Caring for veterans at the end of their lives is a great honor. The US Department of Veterans Affairs (VA) health care professionals (HCPs) find meaning and take pride in providing this care. We are there to support the patient and their family and loved ones around the time of death. When our patients die, we feel the loss and grieve as well. VA health care providers look to our teams to set up rituals that pay tribute to the veteran and to show respect and gratitude for our role in these moments. It is important to recognize the bonds we share and the grief we feel when a veteran dies. The relationships we form, the recognition of loss, and the honoring of the veterans help nourish and maintain us.

Although the number of VA inpatient deaths nationwide has been declining steadily for years, internal reporting by the Palliative and Hospice Care Program Office has shown that the percentage of VA inpatient deaths that occur in hospice settings has steadily grown. Since 2013, more veterans die in VA inpatient hospice beds than in any other hospital setting. Therefore, it is useful to take stock of the way hospice and palliative care providers and staff process and provide support so that they can continue to provide service to veterans.

In the same way that all loss and grief are unique, there are many diverse rituals across VA facilities. This article highlights some of the unique traditions that hospice and palliative care teams have adopted to embrace this remembrance. We hope that by sharing these practices others will be inspired to find ways to reflect on their work and honor the lives of veterans.

The authors reached out to VA palliative care colleagues across the country via the Veterans Health Administration National Hospice and Palliative Care listserve to ask: How does your team practice remembrance? Palliative care providers responded and shared the unique ways they and their teams reflect on these losses.

There are many moments for reflection from the time of death to the weeks and months after, to the entire year of cumulative loss. Some observances start around the time of death. Susan MacDonald, RN, GEC, from Erie VA Medical Center (VAMC) in Pennsylvania reported that following the death of a veteran in the hospice unit, there is a bedside remembrance that includes the chaplain, care team, family, and other loved ones. At the John D. Dingell VAMC in Detroit, Michigan, the clinical chaplain leads a memorial service after a community living center (CLC) resident dies.

Several VAMCs, such as Detroit and Erie, have an Honors Escort or Final Salute. In these ceremonies, family, employees, residents, and other veterans line the hallways to honor the veteran on their departure from the building.¹ At the VA Maine Healthcare System, Kate MacFawn, nurse manager, Inpatient Hospice Unit, explained, “We debrief every death the day after it occurs. The doc[tor]s check in with the nursing staff on each shift, and the rest of the multidisciplinary team discusses [it] in our morning report.”

Palliative care providers consider the physical spaces where the veteran has spent those last moments and the void that is left. Karen Pickler, staff chaplain at Northport VAMC Hospice Unit recounts:

At the time of death, we decorate the tray table with the veteran’s picture, a flag, and an angel. In the CLC they will have a memorial service on Friday if a resident has died that week. This is for the unit and staff. In the past, other residents were not informed of the death. This way, the relationships between residents are honored as well as their natural families.

At VA Boston Healthcare System (VABHS) in Massachusetts in the Inpatient Hospice Unit-CLC, after a veteran dies, a flag, a strand of lights, and a rose in a vase are placed outside the veteran’s room to mark the absence. The VABHS remembrance practice has evolved over time based on input from the team. According to Noah Whiddon, LICSW, CLC complex case coordinator, at a weekly interdisciplinary team (IDT) meeting, the names of veterans who have died in the past week are read, and there is a commemorative ribbon cutting. “Any team member may write the last name of the deceased veteran on the ribbon and place it into a vase,” he said. “One of the nurse team members felt that a moment of silence would be appropriate, and we have added that.”

Every 6 months, VABHS holds a flag burning ceremony to appropriately dispose of worn out flags. Veterans and families are invited. The commemorative ribbons are packaged and burned at this ceremony with the following explanation of the ritual:

We’d like to take a moment to reflect on the lives of veterans we’ve lost in the last 6 months. Each week we remember the veterans for whom we have cared who have passed away. As part of this, we cut a ribbon and inscribe their name on it to commemorate their memory. We might have known these veterans for a few days or for a few years, but each of their lives had meaning for us. The courage that our veterans demonstrate at the end of their lives is an extension of the bravery they displayed in their service to our country. Today we will burn their commemorative ribbons with our country’s flag in tribute to and respect for their selflessness to our country. Please join us in a few moments of silence as their ribbons burn together with our flag.

In the VABHS acute care hospital, the palliative care IDT reserves 30 minutes, twice monthly for a chaplain-led remembrance. A large bowl-shaped shell is placed in the center of the table with smaller shells around it. Any team member can read the names of veterans who have died in prior weeks and share a memory of the patient or family, and then place a smaller shell into the larger bowl. This represents the transition from the smallest part of the universe back into the larger part. At the end, a moment of silence is observed or a poem is read. This tradition was brought to the team by the palliative care chaplain, Douglas Falls, MDiv.

Bimonthly bereavement meetings are held at the James A. Haley Veterans’ Hospital-Pasco County branch, and each veteran who has died is remembered. Whoever wants to share is welcome. “We conclude with a poem, usually shared by the physician, but it can be any team member,” explained Linda Falzetta-Gross, ARNP-BC. “This process is led by the team social worker. In the past, we used to ring a bell prior to each name.”

Bells also are used at the Greater West Los Angeles VAMC in California. At the weekly clinic, veterans who have died are remembered, and each team member has an opportunity to share memories. “We ring a Tibetan bell for a moment without words,” explains Geoffrey Tyrell, palliative care chaplain. “It is introduced with a few words to allow new staff members in our clinic to participate, as a moment of mindfulness to let go of our words and to go inside, to see what we might need for our own wellness.” Afterward the chaplain says a few words and wishes for peace for the veterans and their families. The team also has responded well to more participatory group activities, such as placing rocks in a bowl of water, to symbolize letting go of something that has been difficult.

Additionally, there are practices of a larger scope. Many VAMCs have established facility-wide memorial services annually, biannually, or quarterly. At this time, families and staff come together to remember and honor veterans who have died within the VAMC. These memorials might involve a variety of service lines, such as chaplaincy, voluntary services, nursing, and social work and may consist of an honor guard, music, and readings. In accordance with the Health Insurance Portability and Accountability Act (HIPAA) and privacy regulations, only family members of deceased veterans may speak the names at the ceremony unless written consent is given. At the Tennessee Valley Healthcare System in Nashville, family members may stand and give the name of the person they are honoring. Balloons are released, stories are told, and a poem or appropriate passage is read. Families are given a book pinned with a flag, according to Jennifer C. Crenshaw, clinical staff chaplain. Family members are moved knowing that the VA remembers their loved ones even months after they are gone.

Due to the overwhelming positive feedback from veterans’ families who participated in these ceremonies, on January 24, 2018, Carolyn Clancy, MD, VHA Executive-in-Charge, Office of the Under Secretary for Health issued a memorandum requesting that all VAMCs immediately adopt this best practice: to host periodic ceremonies to publicly recognize and honor deceased veterans in the presence of their families, VA care providers, veterans service organizations and community members. Clancy recommended calling the ceremonies “The Last Roll Call Ceremony of Remembrance.”²

These rituals are a small sample of the rich diversity of practice in VAs across the country. What unifies VA palliative care providers is our mission to serve the veterans, honor their deaths, show respect and gratitude, and recognize that we, too, feel the pain of loss. We mark these moments with solemnity and beauty—a bell, a poem, a prayer—to honor our shared experience caring for veterans.

Caring for veterans at the end of their lives is a great honor. The US Department of Veterans Affairs (VA) health care professionals (HCPs) find meaning and take pride in providing this care. We are there to support the patient and their family and loved ones around the time of death. When our patients die, we feel the loss and grieve as well. VA health care providers look to our teams to set up rituals that pay tribute to the veteran and to show respect and gratitude for our role in these moments. It is important to recognize the bonds we share and the grief we feel when a veteran dies. The relationships we form, the recognition of loss, and the honoring of the veterans help nourish and maintain us.

Although the number of VA inpatient deaths nationwide has been declining steadily for years, internal reporting by the Palliative and Hospice Care Program Office has shown that the percentage of VA inpatient deaths that occur in hospice settings has steadily grown. Since 2013, more veterans die in VA inpatient hospice beds than in any other hospital setting. Therefore, it is useful to take stock of the way hospice and palliative care providers and staff process and provide support so that they can continue to provide service to veterans.

In the same way that all loss and grief are unique, there are many diverse rituals across VA facilities. This article highlights some of the unique traditions that hospice and palliative care teams have adopted to embrace this remembrance. We hope that by sharing these practices others will be inspired to find ways to reflect on their work and honor the lives of veterans.

The authors reached out to VA palliative care colleagues across the country via the Veterans Health Administration National Hospice and Palliative Care listserve to ask: How does your team practice remembrance? Palliative care providers responded and shared the unique ways they and their teams reflect on these losses.

There are many moments for reflection from the time of death to the weeks and months after, to the entire year of cumulative loss. Some observances start around the time of death. Susan MacDonald, RN, GEC, from Erie VA Medical Center (VAMC) in Pennsylvania reported that following the death of a veteran in the hospice unit, there is a bedside remembrance that includes the chaplain, care team, family, and other loved ones. At the John D. Dingell VAMC in Detroit, Michigan, the clinical chaplain leads a memorial service after a community living center (CLC) resident dies.

Several VAMCs, such as Detroit and Erie, have an Honors Escort or Final Salute. In these ceremonies, family, employees, residents, and other veterans line the hallways to honor the veteran on their departure from the building.¹ At the VA Maine Healthcare System, Kate MacFawn, nurse manager, Inpatient Hospice Unit, explained, “We debrief every death the day after it occurs. The doc[tor]s check in with the nursing staff on each shift, and the rest of the multidisciplinary team discusses [it] in our morning report.”

Palliative care providers consider the physical spaces where the veteran has spent those last moments and the void that is left. Karen Pickler, staff chaplain at Northport VAMC Hospice Unit recounts:

At the time of death, we decorate the tray table with the veteran’s picture, a flag, and an angel. In the CLC they will have a memorial service on Friday if a resident has died that week. This is for the unit and staff. In the past, other residents were not informed of the death. This way, the relationships between residents are honored as well as their natural families.

At VA Boston Healthcare System (VABHS) in Massachusetts in the Inpatient Hospice Unit-CLC, after a veteran dies, a flag, a strand of lights, and a rose in a vase are placed outside the veteran’s room to mark the absence. The VABHS remembrance practice has evolved over time based on input from the team. According to Noah Whiddon, LICSW, CLC complex case coordinator, at a weekly interdisciplinary team (IDT) meeting, the names of veterans who have died in the past week are read, and there is a commemorative ribbon cutting. “Any team member may write the last name of the deceased veteran on the ribbon and place it into a vase,” he said. “One of the nurse team members felt that a moment of silence would be appropriate, and we have added that.”

Every 6 months, VABHS holds a flag burning ceremony to appropriately dispose of worn out flags. Veterans and families are invited. The commemorative ribbons are packaged and burned at this ceremony with the following explanation of the ritual:

We’d like to take a moment to reflect on the lives of veterans we’ve lost in the last 6 months. Each week we remember the veterans for whom we have cared who have passed away. As part of this, we cut a ribbon and inscribe their name on it to commemorate their memory. We might have known these veterans for a few days or for a few years, but each of their lives had meaning for us. The courage that our veterans demonstrate at the end of their lives is an extension of the bravery they displayed in their service to our country. Today we will burn their commemorative ribbons with our country’s flag in tribute to and respect for their selflessness to our country. Please join us in a few moments of silence as their ribbons burn together with our flag.

In the VABHS acute care hospital, the palliative care IDT reserves 30 minutes, twice monthly for a chaplain-led remembrance. A large bowl-shaped shell is placed in the center of the table with smaller shells around it. Any team member can read the names of veterans who have died in prior weeks and share a memory of the patient or family, and then place a smaller shell into the larger bowl. This represents the transition from the smallest part of the universe back into the larger part. At the end, a moment of silence is observed or a poem is read. This tradition was brought to the team by the palliative care chaplain, Douglas Falls, MDiv.

Bimonthly bereavement meetings are held at the James A. Haley Veterans’ Hospital-Pasco County branch, and each veteran who has died is remembered. Whoever wants to share is welcome. “We conclude with a poem, usually shared by the physician, but it can be any team member,” explained Linda Falzetta-Gross, ARNP-BC. “This process is led by the team social worker. In the past, we used to ring a bell prior to each name.”

Bells also are used at the Greater West Los Angeles VAMC in California. At the weekly clinic, veterans who have died are remembered, and each team member has an opportunity to share memories. “We ring a Tibetan bell for a moment without words,” explains Geoffrey Tyrell, palliative care chaplain. “It is introduced with a few words to allow new staff members in our clinic to participate, as a moment of mindfulness to let go of our words and to go inside, to see what we might need for our own wellness.” Afterward the chaplain says a few words and wishes for peace for the veterans and their families. The team also has responded well to more participatory group activities, such as placing rocks in a bowl of water, to symbolize letting go of something that has been difficult.

Additionally, there are practices of a larger scope. Many VAMCs have established facility-wide memorial services annually, biannually, or quarterly. At this time, families and staff come together to remember and honor veterans who have died within the VAMC. These memorials might involve a variety of service lines, such as chaplaincy, voluntary services, nursing, and social work and may consist of an honor guard, music, and readings. In accordance with the Health Insurance Portability and Accountability Act (HIPAA) and privacy regulations, only family members of deceased veterans may speak the names at the ceremony unless written consent is given. At the Tennessee Valley Healthcare System in Nashville, family members may stand and give the name of the person they are honoring. Balloons are released, stories are told, and a poem or appropriate passage is read. Families are given a book pinned with a flag, according to Jennifer C. Crenshaw, clinical staff chaplain. Family members are moved knowing that the VA remembers their loved ones even months after they are gone.

Due to the overwhelming positive feedback from veterans’ families who participated in these ceremonies, on January 24, 2018, Carolyn Clancy, MD, VHA Executive-in-Charge, Office of the Under Secretary for Health issued a memorandum requesting that all VAMCs immediately adopt this best practice: to host periodic ceremonies to publicly recognize and honor deceased veterans in the presence of their families, VA care providers, veterans service organizations and community members. Clancy recommended calling the ceremonies “The Last Roll Call Ceremony of Remembrance.”²

These rituals are a small sample of the rich diversity of practice in VAs across the country. What unifies VA palliative care providers is our mission to serve the veterans, honor their deaths, show respect and gratitude, and recognize that we, too, feel the pain of loss. We mark these moments with solemnity and beauty—a bell, a poem, a prayer—to honor our shared experience caring for veterans.

Caring for veterans at the end of their lives is a great honor. The US Department of Veterans Affairs (VA) health care professionals (HCPs) find meaning and take pride in providing this care. We are there to support the patient and their family and loved ones around the time of death. When our patients die, we feel the loss and grieve as well. VA health care providers look to our teams to set up rituals that pay tribute to the veteran and to show respect and gratitude for our role in these moments. It is important to recognize the bonds we share and the grief we feel when a veteran dies. The relationships we form, the recognition of loss, and the honoring of the veterans help nourish and maintain us.

Although the number of VA inpatient deaths nationwide has been declining steadily for years, internal reporting by the Palliative and Hospice Care Program Office has shown that the percentage of VA inpatient deaths that occur in hospice settings has steadily grown. Since 2013, more veterans die in VA inpatient hospice beds than in any other hospital setting. Therefore, it is useful to take stock of the way hospice and palliative care providers and staff process and provide support so that they can continue to provide service to veterans.

In the same way that all loss and grief are unique, there are many diverse rituals across VA facilities. This article highlights some of the unique traditions that hospice and palliative care teams have adopted to embrace this remembrance. We hope that by sharing these practices others will be inspired to find ways to reflect on their work and honor the lives of veterans.

The authors reached out to VA palliative care colleagues across the country via the Veterans Health Administration National Hospice and Palliative Care listserve to ask: How does your team practice remembrance? Palliative care providers responded and shared the unique ways they and their teams reflect on these losses.

There are many moments for reflection from the time of death to the weeks and months after, to the entire year of cumulative loss. Some observances start around the time of death. Susan MacDonald, RN, GEC, from Erie VA Medical Center (VAMC) in Pennsylvania reported that following the death of a veteran in the hospice unit, there is a bedside remembrance that includes the chaplain, care team, family, and other loved ones. At the John D. Dingell VAMC in Detroit, Michigan, the clinical chaplain leads a memorial service after a community living center (CLC) resident dies.

Several VAMCs, such as Detroit and Erie, have an Honors Escort or Final Salute. In these ceremonies, family, employees, residents, and other veterans line the hallways to honor the veteran on their departure from the building.¹ At the VA Maine Healthcare System, Kate MacFawn, nurse manager, Inpatient Hospice Unit, explained, “We debrief every death the day after it occurs. The doc[tor]s check in with the nursing staff on each shift, and the rest of the multidisciplinary team discusses [it] in our morning report.”

Palliative care providers consider the physical spaces where the veteran has spent those last moments and the void that is left. Karen Pickler, staff chaplain at Northport VAMC Hospice Unit recounts:

At the time of death, we decorate the tray table with the veteran’s picture, a flag, and an angel. In the CLC they will have a memorial service on Friday if a resident has died that week. This is for the unit and staff. In the past, other residents were not informed of the death. This way, the relationships between residents are honored as well as their natural families.

At VA Boston Healthcare System (VABHS) in Massachusetts in the Inpatient Hospice Unit-CLC, after a veteran dies, a flag, a strand of lights, and a rose in a vase are placed outside the veteran’s room to mark the absence. The VABHS remembrance practice has evolved over time based on input from the team. According to Noah Whiddon, LICSW, CLC complex case coordinator, at a weekly interdisciplinary team (IDT) meeting, the names of veterans who have died in the past week are read, and there is a commemorative ribbon cutting. “Any team member may write the last name of the deceased veteran on the ribbon and place it into a vase,” he said. “One of the nurse team members felt that a moment of silence would be appropriate, and we have added that.”

Every 6 months, VABHS holds a flag burning ceremony to appropriately dispose of worn out flags. Veterans and families are invited. The commemorative ribbons are packaged and burned at this ceremony with the following explanation of the ritual:

We’d like to take a moment to reflect on the lives of veterans we’ve lost in the last 6 months. Each week we remember the veterans for whom we have cared who have passed away. As part of this, we cut a ribbon and inscribe their name on it to commemorate their memory. We might have known these veterans for a few days or for a few years, but each of their lives had meaning for us. The courage that our veterans demonstrate at the end of their lives is an extension of the bravery they displayed in their service to our country. Today we will burn their commemorative ribbons with our country’s flag in tribute to and respect for their selflessness to our country. Please join us in a few moments of silence as their ribbons burn together with our flag.

In the VABHS acute care hospital, the palliative care IDT reserves 30 minutes, twice monthly for a chaplain-led remembrance. A large bowl-shaped shell is placed in the center of the table with smaller shells around it. Any team member can read the names of veterans who have died in prior weeks and share a memory of the patient or family, and then place a smaller shell into the larger bowl. This represents the transition from the smallest part of the universe back into the larger part. At the end, a moment of silence is observed or a poem is read. This tradition was brought to the team by the palliative care chaplain, Douglas Falls, MDiv.

Bimonthly bereavement meetings are held at the James A. Haley Veterans’ Hospital-Pasco County branch, and each veteran who has died is remembered. Whoever wants to share is welcome. “We conclude with a poem, usually shared by the physician, but it can be any team member,” explained Linda Falzetta-Gross, ARNP-BC. “This process is led by the team social worker. In the past, we used to ring a bell prior to each name.”

Bells also are used at the Greater West Los Angeles VAMC in California. At the weekly clinic, veterans who have died are remembered, and each team member has an opportunity to share memories. “We ring a Tibetan bell for a moment without words,” explains Geoffrey Tyrell, palliative care chaplain. “It is introduced with a few words to allow new staff members in our clinic to participate, as a moment of mindfulness to let go of our words and to go inside, to see what we might need for our own wellness.” Afterward the chaplain says a few words and wishes for peace for the veterans and their families. The team also has responded well to more participatory group activities, such as placing rocks in a bowl of water, to symbolize letting go of something that has been difficult.

Additionally, there are practices of a larger scope. Many VAMCs have established facility-wide memorial services annually, biannually, or quarterly. At this time, families and staff come together to remember and honor veterans who have died within the VAMC. These memorials might involve a variety of service lines, such as chaplaincy, voluntary services, nursing, and social work and may consist of an honor guard, music, and readings. In accordance with the Health Insurance Portability and Accountability Act (HIPAA) and privacy regulations, only family members of deceased veterans may speak the names at the ceremony unless written consent is given. At the Tennessee Valley Healthcare System in Nashville, family members may stand and give the name of the person they are honoring. Balloons are released, stories are told, and a poem or appropriate passage is read. Families are given a book pinned with a flag, according to Jennifer C. Crenshaw, clinical staff chaplain. Family members are moved knowing that the VA remembers their loved ones even months after they are gone.

Due to the overwhelming positive feedback from veterans’ families who participated in these ceremonies, on January 24, 2018, Carolyn Clancy, MD, VHA Executive-in-Charge, Office of the Under Secretary for Health issued a memorandum requesting that all VAMCs immediately adopt this best practice: to host periodic ceremonies to publicly recognize and honor deceased veterans in the presence of their families, VA care providers, veterans service organizations and community members. Clancy recommended calling the ceremonies “The Last Roll Call Ceremony of Remembrance.”²

These rituals are a small sample of the rich diversity of practice in VAs across the country. What unifies VA palliative care providers is our mission to serve the veterans, honor their deaths, show respect and gratitude, and recognize that we, too, feel the pain of loss. We mark these moments with solemnity and beauty—a bell, a poem, a prayer—to honor our shared experience caring for veterans.

Gastroesophageal reflux (GER) is common in infants and often presents a challenge to doctors who try to balance changing evidence with concerns about complications and parents’ concerns about their infant’s discomfort. In a 2018 guideline, the writing committee defined GER as reflux of stomach contents to the esophagus. GER is considered pathologic and, therefore, gastroesophageal reflux disease (GERD) when it is associated with troublesome symptoms and/or complications that can include esophagitis and aspiration.

Infants

GERD is difficult to diagnose in infants. The symptoms of GERD, such as crying after feeds, regurgitation, and irritability, occur commonly in all infants and in any individual infant may not be reflective of GERD. Regurgitation is common, frequent and normal in infants up to 6 months of age. A common challenge occurs when families request treatment for infants with irritability, back arching, and/or regurgitation who are otherwise doing well. In this group of infants it is important to recognize that neither testing nor therapy is indicated unless there is difficulty with feeding, growth, acquisition of milestones, or red flag signs.

In infants with recurrent regurgitation history, physical exam is usually sufficient to distinguish uncomplicated GER from GERD and other more worrisome diagnoses. Red flag symptoms raise the possibility of a different diagnosis. Red flag symptoms include weight loss; lethargy; excessive irritability/pain; onset of vomiting for more than 6 months or persisting past 12-18 months of age; rapidly increasing head circumference; persistent forceful, nocturnal, bloody, or bilious vomiting; abdominal distention; rectal bleeding; and chronic diarrhea. GERD that starts after 6 months of age or which persists after 12 months of age warrants further evaluation, often with referral to a pediatric gastroenterologist.

When GERD is suspected, the first therapeutic steps are to institute behavioral changes. Caregivers should avoid overfeeding and modify the feeding pattern to more frequent feedings consisting of less volume at each feed. The addition of thickeners to feeds does reduce regurgitation, although it may not affect other GERD signs and symptoms. Formula can be thickened with rice cereal, which tends to be an affordable choice that doesn’t clog nipples. Enzymes present in breast milk digest cereal thickeners, so breast milk can be thickened with xanthum gum (after 1 year of age) or carob bean–based products (after 42 weeks gestation).

If these modifications do not improve symptoms, the next step is to change the type of feeds. Some infants in whom GERD is suspected actually have cow’s milk protein allergy (CMPA), so a trial of cow’s milk elimination is warranted. A breastfeeding mother can eliminate all dairy from her diet including casein and whey. Caregivers can switch to an extensively hydrolyzed formula or an amino acid–based formula. The guideline do not recommend soy-based formulas because they are not available in Europe and because a significant percentage of infants with CMPA also develop allergy to soy, and they do not recommend rice hydrolysate formula because of a lack of evidence. Dairy can be reintroduced at a later point. While positional changes including elevating the head of the crib or placing the infant in the left lateral position can help decrease GERD, the American Academy of Pediatrics strongly discourages these positions because of safety concerns, so the guidelines do not recommend positional change.

If a 2-4 week trial of nonpharmacologic interventions fails, the next step is referral to a pediatric gastroenterologist. If a pediatric gastroenterologist is not available, a 4-8 week trial of acid suppressive medication may be given. No trial has shown utility of a trial of acid suppression as a diagnostic test for GERD. Medication should only be used in infants with strongly suspected GERD and, per the guidelines, “should not be used for the treatment of visible regurgitation in otherwise healthy infants.” Medications to treat GER do not have evidence of efficacy, and there is evidence of an increased risk of infection with use of acid suppression, including an increased risk of necrotizing enterocolitis, pneumonia, upper respiratory tract infections, sepsis, urinary tract infections, and Clostridium difficile. If used, proton-pump inhibitors are preferred over histamine-2 receptor blockers. Antacids and alginates are not recommended.
 

Older children

In children with heartburn or regurgitation without red flag symptoms, a trial of lifestyle changes and dietary education may be initiated. If a child is overweight, it is important to inform the patient and parents that excess body weight is associated with GERD. The head of the bed can be elevated along with left lateral positioning. The guidelines do not support any probiotics or herbal medicines.

If bothersome symptoms persist, a trial of acid-suppressing medication for 4-8 weeks is reasonable. A PPI is preferred to a histamine-2 receptor blocker. PPI safety studies are lacking, but case studies suggest an increase in infections in children taking acid-suppressing medications. Therefore, as with infants, if medications are used they should be prescribed at the lowest dose and for the shortest period of time possible. If medications are not helping, or need to be used long term, referral to a pediatric gastroenterologist can be considered. Of note, the guidelines do support a 4-8 week trial of PPIs in older children as a diagnostic test; this differs from the recommendations for infants, in whom a trial for diagnostic purposes is discouraged.
 

Diagnostic testing

Refer to a gastroenterologist for endoscopy in cases of persistent symptoms despite PPI use or failure to wean off medication. If there are no erosions, pH monitoring with pH-impedance monitoring or pH-metry can help distinguish between nonerosive reflux disease (NERD), reflux hypersensitivity, and functional heartburn. If it is performed when a child is off of PPIs, endoscopy can also diagnose PPI-responsive eosinophilic esophagitis. Barium contrast, abdominal ultrasonography, and manometry may be considered during the course of a search for an alternative diagnosis, but they should not be used to diagnose or confirm GERD.

The bottom line

Most GER is physiologic and does not need treatment. First-line treatment for GERD in infants and children is nonpharmacologic intervention.
 

Reference

Rosen R et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-554.

Dr. Oh is a third year resident in the Family Medicine Residency at Abington-Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington - Jefferson Health.

Gastroesophageal reflux (GER) is common in infants and often presents a challenge to doctors who try to balance changing evidence with concerns about complications and parents’ concerns about their infant’s discomfort. In a 2018 guideline, the writing committee defined GER as reflux of stomach contents to the esophagus. GER is considered pathologic and, therefore, gastroesophageal reflux disease (GERD) when it is associated with troublesome symptoms and/or complications that can include esophagitis and aspiration.

Infants

GERD is difficult to diagnose in infants. The symptoms of GERD, such as crying after feeds, regurgitation, and irritability, occur commonly in all infants and in any individual infant may not be reflective of GERD. Regurgitation is common, frequent and normal in infants up to 6 months of age. A common challenge occurs when families request treatment for infants with irritability, back arching, and/or regurgitation who are otherwise doing well. In this group of infants it is important to recognize that neither testing nor therapy is indicated unless there is difficulty with feeding, growth, acquisition of milestones, or red flag signs.

In infants with recurrent regurgitation history, physical exam is usually sufficient to distinguish uncomplicated GER from GERD and other more worrisome diagnoses. Red flag symptoms raise the possibility of a different diagnosis. Red flag symptoms include weight loss; lethargy; excessive irritability/pain; onset of vomiting for more than 6 months or persisting past 12-18 months of age; rapidly increasing head circumference; persistent forceful, nocturnal, bloody, or bilious vomiting; abdominal distention; rectal bleeding; and chronic diarrhea. GERD that starts after 6 months of age or which persists after 12 months of age warrants further evaluation, often with referral to a pediatric gastroenterologist.

When GERD is suspected, the first therapeutic steps are to institute behavioral changes. Caregivers should avoid overfeeding and modify the feeding pattern to more frequent feedings consisting of less volume at each feed. The addition of thickeners to feeds does reduce regurgitation, although it may not affect other GERD signs and symptoms. Formula can be thickened with rice cereal, which tends to be an affordable choice that doesn’t clog nipples. Enzymes present in breast milk digest cereal thickeners, so breast milk can be thickened with xanthum gum (after 1 year of age) or carob bean–based products (after 42 weeks gestation).

If these modifications do not improve symptoms, the next step is to change the type of feeds. Some infants in whom GERD is suspected actually have cow’s milk protein allergy (CMPA), so a trial of cow’s milk elimination is warranted. A breastfeeding mother can eliminate all dairy from her diet including casein and whey. Caregivers can switch to an extensively hydrolyzed formula or an amino acid–based formula. The guideline do not recommend soy-based formulas because they are not available in Europe and because a significant percentage of infants with CMPA also develop allergy to soy, and they do not recommend rice hydrolysate formula because of a lack of evidence. Dairy can be reintroduced at a later point. While positional changes including elevating the head of the crib or placing the infant in the left lateral position can help decrease GERD, the American Academy of Pediatrics strongly discourages these positions because of safety concerns, so the guidelines do not recommend positional change.

If a 2-4 week trial of nonpharmacologic interventions fails, the next step is referral to a pediatric gastroenterologist. If a pediatric gastroenterologist is not available, a 4-8 week trial of acid suppressive medication may be given. No trial has shown utility of a trial of acid suppression as a diagnostic test for GERD. Medication should only be used in infants with strongly suspected GERD and, per the guidelines, “should not be used for the treatment of visible regurgitation in otherwise healthy infants.” Medications to treat GER do not have evidence of efficacy, and there is evidence of an increased risk of infection with use of acid suppression, including an increased risk of necrotizing enterocolitis, pneumonia, upper respiratory tract infections, sepsis, urinary tract infections, and Clostridium difficile. If used, proton-pump inhibitors are preferred over histamine-2 receptor blockers. Antacids and alginates are not recommended.
 

Older children

In children with heartburn or regurgitation without red flag symptoms, a trial of lifestyle changes and dietary education may be initiated. If a child is overweight, it is important to inform the patient and parents that excess body weight is associated with GERD. The head of the bed can be elevated along with left lateral positioning. The guidelines do not support any probiotics or herbal medicines.

If bothersome symptoms persist, a trial of acid-suppressing medication for 4-8 weeks is reasonable. A PPI is preferred to a histamine-2 receptor blocker. PPI safety studies are lacking, but case studies suggest an increase in infections in children taking acid-suppressing medications. Therefore, as with infants, if medications are used they should be prescribed at the lowest dose and for the shortest period of time possible. If medications are not helping, or need to be used long term, referral to a pediatric gastroenterologist can be considered. Of note, the guidelines do support a 4-8 week trial of PPIs in older children as a diagnostic test; this differs from the recommendations for infants, in whom a trial for diagnostic purposes is discouraged.
 

Diagnostic testing

Refer to a gastroenterologist for endoscopy in cases of persistent symptoms despite PPI use or failure to wean off medication. If there are no erosions, pH monitoring with pH-impedance monitoring or pH-metry can help distinguish between nonerosive reflux disease (NERD), reflux hypersensitivity, and functional heartburn. If it is performed when a child is off of PPIs, endoscopy can also diagnose PPI-responsive eosinophilic esophagitis. Barium contrast, abdominal ultrasonography, and manometry may be considered during the course of a search for an alternative diagnosis, but they should not be used to diagnose or confirm GERD.

The bottom line

Most GER is physiologic and does not need treatment. First-line treatment for GERD in infants and children is nonpharmacologic intervention.
 

Reference

Rosen R et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-554.

Dr. Oh is a third year resident in the Family Medicine Residency at Abington-Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington - Jefferson Health.

Gastroesophageal reflux (GER) is common in infants and often presents a challenge to doctors who try to balance changing evidence with concerns about complications and parents’ concerns about their infant’s discomfort. In a 2018 guideline, the writing committee defined GER as reflux of stomach contents to the esophagus. GER is considered pathologic and, therefore, gastroesophageal reflux disease (GERD) when it is associated with troublesome symptoms and/or complications that can include esophagitis and aspiration.

Infants

GERD is difficult to diagnose in infants. The symptoms of GERD, such as crying after feeds, regurgitation, and irritability, occur commonly in all infants and in any individual infant may not be reflective of GERD. Regurgitation is common, frequent and normal in infants up to 6 months of age. A common challenge occurs when families request treatment for infants with irritability, back arching, and/or regurgitation who are otherwise doing well. In this group of infants it is important to recognize that neither testing nor therapy is indicated unless there is difficulty with feeding, growth, acquisition of milestones, or red flag signs.

In infants with recurrent regurgitation history, physical exam is usually sufficient to distinguish uncomplicated GER from GERD and other more worrisome diagnoses. Red flag symptoms raise the possibility of a different diagnosis. Red flag symptoms include weight loss; lethargy; excessive irritability/pain; onset of vomiting for more than 6 months or persisting past 12-18 months of age; rapidly increasing head circumference; persistent forceful, nocturnal, bloody, or bilious vomiting; abdominal distention; rectal bleeding; and chronic diarrhea. GERD that starts after 6 months of age or which persists after 12 months of age warrants further evaluation, often with referral to a pediatric gastroenterologist.

When GERD is suspected, the first therapeutic steps are to institute behavioral changes. Caregivers should avoid overfeeding and modify the feeding pattern to more frequent feedings consisting of less volume at each feed. The addition of thickeners to feeds does reduce regurgitation, although it may not affect other GERD signs and symptoms. Formula can be thickened with rice cereal, which tends to be an affordable choice that doesn’t clog nipples. Enzymes present in breast milk digest cereal thickeners, so breast milk can be thickened with xanthum gum (after 1 year of age) or carob bean–based products (after 42 weeks gestation).

If these modifications do not improve symptoms, the next step is to change the type of feeds. Some infants in whom GERD is suspected actually have cow’s milk protein allergy (CMPA), so a trial of cow’s milk elimination is warranted. A breastfeeding mother can eliminate all dairy from her diet including casein and whey. Caregivers can switch to an extensively hydrolyzed formula or an amino acid–based formula. The guideline do not recommend soy-based formulas because they are not available in Europe and because a significant percentage of infants with CMPA also develop allergy to soy, and they do not recommend rice hydrolysate formula because of a lack of evidence. Dairy can be reintroduced at a later point. While positional changes including elevating the head of the crib or placing the infant in the left lateral position can help decrease GERD, the American Academy of Pediatrics strongly discourages these positions because of safety concerns, so the guidelines do not recommend positional change.

If a 2-4 week trial of nonpharmacologic interventions fails, the next step is referral to a pediatric gastroenterologist. If a pediatric gastroenterologist is not available, a 4-8 week trial of acid suppressive medication may be given. No trial has shown utility of a trial of acid suppression as a diagnostic test for GERD. Medication should only be used in infants with strongly suspected GERD and, per the guidelines, “should not be used for the treatment of visible regurgitation in otherwise healthy infants.” Medications to treat GER do not have evidence of efficacy, and there is evidence of an increased risk of infection with use of acid suppression, including an increased risk of necrotizing enterocolitis, pneumonia, upper respiratory tract infections, sepsis, urinary tract infections, and Clostridium difficile. If used, proton-pump inhibitors are preferred over histamine-2 receptor blockers. Antacids and alginates are not recommended.
 

Older children

In children with heartburn or regurgitation without red flag symptoms, a trial of lifestyle changes and dietary education may be initiated. If a child is overweight, it is important to inform the patient and parents that excess body weight is associated with GERD. The head of the bed can be elevated along with left lateral positioning. The guidelines do not support any probiotics or herbal medicines.

If bothersome symptoms persist, a trial of acid-suppressing medication for 4-8 weeks is reasonable. A PPI is preferred to a histamine-2 receptor blocker. PPI safety studies are lacking, but case studies suggest an increase in infections in children taking acid-suppressing medications. Therefore, as with infants, if medications are used they should be prescribed at the lowest dose and for the shortest period of time possible. If medications are not helping, or need to be used long term, referral to a pediatric gastroenterologist can be considered. Of note, the guidelines do support a 4-8 week trial of PPIs in older children as a diagnostic test; this differs from the recommendations for infants, in whom a trial for diagnostic purposes is discouraged.
 

Diagnostic testing

Refer to a gastroenterologist for endoscopy in cases of persistent symptoms despite PPI use or failure to wean off medication. If there are no erosions, pH monitoring with pH-impedance monitoring or pH-metry can help distinguish between nonerosive reflux disease (NERD), reflux hypersensitivity, and functional heartburn. If it is performed when a child is off of PPIs, endoscopy can also diagnose PPI-responsive eosinophilic esophagitis. Barium contrast, abdominal ultrasonography, and manometry may be considered during the course of a search for an alternative diagnosis, but they should not be used to diagnose or confirm GERD.

The bottom line

Most GER is physiologic and does not need treatment. First-line treatment for GERD in infants and children is nonpharmacologic intervention.
 

Reference

Rosen R et al. Pediatric Gastroesophageal Reflux Clinical Practice Guidelines: Joint Recommendations of the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition and the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. J Pediatr Gastroenterol Nutr. 2018 Mar;66(3):516-554.

Dr. Oh is a third year resident in the Family Medicine Residency at Abington-Jefferson Health. Dr. Skolnik is a professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington - Jefferson Health.

Advanced practice providers (APPs; physician assistants and nurse practitioners) play a vital role in the success of an academic or private gastroenterology practice. Partnership with APPs in the clinical setting can improve inpatient and outpatient workflow and complex chronic care management, optimizing downstream revenue from endoscopy, radiology, and motility studies and enhancing physician productivity in research or academic affairs. In an informal AGA Community survey of physicians throughout the United States, 86% of respondents worked with advanced practice providers, 61% of whom had done so for over 5 years. While APPs may fill diverse roles in gastroenterology practice, there are common principles that may help optimize the physician-APP relationship. We surveyed both APPs and physicians to gain their perspective and present a tool kit to optimize the relationship among APPs and physicians.

The APP perspective

In qualitative interviews with 12 APPs practicing gastroenterology in a variety of specialties in Massachusetts, we aimed to understand 1) what APPs felt they brought to GI practice and 2) how APPs can be best utilized and integrated into GI practice and flow.

All interviewees independently noted that improving patient access to care and providing continuity of care were key benefits they brought to their practice, resulting in the possible downstream prevention of unnecessary emergency room admissions. Additionally, APPs felt that they brought significant value by having the time to listen to patient concerns to allow the team to prioritize care (83%), and provide patient education on their disease or medications (92%).

Though APPs are often utilized based on the individual needs of the practice, physician understanding of the APP skillset (83%) and a clear job description with set expectations up front (75%) were two critical elements of practice integration and job satisfaction on qualitative APP surveys. Additionally, APPs felt that strong mentorship with opportunities for career growth could enhance career satisfaction and improve the overall retention of the APP (100%).

The physician perspective

Informed by themes identified from the qualitative APP survey, we posted an informal, anonymous online survey to physicians on the AGA Community Forum. Nearly all physicians that worked with an APP felt that they were beneficial to their practice. Ninety-seven percent of respondents found that APPs improved patient access to the clinic, while 47% found that APPs decreased phone calls and 43% found that APPs improved administrative burden. Other less commonly cited benefits of APPs included increased practice revenue, improved efficiency of inpatient care, and assistance with procedures.

In building relationships and developing trust with their APPs, respondents valued communication (94%), observed or measured competency through orientation or standardized training (55%), and increased time comanaging patients (48%). However, 52% of respondents were concerned regarding the time required to train an APP to their standards, 45% were concerned regarding knowledge deficits, and 48% were concerned regarding risk of turnover and burnout. Though patient satisfaction was noted as a possible benefit of a physician/APP team approach, physicians also noted a potential concern that it may compromise the existing physician/patient relationship.

Despite concerns regarding training and knowledge deficits, only 29% of respondents had a standard orientation for APPs, 26% had a clearly defined job description, and 32% had formal teaching in their specialty content area.
 

Developing a model for success

Based on the results of these surveys and our practice experience, we present seven recommendations to optimize the APP/physician relationship:

1. Create a clear job description that ensures your APP works to the top of their license and training. This key principle can have a great impact on practice revenue and APP job satisfaction.

2. Develop a plan to train the APP to your standards, whether it be through a dedicated content curriculum or a mentored preceptorship. Most APPs finish formal training with very little gastroenterology specialty expertise, and would benefit from content-based learning in the area of gastroenterology in which they will work. The AGA publishes on-demand webcasts in different content areas, geared toward advanced practice providers (https://www.gastro.org/aga-leadership/initiatives-and-programs/nurse-practitioner-and-physician-assistant-resource-center). The AGA also hosts an annual conference to review GI content and prepare APPs to deliver optimal patient care (https://nppa.gastro.org/).

3. Designate objective criteria by which you will measure competency. Share this model with your APP up front to establish transparent expectations, and meet to review competencies and plans for further training at least annually. This structure presents a model for clinical growth and transparent expectations may enhance APP retention.

4. Establish APP mentorship. Just as for physicians, both clinical and career mentorship are an important part of job satisfaction and retention for APPs.

• Meet regularly. We recommend that mentors schedule weekly meetings with their APPs to review cases, questions/concerns, outstanding clinical work, quality-improvement initiatives and/or research. These regular meetings will keep lines of communication open and may enhance APP retention.

• Provide feedback. Both APPs and physicians benefit from constructive feedback. An annual review should not bring any surprises. Keeping feedback honest and constructive will further strengthen the relationship.

5. Introduce the APP as an integral member of the care team during the initial patient encounter. Whether working in a dedicated subspecialty team (inflammatory bowel disease, hepatology, motility, or hepatobiliary) or as part of a general gastroenterology practice, APPs should be introduced during the initial encounter as a key member of the team to establish rapport. The APP’s name should also be listed in the after-visit summary, on business cards, and on stationary to strengthen the team image. Once a patient is established with an APP and a therapeutic relationship is built, patients often report positive outcomes and maintain follow-up with the APP/physician team. We recommend that the physician see the patient at least every other visit (alternating with the APP) to reinforce the team dynamic and dedication of all members of the team to the patient’s health.

6. Provide a sense of community. Depending on the size of your practice, you can connect APPs within your practice, institution, or at a professional organization level. Belonging to a larger group that understands APP practice provides strong support and APP career satisfaction.

7. Create growth opportunities. In addition to clinical growth, APPs can provide value in leading quality-improvement and research initiatives. Establish goals and timelines for achieving goals up front, and be prepared to protect the APP’s time to achieve these goals. Successful APP growth and development may enhance job satisfaction and lead to reduced turnover. In addition, establishment of APP leaders provides candidates to help design and implement an effective APP program as a practice grows.

The authors wish to recognize research coordinators Casey Silvernale and April Mendez, and Dr. Kyle Staller who assisted with the coordination of the surveys that contributed to this work. Dr. Burke is a gastroenterolgist affiliated with Massachusetts General Hospital, Boston; Dr. Thurler is the Ambulatory Director of advanced practice providers and nursing at Massachusetts General Hospital. The authors had no disclosures.

This story was updated on June 26, 2019.

Advanced practice providers (APPs; physician assistants and nurse practitioners) play a vital role in the success of an academic or private gastroenterology practice. Partnership with APPs in the clinical setting can improve inpatient and outpatient workflow and complex chronic care management, optimizing downstream revenue from endoscopy, radiology, and motility studies and enhancing physician productivity in research or academic affairs. In an informal AGA Community survey of physicians throughout the United States, 86% of respondents worked with advanced practice providers, 61% of whom had done so for over 5 years. While APPs may fill diverse roles in gastroenterology practice, there are common principles that may help optimize the physician-APP relationship. We surveyed both APPs and physicians to gain their perspective and present a tool kit to optimize the relationship among APPs and physicians.

The APP perspective

In qualitative interviews with 12 APPs practicing gastroenterology in a variety of specialties in Massachusetts, we aimed to understand 1) what APPs felt they brought to GI practice and 2) how APPs can be best utilized and integrated into GI practice and flow.

All interviewees independently noted that improving patient access to care and providing continuity of care were key benefits they brought to their practice, resulting in the possible downstream prevention of unnecessary emergency room admissions. Additionally, APPs felt that they brought significant value by having the time to listen to patient concerns to allow the team to prioritize care (83%), and provide patient education on their disease or medications (92%).

Though APPs are often utilized based on the individual needs of the practice, physician understanding of the APP skillset (83%) and a clear job description with set expectations up front (75%) were two critical elements of practice integration and job satisfaction on qualitative APP surveys. Additionally, APPs felt that strong mentorship with opportunities for career growth could enhance career satisfaction and improve the overall retention of the APP (100%).

The physician perspective

Informed by themes identified from the qualitative APP survey, we posted an informal, anonymous online survey to physicians on the AGA Community Forum. Nearly all physicians that worked with an APP felt that they were beneficial to their practice. Ninety-seven percent of respondents found that APPs improved patient access to the clinic, while 47% found that APPs decreased phone calls and 43% found that APPs improved administrative burden. Other less commonly cited benefits of APPs included increased practice revenue, improved efficiency of inpatient care, and assistance with procedures.

In building relationships and developing trust with their APPs, respondents valued communication (94%), observed or measured competency through orientation or standardized training (55%), and increased time comanaging patients (48%). However, 52% of respondents were concerned regarding the time required to train an APP to their standards, 45% were concerned regarding knowledge deficits, and 48% were concerned regarding risk of turnover and burnout. Though patient satisfaction was noted as a possible benefit of a physician/APP team approach, physicians also noted a potential concern that it may compromise the existing physician/patient relationship.

Despite concerns regarding training and knowledge deficits, only 29% of respondents had a standard orientation for APPs, 26% had a clearly defined job description, and 32% had formal teaching in their specialty content area.
 

Developing a model for success

Based on the results of these surveys and our practice experience, we present seven recommendations to optimize the APP/physician relationship:

1. Create a clear job description that ensures your APP works to the top of their license and training. This key principle can have a great impact on practice revenue and APP job satisfaction.

2. Develop a plan to train the APP to your standards, whether it be through a dedicated content curriculum or a mentored preceptorship. Most APPs finish formal training with very little gastroenterology specialty expertise, and would benefit from content-based learning in the area of gastroenterology in which they will work. The AGA publishes on-demand webcasts in different content areas, geared toward advanced practice providers (https://www.gastro.org/aga-leadership/initiatives-and-programs/nurse-practitioner-and-physician-assistant-resource-center). The AGA also hosts an annual conference to review GI content and prepare APPs to deliver optimal patient care (https://nppa.gastro.org/).

3. Designate objective criteria by which you will measure competency. Share this model with your APP up front to establish transparent expectations, and meet to review competencies and plans for further training at least annually. This structure presents a model for clinical growth and transparent expectations may enhance APP retention.

4. Establish APP mentorship. Just as for physicians, both clinical and career mentorship are an important part of job satisfaction and retention for APPs.

• Meet regularly. We recommend that mentors schedule weekly meetings with their APPs to review cases, questions/concerns, outstanding clinical work, quality-improvement initiatives and/or research. These regular meetings will keep lines of communication open and may enhance APP retention.

• Provide feedback. Both APPs and physicians benefit from constructive feedback. An annual review should not bring any surprises. Keeping feedback honest and constructive will further strengthen the relationship.

5. Introduce the APP as an integral member of the care team during the initial patient encounter. Whether working in a dedicated subspecialty team (inflammatory bowel disease, hepatology, motility, or hepatobiliary) or as part of a general gastroenterology practice, APPs should be introduced during the initial encounter as a key member of the team to establish rapport. The APP’s name should also be listed in the after-visit summary, on business cards, and on stationary to strengthen the team image. Once a patient is established with an APP and a therapeutic relationship is built, patients often report positive outcomes and maintain follow-up with the APP/physician team. We recommend that the physician see the patient at least every other visit (alternating with the APP) to reinforce the team dynamic and dedication of all members of the team to the patient’s health.

6. Provide a sense of community. Depending on the size of your practice, you can connect APPs within your practice, institution, or at a professional organization level. Belonging to a larger group that understands APP practice provides strong support and APP career satisfaction.

7. Create growth opportunities. In addition to clinical growth, APPs can provide value in leading quality-improvement and research initiatives. Establish goals and timelines for achieving goals up front, and be prepared to protect the APP’s time to achieve these goals. Successful APP growth and development may enhance job satisfaction and lead to reduced turnover. In addition, establishment of APP leaders provides candidates to help design and implement an effective APP program as a practice grows.

The authors wish to recognize research coordinators Casey Silvernale and April Mendez, and Dr. Kyle Staller who assisted with the coordination of the surveys that contributed to this work. Dr. Burke is a gastroenterolgist affiliated with Massachusetts General Hospital, Boston; Dr. Thurler is the Ambulatory Director of advanced practice providers and nursing at Massachusetts General Hospital. The authors had no disclosures.

This story was updated on June 26, 2019.

Advanced practice providers (APPs; physician assistants and nurse practitioners) play a vital role in the success of an academic or private gastroenterology practice. Partnership with APPs in the clinical setting can improve inpatient and outpatient workflow and complex chronic care management, optimizing downstream revenue from endoscopy, radiology, and motility studies and enhancing physician productivity in research or academic affairs. In an informal AGA Community survey of physicians throughout the United States, 86% of respondents worked with advanced practice providers, 61% of whom had done so for over 5 years. While APPs may fill diverse roles in gastroenterology practice, there are common principles that may help optimize the physician-APP relationship. We surveyed both APPs and physicians to gain their perspective and present a tool kit to optimize the relationship among APPs and physicians.

The APP perspective

In qualitative interviews with 12 APPs practicing gastroenterology in a variety of specialties in Massachusetts, we aimed to understand 1) what APPs felt they brought to GI practice and 2) how APPs can be best utilized and integrated into GI practice and flow.

All interviewees independently noted that improving patient access to care and providing continuity of care were key benefits they brought to their practice, resulting in the possible downstream prevention of unnecessary emergency room admissions. Additionally, APPs felt that they brought significant value by having the time to listen to patient concerns to allow the team to prioritize care (83%), and provide patient education on their disease or medications (92%).

Though APPs are often utilized based on the individual needs of the practice, physician understanding of the APP skillset (83%) and a clear job description with set expectations up front (75%) were two critical elements of practice integration and job satisfaction on qualitative APP surveys. Additionally, APPs felt that strong mentorship with opportunities for career growth could enhance career satisfaction and improve the overall retention of the APP (100%).

The physician perspective

Informed by themes identified from the qualitative APP survey, we posted an informal, anonymous online survey to physicians on the AGA Community Forum. Nearly all physicians that worked with an APP felt that they were beneficial to their practice. Ninety-seven percent of respondents found that APPs improved patient access to the clinic, while 47% found that APPs decreased phone calls and 43% found that APPs improved administrative burden. Other less commonly cited benefits of APPs included increased practice revenue, improved efficiency of inpatient care, and assistance with procedures.

In building relationships and developing trust with their APPs, respondents valued communication (94%), observed or measured competency through orientation or standardized training (55%), and increased time comanaging patients (48%). However, 52% of respondents were concerned regarding the time required to train an APP to their standards, 45% were concerned regarding knowledge deficits, and 48% were concerned regarding risk of turnover and burnout. Though patient satisfaction was noted as a possible benefit of a physician/APP team approach, physicians also noted a potential concern that it may compromise the existing physician/patient relationship.

Despite concerns regarding training and knowledge deficits, only 29% of respondents had a standard orientation for APPs, 26% had a clearly defined job description, and 32% had formal teaching in their specialty content area.
 

Developing a model for success

Based on the results of these surveys and our practice experience, we present seven recommendations to optimize the APP/physician relationship:

1. Create a clear job description that ensures your APP works to the top of their license and training. This key principle can have a great impact on practice revenue and APP job satisfaction.

2. Develop a plan to train the APP to your standards, whether it be through a dedicated content curriculum or a mentored preceptorship. Most APPs finish formal training with very little gastroenterology specialty expertise, and would benefit from content-based learning in the area of gastroenterology in which they will work. The AGA publishes on-demand webcasts in different content areas, geared toward advanced practice providers (https://www.gastro.org/aga-leadership/initiatives-and-programs/nurse-practitioner-and-physician-assistant-resource-center). The AGA also hosts an annual conference to review GI content and prepare APPs to deliver optimal patient care (https://nppa.gastro.org/).

3. Designate objective criteria by which you will measure competency. Share this model with your APP up front to establish transparent expectations, and meet to review competencies and plans for further training at least annually. This structure presents a model for clinical growth and transparent expectations may enhance APP retention.

4. Establish APP mentorship. Just as for physicians, both clinical and career mentorship are an important part of job satisfaction and retention for APPs.

• Meet regularly. We recommend that mentors schedule weekly meetings with their APPs to review cases, questions/concerns, outstanding clinical work, quality-improvement initiatives and/or research. These regular meetings will keep lines of communication open and may enhance APP retention.

• Provide feedback. Both APPs and physicians benefit from constructive feedback. An annual review should not bring any surprises. Keeping feedback honest and constructive will further strengthen the relationship.

5. Introduce the APP as an integral member of the care team during the initial patient encounter. Whether working in a dedicated subspecialty team (inflammatory bowel disease, hepatology, motility, or hepatobiliary) or as part of a general gastroenterology practice, APPs should be introduced during the initial encounter as a key member of the team to establish rapport. The APP’s name should also be listed in the after-visit summary, on business cards, and on stationary to strengthen the team image. Once a patient is established with an APP and a therapeutic relationship is built, patients often report positive outcomes and maintain follow-up with the APP/physician team. We recommend that the physician see the patient at least every other visit (alternating with the APP) to reinforce the team dynamic and dedication of all members of the team to the patient’s health.

6. Provide a sense of community. Depending on the size of your practice, you can connect APPs within your practice, institution, or at a professional organization level. Belonging to a larger group that understands APP practice provides strong support and APP career satisfaction.

7. Create growth opportunities. In addition to clinical growth, APPs can provide value in leading quality-improvement and research initiatives. Establish goals and timelines for achieving goals up front, and be prepared to protect the APP’s time to achieve these goals. Successful APP growth and development may enhance job satisfaction and lead to reduced turnover. In addition, establishment of APP leaders provides candidates to help design and implement an effective APP program as a practice grows.

The authors wish to recognize research coordinators Casey Silvernale and April Mendez, and Dr. Kyle Staller who assisted with the coordination of the surveys that contributed to this work. Dr. Burke is a gastroenterolgist affiliated with Massachusetts General Hospital, Boston; Dr. Thurler is the Ambulatory Director of advanced practice providers and nursing at Massachusetts General Hospital. The authors had no disclosures.

This story was updated on June 26, 2019.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

copyright mates/Fotolia.com

In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

copyright mates/Fotolia.com

In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.

Oral immunotherapy reduced sensitivity to peanuts in allergic individuals, but at the cost of increased risk of anaphylaxis and other reactions, based on a meta-analysis from more than 1,000 patients published in the Lancet.

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In the Peanut Allergen immunotherapy, Clarifying the Evidence (PACE) systematic review and meta-analysis, Derek K. Chu, MD, of McMaster University, Hamilton, Ont., and colleagues reviewed 12 trials conducted between 2011 and 2018 with a total of 1,041 patients (median age, 9 years).

Overall, the risk of anaphylaxis was significantly higher among children who received oral immunotherapy, compared with no therapy (risk ratio, 3.12) as was anaphylaxis frequency (incidence rate ratio, 2.72) and use of epinephrine (RR, 2.21).

In addition, oral immunotherapy increased serious adverse events, compared with no therapy (RR, 1.92). Nonanaphylactic reactions also went up among oral immunotherapy patients, with increased risk for vomiting (RR, 1.79), angioedema (RR, 2.25), upper respiratory tract reactions (RR, 1.36), and lower respiratory tract infections (RR, 1.55).

Quality of life scores were not significantly different between patients who did and did not receive oral immunotherapy, the researchers noted.

The oral immunotherapy consisted of defatted, lightly roasted peanut flour in 10 studies, and a combination of peanut paste, peanut extract, or ground and defatted peanut in the other studies.

The oral immunotherapy did induce desensitization to peanuts in support of earlier studies including the subcutaneous immunotherapy trial, but “this outcome does not translate into achieving the clinical and patient-desired aim of less allergic reactions and anaphylaxis,” Dr. Chu and associates wrote.

However, “rather than take the view that these data denounce current research in oral immunotherapy as not successful, we instead suggest that this research has reached an important milestone in mechanistic but not clinical efficacy. From a clinical or biological perspective, the apparently paradoxical desensitization versus longitudinal clinical findings show the lability and unreliability of allergen thresholds identified during oral food challenges because patients often unpredictably reacted to previously tolerated doses outside of clinic,” they emphasized.

The findings were limited by several factors including the small sample size, compared with similar studies for asthma or cardiovascular conditions, and by incomplete or inconsistent data reporting, the researchers noted. However, the results are the most comprehensive to date, and support the need for food allergy treatments with better safety profiles, using peanut allergy immunotherapy as a model for other food allergies.

Dr. Chu and two other authors reported being investigators on a federally funded ongoing peanut oral immunotherapy trial. Two authors reported receiving a variety of grants from organizations such as the National Institutes of Health; the American Academy of Allergy, Asthma, & Immunology; or pharmaceutical companies.

SOURCE: Chu DK et al. Lancet. 2019 June 1;393:2222-32.

Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.

“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.

To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).

In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.

For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.

The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”

The authors report no conflicts of interest.

SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.

Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.

“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.

To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).

In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.

For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.

The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”

The authors report no conflicts of interest.

SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.

Though responses to topical calcineurin inhibitors (TCIs) plus phototherapy were found to be higher than TCI monotherapy, a meta-analysis of studies on TCI therapy found that both should be used in treatment for patients with vitiligo.

“In addition, the proactive use of TCIs to maintain remission of vitiligo could be promising, considering its high recurrence rate,” wrote Ji Hae Lee, MD, PhD, of the Catholic University of Korea, Seoul, and coauthors in JAMA Dermatology.

To assess TCIs as treatment for vitiligo, the researchers undertook a systematic review and analysis of 56 relevant studies. Eleven of the studies were on the TCI mechanism; 36 were on TCI monotherapy; 12 were on TCI plus phototherapy; and 1 was on TCI maintenance therapy. Treatment responses for each study were measured via the degree of repigmentation on a quartile scale: an at least mild response (25% or greater repigmentation), at least moderate response (50% or greater repigmentation), and marked response (75% or greater repigmentation).

In regard to TCI monotherapy, an at least mild response was achieved in 55% (95% confidence interval, 42.2%-67.8%) of 560 patients in 21 studies. An at least moderate response was achieved in 38.5% (95% CI, 28.2%-48.8%) of 619 patients in 23 studies, and there was a marked response in 18.1% (95% CI, 13.2%-23.1%) of 520 patients in 19 studies.

For TCI plus phototherapy, an at least mild response was achieved in 89.5% (95% CI, 81.1%-97.9%) of 433 patients in eight studies. An at least moderate response was achieved in 72.9% (95% CI, 57.6%-88.2%) of 486 patients in 10 studies, and a marked response was achieved in 47.5% (95% CI, 30.6%-64.4%) of 490 patients in 9 studies.

The authors noted several limitations with their review, including a level of heterogeneity in the study designs, characteristics of the patients, and protocols. They also acknowledged that the quartile scale may be somewhat arbitrary in nature, though they added that it has been the “most commonly used measure and would have been one of the best estimates of the treatment response at this time.”

The authors report no conflicts of interest.

SOURCE: Lee JH et al. Jama Dermatol. 2019 May 29. doi: 10.1001/Jamadermatol.2019.0696.

SAN FRANCISCO – Children with autism often struggle with repairing “messy” interactions with others, and this can impair their ability to communicate and develop properly. The interactive mismatch and repair technique, developed by Ed Tronick, PhD, when he was a researcher at Harvard Medical School and Children’s Hospital, Boston, may be able to guide communication development between an adult and a child with autism.

At the annual meeting of the American Psychiatric Association, Alexandra Harrison, MD, assistant professor of psychiatry at Harvard Medical School, described her experiences applying the technique to her work with autism patients, and showed a video of an awkward interaction she had with a 3-year-old boy with autism. By working to synchronize body movements with “Hal,” as well as inserting 1-second gaps between her statements, she helped him resolve an awkward moment, and Hal ultimately defused the tension by making a joke.

Hal managed to regulate his own uncertainty in the moment and navigate through tension. That small triumph has the potential to grow. “Once they’ve been able to secure some form of regulation with one or two or three individuals who are devoted to them, the hope is that this will spread and they will be able to regulate with individuals who are not as adjusted to them,” Gisele Apter, MD, PhD, a colleague of Dr. Harrison’s and professor of child psychiatry at Normandy Medical School, France, said in an interview. Dr. Apter moderated the session where the video was shown.

Dr. Tronick believes that the infant and caretaker grow together, making meanings together that are increasingly complex and coherent. That growth occurs in part through mismatch and repair interactions. Communication between infants and caregivers is nearly always a messy dance, with waxing and waning attention, changing intentions, and other dynamic factors leading to stops and starts, and awkward moments that the two must find a way to repair before carrying on.

These momentary mismatches, which happen all the time, are in fact a key element of childhood development, according to Dr. Apter. “There’s a lack of synchrony, and we want to get back on track because we push to communicate again. To do that, we have to repair the interaction, and one of the most beautiful things about development with this unbalanced couple is that the adult is generally there to support, to scaffold the child, but just one small step ahead of the infant so that it will enrich its development,” she said. 

But a caregiver with depression or another mental illness, or a child with impaired communication development because of autism, can impede that natural process.

Dr. Tronick’s method aims to provide some structure to the interaction by likening the nonverbal part of the interaction to music and dance. There are vocal rhythms, tone, and pitch, and then there are coordinated patterns of movement, gaze, and facial expressions such as smiles or frowns. The idea is that developmental growth occurs when the infant and the adult create meanings through their interactions.

Such growth can occur in microprocesses – extended moments in which child and caregiver iron out a mismatch in intent or action. Resolving these situations, and then moving forward with the rest of the interaction, helps the child grow in complexity and development by acquiring new meanings.

One-second beats after each statement or sentence lead to predictability. “He can develop an expectancy, and he can anticipate my vocal turns, and that is going to be reassuring to him,” Dr. Harrison said during the presentation. It also allows the caregiver to think through a messy moment, to try something different if one action seems not to be working. “It’s very hard to know how to repair the messiness, because it’s actually not messy enough. It’s too black and white. Something works or it doesn’t work, whereas with most kids you can be a little messy and you have time to get back on track with them.

“With these children [with autism], it requires a level of awareness which is higher. It is helpful for the adult to try to adjust and learn to interact in a different way that is more attuned to the child,” Dr. Apter said.

In the video shown by Dr. Harrison, she and Hal are in the therapy/play area, and Hal’s mother has just left before he could say goodbye. He was very upset by this, but then turned to work building a “map” out of construction toys called H-links that he had been playing with, along with his mother, before she left. Throughout the video, Dr. Harrison attempts to synchronize her body movements with Hal’s, shifting her position when he shifts his, and these get out of alignment and come back in alignment at different times. Several times, body motion synchrony is followed by a statement from Hal.

Dr. Harrison sits on the floor next to him, with Hal faced away from her. At a loss for what to do, she makes a small pile of H-links next to her. Hal notices this, and then moves some of the H-links back to their original position.

Hal says, “The H-links don’t go together that much.”

“They don’t go together that much?” repeats Dr. Harrison.

“Yeah.” He takes more H-block pieces from her pile.

“You wanted to take my ones, too?”

At this point, there is an obvious mismatch, with Hal claiming Dr. Harrison’s H-blocks.

Hal smiles as he takes a few more H-blocks and then says, “Only for boys.”

Then his smile widens and he gazes directly at Dr. Harrison, who meets his with an expression of mock surprise.

“What?”

“Only for boys,” Hal repeats.

Dr. Harrison then strings a long a series of phrases, each separated by 1-second beats. Hal orients himself away from her, smiling slightly: “You mean only boys can play with these? ... Uh oh ... Guess that means ... I’m not allowed! ... Is that right? ... Oh, my gosh ... How did they ever make up that rule, I wonder?”

At this, Hal orients himself toward Dr. Harrison again and smiles widely this time. “You’re tricking me,” says Dr. Harrison, and he gazes downward, though toward her. “But I think you’re trying to tell me that you don’t want me to hand them to you ... You want to get them yourself. ... That right?”

“Yeah. No more giving me pieces,” says Hal.

“Oh, I’m glad I understood. ... I will not give you any more pieces.”

SAN FRANCISCO – Children with autism often struggle with repairing “messy” interactions with others, and this can impair their ability to communicate and develop properly. The interactive mismatch and repair technique, developed by Ed Tronick, PhD, when he was a researcher at Harvard Medical School and Children’s Hospital, Boston, may be able to guide communication development between an adult and a child with autism.

At the annual meeting of the American Psychiatric Association, Alexandra Harrison, MD, assistant professor of psychiatry at Harvard Medical School, described her experiences applying the technique to her work with autism patients, and showed a video of an awkward interaction she had with a 3-year-old boy with autism. By working to synchronize body movements with “Hal,” as well as inserting 1-second gaps between her statements, she helped him resolve an awkward moment, and Hal ultimately defused the tension by making a joke.

Hal managed to regulate his own uncertainty in the moment and navigate through tension. That small triumph has the potential to grow. “Once they’ve been able to secure some form of regulation with one or two or three individuals who are devoted to them, the hope is that this will spread and they will be able to regulate with individuals who are not as adjusted to them,” Gisele Apter, MD, PhD, a colleague of Dr. Harrison’s and professor of child psychiatry at Normandy Medical School, France, said in an interview. Dr. Apter moderated the session where the video was shown.

Dr. Tronick believes that the infant and caretaker grow together, making meanings together that are increasingly complex and coherent. That growth occurs in part through mismatch and repair interactions. Communication between infants and caregivers is nearly always a messy dance, with waxing and waning attention, changing intentions, and other dynamic factors leading to stops and starts, and awkward moments that the two must find a way to repair before carrying on.

These momentary mismatches, which happen all the time, are in fact a key element of childhood development, according to Dr. Apter. “There’s a lack of synchrony, and we want to get back on track because we push to communicate again. To do that, we have to repair the interaction, and one of the most beautiful things about development with this unbalanced couple is that the adult is generally there to support, to scaffold the child, but just one small step ahead of the infant so that it will enrich its development,” she said. 

But a caregiver with depression or another mental illness, or a child with impaired communication development because of autism, can impede that natural process.

Dr. Tronick’s method aims to provide some structure to the interaction by likening the nonverbal part of the interaction to music and dance. There are vocal rhythms, tone, and pitch, and then there are coordinated patterns of movement, gaze, and facial expressions such as smiles or frowns. The idea is that developmental growth occurs when the infant and the adult create meanings through their interactions.

Such growth can occur in microprocesses – extended moments in which child and caregiver iron out a mismatch in intent or action. Resolving these situations, and then moving forward with the rest of the interaction, helps the child grow in complexity and development by acquiring new meanings.

One-second beats after each statement or sentence lead to predictability. “He can develop an expectancy, and he can anticipate my vocal turns, and that is going to be reassuring to him,” Dr. Harrison said during the presentation. It also allows the caregiver to think through a messy moment, to try something different if one action seems not to be working. “It’s very hard to know how to repair the messiness, because it’s actually not messy enough. It’s too black and white. Something works or it doesn’t work, whereas with most kids you can be a little messy and you have time to get back on track with them.

“With these children [with autism], it requires a level of awareness which is higher. It is helpful for the adult to try to adjust and learn to interact in a different way that is more attuned to the child,” Dr. Apter said.

In the video shown by Dr. Harrison, she and Hal are in the therapy/play area, and Hal’s mother has just left before he could say goodbye. He was very upset by this, but then turned to work building a “map” out of construction toys called H-links that he had been playing with, along with his mother, before she left. Throughout the video, Dr. Harrison attempts to synchronize her body movements with Hal’s, shifting her position when he shifts his, and these get out of alignment and come back in alignment at different times. Several times, body motion synchrony is followed by a statement from Hal.

Dr. Harrison sits on the floor next to him, with Hal faced away from her. At a loss for what to do, she makes a small pile of H-links next to her. Hal notices this, and then moves some of the H-links back to their original position.

Hal says, “The H-links don’t go together that much.”

“They don’t go together that much?” repeats Dr. Harrison.

“Yeah.” He takes more H-block pieces from her pile.

“You wanted to take my ones, too?”

At this point, there is an obvious mismatch, with Hal claiming Dr. Harrison’s H-blocks.

Hal smiles as he takes a few more H-blocks and then says, “Only for boys.”

Then his smile widens and he gazes directly at Dr. Harrison, who meets his with an expression of mock surprise.

“What?”

“Only for boys,” Hal repeats.

Dr. Harrison then strings a long a series of phrases, each separated by 1-second beats. Hal orients himself away from her, smiling slightly: “You mean only boys can play with these? ... Uh oh ... Guess that means ... I’m not allowed! ... Is that right? ... Oh, my gosh ... How did they ever make up that rule, I wonder?”

At this, Hal orients himself toward Dr. Harrison again and smiles widely this time. “You’re tricking me,” says Dr. Harrison, and he gazes downward, though toward her. “But I think you’re trying to tell me that you don’t want me to hand them to you ... You want to get them yourself. ... That right?”

“Yeah. No more giving me pieces,” says Hal.

“Oh, I’m glad I understood. ... I will not give you any more pieces.”

SAN FRANCISCO – Children with autism often struggle with repairing “messy” interactions with others, and this can impair their ability to communicate and develop properly. The interactive mismatch and repair technique, developed by Ed Tronick, PhD, when he was a researcher at Harvard Medical School and Children’s Hospital, Boston, may be able to guide communication development between an adult and a child with autism.

At the annual meeting of the American Psychiatric Association, Alexandra Harrison, MD, assistant professor of psychiatry at Harvard Medical School, described her experiences applying the technique to her work with autism patients, and showed a video of an awkward interaction she had with a 3-year-old boy with autism. By working to synchronize body movements with “Hal,” as well as inserting 1-second gaps between her statements, she helped him resolve an awkward moment, and Hal ultimately defused the tension by making a joke.

Hal managed to regulate his own uncertainty in the moment and navigate through tension. That small triumph has the potential to grow. “Once they’ve been able to secure some form of regulation with one or two or three individuals who are devoted to them, the hope is that this will spread and they will be able to regulate with individuals who are not as adjusted to them,” Gisele Apter, MD, PhD, a colleague of Dr. Harrison’s and professor of child psychiatry at Normandy Medical School, France, said in an interview. Dr. Apter moderated the session where the video was shown.

Dr. Tronick believes that the infant and caretaker grow together, making meanings together that are increasingly complex and coherent. That growth occurs in part through mismatch and repair interactions. Communication between infants and caregivers is nearly always a messy dance, with waxing and waning attention, changing intentions, and other dynamic factors leading to stops and starts, and awkward moments that the two must find a way to repair before carrying on.

These momentary mismatches, which happen all the time, are in fact a key element of childhood development, according to Dr. Apter. “There’s a lack of synchrony, and we want to get back on track because we push to communicate again. To do that, we have to repair the interaction, and one of the most beautiful things about development with this unbalanced couple is that the adult is generally there to support, to scaffold the child, but just one small step ahead of the infant so that it will enrich its development,” she said. 

But a caregiver with depression or another mental illness, or a child with impaired communication development because of autism, can impede that natural process.

Dr. Tronick’s method aims to provide some structure to the interaction by likening the nonverbal part of the interaction to music and dance. There are vocal rhythms, tone, and pitch, and then there are coordinated patterns of movement, gaze, and facial expressions such as smiles or frowns. The idea is that developmental growth occurs when the infant and the adult create meanings through their interactions.

Such growth can occur in microprocesses – extended moments in which child and caregiver iron out a mismatch in intent or action. Resolving these situations, and then moving forward with the rest of the interaction, helps the child grow in complexity and development by acquiring new meanings.

One-second beats after each statement or sentence lead to predictability. “He can develop an expectancy, and he can anticipate my vocal turns, and that is going to be reassuring to him,” Dr. Harrison said during the presentation. It also allows the caregiver to think through a messy moment, to try something different if one action seems not to be working. “It’s very hard to know how to repair the messiness, because it’s actually not messy enough. It’s too black and white. Something works or it doesn’t work, whereas with most kids you can be a little messy and you have time to get back on track with them.

“With these children [with autism], it requires a level of awareness which is higher. It is helpful for the adult to try to adjust and learn to interact in a different way that is more attuned to the child,” Dr. Apter said.

In the video shown by Dr. Harrison, she and Hal are in the therapy/play area, and Hal’s mother has just left before he could say goodbye. He was very upset by this, but then turned to work building a “map” out of construction toys called H-links that he had been playing with, along with his mother, before she left. Throughout the video, Dr. Harrison attempts to synchronize her body movements with Hal’s, shifting her position when he shifts his, and these get out of alignment and come back in alignment at different times. Several times, body motion synchrony is followed by a statement from Hal.

Dr. Harrison sits on the floor next to him, with Hal faced away from her. At a loss for what to do, she makes a small pile of H-links next to her. Hal notices this, and then moves some of the H-links back to their original position.

Hal says, “The H-links don’t go together that much.”

“They don’t go together that much?” repeats Dr. Harrison.

“Yeah.” He takes more H-block pieces from her pile.

“You wanted to take my ones, too?”

At this point, there is an obvious mismatch, with Hal claiming Dr. Harrison’s H-blocks.

Hal smiles as he takes a few more H-blocks and then says, “Only for boys.”

Then his smile widens and he gazes directly at Dr. Harrison, who meets his with an expression of mock surprise.

“What?”

“Only for boys,” Hal repeats.

Dr. Harrison then strings a long a series of phrases, each separated by 1-second beats. Hal orients himself away from her, smiling slightly: “You mean only boys can play with these? ... Uh oh ... Guess that means ... I’m not allowed! ... Is that right? ... Oh, my gosh ... How did they ever make up that rule, I wonder?”

At this, Hal orients himself toward Dr. Harrison again and smiles widely this time. “You’re tricking me,” says Dr. Harrison, and he gazes downward, though toward her. “But I think you’re trying to tell me that you don’t want me to hand them to you ... You want to get them yourself. ... That right?”

“Yeah. No more giving me pieces,” says Hal.

“Oh, I’m glad I understood. ... I will not give you any more pieces.”

SAN FRANCISCO – Obsessive-compulsive personality disorder (OCPD) is often confused with obsessive-compulsive disorder (OCD) because of overlapping traits, but there are key differences that psychiatrists should be familiar with. OCPD also presents some key challenges to interpersonal therapy, especially because psychiatrists themselves sometimes share these traits.

“There’s an overlap, and some people have both OCD and OCPD, but some people have just one or the other, and that’s important to tease out because it shifts treatment,” Holly D. Crisp-Han, MD, said in an interview. Dr. Crisp-Han is a clinical associate professor of psychiatry and behavioral sciences at Baylor College of Medicine, Houston. She and her colleague, Glen O. Gabbard, MD, clinical professor of psychiatry at Baylor, chaired a session on dynamic psychotherapy for the treatment of OCPD at the annual meeting of the American Psychiatric Association.

OCPD is the most common personality disorder, with some estimates putting its prevalence as high as nearly 8%. Whereas OCD is characterized by an ego-dystonic need for rituals and specific thoughts, OCPD is defined by ego-syntonic traits. In a study comparing patients with both disorders, researchers found that both groups had reduced psychosocial function and quality of life, but intrusive thoughts and feelings were absent in OCPD. Instead, these patients reported ritualized, methodical behaviors, such as list making, reorganizing personal effects, and repeatedly editing what they had written. OCD patients were also better at delaying rewards.

Dynamic psychotherapy has been shown to achieve better outcomes in OCPD than cognitive-behavioral therapy, though both have a place in the treatment of OCPD, according to Dr. Gabbard. However, it comes with significant challenges. The patient will often challenge the therapist’s interventions and feel threatened by any hint of losing control. Sessions can become ritualized.

OCPD patients are driven by an effort to avoid a tormenting superego rather than seeking pleasure, and they may project this superego onto the therapist. It’s important to identify and interpret patient distortion of the therapist’s attitude toward the patient. Ultimately, the goal of therapy is to modify the patient’s self-expectations.

Couples therapy can be a good idea in cases of extreme ego-syntonicity. The patient’s partner can provide a second perspective to complement the patient’s subjective view of the relationship.

A unique challenge with OCPD is that therapists may see reflections of themselves in the patient. “Many physicians, psychiatrists, and therapists themselves struggle with obsessive-compulsive types of problems. Those types of traits – perfectionism, hard work, overwork, diligence – are rewarded in a career in medicine, and in fact [are] necessary for a career in medicine. We all have to be alert to our own personality traits in order to be able to treat those traits in others,” Dr. Crisp-Han said.” If we don’t recognize those traits in ourselves, then we run the risk of falling into competitive patterns, or idealizations, or other kinds of problems with our patients.”

Therapists who are narcissistically vulnerable may get sucked into power struggles with patients, and can feel undervalued, Dr. Gabbard said. Because rituals can develop, the therapist may also become bored, and even come to feel controlled by the patient’s obsession with the therapeutic process.

But there are other challenges in sessions. The tendency toward ritualization can produce boredom in the therapist. “That’s one of the biggest problems you have, hanging in with somebody who’s repeating the same things over and over again in a dry tone. You start to feel controlled by everything the patient is doing with their agenda,” Dr. Gabbard said during the session. He suggested confronting the patient from time to time. “You can say, ‘Today you don’t sound like you’re that interested in what you’re saying to me; you sound very detached. What’s going on?’ You can feed back to the person how they’re coming across, which can be very valuable.”

Humor is another way to tackle therapy with OCPD patients, because an important therapeutic lesson is to take things a little less seriously, especially in the face of the perfectionism that often haunts OCPD patients. In fact, this can be one of the condition’s most devastating traits, always leading an OCPD patient to feel that he or she is failing, that no accomplishment is ever enough.

“You can work on perfectionism and interpersonal relationships, and the absence of fun and pleasure. This is one of the most fun things to work on in the transference, countertransference relationship. Have a little bit of fun with the patient, because that might be quite foreign,” Dr. Gabbard said. “It can be tricky, because you don’t want to act like you’re laughing at the patient, but you want to introduce some levity and lightness sometimes.”

He gave an example of a patient who was a Catholic priest, who felt intensely guilty over sex. The patient said, “In the Catholic Church, thinking about sex is exactly the same as having sex.” Dr. Gabbard thought for a moment and then replied, “Well, you know, in my experience, that’s not true.”

The patient chuckled along with him. “I tried to point out to him that not all Catholic theologians see it that way,” Dr. Gabbard said.

Dr. Crisp-Han and Dr. Gabbard have collaborated on a book focused on diagnosis and treatment challenges associated with narcissistic patients called “Narcissism and Its Discontents” (American Psychiatric Association Publishing, 2018). They reported no relevant financial disclosures.

SAN FRANCISCO – Obsessive-compulsive personality disorder (OCPD) is often confused with obsessive-compulsive disorder (OCD) because of overlapping traits, but there are key differences that psychiatrists should be familiar with. OCPD also presents some key challenges to interpersonal therapy, especially because psychiatrists themselves sometimes share these traits.

“There’s an overlap, and some people have both OCD and OCPD, but some people have just one or the other, and that’s important to tease out because it shifts treatment,” Holly D. Crisp-Han, MD, said in an interview. Dr. Crisp-Han is a clinical associate professor of psychiatry and behavioral sciences at Baylor College of Medicine, Houston. She and her colleague, Glen O. Gabbard, MD, clinical professor of psychiatry at Baylor, chaired a session on dynamic psychotherapy for the treatment of OCPD at the annual meeting of the American Psychiatric Association.

OCPD is the most common personality disorder, with some estimates putting its prevalence as high as nearly 8%. Whereas OCD is characterized by an ego-dystonic need for rituals and specific thoughts, OCPD is defined by ego-syntonic traits. In a study comparing patients with both disorders, researchers found that both groups had reduced psychosocial function and quality of life, but intrusive thoughts and feelings were absent in OCPD. Instead, these patients reported ritualized, methodical behaviors, such as list making, reorganizing personal effects, and repeatedly editing what they had written. OCD patients were also better at delaying rewards.

Dynamic psychotherapy has been shown to achieve better outcomes in OCPD than cognitive-behavioral therapy, though both have a place in the treatment of OCPD, according to Dr. Gabbard. However, it comes with significant challenges. The patient will often challenge the therapist’s interventions and feel threatened by any hint of losing control. Sessions can become ritualized.

OCPD patients are driven by an effort to avoid a tormenting superego rather than seeking pleasure, and they may project this superego onto the therapist. It’s important to identify and interpret patient distortion of the therapist’s attitude toward the patient. Ultimately, the goal of therapy is to modify the patient’s self-expectations.

Couples therapy can be a good idea in cases of extreme ego-syntonicity. The patient’s partner can provide a second perspective to complement the patient’s subjective view of the relationship.

A unique challenge with OCPD is that therapists may see reflections of themselves in the patient. “Many physicians, psychiatrists, and therapists themselves struggle with obsessive-compulsive types of problems. Those types of traits – perfectionism, hard work, overwork, diligence – are rewarded in a career in medicine, and in fact [are] necessary for a career in medicine. We all have to be alert to our own personality traits in order to be able to treat those traits in others,” Dr. Crisp-Han said.” If we don’t recognize those traits in ourselves, then we run the risk of falling into competitive patterns, or idealizations, or other kinds of problems with our patients.”

Therapists who are narcissistically vulnerable may get sucked into power struggles with patients, and can feel undervalued, Dr. Gabbard said. Because rituals can develop, the therapist may also become bored, and even come to feel controlled by the patient’s obsession with the therapeutic process.

But there are other challenges in sessions. The tendency toward ritualization can produce boredom in the therapist. “That’s one of the biggest problems you have, hanging in with somebody who’s repeating the same things over and over again in a dry tone. You start to feel controlled by everything the patient is doing with their agenda,” Dr. Gabbard said during the session. He suggested confronting the patient from time to time. “You can say, ‘Today you don’t sound like you’re that interested in what you’re saying to me; you sound very detached. What’s going on?’ You can feed back to the person how they’re coming across, which can be very valuable.”

Humor is another way to tackle therapy with OCPD patients, because an important therapeutic lesson is to take things a little less seriously, especially in the face of the perfectionism that often haunts OCPD patients. In fact, this can be one of the condition’s most devastating traits, always leading an OCPD patient to feel that he or she is failing, that no accomplishment is ever enough.

“You can work on perfectionism and interpersonal relationships, and the absence of fun and pleasure. This is one of the most fun things to work on in the transference, countertransference relationship. Have a little bit of fun with the patient, because that might be quite foreign,” Dr. Gabbard said. “It can be tricky, because you don’t want to act like you’re laughing at the patient, but you want to introduce some levity and lightness sometimes.”

He gave an example of a patient who was a Catholic priest, who felt intensely guilty over sex. The patient said, “In the Catholic Church, thinking about sex is exactly the same as having sex.” Dr. Gabbard thought for a moment and then replied, “Well, you know, in my experience, that’s not true.”

The patient chuckled along with him. “I tried to point out to him that not all Catholic theologians see it that way,” Dr. Gabbard said.

Dr. Crisp-Han and Dr. Gabbard have collaborated on a book focused on diagnosis and treatment challenges associated with narcissistic patients called “Narcissism and Its Discontents” (American Psychiatric Association Publishing, 2018). They reported no relevant financial disclosures.

SAN FRANCISCO – Obsessive-compulsive personality disorder (OCPD) is often confused with obsessive-compulsive disorder (OCD) because of overlapping traits, but there are key differences that psychiatrists should be familiar with. OCPD also presents some key challenges to interpersonal therapy, especially because psychiatrists themselves sometimes share these traits.

“There’s an overlap, and some people have both OCD and OCPD, but some people have just one or the other, and that’s important to tease out because it shifts treatment,” Holly D. Crisp-Han, MD, said in an interview. Dr. Crisp-Han is a clinical associate professor of psychiatry and behavioral sciences at Baylor College of Medicine, Houston. She and her colleague, Glen O. Gabbard, MD, clinical professor of psychiatry at Baylor, chaired a session on dynamic psychotherapy for the treatment of OCPD at the annual meeting of the American Psychiatric Association.

OCPD is the most common personality disorder, with some estimates putting its prevalence as high as nearly 8%. Whereas OCD is characterized by an ego-dystonic need for rituals and specific thoughts, OCPD is defined by ego-syntonic traits. In a study comparing patients with both disorders, researchers found that both groups had reduced psychosocial function and quality of life, but intrusive thoughts and feelings were absent in OCPD. Instead, these patients reported ritualized, methodical behaviors, such as list making, reorganizing personal effects, and repeatedly editing what they had written. OCD patients were also better at delaying rewards.

Dynamic psychotherapy has been shown to achieve better outcomes in OCPD than cognitive-behavioral therapy, though both have a place in the treatment of OCPD, according to Dr. Gabbard. However, it comes with significant challenges. The patient will often challenge the therapist’s interventions and feel threatened by any hint of losing control. Sessions can become ritualized.

OCPD patients are driven by an effort to avoid a tormenting superego rather than seeking pleasure, and they may project this superego onto the therapist. It’s important to identify and interpret patient distortion of the therapist’s attitude toward the patient. Ultimately, the goal of therapy is to modify the patient’s self-expectations.

Couples therapy can be a good idea in cases of extreme ego-syntonicity. The patient’s partner can provide a second perspective to complement the patient’s subjective view of the relationship.

A unique challenge with OCPD is that therapists may see reflections of themselves in the patient. “Many physicians, psychiatrists, and therapists themselves struggle with obsessive-compulsive types of problems. Those types of traits – perfectionism, hard work, overwork, diligence – are rewarded in a career in medicine, and in fact [are] necessary for a career in medicine. We all have to be alert to our own personality traits in order to be able to treat those traits in others,” Dr. Crisp-Han said.” If we don’t recognize those traits in ourselves, then we run the risk of falling into competitive patterns, or idealizations, or other kinds of problems with our patients.”

Therapists who are narcissistically vulnerable may get sucked into power struggles with patients, and can feel undervalued, Dr. Gabbard said. Because rituals can develop, the therapist may also become bored, and even come to feel controlled by the patient’s obsession with the therapeutic process.

But there are other challenges in sessions. The tendency toward ritualization can produce boredom in the therapist. “That’s one of the biggest problems you have, hanging in with somebody who’s repeating the same things over and over again in a dry tone. You start to feel controlled by everything the patient is doing with their agenda,” Dr. Gabbard said during the session. He suggested confronting the patient from time to time. “You can say, ‘Today you don’t sound like you’re that interested in what you’re saying to me; you sound very detached. What’s going on?’ You can feed back to the person how they’re coming across, which can be very valuable.”

Humor is another way to tackle therapy with OCPD patients, because an important therapeutic lesson is to take things a little less seriously, especially in the face of the perfectionism that often haunts OCPD patients. In fact, this can be one of the condition’s most devastating traits, always leading an OCPD patient to feel that he or she is failing, that no accomplishment is ever enough.

“You can work on perfectionism and interpersonal relationships, and the absence of fun and pleasure. This is one of the most fun things to work on in the transference, countertransference relationship. Have a little bit of fun with the patient, because that might be quite foreign,” Dr. Gabbard said. “It can be tricky, because you don’t want to act like you’re laughing at the patient, but you want to introduce some levity and lightness sometimes.”

He gave an example of a patient who was a Catholic priest, who felt intensely guilty over sex. The patient said, “In the Catholic Church, thinking about sex is exactly the same as having sex.” Dr. Gabbard thought for a moment and then replied, “Well, you know, in my experience, that’s not true.”

The patient chuckled along with him. “I tried to point out to him that not all Catholic theologians see it that way,” Dr. Gabbard said.

Dr. Crisp-Han and Dr. Gabbard have collaborated on a book focused on diagnosis and treatment challenges associated with narcissistic patients called “Narcissism and Its Discontents” (American Psychiatric Association Publishing, 2018). They reported no relevant financial disclosures.

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN DIEGO – Among patients with asymptomatic gallstones, the need for surgical intervention increases over time to 25%, results from a large, long-term analysis showed.

Doug Brunk/MDedge News

“Most patients with asymptomatic gallstones never develop symptoms and probably don’t need surgical intervention,” lead study author Gareth Morris-Stiff, MD, PhD, said at the annual Digestive Disease Week.

Dr. Morris-Stiff, of the department of general surgery at Cleveland Clinic, said that, while previous studies have evaluated the time to development of gallstone-related complications following identification of asymptomatic gallstones, factors associated with the need for surgical intervention in this population have not been documented. The aims of the current study were to perform a big data analysis to evaluate risk factors associated with intervention in asymptomatic gallstones and to develop a risk stratification tool to aid in patient consultations by predicting individuals likely to need future intervention for their gallstones.

The researchers included Cleveland Clinic patients with CT/US reports containing “cholelithiasis” or “gallstones” between January 1996 and December 2016. Patients were excluded if they had a concurrent or prior event, had an event within 2 months, or lacked follow-up. Data collection included demographic characteristics, comorbid conditions or surgeries, imaging features, and medication use.


Dr. Morris-Stiff and his colleagues constructed Kaplan-Meier curves to analyze time to intervention and calculated cumulative incidence ratios. They used automated forward stepwise competing risk regression to create their model and receiver operating characteristics curves to analyze it.

Of the 49,414 patients identified with asymptomatic gallstones, 22,257 met criteria for analysis. Slightly more than half (51%) were female, their mean age was 61 years, 80% were white, 16% were black, and the rest were from other racial and ethnic groups. The median follow-up was 4.5 years, and the median follow-up of patients undergoing intervention was 3.9 years. This translated to 112,111 total years of observation.

The researchers found that the cumulative incidence of intervention at 15 years was 25% and it increased linearly from the time of initial diagnosis of asymptomatic gallstones. A total of 1,762 patients (7.9%) underwent a surgical procedure, most often cholecystectomy (5.7%). Three factors were associated with a reduced risk for surgical intervention: increasing age (hazard ratio, 0.94; P less than 0.001), male gender (HR, 0.78; P less than 0.001), and statin use (HR, 0.67; P less than 0.001).

Patient variables associated with an increased need for surgical intervention included obesity (HR, 1.44; P less than 0.001) and having a hemolytic disorder (HR, 2.42; P less than 0.001). Gallstone-specific characteristics that increased the need for surgical intervention included a stone size of greater than 9 mm (HR, 1.56; P less than 0.001), the presence of sludge (HR, 1.46; P less than 0.001), the presence of a polyp (HR, 1.68; P less than 0.001), and having multiple stones (HR, 1.69; P less than 0.001).

The analysis enabled Dr. Morris-Stiff and colleagues to generate a Web-based risk score to reliably identify these patients and provide prognostic information for counseling. An app for smartphones based on the score is being developed. The researchers reported having no financial disclosures.

dbrunk@mdedge.com

SAN FRANCISCO – Women in health care are second only to those in arts and entertainment in contacting* the TIME’S UP Legal Defense Fund, according to two founding members of TIME’S UP Healthcare, which was recently launched to address gender inequity and sexual harassment in medicine.

Vidyard Video

“As a psychiatrist who has had physicians as patients ... I’d heard this stuff, and I knew it existed,” said Jessica Gold, MD. But to hear it from people who had choked it down ... I understand what it’s like to be a pharma rep and be told that you have to look pretty or wear a thong to get a doctor to look at you.”

In this video, Dr. Gold and Kali D. Cyrus, MD, MPH, sat down at the annual meeting of the American Psychiatric Association and discussed the goals of TIME’S UP Healthcare and the need to bring transgressions – mainly against women – out in the open. The group also wants to advocate for establishing meaningful standards and policies.

“I feel like [psychiatrists are] trained to look for these kinds of dynamics. We should be trained to intervene ... My dream is [to address] some of the more subtle microaggressions that happen,” Dr. Cyrus said.

She wants to make sure that all women are equitably represented. We need “a procedure in place where people can voice their concerns.”

All of the group’s founding members are women, and men also need to participate as allies. “There are men who want to mentor women, Dr. Gold said. “We do need men to support us ... We also want to hear about their experiences,” Dr. Cyrus said.

Dr. Gold is assistant professor of psychiatry at Washington University in St. Louis. Dr. Cyrus is an assistant professor at Johns Hopkins University in Baltimore, and offers consultation services for conflict management of issues related to identity differences.

ghenderson@mdedge.com

*This story was updated 6/3/2019.

SAN FRANCISCO – Women in health care are second only to those in arts and entertainment in contacting* the TIME’S UP Legal Defense Fund, according to two founding members of TIME’S UP Healthcare, which was recently launched to address gender inequity and sexual harassment in medicine.

Vidyard Video

“As a psychiatrist who has had physicians as patients ... I’d heard this stuff, and I knew it existed,” said Jessica Gold, MD. But to hear it from people who had choked it down ... I understand what it’s like to be a pharma rep and be told that you have to look pretty or wear a thong to get a doctor to look at you.”

In this video, Dr. Gold and Kali D. Cyrus, MD, MPH, sat down at the annual meeting of the American Psychiatric Association and discussed the goals of TIME’S UP Healthcare and the need to bring transgressions – mainly against women – out in the open. The group also wants to advocate for establishing meaningful standards and policies.

“I feel like [psychiatrists are] trained to look for these kinds of dynamics. We should be trained to intervene ... My dream is [to address] some of the more subtle microaggressions that happen,” Dr. Cyrus said.

She wants to make sure that all women are equitably represented. We need “a procedure in place where people can voice their concerns.”

All of the group’s founding members are women, and men also need to participate as allies. “There are men who want to mentor women, Dr. Gold said. “We do need men to support us ... We also want to hear about their experiences,” Dr. Cyrus said.

Dr. Gold is assistant professor of psychiatry at Washington University in St. Louis. Dr. Cyrus is an assistant professor at Johns Hopkins University in Baltimore, and offers consultation services for conflict management of issues related to identity differences.

ghenderson@mdedge.com

*This story was updated 6/3/2019.

SAN FRANCISCO – Women in health care are second only to those in arts and entertainment in contacting* the TIME’S UP Legal Defense Fund, according to two founding members of TIME’S UP Healthcare, which was recently launched to address gender inequity and sexual harassment in medicine.

Vidyard Video

“As a psychiatrist who has had physicians as patients ... I’d heard this stuff, and I knew it existed,” said Jessica Gold, MD. But to hear it from people who had choked it down ... I understand what it’s like to be a pharma rep and be told that you have to look pretty or wear a thong to get a doctor to look at you.”

In this video, Dr. Gold and Kali D. Cyrus, MD, MPH, sat down at the annual meeting of the American Psychiatric Association and discussed the goals of TIME’S UP Healthcare and the need to bring transgressions – mainly against women – out in the open. The group also wants to advocate for establishing meaningful standards and policies.

“I feel like [psychiatrists are] trained to look for these kinds of dynamics. We should be trained to intervene ... My dream is [to address] some of the more subtle microaggressions that happen,” Dr. Cyrus said.

She wants to make sure that all women are equitably represented. We need “a procedure in place where people can voice their concerns.”

All of the group’s founding members are women, and men also need to participate as allies. “There are men who want to mentor women, Dr. Gold said. “We do need men to support us ... We also want to hear about their experiences,” Dr. Cyrus said.

Dr. Gold is assistant professor of psychiatry at Washington University in St. Louis. Dr. Cyrus is an assistant professor at Johns Hopkins University in Baltimore, and offers consultation services for conflict management of issues related to identity differences.

ghenderson@mdedge.com

*This story was updated 6/3/2019.

CHICAGO – In patients with high-risk stage II colon cancer, capecitabine plus oxaliplatin (CAPOX) given for 3 months may have efficacy as good as that of 6 months, with considerably less toxicity, as suggested by results of a new analysis by the IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration.

By contrast, 6 months of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) had better efficacy than that of 3 months of FOLFOX, albeit with significantly more toxicity than the shorter duration of treatment, according to IDEA investigator Timothy Iveson, MD, FRCP, of University Hospital Southampton (England) NHS Foundation Trust.

“As oncologists, we have patients in front of us, and we have the ability to choose which chemotherapy regimen we would choose,” Dr. Iveson said in a presentation at the annual meeting of the American Society of Clinical Oncology, “and we now have good data on both the efficacy and also toxicity of the regimens according to duration of treatment, and therefore, that should really allow us to recommend both the chemotherapy regimen and duration of treatment to our patients.”

The findings echo those of the previous study by the collaborative group, presented at ASCO in 2017 and subsequently published in the New England Journal of Medicine, focused on patients with stage III colon cancer. The overall analysis was negative, in that they could not confirm the noninferiority of 3 versus 6 months of adjuvant FOLFOX or CAPOX in the overall population; however, further analysis showed that, specifically for CAPOX, 3 months of treatment delivered the same efficacy as 6 months, especially in the lower-risk subgroup.

Treatment of stage III colon cancer got “more complicated” as a result of that study, said David P. Ryan, MD, of Harvard Medical School, Boston.

That’s in part because the National Comprehensive Cancer Network (NCCN) colon cancer guidelines subsequently divided stage III disease into low and high risk, with different recommendations for each, he said in an oral presentation at the ASCO meeting.

Specifically, the NCCN’s preferred regimens for low-risk stage III disease (T1-3, N1) are now 3 months of CAPOX or 3-6 months of FOLFOX, while for high-risk stage III disease (T4, N1-2; T any, N2), the preferred regimens are 3-6 months of CAPOX or 6 months of FOLFOX.

“The reason for this study is the toxicity of oxaliplatin, particularly neuropathy,” Dr. Ryan said in his remarks from the podium. “It can be substantial and life altering.” The incidence of grade 2 or greater neuropathy was cut from about 45% to 15% by going from 6 to 3 months of treatment, though reporting of the rate of chronic neuropathy would be informative to better qualify these results, he said.

The more recent prospective, preplanned, pooled analysis from the IDEA group focused on the four phase 3 IDEA studies (SCOT, TOSCA, ACHIEVE-2, and HORG), out of six total studies, that enrolled high-risk stage II patients. Their primary analysis included 3,273 patients, of whom 2,019 received CAPOX and 1,254 received FOLFOX.

Rates of grade 2 or greater neuropathy were 36% for 6 months of treatment, but just 13% for 3 months of treatment. However, in the overall analysis, IDEA investigators could not demonstrate the noninferiority of 3 versus 6 months of treatment in terms of efficacy—similar to what was reported in the previously reported analysis of stage III patients.

Results for CAPOX, however, did demonstrate noninferiority, according to Dr. Iveson, with a 5-year disease-free survival (DFS) of 81.7% for 3 months of treatment versus 82.0% for 6 months, an absolute difference of 0.3%, he said in his presentation. By contrast, the 5-year DFS for FOLFOX was 79.2% for 3 months of treatment versus 86.5%, an absolute 7.3% difference in favor of longer treatment duration.

“Therefore, the data strongly suggest noninferiority of 3 months’ CAPOX treatment compared to 6 months, but equally, it suggests inferiority of 3 months FOLFOX compared to 6 months,” Dr. Iveson said.

Whether these findings also change practice remains to be seen.

Dr. Ryan, discussant for the study, agreed that 3 months of CAPOX, but not FOLFOX, is likely sufficient for patients with high-risk stage II disease, with one caveat: “Remember, it is not proven as the primary endpoint,” he told attendees at ASCO.

He said a new era of adjuvant studies is needed to address individual subsets of colon cancer in the adjuvant setting, particularly those defined by different biologies, such as BRAF-mutant, MSI-high, or HER2-amplified.

“I have little enthusiasm to return to the fundamental question posed by IDEA in a new prospective study, given that the magnitude of benefit or difference is so small,” he said.

Dr. Iveson reported disclosures related to Lilly, Servier, BMS, Celgene, Roche, and Bayer.

CHICAGO – In patients with high-risk stage II colon cancer, capecitabine plus oxaliplatin (CAPOX) given for 3 months may have efficacy as good as that of 6 months, with considerably less toxicity, as suggested by results of a new analysis by the IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration.

By contrast, 6 months of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) had better efficacy than that of 3 months of FOLFOX, albeit with significantly more toxicity than the shorter duration of treatment, according to IDEA investigator Timothy Iveson, MD, FRCP, of University Hospital Southampton (England) NHS Foundation Trust.

“As oncologists, we have patients in front of us, and we have the ability to choose which chemotherapy regimen we would choose,” Dr. Iveson said in a presentation at the annual meeting of the American Society of Clinical Oncology, “and we now have good data on both the efficacy and also toxicity of the regimens according to duration of treatment, and therefore, that should really allow us to recommend both the chemotherapy regimen and duration of treatment to our patients.”

The findings echo those of the previous study by the collaborative group, presented at ASCO in 2017 and subsequently published in the New England Journal of Medicine, focused on patients with stage III colon cancer. The overall analysis was negative, in that they could not confirm the noninferiority of 3 versus 6 months of adjuvant FOLFOX or CAPOX in the overall population; however, further analysis showed that, specifically for CAPOX, 3 months of treatment delivered the same efficacy as 6 months, especially in the lower-risk subgroup.

Treatment of stage III colon cancer got “more complicated” as a result of that study, said David P. Ryan, MD, of Harvard Medical School, Boston.

That’s in part because the National Comprehensive Cancer Network (NCCN) colon cancer guidelines subsequently divided stage III disease into low and high risk, with different recommendations for each, he said in an oral presentation at the ASCO meeting.

Specifically, the NCCN’s preferred regimens for low-risk stage III disease (T1-3, N1) are now 3 months of CAPOX or 3-6 months of FOLFOX, while for high-risk stage III disease (T4, N1-2; T any, N2), the preferred regimens are 3-6 months of CAPOX or 6 months of FOLFOX.

“The reason for this study is the toxicity of oxaliplatin, particularly neuropathy,” Dr. Ryan said in his remarks from the podium. “It can be substantial and life altering.” The incidence of grade 2 or greater neuropathy was cut from about 45% to 15% by going from 6 to 3 months of treatment, though reporting of the rate of chronic neuropathy would be informative to better qualify these results, he said.

The more recent prospective, preplanned, pooled analysis from the IDEA group focused on the four phase 3 IDEA studies (SCOT, TOSCA, ACHIEVE-2, and HORG), out of six total studies, that enrolled high-risk stage II patients. Their primary analysis included 3,273 patients, of whom 2,019 received CAPOX and 1,254 received FOLFOX.

Rates of grade 2 or greater neuropathy were 36% for 6 months of treatment, but just 13% for 3 months of treatment. However, in the overall analysis, IDEA investigators could not demonstrate the noninferiority of 3 versus 6 months of treatment in terms of efficacy—similar to what was reported in the previously reported analysis of stage III patients.

Results for CAPOX, however, did demonstrate noninferiority, according to Dr. Iveson, with a 5-year disease-free survival (DFS) of 81.7% for 3 months of treatment versus 82.0% for 6 months, an absolute difference of 0.3%, he said in his presentation. By contrast, the 5-year DFS for FOLFOX was 79.2% for 3 months of treatment versus 86.5%, an absolute 7.3% difference in favor of longer treatment duration.

“Therefore, the data strongly suggest noninferiority of 3 months’ CAPOX treatment compared to 6 months, but equally, it suggests inferiority of 3 months FOLFOX compared to 6 months,” Dr. Iveson said.

Whether these findings also change practice remains to be seen.

Dr. Ryan, discussant for the study, agreed that 3 months of CAPOX, but not FOLFOX, is likely sufficient for patients with high-risk stage II disease, with one caveat: “Remember, it is not proven as the primary endpoint,” he told attendees at ASCO.

He said a new era of adjuvant studies is needed to address individual subsets of colon cancer in the adjuvant setting, particularly those defined by different biologies, such as BRAF-mutant, MSI-high, or HER2-amplified.

“I have little enthusiasm to return to the fundamental question posed by IDEA in a new prospective study, given that the magnitude of benefit or difference is so small,” he said.

Dr. Iveson reported disclosures related to Lilly, Servier, BMS, Celgene, Roche, and Bayer.

CHICAGO – In patients with high-risk stage II colon cancer, capecitabine plus oxaliplatin (CAPOX) given for 3 months may have efficacy as good as that of 6 months, with considerably less toxicity, as suggested by results of a new analysis by the IDEA (International Duration Evaluation of Adjuvant Chemotherapy) Collaboration.

By contrast, 6 months of fluorouracil, leucovorin, and oxaliplatin (FOLFOX) had better efficacy than that of 3 months of FOLFOX, albeit with significantly more toxicity than the shorter duration of treatment, according to IDEA investigator Timothy Iveson, MD, FRCP, of University Hospital Southampton (England) NHS Foundation Trust.

“As oncologists, we have patients in front of us, and we have the ability to choose which chemotherapy regimen we would choose,” Dr. Iveson said in a presentation at the annual meeting of the American Society of Clinical Oncology, “and we now have good data on both the efficacy and also toxicity of the regimens according to duration of treatment, and therefore, that should really allow us to recommend both the chemotherapy regimen and duration of treatment to our patients.”

The findings echo those of the previous study by the collaborative group, presented at ASCO in 2017 and subsequently published in the New England Journal of Medicine, focused on patients with stage III colon cancer. The overall analysis was negative, in that they could not confirm the noninferiority of 3 versus 6 months of adjuvant FOLFOX or CAPOX in the overall population; however, further analysis showed that, specifically for CAPOX, 3 months of treatment delivered the same efficacy as 6 months, especially in the lower-risk subgroup.

Treatment of stage III colon cancer got “more complicated” as a result of that study, said David P. Ryan, MD, of Harvard Medical School, Boston.

That’s in part because the National Comprehensive Cancer Network (NCCN) colon cancer guidelines subsequently divided stage III disease into low and high risk, with different recommendations for each, he said in an oral presentation at the ASCO meeting.

Specifically, the NCCN’s preferred regimens for low-risk stage III disease (T1-3, N1) are now 3 months of CAPOX or 3-6 months of FOLFOX, while for high-risk stage III disease (T4, N1-2; T any, N2), the preferred regimens are 3-6 months of CAPOX or 6 months of FOLFOX.

“The reason for this study is the toxicity of oxaliplatin, particularly neuropathy,” Dr. Ryan said in his remarks from the podium. “It can be substantial and life altering.” The incidence of grade 2 or greater neuropathy was cut from about 45% to 15% by going from 6 to 3 months of treatment, though reporting of the rate of chronic neuropathy would be informative to better qualify these results, he said.

The more recent prospective, preplanned, pooled analysis from the IDEA group focused on the four phase 3 IDEA studies (SCOT, TOSCA, ACHIEVE-2, and HORG), out of six total studies, that enrolled high-risk stage II patients. Their primary analysis included 3,273 patients, of whom 2,019 received CAPOX and 1,254 received FOLFOX.

Rates of grade 2 or greater neuropathy were 36% for 6 months of treatment, but just 13% for 3 months of treatment. However, in the overall analysis, IDEA investigators could not demonstrate the noninferiority of 3 versus 6 months of treatment in terms of efficacy—similar to what was reported in the previously reported analysis of stage III patients.

Results for CAPOX, however, did demonstrate noninferiority, according to Dr. Iveson, with a 5-year disease-free survival (DFS) of 81.7% for 3 months of treatment versus 82.0% for 6 months, an absolute difference of 0.3%, he said in his presentation. By contrast, the 5-year DFS for FOLFOX was 79.2% for 3 months of treatment versus 86.5%, an absolute 7.3% difference in favor of longer treatment duration.

“Therefore, the data strongly suggest noninferiority of 3 months’ CAPOX treatment compared to 6 months, but equally, it suggests inferiority of 3 months FOLFOX compared to 6 months,” Dr. Iveson said.

Whether these findings also change practice remains to be seen.

Dr. Ryan, discussant for the study, agreed that 3 months of CAPOX, but not FOLFOX, is likely sufficient for patients with high-risk stage II disease, with one caveat: “Remember, it is not proven as the primary endpoint,” he told attendees at ASCO.

He said a new era of adjuvant studies is needed to address individual subsets of colon cancer in the adjuvant setting, particularly those defined by different biologies, such as BRAF-mutant, MSI-high, or HER2-amplified.

“I have little enthusiasm to return to the fundamental question posed by IDEA in a new prospective study, given that the magnitude of benefit or difference is so small,” he said.

Dr. Iveson reported disclosures related to Lilly, Servier, BMS, Celgene, Roche, and Bayer.