Clinical Guidelines

Despite overwhelming evidence indicating vaccines are safe and effective at preventing diseases,¹ physicians are still faced with the dilemma of convincing patients to receive their recommended vaccinations. The topic comes up regularly on television talk shows; presidential debates; or in new documentary films, such as “Vaxxed: From Cover-up to Catastrophe,” which was pulled from the Tribeca Film Festival in March 2016.² The central debate over vaccines traces back almost 20 years to the study published in The Lancet regarding the measles-mumps-rubella vaccine and the link to autism. Although the article was retracted in 2010 and no evidence has been found linking vaccines with autism,^1,3 vaccination coverage gaps still exist. These gaps can leave communities vulnerable to vaccine-preventable diseases.⁴ This lack of protection is especially glaring for the human papillomavirus (HPV) vaccine, putting health care professionals including dermatologists in the position of educating parents and guardians to have their children immunized.

More than 10 years after the federal government approved the first vaccines to fight the cancer-causing HPV, less than half of adolescent girls and only a fifth of adolescent boys are getting immunized. The reasons for the low vaccination rates are particularly complicated because they play not only into fears over vaccines but also over a perceived risk the vaccine may encourage sexual activity in adolescents, which has not been proven.⁵ Another factor is reluctance on the part of physicians to discuss the vaccine with patients and to fully embrace its lifesaving potential. A recent study showed how physicians are contributing to the low rate.⁶ “The single biggest barrier to increasing HPV vaccination is not receiving a health care provider’s recommendation,” said Harvard University researcher Melissa Gilkey.⁷

According to the Centers for Disease Control and Prevention (CDC), as of 2014, only 40% of adolescent girls aged 13 to 17 years had completed the 3-dose course of the HPV vaccine and just 22% of adolescent boys,⁸ which is short of the 80% public health goal set in 2010 by the federal government.⁹ Vexingly, HPV vaccination rates lag behind the other 2 vaccines recommended in the same age group: the tetanus-diphtheria-acellular pertussis booster (88%) and the vaccine to prevent meningococcal disease (79%).⁸

Malo et al⁶ surveyed 776 primary care physicians and reported that more than a quarter of primary care respondents (27%) do not strongly endorse the HPV vaccine when talking with their patients’ families. Nearly 2 in 5 physicians (39%) did not recommend on-time HPV vaccination for their male patients compared to 26% for female patients.⁶

The starkest findings, however, related to how the physicians approached their discussions with parents and guardians. Only half recommended the vaccine the same day they discussed it, and 59% said they approached discussions by assessing the child’s risk for contracting the disease rather than consistently recommending it to all children as a routine immunization.⁶

Despite physician hesitancy, when looking at the facts there should be no debate. In December 2014, the US Food and Drug Administration approved the 9-valent HPV (9vHPV) vaccine for males and females aged 9 to 26 years. The vaccine covers HPV types 6, 11, 16, and 18, which are part of the quadrivalent HPV (qHPV) vaccine, along with HPV types 31, 33, 45, 52, and 58. The 9vHPV vaccine has the potential to offer protection against 30% to 35% more high-grade cervical lesions and to increase cervical cancer prevention from approximately 70% to 90%.¹⁰ It also will protect against 90% of the virus strains responsible for causing anogenital warts. According to CDC estimates, for every year that coverage does not increase, an additional 4400 women will develop cervical cancer. If providers can push the HPV vaccination rate up to the goal rate of 80%, the CDC estimates that 53,000 cases of cervical cancer could be prevented during the lifetime of patients younger than 12 years.¹¹

In a clinical trial of 14,215 women, Joura et al¹² reported that the 9vHPV vaccine had an efficacy of 96.7% to prevent high-grade cervical, vulvar, or vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in women. Antibody responses to HPV-6, 11, 16, and 18 among participants who received the 9vHPV vaccine were noninferior to those who received the qHPV vaccine. The incidence of disease related to HPV-6, 11, 16, and 18 was similar in the 2 vaccine groups. The introduction of 9vHPV vaccination in both males and females was cost saving compared to the qHPV vaccine in cost-effectiveness analyses. Injection-site reactions were slightly more common with the 9vHPV vaccine compared to the qHPV vaccine but were generally mild with less than 0.1% of study participants discontinuing due to vaccine-related adverse events.¹²

Additionally, the vaccine has the potential to offer protection against penile, anal, vulvar, vaginal, and oropharyngeal cancers (OPCs). Data from Joura et al¹² demonstrate that 55% of anal and penile cancers biopsied in the study carried the 5 HPV types that are included only in the 9vHPV vaccine.

Studies also show that the rate of OPC caused by HPV is rising rapidly and increasing more among men than women. Remarkably, OPC is projected to become more common than cervical cancer in 2020, with an estimated 70% of OPCs being caused by HPV in the United States.¹³ Theoretically, the 9vHPV vaccine has the potential to protect against even more cases of OPC because of its even broader coverage.¹⁴

Although optimal timing for the HPV vaccine would still be in preadolescence prior to sexual activity when exposure to HPV is less likely, CDC studies have shown benefit even in older patients who may have already been exposed to 1 or more HPV strains.¹⁵

Simply put, all the combined data highlight the overwhelming importance of HPV vaccination, with the 9vHPV vaccine representing a meaningful advantage over existing HPV vaccines. As physicians, we have a duty to our patients to emphasize the importance of this vaccine. It is a vaccine that has the potential to prevent multiple cancers, cancers for which we currently have no evidence-based prevention modalities, except in the case of cervical cancer. This responsibility falls on all providers, not just primary care providers. With a strong message from providers to vaccinate age-eligible males and females, we can move the United States from among the lowest rates of HPV vaccination to the highest, with subsequent reductions in the national cancer burden to follow.

Despite overwhelming evidence indicating vaccines are safe and effective at preventing diseases,¹ physicians are still faced with the dilemma of convincing patients to receive their recommended vaccinations. The topic comes up regularly on television talk shows; presidential debates; or in new documentary films, such as “Vaxxed: From Cover-up to Catastrophe,” which was pulled from the Tribeca Film Festival in March 2016.² The central debate over vaccines traces back almost 20 years to the study published in The Lancet regarding the measles-mumps-rubella vaccine and the link to autism. Although the article was retracted in 2010 and no evidence has been found linking vaccines with autism,^1,3 vaccination coverage gaps still exist. These gaps can leave communities vulnerable to vaccine-preventable diseases.⁴ This lack of protection is especially glaring for the human papillomavirus (HPV) vaccine, putting health care professionals including dermatologists in the position of educating parents and guardians to have their children immunized.

More than 10 years after the federal government approved the first vaccines to fight the cancer-causing HPV, less than half of adolescent girls and only a fifth of adolescent boys are getting immunized. The reasons for the low vaccination rates are particularly complicated because they play not only into fears over vaccines but also over a perceived risk the vaccine may encourage sexual activity in adolescents, which has not been proven.⁵ Another factor is reluctance on the part of physicians to discuss the vaccine with patients and to fully embrace its lifesaving potential. A recent study showed how physicians are contributing to the low rate.⁶ “The single biggest barrier to increasing HPV vaccination is not receiving a health care provider’s recommendation,” said Harvard University researcher Melissa Gilkey.⁷

According to the Centers for Disease Control and Prevention (CDC), as of 2014, only 40% of adolescent girls aged 13 to 17 years had completed the 3-dose course of the HPV vaccine and just 22% of adolescent boys,⁸ which is short of the 80% public health goal set in 2010 by the federal government.⁹ Vexingly, HPV vaccination rates lag behind the other 2 vaccines recommended in the same age group: the tetanus-diphtheria-acellular pertussis booster (88%) and the vaccine to prevent meningococcal disease (79%).⁸

Malo et al⁶ surveyed 776 primary care physicians and reported that more than a quarter of primary care respondents (27%) do not strongly endorse the HPV vaccine when talking with their patients’ families. Nearly 2 in 5 physicians (39%) did not recommend on-time HPV vaccination for their male patients compared to 26% for female patients.⁶

The starkest findings, however, related to how the physicians approached their discussions with parents and guardians. Only half recommended the vaccine the same day they discussed it, and 59% said they approached discussions by assessing the child’s risk for contracting the disease rather than consistently recommending it to all children as a routine immunization.⁶

Despite physician hesitancy, when looking at the facts there should be no debate. In December 2014, the US Food and Drug Administration approved the 9-valent HPV (9vHPV) vaccine for males and females aged 9 to 26 years. The vaccine covers HPV types 6, 11, 16, and 18, which are part of the quadrivalent HPV (qHPV) vaccine, along with HPV types 31, 33, 45, 52, and 58. The 9vHPV vaccine has the potential to offer protection against 30% to 35% more high-grade cervical lesions and to increase cervical cancer prevention from approximately 70% to 90%.¹⁰ It also will protect against 90% of the virus strains responsible for causing anogenital warts. According to CDC estimates, for every year that coverage does not increase, an additional 4400 women will develop cervical cancer. If providers can push the HPV vaccination rate up to the goal rate of 80%, the CDC estimates that 53,000 cases of cervical cancer could be prevented during the lifetime of patients younger than 12 years.¹¹

In a clinical trial of 14,215 women, Joura et al¹² reported that the 9vHPV vaccine had an efficacy of 96.7% to prevent high-grade cervical, vulvar, or vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in women. Antibody responses to HPV-6, 11, 16, and 18 among participants who received the 9vHPV vaccine were noninferior to those who received the qHPV vaccine. The incidence of disease related to HPV-6, 11, 16, and 18 was similar in the 2 vaccine groups. The introduction of 9vHPV vaccination in both males and females was cost saving compared to the qHPV vaccine in cost-effectiveness analyses. Injection-site reactions were slightly more common with the 9vHPV vaccine compared to the qHPV vaccine but were generally mild with less than 0.1% of study participants discontinuing due to vaccine-related adverse events.¹²

Additionally, the vaccine has the potential to offer protection against penile, anal, vulvar, vaginal, and oropharyngeal cancers (OPCs). Data from Joura et al¹² demonstrate that 55% of anal and penile cancers biopsied in the study carried the 5 HPV types that are included only in the 9vHPV vaccine.

Studies also show that the rate of OPC caused by HPV is rising rapidly and increasing more among men than women. Remarkably, OPC is projected to become more common than cervical cancer in 2020, with an estimated 70% of OPCs being caused by HPV in the United States.¹³ Theoretically, the 9vHPV vaccine has the potential to protect against even more cases of OPC because of its even broader coverage.¹⁴

Although optimal timing for the HPV vaccine would still be in preadolescence prior to sexual activity when exposure to HPV is less likely, CDC studies have shown benefit even in older patients who may have already been exposed to 1 or more HPV strains.¹⁵

Simply put, all the combined data highlight the overwhelming importance of HPV vaccination, with the 9vHPV vaccine representing a meaningful advantage over existing HPV vaccines. As physicians, we have a duty to our patients to emphasize the importance of this vaccine. It is a vaccine that has the potential to prevent multiple cancers, cancers for which we currently have no evidence-based prevention modalities, except in the case of cervical cancer. This responsibility falls on all providers, not just primary care providers. With a strong message from providers to vaccinate age-eligible males and females, we can move the United States from among the lowest rates of HPV vaccination to the highest, with subsequent reductions in the national cancer burden to follow.

Despite overwhelming evidence indicating vaccines are safe and effective at preventing diseases,¹ physicians are still faced with the dilemma of convincing patients to receive their recommended vaccinations. The topic comes up regularly on television talk shows; presidential debates; or in new documentary films, such as “Vaxxed: From Cover-up to Catastrophe,” which was pulled from the Tribeca Film Festival in March 2016.² The central debate over vaccines traces back almost 20 years to the study published in The Lancet regarding the measles-mumps-rubella vaccine and the link to autism. Although the article was retracted in 2010 and no evidence has been found linking vaccines with autism,^1,3 vaccination coverage gaps still exist. These gaps can leave communities vulnerable to vaccine-preventable diseases.⁴ This lack of protection is especially glaring for the human papillomavirus (HPV) vaccine, putting health care professionals including dermatologists in the position of educating parents and guardians to have their children immunized.

More than 10 years after the federal government approved the first vaccines to fight the cancer-causing HPV, less than half of adolescent girls and only a fifth of adolescent boys are getting immunized. The reasons for the low vaccination rates are particularly complicated because they play not only into fears over vaccines but also over a perceived risk the vaccine may encourage sexual activity in adolescents, which has not been proven.⁵ Another factor is reluctance on the part of physicians to discuss the vaccine with patients and to fully embrace its lifesaving potential. A recent study showed how physicians are contributing to the low rate.⁶ “The single biggest barrier to increasing HPV vaccination is not receiving a health care provider’s recommendation,” said Harvard University researcher Melissa Gilkey.⁷

According to the Centers for Disease Control and Prevention (CDC), as of 2014, only 40% of adolescent girls aged 13 to 17 years had completed the 3-dose course of the HPV vaccine and just 22% of adolescent boys,⁸ which is short of the 80% public health goal set in 2010 by the federal government.⁹ Vexingly, HPV vaccination rates lag behind the other 2 vaccines recommended in the same age group: the tetanus-diphtheria-acellular pertussis booster (88%) and the vaccine to prevent meningococcal disease (79%).⁸

Malo et al⁶ surveyed 776 primary care physicians and reported that more than a quarter of primary care respondents (27%) do not strongly endorse the HPV vaccine when talking with their patients’ families. Nearly 2 in 5 physicians (39%) did not recommend on-time HPV vaccination for their male patients compared to 26% for female patients.⁶

The starkest findings, however, related to how the physicians approached their discussions with parents and guardians. Only half recommended the vaccine the same day they discussed it, and 59% said they approached discussions by assessing the child’s risk for contracting the disease rather than consistently recommending it to all children as a routine immunization.⁶

Despite physician hesitancy, when looking at the facts there should be no debate. In December 2014, the US Food and Drug Administration approved the 9-valent HPV (9vHPV) vaccine for males and females aged 9 to 26 years. The vaccine covers HPV types 6, 11, 16, and 18, which are part of the quadrivalent HPV (qHPV) vaccine, along with HPV types 31, 33, 45, 52, and 58. The 9vHPV vaccine has the potential to offer protection against 30% to 35% more high-grade cervical lesions and to increase cervical cancer prevention from approximately 70% to 90%.¹⁰ It also will protect against 90% of the virus strains responsible for causing anogenital warts. According to CDC estimates, for every year that coverage does not increase, an additional 4400 women will develop cervical cancer. If providers can push the HPV vaccination rate up to the goal rate of 80%, the CDC estimates that 53,000 cases of cervical cancer could be prevented during the lifetime of patients younger than 12 years.¹¹

In a clinical trial of 14,215 women, Joura et al¹² reported that the 9vHPV vaccine had an efficacy of 96.7% to prevent high-grade cervical, vulvar, or vaginal dysplasia related to HPV types 31, 33, 45, 52, and 58 in women. Antibody responses to HPV-6, 11, 16, and 18 among participants who received the 9vHPV vaccine were noninferior to those who received the qHPV vaccine. The incidence of disease related to HPV-6, 11, 16, and 18 was similar in the 2 vaccine groups. The introduction of 9vHPV vaccination in both males and females was cost saving compared to the qHPV vaccine in cost-effectiveness analyses. Injection-site reactions were slightly more common with the 9vHPV vaccine compared to the qHPV vaccine but were generally mild with less than 0.1% of study participants discontinuing due to vaccine-related adverse events.¹²

Additionally, the vaccine has the potential to offer protection against penile, anal, vulvar, vaginal, and oropharyngeal cancers (OPCs). Data from Joura et al¹² demonstrate that 55% of anal and penile cancers biopsied in the study carried the 5 HPV types that are included only in the 9vHPV vaccine.

Studies also show that the rate of OPC caused by HPV is rising rapidly and increasing more among men than women. Remarkably, OPC is projected to become more common than cervical cancer in 2020, with an estimated 70% of OPCs being caused by HPV in the United States.¹³ Theoretically, the 9vHPV vaccine has the potential to protect against even more cases of OPC because of its even broader coverage.¹⁴

Although optimal timing for the HPV vaccine would still be in preadolescence prior to sexual activity when exposure to HPV is less likely, CDC studies have shown benefit even in older patients who may have already been exposed to 1 or more HPV strains.¹⁵

Simply put, all the combined data highlight the overwhelming importance of HPV vaccination, with the 9vHPV vaccine representing a meaningful advantage over existing HPV vaccines. As physicians, we have a duty to our patients to emphasize the importance of this vaccine. It is a vaccine that has the potential to prevent multiple cancers, cancers for which we currently have no evidence-based prevention modalities, except in the case of cervical cancer. This responsibility falls on all providers, not just primary care providers. With a strong message from providers to vaccinate age-eligible males and females, we can move the United States from among the lowest rates of HPV vaccination to the highest, with subsequent reductions in the national cancer burden to follow.

WASHINGTON – New American College of Rheumatology recommendations for glucocorticoid-induced osteoporosis prevention and treatment include refinements in risk assessment and treatment.

“These are draft recommendations not yet accepted by ACR,” said Lenore M. Buckley, MD, of Yale University, New Haven, Conn. “They are intended to be dynamic, because risk factors change for patients over time,” she added.

The draft recommendations build upon the 2010 ACR recommendations.

“About 1% of the United States population is on glucocorticoid treatment. Fracture is the most common adverse event, and trabecular bone in the spine is the most vulnerable,” Dr. Buckley explained in her presentation of the recommendations at the annual meeting of the American College of Rheumatology. “The risk of glucocorticoid (GC)-induced fracture is related to dose level and cumulative dose.”

Recommendations for risk assessment

Risk assessment for GC-induced osteoporosis is individualized. “You need to know the patient in front of you. Fracture risk is not just related to GC use, but also to bone mass, age, and race. Older age, female gender, Caucasian race all increase risk, and these factors need to be brought in to assessment,” Dr. Buckley explained.

For men and women over age 40, the Fracture Risk Assessment Tool (FRAX), which calculates the 10-year fracture risk in adults over age 40, should be used for risk assessment, incorporating GC use as a risk factor, she said.

“Adjust risk of FRAX according to dose of glucocorticoid. For 2.5-7.5 mg/day, the FRAX risk is fine, but if the patient is on higher doses, adjust the FRAX accordingly,” she said.

FRAX is not valid for women and men under age 40, she continued. A new recommendation is the inclusion of a moderate risk group based on very low bone mass score (Z score less than –3 below the standard deviation of the mean) and/or rapid bone loss (greater than 10% in 1 year). Patients who had prior GC-associated fracture under 40 years are considered high risk.

A thorough history and physical exam are necessary for all patients, and risk assessment should be done within 6 months of GC initiation. Physical exam should be repeated annually, and bone mineral density (BMD) should be assessed every 2-3 years for patients who continue on GC.
 

Treatment

The proposed treatment recommendations were not age dependent. Patients with moderate to high risk should be treated, in descending order, with oral bisphosphonates, intravenous bisphosphonates, teriparatide (Forteo), and denosumab (Prolia). The order of preference for these treatments was based on cost, efficacy, toxicity, and patient preference.

All patients should take calcium and vitamin D, regardless of risk level.

The proposed recommendations also addressed four special groups considered at significant risk: women of childbearing potential, organ transplant recipients, children, and people on very high doses of GC (greater than 30 mg/day, cumulative dose of 5 g/year).

“For women of childbearing potential, there are emerging data suggesting that bisphosphonates are safe. For this group, consider oral bisphosphonate and teriparatide as a second choice. Animal data suggest that IV bisphosphonates and denosumab are harmful to the fetus,” Dr. Buckley said.

For organ transplant recipients, general recommendations can be followed with two provisions: Kidney transplant recipients should have a work-up for metabolic bone disease, and denosumab should not be used in people on multiple immunosuppressants.

Optimize calcium and vitamin D for children, and treat with oral bisphosphonate, Dr. Buckley continued. If oral bisphosphonates are contraindicated, IV bisphosphonates can be used.

Patients on very high GC dose should be treated with oral bisphosphonates if they are age 30 or older.

Osteoporosis medications can be discontinued in low-risk patients who stop taking GC, but should be continued for those at moderate to high risk.

Patients who benefit from osteoporosis medications but remain at moderate to high risk at the end of 3 years should continue GC treatment.

The authors and sponsors had no relevant financial disclosures.

WASHINGTON – New American College of Rheumatology recommendations for glucocorticoid-induced osteoporosis prevention and treatment include refinements in risk assessment and treatment.

“These are draft recommendations not yet accepted by ACR,” said Lenore M. Buckley, MD, of Yale University, New Haven, Conn. “They are intended to be dynamic, because risk factors change for patients over time,” she added.

The draft recommendations build upon the 2010 ACR recommendations.

“About 1% of the United States population is on glucocorticoid treatment. Fracture is the most common adverse event, and trabecular bone in the spine is the most vulnerable,” Dr. Buckley explained in her presentation of the recommendations at the annual meeting of the American College of Rheumatology. “The risk of glucocorticoid (GC)-induced fracture is related to dose level and cumulative dose.”

Recommendations for risk assessment

Risk assessment for GC-induced osteoporosis is individualized. “You need to know the patient in front of you. Fracture risk is not just related to GC use, but also to bone mass, age, and race. Older age, female gender, Caucasian race all increase risk, and these factors need to be brought in to assessment,” Dr. Buckley explained.

For men and women over age 40, the Fracture Risk Assessment Tool (FRAX), which calculates the 10-year fracture risk in adults over age 40, should be used for risk assessment, incorporating GC use as a risk factor, she said.

“Adjust risk of FRAX according to dose of glucocorticoid. For 2.5-7.5 mg/day, the FRAX risk is fine, but if the patient is on higher doses, adjust the FRAX accordingly,” she said.

FRAX is not valid for women and men under age 40, she continued. A new recommendation is the inclusion of a moderate risk group based on very low bone mass score (Z score less than –3 below the standard deviation of the mean) and/or rapid bone loss (greater than 10% in 1 year). Patients who had prior GC-associated fracture under 40 years are considered high risk.

A thorough history and physical exam are necessary for all patients, and risk assessment should be done within 6 months of GC initiation. Physical exam should be repeated annually, and bone mineral density (BMD) should be assessed every 2-3 years for patients who continue on GC.
 

Treatment

The proposed treatment recommendations were not age dependent. Patients with moderate to high risk should be treated, in descending order, with oral bisphosphonates, intravenous bisphosphonates, teriparatide (Forteo), and denosumab (Prolia). The order of preference for these treatments was based on cost, efficacy, toxicity, and patient preference.

All patients should take calcium and vitamin D, regardless of risk level.

The proposed recommendations also addressed four special groups considered at significant risk: women of childbearing potential, organ transplant recipients, children, and people on very high doses of GC (greater than 30 mg/day, cumulative dose of 5 g/year).

“For women of childbearing potential, there are emerging data suggesting that bisphosphonates are safe. For this group, consider oral bisphosphonate and teriparatide as a second choice. Animal data suggest that IV bisphosphonates and denosumab are harmful to the fetus,” Dr. Buckley said.

For organ transplant recipients, general recommendations can be followed with two provisions: Kidney transplant recipients should have a work-up for metabolic bone disease, and denosumab should not be used in people on multiple immunosuppressants.

Optimize calcium and vitamin D for children, and treat with oral bisphosphonate, Dr. Buckley continued. If oral bisphosphonates are contraindicated, IV bisphosphonates can be used.

Patients on very high GC dose should be treated with oral bisphosphonates if they are age 30 or older.

Osteoporosis medications can be discontinued in low-risk patients who stop taking GC, but should be continued for those at moderate to high risk.

Patients who benefit from osteoporosis medications but remain at moderate to high risk at the end of 3 years should continue GC treatment.

The authors and sponsors had no relevant financial disclosures.

WASHINGTON – New American College of Rheumatology recommendations for glucocorticoid-induced osteoporosis prevention and treatment include refinements in risk assessment and treatment.

“These are draft recommendations not yet accepted by ACR,” said Lenore M. Buckley, MD, of Yale University, New Haven, Conn. “They are intended to be dynamic, because risk factors change for patients over time,” she added.

The draft recommendations build upon the 2010 ACR recommendations.

“About 1% of the United States population is on glucocorticoid treatment. Fracture is the most common adverse event, and trabecular bone in the spine is the most vulnerable,” Dr. Buckley explained in her presentation of the recommendations at the annual meeting of the American College of Rheumatology. “The risk of glucocorticoid (GC)-induced fracture is related to dose level and cumulative dose.”

Recommendations for risk assessment

Risk assessment for GC-induced osteoporosis is individualized. “You need to know the patient in front of you. Fracture risk is not just related to GC use, but also to bone mass, age, and race. Older age, female gender, Caucasian race all increase risk, and these factors need to be brought in to assessment,” Dr. Buckley explained.

For men and women over age 40, the Fracture Risk Assessment Tool (FRAX), which calculates the 10-year fracture risk in adults over age 40, should be used for risk assessment, incorporating GC use as a risk factor, she said.

“Adjust risk of FRAX according to dose of glucocorticoid. For 2.5-7.5 mg/day, the FRAX risk is fine, but if the patient is on higher doses, adjust the FRAX accordingly,” she said.

FRAX is not valid for women and men under age 40, she continued. A new recommendation is the inclusion of a moderate risk group based on very low bone mass score (Z score less than –3 below the standard deviation of the mean) and/or rapid bone loss (greater than 10% in 1 year). Patients who had prior GC-associated fracture under 40 years are considered high risk.

A thorough history and physical exam are necessary for all patients, and risk assessment should be done within 6 months of GC initiation. Physical exam should be repeated annually, and bone mineral density (BMD) should be assessed every 2-3 years for patients who continue on GC.
 

Treatment

The proposed treatment recommendations were not age dependent. Patients with moderate to high risk should be treated, in descending order, with oral bisphosphonates, intravenous bisphosphonates, teriparatide (Forteo), and denosumab (Prolia). The order of preference for these treatments was based on cost, efficacy, toxicity, and patient preference.

All patients should take calcium and vitamin D, regardless of risk level.

The proposed recommendations also addressed four special groups considered at significant risk: women of childbearing potential, organ transplant recipients, children, and people on very high doses of GC (greater than 30 mg/day, cumulative dose of 5 g/year).

“For women of childbearing potential, there are emerging data suggesting that bisphosphonates are safe. For this group, consider oral bisphosphonate and teriparatide as a second choice. Animal data suggest that IV bisphosphonates and denosumab are harmful to the fetus,” Dr. Buckley said.

For organ transplant recipients, general recommendations can be followed with two provisions: Kidney transplant recipients should have a work-up for metabolic bone disease, and denosumab should not be used in people on multiple immunosuppressants.

Optimize calcium and vitamin D for children, and treat with oral bisphosphonate, Dr. Buckley continued. If oral bisphosphonates are contraindicated, IV bisphosphonates can be used.

Patients on very high GC dose should be treated with oral bisphosphonates if they are age 30 or older.

Osteoporosis medications can be discontinued in low-risk patients who stop taking GC, but should be continued for those at moderate to high risk.

Patients who benefit from osteoporosis medications but remain at moderate to high risk at the end of 3 years should continue GC treatment.

The authors and sponsors had no relevant financial disclosures.

SAN FRANCISCO – A new set of policy statements on children’s media use from the American Academy of Pediatrics brings the recommendations into the 21st century.

The new guidance, released at the annual meeting of the AAP, synthesizes the most current evidence on mobile devices, interactivity, educational technology, sleep, obesity, cognitive development, and other aspects of the pervasive digital environment children now grow up in.

“I think our policy statement reflects the changes in the media landscape because not all media use is the same,” Megan A. Moreno, MD, lead author of the policy statement, “Media Use in School-Aged Children and Adolescents,” said during a press conference (Pediatrics. 2016, Oct. doi: 10.1542/peds.2016-2592).

TatyanaGl/Thinkstock

Catherine Cooper Nellist/Frontline Medical News

An earlier introduction to screens

Among the most significant changes to the recommendations for children up to 5 years old is an allowance for introducing media before age 2, the previous policy’s age recommendation.

“If you want to introduce media, 18 months is the age when kids are cognitively ready to start, but we’re not saying parents need to introduce media then,” Dr. Radesky said, adding that more research is needed regarding devices such as tablets before it’s possible to know whether apps can be beneficial in toddlers that young. “There’s not enough evidence to know if interactivity helps or not right now,” she said.

The “Media and Young Minds” policy statement notes that children under age 2 years develop their cognitive, language, motor, and social-emotional skills through hands-on exploration and social interaction with trusted adults.

“Apps can’t do the things that parents’ minds can do or children’s minds can do on their own,” Dr. Radesky said. The policy notes that digital books, or eBooks, can be beneficial when used like a traditional physical book, but interactive elements to these eBooks could be distracting and decrease children’s comprehension.

When parents do choose to introduce media to their children, it’s “crucial that media be a shared experience” between the caregiving adult and the child, she said. “Think of media as a teaching tool, a way to connect and to create, not just to consume,” Dr. Radesky said.
 

What can preschoolers learn?

Although some laboratory research shows toddlers as young as 15 months can learn new words from touch screens, they have difficulty transferring that knowledge to the three-dimensional world. For children aged 3-5 years, however, both well-designed television programming and high-quality learning apps from Public Broadcasting Service (PBS) and the Sesame Workshop have shown benefits. In addition to early literacy, math, and personal and social development skills learned from shows such as Sesame Street, preschoolers have learned literacy skills from those programs’ apps.

But those apps are unfortunately in the minority.

“Most apps parents find under the ‘educational’ category in app stores have no such evidence of efficacy, target only rote academic skills, are not based on established curricula, and use little or no input from developmental specialists and educators,” the “Media and Young Minds” policy states. “The higher-order thinking skills and executive functions essential for school success, such as task persistence, impulse control, emotion regulation, and creative, flexible thinking, are best taught through unstructured and social (not digital) play, as well as responsive parent-child interactions.”

Catherine Cooper Nellist/Frontline Medical News

Risks and recommendations for preschoolers

Heavy media use among preschoolers, meanwhile, carries risks of increased weight – primarily as a result of food advertising and eating while watching TV – as well as reduced sleep and cognitive, language, and social/emotional delays.

“Content is crucial,” the “Media and Young Minds” policy notes. “Experimental evidence shows that switching from violent content to educational/prosocial content results in significant improvement in behavioral symptoms, particularly for low-income boys.”

The key points of the new statement therefore include the following recommendations:

• Limit media use to 1 hour a day in children ages 2 years and older.

• Do not use screens during mealtimes and for 1 hour before bedtime.

• Start discussing family and child media use with parents early in children’s lives.

• Educate parents about early brain development and help families develop a Family Media Use Plan.

• Discourage screen use besides video-chatting in children under 18 months old.

• Encourage caregiving adults to use screen media with children aged 18-24 months, who should not use it on their own.

• Encourage parents to rely on high-quality programming products such as PBS Kids, Sesame Workshop, and Common Sense Media.

• Help parents with challenges such as setting limits, finding alternatives to screen time, and calming children without using media.

• Avoid using screens or media to calm children except during rare extenuating circumstances, such as painful medical procedures and airplane flights.

• Encourage parents to avoid fast-paced programs, apps with distracting content, any media with violent content, and any background television, which can stunt children’s early language development.
 

Understanding older youth’s media use

As children move into school age and adolescence, the opportunities and utilities for media use expand – and so do the risks. Children and teens can benefit from media through gaining social support, learning about healthy behaviors, and discovering new ideas and knowledge, but youth remain at risk for obesity, sleep problems, cyberbullying, compromised privacy, and exposure to inaccurate, inappropriate or unsafe content, the “Media Use in School-Aged Children and Adolescents” policy statement reports.

Despite the wide range of media types available, TV remains the most commonly used media type among school-aged children and teens and is watched an average of 2 hours a day. Still, 91% of boys have access to a video game console, and 84% report playing games online or on a mobile phone. Further, three-quarters of teens own a smartphone and 76% use at least one social media site, with more than 70% maintaining a “social media portfolio” across several platforms.

Such social media use can provide teens with helpful support networks, particularly for those with ongoing illnesses or disabilities or those needing community support as lesbian, gay, bisexual, transgender, questioning, or intersex individuals. Social media can also promote wellness and healthy behaviors such as eating well and not smoking.

Risks for school-aged children and adolescents using media

Yet social media also can open the door to cyberbullying, leading to short-term and long-term social, academic, and health problems. It carries the risk of exploitation of youth or their images, or predation from pornographers and pedophiles. Children and teens must be made aware that the “Internet is forever” and should be taught to consider privacy and confidentiality concerns in their use of social and other media.

Another concern is teens’ “sexting,” in which they share sexually explicit messages and/or partly or fully nude photos. Exposures to unhealthy behaviors, such as substance abuse, sexual behaviors, self-injury, or disordered eating are likewise among the risks of social media, as they are with television and cinema.

In fact, TV/movie content showing alcohol use, smoking, and sexual activity is linked to earlier experimentation among children and adolescents. In addition, each extra hour of television watching is associated with increase in body mass index, as is having a TV set in the bedroom. Enjoying entertainment media while doing school work is linked to poor learning and academics.

Excessive media use may lead to problematic Internet use and Internet gaming disorder as described in the DSM-5, occurring among 4%-8.5% of children and adolescents.

“Symptoms can include a preoccupation with the activity, decreased interest in offline or ‘real life’ relationships, unsuccessful attempts to decrease use and withdrawal symptoms,” the “Media Use in School-Aged Children and Adolescents” policy statement notes.
 

Recommendations for older children

The policy statement advises pediatricians to help families and schools promote understanding of media’s risks and benefits, including awareness of tools to screen for sexting, cyberbullying, problematic Internet use, and Internet gaming disorder. Pediatricians should advocate for training in media literacy in the community and encourage parents to follow the media, sleep, and physical activity guidelines included in the Family Media Plan.

The research was supported by the American Academy of Pediatrics. The authors reported no disclosures.
 

SAN FRANCISCO – A new set of policy statements on children’s media use from the American Academy of Pediatrics brings the recommendations into the 21st century.

The new guidance, released at the annual meeting of the AAP, synthesizes the most current evidence on mobile devices, interactivity, educational technology, sleep, obesity, cognitive development, and other aspects of the pervasive digital environment children now grow up in.

“I think our policy statement reflects the changes in the media landscape because not all media use is the same,” Megan A. Moreno, MD, lead author of the policy statement, “Media Use in School-Aged Children and Adolescents,” said during a press conference (Pediatrics. 2016, Oct. doi: 10.1542/peds.2016-2592).

TatyanaGl/Thinkstock

Catherine Cooper Nellist/Frontline Medical News

An earlier introduction to screens

Among the most significant changes to the recommendations for children up to 5 years old is an allowance for introducing media before age 2, the previous policy’s age recommendation.

“If you want to introduce media, 18 months is the age when kids are cognitively ready to start, but we’re not saying parents need to introduce media then,” Dr. Radesky said, adding that more research is needed regarding devices such as tablets before it’s possible to know whether apps can be beneficial in toddlers that young. “There’s not enough evidence to know if interactivity helps or not right now,” she said.

The “Media and Young Minds” policy statement notes that children under age 2 years develop their cognitive, language, motor, and social-emotional skills through hands-on exploration and social interaction with trusted adults.

“Apps can’t do the things that parents’ minds can do or children’s minds can do on their own,” Dr. Radesky said. The policy notes that digital books, or eBooks, can be beneficial when used like a traditional physical book, but interactive elements to these eBooks could be distracting and decrease children’s comprehension.

When parents do choose to introduce media to their children, it’s “crucial that media be a shared experience” between the caregiving adult and the child, she said. “Think of media as a teaching tool, a way to connect and to create, not just to consume,” Dr. Radesky said.
 

What can preschoolers learn?

Although some laboratory research shows toddlers as young as 15 months can learn new words from touch screens, they have difficulty transferring that knowledge to the three-dimensional world. For children aged 3-5 years, however, both well-designed television programming and high-quality learning apps from Public Broadcasting Service (PBS) and the Sesame Workshop have shown benefits. In addition to early literacy, math, and personal and social development skills learned from shows such as Sesame Street, preschoolers have learned literacy skills from those programs’ apps.

But those apps are unfortunately in the minority.

“Most apps parents find under the ‘educational’ category in app stores have no such evidence of efficacy, target only rote academic skills, are not based on established curricula, and use little or no input from developmental specialists and educators,” the “Media and Young Minds” policy states. “The higher-order thinking skills and executive functions essential for school success, such as task persistence, impulse control, emotion regulation, and creative, flexible thinking, are best taught through unstructured and social (not digital) play, as well as responsive parent-child interactions.”

Catherine Cooper Nellist/Frontline Medical News

Risks and recommendations for preschoolers

Heavy media use among preschoolers, meanwhile, carries risks of increased weight – primarily as a result of food advertising and eating while watching TV – as well as reduced sleep and cognitive, language, and social/emotional delays.

“Content is crucial,” the “Media and Young Minds” policy notes. “Experimental evidence shows that switching from violent content to educational/prosocial content results in significant improvement in behavioral symptoms, particularly for low-income boys.”

The key points of the new statement therefore include the following recommendations:

• Limit media use to 1 hour a day in children ages 2 years and older.

• Do not use screens during mealtimes and for 1 hour before bedtime.

• Start discussing family and child media use with parents early in children’s lives.

• Educate parents about early brain development and help families develop a Family Media Use Plan.

• Discourage screen use besides video-chatting in children under 18 months old.

• Encourage caregiving adults to use screen media with children aged 18-24 months, who should not use it on their own.

• Encourage parents to rely on high-quality programming products such as PBS Kids, Sesame Workshop, and Common Sense Media.

• Help parents with challenges such as setting limits, finding alternatives to screen time, and calming children without using media.

• Avoid using screens or media to calm children except during rare extenuating circumstances, such as painful medical procedures and airplane flights.

• Encourage parents to avoid fast-paced programs, apps with distracting content, any media with violent content, and any background television, which can stunt children’s early language development.
 

Understanding older youth’s media use

As children move into school age and adolescence, the opportunities and utilities for media use expand – and so do the risks. Children and teens can benefit from media through gaining social support, learning about healthy behaviors, and discovering new ideas and knowledge, but youth remain at risk for obesity, sleep problems, cyberbullying, compromised privacy, and exposure to inaccurate, inappropriate or unsafe content, the “Media Use in School-Aged Children and Adolescents” policy statement reports.

Despite the wide range of media types available, TV remains the most commonly used media type among school-aged children and teens and is watched an average of 2 hours a day. Still, 91% of boys have access to a video game console, and 84% report playing games online or on a mobile phone. Further, three-quarters of teens own a smartphone and 76% use at least one social media site, with more than 70% maintaining a “social media portfolio” across several platforms.

Such social media use can provide teens with helpful support networks, particularly for those with ongoing illnesses or disabilities or those needing community support as lesbian, gay, bisexual, transgender, questioning, or intersex individuals. Social media can also promote wellness and healthy behaviors such as eating well and not smoking.

Risks for school-aged children and adolescents using media

Yet social media also can open the door to cyberbullying, leading to short-term and long-term social, academic, and health problems. It carries the risk of exploitation of youth or their images, or predation from pornographers and pedophiles. Children and teens must be made aware that the “Internet is forever” and should be taught to consider privacy and confidentiality concerns in their use of social and other media.

Another concern is teens’ “sexting,” in which they share sexually explicit messages and/or partly or fully nude photos. Exposures to unhealthy behaviors, such as substance abuse, sexual behaviors, self-injury, or disordered eating are likewise among the risks of social media, as they are with television and cinema.

In fact, TV/movie content showing alcohol use, smoking, and sexual activity is linked to earlier experimentation among children and adolescents. In addition, each extra hour of television watching is associated with increase in body mass index, as is having a TV set in the bedroom. Enjoying entertainment media while doing school work is linked to poor learning and academics.

Excessive media use may lead to problematic Internet use and Internet gaming disorder as described in the DSM-5, occurring among 4%-8.5% of children and adolescents.

“Symptoms can include a preoccupation with the activity, decreased interest in offline or ‘real life’ relationships, unsuccessful attempts to decrease use and withdrawal symptoms,” the “Media Use in School-Aged Children and Adolescents” policy statement notes.
 

Recommendations for older children

The policy statement advises pediatricians to help families and schools promote understanding of media’s risks and benefits, including awareness of tools to screen for sexting, cyberbullying, problematic Internet use, and Internet gaming disorder. Pediatricians should advocate for training in media literacy in the community and encourage parents to follow the media, sleep, and physical activity guidelines included in the Family Media Plan.

The research was supported by the American Academy of Pediatrics. The authors reported no disclosures.
 

SAN FRANCISCO – A new set of policy statements on children’s media use from the American Academy of Pediatrics brings the recommendations into the 21st century.

The new guidance, released at the annual meeting of the AAP, synthesizes the most current evidence on mobile devices, interactivity, educational technology, sleep, obesity, cognitive development, and other aspects of the pervasive digital environment children now grow up in.

“I think our policy statement reflects the changes in the media landscape because not all media use is the same,” Megan A. Moreno, MD, lead author of the policy statement, “Media Use in School-Aged Children and Adolescents,” said during a press conference (Pediatrics. 2016, Oct. doi: 10.1542/peds.2016-2592).

TatyanaGl/Thinkstock

Catherine Cooper Nellist/Frontline Medical News

An earlier introduction to screens

Among the most significant changes to the recommendations for children up to 5 years old is an allowance for introducing media before age 2, the previous policy’s age recommendation.

“If you want to introduce media, 18 months is the age when kids are cognitively ready to start, but we’re not saying parents need to introduce media then,” Dr. Radesky said, adding that more research is needed regarding devices such as tablets before it’s possible to know whether apps can be beneficial in toddlers that young. “There’s not enough evidence to know if interactivity helps or not right now,” she said.

The “Media and Young Minds” policy statement notes that children under age 2 years develop their cognitive, language, motor, and social-emotional skills through hands-on exploration and social interaction with trusted adults.

“Apps can’t do the things that parents’ minds can do or children’s minds can do on their own,” Dr. Radesky said. The policy notes that digital books, or eBooks, can be beneficial when used like a traditional physical book, but interactive elements to these eBooks could be distracting and decrease children’s comprehension.

When parents do choose to introduce media to their children, it’s “crucial that media be a shared experience” between the caregiving adult and the child, she said. “Think of media as a teaching tool, a way to connect and to create, not just to consume,” Dr. Radesky said.
 

What can preschoolers learn?

Although some laboratory research shows toddlers as young as 15 months can learn new words from touch screens, they have difficulty transferring that knowledge to the three-dimensional world. For children aged 3-5 years, however, both well-designed television programming and high-quality learning apps from Public Broadcasting Service (PBS) and the Sesame Workshop have shown benefits. In addition to early literacy, math, and personal and social development skills learned from shows such as Sesame Street, preschoolers have learned literacy skills from those programs’ apps.

But those apps are unfortunately in the minority.

“Most apps parents find under the ‘educational’ category in app stores have no such evidence of efficacy, target only rote academic skills, are not based on established curricula, and use little or no input from developmental specialists and educators,” the “Media and Young Minds” policy states. “The higher-order thinking skills and executive functions essential for school success, such as task persistence, impulse control, emotion regulation, and creative, flexible thinking, are best taught through unstructured and social (not digital) play, as well as responsive parent-child interactions.”

Catherine Cooper Nellist/Frontline Medical News

Risks and recommendations for preschoolers

Heavy media use among preschoolers, meanwhile, carries risks of increased weight – primarily as a result of food advertising and eating while watching TV – as well as reduced sleep and cognitive, language, and social/emotional delays.

“Content is crucial,” the “Media and Young Minds” policy notes. “Experimental evidence shows that switching from violent content to educational/prosocial content results in significant improvement in behavioral symptoms, particularly for low-income boys.”

The key points of the new statement therefore include the following recommendations:

• Limit media use to 1 hour a day in children ages 2 years and older.

• Do not use screens during mealtimes and for 1 hour before bedtime.

• Start discussing family and child media use with parents early in children’s lives.

• Educate parents about early brain development and help families develop a Family Media Use Plan.

• Discourage screen use besides video-chatting in children under 18 months old.

• Encourage caregiving adults to use screen media with children aged 18-24 months, who should not use it on their own.

• Encourage parents to rely on high-quality programming products such as PBS Kids, Sesame Workshop, and Common Sense Media.

• Help parents with challenges such as setting limits, finding alternatives to screen time, and calming children without using media.

• Avoid using screens or media to calm children except during rare extenuating circumstances, such as painful medical procedures and airplane flights.

• Encourage parents to avoid fast-paced programs, apps with distracting content, any media with violent content, and any background television, which can stunt children’s early language development.
 

Understanding older youth’s media use

As children move into school age and adolescence, the opportunities and utilities for media use expand – and so do the risks. Children and teens can benefit from media through gaining social support, learning about healthy behaviors, and discovering new ideas and knowledge, but youth remain at risk for obesity, sleep problems, cyberbullying, compromised privacy, and exposure to inaccurate, inappropriate or unsafe content, the “Media Use in School-Aged Children and Adolescents” policy statement reports.

Despite the wide range of media types available, TV remains the most commonly used media type among school-aged children and teens and is watched an average of 2 hours a day. Still, 91% of boys have access to a video game console, and 84% report playing games online or on a mobile phone. Further, three-quarters of teens own a smartphone and 76% use at least one social media site, with more than 70% maintaining a “social media portfolio” across several platforms.

Such social media use can provide teens with helpful support networks, particularly for those with ongoing illnesses or disabilities or those needing community support as lesbian, gay, bisexual, transgender, questioning, or intersex individuals. Social media can also promote wellness and healthy behaviors such as eating well and not smoking.

Risks for school-aged children and adolescents using media

Yet social media also can open the door to cyberbullying, leading to short-term and long-term social, academic, and health problems. It carries the risk of exploitation of youth or their images, or predation from pornographers and pedophiles. Children and teens must be made aware that the “Internet is forever” and should be taught to consider privacy and confidentiality concerns in their use of social and other media.

Another concern is teens’ “sexting,” in which they share sexually explicit messages and/or partly or fully nude photos. Exposures to unhealthy behaviors, such as substance abuse, sexual behaviors, self-injury, or disordered eating are likewise among the risks of social media, as they are with television and cinema.

In fact, TV/movie content showing alcohol use, smoking, and sexual activity is linked to earlier experimentation among children and adolescents. In addition, each extra hour of television watching is associated with increase in body mass index, as is having a TV set in the bedroom. Enjoying entertainment media while doing school work is linked to poor learning and academics.

Excessive media use may lead to problematic Internet use and Internet gaming disorder as described in the DSM-5, occurring among 4%-8.5% of children and adolescents.

“Symptoms can include a preoccupation with the activity, decreased interest in offline or ‘real life’ relationships, unsuccessful attempts to decrease use and withdrawal symptoms,” the “Media Use in School-Aged Children and Adolescents” policy statement notes.
 

Recommendations for older children

The policy statement advises pediatricians to help families and schools promote understanding of media’s risks and benefits, including awareness of tools to screen for sexting, cyberbullying, problematic Internet use, and Internet gaming disorder. Pediatricians should advocate for training in media literacy in the community and encourage parents to follow the media, sleep, and physical activity guidelines included in the Family Media Plan.

The research was supported by the American Academy of Pediatrics. The authors reported no disclosures.
 

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

Both dietary and supplemental calcium should be considered safe for the cardiovascular system as long as total intake doesn’t exceed 2,000-2,500 mg/day – the maximal tolerable level defined by the National Academy of Medicine, according to an updated Clinical Practice Guideline published online October 24 in Annals of Internal Medicine.

For generally healthy patients who don’t consume adequate calcium and take supplements, either alone or in combination with vitamin D, to prevent osteoporosis and related fractures, “discontinuation of supplemental calcium for safety reasons is not necessary and may be harmful to bone health,” said Stephen L. Kopecky, MD, of the Mayo Clinic, Rochester Minn., and his associates on the expert panel that wrote the new guideline.

New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.

The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.

The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.

The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.

This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).

“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.

Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.

However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.

They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.

The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.

While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.

“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.

Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.

The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.

They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.

Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.

New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.

The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.

The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.

The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.

This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).

“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.

Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.

However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.

They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.

The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.

While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.

“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.

Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.

The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.

They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.

Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.

New guidelines on red blood cell blood transfusion recommend a restrictive threshold in which transfusion is not indicated until the hemoglobin level is 7-8 g/dL for most patients, finding that it is safe in most clinical settings.

The updated clinical practice guidelines on transfusion thresholds and storage from the AABB (formerly known as the American Association of Blood Banks), also note that red blood cell units can be used at any time within their licensed dating period, rather than a preference being given to fresher units less than 10 days old.

The guidelines, published online Oct. 12 in JAMA, are an update of the 2012 transfusion guidelines, and are a response to a more than doubling of the number of patients since enrolled in randomized controlled trials of red blood cell transfusions.

The AABB’s clinical transfusion medicine committee, led by Jeffrey L. Carson, MD, of Robert Wood Johnson Medical School, New Brunswick, N.J., analyzed data from 31 randomized controlled trials of 12,587 participants, which compared restrictive transfusion thresholds of 7-8 g/dL to more liberal thresholds of 9-10 g/dL.

This analysis showed that the use of restrictive transfusion protocols was associated with an absolute difference in 30-day mortality of three fewer deaths compared to the more liberal thresholds. There was no significant difference in 30-day mortality in trials that compared a threshold of 8-9 g/dL to a threshold of less than 7 g/dL (JAMA 2016, Oct 12. doi: 10.1001/jama.2016.9185).

“For all other outcomes evaluated, there was no evidence to suggest that patients were harmed by restrictive transfusion protocols, although the quality of the evidence was low for the outcomes of congestive heart failure and rebleeding,” the authors reported.

Based on these findings, they recommended a restrictive red blood cell transfusion threshold, in which transfusion is not indicated until the hemoglobin level is 7 g/dL for hospitalized adult patients who are hemodynamically stable, including critically ill patients.

However for patients undergoing orthopedic or cardiac surgery, or those with preexisting cardiovascular disease, they advised a threshold of 8 g/dL for initiating a red blood cell transfusion.

They also stressed that these recommendations did not apply to patients with acute coronary syndrome, those with severe thrombocytopenia, those treated for hematologic or oncologic disorders who at risk of bleeding, and those with chronic transfusion–dependent anemia, citing a lack of quality randomized controlled trial evidence.

The guideline authors examined the issue of the optimal length of time that red blood cell units should be stored, pointing out that there is currently no formal guidance on the optimal period of red blood cell storage prior to transfusion.

While units of red blood cells can be stored for up to 42 days, the committee said there was some evidence that longer storage may be associated with adverse transfusion outcomes.

“The RBCs stored for longer periods have decreased ability to deliver oxygen due to decreased levels of 2,3-diphsophoglycerate, decreased nitric oxide metabolism, alterations of the RBC membrane leading to increased rigidity, and increased RBC endothelial adherence,” they wrote.

Despite this, the review of 13 randomized controlled trials examining the effect of storage duration found no evidence that fresher units had any impact on mortality compared to standard issue units, nor were there any more adverse events with the standard issue units.

The absolute difference in 30-day mortality was four more deaths per 1,000 with fresher blood, and there was a higher risk of nosocomial infections among patients who received fresher red blood cell units although the authors said the quality of evidence was low.

They therefore recommended that no preference be given to fresher red blood cell units, and that all patients be treated with units chosen at any point within their licensed dating period.

Guideline development was supported by AABB. Four authors declared grants, fees, stock options or consultancies from pharmaceutical companies, but no other conflicts of interest were declared.