placebo group left after taking the mifepristone because of anxiety about bleeding, and had a suction aspiration. The second women completed two of the four doses of progesterone, then requested a suction aspiration.

Dr. Creinin and coauthors wrote that while the study ended early, they found that there were no significant differences in the side effects experienced by patients treated with progesterone, compared with those on placebo – apart from a worsening of some pregnancy symptoms such as vomiting and tiredness.

However, patients should be told of the risk of using mifepristone for medical abortion without using misoprostol, they said, as this was associated with severe hemorrhage even with progesterone treatment.

“Because of the potential dangers for patients who opt not to use misoprostol after mifepristone ingestion, any mifepristone antagonization treatment must be considered experimental,” Dr. Creinin and associates wrote.

The Society of Family Planning Research Fund supported the study. One author declared a consultancy with a laboratory providing medical consultation for clinicians regarding mifepristone, and a second author was an employee of Planned Parenthood. No other conflicts of interest were declared.

A study of high-dose progesterone as a mifepristone antagonist to reverse medical abortion has been stopped early because of safety concerns, but the authors say mifepristone antagonization should not be considered impossible.

In Obstetrics & Gynecology, Mitchell D. Creinin, MD, of the University of California, Davis, and coauthors reported the outcomes of a double-blind, placebo-controlled trial investigating the efficacy and safety of high-dose oral progesterone as a mifepristone antagonist. The study intended to enroll more women at 44–63 days of gestation who were planning surgical abortion, but stopped enrolling after 12 patients because of hemorrhage concerns.

Women were given a 200-mg dose of oral mifepristone, then randomized to either 200 mg oral progesterone or placebo 24 hours later, taken twice daily for 3 days then once daily until their planned surgical abortion 14-16 days after enrollment.

The approved method of medical abortion in the United States involves a combination of mifepristone followed by the prostaglandin analogue misoprostol 24-48 hours later, a combination designed to improve efficacy of the treatment.

There have been reports of some patients changing their minds in between taking the mifepristone and the misoprostol. The fact that mifepristone binds strongly to the progesterone receptor has led to the idea that its action could be reversed with high-dose progesterone as an antagonist.

In this study, three women – two in the placebo group and one in the progesterone group – experienced severe bleeding requiring ambulance transport to the emergency department 2-3 days after taking the mifepristone.

The study found that four of the six patients in the progesterone group, and two of the six patients in the placebo group had continuing pregnancies at 2 weeks.

There were two patients – one in each group – who did not complete the study. One in the placebo group left after taking the mifepristone because of anxiety about bleeding, and had a suction aspiration. The second women completed two of the four doses of progesterone, then requested a suction aspiration.

Dr. Creinin and coauthors wrote that while the study ended early, they found that there were no significant differences in the side effects experienced by patients treated with progesterone, compared with those on placebo – apart from a worsening of some pregnancy symptoms such as vomiting and tiredness.

However, patients should be told of the risk of using mifepristone for medical abortion without using misoprostol, they said, as this was associated with severe hemorrhage even with progesterone treatment.

“Because of the potential dangers for patients who opt not to use misoprostol after mifepristone ingestion, any mifepristone antagonization treatment must be considered experimental,” Dr. Creinin and associates wrote.

The Society of Family Planning Research Fund supported the study. One author declared a consultancy with a laboratory providing medical consultation for clinicians regarding mifepristone, and a second author was an employee of Planned Parenthood. No other conflicts of interest were declared.

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