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Cancer groups offer guidance on immune-related adverse events
The American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have released new guidelines designed to help clinicians manage the unique and sometimes severe side effects associated with cancer immunotherapy agents.
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“The mechanism of action of these anticancer therapies is so much different from anything that we’re used to,” Dr. Schneider said in an interview.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Critical need for guidance
The ASCO and NCCN guidelines are “critically important” to ensure uniform management of common immune-related adverse events, according to Stephen M. Ansell, MD, PhD, professor of medicine and chair of the Lymphoma Group at Mayo Clinic, Rochester, Minn.
“I think it also specifically highlights a few side effects that many people may not necessarily think about, from eye toxicities to thyroid effects, or the type of things that the average oncologist who is now using this in their practice quite regularly may not necessarily think about,” Dr. Ansell said. “Those kind of effects are now clearly outlined with clear guidance about what should be done, and I think that allows oncologists a resource to go and look at this carefully so that they do the right thing.”
The spectrum of adverse effects associated with checkpoint inhibitors is markedly different from what is seen with cytotoxic chemotherapy, the guidelines note. Most often, the side effects are seen in the skin, GI tract, and lungs, as well as the endocrine, adrenal, nervous, thyroid, pituitary, musculoskeletal, cardiovascular, ocular, and hematologic systems.
Stepwise approach
Side effects of checkpoint inhibitors are typically mild, but they can be severe and sometimes life-threatening, according to ASCO and NCCN.
If immune-related adverse events are mild (i.e., grade 1), treatment can continue with close monitoring, according to the guidelines. By contrast, moderate to severe immune-related adverse events can lead to severe declines in organ function and quality of life, or even fatal outcomes, so early detection and proper management are needed.
Grade 2 toxicities warrant suspending immune checkpoint inhibitor treatment, and resuming it once symptoms subside to grade 1 or less, according to the guidelines. Grade 3 toxicities should also prompt suspension of treatment, plus initiation of high-dose corticosteroids tapered over at least 4-6 weeks.
For most toxicities that reach grade 4, permanent discontinuation of checkpoint inhibitors is recommended.
A thoughtful discussion of potential risks and benefits is needed before using immune checkpoint inhibitors in patients who have autoimmune disease or prior organ transplant, according to the guidelines.
Vigilance required
Checkpoint inhibitors have been approved by the Food and Drug Administration to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because immune-related adverse event symptoms can be subtle, according to Julie Brahmer, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focuses specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T-cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
The American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have released new guidelines designed to help clinicians manage the unique and sometimes severe side effects associated with cancer immunotherapy agents.
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“The mechanism of action of these anticancer therapies is so much different from anything that we’re used to,” Dr. Schneider said in an interview.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Critical need for guidance
The ASCO and NCCN guidelines are “critically important” to ensure uniform management of common immune-related adverse events, according to Stephen M. Ansell, MD, PhD, professor of medicine and chair of the Lymphoma Group at Mayo Clinic, Rochester, Minn.
“I think it also specifically highlights a few side effects that many people may not necessarily think about, from eye toxicities to thyroid effects, or the type of things that the average oncologist who is now using this in their practice quite regularly may not necessarily think about,” Dr. Ansell said. “Those kind of effects are now clearly outlined with clear guidance about what should be done, and I think that allows oncologists a resource to go and look at this carefully so that they do the right thing.”
The spectrum of adverse effects associated with checkpoint inhibitors is markedly different from what is seen with cytotoxic chemotherapy, the guidelines note. Most often, the side effects are seen in the skin, GI tract, and lungs, as well as the endocrine, adrenal, nervous, thyroid, pituitary, musculoskeletal, cardiovascular, ocular, and hematologic systems.
Stepwise approach
Side effects of checkpoint inhibitors are typically mild, but they can be severe and sometimes life-threatening, according to ASCO and NCCN.
If immune-related adverse events are mild (i.e., grade 1), treatment can continue with close monitoring, according to the guidelines. By contrast, moderate to severe immune-related adverse events can lead to severe declines in organ function and quality of life, or even fatal outcomes, so early detection and proper management are needed.
Grade 2 toxicities warrant suspending immune checkpoint inhibitor treatment, and resuming it once symptoms subside to grade 1 or less, according to the guidelines. Grade 3 toxicities should also prompt suspension of treatment, plus initiation of high-dose corticosteroids tapered over at least 4-6 weeks.
For most toxicities that reach grade 4, permanent discontinuation of checkpoint inhibitors is recommended.
A thoughtful discussion of potential risks and benefits is needed before using immune checkpoint inhibitors in patients who have autoimmune disease or prior organ transplant, according to the guidelines.
Vigilance required
Checkpoint inhibitors have been approved by the Food and Drug Administration to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because immune-related adverse event symptoms can be subtle, according to Julie Brahmer, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focuses specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T-cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
The American Society of Clinical Oncology (ASCO) and the National Comprehensive Cancer Network (NCCN) have released new guidelines designed to help clinicians manage the unique and sometimes severe side effects associated with cancer immunotherapy agents.
These guidelines meet a growing need to help practicing clinicians identify and best manage immune-related adverse events, according to Bryan J. Schneider, MD, of the University of Michigan Comprehensive Cancer Center, and vice chair of the NCCN Panel on Management of Immunotherapy-Related Toxicities.
“The mechanism of action of these anticancer therapies is so much different from anything that we’re used to,” Dr. Schneider said in an interview.
“We’re experienced with chemotherapy, and we are very comfortable with the side effects,” he said. “The immunotherapy story is just an entirely different world because, as I tell patients, the therapies aren’t directly damaging cancer cells like chemotherapy. Instead, they are helping the immune system to identify the cancer cells as abnormal and mount an assault. Proteins on cancer cells may suppress the immune response and these therapies effectively ‘release these brakes’ so the immune system can attack.”
Critical need for guidance
The ASCO and NCCN guidelines are “critically important” to ensure uniform management of common immune-related adverse events, according to Stephen M. Ansell, MD, PhD, professor of medicine and chair of the Lymphoma Group at Mayo Clinic, Rochester, Minn.
“I think it also specifically highlights a few side effects that many people may not necessarily think about, from eye toxicities to thyroid effects, or the type of things that the average oncologist who is now using this in their practice quite regularly may not necessarily think about,” Dr. Ansell said. “Those kind of effects are now clearly outlined with clear guidance about what should be done, and I think that allows oncologists a resource to go and look at this carefully so that they do the right thing.”
The spectrum of adverse effects associated with checkpoint inhibitors is markedly different from what is seen with cytotoxic chemotherapy, the guidelines note. Most often, the side effects are seen in the skin, GI tract, and lungs, as well as the endocrine, adrenal, nervous, thyroid, pituitary, musculoskeletal, cardiovascular, ocular, and hematologic systems.
Stepwise approach
Side effects of checkpoint inhibitors are typically mild, but they can be severe and sometimes life-threatening, according to ASCO and NCCN.
If immune-related adverse events are mild (i.e., grade 1), treatment can continue with close monitoring, according to the guidelines. By contrast, moderate to severe immune-related adverse events can lead to severe declines in organ function and quality of life, or even fatal outcomes, so early detection and proper management are needed.
Grade 2 toxicities warrant suspending immune checkpoint inhibitor treatment, and resuming it once symptoms subside to grade 1 or less, according to the guidelines. Grade 3 toxicities should also prompt suspension of treatment, plus initiation of high-dose corticosteroids tapered over at least 4-6 weeks.
For most toxicities that reach grade 4, permanent discontinuation of checkpoint inhibitors is recommended.
A thoughtful discussion of potential risks and benefits is needed before using immune checkpoint inhibitors in patients who have autoimmune disease or prior organ transplant, according to the guidelines.
Vigilance required
Checkpoint inhibitors have been approved by the Food and Drug Administration to treat a variety of cancers, including melanoma, lung cancer, and Hodgkin lymphoma, as well as lung, liver, kidney, and bladder cancers.
Clinicians managing patients on checkpoint inhibitors should always be vigilant because immune-related adverse event symptoms can be subtle, according to Julie Brahmer, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore.
“Everyone has to work as a team, which includes being educated on possible side effects to immunotherapy prior to prescribing it,” said Dr. Brahmer, chair of the ASCO panel and vice chair of the NCCN panel that developed the guidelines.
The guidelines were published Feb. 14 in two documents that are similar in content, but different in format. The ASCO guideline was published in the Journal of Clinical Oncology (doi: 10.1200/JCO.2017.77.6385) and the NCCN Clinical Practice Guidelines in Oncology were posted on the NCCN website.
While the first edition of the guidelines focuses specifically on immune checkpoint inhibitors, an update anticipated for 2019 will include guidance on chimeric antigen receptor (CAR) T-cell therapy, which is associated with several important side effects, notably cytokine release syndrome.
Collaboration, consultation part of AAP teen depression guidelines update
The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.
“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.
Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.
“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.
“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”
Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.
“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.
Part I
Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.
For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.
The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.
The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.
Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.
The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.
Part II
Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.
The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.
The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.
The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.
Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.
The final treatment recommendation is for active support of a depressed teen’s referral to mental health if necessary for best management and sharing care if possible, with an understanding of the roles of the primary and specialty clinicians, the guidelines state.
The guidelines project was funded by the Resource for Advancing Children’s Health Institute and the Bell Canada Chair in Adolescent Mood and Anxiety Disorders.
Dr. Cheung and Dr. Zuckerbrot receive book royalties. Dr Zuckerbrot works for child and adolescent psychiatry for primary care (CAP-PC), now a regional provider for Project TEACH in New York State, and she is on the steering committee as well as faculty for the REACH Institute; both of these institutions are described in the guidelines. Peter S. Jensen, MD, has received royalties from Random House, Oxford University Press, and APPI Inc. He is a part owner of a consulting company, CATCH Services LLC. He is the chief executive officer and president of a nonprofit organization, the Resource for Advancing Children’s Health Institute, but receives no compensation. The other authors indicated they have no financial relationships relevant to the guidelines.
“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”
The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.
“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”
Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.
“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”
The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.
“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”
Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.
“Mental health disorders have become one of the new morbidities in pediatric care,” Karalyn Kinsella, MD, said in an interview. “With one in five patients having depression, it is an illness that must be within our domain to identify and treat. I think the guidelines will make providers feel more confident in making a diagnosis and providing initial treatment. For those that do not feel comfortable, hopefully the guidelines will encourage them to seek training.
“I think many providers may be concerned about the time it takes to identify and treat [depression] as well as a lack of expertise,” she noted. “Ideally, the guidelines will streamline the identification and treatment process to make them more manageable during preventative care visits.”
The take-home message for general pediatricians is that a standardized screening tool makes identifying depression relatively easy. “We have been using the PHQ-9 [Patient Health Questionnaire-9] in my office for several years, and it is very easy to administer and score, and is billable,” said Dr. Kinsella. “It can take some practice to tease out some typical teen behaviors, especially on the sleep and fatigue questions, but it provides an opportunity to open up discussion with the teen.
“Treatment [of depression] can be more complicated and time consuming, but rewarding and invaluable to the patient,” she emphasized. “Many states now have psychiatrists available by phone consultation to aid in management of medication. The key is establishing a list of quality counselors for referrals. With those supports and frequent follow-up, pediatricians can play a key role in the treatment of this prevalent and important illness that affects our patients.”
Dr. Kinsella is a pediatrician in Cheshire, Conn., and a member of the Pediatric News editorial advisory board. She was asked to comment on the new AAP teen depression guidelines.
The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.
“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.
Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.
“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.
“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”
Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.
“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.
Part I
Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.
For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.
The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.
The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.
Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.
The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.
Part II
Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.
The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.
The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.
The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.
Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.
The final treatment recommendation is for active support of a depressed teen’s referral to mental health if necessary for best management and sharing care if possible, with an understanding of the roles of the primary and specialty clinicians, the guidelines state.
The guidelines project was funded by the Resource for Advancing Children’s Health Institute and the Bell Canada Chair in Adolescent Mood and Anxiety Disorders.
Dr. Cheung and Dr. Zuckerbrot receive book royalties. Dr Zuckerbrot works for child and adolescent psychiatry for primary care (CAP-PC), now a regional provider for Project TEACH in New York State, and she is on the steering committee as well as faculty for the REACH Institute; both of these institutions are described in the guidelines. Peter S. Jensen, MD, has received royalties from Random House, Oxford University Press, and APPI Inc. He is a part owner of a consulting company, CATCH Services LLC. He is the chief executive officer and president of a nonprofit organization, the Resource for Advancing Children’s Health Institute, but receives no compensation. The other authors indicated they have no financial relationships relevant to the guidelines.
The updated information includes recommendations on collaborative care, practice preparation, establishing networks of referrals, and much more.
“These guidelines were developed for PC clinicians who are in a position to identify and assist youth with depression in their practice settings,” they said. The guidelines apply to individuals aged 10-21 years, and support universal depression screening for those aged 12 and older.
Known as the Guidelines for Adolescent Depression in Primary Care (GLAD-PC), they consist of two parts: Practice Preparation, Identification, Assessment, and Initial Management, with Dr. Zuckerbrot as the lead author, and Treatment and Ongoing Management, led by Amy H. Cheung, MD, of the University of Toronto. They were published online in Pediatrics.
“It has been over 10 years since the [last] guidelines were published and they are supposed to be updated every 5,” Dr. Zuckerbrot said in an interview. “Given the new evidence on screening, psychopharmacology, and collaborative care, the guidelines needed to be revised. The USPSTF [United States Preventive Services Task Force ] and the AAP had already supported universal adolescent depression screening, and these guidelines are finally aligned with those positions.
“Different parts of the guidelines will be the go-to for different pediatricians, depending on where they are in their delivery of mental health care,” she explained. “Some may need help with practice preparation while others may need advice on screening; others may already be prescribing and may need advice on ongoing treatment and follow-up. I think there is something for everyone.”
Implementation of the guidelines is difficult in a short visit, Dr. Zuckerbrot acknowledged. “In addition, pediatricians may not have been well trained in the management of adolescent depression during their residencies.” However, the guidelines discuss both “real teams to support the pediatricians in their efforts, as well as virtual teams when staffing is limited.
“The guidelines advise that pediatricians learn about child psychiatry primary care consultation programs in their state and make use of those free telephone consultation programs.” The guidelines also discuss strategies for collaborative or integrative care, she said.
Part I
Part I of the guidelines, “Practice Preparation, Identification, Assessment, and Initial Management,” includes several recommendations for each topic.
For practice preparation, the guidelines recommend that clinicians seek training in the assessment, diagnosis, and treatment of depression, and that they establish a network of referrals and mental health resources in their communities. This network may include not only health professionals, but also current patients and families who are managing teen depression. If available, state-wide or regional child and adolescent psychiatry consultation programs can be included.
The identification and surveillance section of the guidelines calls for screening all patients aged 12 years and older for depression each year, using a formal screening tool on paper or online. The screening could occur at an annual wellness visit or any other medical visit, such as a sports physical. A second recommendation calls for identifying patients at increased risk for depression because of factors such as personal history, family history, substance use, other psychiatric disorders, frequent somatic complaints, or trauma, and monitoring these individuals regularly for signs of depression using a formal screening tool.
The assessment and diagnosis section states that assessment should include interviews with the patients alone as well as with their families or caregivers, and should include screening teens for functional impairment.
Primary care physicians should evaluate for depression not only if an adolescent tests positive on a screening tool, but also in children who present with any emotional problem as the chief complaint, and in those in whom depression is highly suspected even if they test negative on a formal screening tool, the guidelines state.
The three recommendations for initial management of depression in the primary care setting are educating patients and families about depression; developing a treatment plan (if the primary care clinician has had appropriate training) and setting specific treatment goals in areas of functioning such as at home, with peers, and at school; and developing a safety plan that includes restricting access to weapons or other means of self-harm, according to the guidelines.
Part II
Part II of the recommendations, “Treatment and Ongoing Management,” discusses options for managing depression in the primary care setting and utilizing outside resources.
The treatment recommendations emphasize the use of integrated models, if possible. “There is a growing recognition that complex chronic conditions, such as depression, are most successfully managed with proactive, multidisciplinary, patient-centered care teams,” Dr. Cheung and her associates said.
The recommendation for cases of mild depression calls for a period of “active support and monitoring” for 6-8 weeks before reassessing if the teen shows no improvement. By contrast, for cases of moderate to severe depression or cases with evidence of substance abuse or other psychoses, the recommendation calls for potential consultation with a mental health specialist and a discussion of the roles primary and specialty care will play in treatment. The guidelines include a flow chart for PC physicians to follow.
The guidelines suggest that PC clinicians recommend “scientifically tested and proven treatments,” such as psychotherapies, cognitive behavioral therapy (CBT) or interpersonal psychotherapy for adolescents, and/or antidepressant treatment, such as SSRIs, whenever possible and appropriate. It is important to monitor teens on antidepressants regularly to identify adverse events.
Recommendations for the ongoing management of teens with depression in the primary care setting include regular tracking of progress, reassessment if the teen shows no improvement in 6-8 weeks, and consultation with a mental health professional for those who show only partial improvement after exhausting primary care diagnostic and treatment options. Assessment of depressive symptoms is not the only thing to track. Functioning at home, school, and among peers also is important.
The final treatment recommendation is for active support of a depressed teen’s referral to mental health if necessary for best management and sharing care if possible, with an understanding of the roles of the primary and specialty clinicians, the guidelines state.
The guidelines project was funded by the Resource for Advancing Children’s Health Institute and the Bell Canada Chair in Adolescent Mood and Anxiety Disorders.
Dr. Cheung and Dr. Zuckerbrot receive book royalties. Dr Zuckerbrot works for child and adolescent psychiatry for primary care (CAP-PC), now a regional provider for Project TEACH in New York State, and she is on the steering committee as well as faculty for the REACH Institute; both of these institutions are described in the guidelines. Peter S. Jensen, MD, has received royalties from Random House, Oxford University Press, and APPI Inc. He is a part owner of a consulting company, CATCH Services LLC. He is the chief executive officer and president of a nonprofit organization, the Resource for Advancing Children’s Health Institute, but receives no compensation. The other authors indicated they have no financial relationships relevant to the guidelines.
FROM PEDIATRICS
AGA Guideline: Use goal-directed fluid therapy, early oral feeding in acute pancreatitis
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
Patients with acute pancreatitis should receive “goal-directed” fluid therapy with normal saline or Ringer’s lactate solution rather than hydroxyethyl starch (HES) fluids, states a new guideline from the AGA Institute.
In a single-center randomized trial, hydroxyethyl starch fluids conferred a 3.9-fold increase in the odds of multiorgan failure (95% confidence interval for odds ratio, 1.2-12.0) compared with normal saline in patients with acute pancreatitis, wrote guideline authors Seth D. Crockett, MD, MPH, of the University of North Carolina, Chapel Hill, and his associates. This trial and another randomized study found no mortality benefit for HES compared with fluid resuscitation. The evidence is “very low quality” but mirrors the critical care literature, according to the experts. So far, Ringer’s lactate solution and normal saline have shown similar effects on the risk of organ failure, necrosis, and mortality, but ongoing trials should better clarify this choice, they noted (Gastroenterology. doi: 10.1053/j.gastro.2018.01.032).
The guideline addresses the initial 2-week period of treating acute pancreatitis. It defines goal-directed fluid therapy as titration based on meaningful targets, such as heart rate, mean arterial pressure, central venous pressure, urine output, blood urea nitrogen concentration, and hematocrit. Studies of goal-directed fluid therapy in acute pancreatitis have been unblinded, have used inconsistent outcome measures, and have found no definite benefits over nontargeted fluid therapy, note the guideline authors. Nevertheless, they conditionally recommend goal-directed fluid therapy, partly because a randomized, blinded trial of patients with severe sepsis or septic shock (which physiologically resembles acute pancreatitis) had in-hospital mortality rates of 31% when they received goal-directed fluid therapy and 47% when they received standard fluid therapy (P = .0009).
The guideline recommends against routine use of two interventions: prophylactic antibiotics and urgent endoscopic retrograde cholangiopancreatography (ERCP) for patients with acute pancreatitis. The authors note that no evidence supports routine prophylactic antibiotics for acute pancreatitis patients without cholangitis, and that urgent ERCP did not significantly affect the risk of mortality, multiorgan failure, single-organ failure, infected pancreatic and peripancreatic necrosis, or necrotizing pancreatitis in eight randomized controlled trials of patients with acute gallstone pancreatitis.
The guideline strongly recommends early oral feeding and enteral rather than parenteral nutrition for all patients with acute pancreatitis. In 11 randomized controlled trials, early and delayed feeding led to similar rates of mortality, but delayed feeding produced a 2.5-fold higher risk of necrosis (95% CI for OR, 1.4-4.4) and tended to increase the risk of infected peripancreatic necrosis, multiorgan failure, and total necrotizing pancreatitis, the authors wrote. In another 12 trials, enteral nutrition significantly reduced the risk of infected peripancreatic necrosis, single-organ failure, and multiorgan failure compared with parenteral nutrition.
Clinicians continue to debate cholecystectomy timing in patients with biliary or gallstone pancreatitis. The guidelines strongly recommend same-admission cholecystectomy, citing a randomized controlled trial in which this approach markedly reduced the combined risk of mortality and gallstone-related complications (OR, 0.2, 95% CI, 0.1-0.6), readmission for recurrent pancreatitis (OR, 0.3, 95% CI, 0.1-0.9), and pancreaticobiliary complications (OR, 0.2, 95% CI, 0.1-0.6). “The AGA issued a strong recommendation due to the quality of available evidence and the high likelihood of benefit from early versus delayed cholecystectomy in this patient population,” the experts stated.
Patients with biliary pancreatitis should be evaluated for cholecystectomy during the same admission, while those with alcohol-induced pancreatitis should receive a brief alcohol intervention, according to the guidelines, which also call for better studies of how alcohol and tobacco cessation measures affect risk of recurrent acute pancreatitis, chronic pancreatitis, and pancreatic cancer, as well as quality of life, health care utilization, and mortality.
The authors also noted knowledge gaps concerning the relative benefits of risk stratification tools, the use of prophylactic antibiotics in patients with severe acute pancreatitis or necrotizing pancreatitis, and the timing of ERCP in patients with severe biliary pancreatitis with persistent biliary obstruction.
The guideline was developed with sole funding by the AGA Institute with no external funding. The authors disclosed no relevant conflicts of interest.
Source: Crockett SD et al. Gastroenterology. doi: 10.1053/j.gastro.2018.01.032.
FROM GASTROENTEROLOGY
Guidelines update best practices for hemorrhoid treatment
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
Each year, more than 2.2 million patients in the United States undergo evaluations for symptoms of hemorrhoids, according to updated guidelines on the management of hemorrhoids issued by the American Society of Colon and Rectal Surgeons.
“As a result, it is important to identify symptomatic hemorrhoids as the underlying source of the anorectal symptom and to have a clear understanding of the evaluation and management of this disease process,” wrote Bradley R. Davis, MD, FACS, chief of colon and rectal surgery at the Carolinas Medical Center, Charlotte, N.C., and the fellow members of the Clinical Practice Guidelines Committee of the ASCRS.
The guidelines recommend evaluation of hemorrhoids based on a disease-specific history, and a physical that emphasizes the degree and duration of symptoms and identifies risk factors. But the guideline writers note that the recommendation is a grade 1C because the supporting data mainly come from observational or case studies.
“The cardinal signs of internal hemorrhoids are painless bleeding with bowel movements with intermittent protrusion,” the committee said, also emphasizing that patients should be evaluated for fecal incontinence, which could inform surgical decision making.
In addition, the guidelines call for a complete endoscopic evaluation of the colon for patients who present with symptomatic hemorrhoids and rectal bleeding; this recommendation is based on moderately strong evidence, and presented with a grade of 1B.
Medical management of hemorrhoids may include office-based procedures or surgery, according to the guidelines.
“Most patients with grade I and II and select patients with grade III internal hemorrhoidal disease who fail medical treatment can be effectively treated with office-based procedures, such as banding, sclerotherapy, and infrared coagulation,” the committee wrote, and medical office treatment received a strong grade 1A recommendation based on high-quality evidence. Although office procedures are generally well tolerated, the condition can recur. Bleeding is the most common complication, and it is more likely after rubber-band ligation than other office-based options, the guidelines state.
The guidelines offer a weak recommendation of 2C, based on the lack of quality evidence, for the use of early surgical excision to treat patients with thrombosed external hemorrhoids. “Although most patients treated nonoperatively will experience eventual resolution of their symptoms, excision of thrombosed external hemorrhoids may result in more rapid symptom resolution, lower incidence of recurrence, and longer remission intervals,” the committee noted.
Surgical hemorrhoidectomy received the strongest possible recommendation (1A, based on high-quality evidence) for the treatment of patients with external hemorrhoids or a combination of internal and external hemorrhoids with prolapse.
Surgical options described in the recommendations include surgical excision (hemorrhoidectomy), hemorrhoidopexy, and Doppler-guided hemorrhoidectomy, with citations of studies on each procedure. Data from a meta-analysis of 18 randomized prospective studies comparing hemorrhoidectomy with office-based procedures showed that hemorrhoidectomy was “the most effective treatment for patients with grade III hemorrhoids,” but it was associated with greater pain and complication rates, according to the guidelines.
However, complications in general are low after surgical hemorrhoidectomy, with reported complication rates of 1%-2% for the most common complication of postprocedure hemorrhage, the guidelines state. After surgery, the guidelines recommend with a 1B grade (moderate quality evidence) that patients use “a multimodality pain regimen to reduce narcotic usage and promote a faster recovery.”
The committee members had no financial conflicts to disclose.
SOURCE: Davis BR et al. Dis Colon Rectum. 2018; 61:284-92.
FROM DISEASES OF THE COLON & RECTUM
New C. difficile guidelines recommend fecal microbiota transplants
.
The updated Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children, published in the Feb. 15 edition of Clinical Infectious Diseases (doi: 10.1093/cid/cix1085), address changes in management and diagnosis of the infection, and include recommendations for pediatric infection. The guidelines from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America were lasted published in 2010.
One of the strongest recommendations was on the use of FMTs to treat recurrent C. difficile infection after the failure of antibiotic therapy.
L. Clifford McDonald, MD, of the Centers for Disease Control and Prevention, and his coauthors commented that approximately one-quarter of patients whose infection is treated with vancomycin will likely experience at least one additional episode of infection. Those whose recurrent infection fails to resolve despite repeat courses of antibiotics are a challenging group for clinicians, but one for whom FMT could be a viable alternative treatment approach.
“Anecdotal treatment success rates of fecal microbiota transplantation for recurrent CDI [C. difficile infection] have been high regardless of route of instillation of feces, and have ranged between 77% and 94% with administration via the proximal small bowel; the highest success rates (80%-100%) have been associated with instillation of feces via the colon,” they wrote.
The guidelines also addressed what the authors described as the “evolving controversy” over the best methods for diagnosis, pointing out that there is little consensus about the best laboratory testing method.
“Given these various conundrums and the paucity of large prospective studies, the recommendations, while strong in some instances, are based upon a very low to low quality of evidence,” the authors said.
That aside, they advised that patients with unexplained and new-onset diarrhea (three or more unformed stools in 24 hours) were the preferred target population for testing for C. difficile infection. The most sensitive method of diagnosis in patients with clinical symptoms likely to be C. difficile infection was a nucleic acid amplification test, or a multistep algorithm, rather than a toxin test alone.
The guidelines committee also strongly advised against repeat testing within 7 days during the same episode of diarrhea, and against testing stool from asymptomatic patients, except for the purpose of epidemiologic study. They also noted there was insufficient evidence for the use of biologic markers such as fecal lactoferrin as an adjunct to testing.
The guidelines’ authors found there was not enough evidence to recommend discontinuing proton pump inhibitors to reduce the incidence of C. difficile infection, despite epidemiologic evidence of an association between proton pump inhibitor use and C. difficile infection. Similarly, there was a lack of evidence for the use of probiotics for primary prevention, but the authors noted that meta-analyses suggest probiotics may help prevent C. difficile infection in patients on antibiotics without a history of C. difficile infection.
With respect to antibiotic treatment, they recommended that patients diagnosed with C. difficile infection should first discontinue the inciting antibiotic treatment and then begin therapy with either vancomycin or fidaxomicin. For recurrent infection, they advised a tapered and pulsed regimen of oral vancomycin or a 10-day course of fidaxomicin. If patients had received metronidazole for the primary episode, they should be given a standard 10-day course of vancomycin for recurrent infection, the authors said.
In terms of diagnosis and management of pediatric C. difficile, the guidelines advised against routinely testing infants under 2 years of age with diarrhea, as the rate of C. difficile colonization even among asymptomatic infants can be higher than 40%. Even in children older than age 2, there was only a “weak” recommendation for C. difficile testing in patients with prolonged or worsening diarrhea and other risk factors such as inflammatory bowel disease or recent antibiotic exposure.
Children with a first episode or first recurrence of nonsevere C. difficile should be treated with either metronidazole or vancomycin, the authors wrote, but in the case of more severe illness or second recurrence, oral vancomycin was preferred over metronidazole.
The authors also suggested clinicians consider FMTs for children with recurrent infection that had failed to respond to antibiotics, but noted the quality of evidence for this was very low.
The guidelines were funded by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Six authors declared grants, consultancies, board positions, and other payments from the pharmaceutical industry outside the submitted work. One author also held patents relating to the treatment and prevention of C. difficile infection.
SOURCE: McDonald CL et al. Clin Infect Dis. 2018 Feb 15. doi: 10.1093/cid/cix1085.
.
The updated Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children, published in the Feb. 15 edition of Clinical Infectious Diseases (doi: 10.1093/cid/cix1085), address changes in management and diagnosis of the infection, and include recommendations for pediatric infection. The guidelines from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America were lasted published in 2010.
One of the strongest recommendations was on the use of FMTs to treat recurrent C. difficile infection after the failure of antibiotic therapy.
L. Clifford McDonald, MD, of the Centers for Disease Control and Prevention, and his coauthors commented that approximately one-quarter of patients whose infection is treated with vancomycin will likely experience at least one additional episode of infection. Those whose recurrent infection fails to resolve despite repeat courses of antibiotics are a challenging group for clinicians, but one for whom FMT could be a viable alternative treatment approach.
“Anecdotal treatment success rates of fecal microbiota transplantation for recurrent CDI [C. difficile infection] have been high regardless of route of instillation of feces, and have ranged between 77% and 94% with administration via the proximal small bowel; the highest success rates (80%-100%) have been associated with instillation of feces via the colon,” they wrote.
The guidelines also addressed what the authors described as the “evolving controversy” over the best methods for diagnosis, pointing out that there is little consensus about the best laboratory testing method.
“Given these various conundrums and the paucity of large prospective studies, the recommendations, while strong in some instances, are based upon a very low to low quality of evidence,” the authors said.
That aside, they advised that patients with unexplained and new-onset diarrhea (three or more unformed stools in 24 hours) were the preferred target population for testing for C. difficile infection. The most sensitive method of diagnosis in patients with clinical symptoms likely to be C. difficile infection was a nucleic acid amplification test, or a multistep algorithm, rather than a toxin test alone.
The guidelines committee also strongly advised against repeat testing within 7 days during the same episode of diarrhea, and against testing stool from asymptomatic patients, except for the purpose of epidemiologic study. They also noted there was insufficient evidence for the use of biologic markers such as fecal lactoferrin as an adjunct to testing.
The guidelines’ authors found there was not enough evidence to recommend discontinuing proton pump inhibitors to reduce the incidence of C. difficile infection, despite epidemiologic evidence of an association between proton pump inhibitor use and C. difficile infection. Similarly, there was a lack of evidence for the use of probiotics for primary prevention, but the authors noted that meta-analyses suggest probiotics may help prevent C. difficile infection in patients on antibiotics without a history of C. difficile infection.
With respect to antibiotic treatment, they recommended that patients diagnosed with C. difficile infection should first discontinue the inciting antibiotic treatment and then begin therapy with either vancomycin or fidaxomicin. For recurrent infection, they advised a tapered and pulsed regimen of oral vancomycin or a 10-day course of fidaxomicin. If patients had received metronidazole for the primary episode, they should be given a standard 10-day course of vancomycin for recurrent infection, the authors said.
In terms of diagnosis and management of pediatric C. difficile, the guidelines advised against routinely testing infants under 2 years of age with diarrhea, as the rate of C. difficile colonization even among asymptomatic infants can be higher than 40%. Even in children older than age 2, there was only a “weak” recommendation for C. difficile testing in patients with prolonged or worsening diarrhea and other risk factors such as inflammatory bowel disease or recent antibiotic exposure.
Children with a first episode or first recurrence of nonsevere C. difficile should be treated with either metronidazole or vancomycin, the authors wrote, but in the case of more severe illness or second recurrence, oral vancomycin was preferred over metronidazole.
The authors also suggested clinicians consider FMTs for children with recurrent infection that had failed to respond to antibiotics, but noted the quality of evidence for this was very low.
The guidelines were funded by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Six authors declared grants, consultancies, board positions, and other payments from the pharmaceutical industry outside the submitted work. One author also held patents relating to the treatment and prevention of C. difficile infection.
SOURCE: McDonald CL et al. Clin Infect Dis. 2018 Feb 15. doi: 10.1093/cid/cix1085.
.
The updated Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children, published in the Feb. 15 edition of Clinical Infectious Diseases (doi: 10.1093/cid/cix1085), address changes in management and diagnosis of the infection, and include recommendations for pediatric infection. The guidelines from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America were lasted published in 2010.
One of the strongest recommendations was on the use of FMTs to treat recurrent C. difficile infection after the failure of antibiotic therapy.
L. Clifford McDonald, MD, of the Centers for Disease Control and Prevention, and his coauthors commented that approximately one-quarter of patients whose infection is treated with vancomycin will likely experience at least one additional episode of infection. Those whose recurrent infection fails to resolve despite repeat courses of antibiotics are a challenging group for clinicians, but one for whom FMT could be a viable alternative treatment approach.
“Anecdotal treatment success rates of fecal microbiota transplantation for recurrent CDI [C. difficile infection] have been high regardless of route of instillation of feces, and have ranged between 77% and 94% with administration via the proximal small bowel; the highest success rates (80%-100%) have been associated with instillation of feces via the colon,” they wrote.
The guidelines also addressed what the authors described as the “evolving controversy” over the best methods for diagnosis, pointing out that there is little consensus about the best laboratory testing method.
“Given these various conundrums and the paucity of large prospective studies, the recommendations, while strong in some instances, are based upon a very low to low quality of evidence,” the authors said.
That aside, they advised that patients with unexplained and new-onset diarrhea (three or more unformed stools in 24 hours) were the preferred target population for testing for C. difficile infection. The most sensitive method of diagnosis in patients with clinical symptoms likely to be C. difficile infection was a nucleic acid amplification test, or a multistep algorithm, rather than a toxin test alone.
The guidelines committee also strongly advised against repeat testing within 7 days during the same episode of diarrhea, and against testing stool from asymptomatic patients, except for the purpose of epidemiologic study. They also noted there was insufficient evidence for the use of biologic markers such as fecal lactoferrin as an adjunct to testing.
The guidelines’ authors found there was not enough evidence to recommend discontinuing proton pump inhibitors to reduce the incidence of C. difficile infection, despite epidemiologic evidence of an association between proton pump inhibitor use and C. difficile infection. Similarly, there was a lack of evidence for the use of probiotics for primary prevention, but the authors noted that meta-analyses suggest probiotics may help prevent C. difficile infection in patients on antibiotics without a history of C. difficile infection.
With respect to antibiotic treatment, they recommended that patients diagnosed with C. difficile infection should first discontinue the inciting antibiotic treatment and then begin therapy with either vancomycin or fidaxomicin. For recurrent infection, they advised a tapered and pulsed regimen of oral vancomycin or a 10-day course of fidaxomicin. If patients had received metronidazole for the primary episode, they should be given a standard 10-day course of vancomycin for recurrent infection, the authors said.
In terms of diagnosis and management of pediatric C. difficile, the guidelines advised against routinely testing infants under 2 years of age with diarrhea, as the rate of C. difficile colonization even among asymptomatic infants can be higher than 40%. Even in children older than age 2, there was only a “weak” recommendation for C. difficile testing in patients with prolonged or worsening diarrhea and other risk factors such as inflammatory bowel disease or recent antibiotic exposure.
Children with a first episode or first recurrence of nonsevere C. difficile should be treated with either metronidazole or vancomycin, the authors wrote, but in the case of more severe illness or second recurrence, oral vancomycin was preferred over metronidazole.
The authors also suggested clinicians consider FMTs for children with recurrent infection that had failed to respond to antibiotics, but noted the quality of evidence for this was very low.
The guidelines were funded by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Six authors declared grants, consultancies, board positions, and other payments from the pharmaceutical industry outside the submitted work. One author also held patents relating to the treatment and prevention of C. difficile infection.
SOURCE: McDonald CL et al. Clin Infect Dis. 2018 Feb 15. doi: 10.1093/cid/cix1085.
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point: Fecal microbiota transplants should be considered for use in patients with recurrent Clostridium difficile infection that has not responded to antibiotic therapy.
Major finding: One of the strongest recommendations in the new guidelines on C. difficile infection is to consider use of fecal microbiota transplants in patients with recurrent infection.
Data source: Clinical practice guidelines.
Disclosures: The guidelines were funded by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Six authors declared grants, consultancies, board positions, and other payments from the pharmaceutical industry outside the submitted work. One author also held patents relating to the treatment and prevention of C. difficile infection.
Source: McDonald CL et al. Clin Infect Dis. 2018 Feb 15. doi: 10.1093/cid/cix1085.
USPSTF: Screen all pregnant women for syphilis
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
[email protected]
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
[email protected]
The U.S. Preventive Services Task Force issued a draft recommendation that all pregnant women be screened for syphilis infection.
The recommendation, released Feb. 6, follows an evidence review of studies conducted since the task force’s most recent recommendation in 2009, which also called for universal screening of pregnant women.
“Despite consistent recommendations and legal mandates, screening for syphilis in pregnancy continues to be suboptimal in certain populations,” the evidence review noted. The rate of congenital syphilis in the United States nearly doubled from 2012 to 2016.
“Because the early stages of syphilis often don’t cause any symptoms, screening helps identify the infection in pregnant women who may not realize they have the disease,” task force member Chien-Wen Tseng, MD, of the University of Hawaii, said in a statement.
Treatment is most effective early in pregnancy, and can reduce the chances of congenital syphilis. The draft recommendation calls for pregnant women to be tested at the first prenatal visit or at delivery, if the woman has not received prenatal care.
Comments can be submitted until March 5 at www.uspreventiveservicestaskforce.org/tfcomment.htm.
[email protected]
ASCO expands recommendations on bone-modifying agents in myeloma
Bisphosphonates should be prescribed for any patient receiving treatment for active multiple myeloma, regardless of whether or not there is evidence of lytic bone destruction or spinal compression fracture, according to updated guidelines from the American Society of Clinical Oncology.
Previous guidelines from the society, last updated in 2007, recommended the use of intravenous bisphosphonates for patients with myeloma with evidence of bone disease, according to the expert panel that drafted the update.
The update also introduces recommendations on the monoclonal antibody denosumab, described as an “alternative” to bisphosphonates, according to the guidelines, which were published in the Journal of Clinical Oncology.
“Fewer adverse events related to renal toxicity have been noted with denosumab, compared with zoledronic acid,” and “this may be preferred in patients with compromised renal function,” wrote the expert panel, led by cochairs Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute, Boston, and Robert A. Kyle, MD, of Mayo Clinic, Rochester, Minn.
ASCO guidelines on bisphosphonates in myeloma were first drafted in 2002 and then updated in 2007. The new recommendations on bone-modifying therapy in myeloma are based on review of an additional 35 publications. The new guidelines are “consistent with the previous recommendations” while updating indications for therapy and information on denosumab, according to the expert panel.
Evidence that myeloma patients without lytic bone disease will benefit from intravenous bisphosphonates comes from the randomized MRC IX trial, in which patients who received zoledronic acid had reduced skeletal-related events at relapse and improved progression-free survival.
Denosumab, a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor, was noninferior to zoledronic acid for prevention of skeletal-related events in a randomized phase 3 clinical trial; however, it is “more expensive than zoledronic acid or pamidronate and must be considered in treatment decisions,” the guidelines authors wrote.
The total price in the United States for a 1-year treatment cycle of denosumab is just under $26,000, according to data included in the ASCO guideline. By comparison, the 1-year treatment cycle price for the bisphosphonates ranges from $214 to $697, depending on the regimen.
When intravenous bisphosphonate therapy is warranted, the guideline-recommended schedule is infusion of zoledronic acid 4 mg over at least 15 minutes, or pamidronate 90 mg over 2 hours, every 3-4 weeks.
The guidelines also address osteonecrosis of the jaw (ONJ), a major complication observed not only with the potent bisphosphonates pamidronate and zoledronic acid, but also with denosumab.
The panel said they were in agreement with revised labels from the Food and Drug Administration for zoledronic acid and pamidronate, among other papers or statements addressing ONJ and noted that patients need a comprehensive dental exam and preventive dentistry as appropriate before starting bone-modifying therapy.
“The risk of ONJ has prompted the use of less-frequent dosing of zoledronic acid, which may be an option for patients,” they said in their report.
Guideline authors reported ties to Amgen, Celgene, Millennium Pharmaceuticals, Gilead Sciences, Bristol-Myers Squibb, Novartis, Pfizer, and others.
SOURCE: Anderson K et al. J Clin Oncol. 2018 Jan 17:JCO2017766402. doi: 10.1200/JCO.2017.76.6402.
Bisphosphonates should be prescribed for any patient receiving treatment for active multiple myeloma, regardless of whether or not there is evidence of lytic bone destruction or spinal compression fracture, according to updated guidelines from the American Society of Clinical Oncology.
Previous guidelines from the society, last updated in 2007, recommended the use of intravenous bisphosphonates for patients with myeloma with evidence of bone disease, according to the expert panel that drafted the update.
The update also introduces recommendations on the monoclonal antibody denosumab, described as an “alternative” to bisphosphonates, according to the guidelines, which were published in the Journal of Clinical Oncology.
“Fewer adverse events related to renal toxicity have been noted with denosumab, compared with zoledronic acid,” and “this may be preferred in patients with compromised renal function,” wrote the expert panel, led by cochairs Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute, Boston, and Robert A. Kyle, MD, of Mayo Clinic, Rochester, Minn.
ASCO guidelines on bisphosphonates in myeloma were first drafted in 2002 and then updated in 2007. The new recommendations on bone-modifying therapy in myeloma are based on review of an additional 35 publications. The new guidelines are “consistent with the previous recommendations” while updating indications for therapy and information on denosumab, according to the expert panel.
Evidence that myeloma patients without lytic bone disease will benefit from intravenous bisphosphonates comes from the randomized MRC IX trial, in which patients who received zoledronic acid had reduced skeletal-related events at relapse and improved progression-free survival.
Denosumab, a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor, was noninferior to zoledronic acid for prevention of skeletal-related events in a randomized phase 3 clinical trial; however, it is “more expensive than zoledronic acid or pamidronate and must be considered in treatment decisions,” the guidelines authors wrote.
The total price in the United States for a 1-year treatment cycle of denosumab is just under $26,000, according to data included in the ASCO guideline. By comparison, the 1-year treatment cycle price for the bisphosphonates ranges from $214 to $697, depending on the regimen.
When intravenous bisphosphonate therapy is warranted, the guideline-recommended schedule is infusion of zoledronic acid 4 mg over at least 15 minutes, or pamidronate 90 mg over 2 hours, every 3-4 weeks.
The guidelines also address osteonecrosis of the jaw (ONJ), a major complication observed not only with the potent bisphosphonates pamidronate and zoledronic acid, but also with denosumab.
The panel said they were in agreement with revised labels from the Food and Drug Administration for zoledronic acid and pamidronate, among other papers or statements addressing ONJ and noted that patients need a comprehensive dental exam and preventive dentistry as appropriate before starting bone-modifying therapy.
“The risk of ONJ has prompted the use of less-frequent dosing of zoledronic acid, which may be an option for patients,” they said in their report.
Guideline authors reported ties to Amgen, Celgene, Millennium Pharmaceuticals, Gilead Sciences, Bristol-Myers Squibb, Novartis, Pfizer, and others.
SOURCE: Anderson K et al. J Clin Oncol. 2018 Jan 17:JCO2017766402. doi: 10.1200/JCO.2017.76.6402.
Bisphosphonates should be prescribed for any patient receiving treatment for active multiple myeloma, regardless of whether or not there is evidence of lytic bone destruction or spinal compression fracture, according to updated guidelines from the American Society of Clinical Oncology.
Previous guidelines from the society, last updated in 2007, recommended the use of intravenous bisphosphonates for patients with myeloma with evidence of bone disease, according to the expert panel that drafted the update.
The update also introduces recommendations on the monoclonal antibody denosumab, described as an “alternative” to bisphosphonates, according to the guidelines, which were published in the Journal of Clinical Oncology.
“Fewer adverse events related to renal toxicity have been noted with denosumab, compared with zoledronic acid,” and “this may be preferred in patients with compromised renal function,” wrote the expert panel, led by cochairs Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute, Boston, and Robert A. Kyle, MD, of Mayo Clinic, Rochester, Minn.
ASCO guidelines on bisphosphonates in myeloma were first drafted in 2002 and then updated in 2007. The new recommendations on bone-modifying therapy in myeloma are based on review of an additional 35 publications. The new guidelines are “consistent with the previous recommendations” while updating indications for therapy and information on denosumab, according to the expert panel.
Evidence that myeloma patients without lytic bone disease will benefit from intravenous bisphosphonates comes from the randomized MRC IX trial, in which patients who received zoledronic acid had reduced skeletal-related events at relapse and improved progression-free survival.
Denosumab, a receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitor, was noninferior to zoledronic acid for prevention of skeletal-related events in a randomized phase 3 clinical trial; however, it is “more expensive than zoledronic acid or pamidronate and must be considered in treatment decisions,” the guidelines authors wrote.
The total price in the United States for a 1-year treatment cycle of denosumab is just under $26,000, according to data included in the ASCO guideline. By comparison, the 1-year treatment cycle price for the bisphosphonates ranges from $214 to $697, depending on the regimen.
When intravenous bisphosphonate therapy is warranted, the guideline-recommended schedule is infusion of zoledronic acid 4 mg over at least 15 minutes, or pamidronate 90 mg over 2 hours, every 3-4 weeks.
The guidelines also address osteonecrosis of the jaw (ONJ), a major complication observed not only with the potent bisphosphonates pamidronate and zoledronic acid, but also with denosumab.
The panel said they were in agreement with revised labels from the Food and Drug Administration for zoledronic acid and pamidronate, among other papers or statements addressing ONJ and noted that patients need a comprehensive dental exam and preventive dentistry as appropriate before starting bone-modifying therapy.
“The risk of ONJ has prompted the use of less-frequent dosing of zoledronic acid, which may be an option for patients,” they said in their report.
Guideline authors reported ties to Amgen, Celgene, Millennium Pharmaceuticals, Gilead Sciences, Bristol-Myers Squibb, Novartis, Pfizer, and others.
SOURCE: Anderson K et al. J Clin Oncol. 2018 Jan 17:JCO2017766402. doi: 10.1200/JCO.2017.76.6402.
FROM THE JOURNAL OF CLINICAL ONCOLOGY
nPEP for HIV: Updated CDC guidelines available for primary care physicians
In 2016, the Centers for Disease Control and Prevention provided health care providers with updated recommendations for nonoccupational postexposure prophylaxis (nPEP) with antiretroviral drugs to prevent transmission of HIV following sexual interaction, injection-drug use, or other nonoccupational exposures.1 The new recommendations include the use of more effective and more tolerable drug regimens that employ antiretroviral medications that were approved since the previous guidelines came out in 2005; they also provide updated guidance on exposure assessment, baseline and follow-up HIV testing, and longer-term prevention measures, such as pre-exposure prophylaxis (PrEP).
Screening for HIV infection has been expanding broadly in all health care settings over the past decade, so primary care physicians play an increasingly vital role in preventing HIV infection. Today, primary care physicians are also often the most likely “go-to” health care provider when patients think they may have been exposed to HIV. Clinically, this is an emergency situation, so time is of the essence: Treatment with three powerful antiretrovirals must be initiated within a few hours of – but no later than 72 hours after – an isolated exposure to blood, genital secretions, or other potentially infectious body fluids that may contain HIV.
The key issue for primary care physicians, especially those who have never prescribed PEP before, is advance planning. What you do up front, in terms of organizing materials and training staff, is worth the effort because there is so much at stake – for your patients and for society. The good news is that once you have an established nPEP protocol in place, it stays in place. When a patient asks for help, the protocol kicks in automatically.
Getting ready for nPEP
Prepare your staff:
- Educate your whole staff about the urgency of seeing potential nPEP patients immediately.
- Choose the staff person in your office who will submit requests for PEP medications to the pharmacy and/or pharmaceutical companies; your financial reimbursement staff person is likely a good candidate for this job.
- Learn about patient assistance programs (for uninsured or underinsured patients) and crime victims compensation programs (reimbursement or emergency awards for victims of violent crimes, including rape, for various out-of-pocket expenses including medical expenses).
Keep paperwork and materials on hand:
- Have information and forms for patient assistance programs for pharmaceutical companies supplying the drugs. Pharmaceutical companies are aware of the urgency for nPEP medications and are ready to respond immediately. They may mail the medication so it arrives the next day or, more likely, fax a voucher or other information for the patient to present to a local pharmacist who will fill the prescription.
- Have information on your state’s crime victims compensation program available.
- Consider keeping nPEP Starter Packs (with an initial 3-7 days’ worth of medication) readily available in your office.
Rapid evaluation of patients seeking care after potential exposure to HIV
Effective delivery of nPEP requires prompt initial evaluation of patients and assessment of HIV transmission risk. Take a methodical, step-by-step history of the exposure to address the following basic questions:
- Date and time of exposure? nPEP should be initiated as soon as possible after HIV exposure; it is unlikely to be effective if not initiated within 72 hours or less.
- Frequency of exposure? Type/route of exposure? nPEP is generally reserved for isolated or infrequent exposures that present a substantial risk for HIV acquisition (see Table 1 on HIV acquisition risk below).
- HIV status of exposure source? If the source is positive, is the source person on HIV treatment with antiretroviral therapy? If unknown, is the source person an injecting drug user or a man who has sex with men (MSM)?
Based on the initial evaluation, is nPEP recommended?
Answers to the questions asked during the initial evaluation of the patient will determine whether nPEP is indicated. Along with its updated recommendations, the CDC provided an algorithm to help guide evaluation and treatment.
Preferred HIV test
Administer an HIV test to all patients considered for nPEP, preferably the rapid combined antigen and antibody test (Ag/Ab), or just the antibody test if the Ag/Ab test is not available. nPEP is indicated only for persons without HIV infections. However, if results are not available during the initial evaluation, assume the patient is not infected. If indicated and started, nPEP can be discontinued if tests later shown the patient already has an HIV infection.
Laboratory testing
If nPEP is indicated, conduct laboratory testing. Lab testing is required to document the patient’s HIV status (and that of the source person, when available), identify and manage other conditions potentially resulting from exposure, identify conditions that may affect the nPEP medication regimen, and monitor safety or toxicities to the prescribed regimen.
nPEP treatment regimen for otherwise healthy adults and adolescents
In the absence of randomized clinical trials, data from a case/control study demonstrating an 81% reduction of HIV transmission after use of occupational PEP among hospital workers remains the strongest evidence for the benefit of nPEP.1,2 For patients offered nPEP, recommended treatment includes prescribing either of the following regimens for 28 days:
- Preferred regimen: tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg) once daily plus either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily.
- Alternative regimen: TDF (300 mg) with FTC (200 mg) once daily plus darunavir (DRV) (800 mg) and ritonavir (RTV) (100 mg) once daily.
Additional considerations and nPEP treatment regimens for children, patients with decreased renal function, and pregnant women are included in the CDC guidelines.
Crucial Information for Patients on nPEP
Emphasize the importance of proper dosing and adherence.
Review the patient information for each drug in the regimen, specifically the black boxes, warnings, and side effects, and counsel your patients accordingly.
Transitioning from nPEP to PrEP or from PrEP to nPEP
If you have a patient who engages in behavior that places them at risk for frequent, recurrent exposures to HIV, consider transitioning them to PrEP (pre-exposure prophylaxis) following their 28-day course of nPEP.3 PrEP is a two-drug regimen taken daily on an ongoing basis.
Additionally, for patients who are already on PrEP but who have not taken their medications within a week before the possible exposure, consider initiating nPEP for 28 days and then reintroducing PrEP if their HIV status is negative and the problems with adherence can be addressed moving forward.
Raising Awareness About nPEP
Many people never expect to be exposed to HIV and may not know about the availability of PEP in an emergency situation. You can help raise awareness by making educational materials available in your waiting rooms and exam rooms. Brochures and other HIV/AIDS educational materials for patients are available from the CDC Act Against AIDS campaign.
Summary
The availability of PEP drug regimens that can reduce HIV transmission after a possible acute HIV exposure is an important tool in the portfolio of HIV prevention strategies, which also include HIV screening, condom use, PrEP, and antiretroviral therapy for HIV-positive persons. Primary care providers play a critical role in rapidly evaluating patients appropriate for nPEP and initiating treatment within 72 hours of possible exposure. For patients evaluated and put on a course of nPEP outside of the primary care setting (for example, in an ED or urgent care), primary care physicians should work to achieve optimal communication and collaboration to ensure that they are best prepared to provide their patients with the necessary follow-up testing, counseling, and medical care.
Dr. Dominguez is a Captain, U.S. Public Health Service, epidemiology branch, division of HIV/AIDS prevention, CDC.
Additional resources
- The CDC recommends that everyone between the ages of 13 and 64 get tested for HIV at least once as part of routine health care. As part of its Act Against AIDS initiative, the CDC developed the HIV Screening Standard Care program, which provides free tools and resources to help clinicians and nurses incorporate routine HIV screening into primary care settings.
- HIV guidelines and recommendations .
- Postexposure prophylaxis (PEP)
- Pre-Exposure prophylaxis (PrEP)
References
1. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV. United States, 2016. Accessed March 6, 2017.
2. Cardo DM et al. New Engl J Med. 1997;337(21):1485-90.
3. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014: a clinical practice guideline. Accessed March 6, 2017.
In 2016, the Centers for Disease Control and Prevention provided health care providers with updated recommendations for nonoccupational postexposure prophylaxis (nPEP) with antiretroviral drugs to prevent transmission of HIV following sexual interaction, injection-drug use, or other nonoccupational exposures.1 The new recommendations include the use of more effective and more tolerable drug regimens that employ antiretroviral medications that were approved since the previous guidelines came out in 2005; they also provide updated guidance on exposure assessment, baseline and follow-up HIV testing, and longer-term prevention measures, such as pre-exposure prophylaxis (PrEP).
Screening for HIV infection has been expanding broadly in all health care settings over the past decade, so primary care physicians play an increasingly vital role in preventing HIV infection. Today, primary care physicians are also often the most likely “go-to” health care provider when patients think they may have been exposed to HIV. Clinically, this is an emergency situation, so time is of the essence: Treatment with three powerful antiretrovirals must be initiated within a few hours of – but no later than 72 hours after – an isolated exposure to blood, genital secretions, or other potentially infectious body fluids that may contain HIV.
The key issue for primary care physicians, especially those who have never prescribed PEP before, is advance planning. What you do up front, in terms of organizing materials and training staff, is worth the effort because there is so much at stake – for your patients and for society. The good news is that once you have an established nPEP protocol in place, it stays in place. When a patient asks for help, the protocol kicks in automatically.
Getting ready for nPEP
Prepare your staff:
- Educate your whole staff about the urgency of seeing potential nPEP patients immediately.
- Choose the staff person in your office who will submit requests for PEP medications to the pharmacy and/or pharmaceutical companies; your financial reimbursement staff person is likely a good candidate for this job.
- Learn about patient assistance programs (for uninsured or underinsured patients) and crime victims compensation programs (reimbursement or emergency awards for victims of violent crimes, including rape, for various out-of-pocket expenses including medical expenses).
Keep paperwork and materials on hand:
- Have information and forms for patient assistance programs for pharmaceutical companies supplying the drugs. Pharmaceutical companies are aware of the urgency for nPEP medications and are ready to respond immediately. They may mail the medication so it arrives the next day or, more likely, fax a voucher or other information for the patient to present to a local pharmacist who will fill the prescription.
- Have information on your state’s crime victims compensation program available.
- Consider keeping nPEP Starter Packs (with an initial 3-7 days’ worth of medication) readily available in your office.
Rapid evaluation of patients seeking care after potential exposure to HIV
Effective delivery of nPEP requires prompt initial evaluation of patients and assessment of HIV transmission risk. Take a methodical, step-by-step history of the exposure to address the following basic questions:
- Date and time of exposure? nPEP should be initiated as soon as possible after HIV exposure; it is unlikely to be effective if not initiated within 72 hours or less.
- Frequency of exposure? Type/route of exposure? nPEP is generally reserved for isolated or infrequent exposures that present a substantial risk for HIV acquisition (see Table 1 on HIV acquisition risk below).
- HIV status of exposure source? If the source is positive, is the source person on HIV treatment with antiretroviral therapy? If unknown, is the source person an injecting drug user or a man who has sex with men (MSM)?
Based on the initial evaluation, is nPEP recommended?
Answers to the questions asked during the initial evaluation of the patient will determine whether nPEP is indicated. Along with its updated recommendations, the CDC provided an algorithm to help guide evaluation and treatment.
Preferred HIV test
Administer an HIV test to all patients considered for nPEP, preferably the rapid combined antigen and antibody test (Ag/Ab), or just the antibody test if the Ag/Ab test is not available. nPEP is indicated only for persons without HIV infections. However, if results are not available during the initial evaluation, assume the patient is not infected. If indicated and started, nPEP can be discontinued if tests later shown the patient already has an HIV infection.
Laboratory testing
If nPEP is indicated, conduct laboratory testing. Lab testing is required to document the patient’s HIV status (and that of the source person, when available), identify and manage other conditions potentially resulting from exposure, identify conditions that may affect the nPEP medication regimen, and monitor safety or toxicities to the prescribed regimen.
nPEP treatment regimen for otherwise healthy adults and adolescents
In the absence of randomized clinical trials, data from a case/control study demonstrating an 81% reduction of HIV transmission after use of occupational PEP among hospital workers remains the strongest evidence for the benefit of nPEP.1,2 For patients offered nPEP, recommended treatment includes prescribing either of the following regimens for 28 days:
- Preferred regimen: tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg) once daily plus either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily.
- Alternative regimen: TDF (300 mg) with FTC (200 mg) once daily plus darunavir (DRV) (800 mg) and ritonavir (RTV) (100 mg) once daily.
Additional considerations and nPEP treatment regimens for children, patients with decreased renal function, and pregnant women are included in the CDC guidelines.
Crucial Information for Patients on nPEP
Emphasize the importance of proper dosing and adherence.
Review the patient information for each drug in the regimen, specifically the black boxes, warnings, and side effects, and counsel your patients accordingly.
Transitioning from nPEP to PrEP or from PrEP to nPEP
If you have a patient who engages in behavior that places them at risk for frequent, recurrent exposures to HIV, consider transitioning them to PrEP (pre-exposure prophylaxis) following their 28-day course of nPEP.3 PrEP is a two-drug regimen taken daily on an ongoing basis.
Additionally, for patients who are already on PrEP but who have not taken their medications within a week before the possible exposure, consider initiating nPEP for 28 days and then reintroducing PrEP if their HIV status is negative and the problems with adherence can be addressed moving forward.
Raising Awareness About nPEP
Many people never expect to be exposed to HIV and may not know about the availability of PEP in an emergency situation. You can help raise awareness by making educational materials available in your waiting rooms and exam rooms. Brochures and other HIV/AIDS educational materials for patients are available from the CDC Act Against AIDS campaign.
Summary
The availability of PEP drug regimens that can reduce HIV transmission after a possible acute HIV exposure is an important tool in the portfolio of HIV prevention strategies, which also include HIV screening, condom use, PrEP, and antiretroviral therapy for HIV-positive persons. Primary care providers play a critical role in rapidly evaluating patients appropriate for nPEP and initiating treatment within 72 hours of possible exposure. For patients evaluated and put on a course of nPEP outside of the primary care setting (for example, in an ED or urgent care), primary care physicians should work to achieve optimal communication and collaboration to ensure that they are best prepared to provide their patients with the necessary follow-up testing, counseling, and medical care.
Dr. Dominguez is a Captain, U.S. Public Health Service, epidemiology branch, division of HIV/AIDS prevention, CDC.
Additional resources
- The CDC recommends that everyone between the ages of 13 and 64 get tested for HIV at least once as part of routine health care. As part of its Act Against AIDS initiative, the CDC developed the HIV Screening Standard Care program, which provides free tools and resources to help clinicians and nurses incorporate routine HIV screening into primary care settings.
- HIV guidelines and recommendations .
- Postexposure prophylaxis (PEP)
- Pre-Exposure prophylaxis (PrEP)
References
1. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV. United States, 2016. Accessed March 6, 2017.
2. Cardo DM et al. New Engl J Med. 1997;337(21):1485-90.
3. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014: a clinical practice guideline. Accessed March 6, 2017.
In 2016, the Centers for Disease Control and Prevention provided health care providers with updated recommendations for nonoccupational postexposure prophylaxis (nPEP) with antiretroviral drugs to prevent transmission of HIV following sexual interaction, injection-drug use, or other nonoccupational exposures.1 The new recommendations include the use of more effective and more tolerable drug regimens that employ antiretroviral medications that were approved since the previous guidelines came out in 2005; they also provide updated guidance on exposure assessment, baseline and follow-up HIV testing, and longer-term prevention measures, such as pre-exposure prophylaxis (PrEP).
Screening for HIV infection has been expanding broadly in all health care settings over the past decade, so primary care physicians play an increasingly vital role in preventing HIV infection. Today, primary care physicians are also often the most likely “go-to” health care provider when patients think they may have been exposed to HIV. Clinically, this is an emergency situation, so time is of the essence: Treatment with three powerful antiretrovirals must be initiated within a few hours of – but no later than 72 hours after – an isolated exposure to blood, genital secretions, or other potentially infectious body fluids that may contain HIV.
The key issue for primary care physicians, especially those who have never prescribed PEP before, is advance planning. What you do up front, in terms of organizing materials and training staff, is worth the effort because there is so much at stake – for your patients and for society. The good news is that once you have an established nPEP protocol in place, it stays in place. When a patient asks for help, the protocol kicks in automatically.
Getting ready for nPEP
Prepare your staff:
- Educate your whole staff about the urgency of seeing potential nPEP patients immediately.
- Choose the staff person in your office who will submit requests for PEP medications to the pharmacy and/or pharmaceutical companies; your financial reimbursement staff person is likely a good candidate for this job.
- Learn about patient assistance programs (for uninsured or underinsured patients) and crime victims compensation programs (reimbursement or emergency awards for victims of violent crimes, including rape, for various out-of-pocket expenses including medical expenses).
Keep paperwork and materials on hand:
- Have information and forms for patient assistance programs for pharmaceutical companies supplying the drugs. Pharmaceutical companies are aware of the urgency for nPEP medications and are ready to respond immediately. They may mail the medication so it arrives the next day or, more likely, fax a voucher or other information for the patient to present to a local pharmacist who will fill the prescription.
- Have information on your state’s crime victims compensation program available.
- Consider keeping nPEP Starter Packs (with an initial 3-7 days’ worth of medication) readily available in your office.
Rapid evaluation of patients seeking care after potential exposure to HIV
Effective delivery of nPEP requires prompt initial evaluation of patients and assessment of HIV transmission risk. Take a methodical, step-by-step history of the exposure to address the following basic questions:
- Date and time of exposure? nPEP should be initiated as soon as possible after HIV exposure; it is unlikely to be effective if not initiated within 72 hours or less.
- Frequency of exposure? Type/route of exposure? nPEP is generally reserved for isolated or infrequent exposures that present a substantial risk for HIV acquisition (see Table 1 on HIV acquisition risk below).
- HIV status of exposure source? If the source is positive, is the source person on HIV treatment with antiretroviral therapy? If unknown, is the source person an injecting drug user or a man who has sex with men (MSM)?
Based on the initial evaluation, is nPEP recommended?
Answers to the questions asked during the initial evaluation of the patient will determine whether nPEP is indicated. Along with its updated recommendations, the CDC provided an algorithm to help guide evaluation and treatment.
Preferred HIV test
Administer an HIV test to all patients considered for nPEP, preferably the rapid combined antigen and antibody test (Ag/Ab), or just the antibody test if the Ag/Ab test is not available. nPEP is indicated only for persons without HIV infections. However, if results are not available during the initial evaluation, assume the patient is not infected. If indicated and started, nPEP can be discontinued if tests later shown the patient already has an HIV infection.
Laboratory testing
If nPEP is indicated, conduct laboratory testing. Lab testing is required to document the patient’s HIV status (and that of the source person, when available), identify and manage other conditions potentially resulting from exposure, identify conditions that may affect the nPEP medication regimen, and monitor safety or toxicities to the prescribed regimen.
nPEP treatment regimen for otherwise healthy adults and adolescents
In the absence of randomized clinical trials, data from a case/control study demonstrating an 81% reduction of HIV transmission after use of occupational PEP among hospital workers remains the strongest evidence for the benefit of nPEP.1,2 For patients offered nPEP, recommended treatment includes prescribing either of the following regimens for 28 days:
- Preferred regimen: tenofovir disoproxil fumarate (TDF) (300 mg) with emtricitabine (FTC) (200 mg) once daily plus either raltegravir (RAL) 400 mg twice daily or dolutegravir (DTG) 50 mg daily.
- Alternative regimen: TDF (300 mg) with FTC (200 mg) once daily plus darunavir (DRV) (800 mg) and ritonavir (RTV) (100 mg) once daily.
Additional considerations and nPEP treatment regimens for children, patients with decreased renal function, and pregnant women are included in the CDC guidelines.
Crucial Information for Patients on nPEP
Emphasize the importance of proper dosing and adherence.
Review the patient information for each drug in the regimen, specifically the black boxes, warnings, and side effects, and counsel your patients accordingly.
Transitioning from nPEP to PrEP or from PrEP to nPEP
If you have a patient who engages in behavior that places them at risk for frequent, recurrent exposures to HIV, consider transitioning them to PrEP (pre-exposure prophylaxis) following their 28-day course of nPEP.3 PrEP is a two-drug regimen taken daily on an ongoing basis.
Additionally, for patients who are already on PrEP but who have not taken their medications within a week before the possible exposure, consider initiating nPEP for 28 days and then reintroducing PrEP if their HIV status is negative and the problems with adherence can be addressed moving forward.
Raising Awareness About nPEP
Many people never expect to be exposed to HIV and may not know about the availability of PEP in an emergency situation. You can help raise awareness by making educational materials available in your waiting rooms and exam rooms. Brochures and other HIV/AIDS educational materials for patients are available from the CDC Act Against AIDS campaign.
Summary
The availability of PEP drug regimens that can reduce HIV transmission after a possible acute HIV exposure is an important tool in the portfolio of HIV prevention strategies, which also include HIV screening, condom use, PrEP, and antiretroviral therapy for HIV-positive persons. Primary care providers play a critical role in rapidly evaluating patients appropriate for nPEP and initiating treatment within 72 hours of possible exposure. For patients evaluated and put on a course of nPEP outside of the primary care setting (for example, in an ED or urgent care), primary care physicians should work to achieve optimal communication and collaboration to ensure that they are best prepared to provide their patients with the necessary follow-up testing, counseling, and medical care.
Dr. Dominguez is a Captain, U.S. Public Health Service, epidemiology branch, division of HIV/AIDS prevention, CDC.
Additional resources
- The CDC recommends that everyone between the ages of 13 and 64 get tested for HIV at least once as part of routine health care. As part of its Act Against AIDS initiative, the CDC developed the HIV Screening Standard Care program, which provides free tools and resources to help clinicians and nurses incorporate routine HIV screening into primary care settings.
- HIV guidelines and recommendations .
- Postexposure prophylaxis (PEP)
- Pre-Exposure prophylaxis (PrEP)
References
1. Centers for Disease Control and Prevention. Updated guidelines for antiretroviral postexposure prophylaxis after sexual, injection drug use, or other nonoccupational exposure to HIV. United States, 2016. Accessed March 6, 2017.
2. Cardo DM et al. New Engl J Med. 1997;337(21):1485-90.
3. Centers for Disease Control and Prevention. Preexposure prophylaxis for the prevention of HIV infection in the United States–2014: a clinical practice guideline. Accessed March 6, 2017.
AHA: Heart health helps optimize breast cancer outcomes
Breast cancer outcomes rely on “coexisting cardiovascular health” at every step in the patient journey, the American Heart Association has said in its first-ever scientific statement on the matter.
The statement, published in Circulation provides a comprehensive overview of cardiovascular disease and breast cancer prevalence and shared risk factors, as well as current recommendations on avoiding the cardiotoxic effects of some cancer treatments and strategies to prevent or treat CVD in breast cancer patients.
Cardiovascular disease and breast cancer are two entities that are frequently intertwined, Laxmi S. Mehta, MD, chair of the statement writing group, said in an interview.
“For any oncologic patient, it’s important to also consider their heart in the risk assessment because that also affects survival from the cancer,” said Dr. Mehta, the director of the Women’s Cardiovascular Health Program and an associate professor of medicine at the Ohio State University, Columbus.
Mortality risk attributable to CVD is higher in breast cancer survivors than in women who have no history of breast cancer, according to evidence Dr. Mehta and her colleagues cite in the statement.
Breast cancer and CVD share a number of common and sometimes modifiable risk factors, including dietary patterns, physical activity, and being overweight or obese, and tobacco use. There is “growing awareness” that modifying those risk factors may help prevent some cases of breast cancer.
Even in patients who have a breast cancer diagnosis, “from a cardiology standpoint, lifestyle is going to be key,” said Dr. Mehta. She said breast cancer patients can be encouraged to follow AHA recommendations to aim for 150 minutes of moderate aerobic exercise weekly and to follow an “overall healthy dietary pattern” that limits saturated and trans fats, sodium, red meat, sweets, and sugar-sweetened beverages.
Although left ventricular systolic dysfunction is the most common cardiovascular side effect associated with chemotherapy, other manifestations of early or delayed cardiotoxicity can include heart failure, hypertension, thromboembolic disease, pulmonary hypertension, pericarditis, and myocardial ischemia, according to the AHA scientific statement.
A wide range of standard breast cancer treatments cause cardiovascular adverse effects, including taxanes such as paclitaxel, anthracyclines such as doxorubicin, and alkylating agents such as cisplatin and cyclophosphamide, as outlined in the statement.
Targeted HER-2–directed therapies, including trastuzumab and pertuzumab, are associated with left ventricular dysfunction and heart failure, while emerging therapies, such as the cyclin-dependent kinase 4/6 inhibitors palbociclib and ribociclib, are associated with QTc prolongation, the statement also notes.
Current strategies for monitoring for cardiovascular toxicity, which typically involve myocardial strain imaging, assessing cardiac biomarkers, or a combination of imaging and biomarkers, are outlined in the report.
To mitigate the impact of cancer treatments on cardiovascular health, several oncologic strategies are useful, according to Dr. Mehta and colleagues.
In multiple clinical trials of breast cancer patients receiving doxorubicin or epirubicin, the iron-binding agent dexrazoxane reduced the combined endpoint of decreased left ventricular ejection fraction or development of heart failure, the authors said.
Likewise, clinical trial evidence has suggested cardiotoxicity associated with doxorubicin can be mitigated through administration via infusion as opposed to bolus and with longer versus shorter infusion durations, they continued.
Extreme cases or difficult-to-manage patients can be referred to a center that has an active program in cardio-oncology, a newer and rapidly expanding field, according to Dr. Mehta.
“That’s where there’s tight collaboration in terms of understanding the current treatments, and that’s also where research on how to best take care of these patients will be conducted,” she said.
Dr. Mehta reported no disclosures. Coauthors reported disclosures related to Amgen, Boehringer Ingelheim, Genentech, AstraZeneca, Lilly, Roche, Novartis, and others.
SOURCE: Mehta LS et al. Circulation. 2017 Jan 22. doi: 10.1161/CIR.0000000000000556.
Breast cancer outcomes rely on “coexisting cardiovascular health” at every step in the patient journey, the American Heart Association has said in its first-ever scientific statement on the matter.
The statement, published in Circulation provides a comprehensive overview of cardiovascular disease and breast cancer prevalence and shared risk factors, as well as current recommendations on avoiding the cardiotoxic effects of some cancer treatments and strategies to prevent or treat CVD in breast cancer patients.
Cardiovascular disease and breast cancer are two entities that are frequently intertwined, Laxmi S. Mehta, MD, chair of the statement writing group, said in an interview.
“For any oncologic patient, it’s important to also consider their heart in the risk assessment because that also affects survival from the cancer,” said Dr. Mehta, the director of the Women’s Cardiovascular Health Program and an associate professor of medicine at the Ohio State University, Columbus.
Mortality risk attributable to CVD is higher in breast cancer survivors than in women who have no history of breast cancer, according to evidence Dr. Mehta and her colleagues cite in the statement.
Breast cancer and CVD share a number of common and sometimes modifiable risk factors, including dietary patterns, physical activity, and being overweight or obese, and tobacco use. There is “growing awareness” that modifying those risk factors may help prevent some cases of breast cancer.
Even in patients who have a breast cancer diagnosis, “from a cardiology standpoint, lifestyle is going to be key,” said Dr. Mehta. She said breast cancer patients can be encouraged to follow AHA recommendations to aim for 150 minutes of moderate aerobic exercise weekly and to follow an “overall healthy dietary pattern” that limits saturated and trans fats, sodium, red meat, sweets, and sugar-sweetened beverages.
Although left ventricular systolic dysfunction is the most common cardiovascular side effect associated with chemotherapy, other manifestations of early or delayed cardiotoxicity can include heart failure, hypertension, thromboembolic disease, pulmonary hypertension, pericarditis, and myocardial ischemia, according to the AHA scientific statement.
A wide range of standard breast cancer treatments cause cardiovascular adverse effects, including taxanes such as paclitaxel, anthracyclines such as doxorubicin, and alkylating agents such as cisplatin and cyclophosphamide, as outlined in the statement.
Targeted HER-2–directed therapies, including trastuzumab and pertuzumab, are associated with left ventricular dysfunction and heart failure, while emerging therapies, such as the cyclin-dependent kinase 4/6 inhibitors palbociclib and ribociclib, are associated with QTc prolongation, the statement also notes.
Current strategies for monitoring for cardiovascular toxicity, which typically involve myocardial strain imaging, assessing cardiac biomarkers, or a combination of imaging and biomarkers, are outlined in the report.
To mitigate the impact of cancer treatments on cardiovascular health, several oncologic strategies are useful, according to Dr. Mehta and colleagues.
In multiple clinical trials of breast cancer patients receiving doxorubicin or epirubicin, the iron-binding agent dexrazoxane reduced the combined endpoint of decreased left ventricular ejection fraction or development of heart failure, the authors said.
Likewise, clinical trial evidence has suggested cardiotoxicity associated with doxorubicin can be mitigated through administration via infusion as opposed to bolus and with longer versus shorter infusion durations, they continued.
Extreme cases or difficult-to-manage patients can be referred to a center that has an active program in cardio-oncology, a newer and rapidly expanding field, according to Dr. Mehta.
“That’s where there’s tight collaboration in terms of understanding the current treatments, and that’s also where research on how to best take care of these patients will be conducted,” she said.
Dr. Mehta reported no disclosures. Coauthors reported disclosures related to Amgen, Boehringer Ingelheim, Genentech, AstraZeneca, Lilly, Roche, Novartis, and others.
SOURCE: Mehta LS et al. Circulation. 2017 Jan 22. doi: 10.1161/CIR.0000000000000556.
Breast cancer outcomes rely on “coexisting cardiovascular health” at every step in the patient journey, the American Heart Association has said in its first-ever scientific statement on the matter.
The statement, published in Circulation provides a comprehensive overview of cardiovascular disease and breast cancer prevalence and shared risk factors, as well as current recommendations on avoiding the cardiotoxic effects of some cancer treatments and strategies to prevent or treat CVD in breast cancer patients.
Cardiovascular disease and breast cancer are two entities that are frequently intertwined, Laxmi S. Mehta, MD, chair of the statement writing group, said in an interview.
“For any oncologic patient, it’s important to also consider their heart in the risk assessment because that also affects survival from the cancer,” said Dr. Mehta, the director of the Women’s Cardiovascular Health Program and an associate professor of medicine at the Ohio State University, Columbus.
Mortality risk attributable to CVD is higher in breast cancer survivors than in women who have no history of breast cancer, according to evidence Dr. Mehta and her colleagues cite in the statement.
Breast cancer and CVD share a number of common and sometimes modifiable risk factors, including dietary patterns, physical activity, and being overweight or obese, and tobacco use. There is “growing awareness” that modifying those risk factors may help prevent some cases of breast cancer.
Even in patients who have a breast cancer diagnosis, “from a cardiology standpoint, lifestyle is going to be key,” said Dr. Mehta. She said breast cancer patients can be encouraged to follow AHA recommendations to aim for 150 minutes of moderate aerobic exercise weekly and to follow an “overall healthy dietary pattern” that limits saturated and trans fats, sodium, red meat, sweets, and sugar-sweetened beverages.
Although left ventricular systolic dysfunction is the most common cardiovascular side effect associated with chemotherapy, other manifestations of early or delayed cardiotoxicity can include heart failure, hypertension, thromboembolic disease, pulmonary hypertension, pericarditis, and myocardial ischemia, according to the AHA scientific statement.
A wide range of standard breast cancer treatments cause cardiovascular adverse effects, including taxanes such as paclitaxel, anthracyclines such as doxorubicin, and alkylating agents such as cisplatin and cyclophosphamide, as outlined in the statement.
Targeted HER-2–directed therapies, including trastuzumab and pertuzumab, are associated with left ventricular dysfunction and heart failure, while emerging therapies, such as the cyclin-dependent kinase 4/6 inhibitors palbociclib and ribociclib, are associated with QTc prolongation, the statement also notes.
Current strategies for monitoring for cardiovascular toxicity, which typically involve myocardial strain imaging, assessing cardiac biomarkers, or a combination of imaging and biomarkers, are outlined in the report.
To mitigate the impact of cancer treatments on cardiovascular health, several oncologic strategies are useful, according to Dr. Mehta and colleagues.
In multiple clinical trials of breast cancer patients receiving doxorubicin or epirubicin, the iron-binding agent dexrazoxane reduced the combined endpoint of decreased left ventricular ejection fraction or development of heart failure, the authors said.
Likewise, clinical trial evidence has suggested cardiotoxicity associated with doxorubicin can be mitigated through administration via infusion as opposed to bolus and with longer versus shorter infusion durations, they continued.
Extreme cases or difficult-to-manage patients can be referred to a center that has an active program in cardio-oncology, a newer and rapidly expanding field, according to Dr. Mehta.
“That’s where there’s tight collaboration in terms of understanding the current treatments, and that’s also where research on how to best take care of these patients will be conducted,” she said.
Dr. Mehta reported no disclosures. Coauthors reported disclosures related to Amgen, Boehringer Ingelheim, Genentech, AstraZeneca, Lilly, Roche, Novartis, and others.
SOURCE: Mehta LS et al. Circulation. 2017 Jan 22. doi: 10.1161/CIR.0000000000000556.
FROM CIRCULATION
VIDEO: New stroke guideline embraces imaging-guided thrombectomy
LOS ANGELES – When a panel organized by the American Heart Association’s Stroke Council recently revised the group’s guideline for early management of acute ischemic stroke, they were clear on the overarching change they had to make: Incorporate recent evidence collected in two trials that established brain imaging as the way to identify patients eligible for clot removal treatment by thrombectomy, a change in practice that has made this outcome-altering intervention available to more patients.
“The major take-home message [of the new guideline] is the extension of the time window for treating acute ischemic stroke,” said William J. Powers, MD, chair of the guideline group (Stroke. 2018 Jan 24. doi: 10.1161/STR.0000000000000158).
Based on recently reported results from the DAWN (N Engl J Med. 2018;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Jan 24. doi: 10.1056/NEJMoa1713973) trials “we know that there are patients out to 24 hours from their stroke onset who may benefit” from thrombectomy. “This is a major, major change in how we view care for patients with stroke,” Dr. Powers said in a video interview. “Now there’s much more time. Ideally, we’ll see smaller hospitals develop the ability to do the imaging” that makes it possible to select acute ischemic stroke patients eligible for thrombectomy despite a delay of up to 24 hours from their stroke onset to the time of thrombectomy, said Dr. Powers, professor and chair of neurology at the University of North Carolina, Chapel Hill.
The big priority for the stroke community now that this major change in patient selection was incorporated into a U.S. practice guideline will be acting quickly to implement the steps needed to make this change happen, Dr. Powers and others said.
“The 2015 thrombectomy trials were a big step forward, but we’ve still been constrained by the time window. Allowing treatment out to 24 hours is a tremendous advance,” commented Karen Furie, MD, professor and chair of neurology at Brown University in Providence, R.I., who coauthored an editorial that accompanied the new guideline (Stroke. 2018 Jan 24. doi: 10.1161/STROKEAHA.118.020176). “This radically changes how we approach patients with stroke. It’s a major step forward,” but it also means “a lot of collaboration and thinking through systems of care” to try to implement what the guideline now calls for, she said in an interview. “You need a protocol and to have people look for” the patients who meet the new imaging criterion for receiving thrombectomy. But the stroke community has recently been readying for this moment. People are poised to act on this very quickly,” Dr. Furie said.
The new guideline will mean “changes in process and systems of care,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at the University of California, Los Angeles. The imaging called for “will be practical at some primary stroke centers but not others,” he said, although most hospitals certified to provide stroke care as primary stroke centers or acute stroke–ready hospitals have a CT scanner that could provide the basic imaging needed to assess many patients. (CT angiography and perfusion CT are more informative for determining thrombectomy eligibility.) But interpretation of the brain images to distinguish patients eligible for thrombectomy from those who aren’t will likely happen at comprehensive stroke centers that perform thrombectomy or by experts using remote image reading.
The new guideline will also require changes in the algorithms emergency medicine technicians use to decide where to transport a stroke patient, and improvements in the systems that transport patients from smaller hospitals that do imaging to larger centers that perform thrombectomy, Dr. Saver said. “The current system is terrible at making that transfer. We need to improve door-in/door-out time. It’s been done for patients with ST-elevation MI, and now it must be done for stroke patients.”
Dr. Saver expects that the new guideline will translate most quickly into changes in the imaging and transfer protocols that the Joint Commission may now require from hospitals certified as primary stroke centers or acute stroke-ready hospitals, changes that could be in place sometime later in 2018, he predicted. These are steps “that would really help drive system change.”
Dr. Powers and Dr. Furie had no disclosures. Dr. Saver has received research support and personal fees from Medtronic-Abbott and Neuravia.
LOS ANGELES – When a panel organized by the American Heart Association’s Stroke Council recently revised the group’s guideline for early management of acute ischemic stroke, they were clear on the overarching change they had to make: Incorporate recent evidence collected in two trials that established brain imaging as the way to identify patients eligible for clot removal treatment by thrombectomy, a change in practice that has made this outcome-altering intervention available to more patients.
“The major take-home message [of the new guideline] is the extension of the time window for treating acute ischemic stroke,” said William J. Powers, MD, chair of the guideline group (Stroke. 2018 Jan 24. doi: 10.1161/STR.0000000000000158).
Based on recently reported results from the DAWN (N Engl J Med. 2018;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Jan 24. doi: 10.1056/NEJMoa1713973) trials “we know that there are patients out to 24 hours from their stroke onset who may benefit” from thrombectomy. “This is a major, major change in how we view care for patients with stroke,” Dr. Powers said in a video interview. “Now there’s much more time. Ideally, we’ll see smaller hospitals develop the ability to do the imaging” that makes it possible to select acute ischemic stroke patients eligible for thrombectomy despite a delay of up to 24 hours from their stroke onset to the time of thrombectomy, said Dr. Powers, professor and chair of neurology at the University of North Carolina, Chapel Hill.
The big priority for the stroke community now that this major change in patient selection was incorporated into a U.S. practice guideline will be acting quickly to implement the steps needed to make this change happen, Dr. Powers and others said.
“The 2015 thrombectomy trials were a big step forward, but we’ve still been constrained by the time window. Allowing treatment out to 24 hours is a tremendous advance,” commented Karen Furie, MD, professor and chair of neurology at Brown University in Providence, R.I., who coauthored an editorial that accompanied the new guideline (Stroke. 2018 Jan 24. doi: 10.1161/STROKEAHA.118.020176). “This radically changes how we approach patients with stroke. It’s a major step forward,” but it also means “a lot of collaboration and thinking through systems of care” to try to implement what the guideline now calls for, she said in an interview. “You need a protocol and to have people look for” the patients who meet the new imaging criterion for receiving thrombectomy. But the stroke community has recently been readying for this moment. People are poised to act on this very quickly,” Dr. Furie said.
The new guideline will mean “changes in process and systems of care,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at the University of California, Los Angeles. The imaging called for “will be practical at some primary stroke centers but not others,” he said, although most hospitals certified to provide stroke care as primary stroke centers or acute stroke–ready hospitals have a CT scanner that could provide the basic imaging needed to assess many patients. (CT angiography and perfusion CT are more informative for determining thrombectomy eligibility.) But interpretation of the brain images to distinguish patients eligible for thrombectomy from those who aren’t will likely happen at comprehensive stroke centers that perform thrombectomy or by experts using remote image reading.
The new guideline will also require changes in the algorithms emergency medicine technicians use to decide where to transport a stroke patient, and improvements in the systems that transport patients from smaller hospitals that do imaging to larger centers that perform thrombectomy, Dr. Saver said. “The current system is terrible at making that transfer. We need to improve door-in/door-out time. It’s been done for patients with ST-elevation MI, and now it must be done for stroke patients.”
Dr. Saver expects that the new guideline will translate most quickly into changes in the imaging and transfer protocols that the Joint Commission may now require from hospitals certified as primary stroke centers or acute stroke-ready hospitals, changes that could be in place sometime later in 2018, he predicted. These are steps “that would really help drive system change.”
Dr. Powers and Dr. Furie had no disclosures. Dr. Saver has received research support and personal fees from Medtronic-Abbott and Neuravia.
LOS ANGELES – When a panel organized by the American Heart Association’s Stroke Council recently revised the group’s guideline for early management of acute ischemic stroke, they were clear on the overarching change they had to make: Incorporate recent evidence collected in two trials that established brain imaging as the way to identify patients eligible for clot removal treatment by thrombectomy, a change in practice that has made this outcome-altering intervention available to more patients.
“The major take-home message [of the new guideline] is the extension of the time window for treating acute ischemic stroke,” said William J. Powers, MD, chair of the guideline group (Stroke. 2018 Jan 24. doi: 10.1161/STR.0000000000000158).
Based on recently reported results from the DAWN (N Engl J Med. 2018;378[1]:11-21) and DEFUSE 3 (N Engl J Med. 2018 Jan 24. doi: 10.1056/NEJMoa1713973) trials “we know that there are patients out to 24 hours from their stroke onset who may benefit” from thrombectomy. “This is a major, major change in how we view care for patients with stroke,” Dr. Powers said in a video interview. “Now there’s much more time. Ideally, we’ll see smaller hospitals develop the ability to do the imaging” that makes it possible to select acute ischemic stroke patients eligible for thrombectomy despite a delay of up to 24 hours from their stroke onset to the time of thrombectomy, said Dr. Powers, professor and chair of neurology at the University of North Carolina, Chapel Hill.
The big priority for the stroke community now that this major change in patient selection was incorporated into a U.S. practice guideline will be acting quickly to implement the steps needed to make this change happen, Dr. Powers and others said.
“The 2015 thrombectomy trials were a big step forward, but we’ve still been constrained by the time window. Allowing treatment out to 24 hours is a tremendous advance,” commented Karen Furie, MD, professor and chair of neurology at Brown University in Providence, R.I., who coauthored an editorial that accompanied the new guideline (Stroke. 2018 Jan 24. doi: 10.1161/STROKEAHA.118.020176). “This radically changes how we approach patients with stroke. It’s a major step forward,” but it also means “a lot of collaboration and thinking through systems of care” to try to implement what the guideline now calls for, she said in an interview. “You need a protocol and to have people look for” the patients who meet the new imaging criterion for receiving thrombectomy. But the stroke community has recently been readying for this moment. People are poised to act on this very quickly,” Dr. Furie said.
The new guideline will mean “changes in process and systems of care,” agreed Jeffrey L. Saver, MD, professor of neurology and director of the stroke unit at the University of California, Los Angeles. The imaging called for “will be practical at some primary stroke centers but not others,” he said, although most hospitals certified to provide stroke care as primary stroke centers or acute stroke–ready hospitals have a CT scanner that could provide the basic imaging needed to assess many patients. (CT angiography and perfusion CT are more informative for determining thrombectomy eligibility.) But interpretation of the brain images to distinguish patients eligible for thrombectomy from those who aren’t will likely happen at comprehensive stroke centers that perform thrombectomy or by experts using remote image reading.
The new guideline will also require changes in the algorithms emergency medicine technicians use to decide where to transport a stroke patient, and improvements in the systems that transport patients from smaller hospitals that do imaging to larger centers that perform thrombectomy, Dr. Saver said. “The current system is terrible at making that transfer. We need to improve door-in/door-out time. It’s been done for patients with ST-elevation MI, and now it must be done for stroke patients.”
Dr. Saver expects that the new guideline will translate most quickly into changes in the imaging and transfer protocols that the Joint Commission may now require from hospitals certified as primary stroke centers or acute stroke-ready hospitals, changes that could be in place sometime later in 2018, he predicted. These are steps “that would really help drive system change.”
Dr. Powers and Dr. Furie had no disclosures. Dr. Saver has received research support and personal fees from Medtronic-Abbott and Neuravia.
EXPERT ANALYSIS FROM ISC 2018