User login
USPSTF leans away from pelvic screening
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
Current evidence is insufficient to support screening pelvic exams for the early detection of certain gynecologic conditions in asymptomatic, nonpregnant women, according to a draft recommendation statement issued by the U.S. Preventive Services Task Force.
The draft recommendations and draft evidence review are available online for public comment at www.uspreventiveservicestaskforce.org through July 25, 2016.
The USPSTF defined the lack of evidence to assess the balance of benefits vs. harms of screening pelvic exams as an “I” recommendation, meaning that the balance of benefits and harms cannot be determined. The draft recommendations note that many malignant conditions including gynecologic cancers; infectious diseases such as genital herpes: and benign conditions including polyps, cysts, and fibroids, may be found during a screening pelvic exam. However, potential harms include false-positive and false-negative results, and the potential for invasive treatment and unnecessary diagnostic work-ups.
This is the first statement by the USPSTF specifically addressing pelvic exams to screen for gynecologic conditions in asymptomatic, nonpregnant women. The statement does not change any existing recommendations, such as those for screening tests for early detection of cervical cancer, chlamydia, and gonorrhea.
Pelvic exams are currently covered as part of the well-woman visit under the Affordable Care Act. “Since the coding structure doesn’t parse out individual elements of the visit, this should not result in any coverage changes,” according to the American College of Obstetricians and Gynecologists communications office.
“ACOG is reviewing the USPSTF’s draft recommendation statement and the evidence upon which it is based to assess whether there is a need to update its guidance on the routine pelvic examination,” Dr. Thomas Gellhaus, president of ACOG, said in a statement. “ACOG recommends annual pelvic examinations for patients 21 years of age or older. However, the College recognizes that this recommendation is based on expert opinion, and limitations of the internal pelvic examination for screening should be recognized.”
“The annual well-woman visit is an opportunity for the patient and her ob.gyn. to discuss whether a pelvic examination is appropriate for her. ACOG promotes shared communication and decision making between the patient and the physician regarding pelvic examinations,” said Dr. Gellhaus of the University of Iowa Hospitals and Clinics in Iowa City.
According to the USPSTF draft statement, no studies “were identified that evaluated the benefit of screening with pelvic examination on all-cause mortality, disease-specific morbidity or mortality, or quality of life.” In addition, the USPSTF “found inadequate evidence on the harms of screening for a range of gynecologic conditions with pelvic examination” and “no studies quantified the amount of anxiety associated with screening pelvic examination.”
The draft recommendations are based on a review of the evidence on the benefits, potential harms, and accuracy of screening pelvic examinations for asymptomatic, nonpregnant women aged 18 years and older. The USPSTF concluded that research is lacking in several key areas including the accuracy and efficacy of screening pelvic exams to detect conditions other than trichomoniasis, genital herpes, bacterial vaginosis, and ovarian cancer; and the potential harms (including psychological) of screening pelvic examinations for asymptomatic women.
ICU-based therapy fails to shorten hospital stay
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
Standardized rehabilitation therapy did not reduce hospital length of stay in patients with acute respiratory failure, based on data from a randomized trial of 300 adults published online in JAMA.
Hospital length of stay averaged 10 days for patients in the standardized rehabilitation therapy group (SRT) and 10 days in the control group that received usual ICU care, wrote Dr. Peter E. Morris of the division of pulmonary, critical care and sleep medicine at the University of Kentucky, Lexington, and his colleagues (JAMA. 2016 Jun;315:2694-702. doi: 10.1001/jama.2016.7201).
The patients were followed for 6 months; 84 patients in the SRT group and 81 in the usual group completed the study.
Patients in the SRT group received daily therapy including passive range of motion, physical therapy, and progressive-resistance exercises. The usual care group received weekday physical therapy as determined by the clinical team.
The researchers also assessed secondary outcomes related to physical function and quality of life, including ventilator days, Short Physical Performance Battery (SPPB) score, handgrip, Mini-Mental State Examination, and Functional Performance Inventory (FPI).
Overall, there was no difference in duration of ventilation or ICU care between the two groups, and score of handgrip strength and mental health also were similar at 6 months’ follow up. However, the SF-36 physical function scores were significantly higher in the SRT group (difference, 12.2; 95% confidence interval, 3.8-20.7; P = .001), and the FPI scores and SPPB scores were higher, compared with the usual care group at 6 months.
“These findings from the exploratory analysis may highlight the emerging role of placing long-term outcomes within critical care clinical trial design not only as a secondary outcome, but possibly as the primary outcome,” the researchers noted. “In view of the SPPB, SF-36 PFS, and FPI data at 6 months, the SRT group demonstrated a potential signal of improvement compared with the usual care group that was not evident at hospital discharge,” they wrote.
The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author, Dr. Morris, had no financial conflicts to disclose.
FROM JAMA
Key clinical point: Rehabilitation therapy in the ICU did not reduce hospital stay in patients with acute respiratory failure.
Major finding: The average length of stay was 10 days in both the therapy and control groups.
Data source: A randomized, single-center study including 300 adults with acute respiratory failure.
Disclosures: The study was supported by the National Institutes of Health, National Institute of Nursing Research, and National Heart, Lung, and Blood Institute. Lead author Dr. Morris had no financial conflicts to disclose.
The Promise of Peanut Allergy Prevention Lies in Draft Guidelines
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
The promise of peanut allergy prevention lies in draft guidelines
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Updated guidelines from the National Institute of Allergy and Infectious Diseases for the early introduction of peanut-containing foods to children at increased risk for peanut allergies are on the horizon, pending final approval.
“Two studies recently showed that infants at high risk of developing peanut allergy [infants with egg allergy and or severe eczema] were much less likely to have peanut allergy at age 5 years if they were able to incorporate peanut regularly into the diet between 4 and 11 months of age,” said Dr. Scott H. Sicherer, the Elliot and Roslyn Jaffe Professor of Pediatrics, Allergy and Immunology, and chief of the division of allergy and immunology in the department of pediatrics at the Icahn School of Medicine at Mount Sinai, New York.
“However, adding peanut to the diet at this age requires caution because these infants may already be allergic to peanut, and so allergy testing and care in adding peanut to the diet with medical supervision is needed in this high-risk group,” noted Dr. Sicherer, a member of the expert panel that worked on the guidelines.
The draft guidelines include 43 clinical recommendations for the diagnosis and management of food allergies in children, according to the NIAID website. In particular, the draft guidelines recommend introducing peanut-containing foods to infants aged 4-6 months who are at increased risk for peanut allergy because of severe eczema and/or egg allergies, after an evaluation with skin prick testing or peanut-specific IgE testing.
“Peanut allergy is relatively common and often persistent, and so a strategy that could prevent the allergy is very important,” Dr. Sicherer said in an interview. “However, peanut can be a choking hazard as peanuts or peanut butter, and so families should talk to their pediatrician about how and when to incorporate peanut into the diet, and whether allergy testing and referral to an allergist is needed.”
Support for the guidelines comes from several large studies with promising results, notably the LEAP (Learning Early about Peanut Allergy) trial. A recent extension of that study, known as LEAP-On (Persistence of Oral Tolerance to Peanut), showed that regular consumption of peanut-containing foods from infancy to 5 years provided ongoing protection against allergies, even 6 years after peanut consumption was discontinued for a 1-year period in 550 children (N Eng J Med. 2016 Apr 14;374:1435-43).
In the original LEAP study, 640 infants aged 4-11 months with severe eczema, egg allergy, or both were randomized to dietary peanut consumption or avoidance (N Engl J Med. 2015 Feb 26;372[9]:803-13). The prevalence of peanut allergy at 5 years of age was approximately 2% in the peanut-consumption group, compared with 14% in the peanut-avoidance group.
Another significant randomized trial, the EAT study (Enquiring About Tolerance) tested not only peanut, but also the early introduction of cooked egg, cow’s milk, sesame, wheat, and fish to 1,303 infants aged 3 months and older in the general population. The study’s strict protocol made adherence difficult, but researchers found a significant 67% reduction in the prevalence of food allergies at age 3 years among the children who followed the protocol, compared with controls, with relative risk reductions of 100% and 75%, respectively, for peanut and egg allergies (N Engl J Med. 2016 May 5;374:1733-43).
The next steps for research should make early introduction of peanut-containing foods even more effective at allergy prevention, Dr. Sicherer noted.
“We need to learn more about how much peanut should be incorporated into the diet, how long the protein has to be kept in the diet to have the best preventative effect, and whether this strategy applies to other foods,” he said.
Helmets trump face mask for noninvasive ventilation
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
“Several key clinical messages can be gained from the study by Patel et al.,” wrote Dr. Jeremy R. Beitler, Dr. Robert L. Owens, and Dr. Atul Malhotra, in an accompanying editorial (JAMA 2016 Jun; 315:2401-3.).
“The helmet interface has unique advantages and disadvantages that may influence efficacy of noninvasive positive pressure ventilation (NIV) depending on patient and disease characteristics,” they said. “External validation of the findings by Patel et al. and clarification of appropriate eligibility criteria, optimal ventilator settings, and potential mechanisms of effect are needed before clinicians could consider an expanded role for helmet NIV in routine management. Regardless, it is increasingly clear that there may be an important albeit underinvestigated role for some form of high-level noninvasive respiratory support to prevent intubation, and perhaps mortality, in acute hypoxemic respiratory failure,” they noted.
“In future studies, reporting of interruptions to wearing the prescribed NIV interface continuously, leak severity, biomarkers of lung injury, and sedative administration would help delineate potential mechanisms [of action],” they added.
Dr. Beitler, Dr. Owens, and Dr. Malhotra are all affiliated with the division of pulmonary and critical care medicine at the University of California, San Diego. They had no financial conflicts to disclose.
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
Treating acute respiratory distress syndrome patients with helmets instead of face masks significantly reduced intubation rates and 90-day mortality rates, based on data from a randomized trial of 83 adults published in JAMA.
Acute respiratory distress syndrome (ARDS) can be treated using a face mask, but the mask is often inadequate, forcing patients to undergo intubation that can lead to additional problems including discomfort, delirium, and muscle deterioration, wrote Tianna Hicklin, Ph.D., in a column on the NIH website.
“The proposed mechanism for improved efficacy of these helmets is the preservation of applied pressures and avoidance of air leak. If the helmets indeed do allow clinicians both to be able to increase airway pressures above levels they typically would with mask-NIV and maintain those pressures without unpredictable system leak, that would be of great physiologic importance for patients with acute respiratory failure,” said Dr. Eric J. Gartman.
To explore the potential of noninvasive ventilation (NIV) using a helmet instead of a mask, both of which allow patients to remain awake in the ICU, the researchers randomized 83 adults with ARDS to treatment with either a helmet (44 patients) or a face mask (39 patients).
Intubation incidence was 18% in patients treated with helmets, compared with 62% for those treated with face masks. In addition, patients in the helmet group had significantly more ventilator-free days than the mask group (28 vs. 13; P less than .001), and both hospital mortality and 90-day mortality rates were significantly lower in the helmet group compared to the mask group (27% vs. 49%; P = .04 and 34% vs. 56%; P = .02, respectively)
Adverse event rates were rare, and similar between the helmet and mask groups. Three interface-related skin ulcers occurred in each group; nose ulcers in 7% of the mask group and neck ulcers in 7% of the helmet group.
The study population included adults aged 18 years and older who were admitted to the ICU at the University of Chicago between September 2012 and September 2015 and required face mask NIV. The average age of the patients was 58 years in the helmet group and 61 years in the mask group; there were no significant demographic differences between the groups. The most common causes of acute respiratory failure in both groups were pneumonia and pneumonia caused by immunosuppression.
The study results were limited by several factors including a lack of blinding, the need for a learning curve for clinicians using the helmet, and the potential for patient-ventilator dyssynchrony in the helmet group, noted Dr. Bhakti K. Patel of the University of Chicago and her colleagues (JAMA 2016;315:2435-41). Multicenter studies are needed to support the findings, they added. However, the findings “affirm the far-reaching benefits of spontaneous yet highly supported ventilation in an awake, animated patient over invasive medical ventilation via endotracheal tube,” they wrote. “These findings warrant further investigation of helmet NIV for patients with ARDS and other types of AHRF [acute hypoxemic respiratory failure], particularly with attention to long-term outcomes.”
The researchers had no financial conflicts to disclose.
“While the results of this study are very impressive, it is a single-center study, and obviously a larger multicenter trial (with all types of institutions included – not just large academic centers) would be helpful to elucidate the benefit of this technique and support a change in standard of care in the use of NIV. A change to this system would be a very large culture shift in NIV and would mean a significant amount of training (physician, nursing, respiratory care), purchasing the helmets, and ensuring that it is implemented properly and safely. As stated by the authors, this fact is similar to the change the occurred originally with NIV – but if their results reflect a true benefit over FM-NIV [face mask-noninvasive ventilation], such a large change would certainly be worth the effort,” Dr. Gartman said.
In a related study published in the Journal of Cardiothoracic and Vascular Anesthesia, patients treated with noninvasive positive pressure ventilation (NPPV) through helmets had significantly lower heart rates, lower average arterial pressure, and improved left ventricular ejection fraction at the end of treatment, compared with patients treated with ventilation masks and controls. Dr. Yi Yang of Capital Medical University in Beijing, China, and colleagues conducted the prospective study of 75 adults experiencing hypoxemia within 24 hours of extubation after Stanford type A aortic dissection. The participants were divided into three 25-patient groups. The control group was treated with high-flux inhalation of oxygen via a Venturi mask, another group was treated with NPPV via a mask, and the third group was treated with NPPV via a helmet. (J Card Vasc Anesth. 2016. http://dx.doi.org/10.1053/j.jvca.2016.03.129).
The study was funded by China’s public welfare industry of health.
FROM JAMA
Key clinical point: Patients with ARDS who were treated with noninvasive continuous positive airway pressure ventilation via a helmet needed significantly less intubation and had significantly higher survival rates through 90 days than did those treated with noninvasive ventilation via face masks.
Major finding: Intubation incidence was 18% in patients treated with helmets vs. 62% for those treated with face masks; 90-day survival rates for the helmet and mask groups were 66% and 44%, respectively.
Data source: A randomized, single center study of 83 patients with ARDS.
Disclosures: The researchers had no financial conflicts to disclose. The study was funded in part by the National Heart, Lung, and Blood Institute at the National Institutes of Health.
One meal increases odds of doctors prescribing drugs
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
“Is it necessary to prove a causal relationship between industry payments to physicians and the prescribing of brand-name medications?” asked Dr. Robert Steinbrook in an editor’s note accompanying the study. “Other than research support, product development, and bona fide consulting related to specific research programs and projects, it is already evident that there are few reasons for physicians to have financial associations with industry,” he wrote. “Although the association between industry payments to physicians and higher rates of prescribing of brand-name medications is not in dispute, none of these studies have established a cause-and-effect relationship,” he noted. One possible reason for the association: “Physicians may choose to attend industry events where information is provided about drugs that they already prefer,” he said. However, if drug companies and device manufacturers spent less money on physician activities and more on independent safety, effectiveness, and affordability studies, “our patients and the health care system would be better off,” he said (JAMA Intern. Med. 2016, published online June 20).
Dr. Steinbrook is editor at large for JAMA Internal Medicine. He had no relevant financial conflicts to disclose.
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
Doctors who accepted a single, industry-sponsored meal worth less than $20 were significantly more likely to prescribe the featured drug to Medicare patients, based on data from a cross-sectional study of 279,669 physicians. The findings were published online June 20 in JAMA Internal Medicine (JAMA Intern. Med. 2016 Jun. doi: 10.1001/jamainternmed.2016.2765).
In a multivariate analysis, physicians who received a single meal related to the promoted drug were 1.8 times more likely to prescribe rosuvastatin than other statins, 1.7 times more likely to prescribe nebivolol than other beta-blockers, 1.5 times more likely to prescribe olmesartan than other ACE inhibitors or ARBs, and more than twice as likely to prescribe desvenlafaxine than other SSRIs and serotonin norepinephrine reuptake inhibitors (odds ratio, 2.18).
These differences remained significant after controlling for factors including prescribing volume, physician specialty, practice setting, and demographics. Prescribing rates increased with additional meals and more expensive meals.
Previous studies have identified associations between increased prescribing and industry payments to physicians, wrote Colette DeJong, a research fellow at the University of California, San Francisco, Center for Healthcare Value, and her colleagues. However, “It is not known whether much smaller payments, such as sponsored meals, are associated with increased prescribing of the promoted brand-name drug over therapeutic alternatives,” they noted.
The researchers reviewed data from the federal Open Payments program from Aug. 1 through Dec. 31, 2013, as well as Medicare Part D prescribing data for 2013.
The results were limited by the cross-sectional nature of the study and the limitations of data from the Open Payments program, and the data reflect an association, not a cause-and-effect relationship, the researchers noted. However, “Our results are consistent with recent analyses that linked federal or state-level physician payment records with Medicare Part D prescribing data,” and with smaller studies, they said. “Future research could compare industry-sponsored meals and other methods for disseminating drug information, such as academic detailing and independent drug bulletins, with respect to the cost and quality of prescribing,” they added. The researchers had no financial conflicts to disclose.
Read the full study here: http://archinte.jamanetwork.com/article.aspx?doi=10.1001/jamainternmed.2016.2765.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Industry-sponsored meals were associated with higher prescribing rates of the featured drug to Medicare patients.
Major finding: Doctors were significantly more likely to prescribe rosuvastatin, nebivolol, and olmesartan, and more than twice as likely to prescribe desvenlafaxine (OR, 2.18) over those drugs’ competitors if they received a $20 or less complimentary meal from the company promoting the drug of interest.
Data source: A cross-sectional study of 279,669 physicians.
Disclosures: The researchers had no financial conflicts to disclose.
Task force affirms value of colorectal cancer screening
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
FROM JAMA
Key clinical point: Colorectal cancer screening is recommended for all adults aged 50-75 years, and several screening methods are supported by evidence-based research.
Major finding: In four randomized trials including 458,002 patients, one- or two-time screening via flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73.
Data source: Studies were selected based on searches of MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials.
Disclosures: The researchers had no relevant financial conflicts to disclose. The research was supported by AHRQ under a contract with the USPSTF.
TNF Blocker Safety May Differ in RA and Psoriasis Patients
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
TNF blocker safety may differ in RA and psoriasis patients
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: TNF-antagonists provoke different adverse events in patients with RA than in those with psoriasis, and safety data should be extrapolated with caution.
Major finding: The risk of serious adverse events associated with anti-TNF therapy was approximately twice as high in RA patients as in psoriasis patients (hazard ratio, 0.54).
Data source: A pair of prospective studies including 4,117 adults with RA or psoriasis who received anti-TNF agents.
Disclosures: The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Midodrine cuts ICU days in septic shock patients
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
FROM CHEST
Key clinical point: Midodrine may reduce ICU length of stay by reducing the need for intravenous vasopressors in patients recovering from septic shock.
Major finding: The mean intravenous vasopressor duration was 2.9 days for patients who received midodrine vs. 3.8 days for controls who received intravenous vasopressors alone.
Data source: A retrospective study involving 275 patients that was conducted in a single medical intensive care unit.
Disclosures: The researchers had no financial conflicts to disclose.