Legal abortions in the United States are safe and effective, and serious complications are rare, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.

Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.

The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.

In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.

dwatson@mdedge.com

Legal abortions in the United States are safe and effective, and serious complications are rare, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.

Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.

The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.

In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.

dwatson@mdedge.com

Legal abortions in the United States are safe and effective, and serious complications are rare, according to a consensus study report by the National Academies of Science, Engineering, and Medicine.

Six private foundations commissioned a comprehensive report from the National Academies, which focused on eight questions related to the safety and quality of U.S. abortion care. The resulting Committee on Reproductive Health Services limited itself to these questions and did not make specific policy or clinical recommendations, though they did note that “state regulations have created barriers to optimizing each dimension of quality care.” The report was released on March 16.

The committee focused on the four legal abortion methods in the United States – medication, aspiration, dilation and evacuation (D&E), and induction – and concluded that all four are safe, but that induction is so rare that there is a lack of quality research on the procedure’s risks in women with prior cesarean deliveries. D&E, though less painful, costly, and time consuming than induction, is banned in Mississippi and West Virginia (with exceptions for emergencies) and limited elsewhere in the country by a lack of physicians trained to perform the procedure.

In attempting to assess the physical and mental health risks of abortion procedures, the committee found that “much of the published literature on these topics does not meet scientific standards for rigorous, unbiased research.” Surveying research that they considered high quality, the committee concluded that there is no increased risk of secondary infertility, pregnancy-related hypertensive disorders, abnormal placentation, preterm birth, breast cancer, or mental health disorders such as depression, anxiety, or posttraumatic stress disorder associated with a woman having an abortion.

dwatson@mdedge.com

A Pap test combined with assays for gene mutations showed an 81% and 33% sensitivity or identifying endometrial and ovarian cancer, respectively.

In a study published in Science Translational Medicine, Yuxuan Wang, MD, of Johns Hopkins University, Baltimore, and her colleagues used a polymerase chain reaction–based test known as PapSEEK to examine Pap brush samples from 382 women with endometrial cancer, 245 women with ovarian cancer, and 714 women without cancer.

Overall, 81% of the endometrial cancer patients and 29% of the ovarian cancer patients had detectable mutations on Pap smears taken with a Pap brush. Among endometrial cancer patients, the genetic test identified mutations in 78% of patients with early-stage disease and 89% of those with late-stage disease. Among ovarian cancer patients, the genetic test identified 28% of patients with early-stage disease and 30% of those with late-stage disease.

The investigators also used the genetic test on Tao brush samples from the intrauterine cavity from a subset of 123 patients with endometrial cancer, 51 with ovarian cancer, and 125 controls and identified genetic mutations in 93% and 45% of endometrial and ovarian cancers, respectively.

The results demonstrate the potential of mutation-based diagnostic testing, and samples taken with the Tao brush may be especially helpful for ovarian cancers, especially in samples combining Pap and plasma sample data, the researchers said.

The study was limited by several factors including its retrospective design and having a study population confined to women with known cancers, the researchers noted. More research is needed, but results suggest the potential for DNA analysis to catch cancers early in a screening setting, they said. “Our study lays the foundation for evaluating PapSEEK in a large prospective study,” ideally including patients at high risk for gynecologic cancers, they added.

The study was funded by multiple sources including the Virginia and D.K. Ludwig Fund for Cancer Research, the National Institutes of Health, and the Stand Up to Cancer Colorectal Dream Team Translational Research Grant. Dr. Wang and several coauthors disclosed patent, equity, and royalty interest in technologies discussed in the paper. Four coauthors are cofounders of and stockholders in PapGene, which has licensed technologies related to the work described in the paper.

SOURCE: Wang Y et al. Sci Transl Med. 2018 Mar 21;10(433):eaap8793.

A Pap test combined with assays for gene mutations showed an 81% and 33% sensitivity or identifying endometrial and ovarian cancer, respectively.

In a study published in Science Translational Medicine, Yuxuan Wang, MD, of Johns Hopkins University, Baltimore, and her colleagues used a polymerase chain reaction–based test known as PapSEEK to examine Pap brush samples from 382 women with endometrial cancer, 245 women with ovarian cancer, and 714 women without cancer.

Overall, 81% of the endometrial cancer patients and 29% of the ovarian cancer patients had detectable mutations on Pap smears taken with a Pap brush. Among endometrial cancer patients, the genetic test identified mutations in 78% of patients with early-stage disease and 89% of those with late-stage disease. Among ovarian cancer patients, the genetic test identified 28% of patients with early-stage disease and 30% of those with late-stage disease.

The investigators also used the genetic test on Tao brush samples from the intrauterine cavity from a subset of 123 patients with endometrial cancer, 51 with ovarian cancer, and 125 controls and identified genetic mutations in 93% and 45% of endometrial and ovarian cancers, respectively.

The results demonstrate the potential of mutation-based diagnostic testing, and samples taken with the Tao brush may be especially helpful for ovarian cancers, especially in samples combining Pap and plasma sample data, the researchers said.

The study was limited by several factors including its retrospective design and having a study population confined to women with known cancers, the researchers noted. More research is needed, but results suggest the potential for DNA analysis to catch cancers early in a screening setting, they said. “Our study lays the foundation for evaluating PapSEEK in a large prospective study,” ideally including patients at high risk for gynecologic cancers, they added.

The study was funded by multiple sources including the Virginia and D.K. Ludwig Fund for Cancer Research, the National Institutes of Health, and the Stand Up to Cancer Colorectal Dream Team Translational Research Grant. Dr. Wang and several coauthors disclosed patent, equity, and royalty interest in technologies discussed in the paper. Four coauthors are cofounders of and stockholders in PapGene, which has licensed technologies related to the work described in the paper.

SOURCE: Wang Y et al. Sci Transl Med. 2018 Mar 21;10(433):eaap8793.

A Pap test combined with assays for gene mutations showed an 81% and 33% sensitivity or identifying endometrial and ovarian cancer, respectively.

In a study published in Science Translational Medicine, Yuxuan Wang, MD, of Johns Hopkins University, Baltimore, and her colleagues used a polymerase chain reaction–based test known as PapSEEK to examine Pap brush samples from 382 women with endometrial cancer, 245 women with ovarian cancer, and 714 women without cancer.

Overall, 81% of the endometrial cancer patients and 29% of the ovarian cancer patients had detectable mutations on Pap smears taken with a Pap brush. Among endometrial cancer patients, the genetic test identified mutations in 78% of patients with early-stage disease and 89% of those with late-stage disease. Among ovarian cancer patients, the genetic test identified 28% of patients with early-stage disease and 30% of those with late-stage disease.

The investigators also used the genetic test on Tao brush samples from the intrauterine cavity from a subset of 123 patients with endometrial cancer, 51 with ovarian cancer, and 125 controls and identified genetic mutations in 93% and 45% of endometrial and ovarian cancers, respectively.

The results demonstrate the potential of mutation-based diagnostic testing, and samples taken with the Tao brush may be especially helpful for ovarian cancers, especially in samples combining Pap and plasma sample data, the researchers said.

The study was limited by several factors including its retrospective design and having a study population confined to women with known cancers, the researchers noted. More research is needed, but results suggest the potential for DNA analysis to catch cancers early in a screening setting, they said. “Our study lays the foundation for evaluating PapSEEK in a large prospective study,” ideally including patients at high risk for gynecologic cancers, they added.

The study was funded by multiple sources including the Virginia and D.K. Ludwig Fund for Cancer Research, the National Institutes of Health, and the Stand Up to Cancer Colorectal Dream Team Translational Research Grant. Dr. Wang and several coauthors disclosed patent, equity, and royalty interest in technologies discussed in the paper. Four coauthors are cofounders of and stockholders in PapGene, which has licensed technologies related to the work described in the paper.

SOURCE: Wang Y et al. Sci Transl Med. 2018 Mar 21;10(433):eaap8793.

Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.

A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.

“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.

Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term ­data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”

Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.

Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.

“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.

Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.

Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.

With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.

As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.

ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).

“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.

“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”

SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.

Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.

A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.

“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.

Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term ­data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”

Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.

Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.

“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.

Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.

Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.

With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.

As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.

ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).

“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.

“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”

SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.

Hypofractionation is the preferred means of giving whole breast irradiation to women with invasive breast cancer, according to updated guidance from the American Society for Radiation Oncology.

A dose of 4,000 cGy given in 15 fractions or 4,250 cGy in 16 fractions is recommended, with or without inclusion of the low axilla, and regardless of a variety of factors such as tumor grade, prior chemotherapy, and patient age.

“Previously, accelerated treatment was recommended only for certain patients, including older patients and those with less advanced disease,” Benjamin Smith, MD, one of the cochairs of the guideline task force, said in an ASTRO news release.

Dr. Smith, of the University of Texas MD Anderson Cancer Center, Houston, added that recent long-term ­data from several large trials “strongly support the safety and efficacy of accelerated treatment for most breast cancer patients.”

Treatment decisions and plans still need to be individualized, but the updated ASTRO guidance notes that whole breast irradiation (WBI) can be offered to most women with invasive breast cancer independent of breast size and whether or not the cancer is in the left or right breast, provided that homogeneous dosing can be achieved. Hormone receptor, HER2 status, and postsurgical margin status also appear not to matter.

Historically, conventional fractionation (CF) with or without a tumor bed boost was used for WBI, Dr. Smith and associates wrote in the guidelines, which were published online in Practical Radiation Oncology. This consisted of daily doses of 180-200 cGy for a total dose of 4,500-5,000 cGy.

“Recognizing the limitations of CF for convenience and cost, randomized trials in the 1990s and 2000s investigated if moderate hypofractionation [HF], defined as daily doses of 265-330 cGy, could yield oncologic and functional/cosmetic outcomes similar to CF-WBI,” they said.

Initial results of these trials “supported the safety and effectiveness of HF-WBI” and were then used to form ASTRO’s 2011 guideline on dose fractionation for WBI. With longer term data from these trials now available, it was time to review the evidence again. A systematic literature review was thus conducted to identify all relevant studies published during 2009-2016, and 100 articles met the task force criteria and were used to create the updated guideline.

Aside from the delivery and dosing of WBI, other key recommendations look at the use of a radiation boost to the tumor bed, and preferred techniques for treatment planning.

With regards to a radiation boost, this needs to be considered on an individual basis but can be independent of any previous WBI. A radiation boost is recommended if patients have any grade invasive cancer and are aged 50 years or younger, have a high-grade tumor and are aged 51-70 years, or if there is a positive margin following surgery. A radiation boost also is recommended in women with ductal carcinoma in situ if they are aged 50 years or younger, have a high-grade tumor, and positive or close postsurgical margins.

As for treatment planning, 3-dimensional conformal treatment planning with a “field-in-field” technique is recommended as the initial approach. This is to minimize the volume of breast tissue that receives more than 105% of the radiation dose. The guideline also covers optimal patient positioning and how to avoid nearby tissues and organs, such as the heart, lungs and contralateral breast.

ASTRO hopes that the updated guideline will increase the use of hypofractionation, which has been reportedly low in recent years, with as few as 35% of eligible patients received hypofractionation in one study (JAMA. 2014;312[23]:2542-50).

“We hope that this guideline encourages providers to counsel their patients on options including hypofractionation,” said Reshma Jagsi, MD, DPhil, professor of radiation oncology at the University of Michigan, Ann Arbor, who cochaired the guideline task force with Dr. Smith.

“Hypofractionated radiation therapy offers patients a more convenient and lower cost option for their treatment without compromising the likelihood that their cancer will return or increasing their risk of side effects,” Dr. Jagsi noted. Furthermore, “a shorter course of radiation equates to more time with family, less time away from work and lower treatment costs.”

SOURCE: Smith BD et al. Pract Radiat Oncol. 2018 March 12. doi: 10.1016/j.prro.2018.01.012.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

Hospital boards play an important role in quality improvement (QI), and now researchers in England have developed a framework they can use to help develop their QI capability by comparing 15 health care organizations.

“We already know that certain board practices are associated with higher quality care,” said lead researcher Lorelei Jones, PhD. “For example, hospital boards that regularly review quality performance have better patient outcomes. But we don’t know a lot about what boards actually do, or what ‘good’ looks like in relation to quality governance. There is a lot of guidance for boards on what they should be doing, but very little research evidence.”

In their study, researchers developed an evidence-based measure of QI “maturity” – how developed boards were in how they led and oversaw quality improvement. They applied this measure to various organizations and then looked at the characteristics of organizations that showed a highly developed approach to QI.

“Organizations with higher levels of QI maturity prioritized QI; balanced attention to short-term (external) priorities with a long-term (internal) investment in QI; used data for quality improvement, not just quality assurance; engaged staff and patients in QI; and had a culture of continuous improvement,” Dr. Jones said. These characteristics often seemed to be facilitated by clinical leaders; the study also highlighted the importance of board-level clinical leaders in hospitals, she said.

Researchers found that organizations with a highly developed approach to QI did the following:

• Brought in-depth knowledge and understanding of quality issues and provided the board with meaningful analyses of data.
• Contributed knowledge of relevant developments in national policy and links to external networks.
• Played an important role as “boundary spanners,” providing a link between “the board and the ward,” making connections between sources of data and aligning external demands with internal priorities.

“Boards can use our framework to help develop their QI capability,” Dr. Jones said. “For example, boards can use it to do a gap analysis to explore areas that might need strengthening and for ideas on how they could do this.”

Reference

Jones L et al. How do hospital boards govern for quality improvement? A mixed methods study of 15 organisations in England. BMJ Qual Saf. 2017 Dec;26(12):978-86.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

mzoler@mdedge.com

SOURCE: Connolly S. ACC 2018.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

mzoler@mdedge.com

SOURCE: Connolly S. ACC 2018.

ORLANDO – Andexanet alfa, a new agent that reverses the anticoagulant effect of direct factor Xa inhibitors, showed an acceptable level of efficacy and safety in 227 patients who received the drug in the agent’s pivotal trial.

These results, which placed andexanet in the same ballpark for efficacy and safety as idarucizumab (Praxbind), approved in 2015 for reversing the anticoagulant dabigatran (Pradaxa), suggest that andexanet is likely on track for its own Food and Drug Administration marketing approval, Stuart Connolly, MD, said at the annual meeting of the American College of Cardiology.

Mitchel L. Zoler/MDedge News

Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa) previously announced that it expected Food and Drug Administration action on its marketing application by May 2018.

Andexanet reversal “has similar efficacy and safety as seen with other reversal agents” for other types of anticoagulants, said Dr. Connolly, a professor of medicine and an electrophysiologist at McMaster University in Hamilton, Ont. In the trial results he reported, andexanet treatment of patients who were bleeding while on treatment with a direct factor Xa inhibitor had an 83% rate of hemostatic efficacy and an 11% rate of thrombotic events. By comparison, idarucizumab, the FDA-approved reversal agent for the anticoagulant dabigatran, produced a 68% hemostatic efficacy and a 6% rate of thrombotic events in the idarucizumab pivotal trial, RE-VERSE AD (N Engl J Med. 2015 Aug 6;373[6]:511-20).

Clinicians administered andexanet alfa as a bolus followed by a 2-hour continuous infusion, with hemostatic efficacy assessed 12 hours after the start of treatment. The results showed that factor Xa inhibition fell by about 75%-90% within minutes of starting the bolus and remained depressed at that level during the infusion but then began recovering by 2 hours after the stop of infusion. Andexanet is a factor Xa “decoy” molecule that acts by latching onto the inhibitor molecules and thereby preventing them from interacting with actual factor Xa, but andexanet also has a short half life and hence the effect quickly reduces once treatment stops.

“There is no doubt that andexanet rapidly decreases anti–factor Xa activity,” he said.

Adjudicated efficacy results were available for 132 patients and showed good or excellent hemostasis achieved on andexanet in 109 patients (83%), Dr. Connolly reported. The effect on hemostasis was consistent regardless of patient age, sex, bleeding site, type of anticoagulant, and dosage tested.

Thrombotic events during the 30 days following treatment occurred in 24 of 227 patients (11%) who received andexanet and were evaluable for safety. Notably, no clustering of thrombotic events occurred early, even among the 129 patients who restarted on an anticoagulant during the 30 days after treatment. Among the 129 patients who restarted on an anticoagulant, 9 (7%) had a thrombotic event during the 30-day follow-up, compared with 15 events among 98 patients (15%) who did not restart on an anticoagulant.

Dr. Connolly acknowledged that a limitation of the ANNEXA-4 study is the absence of a control group, but he added that he and his associates believed randomizing patients with a serious bleed to placebo control would not have been “practical, feasible, or ethical.”

ANNEXA-4 is sponsored by Portola Pharmaceuticals, the company developing andexanet alfa (AndexXa). Dr. Connolly has been a consultant to Portola, and also to Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, and Sanofi-Aventis. Dr. Kirtane has received research support from several device manufacturers.

mzoler@mdedge.com

SOURCE: Connolly S. ACC 2018.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

Annette Katz didn’t expect to be part of a major social movement. She didn’t set out to take on a major health organization. But that all began to change when a coworker saw her fighting back tears and joined Katz to report to her union what amounted to a criminal sexual offense at a Cleveland Veterans Affairs Medical Center in 2012 and 2013.

Four years later, Katz, a licensed practical nurse at the hospital, testified in a court deposition that a male nursing assistant had shoved her into a linen closet and groped her and subjected her to an onslaught of lewd comments.

In speaking out and taking legal action, Katz joined a growing group of women who are combating sexual harassment in the medical field at every level, from patients’ bedsides to the executive boardroom.

Much as the #MeToo moment has raised awareness of sexual harassment in business, politics, media, and Hollywood, it is prompting women in medicine to take on a health system where workers have traditionally been discouraged from making waves and where hierarchies are ever-present and all-commanding. While the health care field overall has far more women than men, in many stations of power the top of the pyramid is overwhelmingly male, with women occupying the vast base.

In a recent survey, 30% of women on medical faculties reported experiencing sexual harassment at work within the past 2 years, said Reshma Jagsi, MD, who conducted the poll. That share is comparable to results in other sectors and, as elsewhere, in medicine it had been mostly taboo to discuss before last year.

“We know harassment is more common in fields where there are strong power differentials,” said Dr. Jagsi, director of the Center for Bioethics and Social Sciences in Medicine at the University of Michigan, Ann Arbor. “And we know medicine is very hierarchical.”

Workers in the health care and social assistance field reported 4,738 cases of sexual harassment from fiscal 2005 through 2015, eclipsed only by fields such as hospitality and manufacturing, where men make up a greater proportion of the workforce, according to data gathered by the Equal Employment Opportunity Commission.

A Kaiser Health News review of dozens of legal cases across the U.S. shows similar patterns in the waves of harassment cases that have cropped up in other fields, from entertainment to sports to journalism: The harassers are typically male. The alleged harasser supervises or outranks the alleged victim. There are slaps on the butt, lewd comments, and requests for sex. When superiors are confronted with reports of bad behavior, the victims, mostly women, are disbelieved, demoted, or fired.

But recently, physicians have taken to Twitter using the #MeTooMedicine tag, sharing anecdotes and linking to blogs that chronicle powerful doctors harassing them or disrobing at professional conferences.

Women who work in cardiology recently told the cardiology trade publication TCTMD that they felt the problem was particularly widespread in their specialty, where females account for 14% of the physicians. A Los Angeles anesthesiologist made waves in a blog post urging “prettier” women to adopt a “professional-looking, even severe, hair style” to be taken seriously and to consider self-defense classes.

Among those speaking out is Jennifer Gunter, MD, a San Francisco obstetrician-gynecologist, who recently wrote a blog post about being groped in 2014 by a prominent colleague at a medical conference – even naming him.

“I think nothing will change unless people are able to name people and institutions are held accountable,” she said in an interview. “I don’t think without massive public discourse and exposure that things will change.”

Lawsuits, many settled or still making their way through the courts, describe encounters.

A Florida nurse claimed that in 2014, a surgeon made lewd comments about her breasts, asking her in a room full of people if he should “refer to her as ‘JJ’ or ‘Jugs,’ ” the nurse’s lawsuit says. The nurse said she “responded that she wished to be called by her name.”

In other cases: A phlebotomist in New York alleged in a lawsuit that a doctor in her medical practice gave her a box of Valentine’s Day candy and moved in for an unwanted kiss on the mouth. A Florida medical resident alleged that a supervising doctor told her she looked like a “slutty whore.” A Nebraska nurse claimed that a doctor she traveled with to a professional conference offered to buy her a bikini, if he could see her in it, and an extra night in a hotel, if they could share the room. She declined.

A Pennsylvania nurse described the unsatisfying response she got after reporting that a colleague had pressed his pelvis against her and flipped through her phone for “naked pictures.” A supervisor to whom she reported the conduct expressed exasperation, saying “I can’t deal with this” and “What do you want?”

Kayla Behbahani, DO, chief psychiatry resident at University of Massachusetts Memorial Medical Center, did not file a lawsuit but recently wrote about sexual harassment by a subordinate. In an interview, she said her instincts were to pity the man, and also to follow a dictate that’s drilled into medical students: Don’t make waves. So, she disclosed the harassment only after another woman’s complaint launched an investigation.

“As a professional, I come from a culture where you go with the flow,” Dr. Behbahani said. “You deal with what you’re dealt. In that regard, it was a dilemma for me.”

Annette Katz, the Veterans Affairs nurse, initially didn’t complain about the harassment. A single mother with two children, she needed her job. Her attacker, MD Garrett, was also a nursing assistant but had more seniority, was a veteran, and was friends with her boss.

“I really did feel that I would lose my job,” Ms. Katz said in an interview. “I would be that troublemaker.”

But as the abuse escalated, she went to the VA inspector general and the Cleveland police.

She estimated that five times Mr. Garrett pushed her into a closet where he would ask for sex. She would “tell him ‘no’ and fight my way out of [his] grip,” her statement said. He shoved her into an unconscious patient’s bathroom and would “try to restrain me, but I eventually could break free.”

After one such assault, a colleague noticed tears in Ms. Katz’s eyes. The coworker shared with Ms. Katz that she, too, had been a target of Mr. Garrett’s lewd behavior.

Ms. Katz and the colleague filed complaints in March 2013 with their union, the police, and with their managers. That July, Mr. Garrett was indicted by a grand jury and later pleaded guilty to three counts of sexual imposition and one count of unlawful restraint. He was also dismissed from his job.

Reached by phone, Mr. Garrett said he agreed to the plea because he was facing multiple felonies and didn’t know what a jury would do. He said that even though he pleaded guilty to four misdemeanors, he did not commit the crimes of which he was accused. “There was no harassment; she and I were friends,” he said.

In 2013, Ms. Katz sued the VA, alleging that it failed to protect her from harassment and retaliated against her by refusing to give her a job-site transfer before firing her for not showing up to work.

The VA attorneys argued that the department had no direct knowledge of harassing behavior before Ms. Katz reported it, and that once it was informed, immediate action was taken. Veterans Affairs Deputy Press Secretary Lydia Blaha said in an email that anyone engaged in sexual harassment is swiftly held accountable.

The U.S. Department of Veterans Affairs agreed in February to pay $161,500 to settle Ms. Katz’s lawsuit.

Ms. Katz said it was costly and emotional to press on with her legal case but hopes it helps other women see that seeking justice is worthwhile. “I do think there are a lot of women who just suffer in silence,” she said.

Dr. Gunter, the San Francisco physician-blogger, said that needed change will come only when people who are more established across all professions stand up for those who are more junior. “Speaking quietly, going to HR – if that worked, we wouldn’t be here,” she said.

It’s ironic, she said, that as a gynecologist she’s trained to believe patients’ claims about sexual assault. In the workplace, though, it’s well known that raising such matters can backfire. She added: “Physicians should be setting a standard on this.”

KHN’s coverage of these topics is supported by the John A. Hartford Foundation and The David and Lucile Packard Foundation. Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of the Kaiser Family Foundation that is not affiliated with Kaiser Permanente.

MAUI, HAWAII – Misconceptions abound regarding inflammatory bowel disease (IBD) in the elderly, Uma Mahadevan, MD, said at the Gastroenterology, IBD, Liver Disease meeting.

Bruce Jancin/Frontline Medical News

IBD in older individuals is actually very common

A Swedish national registry study of all 27,834 patients diagnosed with IBD in that country during 2006-2013 showed that 23% were first diagnosed at age 60 or older, with an incidence rate of 35 per 100,000 person-years for Crohn’s disease and 19 per 100,000 person-years for ulcerative colitis (Gastroenterology. 2018 Feb;154[3]:518-528e15.

“One in four to one in five of your new IBD patients are going to be over the age of 60. That’s pretty impressive,” Dr. Mahadevan said.

Genetics is less important in the pathophysiology of older-onset IBD. In one study, a positive family history of Crohn’s disease was present in 16% of affected patients under age 17 but in only 7% of those with disease onset after age 60. Similarly, a positive family history was present in 13% of ulcerative colitis patients under age 17 but in just 3% of those with onset after 60.

If genetics plays a minimal role in elderly-onset IBD, then what are the drivers? Two contributors are immunosenescence and age-related changes in the gut microbiota. Aging is accompanied by diminished T-cell responses marked by impaired memory T cells and a reduction in naive T-cell precursors.

“As the rest of you starts to age and sag, so do your T cells,” the gastroenterologist quipped.

Aging also brings physiologic alterations in gastrointestinal motility and transit. Together with changes in diet and an increase in comorbid conditions, with consequent need for a raft of medications, the end result is reduced abundance and diversity of anaerobes in the microbiota. This has immunologic implications.

Elderly IBD isn’t less severe

During a median of 4.2 years of follow-up in the Swedish national study, patients diagnosed with IBD after age 60 had more IBD-related hospitalizations and overall health care utilization than those diagnosed at ages 18-59. The incidence of extraintestinal disease manifestations was similar in the elderly and younger-adult patients; however, bowel surgery was significantly more common in the elderly patients, with a 13% rate after 5 years versus 10% in patients diagnosed as younger adults.

Moreover, elderly patients were less likely to use biologic agents and received much more systemic corticosteroid therapy than younger adults. These findings suggest that the reason elderly patients aren’t using biologics isn’t because their disease is milder, but rather because their physicians are afraid of using biologics. Due to their overconcern about risks of malignancy and serious infections, many physicians opt instead for repeated courses of corticosteroids, which is an inappropriate treatment strategy, Dr. Mahadevan said.

A cross-sectional U.S. study utilizing data from the National Inpatient Sample demonstrated that 25% of all patients hospitalized for IBD were above age 65. The study by investigators at the Medical College of Wisconsin, Milwaukee, found that age greater than 65 was an independent risk factor for in-hospital mortality. Indeed, even after adjustment for comorbidity in a multivariate logistic regression analysis, IBD patients above age 65 had a sobering 3.9-fold greater risk of in-hospital mortality (Inflamm Bowel Dis. 2009 Feb;15[2]182-9).

Another piece of evidence that elderly-onset IBD isn’t less severe comes from a Canadian cohort study of all newly diagnosed cases of IBD in Ontario during 1999-2008. The elderly-onset ulcerative colitis patients were one-third more likely to undergo IBD-related surgery than those diagnosed at ages 18-40. Older-onset Crohn’s disease patients weren’t more likely to have IBD-related operations than younger-onset patients; however, IBD-specific mortality was significantly greater in elderly-onset Crohn’s disease patients than in those diagnosed in middle age or as young adults, by a margin of 33.1 cases to 5.6 cases to 1.0 case per 10,000 person-years (Inflamm Bowel Dis. 2017 Feb;23[2]:218-23).

Treatment of IBD in the elderly

Dr. Mahadevan emphasized that, if elderly patients need biologic therapy because their disease isn’t being adequately controlled with more conservative management strategies, then they should get it. The higher rates of IBD-related surgery and in-hospital mortality in elderly IBD patients argue in favor of that strategy in order to keep them out of the hospital and optimize quality of life.

Her go-to biologics in elderly IBD patients are vedolizumab (Entyvio) and ustekinumab (Stelara): “In my older patients I reach for these two first.”

This is because of the well-documented, excellent safety profiles of those two biologics, which are particularly relevant in an elderly population at increased background risk for lymphoma and serious infections. A pooled analysis of three clinical trials of ustekinumab in induction therapy for Crohn’s disease showed an adverse event risk no different from placebo (J Comp Eff Res. 2017 Oct;6[7]:601-12). Vedolizumab, like ustekinumab, doesn’t carry a black box warning for lymphoma, and the biologic had no increase in any infections in an analysis of six clinical trials entailing more than 4,800 person-years of vedolizumab exposure (Gut. 2017 May;66[5]:839-51).

She provided three illustrative clinical scenarios, each involving a 62-year-old fit and active patient. If that patient had newly diagnosed moderate to severe ulcerative colitis, had failed on 5-aminosalicylic acid, and had good symptomatic control on prednisone, that’s someone who needs a steroid-sparing drug, and she would choose vedolizumab based upon its track record. If that active 62-year-old had moderate to severe ileal and perianal Crohn’s disease, she would opt for ustekinumab or a tumor necrosis factor inhibitor. But if that older patient was hospitalized with newly diagnosed severe ulcerative colitis that was only partially responsive to intravenous steroids, she would eschew vedolizumab and ustekinumab and turn to infliximab (Remicade).

“That patient should get infliximab just like a 32-year-old would. You need to give this patient the best shot [at avoiding colectomy], and to this day the data still supports infliximab in that population,” Dr. Mahadevan said.

Complicating management in the elderly are the commonly encountered challenges posed by polypharmacy, frailty, history of skin cancer or solid organ tumors, and heart failure. In one study, older patients with Crohn’s disease were on an average of 10 medications, ulcerative colitis patients on nine. Forty percent of the patients had potential drug-drug interactions involving their IBD medications (Inflamm Bowel Dis. 2015 Jun;21[6]:1392-400). These are situations that require individually tailored immunosuppressive decision-making.

Dr. Mahadevan reported receiving research support from the Crohn’s and Colitis Foundation, Celgene, and Pfizer and serving as a consultant to those pharmaceutical companies as well as AbbVie, Janssen, and Takeda.

bjancin@frontlinemedcom.com

MAUI, HAWAII – Misconceptions abound regarding inflammatory bowel disease (IBD) in the elderly, Uma Mahadevan, MD, said at the Gastroenterology, IBD, Liver Disease meeting.

Bruce Jancin/Frontline Medical News

IBD in older individuals is actually very common

A Swedish national registry study of all 27,834 patients diagnosed with IBD in that country during 2006-2013 showed that 23% were first diagnosed at age 60 or older, with an incidence rate of 35 per 100,000 person-years for Crohn’s disease and 19 per 100,000 person-years for ulcerative colitis (Gastroenterology. 2018 Feb;154[3]:518-528e15.

“One in four to one in five of your new IBD patients are going to be over the age of 60. That’s pretty impressive,” Dr. Mahadevan said.

Genetics is less important in the pathophysiology of older-onset IBD. In one study, a positive family history of Crohn’s disease was present in 16% of affected patients under age 17 but in only 7% of those with disease onset after age 60. Similarly, a positive family history was present in 13% of ulcerative colitis patients under age 17 but in just 3% of those with onset after 60.

If genetics plays a minimal role in elderly-onset IBD, then what are the drivers? Two contributors are immunosenescence and age-related changes in the gut microbiota. Aging is accompanied by diminished T-cell responses marked by impaired memory T cells and a reduction in naive T-cell precursors.

“As the rest of you starts to age and sag, so do your T cells,” the gastroenterologist quipped.

Aging also brings physiologic alterations in gastrointestinal motility and transit. Together with changes in diet and an increase in comorbid conditions, with consequent need for a raft of medications, the end result is reduced abundance and diversity of anaerobes in the microbiota. This has immunologic implications.

Elderly IBD isn’t less severe

During a median of 4.2 years of follow-up in the Swedish national study, patients diagnosed with IBD after age 60 had more IBD-related hospitalizations and overall health care utilization than those diagnosed at ages 18-59. The incidence of extraintestinal disease manifestations was similar in the elderly and younger-adult patients; however, bowel surgery was significantly more common in the elderly patients, with a 13% rate after 5 years versus 10% in patients diagnosed as younger adults.

Moreover, elderly patients were less likely to use biologic agents and received much more systemic corticosteroid therapy than younger adults. These findings suggest that the reason elderly patients aren’t using biologics isn’t because their disease is milder, but rather because their physicians are afraid of using biologics. Due to their overconcern about risks of malignancy and serious infections, many physicians opt instead for repeated courses of corticosteroids, which is an inappropriate treatment strategy, Dr. Mahadevan said.

A cross-sectional U.S. study utilizing data from the National Inpatient Sample demonstrated that 25% of all patients hospitalized for IBD were above age 65. The study by investigators at the Medical College of Wisconsin, Milwaukee, found that age greater than 65 was an independent risk factor for in-hospital mortality. Indeed, even after adjustment for comorbidity in a multivariate logistic regression analysis, IBD patients above age 65 had a sobering 3.9-fold greater risk of in-hospital mortality (Inflamm Bowel Dis. 2009 Feb;15[2]182-9).

Another piece of evidence that elderly-onset IBD isn’t less severe comes from a Canadian cohort study of all newly diagnosed cases of IBD in Ontario during 1999-2008. The elderly-onset ulcerative colitis patients were one-third more likely to undergo IBD-related surgery than those diagnosed at ages 18-40. Older-onset Crohn’s disease patients weren’t more likely to have IBD-related operations than younger-onset patients; however, IBD-specific mortality was significantly greater in elderly-onset Crohn’s disease patients than in those diagnosed in middle age or as young adults, by a margin of 33.1 cases to 5.6 cases to 1.0 case per 10,000 person-years (Inflamm Bowel Dis. 2017 Feb;23[2]:218-23).

Treatment of IBD in the elderly

Dr. Mahadevan emphasized that, if elderly patients need biologic therapy because their disease isn’t being adequately controlled with more conservative management strategies, then they should get it. The higher rates of IBD-related surgery and in-hospital mortality in elderly IBD patients argue in favor of that strategy in order to keep them out of the hospital and optimize quality of life.

Her go-to biologics in elderly IBD patients are vedolizumab (Entyvio) and ustekinumab (Stelara): “In my older patients I reach for these two first.”

This is because of the well-documented, excellent safety profiles of those two biologics, which are particularly relevant in an elderly population at increased background risk for lymphoma and serious infections. A pooled analysis of three clinical trials of ustekinumab in induction therapy for Crohn’s disease showed an adverse event risk no different from placebo (J Comp Eff Res. 2017 Oct;6[7]:601-12). Vedolizumab, like ustekinumab, doesn’t carry a black box warning for lymphoma, and the biologic had no increase in any infections in an analysis of six clinical trials entailing more than 4,800 person-years of vedolizumab exposure (Gut. 2017 May;66[5]:839-51).

She provided three illustrative clinical scenarios, each involving a 62-year-old fit and active patient. If that patient had newly diagnosed moderate to severe ulcerative colitis, had failed on 5-aminosalicylic acid, and had good symptomatic control on prednisone, that’s someone who needs a steroid-sparing drug, and she would choose vedolizumab based upon its track record. If that active 62-year-old had moderate to severe ileal and perianal Crohn’s disease, she would opt for ustekinumab or a tumor necrosis factor inhibitor. But if that older patient was hospitalized with newly diagnosed severe ulcerative colitis that was only partially responsive to intravenous steroids, she would eschew vedolizumab and ustekinumab and turn to infliximab (Remicade).

“That patient should get infliximab just like a 32-year-old would. You need to give this patient the best shot [at avoiding colectomy], and to this day the data still supports infliximab in that population,” Dr. Mahadevan said.

Complicating management in the elderly are the commonly encountered challenges posed by polypharmacy, frailty, history of skin cancer or solid organ tumors, and heart failure. In one study, older patients with Crohn’s disease were on an average of 10 medications, ulcerative colitis patients on nine. Forty percent of the patients had potential drug-drug interactions involving their IBD medications (Inflamm Bowel Dis. 2015 Jun;21[6]:1392-400). These are situations that require individually tailored immunosuppressive decision-making.

Dr. Mahadevan reported receiving research support from the Crohn’s and Colitis Foundation, Celgene, and Pfizer and serving as a consultant to those pharmaceutical companies as well as AbbVie, Janssen, and Takeda.

bjancin@frontlinemedcom.com

MAUI, HAWAII – Misconceptions abound regarding inflammatory bowel disease (IBD) in the elderly, Uma Mahadevan, MD, said at the Gastroenterology, IBD, Liver Disease meeting.

Bruce Jancin/Frontline Medical News

IBD in older individuals is actually very common

A Swedish national registry study of all 27,834 patients diagnosed with IBD in that country during 2006-2013 showed that 23% were first diagnosed at age 60 or older, with an incidence rate of 35 per 100,000 person-years for Crohn’s disease and 19 per 100,000 person-years for ulcerative colitis (Gastroenterology. 2018 Feb;154[3]:518-528e15.

“One in four to one in five of your new IBD patients are going to be over the age of 60. That’s pretty impressive,” Dr. Mahadevan said.

Genetics is less important in the pathophysiology of older-onset IBD. In one study, a positive family history of Crohn’s disease was present in 16% of affected patients under age 17 but in only 7% of those with disease onset after age 60. Similarly, a positive family history was present in 13% of ulcerative colitis patients under age 17 but in just 3% of those with onset after 60.

If genetics plays a minimal role in elderly-onset IBD, then what are the drivers? Two contributors are immunosenescence and age-related changes in the gut microbiota. Aging is accompanied by diminished T-cell responses marked by impaired memory T cells and a reduction in naive T-cell precursors.

“As the rest of you starts to age and sag, so do your T cells,” the gastroenterologist quipped.

Aging also brings physiologic alterations in gastrointestinal motility and transit. Together with changes in diet and an increase in comorbid conditions, with consequent need for a raft of medications, the end result is reduced abundance and diversity of anaerobes in the microbiota. This has immunologic implications.

Elderly IBD isn’t less severe

During a median of 4.2 years of follow-up in the Swedish national study, patients diagnosed with IBD after age 60 had more IBD-related hospitalizations and overall health care utilization than those diagnosed at ages 18-59. The incidence of extraintestinal disease manifestations was similar in the elderly and younger-adult patients; however, bowel surgery was significantly more common in the elderly patients, with a 13% rate after 5 years versus 10% in patients diagnosed as younger adults.

Moreover, elderly patients were less likely to use biologic agents and received much more systemic corticosteroid therapy than younger adults. These findings suggest that the reason elderly patients aren’t using biologics isn’t because their disease is milder, but rather because their physicians are afraid of using biologics. Due to their overconcern about risks of malignancy and serious infections, many physicians opt instead for repeated courses of corticosteroids, which is an inappropriate treatment strategy, Dr. Mahadevan said.

A cross-sectional U.S. study utilizing data from the National Inpatient Sample demonstrated that 25% of all patients hospitalized for IBD were above age 65. The study by investigators at the Medical College of Wisconsin, Milwaukee, found that age greater than 65 was an independent risk factor for in-hospital mortality. Indeed, even after adjustment for comorbidity in a multivariate logistic regression analysis, IBD patients above age 65 had a sobering 3.9-fold greater risk of in-hospital mortality (Inflamm Bowel Dis. 2009 Feb;15[2]182-9).

Another piece of evidence that elderly-onset IBD isn’t less severe comes from a Canadian cohort study of all newly diagnosed cases of IBD in Ontario during 1999-2008. The elderly-onset ulcerative colitis patients were one-third more likely to undergo IBD-related surgery than those diagnosed at ages 18-40. Older-onset Crohn’s disease patients weren’t more likely to have IBD-related operations than younger-onset patients; however, IBD-specific mortality was significantly greater in elderly-onset Crohn’s disease patients than in those diagnosed in middle age or as young adults, by a margin of 33.1 cases to 5.6 cases to 1.0 case per 10,000 person-years (Inflamm Bowel Dis. 2017 Feb;23[2]:218-23).

Treatment of IBD in the elderly

Dr. Mahadevan emphasized that, if elderly patients need biologic therapy because their disease isn’t being adequately controlled with more conservative management strategies, then they should get it. The higher rates of IBD-related surgery and in-hospital mortality in elderly IBD patients argue in favor of that strategy in order to keep them out of the hospital and optimize quality of life.

Her go-to biologics in elderly IBD patients are vedolizumab (Entyvio) and ustekinumab (Stelara): “In my older patients I reach for these two first.”

This is because of the well-documented, excellent safety profiles of those two biologics, which are particularly relevant in an elderly population at increased background risk for lymphoma and serious infections. A pooled analysis of three clinical trials of ustekinumab in induction therapy for Crohn’s disease showed an adverse event risk no different from placebo (J Comp Eff Res. 2017 Oct;6[7]:601-12). Vedolizumab, like ustekinumab, doesn’t carry a black box warning for lymphoma, and the biologic had no increase in any infections in an analysis of six clinical trials entailing more than 4,800 person-years of vedolizumab exposure (Gut. 2017 May;66[5]:839-51).

She provided three illustrative clinical scenarios, each involving a 62-year-old fit and active patient. If that patient had newly diagnosed moderate to severe ulcerative colitis, had failed on 5-aminosalicylic acid, and had good symptomatic control on prednisone, that’s someone who needs a steroid-sparing drug, and she would choose vedolizumab based upon its track record. If that active 62-year-old had moderate to severe ileal and perianal Crohn’s disease, she would opt for ustekinumab or a tumor necrosis factor inhibitor. But if that older patient was hospitalized with newly diagnosed severe ulcerative colitis that was only partially responsive to intravenous steroids, she would eschew vedolizumab and ustekinumab and turn to infliximab (Remicade).

“That patient should get infliximab just like a 32-year-old would. You need to give this patient the best shot [at avoiding colectomy], and to this day the data still supports infliximab in that population,” Dr. Mahadevan said.

Complicating management in the elderly are the commonly encountered challenges posed by polypharmacy, frailty, history of skin cancer or solid organ tumors, and heart failure. In one study, older patients with Crohn’s disease were on an average of 10 medications, ulcerative colitis patients on nine. Forty percent of the patients had potential drug-drug interactions involving their IBD medications (Inflamm Bowel Dis. 2015 Jun;21[6]:1392-400). These are situations that require individually tailored immunosuppressive decision-making.

Dr. Mahadevan reported receiving research support from the Crohn’s and Colitis Foundation, Celgene, and Pfizer and serving as a consultant to those pharmaceutical companies as well as AbbVie, Janssen, and Takeda.

bjancin@frontlinemedcom.com

ORLANDO – Children and adults with peanut allergy who received a novel oral immunotherapy were able to tolerate higher doses of peanut protein, compared with those receiving placebo, according to research results.

Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.

copyright mates/Fotolia.com

“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.

The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.

It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”

Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.

The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.

“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”

The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.

SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.

ORLANDO – Children and adults with peanut allergy who received a novel oral immunotherapy were able to tolerate higher doses of peanut protein, compared with those receiving placebo, according to research results.

Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.

copyright mates/Fotolia.com

“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.

The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.

It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”

Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.

The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.

“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”

The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.

SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.

ORLANDO – Children and adults with peanut allergy who received a novel oral immunotherapy were able to tolerate higher doses of peanut protein, compared with those receiving placebo, according to research results.

Stacie M. Jones, MD, of the University of Arkansas and Arkansas Children’s Hospital, Little Rock, presented the late-breaking results from the pivotal PALISADE trial at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization, in which Dr. Jones and her colleagues sought to examine the safety and efficacy of the novel oral immunotherapy AR101 for patients with peanut allergy.

copyright mates/Fotolia.com

“Tolerance at 600 mg should indicate, not prove, but indicate that this therapy should be able to provide protection for the vast majority of individuals treated,” Dr. Jones said in an interview.

The majority of patients in the study experienced an adverse event; however, those who received AR101 experienced more events, and more events that were considered serious, she said. Patients in the treatment arm also experienced more treatment-related hypersensitivity, compared with patients in the placebo arm (14.5% vs. 3.2%), nearly all of which were mild to moderate.

It is important to note two key safety outcomes regarding AR101, Dr. Jones said. First, that one patient was diagnosed with eosinophilic esophagitis (EoE) during the study. “EoE has been a recurring theme with oral immunotherapy. Previous data showed EoE diagnoses in as many as 2%-5% of patients, and although one is certainly less than that, it is still important.”

Secondly, she pointed out that 6.7% of patients in the treatment group withdrew as a result of gastrointestinal adverse events. “This is a lower percentage than previously published data, but I don’t think you can understate this safety concern,” Dr. Jones said.

The efficacy of AR101 has prompted energy and hope for children with a peanut allergy. In the weeks following her presentation at AAAAI/WAO, Dr. Jones said she has been inundated with emails and calls from allergists asking for these data. However, she called for caution and patience, saying that it is important for the therapy to clear the appropriate steps in the process.

“This should not change clinical care that much in the next 12-18 months,” Dr. Jones said. “But it is very hopeful that this will be a new therapy on the market.”

The PALISADE trial was funded by Aimmune Therapeutics, and Dr. Jones reported holding an advisory board position for Aimmune Therapeutics, as well as having received other forms of support from biotech, pharmaceutical, and governmental organizations.

SOURCE: Jones SM et al. AAAAI/WAO Joint Congress, Abstract L6.

ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

Nick Andrews/MDedge News

SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.

op@mededge.com

ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

Nick Andrews/MDedge News

SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.

op@mededge.com

ORLANDO – Omalizumab increased reaction-free rapid drug desensitization for patients with hypersensitivity to chemotherapy, according to research presented at the joint congress of the American Academy of Allergy, Asthma, and Immunology and the World Asthma Organization.

Nick Andrews/MDedge News

SOURCE: Hong DI et al. AAAAI/WAO Joint Congress, Poster L33.

op@mededge.com

A family-focused middle school intervention can help reduce alcohol abuse and alcohol use disorders (AUD) in Mexican American adolescents who are at heightened risk for problem drinking, according to Nancy A. Gonzales, PhD, and her associates.

The report was published March 21 in JAMA Psychiatry.

The investigators examined 5-year follow-up results of a randomized controlled trial, Bridges/Puentes, a 9-week, evidence-based intervention aimed at helping urban, low-income Mexican American teens succeed at school. Among other features, the Bridges/Puentes intervention promoted cultural strengths that had been identified in previous interventions aimed at Latino youth.

“This blend of evidence-based practices and good recruitment rates, retention, and fidelity provided a strong foundation for testing the sustained results of middle school prevention for Latinos,” wrote Dr. Gonzales of the department of psychology and the REACH Institute at Arizona State University, Tempe, and her associates.

Highwaystarz-Photography/Thinkstock

llaubach@mdedge.com

SOURCE: Gonzales NA et al. doi: 10.1001/jamapsychiatry.2018.0058.

A family-focused middle school intervention can help reduce alcohol abuse and alcohol use disorders (AUD) in Mexican American adolescents who are at heightened risk for problem drinking, according to Nancy A. Gonzales, PhD, and her associates.

The report was published March 21 in JAMA Psychiatry.

The investigators examined 5-year follow-up results of a randomized controlled trial, Bridges/Puentes, a 9-week, evidence-based intervention aimed at helping urban, low-income Mexican American teens succeed at school. Among other features, the Bridges/Puentes intervention promoted cultural strengths that had been identified in previous interventions aimed at Latino youth.

“This blend of evidence-based practices and good recruitment rates, retention, and fidelity provided a strong foundation for testing the sustained results of middle school prevention for Latinos,” wrote Dr. Gonzales of the department of psychology and the REACH Institute at Arizona State University, Tempe, and her associates.

Highwaystarz-Photography/Thinkstock

llaubach@mdedge.com

SOURCE: Gonzales NA et al. doi: 10.1001/jamapsychiatry.2018.0058.

A family-focused middle school intervention can help reduce alcohol abuse and alcohol use disorders (AUD) in Mexican American adolescents who are at heightened risk for problem drinking, according to Nancy A. Gonzales, PhD, and her associates.

The report was published March 21 in JAMA Psychiatry.

The investigators examined 5-year follow-up results of a randomized controlled trial, Bridges/Puentes, a 9-week, evidence-based intervention aimed at helping urban, low-income Mexican American teens succeed at school. Among other features, the Bridges/Puentes intervention promoted cultural strengths that had been identified in previous interventions aimed at Latino youth.

“This blend of evidence-based practices and good recruitment rates, retention, and fidelity provided a strong foundation for testing the sustained results of middle school prevention for Latinos,” wrote Dr. Gonzales of the department of psychology and the REACH Institute at Arizona State University, Tempe, and her associates.

Highwaystarz-Photography/Thinkstock

llaubach@mdedge.com

SOURCE: Gonzales NA et al. doi: 10.1001/jamapsychiatry.2018.0058.