Is HCAHPS Hurting Our Patients?

Speakers: Suparna Dutta, MD, MS, MPH, and John Biebelhausen, MD, MBA

Explore the unintended consequences of assessing patient satisfaction and labeling pain as “the fifth vital sign” in the midst of a national opioid epidemic. The Hospital Consumer Assessment of Healthcare Providers and Systems, which was developed by the Centers for Medicare & Medicaid Services to assess the inpatient experience and impacts hospital reimbursement, includes directed questions about pain management.

Join us as we review the background of HCAHPS, its potential unintended impacts over the years, as well as current and future efforts of SHM toward improving health policy in this domain.

Hello, My Name Is POCUS (Point-of-Care Ultrasound)

Speaker: Nilam Soni, MD, MS, FHM

Point-of-care ultrasound is being used by more hospitalists to perform bedside diagnostics and to guide invasive procedures. However, most practicing hospitalists completed their training before point-of-care ultrasound education was common in medical school and residency curricula. This interactive session will:

• Explain what point-of-care ultrasonography is and how hospitalists are currently using it.
• Highlight some of the unique point-of-care ultrasound activities at HM17.
• Describe the launch of a new point-of-care ultrasound certification program offered by SHM & ACCP.

The Best-Kept Secrets from the State of Hospital Medicine Report

Speaker: Johnbuck Creamer, MD, SFHM

The State of Hospital Medicine Report is powered by SHM’s biannual survey that recently captured data from nearly 600 HM groups, augmented by additional hospitalist data licensed from MGMA. We’ll explore trends and difference among groups, including:

• Compensation per wRVU and use of nocturnists are increasing.
• Turnover rates are decreasing.
• Compensation for quality performance varies greatly among academic, nonacademic, and pediatric practice groups.
• NP/PA utilization rates are very different between East and West U.S. regions.
• Family Practice presence is increasing in adult-only practice groups.
• Academic groups are falling further behind in CPT coding levels.

We Need to Talk: Opioid-Related Respiratory Failure & Death

Speaker: Thomas Frederickson, MD, SFHM

Discussion topics:

• The opioid epidemic – not just an outpatient issue.
• How opioids can cause respiratory arrest and death, and why current screening and monitoring strategies can fail.
• What works – examples of successful strategies that have been implemented and have saved lives.

PediBOOST^®: Kids Need Better Care Transitions, Too!

Speaker: James O’Callaghan, MD, SFHM

PediBOOST is a pediatric-specific adaption of the SHM Project BOOST^® (Better Outcomes by Optimizing Safe Transitions) quality initiative. The goal is to improve poor discharge processes (demonstrated by low patient satisfaction and worse clinical outcomes, not just higher hospital readmission rates).

It considers unique problems for hospitalized children, including:

• Medication issues – palatability and adherence concerns, need for compounding.
• Equipment issues – portability use for home and school.
• Education issues – engagement of patient, as developmentally appropriate, along with training of all providers who might care for the patient (parents, teachers).

How Hospitalists Really Feel about EMRs

Speaker: Rupesh Prasad, MD, MPH, SFHM

Electronic medical record use has tremendously increased in the last few years.

• What are the potential benefits of use – have they been realized?
• What do the hospitalists think:
• How have EMRs impacted patient safety?
• How have EMRs impacted patient face to face time?
• What are hospitalists’ frustrations about EMRs?

Improve Your Interactions with the 5 Rs of Cultural Humility

Speaker: O’Neil Pyke, MD, SFHM

As the proverbial stranger at the bedside, HM providers are tasked with a very challenging proposition: meet a new patient in their most vulnerable state and quickly establish effective lines of communication and trust and provide patient-centric care, ultimately yielding a satisfied patient (and family) irrespective of the clinical outcome. With increased focus on patient experience and satisfaction, it is imperative that hospitals and health systems equip all hospitalists with the tools needed to deliver culturally competent care to all patients served.

The goal of the 5 Rs is to equip HM providers with tangible resources and easy to understand reminders that focus on encouraging awareness and, ultimately, deliver culturally “humble” care to all patients (and family members).

• Respect: Hospitalists will treat every person with the utmost respect and strive to preserve patient dignity.
• Regard: Hospitalists will hold every person in their highest regard and not allow unconscious biases to manifest, exercising utmost sensitivity to anticipated differences in beliefs, value systems, and preferences.
• Relevance: Hospitalists will expect cultural humility to be relevant and apply this practice to every encounter.
• Reflection: Hospitalists will approach every encounter with humility and understanding that there is always something to learn from everyone.
• Resiliency: In order to provide better care for hospitalized patients, hospitalists will embody the practice of cultural humility to enhance personal resiliency and compassion for all.

It’s Critical: Hospitalists in the ICU

Speaker: Joseph Sweigart, MD

We hope to:

• Describe formation of purpose of the critical care task force within the Education Committee.
• Discuss the creation and execution of the SHM critical care survey.
• Present selected results including:
• Introduce strategies to address the practice gaps identified including:

Palliative Care in Hospital Medicine: Figuring Out What Matters Most

Speaker: Rab Razzak, MBBS, MD

We aim to:

• Discuss the overall definition of palliative care. It is for all seriously ill patients and focuses on human-centered care and quality of life, best provided early in an illness.
• Idea of primary palliative care and role of hospitalists. Most palliative care is provided by frontline clinicians, and hospitalists are optimally positioned to support seriously ill patients and their families. It is crucial for HM to involve palliative care specialists when needed.
• Effective communication about serious illness – words that work and how to operationalize human-centered care while honestly discussing serious illness.
  

Is HCAHPS Hurting Our Patients?

Speakers: Suparna Dutta, MD, MS, MPH, and John Biebelhausen, MD, MBA

Explore the unintended consequences of assessing patient satisfaction and labeling pain as “the fifth vital sign” in the midst of a national opioid epidemic. The Hospital Consumer Assessment of Healthcare Providers and Systems, which was developed by the Centers for Medicare & Medicaid Services to assess the inpatient experience and impacts hospital reimbursement, includes directed questions about pain management.

Join us as we review the background of HCAHPS, its potential unintended impacts over the years, as well as current and future efforts of SHM toward improving health policy in this domain.

Hello, My Name Is POCUS (Point-of-Care Ultrasound)

Speaker: Nilam Soni, MD, MS, FHM

Point-of-care ultrasound is being used by more hospitalists to perform bedside diagnostics and to guide invasive procedures. However, most practicing hospitalists completed their training before point-of-care ultrasound education was common in medical school and residency curricula. This interactive session will:

• Explain what point-of-care ultrasonography is and how hospitalists are currently using it.
• Highlight some of the unique point-of-care ultrasound activities at HM17.
• Describe the launch of a new point-of-care ultrasound certification program offered by SHM & ACCP.

The Best-Kept Secrets from the State of Hospital Medicine Report

Speaker: Johnbuck Creamer, MD, SFHM

The State of Hospital Medicine Report is powered by SHM’s biannual survey that recently captured data from nearly 600 HM groups, augmented by additional hospitalist data licensed from MGMA. We’ll explore trends and difference among groups, including:

• Compensation per wRVU and use of nocturnists are increasing.
• Turnover rates are decreasing.
• Compensation for quality performance varies greatly among academic, nonacademic, and pediatric practice groups.
• NP/PA utilization rates are very different between East and West U.S. regions.
• Family Practice presence is increasing in adult-only practice groups.
• Academic groups are falling further behind in CPT coding levels.

We Need to Talk: Opioid-Related Respiratory Failure & Death

Speaker: Thomas Frederickson, MD, SFHM

Discussion topics:

• The opioid epidemic – not just an outpatient issue.
• How opioids can cause respiratory arrest and death, and why current screening and monitoring strategies can fail.
• What works – examples of successful strategies that have been implemented and have saved lives.

PediBOOST^®: Kids Need Better Care Transitions, Too!

Speaker: James O’Callaghan, MD, SFHM

PediBOOST is a pediatric-specific adaption of the SHM Project BOOST^® (Better Outcomes by Optimizing Safe Transitions) quality initiative. The goal is to improve poor discharge processes (demonstrated by low patient satisfaction and worse clinical outcomes, not just higher hospital readmission rates).

It considers unique problems for hospitalized children, including:

• Medication issues – palatability and adherence concerns, need for compounding.
• Equipment issues – portability use for home and school.
• Education issues – engagement of patient, as developmentally appropriate, along with training of all providers who might care for the patient (parents, teachers).

How Hospitalists Really Feel about EMRs

Speaker: Rupesh Prasad, MD, MPH, SFHM

Electronic medical record use has tremendously increased in the last few years.

• What are the potential benefits of use – have they been realized?
• What do the hospitalists think:
• How have EMRs impacted patient safety?
• How have EMRs impacted patient face to face time?
• What are hospitalists’ frustrations about EMRs?

Improve Your Interactions with the 5 Rs of Cultural Humility

Speaker: O’Neil Pyke, MD, SFHM

As the proverbial stranger at the bedside, HM providers are tasked with a very challenging proposition: meet a new patient in their most vulnerable state and quickly establish effective lines of communication and trust and provide patient-centric care, ultimately yielding a satisfied patient (and family) irrespective of the clinical outcome. With increased focus on patient experience and satisfaction, it is imperative that hospitals and health systems equip all hospitalists with the tools needed to deliver culturally competent care to all patients served.

The goal of the 5 Rs is to equip HM providers with tangible resources and easy to understand reminders that focus on encouraging awareness and, ultimately, deliver culturally “humble” care to all patients (and family members).

• Respect: Hospitalists will treat every person with the utmost respect and strive to preserve patient dignity.
• Regard: Hospitalists will hold every person in their highest regard and not allow unconscious biases to manifest, exercising utmost sensitivity to anticipated differences in beliefs, value systems, and preferences.
• Relevance: Hospitalists will expect cultural humility to be relevant and apply this practice to every encounter.
• Reflection: Hospitalists will approach every encounter with humility and understanding that there is always something to learn from everyone.
• Resiliency: In order to provide better care for hospitalized patients, hospitalists will embody the practice of cultural humility to enhance personal resiliency and compassion for all.

It’s Critical: Hospitalists in the ICU

Speaker: Joseph Sweigart, MD

We hope to:

• Describe formation of purpose of the critical care task force within the Education Committee.
• Discuss the creation and execution of the SHM critical care survey.
• Present selected results including:
• Introduce strategies to address the practice gaps identified including:

Palliative Care in Hospital Medicine: Figuring Out What Matters Most

Speaker: Rab Razzak, MBBS, MD

We aim to:

• Discuss the overall definition of palliative care. It is for all seriously ill patients and focuses on human-centered care and quality of life, best provided early in an illness.
• Idea of primary palliative care and role of hospitalists. Most palliative care is provided by frontline clinicians, and hospitalists are optimally positioned to support seriously ill patients and their families. It is crucial for HM to involve palliative care specialists when needed.
• Effective communication about serious illness – words that work and how to operationalize human-centered care while honestly discussing serious illness.
  

Is HCAHPS Hurting Our Patients?

Speakers: Suparna Dutta, MD, MS, MPH, and John Biebelhausen, MD, MBA

Explore the unintended consequences of assessing patient satisfaction and labeling pain as “the fifth vital sign” in the midst of a national opioid epidemic. The Hospital Consumer Assessment of Healthcare Providers and Systems, which was developed by the Centers for Medicare & Medicaid Services to assess the inpatient experience and impacts hospital reimbursement, includes directed questions about pain management.

Join us as we review the background of HCAHPS, its potential unintended impacts over the years, as well as current and future efforts of SHM toward improving health policy in this domain.

Hello, My Name Is POCUS (Point-of-Care Ultrasound)

Speaker: Nilam Soni, MD, MS, FHM

Point-of-care ultrasound is being used by more hospitalists to perform bedside diagnostics and to guide invasive procedures. However, most practicing hospitalists completed their training before point-of-care ultrasound education was common in medical school and residency curricula. This interactive session will:

• Explain what point-of-care ultrasonography is and how hospitalists are currently using it.
• Highlight some of the unique point-of-care ultrasound activities at HM17.
• Describe the launch of a new point-of-care ultrasound certification program offered by SHM & ACCP.

The Best-Kept Secrets from the State of Hospital Medicine Report

Speaker: Johnbuck Creamer, MD, SFHM

The State of Hospital Medicine Report is powered by SHM’s biannual survey that recently captured data from nearly 600 HM groups, augmented by additional hospitalist data licensed from MGMA. We’ll explore trends and difference among groups, including:

• Compensation per wRVU and use of nocturnists are increasing.
• Turnover rates are decreasing.
• Compensation for quality performance varies greatly among academic, nonacademic, and pediatric practice groups.
• NP/PA utilization rates are very different between East and West U.S. regions.
• Family Practice presence is increasing in adult-only practice groups.
• Academic groups are falling further behind in CPT coding levels.

We Need to Talk: Opioid-Related Respiratory Failure & Death

Speaker: Thomas Frederickson, MD, SFHM

Discussion topics:

• The opioid epidemic – not just an outpatient issue.
• How opioids can cause respiratory arrest and death, and why current screening and monitoring strategies can fail.
• What works – examples of successful strategies that have been implemented and have saved lives.

PediBOOST^®: Kids Need Better Care Transitions, Too!

Speaker: James O’Callaghan, MD, SFHM

PediBOOST is a pediatric-specific adaption of the SHM Project BOOST^® (Better Outcomes by Optimizing Safe Transitions) quality initiative. The goal is to improve poor discharge processes (demonstrated by low patient satisfaction and worse clinical outcomes, not just higher hospital readmission rates).

It considers unique problems for hospitalized children, including:

• Medication issues – palatability and adherence concerns, need for compounding.
• Equipment issues – portability use for home and school.
• Education issues – engagement of patient, as developmentally appropriate, along with training of all providers who might care for the patient (parents, teachers).

How Hospitalists Really Feel about EMRs

Speaker: Rupesh Prasad, MD, MPH, SFHM

Electronic medical record use has tremendously increased in the last few years.

• What are the potential benefits of use – have they been realized?
• What do the hospitalists think:
• How have EMRs impacted patient safety?
• How have EMRs impacted patient face to face time?
• What are hospitalists’ frustrations about EMRs?

Improve Your Interactions with the 5 Rs of Cultural Humility

Speaker: O’Neil Pyke, MD, SFHM

As the proverbial stranger at the bedside, HM providers are tasked with a very challenging proposition: meet a new patient in their most vulnerable state and quickly establish effective lines of communication and trust and provide patient-centric care, ultimately yielding a satisfied patient (and family) irrespective of the clinical outcome. With increased focus on patient experience and satisfaction, it is imperative that hospitals and health systems equip all hospitalists with the tools needed to deliver culturally competent care to all patients served.

The goal of the 5 Rs is to equip HM providers with tangible resources and easy to understand reminders that focus on encouraging awareness and, ultimately, deliver culturally “humble” care to all patients (and family members).

• Respect: Hospitalists will treat every person with the utmost respect and strive to preserve patient dignity.
• Regard: Hospitalists will hold every person in their highest regard and not allow unconscious biases to manifest, exercising utmost sensitivity to anticipated differences in beliefs, value systems, and preferences.
• Relevance: Hospitalists will expect cultural humility to be relevant and apply this practice to every encounter.
• Reflection: Hospitalists will approach every encounter with humility and understanding that there is always something to learn from everyone.
• Resiliency: In order to provide better care for hospitalized patients, hospitalists will embody the practice of cultural humility to enhance personal resiliency and compassion for all.

It’s Critical: Hospitalists in the ICU

Speaker: Joseph Sweigart, MD

We hope to:

• Describe formation of purpose of the critical care task force within the Education Committee.
• Discuss the creation and execution of the SHM critical care survey.
• Present selected results including:
• Introduce strategies to address the practice gaps identified including:

Palliative Care in Hospital Medicine: Figuring Out What Matters Most

Speaker: Rab Razzak, MBBS, MD

We aim to:

• Discuss the overall definition of palliative care. It is for all seriously ill patients and focuses on human-centered care and quality of life, best provided early in an illness.
• Idea of primary palliative care and role of hospitalists. Most palliative care is provided by frontline clinicians, and hospitalists are optimally positioned to support seriously ill patients and their families. It is crucial for HM to involve palliative care specialists when needed.
• Effective communication about serious illness – words that work and how to operationalize human-centered care while honestly discussing serious illness.
  

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

• Repair when possible for patients with NVE (COR I, LOE B).
• When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
• Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
• In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

• Repair when possible for patients with NVE (COR I, LOE B).
• When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
• Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
• In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

Infective endocarditis (IE) is a devastating complication of heart valve disease that, left untreated, can be fatal. Management requires a multidisciplinary approach, and many of the respective medical societies that represent the participating specialties have developed guidelines. Now, the American Association for Thoracic Surgery has published “Consensus Guidelines for the Surgical Treatment of Infective Endocarditis” to guide thoracic and cardiovascular surgeons in making decisions of when to operate in cases of IE (J Thorac Cardiovasc Surg. 2017 Jan 24. doi: 10.1016/j.jtcvs.2016.09.093).

• Repair when possible for patients with NVE (COR I, LOE B).
• When replacement is indicated, the surgeon should base valve choice on normal criteria – age, life expectancy, comorbidities, and expected compliance with anticoagulation (COR I, LOE B).
• Avoid use of mechanical valves in patients with intracranial bleeding or who have had a major stroke (COR IIA, LOE C).
• In patients with invasive disease and deconstruction, reconstruction should depend on the involved valve, severity of destruction, and available options for cardiac reconstruction (COR I, LOE B).

The AATS guidelines also challenge conventional thinking on the practice of soaking a gel-impregnated graft with antimicrobials targeting a specific organism. “We found no evidence to support this practice,” Dr. Pettersson and his coauthors said (COR IIB, LOE B). They came to the same conclusion with regard to the use of local antimicrobials or antiseptics during irrigation after debridement and local injection of antimicrobials around the infected area (COR I, LOE C).

The guidelines provide direction on a host of other surgical issues in IE: use of aortic valve grafts; when to remove or replace noninfected grafts; when to remove pacemakers; the role of drainage; postoperative management; follow-up; and additional screening. They also shed insight into what the guideline authors call “residual controversies,” including surgery for injection drug users (use “all available resources and options for drug rehabilitation”) and dialysis patients (“it is reasonable to offer surgery when the additional burden of comorbidities is not overwhelming”). They also acknowledge seven different scenarios that lack clear evidence for intervention but require the surgeon to determine the need for surgery, ranging from timing of surgery for IE in patients with neurologic complications to how to treat patients with functional valve issues after being cured of IE.

The guideline writers acknowledged that institutional funds supported the work. Dr. Pettersson had no financial relationships to disclose.

*Correction 5/172017: It was incorrectly stated that these complications were not addressed in the guidelines due to lack of evidence

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

[email protected]

On Twitter @whitneymcknight

The Food and Drug Administration is restricting the use of two opiates – codeine and tramadol – in children, and also warns they are potentially dangerous to infants of breastfeeding women.

Codeine is approved to treat pain and cough; tramadol is approved to treat pain.

“We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe,” Douglas Throckmorton, MD, the deputy center director for regulatory programs at the FDA Center for Drug Evaluation and Research, said in a statement.

In the current safety statement, the FDA said it will require additional labeling changes, including contraindications for use of codeine or tramadol in all children younger than 12 years of age and a new contraindication for tramadol in children younger than 18 years being treated for pain after tonsillectomy and/or adenoidectomy, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers.

Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults, the agency noted.

The agency cited particular concerns over those who are “ultra-rapid metabolizers” of substrates of the cytochrome P450 isoenzyme 2D6 (CYP2D6) genotype. These people more quickly convert codeine into potentially dangerously high levels of morphine, which can lead to fatal respiratory depression.

Supporting the restrictions and warning were data on 64 cases of respiratory depression that occurred worldwide between 1969 and 2015, when a codeine-based medicine was used in children younger than 18 years. Twenty-four of these children died.

The most frequently cited medicines in the cases were acetaminophen with codeine and promethazine with codeine with or without phenylephrine, either given to soothe postoperative pain, general pain, sore or strep throat pain, or cough and cold.

Ten of the 64 cases implicated the CYP2D6 genotype. Seven of the patients were “ultrarapid metabolizers,” five of whom died.

Data cited on tramadol included nine worldwide cases of tramadol-related respiratory depression occurring between 1969 and 2016, resulting in the deaths of three children, all under the age of 6 years, and all of whom were taking the drug for postoperative pain or fever.

All but one case of respiratory depression occurred within the first 24 hours of taking the drug. One of the patients was genotyped for CYP2D6, and found to have three functional alleles consistent with ultrarapid metabolism.

Mothers who are ultrarapid metabolizers of codeine can have high levels of morphine in their breast milk that are dangerous to their breastfed infants, whereas there is less of a threat posed by women with normal codeine metabolism because the amount of codeine secreted into the breast milk is low and dose dependent.

The FDA stated that data reveal numerous reports of respiratory depression and at least one death in infants of breastfeeding mothers taking these medicines, particularly mothers with the CYP2D6 genotype. Although there are FDA-cleared tests for ultrarapid metabolism, they are not commonly used.

The agency stated that breastfeeding women taking any opioid pain medicine, including codeine or tramadol should contact their health care provider if they notice the infant is sleeping more than 4 hours at a time, or if the infant is having difficulty breastfeeding or seems limp.

Clinicians are urged to report side effects that occur while using codeine or tramadol to the FDA’s MedWatch Adverse Event Reporting program.

[email protected]

On Twitter @whitneymcknight

In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

[email protected]

In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

[email protected]

In patients with inflammatory bowel disease and spondyloarthritis (IBD-SpA), dactylitis, enthesitis, and anterior uveitis (AU) are significantly less frequent than in patients with other types of SpA, according to Fabrizio Cantini, MD, and his associates.

In a 12-month, case-control study, 88 patients with IBD-SpA, 29 with ulcerative colitis (UC), and 59 with Crohn’s disease (CD) were examined along with the 176 patients with SpA in the control group. Results showed a significantly lower occurrence of dactylitis in case patients, with 4 episodes (4.5%) in IBD-SpA patients and 30 (17.4%) in controls (P = .008). The comparison of the frequency of dactylitis in patients with UC-SpA and in patients with CD-SpA found no significant differences between the two (3.4% and 5.08%, respectively; P = .843). Enthesitis was significantly lower in IBD-SpA, occurring in 16 out of 88 patients (18.1%), compared with in 78 out of 176 controls (44.3%; P less than .001). AU was also recorded in 3 (3.4%) of the patients with IBD-SpA and in 26 controls (14.7%; P = .010), and B27 positivity was recorded in 10 (11.3%) of patients with IBD-SpA and in 70 (39.8%) of patients with SpA (P less than .001).

There was a significantly lower occurrence of dactylitis reported in IBD-SpA patients without psoriasis (1 case in 74 patients; P = .001) compared with the control group, while dactylitis occurrence was not significantly different in 3 out of 14 patients (21.4%) with coexistent psoriasis (P = .960). Enthesitis was significantly higher in 14 IBD-SpA patients with associated psoriasis (50%), compared with the remaining 74 cases (12.1%; P = .003). It was noted that enthesitis occurrence was not different in patients with UC and in those with CD (P = .103).

“The results of our case-control study show that dactylitis, enthesitis, and AU are significantly less frequent in IBD-SpA, compared with other types of SpA,” researchers concluded. “Owing to the frequent association of psoriasis with IBD, and especially with CD, the coexistence of skin disease should be taken into account when evaluating the prevalence of dactylitis and enthesitis in patients with IBD-SpA.”

Find the full study in the Journal of Rheumatology (doi: 10.3899/jrheum.161518).

[email protected]

Most adults experience problems with sleep from time to time, and 6%-10% meet diagnostic criteria for chronic insomnia. Many of these patients present to their primary care clinicians looking for help. This clinical practice guideline from the American College of Physicians provides recommendations based on a review of studies published during the previous decade, which were assessed in terms of the strength of the recommendation and the quality of evidence. The guideline resulted in two recommendations:

1: All adult patients should receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia. (strong recommendation)

2: Clinicians should use a shared decision-making approach discussing the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (weak recommendation)

Cognitive behavioral therapy for insomnia (CBT-I)

Cognitive behavioral therapy for insomnia encompasses a variety of measures that aim to change patients’ habits and beliefs associated with sleep. These measures include general “sleep hygiene” interventions, as well as stimulus control, sleep restriction, relaxation training, and cognitive reframing. With sleep hygiene, patients are educated about environmental factors that affect sleep, such as avoiding caffeine late in the day, limiting alcohol intake, having a regular sleep schedule, avoiding napping, the importance of exercise, and the importance of a quiet dark room in which to sleep. Examples of stimulus control include going to bed only when sleepy, and avoiding reading and watching TV in the bedroom. Sleep restriction limits the time in bed with strict sleep and wake-up times, gradually increasing time in bed as sleep efficiency improves.

Clinicians may find it surprising that this guideline makes such a strong, clear case for the primacy of behavioral measures in the treatment of chronic insomnia. The authors make a number of points in support of this position.

First, the effects of behavioral interventions appear to be robust – at least comparable to the short-term effects of medications – and often significantly better. For example, various studies of CBT-I show a decrease in sleep onset latency (how long it takes to fall asleep after going to bed) of between 12 and 31 minutes and an increase in total sleep time of 40 minutes. This compares favorably to the short-term effects of commonly used sleep medications.

Second, the effects of behavioral interventions are long-lasting compared with medications, which are usually approved for only short-term use, lose effectiveness over time, and have no benefit at all once they’re no longer being taken. Finally, there appear to be no harms associated with CBT-I, compared with significant adverse effects of medications.

One challenge is that access to effective behavioral interventions for insomnia can be an issue. On the other hand, a number of behavioral delivery methods were examined, and found to be effective, including in-person individual or group therapy, telephone- or Web-based modules or apps, and self-help books. An editorial accompanying the guidelines calls for efforts to increase the availability of behavioral modalities for insomnia.

Pharmacologic therapy

The recommendation to use pharmacologic therapy for insomnia is much more qualified than that for CBT-I, with language about shared decision-making, discussion of risks and benefits, emphasis on short-term use, and a provision that it be used only after an unsatisfactory trial of CBT-I alone. In addition, this recommendation is classified as “weak,” and the associated evidence “low-quality.” Medications reviewed included eszopiclone, zaleplon, zolpidem, orexin receptor antagonist, melatonin, ramelteon, and benzodiazepines.

There are several reasons why pharmacologic therapy is deemphasized. First, as noted above, the effects of commonly used medications are modest. As an example, typical patients with chronic insomnia will have sleep-onset latency of 60-70 minutes. Medications reviewed for this guideline decreased this time by approximately 10-20 minutes in short-term studies, so patients still took 40-60 minutes to fall asleep. Similar modest short-term effects were seen in terms of increasing total sleep time.

A second issue with pharmacologic therapy is that while many patients with chronic insomnia seek to use medications long term, the available studies have tended to look only at short-term use, and those studies with longer duration show a diminution of medication effect over time.

Finally, there are significant adverse effects associated with sedative-hypnotic medications, including somnolence, anxiety, confusion, and disturbance in attention. This is problematic, considering that these are precisely the symptoms that patients may be hoping to avoid when they take medications to help them sleep. Even patients who may not feel impaired often show demonstrable deficits in attention and performance following use of sleep medications; this issue is reflected in the boxed warnings that accompany several commonly prescribed agents.

It is noted in the evidence reviews that there are differences among the available medications. The nonbenzodiazepine hypnotics eszopiclone and zolpidem as well as the orexin receptor antagonist suvorexant improved short-term sleep quality, though the effect was small and there was significant evidence of harm as described above. Benzodiazepine hypnotics, melatonin agonists, and antidepressants studied had little or low-quality evidence to support efficacy on improving sleep. For melatonin and ramelteon, the evidence review notes that adverse effects did not differ between the medication and the placebo groups, though two open-label longer-term studies showed evidence of adverse effects with ramelteon. It is also important to note that patients studied in medication trials were mostly healthy middle-aged individuals; it is possible that the side effects of sleep medications may be greater in those who are older or more infirm.
 

Bottom line

This guideline from the American College of Physicians strongly endorses the use of tailored cognitive behavioral therapy modalities for the initial treatment of patients with chronic insomnia. Medications are given a weak recommendation for a limited back-up role.

Dr. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

References

Qaseem A, et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125-33.

Brasure M. Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:113-24.

Wilt TJ, et al. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:103-12.

Most adults experience problems with sleep from time to time, and 6%-10% meet diagnostic criteria for chronic insomnia. Many of these patients present to their primary care clinicians looking for help. This clinical practice guideline from the American College of Physicians provides recommendations based on a review of studies published during the previous decade, which were assessed in terms of the strength of the recommendation and the quality of evidence. The guideline resulted in two recommendations:

1: All adult patients should receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia. (strong recommendation)

2: Clinicians should use a shared decision-making approach discussing the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (weak recommendation)

Cognitive behavioral therapy for insomnia (CBT-I)

Cognitive behavioral therapy for insomnia encompasses a variety of measures that aim to change patients’ habits and beliefs associated with sleep. These measures include general “sleep hygiene” interventions, as well as stimulus control, sleep restriction, relaxation training, and cognitive reframing. With sleep hygiene, patients are educated about environmental factors that affect sleep, such as avoiding caffeine late in the day, limiting alcohol intake, having a regular sleep schedule, avoiding napping, the importance of exercise, and the importance of a quiet dark room in which to sleep. Examples of stimulus control include going to bed only when sleepy, and avoiding reading and watching TV in the bedroom. Sleep restriction limits the time in bed with strict sleep and wake-up times, gradually increasing time in bed as sleep efficiency improves.

Clinicians may find it surprising that this guideline makes such a strong, clear case for the primacy of behavioral measures in the treatment of chronic insomnia. The authors make a number of points in support of this position.

First, the effects of behavioral interventions appear to be robust – at least comparable to the short-term effects of medications – and often significantly better. For example, various studies of CBT-I show a decrease in sleep onset latency (how long it takes to fall asleep after going to bed) of between 12 and 31 minutes and an increase in total sleep time of 40 minutes. This compares favorably to the short-term effects of commonly used sleep medications.

Second, the effects of behavioral interventions are long-lasting compared with medications, which are usually approved for only short-term use, lose effectiveness over time, and have no benefit at all once they’re no longer being taken. Finally, there appear to be no harms associated with CBT-I, compared with significant adverse effects of medications.

One challenge is that access to effective behavioral interventions for insomnia can be an issue. On the other hand, a number of behavioral delivery methods were examined, and found to be effective, including in-person individual or group therapy, telephone- or Web-based modules or apps, and self-help books. An editorial accompanying the guidelines calls for efforts to increase the availability of behavioral modalities for insomnia.

Pharmacologic therapy

The recommendation to use pharmacologic therapy for insomnia is much more qualified than that for CBT-I, with language about shared decision-making, discussion of risks and benefits, emphasis on short-term use, and a provision that it be used only after an unsatisfactory trial of CBT-I alone. In addition, this recommendation is classified as “weak,” and the associated evidence “low-quality.” Medications reviewed included eszopiclone, zaleplon, zolpidem, orexin receptor antagonist, melatonin, ramelteon, and benzodiazepines.

There are several reasons why pharmacologic therapy is deemphasized. First, as noted above, the effects of commonly used medications are modest. As an example, typical patients with chronic insomnia will have sleep-onset latency of 60-70 minutes. Medications reviewed for this guideline decreased this time by approximately 10-20 minutes in short-term studies, so patients still took 40-60 minutes to fall asleep. Similar modest short-term effects were seen in terms of increasing total sleep time.

A second issue with pharmacologic therapy is that while many patients with chronic insomnia seek to use medications long term, the available studies have tended to look only at short-term use, and those studies with longer duration show a diminution of medication effect over time.

Finally, there are significant adverse effects associated with sedative-hypnotic medications, including somnolence, anxiety, confusion, and disturbance in attention. This is problematic, considering that these are precisely the symptoms that patients may be hoping to avoid when they take medications to help them sleep. Even patients who may not feel impaired often show demonstrable deficits in attention and performance following use of sleep medications; this issue is reflected in the boxed warnings that accompany several commonly prescribed agents.

It is noted in the evidence reviews that there are differences among the available medications. The nonbenzodiazepine hypnotics eszopiclone and zolpidem as well as the orexin receptor antagonist suvorexant improved short-term sleep quality, though the effect was small and there was significant evidence of harm as described above. Benzodiazepine hypnotics, melatonin agonists, and antidepressants studied had little or low-quality evidence to support efficacy on improving sleep. For melatonin and ramelteon, the evidence review notes that adverse effects did not differ between the medication and the placebo groups, though two open-label longer-term studies showed evidence of adverse effects with ramelteon. It is also important to note that patients studied in medication trials were mostly healthy middle-aged individuals; it is possible that the side effects of sleep medications may be greater in those who are older or more infirm.
 

Bottom line

This guideline from the American College of Physicians strongly endorses the use of tailored cognitive behavioral therapy modalities for the initial treatment of patients with chronic insomnia. Medications are given a weak recommendation for a limited back-up role.

Dr. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

References

Qaseem A, et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125-33.

Brasure M. Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:113-24.

Wilt TJ, et al. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:103-12.

Most adults experience problems with sleep from time to time, and 6%-10% meet diagnostic criteria for chronic insomnia. Many of these patients present to their primary care clinicians looking for help. This clinical practice guideline from the American College of Physicians provides recommendations based on a review of studies published during the previous decade, which were assessed in terms of the strength of the recommendation and the quality of evidence. The guideline resulted in two recommendations:

1: All adult patients should receive cognitive behavioral therapy for insomnia (CBT-I) as the initial treatment for chronic insomnia. (strong recommendation)

2: Clinicians should use a shared decision-making approach discussing the benefits, harms, and costs of short-term use of medications, to decide whether to add pharmacological therapy in adults with chronic insomnia in whom cognitive behavioral therapy for insomnia (CBT-I) alone was unsuccessful. (weak recommendation)

Cognitive behavioral therapy for insomnia (CBT-I)

Cognitive behavioral therapy for insomnia encompasses a variety of measures that aim to change patients’ habits and beliefs associated with sleep. These measures include general “sleep hygiene” interventions, as well as stimulus control, sleep restriction, relaxation training, and cognitive reframing. With sleep hygiene, patients are educated about environmental factors that affect sleep, such as avoiding caffeine late in the day, limiting alcohol intake, having a regular sleep schedule, avoiding napping, the importance of exercise, and the importance of a quiet dark room in which to sleep. Examples of stimulus control include going to bed only when sleepy, and avoiding reading and watching TV in the bedroom. Sleep restriction limits the time in bed with strict sleep and wake-up times, gradually increasing time in bed as sleep efficiency improves.

Clinicians may find it surprising that this guideline makes such a strong, clear case for the primacy of behavioral measures in the treatment of chronic insomnia. The authors make a number of points in support of this position.

First, the effects of behavioral interventions appear to be robust – at least comparable to the short-term effects of medications – and often significantly better. For example, various studies of CBT-I show a decrease in sleep onset latency (how long it takes to fall asleep after going to bed) of between 12 and 31 minutes and an increase in total sleep time of 40 minutes. This compares favorably to the short-term effects of commonly used sleep medications.

Second, the effects of behavioral interventions are long-lasting compared with medications, which are usually approved for only short-term use, lose effectiveness over time, and have no benefit at all once they’re no longer being taken. Finally, there appear to be no harms associated with CBT-I, compared with significant adverse effects of medications.

One challenge is that access to effective behavioral interventions for insomnia can be an issue. On the other hand, a number of behavioral delivery methods were examined, and found to be effective, including in-person individual or group therapy, telephone- or Web-based modules or apps, and self-help books. An editorial accompanying the guidelines calls for efforts to increase the availability of behavioral modalities for insomnia.

Pharmacologic therapy

The recommendation to use pharmacologic therapy for insomnia is much more qualified than that for CBT-I, with language about shared decision-making, discussion of risks and benefits, emphasis on short-term use, and a provision that it be used only after an unsatisfactory trial of CBT-I alone. In addition, this recommendation is classified as “weak,” and the associated evidence “low-quality.” Medications reviewed included eszopiclone, zaleplon, zolpidem, orexin receptor antagonist, melatonin, ramelteon, and benzodiazepines.

There are several reasons why pharmacologic therapy is deemphasized. First, as noted above, the effects of commonly used medications are modest. As an example, typical patients with chronic insomnia will have sleep-onset latency of 60-70 minutes. Medications reviewed for this guideline decreased this time by approximately 10-20 minutes in short-term studies, so patients still took 40-60 minutes to fall asleep. Similar modest short-term effects were seen in terms of increasing total sleep time.

A second issue with pharmacologic therapy is that while many patients with chronic insomnia seek to use medications long term, the available studies have tended to look only at short-term use, and those studies with longer duration show a diminution of medication effect over time.

Finally, there are significant adverse effects associated with sedative-hypnotic medications, including somnolence, anxiety, confusion, and disturbance in attention. This is problematic, considering that these are precisely the symptoms that patients may be hoping to avoid when they take medications to help them sleep. Even patients who may not feel impaired often show demonstrable deficits in attention and performance following use of sleep medications; this issue is reflected in the boxed warnings that accompany several commonly prescribed agents.

It is noted in the evidence reviews that there are differences among the available medications. The nonbenzodiazepine hypnotics eszopiclone and zolpidem as well as the orexin receptor antagonist suvorexant improved short-term sleep quality, though the effect was small and there was significant evidence of harm as described above. Benzodiazepine hypnotics, melatonin agonists, and antidepressants studied had little or low-quality evidence to support efficacy on improving sleep. For melatonin and ramelteon, the evidence review notes that adverse effects did not differ between the medication and the placebo groups, though two open-label longer-term studies showed evidence of adverse effects with ramelteon. It is also important to note that patients studied in medication trials were mostly healthy middle-aged individuals; it is possible that the side effects of sleep medications may be greater in those who are older or more infirm.
 

Bottom line

This guideline from the American College of Physicians strongly endorses the use of tailored cognitive behavioral therapy modalities for the initial treatment of patients with chronic insomnia. Medications are given a weak recommendation for a limited back-up role.

Dr. Clark is associate director of the family medicine residency program at Abington (Pa.) Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Thomas Jefferson University, Philadelphia, and associate director of the family medicine residency program at Abington Jefferson Health.

References

Qaseem A, et al. Management of Chronic Insomnia Disorder in Adults: A Clinical Practice Guideline From the American College of Physicians. Ann Intern Med. 2016;165:125-33.

Brasure M. Psychological and Behavioral Interventions for Managing Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:113-24.

Wilt TJ, et al. Pharmacologic Treatment of Insomnia Disorder: An Evidence Report for a Clinical Practice Guideline by the American College of Physicians. Ann Intern Med. 2016;165:103-12.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Although the GOP-controlled Congress is pledging its continued interest – despite stalls and snags – in dismantling Obamacare, some “red state” legislatures are changing course and showing a newfound interest in embracing the health law’s Medicaid expansion.

And a study published April 12 in Health Affairs adds to these discussions, percolating in places such as Kansas, Georgia, Virginia, North Carolina, and Maine. Thirty-one states plus the District of Columbia already opted to pursue the expansion, which provided federal funding to broaden eligibility to include most low-income adults with incomes up to 138 percent of the federal poverty level (about $16,000 for an individual).

Researchers analyzed data from the National Association of State Budget Officers for fiscal years 2010-2015 to assess the fiscal effects of expansion’s first 2 years.

Their findings address arguments put forth by some GOP lawmakers, who say the expansion will add to the nation’s budget deficit and saddle states with additional coverage costs, forcing them to skimp on other budget priorities like education or transportation.

The researchers concluded that when states expanded eligibility for the low-income health insurance program they did see larger health care expenditures – but those costs were covered with federal funding. In addition, expansion states didn’t have to skimp on other policy priorities – such as environment, housing, and other public health initiatives – to make ends meet.

“This is a potential big benefit, not only to people who get coverage, but to state economies,” said Benjamin Sommers, MD, PhD, an associate professor of health policy and economics at Harvard University’s public health school, and the study’s first author.

This finding – that states expanding Medicaid didn’t encounter unforeseen budget problems – shouldn’t be surprising.

“Expansion is basically free” to the states, agreed Massachusetts Institute of Technology economist Jonathan Gruber, PhD, one of Obamacare’s architects who worked with Dr. Sommers to systematically compare the budgets of all 50 states to examine Medicaid expansion’s impact. “That’s the big insight,” he said. “There’s no sort of hidden downside.”

And that may be part of what’s fueling this renewed interest, said Edwin Park, vice president for health policy at the left-leaning Center for Budget and Policy Priorities. These states are seeing the federal windfall their neighbors received while trying to navigate public health concerns like opioid addiction, he said. They “are looking at how their neighbors or expansion states have done and see the benefits,” Mr. Park said. “The primary argument against the expansion on the state level has been it’s going to break the bank. The research demonstrates that’s not the case.”

But a caveat: The data used in this analysis reflected only years during which the federal government picked up 100% of the tab for expanding Medicaid eligibility and therefore could overestimate the benefit to state budgets. That’s because in 2017 that federal support begins to taper off, and by 2020 states have to pay 10 percent of the expansion costs themselves.

That means policymakers should exert caution in reading too much into this study, said Tom Miller, a resident fellow at the conservative American Enterprise Institute. Because states will eventually shoulder more of the cost, he said, studies that assess its budgetary impact are preliminary at best. Plus, Miller said, other factors such as relative economic growth could have padded state budgets in the years studied – masking any unintended costs with a bigger Medicaid program. It’s unclear whether in times of downturn Medicaid would take a bigger bite out of state budgets.

“It’s just the beginning of this – it’s an early snapshot,” he said.

Dr. Sommers argued the limited data set means researchers should continue to track how state budgets compare between expansion and nonexpansion states. But even when states do take on more of Medicaid’s cost, that may not pose such a burden, suggested Sara Rosenbaum, a professor of health law and policy at George Washington University. Expanding Medicaid brings in other potential economic benefits that this paper doesn’t account for – less uncompensated care in hospitals, for instance – that could offset the expenditures states ultimately take up.

A bigger concern, some experts say, is that – even without the Obamacare repeal – some GOP health proposals would change the federal government’s Medicaid funding mechanism from being an open-ended match to a block grant or per-capita cap in an effort to curb national spending. Those proposals would take away at least some of the federal dollars that have insulated state budgets.

“Ironically, all the arguments that have been made against expansion for years – like creating a hole in the state budget or breaking the bank – that’s exactly what a per-capita grant or block grant does,” Park said.

As more states take on the Medicaid debate, those consequences matter, both Dr. Sommers and Dr. Gruber said. And not just for state budgets – for consumers, too.

“The main lesson is there’s no sort of big hidden cost of expanding Medicaid. What you see is what you get,” Dr. Gruber said. “You get free health insurance for your citizens.”
 

Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.

Physical frailty negatively affects the course of late-life depression and requires multifaceted interventions, according to a new analysis from a study of depression in seniors.

Researchers in the Netherlands worked with participants from the Netherlands Study of Depression in Older Persons, an ongoing cohort study of people aged 60-93 years who have been diagnosed with a depressive disorder.

From the cohort, the researchers examined 285 participants for a 2-year period with physical tests (such as a walking test and a hand grip strength test) and questionnaires aimed at assessing the course of participants’ depression and their physical health.

“The present study, to our knowledge, is the first to examine the longitudinal association between physical frailty and the course of depression in a sample of clinically depressed older persons,” wrote Rose M. Collard, PhD, of the department of psychiatry at Radboud University Medical Center, Nijmegen, the Netherlands, and her coauthors (Eur Psychiatry. 2017 Jan 24;43:66-72). “Our results confirm that late-life depression is a highly persisting disorder, with half of the patients not achieving remission at 2-year follow-up.”

More “performance-based” frailty was associated with nonremission of depression, while “vitality-based” frailty was associated with remission.

The authors commented that “this latter result puzzled us, but a possible explanation might be that the vitality-based dimension of frailty reflects a classic, uncomplicated clinical depression,” which is more treatable.

[email protected]

Physical frailty negatively affects the course of late-life depression and requires multifaceted interventions, according to a new analysis from a study of depression in seniors.

Researchers in the Netherlands worked with participants from the Netherlands Study of Depression in Older Persons, an ongoing cohort study of people aged 60-93 years who have been diagnosed with a depressive disorder.

From the cohort, the researchers examined 285 participants for a 2-year period with physical tests (such as a walking test and a hand grip strength test) and questionnaires aimed at assessing the course of participants’ depression and their physical health.

“The present study, to our knowledge, is the first to examine the longitudinal association between physical frailty and the course of depression in a sample of clinically depressed older persons,” wrote Rose M. Collard, PhD, of the department of psychiatry at Radboud University Medical Center, Nijmegen, the Netherlands, and her coauthors (Eur Psychiatry. 2017 Jan 24;43:66-72). “Our results confirm that late-life depression is a highly persisting disorder, with half of the patients not achieving remission at 2-year follow-up.”

More “performance-based” frailty was associated with nonremission of depression, while “vitality-based” frailty was associated with remission.

The authors commented that “this latter result puzzled us, but a possible explanation might be that the vitality-based dimension of frailty reflects a classic, uncomplicated clinical depression,” which is more treatable.

[email protected]

Physical frailty negatively affects the course of late-life depression and requires multifaceted interventions, according to a new analysis from a study of depression in seniors.

Researchers in the Netherlands worked with participants from the Netherlands Study of Depression in Older Persons, an ongoing cohort study of people aged 60-93 years who have been diagnosed with a depressive disorder.

From the cohort, the researchers examined 285 participants for a 2-year period with physical tests (such as a walking test and a hand grip strength test) and questionnaires aimed at assessing the course of participants’ depression and their physical health.

“The present study, to our knowledge, is the first to examine the longitudinal association between physical frailty and the course of depression in a sample of clinically depressed older persons,” wrote Rose M. Collard, PhD, of the department of psychiatry at Radboud University Medical Center, Nijmegen, the Netherlands, and her coauthors (Eur Psychiatry. 2017 Jan 24;43:66-72). “Our results confirm that late-life depression is a highly persisting disorder, with half of the patients not achieving remission at 2-year follow-up.”

More “performance-based” frailty was associated with nonremission of depression, while “vitality-based” frailty was associated with remission.

The authors commented that “this latter result puzzled us, but a possible explanation might be that the vitality-based dimension of frailty reflects a classic, uncomplicated clinical depression,” which is more treatable.

[email protected]

Initiating disease-modifying antirheumatic drugs within 6 months of a diagnosis of rheumatoid arthritis is associated with significantly lower disability scores over the long term, new research suggests.

Better diagnosis and access to early treatment has also likely played a role in a global decline in mortality from rheumatoid arthritis over a recent 25-year period, according to an analysis of World Health Organization and United Nations data, but the decline has occurred unequally across countries.

Impact of early treatment on disability

In the first of two separate studies published online April 20 in Arthritis & Rheumatology, U.K. researchers followed 602 patients from the Norfolk Arthritis Register for 20 years, starting in 1990-1994, and collected clinical data at baseline and years 1-3, 5, 7, 10, 15, and 20.

PositiveFocus/Thinkstock

An uneven global decline in mortality from RA

Meanwhile, a second study showed that mortality from rheumatoid arthritis declined globally across 31 countries from 1987 to 2011, according to data from the World Health Organization mortality database and the United Nations.

The absolute number of deaths where rheumatoid arthritis was registered as the underlying cause of death declined from 0.12% of all-cause deaths in 1987 to 0.09% of all-cause deaths in 2011 (Arthritis Rheumatol. 2017 April 20. doi: 10.1002/art.40091).

The mean age-standardized mortality rate declined by 48.2%, from 7.1 per million person-years in 1987-1989 to 3.7 in 2009-2011.

However, there was considerable variation between countries; the greatest reduction was seen in Finland, which had an absolute reduction of 20.6 fewer deaths per million person-years, while Croatia had an increase of 3.7 deaths per million person-years.

Younger people with rheumatoid arthritis showed the greatest reductions in mortality, while those in older age groups had smaller reductions in mortality.

“It has been suggested that changes in the management of RA toward early and aggressive treatment with disease-modifying antirheumatic drugs and subsequent biologic therapies has led to better health status and lower mortality for most people with RA over time,” wrote first author Aliasghar A. Kiadaliri, PhD, of Lund (Sweden) University, and his coauthors.

“These findings alongside aging of the population and fall in mortality may lead to an increase in the number of people with RA. Given that it appears that people with RA are now living longer, increase in burden of RA on health care systems is expected and policy makers should be made aware about to appropriately plan for this anticipated increase.”

The first study was supported by Arthritis Research UK. The second study was supported by the Swedish Research Council, Crafoord Foundation, Greta and Johan Kocks Foundation, the Faculty of Medicine Lund University, governmental funding of clinical research within Sweden’s National Health Service. No conflicts of interest were declared for either paper.

Initiating disease-modifying antirheumatic drugs within 6 months of a diagnosis of rheumatoid arthritis is associated with significantly lower disability scores over the long term, new research suggests.

Better diagnosis and access to early treatment has also likely played a role in a global decline in mortality from rheumatoid arthritis over a recent 25-year period, according to an analysis of World Health Organization and United Nations data, but the decline has occurred unequally across countries.

Impact of early treatment on disability

In the first of two separate studies published online April 20 in Arthritis & Rheumatology, U.K. researchers followed 602 patients from the Norfolk Arthritis Register for 20 years, starting in 1990-1994, and collected clinical data at baseline and years 1-3, 5, 7, 10, 15, and 20.

PositiveFocus/Thinkstock

An uneven global decline in mortality from RA

Meanwhile, a second study showed that mortality from rheumatoid arthritis declined globally across 31 countries from 1987 to 2011, according to data from the World Health Organization mortality database and the United Nations.

The absolute number of deaths where rheumatoid arthritis was registered as the underlying cause of death declined from 0.12% of all-cause deaths in 1987 to 0.09% of all-cause deaths in 2011 (Arthritis Rheumatol. 2017 April 20. doi: 10.1002/art.40091).

The mean age-standardized mortality rate declined by 48.2%, from 7.1 per million person-years in 1987-1989 to 3.7 in 2009-2011.

However, there was considerable variation between countries; the greatest reduction was seen in Finland, which had an absolute reduction of 20.6 fewer deaths per million person-years, while Croatia had an increase of 3.7 deaths per million person-years.

Younger people with rheumatoid arthritis showed the greatest reductions in mortality, while those in older age groups had smaller reductions in mortality.

“It has been suggested that changes in the management of RA toward early and aggressive treatment with disease-modifying antirheumatic drugs and subsequent biologic therapies has led to better health status and lower mortality for most people with RA over time,” wrote first author Aliasghar A. Kiadaliri, PhD, of Lund (Sweden) University, and his coauthors.

“These findings alongside aging of the population and fall in mortality may lead to an increase in the number of people with RA. Given that it appears that people with RA are now living longer, increase in burden of RA on health care systems is expected and policy makers should be made aware about to appropriately plan for this anticipated increase.”

The first study was supported by Arthritis Research UK. The second study was supported by the Swedish Research Council, Crafoord Foundation, Greta and Johan Kocks Foundation, the Faculty of Medicine Lund University, governmental funding of clinical research within Sweden’s National Health Service. No conflicts of interest were declared for either paper.

Initiating disease-modifying antirheumatic drugs within 6 months of a diagnosis of rheumatoid arthritis is associated with significantly lower disability scores over the long term, new research suggests.

Better diagnosis and access to early treatment has also likely played a role in a global decline in mortality from rheumatoid arthritis over a recent 25-year period, according to an analysis of World Health Organization and United Nations data, but the decline has occurred unequally across countries.

Impact of early treatment on disability

In the first of two separate studies published online April 20 in Arthritis & Rheumatology, U.K. researchers followed 602 patients from the Norfolk Arthritis Register for 20 years, starting in 1990-1994, and collected clinical data at baseline and years 1-3, 5, 7, 10, 15, and 20.

PositiveFocus/Thinkstock

An uneven global decline in mortality from RA

Meanwhile, a second study showed that mortality from rheumatoid arthritis declined globally across 31 countries from 1987 to 2011, according to data from the World Health Organization mortality database and the United Nations.

The absolute number of deaths where rheumatoid arthritis was registered as the underlying cause of death declined from 0.12% of all-cause deaths in 1987 to 0.09% of all-cause deaths in 2011 (Arthritis Rheumatol. 2017 April 20. doi: 10.1002/art.40091).

The mean age-standardized mortality rate declined by 48.2%, from 7.1 per million person-years in 1987-1989 to 3.7 in 2009-2011.

However, there was considerable variation between countries; the greatest reduction was seen in Finland, which had an absolute reduction of 20.6 fewer deaths per million person-years, while Croatia had an increase of 3.7 deaths per million person-years.

Younger people with rheumatoid arthritis showed the greatest reductions in mortality, while those in older age groups had smaller reductions in mortality.

“It has been suggested that changes in the management of RA toward early and aggressive treatment with disease-modifying antirheumatic drugs and subsequent biologic therapies has led to better health status and lower mortality for most people with RA over time,” wrote first author Aliasghar A. Kiadaliri, PhD, of Lund (Sweden) University, and his coauthors.

“These findings alongside aging of the population and fall in mortality may lead to an increase in the number of people with RA. Given that it appears that people with RA are now living longer, increase in burden of RA on health care systems is expected and policy makers should be made aware about to appropriately plan for this anticipated increase.”

The first study was supported by Arthritis Research UK. The second study was supported by the Swedish Research Council, Crafoord Foundation, Greta and Johan Kocks Foundation, the Faculty of Medicine Lund University, governmental funding of clinical research within Sweden’s National Health Service. No conflicts of interest were declared for either paper.

SAN DIEGO – If you consider participating in an alternative payment model for your practice, expect to devote a lot of time to work flow changes, according to Blase N. Polite, MD.

“The culture change is one of the hardest things people face as they go into alternative payment models,” Dr. Polite, deputy section chief of clinical operations at the University of Chicago Medical Center, said at the annual meeting of the American College of Physicians.

“You want work flow changes designed to enable you to take better care of your patients in a consistent manner,” he noted. “It has to be designed with a busy clinic and a busy clinician in mind. You want to be able to share the work flow burden among different groups in the system, so it’s important to allow individuals to work at the upper end of their training.”

[email protected]

SAN DIEGO – If you consider participating in an alternative payment model for your practice, expect to devote a lot of time to work flow changes, according to Blase N. Polite, MD.

“The culture change is one of the hardest things people face as they go into alternative payment models,” Dr. Polite, deputy section chief of clinical operations at the University of Chicago Medical Center, said at the annual meeting of the American College of Physicians.

“You want work flow changes designed to enable you to take better care of your patients in a consistent manner,” he noted. “It has to be designed with a busy clinic and a busy clinician in mind. You want to be able to share the work flow burden among different groups in the system, so it’s important to allow individuals to work at the upper end of their training.”

[email protected]

SAN DIEGO – If you consider participating in an alternative payment model for your practice, expect to devote a lot of time to work flow changes, according to Blase N. Polite, MD.

“The culture change is one of the hardest things people face as they go into alternative payment models,” Dr. Polite, deputy section chief of clinical operations at the University of Chicago Medical Center, said at the annual meeting of the American College of Physicians.

“You want work flow changes designed to enable you to take better care of your patients in a consistent manner,” he noted. “It has to be designed with a busy clinic and a busy clinician in mind. You want to be able to share the work flow burden among different groups in the system, so it’s important to allow individuals to work at the upper end of their training.”

[email protected]

To the Editor:

Atopic dermatitis (AD) is a common skin condition with an increasing prevalence, affecting up to 20% of children and 3% of adults.^1,2 More than 80% of patients with AD have elevated IgE levels.^3,4 IgE modulates the inflammatory response in AD in several ways including “a biphasic immediate/late phase reaction, allergen presentation by IgE-bearing Langerhans cells, allergen-induced activation of IgE-bearing macrophages, and IgE autoreactivity to human proteins.”⁵ Historically, most therapies have focused on mitigating the allergic symptoms caused by degranulated effector cells, such as antihistamines. However, a new class of biologically engineered medications (eg, anti-IgE [omalizumab]) aim to prevent the initiation of the allergic response.⁶ Variable success has been reported using omalizumab in the treatment of AD, though the majority of studies have shown improvement, especially when used in combination with conventional therapies.^4,5,7-22 Omalizumab dosage is determined by body weight and pretreatment serum total IgE levels and is administered via subcutaneous injections every 2 to 4 weeks.^6,7,23-26 However, the dosing tables are based on asthma therapy, in which serum IgE levels may be much lower than chronic AD,^7,24 and the appropriate dosage in AD patients with markedly elevated IgE is unclear. We report an interesting case of a 57-year-old man with erythroderma from long-standing severe chronic AD that was unresponsive to conventional therapy as well as an associated serum IgE level of 17,183 IU/mL who dramatically improved when omalizumab was added to his treatment regimen.

A 57-year-old man presented with essentially 100% body surface area involvement of AD with erythroderma and pruritus. Severe AD developed at infancy and cleared at 5 years of age; childhood onset of asthma was responsive to theophylline and oral inhalers. He developed recurrent AD and asthma at 38 years of age, which was progressive and developed into severe recalcitrant erythroderma by 50 years of age. His AD was unresponsive to multiple therapies, including topical steroids, antibiotics, tacrolimus, bleach baths, antihistamines, methotrexate (15 mg weekly for 1 year, then 12.5 mg weekly for 6 months), UVB phototherapy, and psoralen plus UVA photochemotherapy. He had minimal improvement with cyclosporine (200 mg daily for 4 weeks) and mycophenolate mofetil (3 g daily), and required systemic steroids for relief. The skin was violaceous and lichenified (Figure, A). Laboratory studies were normal, except for a serum IgE level of 17,183 IU/mL (reference range, <150 IU/mL) and peripheral blood eosinophilia up to 29.8% (reference range, 1%–5%) of the differential. Skin biopsies showed AD progressing to lichen simplex chronicus. Omalizumab was added to the therapeutic regimen at a dose of 375 mg every 2 weeks, with noticeable improvement after 3 months. The patient had approximately 80% to 90% clearing with resolution of erythroderma and pruritus, and only limited residual lichenification (Figure, B). The mycophenolate was tapered slowly, and the patient experienced a mild flare at 1 g daily. He is presently on 1 g of mycophenolate daily and omalizumab (375 mg every 2 weeks) and remains remarkably improved. His IgE level decreased to 11,983 IU/mL.

Omalizumab is a monoclonal IgG1 antibody that specifically binds to the FcεRI domain of serum IgE. It blocks binding to high-affinity receptors on effector cells, primarily mast cells, basophils, macrophages, and dendritic cells; it also decreases free IgE serum levels and downregulates the IgE receptor.^{4,6-10,23-25,27,28} Currently, omalizumab is US Food and Drug Administration approved for moderate to severe persistent asthma in patients 6 years or older with a positive aeroallergen skin test and IgE levels up to 700 IU/mL.^{6,7,23-25,27,28}

However, scattered case reports and small case series have described variable success in the treatment of severe AD that is unresponsive to conventional therapy in patients with markedly elevated serum IgE levels.^4,5,7-22 The majority of patients (approximately 80% of published cases yielded by a PubMed search of articles indexed for MEDLINE using the search terms omalizumab and atopic dermatitis) showed improvement when measured by clinical severity scores and quality of life improvement, especially when used in conjunction with conventional therapy. Possible reasons for reported treatment failure include insufficient dosage, lack of established treatment guidelines for markedly elevated serum IgE levels, severity of disease, or variable response with failure to lower IgE level below a required threshold.^7,9,23,24,27

Krathen and Hsu⁹ reported treatment failure with omalizumab for AD in 3 patients with serum IgE levels ranging from 5440 and 24,400 IU/mL, and one review indicated omalizumab may work best in patients with only moderately elevated serum IgE levels.²¹ However, Toledo et al¹⁸ reported efficacy of low-dose omalizumab for pretreatment IgE levels up to 30,000 IU/mL in 6 of 11 reported cases. The pretreatment serum IgE level is not predictive of response, and lowering the serum IgE level without normalization can be efficacious,^12,23 as in the current case. Serum IgE levels are not used for monitoring therapeutic response or calculating future dosing, given potential increases in serum IgE levels during and after therapy (for up to 12 months) secondary to the formation of anti-IgE:IgE complexes.^6,28 Omalizumab appears most effective when used in combination with conventional therapies. Hopefully ongoing studies will further elucidate the role of omalizumab in recalcitrant AD with elevated serum IgE levels.

To the Editor:

Atopic dermatitis (AD) is a common skin condition with an increasing prevalence, affecting up to 20% of children and 3% of adults.^1,2 More than 80% of patients with AD have elevated IgE levels.^3,4 IgE modulates the inflammatory response in AD in several ways including “a biphasic immediate/late phase reaction, allergen presentation by IgE-bearing Langerhans cells, allergen-induced activation of IgE-bearing macrophages, and IgE autoreactivity to human proteins.”⁵ Historically, most therapies have focused on mitigating the allergic symptoms caused by degranulated effector cells, such as antihistamines. However, a new class of biologically engineered medications (eg, anti-IgE [omalizumab]) aim to prevent the initiation of the allergic response.⁶ Variable success has been reported using omalizumab in the treatment of AD, though the majority of studies have shown improvement, especially when used in combination with conventional therapies.^4,5,7-22 Omalizumab dosage is determined by body weight and pretreatment serum total IgE levels and is administered via subcutaneous injections every 2 to 4 weeks.^6,7,23-26 However, the dosing tables are based on asthma therapy, in which serum IgE levels may be much lower than chronic AD,^7,24 and the appropriate dosage in AD patients with markedly elevated IgE is unclear. We report an interesting case of a 57-year-old man with erythroderma from long-standing severe chronic AD that was unresponsive to conventional therapy as well as an associated serum IgE level of 17,183 IU/mL who dramatically improved when omalizumab was added to his treatment regimen.

A 57-year-old man presented with essentially 100% body surface area involvement of AD with erythroderma and pruritus. Severe AD developed at infancy and cleared at 5 years of age; childhood onset of asthma was responsive to theophylline and oral inhalers. He developed recurrent AD and asthma at 38 years of age, which was progressive and developed into severe recalcitrant erythroderma by 50 years of age. His AD was unresponsive to multiple therapies, including topical steroids, antibiotics, tacrolimus, bleach baths, antihistamines, methotrexate (15 mg weekly for 1 year, then 12.5 mg weekly for 6 months), UVB phototherapy, and psoralen plus UVA photochemotherapy. He had minimal improvement with cyclosporine (200 mg daily for 4 weeks) and mycophenolate mofetil (3 g daily), and required systemic steroids for relief. The skin was violaceous and lichenified (Figure, A). Laboratory studies were normal, except for a serum IgE level of 17,183 IU/mL (reference range, <150 IU/mL) and peripheral blood eosinophilia up to 29.8% (reference range, 1%–5%) of the differential. Skin biopsies showed AD progressing to lichen simplex chronicus. Omalizumab was added to the therapeutic regimen at a dose of 375 mg every 2 weeks, with noticeable improvement after 3 months. The patient had approximately 80% to 90% clearing with resolution of erythroderma and pruritus, and only limited residual lichenification (Figure, B). The mycophenolate was tapered slowly, and the patient experienced a mild flare at 1 g daily. He is presently on 1 g of mycophenolate daily and omalizumab (375 mg every 2 weeks) and remains remarkably improved. His IgE level decreased to 11,983 IU/mL.

Omalizumab is a monoclonal IgG1 antibody that specifically binds to the FcεRI domain of serum IgE. It blocks binding to high-affinity receptors on effector cells, primarily mast cells, basophils, macrophages, and dendritic cells; it also decreases free IgE serum levels and downregulates the IgE receptor.^{4,6-10,23-25,27,28} Currently, omalizumab is US Food and Drug Administration approved for moderate to severe persistent asthma in patients 6 years or older with a positive aeroallergen skin test and IgE levels up to 700 IU/mL.^{6,7,23-25,27,28}

However, scattered case reports and small case series have described variable success in the treatment of severe AD that is unresponsive to conventional therapy in patients with markedly elevated serum IgE levels.^4,5,7-22 The majority of patients (approximately 80% of published cases yielded by a PubMed search of articles indexed for MEDLINE using the search terms omalizumab and atopic dermatitis) showed improvement when measured by clinical severity scores and quality of life improvement, especially when used in conjunction with conventional therapy. Possible reasons for reported treatment failure include insufficient dosage, lack of established treatment guidelines for markedly elevated serum IgE levels, severity of disease, or variable response with failure to lower IgE level below a required threshold.^7,9,23,24,27

Krathen and Hsu⁹ reported treatment failure with omalizumab for AD in 3 patients with serum IgE levels ranging from 5440 and 24,400 IU/mL, and one review indicated omalizumab may work best in patients with only moderately elevated serum IgE levels.²¹ However, Toledo et al¹⁸ reported efficacy of low-dose omalizumab for pretreatment IgE levels up to 30,000 IU/mL in 6 of 11 reported cases. The pretreatment serum IgE level is not predictive of response, and lowering the serum IgE level without normalization can be efficacious,^12,23 as in the current case. Serum IgE levels are not used for monitoring therapeutic response or calculating future dosing, given potential increases in serum IgE levels during and after therapy (for up to 12 months) secondary to the formation of anti-IgE:IgE complexes.^6,28 Omalizumab appears most effective when used in combination with conventional therapies. Hopefully ongoing studies will further elucidate the role of omalizumab in recalcitrant AD with elevated serum IgE levels.

To the Editor:

Atopic dermatitis (AD) is a common skin condition with an increasing prevalence, affecting up to 20% of children and 3% of adults.^1,2 More than 80% of patients with AD have elevated IgE levels.^3,4 IgE modulates the inflammatory response in AD in several ways including “a biphasic immediate/late phase reaction, allergen presentation by IgE-bearing Langerhans cells, allergen-induced activation of IgE-bearing macrophages, and IgE autoreactivity to human proteins.”⁵ Historically, most therapies have focused on mitigating the allergic symptoms caused by degranulated effector cells, such as antihistamines. However, a new class of biologically engineered medications (eg, anti-IgE [omalizumab]) aim to prevent the initiation of the allergic response.⁶ Variable success has been reported using omalizumab in the treatment of AD, though the majority of studies have shown improvement, especially when used in combination with conventional therapies.^4,5,7-22 Omalizumab dosage is determined by body weight and pretreatment serum total IgE levels and is administered via subcutaneous injections every 2 to 4 weeks.^6,7,23-26 However, the dosing tables are based on asthma therapy, in which serum IgE levels may be much lower than chronic AD,^7,24 and the appropriate dosage in AD patients with markedly elevated IgE is unclear. We report an interesting case of a 57-year-old man with erythroderma from long-standing severe chronic AD that was unresponsive to conventional therapy as well as an associated serum IgE level of 17,183 IU/mL who dramatically improved when omalizumab was added to his treatment regimen.

A 57-year-old man presented with essentially 100% body surface area involvement of AD with erythroderma and pruritus. Severe AD developed at infancy and cleared at 5 years of age; childhood onset of asthma was responsive to theophylline and oral inhalers. He developed recurrent AD and asthma at 38 years of age, which was progressive and developed into severe recalcitrant erythroderma by 50 years of age. His AD was unresponsive to multiple therapies, including topical steroids, antibiotics, tacrolimus, bleach baths, antihistamines, methotrexate (15 mg weekly for 1 year, then 12.5 mg weekly for 6 months), UVB phototherapy, and psoralen plus UVA photochemotherapy. He had minimal improvement with cyclosporine (200 mg daily for 4 weeks) and mycophenolate mofetil (3 g daily), and required systemic steroids for relief. The skin was violaceous and lichenified (Figure, A). Laboratory studies were normal, except for a serum IgE level of 17,183 IU/mL (reference range, <150 IU/mL) and peripheral blood eosinophilia up to 29.8% (reference range, 1%–5%) of the differential. Skin biopsies showed AD progressing to lichen simplex chronicus. Omalizumab was added to the therapeutic regimen at a dose of 375 mg every 2 weeks, with noticeable improvement after 3 months. The patient had approximately 80% to 90% clearing with resolution of erythroderma and pruritus, and only limited residual lichenification (Figure, B). The mycophenolate was tapered slowly, and the patient experienced a mild flare at 1 g daily. He is presently on 1 g of mycophenolate daily and omalizumab (375 mg every 2 weeks) and remains remarkably improved. His IgE level decreased to 11,983 IU/mL.

Omalizumab is a monoclonal IgG1 antibody that specifically binds to the FcεRI domain of serum IgE. It blocks binding to high-affinity receptors on effector cells, primarily mast cells, basophils, macrophages, and dendritic cells; it also decreases free IgE serum levels and downregulates the IgE receptor.^{4,6-10,23-25,27,28} Currently, omalizumab is US Food and Drug Administration approved for moderate to severe persistent asthma in patients 6 years or older with a positive aeroallergen skin test and IgE levels up to 700 IU/mL.^{6,7,23-25,27,28}

However, scattered case reports and small case series have described variable success in the treatment of severe AD that is unresponsive to conventional therapy in patients with markedly elevated serum IgE levels.^4,5,7-22 The majority of patients (approximately 80% of published cases yielded by a PubMed search of articles indexed for MEDLINE using the search terms omalizumab and atopic dermatitis) showed improvement when measured by clinical severity scores and quality of life improvement, especially when used in conjunction with conventional therapy. Possible reasons for reported treatment failure include insufficient dosage, lack of established treatment guidelines for markedly elevated serum IgE levels, severity of disease, or variable response with failure to lower IgE level below a required threshold.^7,9,23,24,27

Krathen and Hsu⁹ reported treatment failure with omalizumab for AD in 3 patients with serum IgE levels ranging from 5440 and 24,400 IU/mL, and one review indicated omalizumab may work best in patients with only moderately elevated serum IgE levels.²¹ However, Toledo et al¹⁸ reported efficacy of low-dose omalizumab for pretreatment IgE levels up to 30,000 IU/mL in 6 of 11 reported cases. The pretreatment serum IgE level is not predictive of response, and lowering the serum IgE level without normalization can be efficacious,^12,23 as in the current case. Serum IgE levels are not used for monitoring therapeutic response or calculating future dosing, given potential increases in serum IgE levels during and after therapy (for up to 12 months) secondary to the formation of anti-IgE:IgE complexes.^6,28 Omalizumab appears most effective when used in combination with conventional therapies. Hopefully ongoing studies will further elucidate the role of omalizumab in recalcitrant AD with elevated serum IgE levels.