Guidelines

Importance

The prevention and treatment of traveler’s diarrhea (TD) is a common reason that patients consult their physician prior to foreign travel. TD can result in lost time and opportunity, as well as overseas medical encounters and hospitalization. This guideline by the International Society of Travel Medicine provides clinically relevant, useful, and practical guidance to providers regarding the use of antibiotic and nonantibiotic therapies for the prevention and treatment of TD.

Prophylaxis

The panel recommends that antimicrobial prophylaxis should not be used routinely in travelers, but it should be considered for travelers who are at high risk of health-related complications of TD (both strong recommendations, low/very low level of evidence [LOE]). High-risk individuals include those with a history of clinically significant long-term morbidity following an enteric infection or serious chronic illnesses that predisposes them for TD-related complications. Bismuth subsalicylate (BSS) may be considered for any traveler to prevent TD (3, strong recommendation, high LOE). Studies show that a lower dose of 1.05 g/day is preventive, although it is unclear whether it is as effective as higher doses of 2.1 g/day or 4.2 g/day. When prophylaxis is indicated, travelers should be prescribed rifaximin (strong recommendation, moderate LOE) based on susceptibility of most enteric pathogens and the drug’s extremely favorable safety profile. Fluoroquinolones (FQ) are no longer recommended for prophylaxis (strong recommendation, low/very low LOE) because of neurologic and musculoskeletal side effects that may outweigh benefits, as well as emerging resistance of enteric pathogens (70%-80% in Campylobacter spp. from Nepal and Thailand and 65% in Enterotoxigenic Escherichia coli [ETEC] and Enteroaggregative E. coli [EAEC] in India).

Treatment

The following treatment recommendations are based on the classification of TD using functional effects of severity; therefore, the panel made new definitions for TD severity. This is a change from previous definitions that utilized a traditional frequency-based algorithm in order to tailor therapy for the individual. Individuals can be prescribed antibiotics and antimotility agents to take with them during travel, along with advice regarding how to judge when to use each agent.

Mild: diarrhea that is tolerable, is not distressing, and does not interfere with planned activities.

Encourage supportive measures such as rehydration and nonantibiotic, antimotility drugs, such as loperamide or BSS (both strong recommendations, moderate LOE).

Moderate: diarrhea that is distressing or interferes with planned activities.

Antibiotics may be used (weak recommendation, moderate LOE) as early and effective treatment may mitigate the well-described chronic health consequences including irritable bowel syndrome. Three options exist. FQs may be used outside of Southeast and South Asia (strong recommendation, moderate LOE), but their potential for adverse effects and musculoskeletal consequences must be considered. Azithromycin may be used (strong recommendation, high LOE) because studies show no significant differences in efficacy between it and FQs, limited resistance to common TD pathogens (although concerns exist in Nepal), and good side effect profile. Another choice is rifaximin (weak recommendation, moderate LOE), although one should exercise caution for empirical therapy in regions in which being at high risk of invasive pathogens is anticipated.

Loperamide may be used as adjunctive therapy for moderate to severe TD (strong recommendation, high LOE) to add symptomatic relief with curative treatment or as monotherapy in moderate TD (strong recommendation, high LOE). This is specifically true in children aged 2-11 years, in whom loperamide is beneficial without causing severe side effects.

Severe: diarrhea that is incapacitating or completely prevents planned activities; all dysentery (passage of grossly bloody stools).

Antibiotics should be used (strong recommendation, high LOE). Azithromycin is the preferred choice and is first-line for dysentery or febrile diarrhea (strong recommendation, moderate LOE) because of the likelihood of FQ-resistant bacteria being the cause of dysentery. FQs and rifaximin are also choices that can be used to treat severe, nondysenteric TD (both weak recommendations, moderate LOE).

Furthermore, single-dose antibiotics may be used to treat moderate or severe TD (strong recommendation, high LOE) because studies have shown equivalent efficacy for treatment of watery noninvasive diarrhea among FQs (3 days, single dose), azithromycin (3 days, single dose), and rifaximin (3 days, three times daily).

Persistent: diarrhea lasting longer than 2 weeks.

Functional bowel disease (FBD) may occur after bouts of TD and may meet Rome III or IV criteria for irritable bowel syndrome. Thus, in a traveler without pretravel GI disease, in whom the evaluation for microbial etiologies and underlying GI disease is negative, postinfectious FBD must be considered.

Follow-up and diagnostic testing

The panel recommends microbiological testing in returning travelers with severe or persistent symptoms, bloody/mucousy diarrhea, or in those who fail empiric therapy (strong recommendation, low/very low LOE). Molecular testing, aimed at a broad range of clinically relevant pathogens, is preferred when rapid results are clinically important or nonmolecular tests have failed to establish a diagnosis. Furthermore, molecular testing may, in some cases, detect colonization rather than infection.
 

The bottom line

The expert panel made 20 graded recommendations to help guide the provider with nonantibiotic and antibiotic prophylaxis and treatment of TD. The main take-home points include:

• Prophylaxis should be considered only in high-risk groups; rifaximin is the first choice, and BSS is a second option.
• All travelers should be provided with loperamide and an antibiotic for self-treatment if needed.
• Mild diarrhea should be treated with increased fluid intake and loperamide or BSS.
• Moderate to severe diarrhea should be treated with single-dose antimicrobial therapy of FQ or azithromycin or with rifaximin dosing three times a day.
• Instead of antibiotics, loperamide may be considered as monotherapy for moderate diarrhea; loperamide can be used with antibiotics for both moderate and severe TD.

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

Reference:

J Travel Med. 2017 Apr 1;24(suppl_1):S57-74.

Importance

The prevention and treatment of traveler’s diarrhea (TD) is a common reason that patients consult their physician prior to foreign travel. TD can result in lost time and opportunity, as well as overseas medical encounters and hospitalization. This guideline by the International Society of Travel Medicine provides clinically relevant, useful, and practical guidance to providers regarding the use of antibiotic and nonantibiotic therapies for the prevention and treatment of TD.

Prophylaxis

The panel recommends that antimicrobial prophylaxis should not be used routinely in travelers, but it should be considered for travelers who are at high risk of health-related complications of TD (both strong recommendations, low/very low level of evidence [LOE]). High-risk individuals include those with a history of clinically significant long-term morbidity following an enteric infection or serious chronic illnesses that predisposes them for TD-related complications. Bismuth subsalicylate (BSS) may be considered for any traveler to prevent TD (3, strong recommendation, high LOE). Studies show that a lower dose of 1.05 g/day is preventive, although it is unclear whether it is as effective as higher doses of 2.1 g/day or 4.2 g/day. When prophylaxis is indicated, travelers should be prescribed rifaximin (strong recommendation, moderate LOE) based on susceptibility of most enteric pathogens and the drug’s extremely favorable safety profile. Fluoroquinolones (FQ) are no longer recommended for prophylaxis (strong recommendation, low/very low LOE) because of neurologic and musculoskeletal side effects that may outweigh benefits, as well as emerging resistance of enteric pathogens (70%-80% in Campylobacter spp. from Nepal and Thailand and 65% in Enterotoxigenic Escherichia coli [ETEC] and Enteroaggregative E. coli [EAEC] in India).

Treatment

The following treatment recommendations are based on the classification of TD using functional effects of severity; therefore, the panel made new definitions for TD severity. This is a change from previous definitions that utilized a traditional frequency-based algorithm in order to tailor therapy for the individual. Individuals can be prescribed antibiotics and antimotility agents to take with them during travel, along with advice regarding how to judge when to use each agent.

Mild: diarrhea that is tolerable, is not distressing, and does not interfere with planned activities.

Encourage supportive measures such as rehydration and nonantibiotic, antimotility drugs, such as loperamide or BSS (both strong recommendations, moderate LOE).

Moderate: diarrhea that is distressing or interferes with planned activities.

Antibiotics may be used (weak recommendation, moderate LOE) as early and effective treatment may mitigate the well-described chronic health consequences including irritable bowel syndrome. Three options exist. FQs may be used outside of Southeast and South Asia (strong recommendation, moderate LOE), but their potential for adverse effects and musculoskeletal consequences must be considered. Azithromycin may be used (strong recommendation, high LOE) because studies show no significant differences in efficacy between it and FQs, limited resistance to common TD pathogens (although concerns exist in Nepal), and good side effect profile. Another choice is rifaximin (weak recommendation, moderate LOE), although one should exercise caution for empirical therapy in regions in which being at high risk of invasive pathogens is anticipated.

Loperamide may be used as adjunctive therapy for moderate to severe TD (strong recommendation, high LOE) to add symptomatic relief with curative treatment or as monotherapy in moderate TD (strong recommendation, high LOE). This is specifically true in children aged 2-11 years, in whom loperamide is beneficial without causing severe side effects.

Severe: diarrhea that is incapacitating or completely prevents planned activities; all dysentery (passage of grossly bloody stools).

Antibiotics should be used (strong recommendation, high LOE). Azithromycin is the preferred choice and is first-line for dysentery or febrile diarrhea (strong recommendation, moderate LOE) because of the likelihood of FQ-resistant bacteria being the cause of dysentery. FQs and rifaximin are also choices that can be used to treat severe, nondysenteric TD (both weak recommendations, moderate LOE).

Furthermore, single-dose antibiotics may be used to treat moderate or severe TD (strong recommendation, high LOE) because studies have shown equivalent efficacy for treatment of watery noninvasive diarrhea among FQs (3 days, single dose), azithromycin (3 days, single dose), and rifaximin (3 days, three times daily).

Persistent: diarrhea lasting longer than 2 weeks.

Functional bowel disease (FBD) may occur after bouts of TD and may meet Rome III or IV criteria for irritable bowel syndrome. Thus, in a traveler without pretravel GI disease, in whom the evaluation for microbial etiologies and underlying GI disease is negative, postinfectious FBD must be considered.

Follow-up and diagnostic testing

The panel recommends microbiological testing in returning travelers with severe or persistent symptoms, bloody/mucousy diarrhea, or in those who fail empiric therapy (strong recommendation, low/very low LOE). Molecular testing, aimed at a broad range of clinically relevant pathogens, is preferred when rapid results are clinically important or nonmolecular tests have failed to establish a diagnosis. Furthermore, molecular testing may, in some cases, detect colonization rather than infection.
 

The bottom line

The expert panel made 20 graded recommendations to help guide the provider with nonantibiotic and antibiotic prophylaxis and treatment of TD. The main take-home points include:

• Prophylaxis should be considered only in high-risk groups; rifaximin is the first choice, and BSS is a second option.
• All travelers should be provided with loperamide and an antibiotic for self-treatment if needed.
• Mild diarrhea should be treated with increased fluid intake and loperamide or BSS.
• Moderate to severe diarrhea should be treated with single-dose antimicrobial therapy of FQ or azithromycin or with rifaximin dosing three times a day.
• Instead of antibiotics, loperamide may be considered as monotherapy for moderate diarrhea; loperamide can be used with antibiotics for both moderate and severe TD.

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

Reference:

J Travel Med. 2017 Apr 1;24(suppl_1):S57-74.

Importance

The prevention and treatment of traveler’s diarrhea (TD) is a common reason that patients consult their physician prior to foreign travel. TD can result in lost time and opportunity, as well as overseas medical encounters and hospitalization. This guideline by the International Society of Travel Medicine provides clinically relevant, useful, and practical guidance to providers regarding the use of antibiotic and nonantibiotic therapies for the prevention and treatment of TD.

Prophylaxis

The panel recommends that antimicrobial prophylaxis should not be used routinely in travelers, but it should be considered for travelers who are at high risk of health-related complications of TD (both strong recommendations, low/very low level of evidence [LOE]). High-risk individuals include those with a history of clinically significant long-term morbidity following an enteric infection or serious chronic illnesses that predisposes them for TD-related complications. Bismuth subsalicylate (BSS) may be considered for any traveler to prevent TD (3, strong recommendation, high LOE). Studies show that a lower dose of 1.05 g/day is preventive, although it is unclear whether it is as effective as higher doses of 2.1 g/day or 4.2 g/day. When prophylaxis is indicated, travelers should be prescribed rifaximin (strong recommendation, moderate LOE) based on susceptibility of most enteric pathogens and the drug’s extremely favorable safety profile. Fluoroquinolones (FQ) are no longer recommended for prophylaxis (strong recommendation, low/very low LOE) because of neurologic and musculoskeletal side effects that may outweigh benefits, as well as emerging resistance of enteric pathogens (70%-80% in Campylobacter spp. from Nepal and Thailand and 65% in Enterotoxigenic Escherichia coli [ETEC] and Enteroaggregative E. coli [EAEC] in India).

Treatment

The following treatment recommendations are based on the classification of TD using functional effects of severity; therefore, the panel made new definitions for TD severity. This is a change from previous definitions that utilized a traditional frequency-based algorithm in order to tailor therapy for the individual. Individuals can be prescribed antibiotics and antimotility agents to take with them during travel, along with advice regarding how to judge when to use each agent.

Mild: diarrhea that is tolerable, is not distressing, and does not interfere with planned activities.

Encourage supportive measures such as rehydration and nonantibiotic, antimotility drugs, such as loperamide or BSS (both strong recommendations, moderate LOE).

Moderate: diarrhea that is distressing or interferes with planned activities.

Antibiotics may be used (weak recommendation, moderate LOE) as early and effective treatment may mitigate the well-described chronic health consequences including irritable bowel syndrome. Three options exist. FQs may be used outside of Southeast and South Asia (strong recommendation, moderate LOE), but their potential for adverse effects and musculoskeletal consequences must be considered. Azithromycin may be used (strong recommendation, high LOE) because studies show no significant differences in efficacy between it and FQs, limited resistance to common TD pathogens (although concerns exist in Nepal), and good side effect profile. Another choice is rifaximin (weak recommendation, moderate LOE), although one should exercise caution for empirical therapy in regions in which being at high risk of invasive pathogens is anticipated.

Loperamide may be used as adjunctive therapy for moderate to severe TD (strong recommendation, high LOE) to add symptomatic relief with curative treatment or as monotherapy in moderate TD (strong recommendation, high LOE). This is specifically true in children aged 2-11 years, in whom loperamide is beneficial without causing severe side effects.

Severe: diarrhea that is incapacitating or completely prevents planned activities; all dysentery (passage of grossly bloody stools).

Antibiotics should be used (strong recommendation, high LOE). Azithromycin is the preferred choice and is first-line for dysentery or febrile diarrhea (strong recommendation, moderate LOE) because of the likelihood of FQ-resistant bacteria being the cause of dysentery. FQs and rifaximin are also choices that can be used to treat severe, nondysenteric TD (both weak recommendations, moderate LOE).

Furthermore, single-dose antibiotics may be used to treat moderate or severe TD (strong recommendation, high LOE) because studies have shown equivalent efficacy for treatment of watery noninvasive diarrhea among FQs (3 days, single dose), azithromycin (3 days, single dose), and rifaximin (3 days, three times daily).

Persistent: diarrhea lasting longer than 2 weeks.

Functional bowel disease (FBD) may occur after bouts of TD and may meet Rome III or IV criteria for irritable bowel syndrome. Thus, in a traveler without pretravel GI disease, in whom the evaluation for microbial etiologies and underlying GI disease is negative, postinfectious FBD must be considered.

Follow-up and diagnostic testing

The panel recommends microbiological testing in returning travelers with severe or persistent symptoms, bloody/mucousy diarrhea, or in those who fail empiric therapy (strong recommendation, low/very low LOE). Molecular testing, aimed at a broad range of clinically relevant pathogens, is preferred when rapid results are clinically important or nonmolecular tests have failed to establish a diagnosis. Furthermore, molecular testing may, in some cases, detect colonization rather than infection.
 

The bottom line

The expert panel made 20 graded recommendations to help guide the provider with nonantibiotic and antibiotic prophylaxis and treatment of TD. The main take-home points include:

• Prophylaxis should be considered only in high-risk groups; rifaximin is the first choice, and BSS is a second option.
• All travelers should be provided with loperamide and an antibiotic for self-treatment if needed.
• Mild diarrhea should be treated with increased fluid intake and loperamide or BSS.
• Moderate to severe diarrhea should be treated with single-dose antimicrobial therapy of FQ or azithromycin or with rifaximin dosing three times a day.
• Instead of antibiotics, loperamide may be considered as monotherapy for moderate diarrhea; loperamide can be used with antibiotics for both moderate and severe TD.

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

Reference:

J Travel Med. 2017 Apr 1;24(suppl_1):S57-74.

Patients with inflammatory bowel disease (IBD) will soon have access to new biosimilars to infliximab, adalimumab, and other monoclonal antibodies, experts wrote in an American Gastroenterological Association clinical practice update.

“It is anticipated that biosimilars for IBD are here to stay,” wrote Laura E. Raffals, MD, of the Mayo Clinic in Rochester, Minn., and her associates in Clinical Gastroenterology and Hepatology. “Provided that the regulatory pathway remains rigorous and postmarketing surveillance is performed adequately, clinicians and patients can be reassured that these agents will provide the same well-described effectiveness for moderate to severe Crohn’s disease and ulcerative colitis, without new safety concerns.”

Evidence supports the use of biosimilars in IBD, but switching patients in stable remission on infliximab (Remicade) to a biosimilar, namely infliximab-dyyb (Inflectra), should remain a case-by-case choice, according to an AGA clinical practice update. Pending more safety data, the update’s authors recommended against nonmedical switches during pregnancy and urge special attention when considering whether to switch children.

Biologics have revolutionized IBD treatment, but at a steep price. As patents expire, companies have developed biosimilar agents that aim to conserve safety and efficacy at lower cost. Studies support this idea, although whether initiating or switching to biosimilars will save patients (versus hospitals or payers) money “remains to be seen,” the practice update states.

The FDA approval process for biosimilars is more rigorous than that for generics, but it skips the multiple phases of clinical trials required to approve reference biologics. Instead, the FDA requires robust evidence that the biosimilar has comparable structure, function, immunogenicity, animal toxicity, pharmacokinetics and pharmacodynamics, and clinical safety and efficacy in humans. Under U.S. law, a biosimilar cannot be FDA approved if its clinically active components differ from the reference product or it shows clinically meaningful differences in safety, potency, or purity.

So far, five biosimilars have been approved by the FDA for use in IBD, although not all are on the market yet: infliximab-dyyb (Inflectra), adalimumab-atta (Amjevita), infliximab-abda (Renflexis), adalimumab-adbm (Cyltezo), and infliximab-qbtx (Ixifi). Most postmarketing studies of their use involved patients on stable doses of Remicade who switched to biosimilar infliximab-dyyb (Inflectra).

The best known of these studies is the double-blind, randomized NOR-SWITCH trial, in which patients with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or chronic plaque psoriasis on Remicade either continued it or switched to biosimilar infliximab-dyyb (Inflectra). At week 52, both safety and the likelihood of worsening disease activity were similar regardless of treatment randomization. The study was not powered to assess subgroup outcomes in Crohn’s disease or ulcerative colitis, the practice update notes.

More recently, the results of the 16-week SECURE trial also indicated that switching to infliximab-dyyb (Inflectra) was safe and well tolerated by patients with remitted IBD. However, the FDA has not yet designated any biosimilar as “interchangeable” with an approved biologic confirmed safe in multiple switches, the practice update notes. As a result, state laws prohibit patients from being switched to a biosimilar without notification. Both the NOR-SWITCH and SECURE trials were done in Europe.

Clinicians also must understand that antidrug antibodies to originator and biosimilar infliximab cross-react with each other, the experts emphasized. Switching patients with antibodies to Remicade or a biosimilar to the other product therefore risks an immediate hypersensitivity reaction, including life-threatening anaphylaxis.

The authors disclosed no external funding sources. One author disclosed ties to AbbVie, Janssen, Pfizer, Merck, Samsung Bioepis, and Amgen. The rest reported having no conflicts of interest.

SOURCE: Raffals LA et al. Clin Gastroenterol Hepatol. 2018 Sep 6. doi: 10.1016/j.cgh.2018.08.064.

Patients with inflammatory bowel disease (IBD) will soon have access to new biosimilars to infliximab, adalimumab, and other monoclonal antibodies, experts wrote in an American Gastroenterological Association clinical practice update.

“It is anticipated that biosimilars for IBD are here to stay,” wrote Laura E. Raffals, MD, of the Mayo Clinic in Rochester, Minn., and her associates in Clinical Gastroenterology and Hepatology. “Provided that the regulatory pathway remains rigorous and postmarketing surveillance is performed adequately, clinicians and patients can be reassured that these agents will provide the same well-described effectiveness for moderate to severe Crohn’s disease and ulcerative colitis, without new safety concerns.”

Evidence supports the use of biosimilars in IBD, but switching patients in stable remission on infliximab (Remicade) to a biosimilar, namely infliximab-dyyb (Inflectra), should remain a case-by-case choice, according to an AGA clinical practice update. Pending more safety data, the update’s authors recommended against nonmedical switches during pregnancy and urge special attention when considering whether to switch children.

Biologics have revolutionized IBD treatment, but at a steep price. As patents expire, companies have developed biosimilar agents that aim to conserve safety and efficacy at lower cost. Studies support this idea, although whether initiating or switching to biosimilars will save patients (versus hospitals or payers) money “remains to be seen,” the practice update states.

The FDA approval process for biosimilars is more rigorous than that for generics, but it skips the multiple phases of clinical trials required to approve reference biologics. Instead, the FDA requires robust evidence that the biosimilar has comparable structure, function, immunogenicity, animal toxicity, pharmacokinetics and pharmacodynamics, and clinical safety and efficacy in humans. Under U.S. law, a biosimilar cannot be FDA approved if its clinically active components differ from the reference product or it shows clinically meaningful differences in safety, potency, or purity.

So far, five biosimilars have been approved by the FDA for use in IBD, although not all are on the market yet: infliximab-dyyb (Inflectra), adalimumab-atta (Amjevita), infliximab-abda (Renflexis), adalimumab-adbm (Cyltezo), and infliximab-qbtx (Ixifi). Most postmarketing studies of their use involved patients on stable doses of Remicade who switched to biosimilar infliximab-dyyb (Inflectra).

The best known of these studies is the double-blind, randomized NOR-SWITCH trial, in which patients with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or chronic plaque psoriasis on Remicade either continued it or switched to biosimilar infliximab-dyyb (Inflectra). At week 52, both safety and the likelihood of worsening disease activity were similar regardless of treatment randomization. The study was not powered to assess subgroup outcomes in Crohn’s disease or ulcerative colitis, the practice update notes.

More recently, the results of the 16-week SECURE trial also indicated that switching to infliximab-dyyb (Inflectra) was safe and well tolerated by patients with remitted IBD. However, the FDA has not yet designated any biosimilar as “interchangeable” with an approved biologic confirmed safe in multiple switches, the practice update notes. As a result, state laws prohibit patients from being switched to a biosimilar without notification. Both the NOR-SWITCH and SECURE trials were done in Europe.

Clinicians also must understand that antidrug antibodies to originator and biosimilar infliximab cross-react with each other, the experts emphasized. Switching patients with antibodies to Remicade or a biosimilar to the other product therefore risks an immediate hypersensitivity reaction, including life-threatening anaphylaxis.

The authors disclosed no external funding sources. One author disclosed ties to AbbVie, Janssen, Pfizer, Merck, Samsung Bioepis, and Amgen. The rest reported having no conflicts of interest.

SOURCE: Raffals LA et al. Clin Gastroenterol Hepatol. 2018 Sep 6. doi: 10.1016/j.cgh.2018.08.064.

Patients with inflammatory bowel disease (IBD) will soon have access to new biosimilars to infliximab, adalimumab, and other monoclonal antibodies, experts wrote in an American Gastroenterological Association clinical practice update.

“It is anticipated that biosimilars for IBD are here to stay,” wrote Laura E. Raffals, MD, of the Mayo Clinic in Rochester, Minn., and her associates in Clinical Gastroenterology and Hepatology. “Provided that the regulatory pathway remains rigorous and postmarketing surveillance is performed adequately, clinicians and patients can be reassured that these agents will provide the same well-described effectiveness for moderate to severe Crohn’s disease and ulcerative colitis, without new safety concerns.”

Evidence supports the use of biosimilars in IBD, but switching patients in stable remission on infliximab (Remicade) to a biosimilar, namely infliximab-dyyb (Inflectra), should remain a case-by-case choice, according to an AGA clinical practice update. Pending more safety data, the update’s authors recommended against nonmedical switches during pregnancy and urge special attention when considering whether to switch children.

Biologics have revolutionized IBD treatment, but at a steep price. As patents expire, companies have developed biosimilar agents that aim to conserve safety and efficacy at lower cost. Studies support this idea, although whether initiating or switching to biosimilars will save patients (versus hospitals or payers) money “remains to be seen,” the practice update states.

The FDA approval process for biosimilars is more rigorous than that for generics, but it skips the multiple phases of clinical trials required to approve reference biologics. Instead, the FDA requires robust evidence that the biosimilar has comparable structure, function, immunogenicity, animal toxicity, pharmacokinetics and pharmacodynamics, and clinical safety and efficacy in humans. Under U.S. law, a biosimilar cannot be FDA approved if its clinically active components differ from the reference product or it shows clinically meaningful differences in safety, potency, or purity.

So far, five biosimilars have been approved by the FDA for use in IBD, although not all are on the market yet: infliximab-dyyb (Inflectra), adalimumab-atta (Amjevita), infliximab-abda (Renflexis), adalimumab-adbm (Cyltezo), and infliximab-qbtx (Ixifi). Most postmarketing studies of their use involved patients on stable doses of Remicade who switched to biosimilar infliximab-dyyb (Inflectra).

The best known of these studies is the double-blind, randomized NOR-SWITCH trial, in which patients with Crohn’s disease, ulcerative colitis, spondyloarthritis, rheumatoid arthritis, psoriatic arthritis, or chronic plaque psoriasis on Remicade either continued it or switched to biosimilar infliximab-dyyb (Inflectra). At week 52, both safety and the likelihood of worsening disease activity were similar regardless of treatment randomization. The study was not powered to assess subgroup outcomes in Crohn’s disease or ulcerative colitis, the practice update notes.

More recently, the results of the 16-week SECURE trial also indicated that switching to infliximab-dyyb (Inflectra) was safe and well tolerated by patients with remitted IBD. However, the FDA has not yet designated any biosimilar as “interchangeable” with an approved biologic confirmed safe in multiple switches, the practice update notes. As a result, state laws prohibit patients from being switched to a biosimilar without notification. Both the NOR-SWITCH and SECURE trials were done in Europe.

Clinicians also must understand that antidrug antibodies to originator and biosimilar infliximab cross-react with each other, the experts emphasized. Switching patients with antibodies to Remicade or a biosimilar to the other product therefore risks an immediate hypersensitivity reaction, including life-threatening anaphylaxis.

The authors disclosed no external funding sources. One author disclosed ties to AbbVie, Janssen, Pfizer, Merck, Samsung Bioepis, and Amgen. The rest reported having no conflicts of interest.

SOURCE: Raffals LA et al. Clin Gastroenterol Hepatol. 2018 Sep 6. doi: 10.1016/j.cgh.2018.08.064.

Ideally, pregnant women with inflammatory bowel disease (IBD) should receive coordinated care from gastroenterologists and maternal-fetal medicine specialists, plus additional input from nutritionists, lactation counselors, and colorectal surgeons as needed, states a new report from the American Gastroenterological Association.

But in reality, these women often receive scant and conflicting advice from health care providers, writes Uma Mahadevan, MD, of the University of California, San Francisco, with her associates in Gastroenterology.

An “explosion” of new treatments in the past 15 years has given hope to many women with IBD who wish to be healthy enough to conceive, the experts noted. But in a recent AGA survey, more than 40% of obstetrician/gynecologist (OB/GYN) providers felt that women with IBD received inadequate information about pregnancy, compared with patients with other immune-mediated diseases. Strikingly, 94% of surveyed clinicians said they had patients stop taking their IBD medications during pregnancy because they feared harm to the fetus. In doing so, these patients actually risked greater disease activity, perinatal flares, and adverse pregnancy outcomes.

Therefore, the AGA, in partnership with the Crohn’s & Colitis Foundation, the Society for Maternal-Fetal Medicine, and Girls With Guts, crafted a standardized, evidence-based care pathway for health care providers from diverse disciplines who treat women with IBD in all stages of family planning. Its authors recommended that a maternal-fetal medicine specialist oversee obstetric care whenever possible. A gastroenterologist should continue IBD care by seeing the patient once during the first or second trimester and thereafter depending on IBD severity. The patient should receive a “clear and easily understandable consensus plan” for managing complex care during and after pregnancy, according to the pathway.

Aminosalicylates, biologics, and immunomodulators can be continued during pregnancy and delivery. Biologics have not shown teratogenicity in large studies, but monotherapy is preferred to reduce infection risk in infants. Clinicians should calculate weight-based doses according to prepregnancy weight. Doses can be tweaked to achieve minimal trough levels near delivery.

During pregnancy, patients should stop antidiarrheal therapy with loperamide and diphenoxylate when possible. Proinflammatory mediators are known to damage hippocampal neurogenesis and neuronal cytoarchitecture during brain development, so patients should understand the need for good inflammatory control during pregnancy. However, biologic therapy is preferred, and patients should only use corticosteroids adjunctively if needed for flares.

The usual indications guide the choice between a vaginal or cesarean delivery, the pathway states. Vaginal delivery often is possible for patients without active perineal disease, while cesarean is recommended for women with prior perineal surgery or active perineal disease or rectovaginal fistulas. The perineal area can be examined for active disease during the routine visit for group B streptococcus screening culture at 35-37 weeks’ gestation. For women who have had ileal-pouch anal anastomosis surgery, mode of delivery does not seem to affect pouch function, but cesarean delivery is thought to prevent anal sphincter injury and the accompanying risk of incontinence.

For ostomy patients, stretching of the abdominal wall during pregnancy can lead to stomal problems, such as displacement, enlargement, retraction, stenosis, and prolapse. A nutritionist can help ostomy patients avoid excess weight gain, and a colorectal surgeon and ostomy/wound nurse can help coordinate postpartum care. If cesarean delivery is needed, simply covering the ostomy with gauze sufficiently protects the operative field.

Since IBD increases the risk of venous thromboembolism, clinicians should consider prophylactic anticoagulation after cesarean delivery and during a hospitalization for IBD flares, according to the care pathway. Breastfeeding women can receive unfractionated heparin, low-molecular-weight heparin, or warfarin up to 3-6 weeks post partum, but they should not receive oral direct thrombin or factor Xa inhibitors.

In addition, most IBD medications are either undetectable in breast milk or are secreted at such low concentrations that they pose no known risk to infants. Therefore, patients can continue IBD medications after delivery – except methotrexate, which has not been sufficiently studied to assess its safety. Breastfeeding women with IBD should avoid using fenugreek to increase milk production, since it can cause diarrhea and bleeding.

Finally, infants should not receive live vaccines during the first 6 months after birth if their mothers received biologics besides certolizumab during the third trimester, the pathway notes. In the United States, this applies only to the oral rotavirus vaccine.

For more information about the care pathway and resources for your patients, visit IBDParenthoodProject.org.

SOURCE: Mahadevan U et al. Gastroenterology. 2019 Jan 15. doi: 10.1053/j.gastro.2018.12.022.

Ideally, pregnant women with inflammatory bowel disease (IBD) should receive coordinated care from gastroenterologists and maternal-fetal medicine specialists, plus additional input from nutritionists, lactation counselors, and colorectal surgeons as needed, states a new report from the American Gastroenterological Association.

But in reality, these women often receive scant and conflicting advice from health care providers, writes Uma Mahadevan, MD, of the University of California, San Francisco, with her associates in Gastroenterology.

An “explosion” of new treatments in the past 15 years has given hope to many women with IBD who wish to be healthy enough to conceive, the experts noted. But in a recent AGA survey, more than 40% of obstetrician/gynecologist (OB/GYN) providers felt that women with IBD received inadequate information about pregnancy, compared with patients with other immune-mediated diseases. Strikingly, 94% of surveyed clinicians said they had patients stop taking their IBD medications during pregnancy because they feared harm to the fetus. In doing so, these patients actually risked greater disease activity, perinatal flares, and adverse pregnancy outcomes.

Therefore, the AGA, in partnership with the Crohn’s & Colitis Foundation, the Society for Maternal-Fetal Medicine, and Girls With Guts, crafted a standardized, evidence-based care pathway for health care providers from diverse disciplines who treat women with IBD in all stages of family planning. Its authors recommended that a maternal-fetal medicine specialist oversee obstetric care whenever possible. A gastroenterologist should continue IBD care by seeing the patient once during the first or second trimester and thereafter depending on IBD severity. The patient should receive a “clear and easily understandable consensus plan” for managing complex care during and after pregnancy, according to the pathway.

Aminosalicylates, biologics, and immunomodulators can be continued during pregnancy and delivery. Biologics have not shown teratogenicity in large studies, but monotherapy is preferred to reduce infection risk in infants. Clinicians should calculate weight-based doses according to prepregnancy weight. Doses can be tweaked to achieve minimal trough levels near delivery.

During pregnancy, patients should stop antidiarrheal therapy with loperamide and diphenoxylate when possible. Proinflammatory mediators are known to damage hippocampal neurogenesis and neuronal cytoarchitecture during brain development, so patients should understand the need for good inflammatory control during pregnancy. However, biologic therapy is preferred, and patients should only use corticosteroids adjunctively if needed for flares.

The usual indications guide the choice between a vaginal or cesarean delivery, the pathway states. Vaginal delivery often is possible for patients without active perineal disease, while cesarean is recommended for women with prior perineal surgery or active perineal disease or rectovaginal fistulas. The perineal area can be examined for active disease during the routine visit for group B streptococcus screening culture at 35-37 weeks’ gestation. For women who have had ileal-pouch anal anastomosis surgery, mode of delivery does not seem to affect pouch function, but cesarean delivery is thought to prevent anal sphincter injury and the accompanying risk of incontinence.

For ostomy patients, stretching of the abdominal wall during pregnancy can lead to stomal problems, such as displacement, enlargement, retraction, stenosis, and prolapse. A nutritionist can help ostomy patients avoid excess weight gain, and a colorectal surgeon and ostomy/wound nurse can help coordinate postpartum care. If cesarean delivery is needed, simply covering the ostomy with gauze sufficiently protects the operative field.

Since IBD increases the risk of venous thromboembolism, clinicians should consider prophylactic anticoagulation after cesarean delivery and during a hospitalization for IBD flares, according to the care pathway. Breastfeeding women can receive unfractionated heparin, low-molecular-weight heparin, or warfarin up to 3-6 weeks post partum, but they should not receive oral direct thrombin or factor Xa inhibitors.

In addition, most IBD medications are either undetectable in breast milk or are secreted at such low concentrations that they pose no known risk to infants. Therefore, patients can continue IBD medications after delivery – except methotrexate, which has not been sufficiently studied to assess its safety. Breastfeeding women with IBD should avoid using fenugreek to increase milk production, since it can cause diarrhea and bleeding.

Finally, infants should not receive live vaccines during the first 6 months after birth if their mothers received biologics besides certolizumab during the third trimester, the pathway notes. In the United States, this applies only to the oral rotavirus vaccine.

For more information about the care pathway and resources for your patients, visit IBDParenthoodProject.org.

SOURCE: Mahadevan U et al. Gastroenterology. 2019 Jan 15. doi: 10.1053/j.gastro.2018.12.022.

Ideally, pregnant women with inflammatory bowel disease (IBD) should receive coordinated care from gastroenterologists and maternal-fetal medicine specialists, plus additional input from nutritionists, lactation counselors, and colorectal surgeons as needed, states a new report from the American Gastroenterological Association.

But in reality, these women often receive scant and conflicting advice from health care providers, writes Uma Mahadevan, MD, of the University of California, San Francisco, with her associates in Gastroenterology.

An “explosion” of new treatments in the past 15 years has given hope to many women with IBD who wish to be healthy enough to conceive, the experts noted. But in a recent AGA survey, more than 40% of obstetrician/gynecologist (OB/GYN) providers felt that women with IBD received inadequate information about pregnancy, compared with patients with other immune-mediated diseases. Strikingly, 94% of surveyed clinicians said they had patients stop taking their IBD medications during pregnancy because they feared harm to the fetus. In doing so, these patients actually risked greater disease activity, perinatal flares, and adverse pregnancy outcomes.

Therefore, the AGA, in partnership with the Crohn’s & Colitis Foundation, the Society for Maternal-Fetal Medicine, and Girls With Guts, crafted a standardized, evidence-based care pathway for health care providers from diverse disciplines who treat women with IBD in all stages of family planning. Its authors recommended that a maternal-fetal medicine specialist oversee obstetric care whenever possible. A gastroenterologist should continue IBD care by seeing the patient once during the first or second trimester and thereafter depending on IBD severity. The patient should receive a “clear and easily understandable consensus plan” for managing complex care during and after pregnancy, according to the pathway.

Aminosalicylates, biologics, and immunomodulators can be continued during pregnancy and delivery. Biologics have not shown teratogenicity in large studies, but monotherapy is preferred to reduce infection risk in infants. Clinicians should calculate weight-based doses according to prepregnancy weight. Doses can be tweaked to achieve minimal trough levels near delivery.

During pregnancy, patients should stop antidiarrheal therapy with loperamide and diphenoxylate when possible. Proinflammatory mediators are known to damage hippocampal neurogenesis and neuronal cytoarchitecture during brain development, so patients should understand the need for good inflammatory control during pregnancy. However, biologic therapy is preferred, and patients should only use corticosteroids adjunctively if needed for flares.

The usual indications guide the choice between a vaginal or cesarean delivery, the pathway states. Vaginal delivery often is possible for patients without active perineal disease, while cesarean is recommended for women with prior perineal surgery or active perineal disease or rectovaginal fistulas. The perineal area can be examined for active disease during the routine visit for group B streptococcus screening culture at 35-37 weeks’ gestation. For women who have had ileal-pouch anal anastomosis surgery, mode of delivery does not seem to affect pouch function, but cesarean delivery is thought to prevent anal sphincter injury and the accompanying risk of incontinence.

For ostomy patients, stretching of the abdominal wall during pregnancy can lead to stomal problems, such as displacement, enlargement, retraction, stenosis, and prolapse. A nutritionist can help ostomy patients avoid excess weight gain, and a colorectal surgeon and ostomy/wound nurse can help coordinate postpartum care. If cesarean delivery is needed, simply covering the ostomy with gauze sufficiently protects the operative field.

Since IBD increases the risk of venous thromboembolism, clinicians should consider prophylactic anticoagulation after cesarean delivery and during a hospitalization for IBD flares, according to the care pathway. Breastfeeding women can receive unfractionated heparin, low-molecular-weight heparin, or warfarin up to 3-6 weeks post partum, but they should not receive oral direct thrombin or factor Xa inhibitors.

In addition, most IBD medications are either undetectable in breast milk or are secreted at such low concentrations that they pose no known risk to infants. Therefore, patients can continue IBD medications after delivery – except methotrexate, which has not been sufficiently studied to assess its safety. Breastfeeding women with IBD should avoid using fenugreek to increase milk production, since it can cause diarrhea and bleeding.

Finally, infants should not receive live vaccines during the first 6 months after birth if their mothers received biologics besides certolizumab during the third trimester, the pathway notes. In the United States, this applies only to the oral rotavirus vaccine.

For more information about the care pathway and resources for your patients, visit IBDParenthoodProject.org.

SOURCE: Mahadevan U et al. Gastroenterology. 2019 Jan 15. doi: 10.1053/j.gastro.2018.12.022.

NEW ORLEANS – In new guidelines for the pharmacologic management of osteoporosis, bisphosphonates have been identified as the first-line therapy with denosumab (Prolia) listed as an acceptable alternative that is particularly well suited for high-risk patients, according to a presentation at the annual meeting of the Endocrine Society.

“We hope our guideline will not only improve patient care but provide confidence in treatment,” reported guideline writing committee member Clifford J. Rosen, MD, director of the Center for Clinical and Translational Research at Maine Medical Center Research Institute, Scarborough.

The new guidelines are evidence based, relying on randomized, controlled trials to evaluate the data quality of treatment options with GRADE methodology, but Dr. Rosen said that the guideline writing committee also considered patient preferences because of concerns about the abundant evidence that adherence to pharmacologic therapies for osteoporosis is poor.

“There is a considerable gap in the treatment of osteoporosis. Most women will not take anti-osteoporosis therapies despite their efficacy, and those who do often stop,” Dr. Rosen observed. He said it was the intention of the writing committee to provide acceptable recommendations with a clear outline of benefits and risks in order to enlist patients more successfully in understanding and participating in fracture prevention.


The Endocrine Society guidelines, which are available online and will soon appear in print (J Clin Endocrinol Metab. 2019;104:1-28), are focused on pharmacologic management and therefore differ from guidelines on diagnosis and treatment published previously by the American Association of Clinical Endocrinologists (AACE) (Endocr Pract. 2016;22[Suppl 4]:1-42).

The AACE guidelines, which devote considerable space to prevention, indicated that bisphosphonates should “be generally considered as initial options for most patients who are candidates for treatment.” The AACE guidelines identify denosumab as the “treatment of choice” in patients with renal insufficiency (although not in those on dialysis or with end-stage renal disease).

In outlining some of the key features of the new guidelines at ENDO 2019, Dr. Rosen drew attention to a call for reevaluation of the need for bisphosphonates after patients have been on this therapy for 3 or more years. For those found at this time to be at low or moderate risk of fracture, a drug holiday is recommended based on guideline-cited evidence that bisphosphonates offer a residual therapeutic effect after stopping.

However, stopping is not recommended in those who remain at high risk. In these patients, bone density should be monitored at regular intervals for the goal of switching or intensifying therapy if needed. This includes use of teriparatide (Forteo) or abaloparatide (Tymlos) for periods of up to 2 years in patients with a history of severe or multiple fractures. These and other choices are included in a detailed algorithm covering both low- and high-risk patients.


Although many postmenopausal women hope to avoid pharmacologic therapy with high dietary intake of calcium and vitamin D, Dr. Rosen stressed the limited benefit of these nutrients in preventing fracture for those with established osteoporosis. While acknowledging that calcium and vitamin D enhance mineralization and maintenance of bone mass, he characterized them as “supplements” once pharmacologic therapies are indicated.

Unsurprisingly, patients prefer oral therapies that are effective but with a low burden of adverse events, according to a review of evidence undertaken by the guideline committee. Cost was a less important consideration. Dr. Rosen indicated that recognizing patient goals and priorities while explaining relative risks might engage patients in selecting a therapy to which they are willing to adhere.

He reported having no relevant financial relationships.

NEW ORLEANS – In new guidelines for the pharmacologic management of osteoporosis, bisphosphonates have been identified as the first-line therapy with denosumab (Prolia) listed as an acceptable alternative that is particularly well suited for high-risk patients, according to a presentation at the annual meeting of the Endocrine Society.

“We hope our guideline will not only improve patient care but provide confidence in treatment,” reported guideline writing committee member Clifford J. Rosen, MD, director of the Center for Clinical and Translational Research at Maine Medical Center Research Institute, Scarborough.

The new guidelines are evidence based, relying on randomized, controlled trials to evaluate the data quality of treatment options with GRADE methodology, but Dr. Rosen said that the guideline writing committee also considered patient preferences because of concerns about the abundant evidence that adherence to pharmacologic therapies for osteoporosis is poor.

“There is a considerable gap in the treatment of osteoporosis. Most women will not take anti-osteoporosis therapies despite their efficacy, and those who do often stop,” Dr. Rosen observed. He said it was the intention of the writing committee to provide acceptable recommendations with a clear outline of benefits and risks in order to enlist patients more successfully in understanding and participating in fracture prevention.


The Endocrine Society guidelines, which are available online and will soon appear in print (J Clin Endocrinol Metab. 2019;104:1-28), are focused on pharmacologic management and therefore differ from guidelines on diagnosis and treatment published previously by the American Association of Clinical Endocrinologists (AACE) (Endocr Pract. 2016;22[Suppl 4]:1-42).

The AACE guidelines, which devote considerable space to prevention, indicated that bisphosphonates should “be generally considered as initial options for most patients who are candidates for treatment.” The AACE guidelines identify denosumab as the “treatment of choice” in patients with renal insufficiency (although not in those on dialysis or with end-stage renal disease).

In outlining some of the key features of the new guidelines at ENDO 2019, Dr. Rosen drew attention to a call for reevaluation of the need for bisphosphonates after patients have been on this therapy for 3 or more years. For those found at this time to be at low or moderate risk of fracture, a drug holiday is recommended based on guideline-cited evidence that bisphosphonates offer a residual therapeutic effect after stopping.

However, stopping is not recommended in those who remain at high risk. In these patients, bone density should be monitored at regular intervals for the goal of switching or intensifying therapy if needed. This includes use of teriparatide (Forteo) or abaloparatide (Tymlos) for periods of up to 2 years in patients with a history of severe or multiple fractures. These and other choices are included in a detailed algorithm covering both low- and high-risk patients.


Although many postmenopausal women hope to avoid pharmacologic therapy with high dietary intake of calcium and vitamin D, Dr. Rosen stressed the limited benefit of these nutrients in preventing fracture for those with established osteoporosis. While acknowledging that calcium and vitamin D enhance mineralization and maintenance of bone mass, he characterized them as “supplements” once pharmacologic therapies are indicated.

Unsurprisingly, patients prefer oral therapies that are effective but with a low burden of adverse events, according to a review of evidence undertaken by the guideline committee. Cost was a less important consideration. Dr. Rosen indicated that recognizing patient goals and priorities while explaining relative risks might engage patients in selecting a therapy to which they are willing to adhere.

He reported having no relevant financial relationships.

NEW ORLEANS – In new guidelines for the pharmacologic management of osteoporosis, bisphosphonates have been identified as the first-line therapy with denosumab (Prolia) listed as an acceptable alternative that is particularly well suited for high-risk patients, according to a presentation at the annual meeting of the Endocrine Society.

“We hope our guideline will not only improve patient care but provide confidence in treatment,” reported guideline writing committee member Clifford J. Rosen, MD, director of the Center for Clinical and Translational Research at Maine Medical Center Research Institute, Scarborough.

The new guidelines are evidence based, relying on randomized, controlled trials to evaluate the data quality of treatment options with GRADE methodology, but Dr. Rosen said that the guideline writing committee also considered patient preferences because of concerns about the abundant evidence that adherence to pharmacologic therapies for osteoporosis is poor.

“There is a considerable gap in the treatment of osteoporosis. Most women will not take anti-osteoporosis therapies despite their efficacy, and those who do often stop,” Dr. Rosen observed. He said it was the intention of the writing committee to provide acceptable recommendations with a clear outline of benefits and risks in order to enlist patients more successfully in understanding and participating in fracture prevention.


The Endocrine Society guidelines, which are available online and will soon appear in print (J Clin Endocrinol Metab. 2019;104:1-28), are focused on pharmacologic management and therefore differ from guidelines on diagnosis and treatment published previously by the American Association of Clinical Endocrinologists (AACE) (Endocr Pract. 2016;22[Suppl 4]:1-42).

The AACE guidelines, which devote considerable space to prevention, indicated that bisphosphonates should “be generally considered as initial options for most patients who are candidates for treatment.” The AACE guidelines identify denosumab as the “treatment of choice” in patients with renal insufficiency (although not in those on dialysis or with end-stage renal disease).

In outlining some of the key features of the new guidelines at ENDO 2019, Dr. Rosen drew attention to a call for reevaluation of the need for bisphosphonates after patients have been on this therapy for 3 or more years. For those found at this time to be at low or moderate risk of fracture, a drug holiday is recommended based on guideline-cited evidence that bisphosphonates offer a residual therapeutic effect after stopping.

However, stopping is not recommended in those who remain at high risk. In these patients, bone density should be monitored at regular intervals for the goal of switching or intensifying therapy if needed. This includes use of teriparatide (Forteo) or abaloparatide (Tymlos) for periods of up to 2 years in patients with a history of severe or multiple fractures. These and other choices are included in a detailed algorithm covering both low- and high-risk patients.


Although many postmenopausal women hope to avoid pharmacologic therapy with high dietary intake of calcium and vitamin D, Dr. Rosen stressed the limited benefit of these nutrients in preventing fracture for those with established osteoporosis. While acknowledging that calcium and vitamin D enhance mineralization and maintenance of bone mass, he characterized them as “supplements” once pharmacologic therapies are indicated.

Unsurprisingly, patients prefer oral therapies that are effective but with a low burden of adverse events, according to a review of evidence undertaken by the guideline committee. Cost was a less important consideration. Dr. Rosen indicated that recognizing patient goals and priorities while explaining relative risks might engage patients in selecting a therapy to which they are willing to adhere.

He reported having no relevant financial relationships.

Knee osteoarthritis (OA) affects almost 9.3 million adults in the US and accounts for $27 billion in annual health care expenses.^1,2 Due to the increasing cost of health care and an aging population, there has been renewed interest in establishing criteria for nonarthroplasty treatment of knee OA.

In 2013, using the RAND/UCLA Appropriateness method, the American Academy of Orthopaedic Surgeons (AAOS) developed an appropriate use criteria (AUC) for nonarthroplasty management of primary OA of the knee, based on orthopaedic literature and expert opinion.³ Interventions such as activity modification, weight loss, prescribed physical therapy, nonsteroidal anti-inflammatory drugs, tramadol, prescribed oral or transcutaneous opioids, acetaminophen, intra-articular corticosteroids, hinged or unloading knee braces, arthroscopic partial menisectomy or loose body removal, and realignment osteotomy were assessed. An algorithm was developed for 576 patients scenarios that incorporated patient-specific, prognostic/predictor variables to assign designations of “appropriate,” “may be appropriate,” or “rarely appropriate,” to treatment interventions.^4,5 An online version of the algorithm (orthoguidelines.org) is available for physicians and surgeons to judge appropriateness of nonarthroplasty treatments; however, it is not intended to mandate candidacy for treatment or intervention.

Clinical evaluation of the AAOS AUC is necessary to determine how treatment recommendations correlate with current practice. A recent examination of the AAOS Appropriateness System for Surgical Management of Knee OA found that prognostic/predictor variables, such as patient age, OA severity, and pattern of knee OA involvement were more heavily weighted when determining arthroplasty appropriateness than was pain severity or functional loss.⁶ Furthermore, non-AAOS AUC prognostic/predictor variables, such as race and gender, have been linked to disparities in utilization of knee OA interventions.^7-9 Such disparities can be costly not just from a patient perceptive, but also employer and societal perspectives.¹⁰

The Department of Veterans Affairs (VA) health care system represents a model of equal-access-to care system in the US that is ideal for examination of issues about health care utilization and any disparities within the AAOS AUC model and has previously been used to assess utilization of total knee arthroplasty.⁹ The aim of this study was to characterize utilization of the AAOS AUC for nonarthroplasty treatment of knee OA in a VA patient population. We asked the following questions: (1) What variables are predictive of receiving a greater number of AAOS AUC evaluated nonarthroplasty treatments? (2) What variables are predictive of receiving “rarely appropriate” AAOS AUC evaluated nonarthroplasty treatment? (3) What factors are predictive of duration of nonarthroplasty care until total knee arthroplasty (TKA)?

Methods

The institutional review board at the Louis Stokes Cleveland VA Medical Center in Ohio approved a retrospective chart review of nonarthroplasty treatments utilized by patients presenting to its orthopaedic section who subsequently underwent knee arthroplasty between 2013 and 2016. Eligibility criteria included patients aged ≥ 30 years with a diagnosis of unilateral or bilateral primary knee OA. Patients with posttraumatic OA, inflammatory arthritis, and a history of infectious arthritis or Charcot arthropathy of the knee were excluded. Patients with a body mass index (BMI) > 40 or a hemoglobin A_1c > 8.0 at presentation were excluded as nonarthroplasty care was the recommended course of treatment above these thresholds.

Data collected included race, gender, duration of nonarthroplasty treatment, BMI, and Kellgren-Lawrence classification of knee OA at time of presentation for symptomatic knee OA.¹¹ All AAOS AUC-evaluated nonarthroplasty treatments utilized prior to arthroplasty intervention also were recorded (Table 1). 

Statistical Analysis

Statistical analysis was completed with GraphPad Software Prism 7.0a (La Jolla, CA) and Mathworks MatLab R2016b software (Natick, MA). Univariate analysis with Student t tests with Welch corrections in the setting of unequal variance, Mann-Whitney nonparametric tests, and Fisher exact test were generated in the appropriate setting. Multivariable analyses also were conducted. For continuous outcomes, stepwise multiple linear regression was used to generate predictive models; for binary outcomes, binomial logistic regression was used.

Factors analyzed in regression modeling for the total number of AAOS AUC evaluated nonarthroplasty treatments utilized and the likelihood of receiving a rarely appropriate treatment included gender, race, function-limiting pain, range of motion (ROM), ligamentous instability, arthritis pattern, limb alignment, mechanical symptoms, BMI, age, and Kellgren-Lawrence grade. Factors analyzed in timing of TKA included the above variables plus the total number of AUC interventions, whether the patient received an inappropriate intervention, and average appropriateness of the interventions received. Residual analysis with Cook’s distance was used to identify outliers in regression. Observations with Cook’s distance > 3 times the mean Cook’s distance were identified as potential outliers, and models were adjusted accordingly. All statistical analyses were 2-tailed. Statistical significance was set to P ≤ .05 for all outputs.

Results

In the study, 97.8% of participants identified as male, and the mean age was 62.8 years (Table 3). 

Appropriate Use Criteria Interventions

Patients received a mean of 5.2 AAOS AUC evaluated interventions before undergoing arthroplasty management at a mean of 32.3 months (range 2-181 months) from initial presentation. The majority of these interventions were classified as either appropriate or may be appropriate, according to the AUC definitions (95.1%). Self-management and physical therapy programs were widely utilized (100% and 90.1%, respectively), with all use of these interventions classified as appropriate.

Hinged or unloader knee braces were utilized in about half the study patients; this intervention was classified as rarely appropriate in 4.4% of these patients. Medical therapy was also widely used, with all use of NSAIDs, acetaminophen, and tramadol classified as appropriate or may be appropriate. Oral or transcutaneous opioid medications were prescribed in 14.3% of patients, with 92.3% of this use classified as rarely appropriate. Although the opioid medication prescribing provider was not specifically evaluated, there were no instances in which the orthopaedic service provided an oral or transcutaneous opioid prescriptions. Procedural interventions, with the exception of corticosteroid injections, were uncommon; no patient received realignment osteotomy, and only 12.1% of patients underwent arthroscopy. The use of arthroscopy was deemed rarely appropriate in 72.7% of these cases.

Factors Associated With AAOS AUC Intervention Use

There was no difference in the number of AAOS AUC evaluated interventions received based on BMI (mean [SD] BMI < 35, 5.2 [1.0] vs BMI ≥ 35, 5.3 [1.1], P = .49), age (mean [SD] aged < 60 years, 5.4 [1.0] vs aged ≥ 60 years, 5.1 [1.2], P = .23), or Kellgren-Lawrence arthritic grade (mean [SD] grade ≤ 2, 5.5 [1.0] vs grade > 2, 5.1 [1.1], P = .06). These variables also were not associated with receiving a rarely appropriate intervention (mean [SD] BMI < 35, 0.27 [0.5] vs BMI > 35, 0.2 [0.4], P = .81; aged > 60 years, 0.3 [0.5] vs aged < 60 years, 0.2 [0.4], P = .26; Kellgren-Lawrence grade < 2, 0.4 [0.6] vs grade > 2, 0.2 [0.4], P = .1).

Regression modeling to predict total number of AAOS AUC evaluated interventions received produced a significant model (R² = 0.111, P = .006). The presence of ligamentous instability (β coefficient, -1.61) and the absence of mechanical symptoms (β coefficient, -0.67) were negative predictors of number of AUC interventions received. Variance inflation factors were 1.014 and 1.012, respectively. Likewise, regression modeling to identify factors predictive of receiving a rarely appropriate intervention also produced a significant model (pseudo R²= 0.06, P = .025), with lower Kellgren-Lawrence grade the only significant predictor of receiving a rarely appropriate intervention (odds ratio [OR] 0.54; 95% CI, 0.42 -0.72, per unit increase).

Timing from presentation to arthroplasty intervention was also evaluated. Age was a negative predictor (β coefficient -1.61), while positive predictors were reduced ROM (β coefficient 15.72) and having more AUC interventions (β coefficient 7.31) (model R²= 0.29, P = < .001). Age was the most significant predictor. Variance inflations factors were 1.02, 1.01, and 1.03, respectively. Receiving a rarely appropriate intervention was not associated with TKA timing.

Discussion

This single-center retrospective study examined the utilization of AAOS AUC-evaluated nonarthroplasty interventions for symptomatic knee OA prior to TKA. The aims of this study were to validate the AAOS AUC in a clinical setting and identify predictors of AAOS AUC utilization. In particular, this study focused on the number of interventions utilized prior to knee arthroplasty, whether interventions receiving a designation of rarely appropriate were used, and the duration of nonarthroplasty treatment.

Patients with knee instability used fewer total AAOS AUC evaluated interventions prior to TKA. Subjective instability has been reported as high as 27% in patients with OA and has been associated with fear of falling, poor balance confidence, activity limitations, and lower Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function scores.¹² However, it has not been found to correlate with knee laxity.¹³ Nevertheless, significant functional impairment with the risk of falling may reduce the number of nonarthroplasty interventions attempted. On the other hand, the presence of mechanical symptoms resulted in greater utilization of nonarthroplasty interventions. This is likely due to the greater utilization of arthroscopic partial menisectomy or loose body removal in this group of patients. Despite its inclusion as an AAOS AUC evaluated intervention, arthroscopy remains a contentious treatment for symptomatic knee pain in the setting of OA.^14,15

For every unit decrease in Kellgren-Lawrence OA grade, patients were 54% more likely to receive a rarely appropriate intervention prior to knee arthroplasty. This is supported by the recent literature examining the AAOS AUC for surgical management of knee OA. Riddle and colleagues developed a classification tree to determine the contributions of various prognostic variables in final classifications of the 864 clinical vignettes used to develop the appropriateness algorithm and found that OA severity was strongly favored, with only 4 of the 432 vignettes with severe knee OA judged as rarely appropriate for surgical intervention.⁶

Our findings, too, may be explained by an AAOS AUC system that too heavily weighs radiographic severity of knee OA, resulting in more frequent rarely appropriate interventions in patients with less severe arthritis, including nonarthroplasty treatments. It is likely that rarely appropriate interventions were attempted in this subset of our study cohort based on patient’s subjective symptoms and functional status, both of which have been shown to be discordant with radiographic severity of knee OA.¹⁶

Oral or transcutaneous prescribed opioid medications were the most frequent intervention that received a rarely appropriate designation. Patients with preoperative opioid use undergoing TKA have been shown to have a greater risk for postoperative complications and longer hospital stay, particularly those patients aged < 75 years. Younger age, use of more interventions, and decreased knee ROM at presentation were predictive of longer duration of nonarthroplasty treatment. The use of more AAOS AUC evaluated interventions in these patients suggests that the AAOS AUC model may effectively be used to manage symptomatic OA, increasing the time from presentation to knee arthroplasty.

Interestingly, the use of rarely appropriate interventions did not affect TKA timing, as would be expected in a clinically effective nonarthroplasty treatment model. The reasons for rarely appropriate nonsurgical interventions are complex and require further investigation. One possible explanation is that decreased ROM was a marker for mechanical symptoms that necessitated additional intervention in the form of knee arthroscopy, delaying time to TKA.

Limitations

There are several limitations of this study. First, the small sample size (N = 90) requires acknowledgment; however, this limitation reflects the difficulty in following patients for years prior to an operative intervention. Second, the study population consists of veterans using the VA system and may not be reflective of the general population, differing with respect to gender, racial, and socioeconomic factors. Nevertheless, studies examining TKA utilization found, aside from racial and ethnic variability, patient gender and age do not affect arthroplasty utilization rate in the VA system.¹⁷

Additional limitations stem from the retrospective nature of this study. While the Computerized Patient Record System and centralized care of the VA system allows for review of all physical therapy consultations, orthotic consultations, and medications within the VA system, any treatments and intervention delivered by non-VA providers were not captured. Furthermore, the ability to assess for confounding variables limiting the prescription of certain medications, such as chronic kidney disease with NSAIDs or liver disease with acetaminophen, was limited by our study design.

Although our study suffers from selection bias with respect to examination of nonarthroplasty treatment in patients who have ultimately undergone TKA, we feel that this subset of patients with symptomatic knee OA represents the majority of patients evaluated for knee OA by orthopaedic surgeons in the clinic setting. It should be noted that although realignment osteotomies were sometimes indicated as appropriate by AAOS AUC model in our study population, this intervention was never performed due to patient and surgeon preference. Additionally, although it is not an AAOS AUC evaluated intervention, viscosupplementation was sporadically used during the study period; however, it is now off formulary at the investigation institution.

Conclusion

Our study suggests that patients without knee instability use more nonarthroplasty treatments over a longer period before TKA, and those patients with less severe knee OA are at risk of receiving an intervention judged to be rarely appropriate by the AAOS AUC. Such interventions do not affect timing of TKA. Nonarthroplasty care should be individualized to patients’ needs, and the decision to proceed with arthroplasty should be considered only after exhausting appropriate conservative measures. We recommend that providers use the AAOS AUC, especially when treating younger patients with less severe knee OA, particularly if considering opiate therapy or knee arthroscopy.

Acknowledgments
The authors would like to acknowledge Patrick Getty, MD, for his surgical care of some of the study patients. This material is the result of work supported with resources and the use of facilities at the Louis Stokes Cleveland VA Medical Center in Ohio.

Knee osteoarthritis (OA) affects almost 9.3 million adults in the US and accounts for $27 billion in annual health care expenses.^1,2 Due to the increasing cost of health care and an aging population, there has been renewed interest in establishing criteria for nonarthroplasty treatment of knee OA.

In 2013, using the RAND/UCLA Appropriateness method, the American Academy of Orthopaedic Surgeons (AAOS) developed an appropriate use criteria (AUC) for nonarthroplasty management of primary OA of the knee, based on orthopaedic literature and expert opinion.³ Interventions such as activity modification, weight loss, prescribed physical therapy, nonsteroidal anti-inflammatory drugs, tramadol, prescribed oral or transcutaneous opioids, acetaminophen, intra-articular corticosteroids, hinged or unloading knee braces, arthroscopic partial menisectomy or loose body removal, and realignment osteotomy were assessed. An algorithm was developed for 576 patients scenarios that incorporated patient-specific, prognostic/predictor variables to assign designations of “appropriate,” “may be appropriate,” or “rarely appropriate,” to treatment interventions.^4,5 An online version of the algorithm (orthoguidelines.org) is available for physicians and surgeons to judge appropriateness of nonarthroplasty treatments; however, it is not intended to mandate candidacy for treatment or intervention.

Clinical evaluation of the AAOS AUC is necessary to determine how treatment recommendations correlate with current practice. A recent examination of the AAOS Appropriateness System for Surgical Management of Knee OA found that prognostic/predictor variables, such as patient age, OA severity, and pattern of knee OA involvement were more heavily weighted when determining arthroplasty appropriateness than was pain severity or functional loss.⁶ Furthermore, non-AAOS AUC prognostic/predictor variables, such as race and gender, have been linked to disparities in utilization of knee OA interventions.^7-9 Such disparities can be costly not just from a patient perceptive, but also employer and societal perspectives.¹⁰

The Department of Veterans Affairs (VA) health care system represents a model of equal-access-to care system in the US that is ideal for examination of issues about health care utilization and any disparities within the AAOS AUC model and has previously been used to assess utilization of total knee arthroplasty.⁹ The aim of this study was to characterize utilization of the AAOS AUC for nonarthroplasty treatment of knee OA in a VA patient population. We asked the following questions: (1) What variables are predictive of receiving a greater number of AAOS AUC evaluated nonarthroplasty treatments? (2) What variables are predictive of receiving “rarely appropriate” AAOS AUC evaluated nonarthroplasty treatment? (3) What factors are predictive of duration of nonarthroplasty care until total knee arthroplasty (TKA)?

Methods

The institutional review board at the Louis Stokes Cleveland VA Medical Center in Ohio approved a retrospective chart review of nonarthroplasty treatments utilized by patients presenting to its orthopaedic section who subsequently underwent knee arthroplasty between 2013 and 2016. Eligibility criteria included patients aged ≥ 30 years with a diagnosis of unilateral or bilateral primary knee OA. Patients with posttraumatic OA, inflammatory arthritis, and a history of infectious arthritis or Charcot arthropathy of the knee were excluded. Patients with a body mass index (BMI) > 40 or a hemoglobin A_1c > 8.0 at presentation were excluded as nonarthroplasty care was the recommended course of treatment above these thresholds.

Data collected included race, gender, duration of nonarthroplasty treatment, BMI, and Kellgren-Lawrence classification of knee OA at time of presentation for symptomatic knee OA.¹¹ All AAOS AUC-evaluated nonarthroplasty treatments utilized prior to arthroplasty intervention also were recorded (Table 1). 

Statistical Analysis

Statistical analysis was completed with GraphPad Software Prism 7.0a (La Jolla, CA) and Mathworks MatLab R2016b software (Natick, MA). Univariate analysis with Student t tests with Welch corrections in the setting of unequal variance, Mann-Whitney nonparametric tests, and Fisher exact test were generated in the appropriate setting. Multivariable analyses also were conducted. For continuous outcomes, stepwise multiple linear regression was used to generate predictive models; for binary outcomes, binomial logistic regression was used.

Factors analyzed in regression modeling for the total number of AAOS AUC evaluated nonarthroplasty treatments utilized and the likelihood of receiving a rarely appropriate treatment included gender, race, function-limiting pain, range of motion (ROM), ligamentous instability, arthritis pattern, limb alignment, mechanical symptoms, BMI, age, and Kellgren-Lawrence grade. Factors analyzed in timing of TKA included the above variables plus the total number of AUC interventions, whether the patient received an inappropriate intervention, and average appropriateness of the interventions received. Residual analysis with Cook’s distance was used to identify outliers in regression. Observations with Cook’s distance > 3 times the mean Cook’s distance were identified as potential outliers, and models were adjusted accordingly. All statistical analyses were 2-tailed. Statistical significance was set to P ≤ .05 for all outputs.

Results

In the study, 97.8% of participants identified as male, and the mean age was 62.8 years (Table 3). 

Appropriate Use Criteria Interventions

Patients received a mean of 5.2 AAOS AUC evaluated interventions before undergoing arthroplasty management at a mean of 32.3 months (range 2-181 months) from initial presentation. The majority of these interventions were classified as either appropriate or may be appropriate, according to the AUC definitions (95.1%). Self-management and physical therapy programs were widely utilized (100% and 90.1%, respectively), with all use of these interventions classified as appropriate.

Hinged or unloader knee braces were utilized in about half the study patients; this intervention was classified as rarely appropriate in 4.4% of these patients. Medical therapy was also widely used, with all use of NSAIDs, acetaminophen, and tramadol classified as appropriate or may be appropriate. Oral or transcutaneous opioid medications were prescribed in 14.3% of patients, with 92.3% of this use classified as rarely appropriate. Although the opioid medication prescribing provider was not specifically evaluated, there were no instances in which the orthopaedic service provided an oral or transcutaneous opioid prescriptions. Procedural interventions, with the exception of corticosteroid injections, were uncommon; no patient received realignment osteotomy, and only 12.1% of patients underwent arthroscopy. The use of arthroscopy was deemed rarely appropriate in 72.7% of these cases.

Factors Associated With AAOS AUC Intervention Use

There was no difference in the number of AAOS AUC evaluated interventions received based on BMI (mean [SD] BMI < 35, 5.2 [1.0] vs BMI ≥ 35, 5.3 [1.1], P = .49), age (mean [SD] aged < 60 years, 5.4 [1.0] vs aged ≥ 60 years, 5.1 [1.2], P = .23), or Kellgren-Lawrence arthritic grade (mean [SD] grade ≤ 2, 5.5 [1.0] vs grade > 2, 5.1 [1.1], P = .06). These variables also were not associated with receiving a rarely appropriate intervention (mean [SD] BMI < 35, 0.27 [0.5] vs BMI > 35, 0.2 [0.4], P = .81; aged > 60 years, 0.3 [0.5] vs aged < 60 years, 0.2 [0.4], P = .26; Kellgren-Lawrence grade < 2, 0.4 [0.6] vs grade > 2, 0.2 [0.4], P = .1).

Regression modeling to predict total number of AAOS AUC evaluated interventions received produced a significant model (R² = 0.111, P = .006). The presence of ligamentous instability (β coefficient, -1.61) and the absence of mechanical symptoms (β coefficient, -0.67) were negative predictors of number of AUC interventions received. Variance inflation factors were 1.014 and 1.012, respectively. Likewise, regression modeling to identify factors predictive of receiving a rarely appropriate intervention also produced a significant model (pseudo R²= 0.06, P = .025), with lower Kellgren-Lawrence grade the only significant predictor of receiving a rarely appropriate intervention (odds ratio [OR] 0.54; 95% CI, 0.42 -0.72, per unit increase).

Timing from presentation to arthroplasty intervention was also evaluated. Age was a negative predictor (β coefficient -1.61), while positive predictors were reduced ROM (β coefficient 15.72) and having more AUC interventions (β coefficient 7.31) (model R²= 0.29, P = < .001). Age was the most significant predictor. Variance inflations factors were 1.02, 1.01, and 1.03, respectively. Receiving a rarely appropriate intervention was not associated with TKA timing.

Discussion

This single-center retrospective study examined the utilization of AAOS AUC-evaluated nonarthroplasty interventions for symptomatic knee OA prior to TKA. The aims of this study were to validate the AAOS AUC in a clinical setting and identify predictors of AAOS AUC utilization. In particular, this study focused on the number of interventions utilized prior to knee arthroplasty, whether interventions receiving a designation of rarely appropriate were used, and the duration of nonarthroplasty treatment.

Patients with knee instability used fewer total AAOS AUC evaluated interventions prior to TKA. Subjective instability has been reported as high as 27% in patients with OA and has been associated with fear of falling, poor balance confidence, activity limitations, and lower Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function scores.¹² However, it has not been found to correlate with knee laxity.¹³ Nevertheless, significant functional impairment with the risk of falling may reduce the number of nonarthroplasty interventions attempted. On the other hand, the presence of mechanical symptoms resulted in greater utilization of nonarthroplasty interventions. This is likely due to the greater utilization of arthroscopic partial menisectomy or loose body removal in this group of patients. Despite its inclusion as an AAOS AUC evaluated intervention, arthroscopy remains a contentious treatment for symptomatic knee pain in the setting of OA.^14,15

For every unit decrease in Kellgren-Lawrence OA grade, patients were 54% more likely to receive a rarely appropriate intervention prior to knee arthroplasty. This is supported by the recent literature examining the AAOS AUC for surgical management of knee OA. Riddle and colleagues developed a classification tree to determine the contributions of various prognostic variables in final classifications of the 864 clinical vignettes used to develop the appropriateness algorithm and found that OA severity was strongly favored, with only 4 of the 432 vignettes with severe knee OA judged as rarely appropriate for surgical intervention.⁶

Our findings, too, may be explained by an AAOS AUC system that too heavily weighs radiographic severity of knee OA, resulting in more frequent rarely appropriate interventions in patients with less severe arthritis, including nonarthroplasty treatments. It is likely that rarely appropriate interventions were attempted in this subset of our study cohort based on patient’s subjective symptoms and functional status, both of which have been shown to be discordant with radiographic severity of knee OA.¹⁶

Oral or transcutaneous prescribed opioid medications were the most frequent intervention that received a rarely appropriate designation. Patients with preoperative opioid use undergoing TKA have been shown to have a greater risk for postoperative complications and longer hospital stay, particularly those patients aged < 75 years. Younger age, use of more interventions, and decreased knee ROM at presentation were predictive of longer duration of nonarthroplasty treatment. The use of more AAOS AUC evaluated interventions in these patients suggests that the AAOS AUC model may effectively be used to manage symptomatic OA, increasing the time from presentation to knee arthroplasty.

Interestingly, the use of rarely appropriate interventions did not affect TKA timing, as would be expected in a clinically effective nonarthroplasty treatment model. The reasons for rarely appropriate nonsurgical interventions are complex and require further investigation. One possible explanation is that decreased ROM was a marker for mechanical symptoms that necessitated additional intervention in the form of knee arthroscopy, delaying time to TKA.

Limitations

There are several limitations of this study. First, the small sample size (N = 90) requires acknowledgment; however, this limitation reflects the difficulty in following patients for years prior to an operative intervention. Second, the study population consists of veterans using the VA system and may not be reflective of the general population, differing with respect to gender, racial, and socioeconomic factors. Nevertheless, studies examining TKA utilization found, aside from racial and ethnic variability, patient gender and age do not affect arthroplasty utilization rate in the VA system.¹⁷

Additional limitations stem from the retrospective nature of this study. While the Computerized Patient Record System and centralized care of the VA system allows for review of all physical therapy consultations, orthotic consultations, and medications within the VA system, any treatments and intervention delivered by non-VA providers were not captured. Furthermore, the ability to assess for confounding variables limiting the prescription of certain medications, such as chronic kidney disease with NSAIDs or liver disease with acetaminophen, was limited by our study design.

Although our study suffers from selection bias with respect to examination of nonarthroplasty treatment in patients who have ultimately undergone TKA, we feel that this subset of patients with symptomatic knee OA represents the majority of patients evaluated for knee OA by orthopaedic surgeons in the clinic setting. It should be noted that although realignment osteotomies were sometimes indicated as appropriate by AAOS AUC model in our study population, this intervention was never performed due to patient and surgeon preference. Additionally, although it is not an AAOS AUC evaluated intervention, viscosupplementation was sporadically used during the study period; however, it is now off formulary at the investigation institution.

Conclusion

Our study suggests that patients without knee instability use more nonarthroplasty treatments over a longer period before TKA, and those patients with less severe knee OA are at risk of receiving an intervention judged to be rarely appropriate by the AAOS AUC. Such interventions do not affect timing of TKA. Nonarthroplasty care should be individualized to patients’ needs, and the decision to proceed with arthroplasty should be considered only after exhausting appropriate conservative measures. We recommend that providers use the AAOS AUC, especially when treating younger patients with less severe knee OA, particularly if considering opiate therapy or knee arthroscopy.

Acknowledgments
The authors would like to acknowledge Patrick Getty, MD, for his surgical care of some of the study patients. This material is the result of work supported with resources and the use of facilities at the Louis Stokes Cleveland VA Medical Center in Ohio.

Knee osteoarthritis (OA) affects almost 9.3 million adults in the US and accounts for $27 billion in annual health care expenses.^1,2 Due to the increasing cost of health care and an aging population, there has been renewed interest in establishing criteria for nonarthroplasty treatment of knee OA.

In 2013, using the RAND/UCLA Appropriateness method, the American Academy of Orthopaedic Surgeons (AAOS) developed an appropriate use criteria (AUC) for nonarthroplasty management of primary OA of the knee, based on orthopaedic literature and expert opinion.³ Interventions such as activity modification, weight loss, prescribed physical therapy, nonsteroidal anti-inflammatory drugs, tramadol, prescribed oral or transcutaneous opioids, acetaminophen, intra-articular corticosteroids, hinged or unloading knee braces, arthroscopic partial menisectomy or loose body removal, and realignment osteotomy were assessed. An algorithm was developed for 576 patients scenarios that incorporated patient-specific, prognostic/predictor variables to assign designations of “appropriate,” “may be appropriate,” or “rarely appropriate,” to treatment interventions.^4,5 An online version of the algorithm (orthoguidelines.org) is available for physicians and surgeons to judge appropriateness of nonarthroplasty treatments; however, it is not intended to mandate candidacy for treatment or intervention.

Clinical evaluation of the AAOS AUC is necessary to determine how treatment recommendations correlate with current practice. A recent examination of the AAOS Appropriateness System for Surgical Management of Knee OA found that prognostic/predictor variables, such as patient age, OA severity, and pattern of knee OA involvement were more heavily weighted when determining arthroplasty appropriateness than was pain severity or functional loss.⁶ Furthermore, non-AAOS AUC prognostic/predictor variables, such as race and gender, have been linked to disparities in utilization of knee OA interventions.^7-9 Such disparities can be costly not just from a patient perceptive, but also employer and societal perspectives.¹⁰

The Department of Veterans Affairs (VA) health care system represents a model of equal-access-to care system in the US that is ideal for examination of issues about health care utilization and any disparities within the AAOS AUC model and has previously been used to assess utilization of total knee arthroplasty.⁹ The aim of this study was to characterize utilization of the AAOS AUC for nonarthroplasty treatment of knee OA in a VA patient population. We asked the following questions: (1) What variables are predictive of receiving a greater number of AAOS AUC evaluated nonarthroplasty treatments? (2) What variables are predictive of receiving “rarely appropriate” AAOS AUC evaluated nonarthroplasty treatment? (3) What factors are predictive of duration of nonarthroplasty care until total knee arthroplasty (TKA)?

Methods

The institutional review board at the Louis Stokes Cleveland VA Medical Center in Ohio approved a retrospective chart review of nonarthroplasty treatments utilized by patients presenting to its orthopaedic section who subsequently underwent knee arthroplasty between 2013 and 2016. Eligibility criteria included patients aged ≥ 30 years with a diagnosis of unilateral or bilateral primary knee OA. Patients with posttraumatic OA, inflammatory arthritis, and a history of infectious arthritis or Charcot arthropathy of the knee were excluded. Patients with a body mass index (BMI) > 40 or a hemoglobin A_1c > 8.0 at presentation were excluded as nonarthroplasty care was the recommended course of treatment above these thresholds.

Data collected included race, gender, duration of nonarthroplasty treatment, BMI, and Kellgren-Lawrence classification of knee OA at time of presentation for symptomatic knee OA.¹¹ All AAOS AUC-evaluated nonarthroplasty treatments utilized prior to arthroplasty intervention also were recorded (Table 1). 

Statistical Analysis

Statistical analysis was completed with GraphPad Software Prism 7.0a (La Jolla, CA) and Mathworks MatLab R2016b software (Natick, MA). Univariate analysis with Student t tests with Welch corrections in the setting of unequal variance, Mann-Whitney nonparametric tests, and Fisher exact test were generated in the appropriate setting. Multivariable analyses also were conducted. For continuous outcomes, stepwise multiple linear regression was used to generate predictive models; for binary outcomes, binomial logistic regression was used.

Factors analyzed in regression modeling for the total number of AAOS AUC evaluated nonarthroplasty treatments utilized and the likelihood of receiving a rarely appropriate treatment included gender, race, function-limiting pain, range of motion (ROM), ligamentous instability, arthritis pattern, limb alignment, mechanical symptoms, BMI, age, and Kellgren-Lawrence grade. Factors analyzed in timing of TKA included the above variables plus the total number of AUC interventions, whether the patient received an inappropriate intervention, and average appropriateness of the interventions received. Residual analysis with Cook’s distance was used to identify outliers in regression. Observations with Cook’s distance > 3 times the mean Cook’s distance were identified as potential outliers, and models were adjusted accordingly. All statistical analyses were 2-tailed. Statistical significance was set to P ≤ .05 for all outputs.

Results

In the study, 97.8% of participants identified as male, and the mean age was 62.8 years (Table 3). 

Appropriate Use Criteria Interventions

Patients received a mean of 5.2 AAOS AUC evaluated interventions before undergoing arthroplasty management at a mean of 32.3 months (range 2-181 months) from initial presentation. The majority of these interventions were classified as either appropriate or may be appropriate, according to the AUC definitions (95.1%). Self-management and physical therapy programs were widely utilized (100% and 90.1%, respectively), with all use of these interventions classified as appropriate.

Hinged or unloader knee braces were utilized in about half the study patients; this intervention was classified as rarely appropriate in 4.4% of these patients. Medical therapy was also widely used, with all use of NSAIDs, acetaminophen, and tramadol classified as appropriate or may be appropriate. Oral or transcutaneous opioid medications were prescribed in 14.3% of patients, with 92.3% of this use classified as rarely appropriate. Although the opioid medication prescribing provider was not specifically evaluated, there were no instances in which the orthopaedic service provided an oral or transcutaneous opioid prescriptions. Procedural interventions, with the exception of corticosteroid injections, were uncommon; no patient received realignment osteotomy, and only 12.1% of patients underwent arthroscopy. The use of arthroscopy was deemed rarely appropriate in 72.7% of these cases.

Factors Associated With AAOS AUC Intervention Use

There was no difference in the number of AAOS AUC evaluated interventions received based on BMI (mean [SD] BMI < 35, 5.2 [1.0] vs BMI ≥ 35, 5.3 [1.1], P = .49), age (mean [SD] aged < 60 years, 5.4 [1.0] vs aged ≥ 60 years, 5.1 [1.2], P = .23), or Kellgren-Lawrence arthritic grade (mean [SD] grade ≤ 2, 5.5 [1.0] vs grade > 2, 5.1 [1.1], P = .06). These variables also were not associated with receiving a rarely appropriate intervention (mean [SD] BMI < 35, 0.27 [0.5] vs BMI > 35, 0.2 [0.4], P = .81; aged > 60 years, 0.3 [0.5] vs aged < 60 years, 0.2 [0.4], P = .26; Kellgren-Lawrence grade < 2, 0.4 [0.6] vs grade > 2, 0.2 [0.4], P = .1).

Regression modeling to predict total number of AAOS AUC evaluated interventions received produced a significant model (R² = 0.111, P = .006). The presence of ligamentous instability (β coefficient, -1.61) and the absence of mechanical symptoms (β coefficient, -0.67) were negative predictors of number of AUC interventions received. Variance inflation factors were 1.014 and 1.012, respectively. Likewise, regression modeling to identify factors predictive of receiving a rarely appropriate intervention also produced a significant model (pseudo R²= 0.06, P = .025), with lower Kellgren-Lawrence grade the only significant predictor of receiving a rarely appropriate intervention (odds ratio [OR] 0.54; 95% CI, 0.42 -0.72, per unit increase).

Timing from presentation to arthroplasty intervention was also evaluated. Age was a negative predictor (β coefficient -1.61), while positive predictors were reduced ROM (β coefficient 15.72) and having more AUC interventions (β coefficient 7.31) (model R²= 0.29, P = < .001). Age was the most significant predictor. Variance inflations factors were 1.02, 1.01, and 1.03, respectively. Receiving a rarely appropriate intervention was not associated with TKA timing.

Discussion

This single-center retrospective study examined the utilization of AAOS AUC-evaluated nonarthroplasty interventions for symptomatic knee OA prior to TKA. The aims of this study were to validate the AAOS AUC in a clinical setting and identify predictors of AAOS AUC utilization. In particular, this study focused on the number of interventions utilized prior to knee arthroplasty, whether interventions receiving a designation of rarely appropriate were used, and the duration of nonarthroplasty treatment.

Patients with knee instability used fewer total AAOS AUC evaluated interventions prior to TKA. Subjective instability has been reported as high as 27% in patients with OA and has been associated with fear of falling, poor balance confidence, activity limitations, and lower Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical function scores.¹² However, it has not been found to correlate with knee laxity.¹³ Nevertheless, significant functional impairment with the risk of falling may reduce the number of nonarthroplasty interventions attempted. On the other hand, the presence of mechanical symptoms resulted in greater utilization of nonarthroplasty interventions. This is likely due to the greater utilization of arthroscopic partial menisectomy or loose body removal in this group of patients. Despite its inclusion as an AAOS AUC evaluated intervention, arthroscopy remains a contentious treatment for symptomatic knee pain in the setting of OA.^14,15

For every unit decrease in Kellgren-Lawrence OA grade, patients were 54% more likely to receive a rarely appropriate intervention prior to knee arthroplasty. This is supported by the recent literature examining the AAOS AUC for surgical management of knee OA. Riddle and colleagues developed a classification tree to determine the contributions of various prognostic variables in final classifications of the 864 clinical vignettes used to develop the appropriateness algorithm and found that OA severity was strongly favored, with only 4 of the 432 vignettes with severe knee OA judged as rarely appropriate for surgical intervention.⁶

Our findings, too, may be explained by an AAOS AUC system that too heavily weighs radiographic severity of knee OA, resulting in more frequent rarely appropriate interventions in patients with less severe arthritis, including nonarthroplasty treatments. It is likely that rarely appropriate interventions were attempted in this subset of our study cohort based on patient’s subjective symptoms and functional status, both of which have been shown to be discordant with radiographic severity of knee OA.¹⁶

Oral or transcutaneous prescribed opioid medications were the most frequent intervention that received a rarely appropriate designation. Patients with preoperative opioid use undergoing TKA have been shown to have a greater risk for postoperative complications and longer hospital stay, particularly those patients aged < 75 years. Younger age, use of more interventions, and decreased knee ROM at presentation were predictive of longer duration of nonarthroplasty treatment. The use of more AAOS AUC evaluated interventions in these patients suggests that the AAOS AUC model may effectively be used to manage symptomatic OA, increasing the time from presentation to knee arthroplasty.

Interestingly, the use of rarely appropriate interventions did not affect TKA timing, as would be expected in a clinically effective nonarthroplasty treatment model. The reasons for rarely appropriate nonsurgical interventions are complex and require further investigation. One possible explanation is that decreased ROM was a marker for mechanical symptoms that necessitated additional intervention in the form of knee arthroscopy, delaying time to TKA.

Limitations

There are several limitations of this study. First, the small sample size (N = 90) requires acknowledgment; however, this limitation reflects the difficulty in following patients for years prior to an operative intervention. Second, the study population consists of veterans using the VA system and may not be reflective of the general population, differing with respect to gender, racial, and socioeconomic factors. Nevertheless, studies examining TKA utilization found, aside from racial and ethnic variability, patient gender and age do not affect arthroplasty utilization rate in the VA system.¹⁷

Additional limitations stem from the retrospective nature of this study. While the Computerized Patient Record System and centralized care of the VA system allows for review of all physical therapy consultations, orthotic consultations, and medications within the VA system, any treatments and intervention delivered by non-VA providers were not captured. Furthermore, the ability to assess for confounding variables limiting the prescription of certain medications, such as chronic kidney disease with NSAIDs or liver disease with acetaminophen, was limited by our study design.

Although our study suffers from selection bias with respect to examination of nonarthroplasty treatment in patients who have ultimately undergone TKA, we feel that this subset of patients with symptomatic knee OA represents the majority of patients evaluated for knee OA by orthopaedic surgeons in the clinic setting. It should be noted that although realignment osteotomies were sometimes indicated as appropriate by AAOS AUC model in our study population, this intervention was never performed due to patient and surgeon preference. Additionally, although it is not an AAOS AUC evaluated intervention, viscosupplementation was sporadically used during the study period; however, it is now off formulary at the investigation institution.

Conclusion

Our study suggests that patients without knee instability use more nonarthroplasty treatments over a longer period before TKA, and those patients with less severe knee OA are at risk of receiving an intervention judged to be rarely appropriate by the AAOS AUC. Such interventions do not affect timing of TKA. Nonarthroplasty care should be individualized to patients’ needs, and the decision to proceed with arthroplasty should be considered only after exhausting appropriate conservative measures. We recommend that providers use the AAOS AUC, especially when treating younger patients with less severe knee OA, particularly if considering opiate therapy or knee arthroscopy.

Acknowledgments
The authors would like to acknowledge Patrick Getty, MD, for his surgical care of some of the study patients. This material is the result of work supported with resources and the use of facilities at the Louis Stokes Cleveland VA Medical Center in Ohio.

An expert panel appointed by the American Society of Clinical Oncology has issued a new guideline for the treatment and follow-up of patients with early-stage colorectal cancer.

The multidisciplinary, multinational panel identified and reviewed previous guidelines from 12 different developers to create the new ASCO guideline; of these, recommendations from six guidelines were adapted into the evidence base. All recommendations have a consensus rate of at least 75%.

For patients with basic, nonobstructing stage I-IIA colon cancer, open resection is recommended; those with enhanced disease should receive laparoscopic or minimally invasive surgery. For nonobstructing stage IIB-IIC colon cancer, recommended treatment for basic disease is open resection; emergency surgical resection is recommended in enhanced disease.

Treatment for basic, obstructing IIB-IIC disease is resection and/or diversion and is emergency surgical resection in enhanced disease. In left-sided, stage IIB-IIC disease, colonic stent placement is recommended. In high-risk, obstructing stage II disease or in T4N0/T3N0 disease with high-risk features, adjuvant chemotherapy is recommended.

In cT1N0 and cT2n0 rectal cancer, total mesorectal excision is recommended; for cT3n0, total mesorectal excision is recommended in basic and limited cases, with diversion recommended in other cases. For resectable cT3N0 rectal cancer, patients should receive base neoadjuvant chemotherapy.

For follow-up, patients should receive a combination of medical history, physical examination, carcinoembryonic antigen testing, imaging, and endoscopy, with the frequency depending on patient setting.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, according to the guideline.

Several members of the expert panel reported conflicts of interest.

[email protected]

SOURCE: Costas-Chavarri A et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00214.

An expert panel appointed by the American Society of Clinical Oncology has issued a new guideline for the treatment and follow-up of patients with early-stage colorectal cancer.

The multidisciplinary, multinational panel identified and reviewed previous guidelines from 12 different developers to create the new ASCO guideline; of these, recommendations from six guidelines were adapted into the evidence base. All recommendations have a consensus rate of at least 75%.

For patients with basic, nonobstructing stage I-IIA colon cancer, open resection is recommended; those with enhanced disease should receive laparoscopic or minimally invasive surgery. For nonobstructing stage IIB-IIC colon cancer, recommended treatment for basic disease is open resection; emergency surgical resection is recommended in enhanced disease.

Treatment for basic, obstructing IIB-IIC disease is resection and/or diversion and is emergency surgical resection in enhanced disease. In left-sided, stage IIB-IIC disease, colonic stent placement is recommended. In high-risk, obstructing stage II disease or in T4N0/T3N0 disease with high-risk features, adjuvant chemotherapy is recommended.

In cT1N0 and cT2n0 rectal cancer, total mesorectal excision is recommended; for cT3n0, total mesorectal excision is recommended in basic and limited cases, with diversion recommended in other cases. For resectable cT3N0 rectal cancer, patients should receive base neoadjuvant chemotherapy.

For follow-up, patients should receive a combination of medical history, physical examination, carcinoembryonic antigen testing, imaging, and endoscopy, with the frequency depending on patient setting.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, according to the guideline.

Several members of the expert panel reported conflicts of interest.

[email protected]

SOURCE: Costas-Chavarri A et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00214.

An expert panel appointed by the American Society of Clinical Oncology has issued a new guideline for the treatment and follow-up of patients with early-stage colorectal cancer.

The multidisciplinary, multinational panel identified and reviewed previous guidelines from 12 different developers to create the new ASCO guideline; of these, recommendations from six guidelines were adapted into the evidence base. All recommendations have a consensus rate of at least 75%.

For patients with basic, nonobstructing stage I-IIA colon cancer, open resection is recommended; those with enhanced disease should receive laparoscopic or minimally invasive surgery. For nonobstructing stage IIB-IIC colon cancer, recommended treatment for basic disease is open resection; emergency surgical resection is recommended in enhanced disease.

Treatment for basic, obstructing IIB-IIC disease is resection and/or diversion and is emergency surgical resection in enhanced disease. In left-sided, stage IIB-IIC disease, colonic stent placement is recommended. In high-risk, obstructing stage II disease or in T4N0/T3N0 disease with high-risk features, adjuvant chemotherapy is recommended.

In cT1N0 and cT2n0 rectal cancer, total mesorectal excision is recommended; for cT3n0, total mesorectal excision is recommended in basic and limited cases, with diversion recommended in other cases. For resectable cT3N0 rectal cancer, patients should receive base neoadjuvant chemotherapy.

For follow-up, patients should receive a combination of medical history, physical examination, carcinoembryonic antigen testing, imaging, and endoscopy, with the frequency depending on patient setting.

More information, including a data supplement with additional evidence tables, a methodology supplement with information about evidence quality and strength of recommendations, slide sets, and clinical tools and resources is available at www.asco.org/resource-stratified-guidelines, according to the guideline.

Several members of the expert panel reported conflicts of interest.

[email protected]

SOURCE: Costas-Chavarri A et al. J Glob Oncol. 2019 Feb 25. doi: 10.1200/JGO.18.00214.

The American Academy of Pediatrics has released new guidance about how you can protect yourself from liability risks when caring for children during disasters.

In a 2019 technical report, the AAP outlines common claims that can arise when treating children during disasters and how certain circumstances can force you to deviate from routine medical practices. In an accompanying policy statement by the AAP committee on medical liability and risk management, recommendations are offered for how to prepare for and prevent such legal risks.

During disasters, liability dangers can increase when circumstances “devolve into an environment of limited choices for both patients and providers,” and you have fewer treatment options available to you, according to the guidance authored by New York pediatrician Dr. Robin L. Altman and her associates.

Common claims that stem from treating patients during disasters are negligence, abandonment, and lack of informed consent. The AAP technical report offers examples about how these accusations can occur, including:

• When during a disaster, you are forced to alter treatment because of scarce medical supplies or equipment, you may later be accused of negligence if the patient’s outcome is negatively affected by the modified treatment.
• When a disaster progresses to overwhelming conditions, and you must practice in an altered health care environment that demands atypical actions, such actions may later be questioned and be accused of providing suboptimal care. Documentation of medical decision making for instance, a primary defense for one’s actions, may be compromised because of an inoperable electronic medical record. Similarly, past medical history may be unavailable, which may impact the appropriateness of care provision.
• In chaotic conditions, you may have to stop treating some patients to focus their time and resources elsewhere, which may lead to an abandonment claim, defined as unilateral termination of a physician-patient relationship – without proper patient notice – when treatment is still required. An abandonment claim also may arise when you have to make decisions in extreme conditions about which patients to transfer or evacuate first and whom to leave behind.
• When providing medical care to children during disasters, a lack of informed consent claim can arise if adequate parental permission is unattainable. This may result from families that are separated or displaced children in need of medical care.

Other claims that can arise from providing care during disasters include HIPAA breaches, licensing violations, discrimination claims, and Emergency Medical Treatment and Labor Act (EMTALA) violations, among others.

To reduce liability risks, you should strive to understand liability risks and limitations during disasters and take steps to mitigate them by crafting a disaster readiness plan, according to the AAP policy statement. The plan should include provider and staff education on improving medical care during disasters and how best to document medical decisions made in disaster-affected health care environments. Proactively identifying obstacles to care during disasters also is key. You can use the AAP division of state government affairs as a resource; it can provide current information on disaster liability in the different states.

You also should understand potential limits to your medical malpractice insurance coverage during disasters and take steps to add coverage for identified gaps, according to the AAP guidelines.

merznatalia/Thinkstock

AAP recommends that you advocate for your health center to have active disaster plans that cover children’s needs and for your hospital to conduct regular drills that test pediatric capabilities. Throughout the guidelines, the AAP calls on the U.S. Department of Health and Human Services to review current state and federal liability laws, and for the agency to recommend new laws that address disaster-response liability protections for doctors. HHS also should assess the liability coverage needs of physicians during crisis times and take action to reduce inconsistencies in state malpractice protections for volunteer physicians and nonvolunteer physicians, according to AAP.

The AAP policy statement is timely because of the number of recent disasters in the United States, said Dr. Altman, lead author of the two papers.

Citing the Federal Emergency Management Agency, Dr. Altman said there were 59 major disaster declarations and 16 emergency declarations in 2017, along with more than 300 mass shooting incidents and more than 110 other man-made disasters such as fires and industrial accidents.

“Disaster conditions can result in pediatric health care providers being faced with the need to address medical conditions outside of their scope of training and experience, without access to the usual fund of patient history and background information, without the usual input or consent from parents or guardians, without the usual assistance of data such as laboratory values or physiologic monitoring, and without knowledge of how long dire conditions will last,” Dr. Altman said in an AAP News statement. “In addition, this can occur within the backdrop of one’s own physical exhaustion, concerns for the safety of one’s own family members, and the risk of loss of valuable and expensive professional property and supplies.”

The AAP guidance can help pediatricians understand the unique professional liability risks that may occur when caring for pediatric patients and families during a disaster, she said.

“It is the hope that this will raise awareness, improve preparedness, and reduce potential deficiencies in professional liability protections for health care providers trying to do their best to care for patients during these infrequent, yet debilitating, events,” Dr. Altman said in the statement.

There was no external funding, and the authors indicated they had no relevant financial disclosures.

SOURCES: Pediatrics. 2019. doi: 10.1542/peds.2018-3892; Pediatrics. 2019. doi: 10.1542/peds.2018-3893.

The American Academy of Pediatrics has released new guidance about how you can protect yourself from liability risks when caring for children during disasters.

In a 2019 technical report, the AAP outlines common claims that can arise when treating children during disasters and how certain circumstances can force you to deviate from routine medical practices. In an accompanying policy statement by the AAP committee on medical liability and risk management, recommendations are offered for how to prepare for and prevent such legal risks.

During disasters, liability dangers can increase when circumstances “devolve into an environment of limited choices for both patients and providers,” and you have fewer treatment options available to you, according to the guidance authored by New York pediatrician Dr. Robin L. Altman and her associates.

Common claims that stem from treating patients during disasters are negligence, abandonment, and lack of informed consent. The AAP technical report offers examples about how these accusations can occur, including:

• When during a disaster, you are forced to alter treatment because of scarce medical supplies or equipment, you may later be accused of negligence if the patient’s outcome is negatively affected by the modified treatment.
• When a disaster progresses to overwhelming conditions, and you must practice in an altered health care environment that demands atypical actions, such actions may later be questioned and be accused of providing suboptimal care. Documentation of medical decision making for instance, a primary defense for one’s actions, may be compromised because of an inoperable electronic medical record. Similarly, past medical history may be unavailable, which may impact the appropriateness of care provision.
• In chaotic conditions, you may have to stop treating some patients to focus their time and resources elsewhere, which may lead to an abandonment claim, defined as unilateral termination of a physician-patient relationship – without proper patient notice – when treatment is still required. An abandonment claim also may arise when you have to make decisions in extreme conditions about which patients to transfer or evacuate first and whom to leave behind.
• When providing medical care to children during disasters, a lack of informed consent claim can arise if adequate parental permission is unattainable. This may result from families that are separated or displaced children in need of medical care.

Other claims that can arise from providing care during disasters include HIPAA breaches, licensing violations, discrimination claims, and Emergency Medical Treatment and Labor Act (EMTALA) violations, among others.

To reduce liability risks, you should strive to understand liability risks and limitations during disasters and take steps to mitigate them by crafting a disaster readiness plan, according to the AAP policy statement. The plan should include provider and staff education on improving medical care during disasters and how best to document medical decisions made in disaster-affected health care environments. Proactively identifying obstacles to care during disasters also is key. You can use the AAP division of state government affairs as a resource; it can provide current information on disaster liability in the different states.

You also should understand potential limits to your medical malpractice insurance coverage during disasters and take steps to add coverage for identified gaps, according to the AAP guidelines.

merznatalia/Thinkstock

AAP recommends that you advocate for your health center to have active disaster plans that cover children’s needs and for your hospital to conduct regular drills that test pediatric capabilities. Throughout the guidelines, the AAP calls on the U.S. Department of Health and Human Services to review current state and federal liability laws, and for the agency to recommend new laws that address disaster-response liability protections for doctors. HHS also should assess the liability coverage needs of physicians during crisis times and take action to reduce inconsistencies in state malpractice protections for volunteer physicians and nonvolunteer physicians, according to AAP.

The AAP policy statement is timely because of the number of recent disasters in the United States, said Dr. Altman, lead author of the two papers.

Citing the Federal Emergency Management Agency, Dr. Altman said there were 59 major disaster declarations and 16 emergency declarations in 2017, along with more than 300 mass shooting incidents and more than 110 other man-made disasters such as fires and industrial accidents.

“Disaster conditions can result in pediatric health care providers being faced with the need to address medical conditions outside of their scope of training and experience, without access to the usual fund of patient history and background information, without the usual input or consent from parents or guardians, without the usual assistance of data such as laboratory values or physiologic monitoring, and without knowledge of how long dire conditions will last,” Dr. Altman said in an AAP News statement. “In addition, this can occur within the backdrop of one’s own physical exhaustion, concerns for the safety of one’s own family members, and the risk of loss of valuable and expensive professional property and supplies.”

The AAP guidance can help pediatricians understand the unique professional liability risks that may occur when caring for pediatric patients and families during a disaster, she said.

“It is the hope that this will raise awareness, improve preparedness, and reduce potential deficiencies in professional liability protections for health care providers trying to do their best to care for patients during these infrequent, yet debilitating, events,” Dr. Altman said in the statement.

There was no external funding, and the authors indicated they had no relevant financial disclosures.

SOURCES: Pediatrics. 2019. doi: 10.1542/peds.2018-3892; Pediatrics. 2019. doi: 10.1542/peds.2018-3893.

The American Academy of Pediatrics has released new guidance about how you can protect yourself from liability risks when caring for children during disasters.

In a 2019 technical report, the AAP outlines common claims that can arise when treating children during disasters and how certain circumstances can force you to deviate from routine medical practices. In an accompanying policy statement by the AAP committee on medical liability and risk management, recommendations are offered for how to prepare for and prevent such legal risks.

During disasters, liability dangers can increase when circumstances “devolve into an environment of limited choices for both patients and providers,” and you have fewer treatment options available to you, according to the guidance authored by New York pediatrician Dr. Robin L. Altman and her associates.

Common claims that stem from treating patients during disasters are negligence, abandonment, and lack of informed consent. The AAP technical report offers examples about how these accusations can occur, including:

• When during a disaster, you are forced to alter treatment because of scarce medical supplies or equipment, you may later be accused of negligence if the patient’s outcome is negatively affected by the modified treatment.
• When a disaster progresses to overwhelming conditions, and you must practice in an altered health care environment that demands atypical actions, such actions may later be questioned and be accused of providing suboptimal care. Documentation of medical decision making for instance, a primary defense for one’s actions, may be compromised because of an inoperable electronic medical record. Similarly, past medical history may be unavailable, which may impact the appropriateness of care provision.
• In chaotic conditions, you may have to stop treating some patients to focus their time and resources elsewhere, which may lead to an abandonment claim, defined as unilateral termination of a physician-patient relationship – without proper patient notice – when treatment is still required. An abandonment claim also may arise when you have to make decisions in extreme conditions about which patients to transfer or evacuate first and whom to leave behind.
• When providing medical care to children during disasters, a lack of informed consent claim can arise if adequate parental permission is unattainable. This may result from families that are separated or displaced children in need of medical care.

Other claims that can arise from providing care during disasters include HIPAA breaches, licensing violations, discrimination claims, and Emergency Medical Treatment and Labor Act (EMTALA) violations, among others.

To reduce liability risks, you should strive to understand liability risks and limitations during disasters and take steps to mitigate them by crafting a disaster readiness plan, according to the AAP policy statement. The plan should include provider and staff education on improving medical care during disasters and how best to document medical decisions made in disaster-affected health care environments. Proactively identifying obstacles to care during disasters also is key. You can use the AAP division of state government affairs as a resource; it can provide current information on disaster liability in the different states.

You also should understand potential limits to your medical malpractice insurance coverage during disasters and take steps to add coverage for identified gaps, according to the AAP guidelines.

merznatalia/Thinkstock

AAP recommends that you advocate for your health center to have active disaster plans that cover children’s needs and for your hospital to conduct regular drills that test pediatric capabilities. Throughout the guidelines, the AAP calls on the U.S. Department of Health and Human Services to review current state and federal liability laws, and for the agency to recommend new laws that address disaster-response liability protections for doctors. HHS also should assess the liability coverage needs of physicians during crisis times and take action to reduce inconsistencies in state malpractice protections for volunteer physicians and nonvolunteer physicians, according to AAP.

The AAP policy statement is timely because of the number of recent disasters in the United States, said Dr. Altman, lead author of the two papers.

Citing the Federal Emergency Management Agency, Dr. Altman said there were 59 major disaster declarations and 16 emergency declarations in 2017, along with more than 300 mass shooting incidents and more than 110 other man-made disasters such as fires and industrial accidents.

“Disaster conditions can result in pediatric health care providers being faced with the need to address medical conditions outside of their scope of training and experience, without access to the usual fund of patient history and background information, without the usual input or consent from parents or guardians, without the usual assistance of data such as laboratory values or physiologic monitoring, and without knowledge of how long dire conditions will last,” Dr. Altman said in an AAP News statement. “In addition, this can occur within the backdrop of one’s own physical exhaustion, concerns for the safety of one’s own family members, and the risk of loss of valuable and expensive professional property and supplies.”

The AAP guidance can help pediatricians understand the unique professional liability risks that may occur when caring for pediatric patients and families during a disaster, she said.

“It is the hope that this will raise awareness, improve preparedness, and reduce potential deficiencies in professional liability protections for health care providers trying to do their best to care for patients during these infrequent, yet debilitating, events,” Dr. Altman said in the statement.

There was no external funding, and the authors indicated they had no relevant financial disclosures.

SOURCES: Pediatrics. 2019. doi: 10.1542/peds.2018-3892; Pediatrics. 2019. doi: 10.1542/peds.2018-3893.

Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

[email protected]

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

[email protected]

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

Babies should not be delivered before 39 0/7 weeks’ gestation by means besides spontaneous vaginal delivery, in the absence of medical indications for an earlier delivery.

Herjua/Thinkstock

“Although there are specific indications for delivery before 39 weeks of gestation, a nonmedically indicated early-term delivery should be avoided,” wrote the authors of the new opinion, developed by the American College of Obstetricians and Gynecologists committee on obstetric practice and the Society for Maternal-Fetal Medicine.

The opinion, which replaces a 2013 statement, clarifies that their recommendations include avoiding cesarean delivery, labor induction, and cervical ripening before 39 0/7 weeks of gestation, unless a medical indication exists for earlier delivery.

The new opinion statement relied, in part, on a recent systematic review finding that late-preterm and early-term children do not fare as well as do term-delivered children in a variety of cognitive and educational domains. The opinion statement acknowledges that it’s not clear why children delivered earlier are showing performance difficulties and that it is possible that medical indications for an earlier delivery contributed to the differences.

Immediate outcomes for neonates delivered in the late preterm and early term period also are worse, compared with those delivered at term, according to several studies cited in the opinion. For example, composite morbidity was higher for infants delivered at both 37 and 38 weeks gestation, compared with those delivered at 39 weeks, with adjusted odds ratios for the composite outcome of 2.1 and 1.5, respectively (N Engl J Med. 2009 Jan 8;360[2]:111-20).

And lung maturity alone should not guide delivery, wrote the authors of the opinion. “Because nonrespiratory morbidities also are increased in early-term deliveries, documentation of fetal pulmonary maturity does not justify an early nonmedically indicated delivery,” they said, adding that physicians should not perform amniocentesis to determine lung maturity in an effort to guide delivery timing.

Because intrapartum demise remains a risk as long as a woman is pregnant, the potential for adverse neonatal outcomes with early delivery has to be balanced against the risk of stillbirth with continued gestation, the opinion authors acknowledged. But, they said, this question has been addressed by “multiple studies using national population level data,” which show that “even as the gestational age at term has increased in response to efforts to reduce early elective delivery, these efforts have not adversely affected stillbirth rates nationally or even in states with the greatest reductions in early elective delivery.”

Formal programs to reduce nonmedically indicated early-term deliveries have been successful. For example, the state of South Carolina achieved a reduction of almost 50% in nonmedically indicated early-term deliveries over the course of just 1 year. The South Carolina Birth Outcomes Initiative led a collaborative effort to institute a “hard-stop” policy against nonmedically indicated early-term deliveries that resulted in an absolute 4.7% decrease in late-preterm birth during 2011-2012. Similar efforts in Oregon and Ohio have reported significant reductions as well, with no increases in adverse neonatal outcomes.

Various policy approaches have been tried to achieve a reduction in nonmedically indicated late-preterm and early-term birth. These range from awareness raising and education, to “soft-stop” policies in which health care providers agree not to deliver before 39 weeks without medical indication, to “hard-stop” policies in which hospitals prohibit the nonindicated deliveries. In one comparative outcomes study, the hard-stop policy was the most effective, with a drop from 8.2% to 1.7% in nonindicated early deliveries, but the soft-stop policy also produced a decrease from 8.4% to 3.3% (P = .007 and .025, respectively). The educational approach didn’t produce a significant drop in nonmedically indicated early deliveries (Am J Obstet Gynecol. 2010 Nov;203[5]:449.e1-6).

In a separate, preexisting statement (Obstet Gynecol. 2019;133:e151-5), ACOG has outlined the management of medically indicated late-preterm and early-term deliveries and has developed an app (www.acog.org/acogapp) as a decision tool for indicated deliveries.

Examples cited by the current opinion statement authors of medical indications for early delivery include maternal factors such as preeclampsia, gestational hypertension, and poorly controlled diabetes. Placentation problems, fetal growth restriction, and prior cesarean deliveries also may warrant earlier delivery, as may a host of other complications. If an earlier delivery is planned, the committee authors recommend full discussion with the patient and clear documentation of the indications and discussion.

[email protected]

SOURCE: Obstet Gynecol. 2019 Feb;133[2]:e156-63.

For children and adolescents with strong clinical suspicion for celiac disease, repeated transglutaminase-2-IgA (TG2-IgA) levels that are more than 10 times higher than the upper limit of normal often suffices for diagnosis, according to an American Gastroenterological Association clinical practice update and expert review.

This approach precludes the need for esophagogastroduodenoscopy (EGD) in about 30%-50% of cases, wrote Steffen Husby, MD, PhD, of Odense University Hospital (Denmark), together with his associates in Gastroenterology. “When such a strongly positive TG2-IgA is combined with a positive endomysial antibody in a second blood sample, the positive predictive value for celiac disease is virtually 100%.” But for adults, they recommend confirmatory histologic analysis of duodenal biopsies with Marsh classification, counting of lymphocytes per high-power field, and morphometry.

Transglutaminase-2 is the major autoantigen present in celiac disease and can now be assessed with accurate, convenient, high-throughput tests, such as enzyme-linked immunosorbent assays. To maximize test TG2-IgA accuracy, Dr. Husby and his associates recommend testing patients who have compatible signs and symptoms of celiac disease or are asymptomatic but have other risk factors, such as confirmed autoimmune diseases (type 1 diabetes, autoimmune thyroid or liver diseases), chromosome abnormalities (Down or Turner syndrome), or first-degree relatives with celiac disease.

Several other serologic tests are available but have a more limited role in diagnosing celiac disease, according to the practice update. Perhaps most useful is the endomysial antibody (EMA) test, which evaluates tissue-bound TG2-IgA. This test is highly specific but labor-intensive and user-sensitive and thus is best used to confirm a positive TG2-IgA result. Deamidated gliadin peptide antibody assays are less accurate than TG2-IgA, while HLA-DQ2/DQ8 testing is best reserved for cases where the diagnosis is complicated by a prior gluten-free diet or inconclusive antibody titers or histology.

SOURCE: Husby S et al. Gastroenterology. 2018 Dec 19. doi: 10.1053/j.gastro.2018.12.010.

For children and adolescents with strong clinical suspicion for celiac disease, repeated transglutaminase-2-IgA (TG2-IgA) levels that are more than 10 times higher than the upper limit of normal often suffices for diagnosis, according to an American Gastroenterological Association clinical practice update and expert review.

This approach precludes the need for esophagogastroduodenoscopy (EGD) in about 30%-50% of cases, wrote Steffen Husby, MD, PhD, of Odense University Hospital (Denmark), together with his associates in Gastroenterology. “When such a strongly positive TG2-IgA is combined with a positive endomysial antibody in a second blood sample, the positive predictive value for celiac disease is virtually 100%.” But for adults, they recommend confirmatory histologic analysis of duodenal biopsies with Marsh classification, counting of lymphocytes per high-power field, and morphometry.

Transglutaminase-2 is the major autoantigen present in celiac disease and can now be assessed with accurate, convenient, high-throughput tests, such as enzyme-linked immunosorbent assays. To maximize test TG2-IgA accuracy, Dr. Husby and his associates recommend testing patients who have compatible signs and symptoms of celiac disease or are asymptomatic but have other risk factors, such as confirmed autoimmune diseases (type 1 diabetes, autoimmune thyroid or liver diseases), chromosome abnormalities (Down or Turner syndrome), or first-degree relatives with celiac disease.

Several other serologic tests are available but have a more limited role in diagnosing celiac disease, according to the practice update. Perhaps most useful is the endomysial antibody (EMA) test, which evaluates tissue-bound TG2-IgA. This test is highly specific but labor-intensive and user-sensitive and thus is best used to confirm a positive TG2-IgA result. Deamidated gliadin peptide antibody assays are less accurate than TG2-IgA, while HLA-DQ2/DQ8 testing is best reserved for cases where the diagnosis is complicated by a prior gluten-free diet or inconclusive antibody titers or histology.

SOURCE: Husby S et al. Gastroenterology. 2018 Dec 19. doi: 10.1053/j.gastro.2018.12.010.

For children and adolescents with strong clinical suspicion for celiac disease, repeated transglutaminase-2-IgA (TG2-IgA) levels that are more than 10 times higher than the upper limit of normal often suffices for diagnosis, according to an American Gastroenterological Association clinical practice update and expert review.

This approach precludes the need for esophagogastroduodenoscopy (EGD) in about 30%-50% of cases, wrote Steffen Husby, MD, PhD, of Odense University Hospital (Denmark), together with his associates in Gastroenterology. “When such a strongly positive TG2-IgA is combined with a positive endomysial antibody in a second blood sample, the positive predictive value for celiac disease is virtually 100%.” But for adults, they recommend confirmatory histologic analysis of duodenal biopsies with Marsh classification, counting of lymphocytes per high-power field, and morphometry.

Transglutaminase-2 is the major autoantigen present in celiac disease and can now be assessed with accurate, convenient, high-throughput tests, such as enzyme-linked immunosorbent assays. To maximize test TG2-IgA accuracy, Dr. Husby and his associates recommend testing patients who have compatible signs and symptoms of celiac disease or are asymptomatic but have other risk factors, such as confirmed autoimmune diseases (type 1 diabetes, autoimmune thyroid or liver diseases), chromosome abnormalities (Down or Turner syndrome), or first-degree relatives with celiac disease.

Several other serologic tests are available but have a more limited role in diagnosing celiac disease, according to the practice update. Perhaps most useful is the endomysial antibody (EMA) test, which evaluates tissue-bound TG2-IgA. This test is highly specific but labor-intensive and user-sensitive and thus is best used to confirm a positive TG2-IgA result. Deamidated gliadin peptide antibody assays are less accurate than TG2-IgA, while HLA-DQ2/DQ8 testing is best reserved for cases where the diagnosis is complicated by a prior gluten-free diet or inconclusive antibody titers or histology.

SOURCE: Husby S et al. Gastroenterology. 2018 Dec 19. doi: 10.1053/j.gastro.2018.12.010.

The American Heart Association has included obesity and severe obesity in its updated scientific statement outlining risk factors and considerations for cardiovascular risk reduction in high-risk pediatric patients.

The scientific statement is an update to a 2006 American Heart Association (AHA) statement, adding details about obesity as an at-risk condition and severe obesity as a moderate-risk condition. Other additions include classifying type 2 diabetes as a high-risk condition and expanding on new risk factors for cardiovascular disease (CVD) among patients who received treatment for childhood cancer.

The AHA said the statement is aimed at pediatric cardiologists, primary care physicians, and subspecialists who care for at-risk pediatric patients, as well as providers who will care for these patients as they transition to adult life.
 

Obesity

In the AHA scientific statement, Sarah de Ferranti, MD, MPH, of Boston Children’s Hospital, chair of the writing group, and her colleagues, highlighted a 2016 study that identified a twofold to threefold higher risk of CVD-related mortality among patients who were overweight or obese, compared with patients of normal weight (Diabetes Care. 2016 Nov;39[11]:1996-2003).

Patients with obesity and severe obesity are at increased risk of aortic or coronary fatty streaks, dyslipidemia, high blood pressure, hyperglycemia, and insulin resistance, as well as inflammatory and oxidative stress, the AHA writing group noted.

They estimated that approximately 6% of U.S. children aged 2-19 years old are considered severely obese.

After identifying patients with obesity, the writing group said, a “multimodal and graduated approach to treatment” for these patients is generally warranted, with a focus on dietary and lifestyle changes, and use of pharmacotherapy and bariatric surgery if indicated.

However, the authors said therapeutic life change modification “is limited in severe obesity because of small effect size and difficulty with sustainability,” while use of pharmacotherapy for treatment of pediatric obesity remains understudied and medications such as orlistat and metformin offer only modest weight loss.

Bariatric surgery, “the only treatment for severe pediatric obesity consistently associated with clinically meaningful and durable weight loss,” is not consistently offered to patients under 12 years old, they added.
 

Diabetes

The AHA statement also addresses risks from type 1 (T1D) and type 2 diabetes (T2D). Children with T1D and T2D are at increased risk for dyslipidemia, hypertension, microalbuminuria, and obesity. Annual screening for these patients is indicated, and cardiovascular risk factor reduction can be achieved by managing hyperglycemia, controlling weight gain as a result of medication, and implementing therapeutic lifestyle changes, when possible.

Childhood cancer

As survival rates from childhood cancer have improved, there is a need to address the increased risk of cardiovascular-related mortality (estimated at 8-10 times higher than the general population) as well as cancer relapse, according to the writing group.

Among patients recruited to the Childhood Cancer Survivor Study, there was a 9-fold increase in cerebrovascular accident, 10-fold increased risk of coronary artery disease, and 15-fold increase in heart failure for childhood cancer survivors, compared with their siblings who were cancer free.

Cancer treatments such as radiation exposure are linked to increased rates of myocardial infarction, heart failure, valvular abnormalities, and pericardial disease at a twofold to sixfold higher rate when administered at a greater than 1,500 centigray dose, compared to cancer survivors who did not receive radiation, the authors wrote.

Anthracycline treatment is associated with a dose-dependent increase in the risk of dilated cardiomyopathy, while hematopoietic stem cell transplantation may increase the risk of CVD-related mortality from heart failure, cerebrovascular accident, cardiomyopathy, coronary artery disease, and rhythm disorders.

In treating childhood cancer survivors for CVD risk factors, “a low threshold should be used when considering the initiation of pharmacological agents because of the high risk of these youth,” and standard pharmacotherapies can be used, the authors said. “Treatment of cardiovascular risk factors should consider the cancer therapies the patient has received previously.”

In the AHA statement, Dr. de Ferranti and her colleagues also outlined epidemiology, screening, and treatment data for other cardiovascular risk factors such as familial hypercholesterolemia, Lipoprotein(a), hypertension, chronic kidney disease, congenital heart disease, Kawasaki disease, and heart transplantation.

Some members of the writing group reported research grants from Amgen, Sanofi, the Wisconsin Partnership Program, and the National Institutes of Health. One author reported unpaid consultancies with Novo Nordisk, Orexigen, and Vivus.

SOURCE: de Ferranti SD et al. Circulation. 2019 Feb 25. doi: 10.1161/CIR.0000000000000618.

The American Heart Association has included obesity and severe obesity in its updated scientific statement outlining risk factors and considerations for cardiovascular risk reduction in high-risk pediatric patients.

The scientific statement is an update to a 2006 American Heart Association (AHA) statement, adding details about obesity as an at-risk condition and severe obesity as a moderate-risk condition. Other additions include classifying type 2 diabetes as a high-risk condition and expanding on new risk factors for cardiovascular disease (CVD) among patients who received treatment for childhood cancer.

The AHA said the statement is aimed at pediatric cardiologists, primary care physicians, and subspecialists who care for at-risk pediatric patients, as well as providers who will care for these patients as they transition to adult life.
 

Obesity

In the AHA scientific statement, Sarah de Ferranti, MD, MPH, of Boston Children’s Hospital, chair of the writing group, and her colleagues, highlighted a 2016 study that identified a twofold to threefold higher risk of CVD-related mortality among patients who were overweight or obese, compared with patients of normal weight (Diabetes Care. 2016 Nov;39[11]:1996-2003).

Patients with obesity and severe obesity are at increased risk of aortic or coronary fatty streaks, dyslipidemia, high blood pressure, hyperglycemia, and insulin resistance, as well as inflammatory and oxidative stress, the AHA writing group noted.

They estimated that approximately 6% of U.S. children aged 2-19 years old are considered severely obese.

After identifying patients with obesity, the writing group said, a “multimodal and graduated approach to treatment” for these patients is generally warranted, with a focus on dietary and lifestyle changes, and use of pharmacotherapy and bariatric surgery if indicated.

However, the authors said therapeutic life change modification “is limited in severe obesity because of small effect size and difficulty with sustainability,” while use of pharmacotherapy for treatment of pediatric obesity remains understudied and medications such as orlistat and metformin offer only modest weight loss.

Bariatric surgery, “the only treatment for severe pediatric obesity consistently associated with clinically meaningful and durable weight loss,” is not consistently offered to patients under 12 years old, they added.
 

Diabetes

The AHA statement also addresses risks from type 1 (T1D) and type 2 diabetes (T2D). Children with T1D and T2D are at increased risk for dyslipidemia, hypertension, microalbuminuria, and obesity. Annual screening for these patients is indicated, and cardiovascular risk factor reduction can be achieved by managing hyperglycemia, controlling weight gain as a result of medication, and implementing therapeutic lifestyle changes, when possible.

Childhood cancer

As survival rates from childhood cancer have improved, there is a need to address the increased risk of cardiovascular-related mortality (estimated at 8-10 times higher than the general population) as well as cancer relapse, according to the writing group.

Among patients recruited to the Childhood Cancer Survivor Study, there was a 9-fold increase in cerebrovascular accident, 10-fold increased risk of coronary artery disease, and 15-fold increase in heart failure for childhood cancer survivors, compared with their siblings who were cancer free.

Cancer treatments such as radiation exposure are linked to increased rates of myocardial infarction, heart failure, valvular abnormalities, and pericardial disease at a twofold to sixfold higher rate when administered at a greater than 1,500 centigray dose, compared to cancer survivors who did not receive radiation, the authors wrote.

Anthracycline treatment is associated with a dose-dependent increase in the risk of dilated cardiomyopathy, while hematopoietic stem cell transplantation may increase the risk of CVD-related mortality from heart failure, cerebrovascular accident, cardiomyopathy, coronary artery disease, and rhythm disorders.

In treating childhood cancer survivors for CVD risk factors, “a low threshold should be used when considering the initiation of pharmacological agents because of the high risk of these youth,” and standard pharmacotherapies can be used, the authors said. “Treatment of cardiovascular risk factors should consider the cancer therapies the patient has received previously.”

In the AHA statement, Dr. de Ferranti and her colleagues also outlined epidemiology, screening, and treatment data for other cardiovascular risk factors such as familial hypercholesterolemia, Lipoprotein(a), hypertension, chronic kidney disease, congenital heart disease, Kawasaki disease, and heart transplantation.

Some members of the writing group reported research grants from Amgen, Sanofi, the Wisconsin Partnership Program, and the National Institutes of Health. One author reported unpaid consultancies with Novo Nordisk, Orexigen, and Vivus.

SOURCE: de Ferranti SD et al. Circulation. 2019 Feb 25. doi: 10.1161/CIR.0000000000000618.

The American Heart Association has included obesity and severe obesity in its updated scientific statement outlining risk factors and considerations for cardiovascular risk reduction in high-risk pediatric patients.

The scientific statement is an update to a 2006 American Heart Association (AHA) statement, adding details about obesity as an at-risk condition and severe obesity as a moderate-risk condition. Other additions include classifying type 2 diabetes as a high-risk condition and expanding on new risk factors for cardiovascular disease (CVD) among patients who received treatment for childhood cancer.

The AHA said the statement is aimed at pediatric cardiologists, primary care physicians, and subspecialists who care for at-risk pediatric patients, as well as providers who will care for these patients as they transition to adult life.
 

Obesity

In the AHA scientific statement, Sarah de Ferranti, MD, MPH, of Boston Children’s Hospital, chair of the writing group, and her colleagues, highlighted a 2016 study that identified a twofold to threefold higher risk of CVD-related mortality among patients who were overweight or obese, compared with patients of normal weight (Diabetes Care. 2016 Nov;39[11]:1996-2003).

Patients with obesity and severe obesity are at increased risk of aortic or coronary fatty streaks, dyslipidemia, high blood pressure, hyperglycemia, and insulin resistance, as well as inflammatory and oxidative stress, the AHA writing group noted.

They estimated that approximately 6% of U.S. children aged 2-19 years old are considered severely obese.

After identifying patients with obesity, the writing group said, a “multimodal and graduated approach to treatment” for these patients is generally warranted, with a focus on dietary and lifestyle changes, and use of pharmacotherapy and bariatric surgery if indicated.

However, the authors said therapeutic life change modification “is limited in severe obesity because of small effect size and difficulty with sustainability,” while use of pharmacotherapy for treatment of pediatric obesity remains understudied and medications such as orlistat and metformin offer only modest weight loss.

Bariatric surgery, “the only treatment for severe pediatric obesity consistently associated with clinically meaningful and durable weight loss,” is not consistently offered to patients under 12 years old, they added.
 

Diabetes

The AHA statement also addresses risks from type 1 (T1D) and type 2 diabetes (T2D). Children with T1D and T2D are at increased risk for dyslipidemia, hypertension, microalbuminuria, and obesity. Annual screening for these patients is indicated, and cardiovascular risk factor reduction can be achieved by managing hyperglycemia, controlling weight gain as a result of medication, and implementing therapeutic lifestyle changes, when possible.

Childhood cancer

As survival rates from childhood cancer have improved, there is a need to address the increased risk of cardiovascular-related mortality (estimated at 8-10 times higher than the general population) as well as cancer relapse, according to the writing group.

Among patients recruited to the Childhood Cancer Survivor Study, there was a 9-fold increase in cerebrovascular accident, 10-fold increased risk of coronary artery disease, and 15-fold increase in heart failure for childhood cancer survivors, compared with their siblings who were cancer free.

Cancer treatments such as radiation exposure are linked to increased rates of myocardial infarction, heart failure, valvular abnormalities, and pericardial disease at a twofold to sixfold higher rate when administered at a greater than 1,500 centigray dose, compared to cancer survivors who did not receive radiation, the authors wrote.

Anthracycline treatment is associated with a dose-dependent increase in the risk of dilated cardiomyopathy, while hematopoietic stem cell transplantation may increase the risk of CVD-related mortality from heart failure, cerebrovascular accident, cardiomyopathy, coronary artery disease, and rhythm disorders.

In treating childhood cancer survivors for CVD risk factors, “a low threshold should be used when considering the initiation of pharmacological agents because of the high risk of these youth,” and standard pharmacotherapies can be used, the authors said. “Treatment of cardiovascular risk factors should consider the cancer therapies the patient has received previously.”

In the AHA statement, Dr. de Ferranti and her colleagues also outlined epidemiology, screening, and treatment data for other cardiovascular risk factors such as familial hypercholesterolemia, Lipoprotein(a), hypertension, chronic kidney disease, congenital heart disease, Kawasaki disease, and heart transplantation.

Some members of the writing group reported research grants from Amgen, Sanofi, the Wisconsin Partnership Program, and the National Institutes of Health. One author reported unpaid consultancies with Novo Nordisk, Orexigen, and Vivus.

SOURCE: de Ferranti SD et al. Circulation. 2019 Feb 25. doi: 10.1161/CIR.0000000000000618.