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Small skin abscesses: Add antibiotics to drainage
For patients who have a single, small skin abscess, the addition of oral antibiotics to standard incision and drainage of the lesion improves cure rates and decreases recurrence rates, according to a study published online June 28 in the New England Journal of Medicine.
The results of this multicenter prospective randomized double-blind placebo-controlled trial, taken together with those of another recent large study, “call into question the perception – largely based on expert opinion or smaller, underpowered, and lower-quality noninferiority trials – that cure rates do not improve with the addition of systemic antibiotic treatment after incision and drainage,” said Robert S. Daum, MD, professor of pediatrics at the University of Chicago, and his associates.
The trial involved 786 patients of all ages (64% were adults and 36% were children; mean age was 25.5 years) who had a single, uncomplicated skin abscess of 5 cm or smaller and were treated at the University of Chicago; San Francisco General Hospital; Harbor-UCLA Medical Center; Vanderbilt University Medical Center, Nashville; Washington University, St. Louis; or Emory University, Atlanta. A total of 266 patients were assigned to receive oral clindamycin, 263 to receive oral trimethoprim–sulfamethoxazole (TMP-SMX), and 257 to receive matching placebo for 10 days after the lesions were incised and drained.
At follow-up 7-10 days following the conclusion of treatment, the rates of clinical cure were 83.1% with clindamycin and 81.7% with TMP-SMX, both significantly greater than the 68.9% cure rate with placebo (P less than .001 for both comparisons). Similarly, at 1-month follow-up, 78.6% of the clindamycin group and 73.0% of the TMP-SMX group “remained cured,” compared with 62.6% of the placebo group (N Engl J Med. 2017 June 28. doi: 10.1056/NEJMoa1607033).
Among those with cultures positive for Staphylococcus aureus, cure rates 7-10 days after treatment ended were 83.5% and 83.2% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (63.8%). Among those positive for methicillin-resistant S. aureus, cure rates were 81.7% and 84.6% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (62.9%).
The rate of treatment-associated adverse events was higher with clindamycin (21.9%) than with TMP-SMX (11.1%) or with placebo (12.5%). The most common adverse events were diarrhea and nausea, which were mild to moderate in severity and resolved with sequelae. There were no cases of Clostridium difficile–associated diarrhea or severe allergic reactions. One patient had a hypersensitivity reaction that was considered to be related to TMP-SMX, which involved fever, rash, thrombocytopenia, and hepatitis and which resolved without sequelae.
The National Institute of Allergy and Infectious Diseases and the National Center for Research Resources supported the study. Dr. Daum reported ties to Pfizer, Dynavax, Theravance, and Merck, and his associates reported ties to numerous industry sources.
For patients who have a single, small skin abscess, the addition of oral antibiotics to standard incision and drainage of the lesion improves cure rates and decreases recurrence rates, according to a study published online June 28 in the New England Journal of Medicine.
The results of this multicenter prospective randomized double-blind placebo-controlled trial, taken together with those of another recent large study, “call into question the perception – largely based on expert opinion or smaller, underpowered, and lower-quality noninferiority trials – that cure rates do not improve with the addition of systemic antibiotic treatment after incision and drainage,” said Robert S. Daum, MD, professor of pediatrics at the University of Chicago, and his associates.
The trial involved 786 patients of all ages (64% were adults and 36% were children; mean age was 25.5 years) who had a single, uncomplicated skin abscess of 5 cm or smaller and were treated at the University of Chicago; San Francisco General Hospital; Harbor-UCLA Medical Center; Vanderbilt University Medical Center, Nashville; Washington University, St. Louis; or Emory University, Atlanta. A total of 266 patients were assigned to receive oral clindamycin, 263 to receive oral trimethoprim–sulfamethoxazole (TMP-SMX), and 257 to receive matching placebo for 10 days after the lesions were incised and drained.
At follow-up 7-10 days following the conclusion of treatment, the rates of clinical cure were 83.1% with clindamycin and 81.7% with TMP-SMX, both significantly greater than the 68.9% cure rate with placebo (P less than .001 for both comparisons). Similarly, at 1-month follow-up, 78.6% of the clindamycin group and 73.0% of the TMP-SMX group “remained cured,” compared with 62.6% of the placebo group (N Engl J Med. 2017 June 28. doi: 10.1056/NEJMoa1607033).
Among those with cultures positive for Staphylococcus aureus, cure rates 7-10 days after treatment ended were 83.5% and 83.2% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (63.8%). Among those positive for methicillin-resistant S. aureus, cure rates were 81.7% and 84.6% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (62.9%).
The rate of treatment-associated adverse events was higher with clindamycin (21.9%) than with TMP-SMX (11.1%) or with placebo (12.5%). The most common adverse events were diarrhea and nausea, which were mild to moderate in severity and resolved with sequelae. There were no cases of Clostridium difficile–associated diarrhea or severe allergic reactions. One patient had a hypersensitivity reaction that was considered to be related to TMP-SMX, which involved fever, rash, thrombocytopenia, and hepatitis and which resolved without sequelae.
The National Institute of Allergy and Infectious Diseases and the National Center for Research Resources supported the study. Dr. Daum reported ties to Pfizer, Dynavax, Theravance, and Merck, and his associates reported ties to numerous industry sources.
For patients who have a single, small skin abscess, the addition of oral antibiotics to standard incision and drainage of the lesion improves cure rates and decreases recurrence rates, according to a study published online June 28 in the New England Journal of Medicine.
The results of this multicenter prospective randomized double-blind placebo-controlled trial, taken together with those of another recent large study, “call into question the perception – largely based on expert opinion or smaller, underpowered, and lower-quality noninferiority trials – that cure rates do not improve with the addition of systemic antibiotic treatment after incision and drainage,” said Robert S. Daum, MD, professor of pediatrics at the University of Chicago, and his associates.
The trial involved 786 patients of all ages (64% were adults and 36% were children; mean age was 25.5 years) who had a single, uncomplicated skin abscess of 5 cm or smaller and were treated at the University of Chicago; San Francisco General Hospital; Harbor-UCLA Medical Center; Vanderbilt University Medical Center, Nashville; Washington University, St. Louis; or Emory University, Atlanta. A total of 266 patients were assigned to receive oral clindamycin, 263 to receive oral trimethoprim–sulfamethoxazole (TMP-SMX), and 257 to receive matching placebo for 10 days after the lesions were incised and drained.
At follow-up 7-10 days following the conclusion of treatment, the rates of clinical cure were 83.1% with clindamycin and 81.7% with TMP-SMX, both significantly greater than the 68.9% cure rate with placebo (P less than .001 for both comparisons). Similarly, at 1-month follow-up, 78.6% of the clindamycin group and 73.0% of the TMP-SMX group “remained cured,” compared with 62.6% of the placebo group (N Engl J Med. 2017 June 28. doi: 10.1056/NEJMoa1607033).
Among those with cultures positive for Staphylococcus aureus, cure rates 7-10 days after treatment ended were 83.5% and 83.2% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (63.8%). Among those positive for methicillin-resistant S. aureus, cure rates were 81.7% and 84.6% in the clindamycin and TMP-SMX groups, respectively, significantly higher than in the placebo group (62.9%).
The rate of treatment-associated adverse events was higher with clindamycin (21.9%) than with TMP-SMX (11.1%) or with placebo (12.5%). The most common adverse events were diarrhea and nausea, which were mild to moderate in severity and resolved with sequelae. There were no cases of Clostridium difficile–associated diarrhea or severe allergic reactions. One patient had a hypersensitivity reaction that was considered to be related to TMP-SMX, which involved fever, rash, thrombocytopenia, and hepatitis and which resolved without sequelae.
The National Institute of Allergy and Infectious Diseases and the National Center for Research Resources supported the study. Dr. Daum reported ties to Pfizer, Dynavax, Theravance, and Merck, and his associates reported ties to numerous industry sources.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: For patients who have a single, small skin abscess, the addition of oral antibiotics to standard incision and drainage of the lesion improves cure rates and decreases recurrence rates.
Major finding: At follow-up 7-10 days following the completion of treatment, clinical cure rates were 83.1% with clindamycin and 81.7% with TMP-SMX, both significantly greater than the 68.9% cure rate with placebo.
Data source: A multicenter prospective randomized double-blind placebo-controlled trial involving 786 adults and children who had single, small skin abscesses.
Disclosures: The National Institute of Allergy and Infectious Diseases and the National Center for Research Resources supported the study. Dr. Daum reported ties to Pfizer, Dynavax, Theravance, and Merck, and his associates reported ties to numerous industry sources.
Childhood asthma linked to high LV mass later
A history of childhood asthma correlates with high left ventricular mass, a prominent indicator of cardiac damage, in asymptomatic healthy young adults, according to a report published online June 26 in JACC: Heart Failure.
“Our data suggest that aggressive lifestyle modifications or even pharmacologic treatment may be applied to people with a [childhood] history of asthma. … to lower cardiovascular risk,” said Dianjianyi Sun, MD, PhD, of the department of epidemiology, Tulane University, New Orleans, and his associates.
Both mean left ventricular mass (169 g) and mean left ventricular mass index (41 g/m2) were significantly higher in participants who’d had childhood asthma than in those who had not (158 g and 38 g/m2, respectively). This correlation was independent of major cardiovascular risk factors such as race, smoking status, hypertension status, use of antihypertensive medications, C-reactive protein levels, heart rate, and body mass index, the investigators said (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.03.009).
The association was strongest among young adults who had higher systolic blood pressure (prehypertension or hypertension).
This study was supported by the National Institutes of Health, the Boston Obesity Nutrition Research Center, the United States-Israel Binational Science Foundation, and the American Heart Association. Dr. Sun and his associates reported having no relevant financial disclosures.
Sun et al. report that healthy young adults who had asthma during childhood have a significantly greater left ventricular mass index, by about 8%, than do those who didn’t have the condition.
On an individual patient level, such a difference confers a relatively small incremental risk of incident cardiovascular disease: a roughly 1.08-fold increase. However, at the population level, where there are many major comorbidities, the public health implications could be substantial. Targeting these patients for intensified cardiovascular risk reduction could have important benefits.
John S. Gottdiener, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Gottdiener made these remarks in an editorial comment accompanying Dr. Sun’s report (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.05.003).
Sun et al. report that healthy young adults who had asthma during childhood have a significantly greater left ventricular mass index, by about 8%, than do those who didn’t have the condition.
On an individual patient level, such a difference confers a relatively small incremental risk of incident cardiovascular disease: a roughly 1.08-fold increase. However, at the population level, where there are many major comorbidities, the public health implications could be substantial. Targeting these patients for intensified cardiovascular risk reduction could have important benefits.
John S. Gottdiener, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Gottdiener made these remarks in an editorial comment accompanying Dr. Sun’s report (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.05.003).
Sun et al. report that healthy young adults who had asthma during childhood have a significantly greater left ventricular mass index, by about 8%, than do those who didn’t have the condition.
On an individual patient level, such a difference confers a relatively small incremental risk of incident cardiovascular disease: a roughly 1.08-fold increase. However, at the population level, where there are many major comorbidities, the public health implications could be substantial. Targeting these patients for intensified cardiovascular risk reduction could have important benefits.
John S. Gottdiener, MD, is at the University of Maryland Medical Center, Baltimore. He reported having no relevant financial disclosures. Dr. Gottdiener made these remarks in an editorial comment accompanying Dr. Sun’s report (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.05.003).
A history of childhood asthma correlates with high left ventricular mass, a prominent indicator of cardiac damage, in asymptomatic healthy young adults, according to a report published online June 26 in JACC: Heart Failure.
“Our data suggest that aggressive lifestyle modifications or even pharmacologic treatment may be applied to people with a [childhood] history of asthma. … to lower cardiovascular risk,” said Dianjianyi Sun, MD, PhD, of the department of epidemiology, Tulane University, New Orleans, and his associates.
Both mean left ventricular mass (169 g) and mean left ventricular mass index (41 g/m2) were significantly higher in participants who’d had childhood asthma than in those who had not (158 g and 38 g/m2, respectively). This correlation was independent of major cardiovascular risk factors such as race, smoking status, hypertension status, use of antihypertensive medications, C-reactive protein levels, heart rate, and body mass index, the investigators said (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.03.009).
The association was strongest among young adults who had higher systolic blood pressure (prehypertension or hypertension).
This study was supported by the National Institutes of Health, the Boston Obesity Nutrition Research Center, the United States-Israel Binational Science Foundation, and the American Heart Association. Dr. Sun and his associates reported having no relevant financial disclosures.
A history of childhood asthma correlates with high left ventricular mass, a prominent indicator of cardiac damage, in asymptomatic healthy young adults, according to a report published online June 26 in JACC: Heart Failure.
“Our data suggest that aggressive lifestyle modifications or even pharmacologic treatment may be applied to people with a [childhood] history of asthma. … to lower cardiovascular risk,” said Dianjianyi Sun, MD, PhD, of the department of epidemiology, Tulane University, New Orleans, and his associates.
Both mean left ventricular mass (169 g) and mean left ventricular mass index (41 g/m2) were significantly higher in participants who’d had childhood asthma than in those who had not (158 g and 38 g/m2, respectively). This correlation was independent of major cardiovascular risk factors such as race, smoking status, hypertension status, use of antihypertensive medications, C-reactive protein levels, heart rate, and body mass index, the investigators said (JACC: Heart Failure. 2017 Jun 26. doi: 10.1016/j.jchf.2017.03.009).
The association was strongest among young adults who had higher systolic blood pressure (prehypertension or hypertension).
This study was supported by the National Institutes of Health, the Boston Obesity Nutrition Research Center, the United States-Israel Binational Science Foundation, and the American Heart Association. Dr. Sun and his associates reported having no relevant financial disclosures.
FROM JACC: HEART FAILURE
Key clinical point: Childhood asthma is associated with high left ventricular mass in asymptomatic young adults.
Major finding: Both mean left ventricular mass (169 g) and mean left ventricular mass index (41 g/m2) were significantly higher in participants who’d had childhood asthma than in those who had not (158 g and 38 g/m2, respectively).
Data source: A secondary analysis of data from the Bogalusa Heart Study, involving 1,118 participants followed for an average of 10 years.
Disclosures: This study was supported by the National Heart, Lung, and Blood Institute, the National Institute of Diabetes and Digestive and Kidney Diseases, the Boston Obesity Nutrition Research Center, the United States-Israel Binational Science Foundation, and the American Heart Association. Dr. Sun and his associates reported having no relevant financial disclosures.
Study shows that 20% of inpatients given antibiotics develop adverse reactions
Twenty percent of hospitalized adults given antibiotics develop adverse drug events, including GI, nephrotoxic, hematologic, cardiac, and neurotoxic effects, according to a report in JAMA Internal Medicine.
This high frequency of adverse reactions “may not be recognized by clinicians because [these events] have varied manifestations, clinicians may be unaware of the risks associated with specific antibiotic agents, or because they occur after patients are discharged from the hospital,” said Pranita D. Tamma, MD, of the division of pediatric infectious diseases, Johns Hopkins University, Baltimore, and her associates.
They assessed antibiotic-associated adverse drug events in all 1,488 adults admitted to four general medicine services at a single medical center during a 9-month period and given at least 24 hours of any antibiotic therapy. The most common indications for antibiotics were urinary tract infections (12%), skin and soft-tissue infections (8%), and community-acquired pneumonia (7%).
Perhaps as important, the researchers noted, 19% of these adverse drug events were attributed to unnecessary antibiotics – drugs given for conditions for which they were not clinically indicated according to the hospital’s own antibiotic guidelines. These included asymptomatic bacteriuria, aspiration pneumonitis, and heart failure (JAMA Intern. Med. 2017 June 12. doi: 10.1001/jamainternmed.2017.1938).
The most common adverse reactions that developed within 30 days were GI, renal, and hematologic abnormalities. Neurotoxic effects included encephalopathy and seizures; cardiotoxic effects included QTc prolongation. Less frequent adverse events included anaphylaxis, daptomycin-associated myositis, trimethoprim/sulfamethoxazole-associated pancreatitis, linezolid-associated neuropathy, and ciprofloxacin-related tendinitis. The most common adverse reactions that developed within 90 days were C. difficile infections and infections involving multidrug-resistant organisms.
“Our findings underscore the importance of avoiding unnecessary antibiotic prescribing to reduce the harm that can result from antibiotic-associated adverse drug events,” Dr. Tamma and her associates said.
Twenty percent of hospitalized adults given antibiotics develop adverse drug events, including GI, nephrotoxic, hematologic, cardiac, and neurotoxic effects, according to a report in JAMA Internal Medicine.
This high frequency of adverse reactions “may not be recognized by clinicians because [these events] have varied manifestations, clinicians may be unaware of the risks associated with specific antibiotic agents, or because they occur after patients are discharged from the hospital,” said Pranita D. Tamma, MD, of the division of pediatric infectious diseases, Johns Hopkins University, Baltimore, and her associates.
They assessed antibiotic-associated adverse drug events in all 1,488 adults admitted to four general medicine services at a single medical center during a 9-month period and given at least 24 hours of any antibiotic therapy. The most common indications for antibiotics were urinary tract infections (12%), skin and soft-tissue infections (8%), and community-acquired pneumonia (7%).
Perhaps as important, the researchers noted, 19% of these adverse drug events were attributed to unnecessary antibiotics – drugs given for conditions for which they were not clinically indicated according to the hospital’s own antibiotic guidelines. These included asymptomatic bacteriuria, aspiration pneumonitis, and heart failure (JAMA Intern. Med. 2017 June 12. doi: 10.1001/jamainternmed.2017.1938).
The most common adverse reactions that developed within 30 days were GI, renal, and hematologic abnormalities. Neurotoxic effects included encephalopathy and seizures; cardiotoxic effects included QTc prolongation. Less frequent adverse events included anaphylaxis, daptomycin-associated myositis, trimethoprim/sulfamethoxazole-associated pancreatitis, linezolid-associated neuropathy, and ciprofloxacin-related tendinitis. The most common adverse reactions that developed within 90 days were C. difficile infections and infections involving multidrug-resistant organisms.
“Our findings underscore the importance of avoiding unnecessary antibiotic prescribing to reduce the harm that can result from antibiotic-associated adverse drug events,” Dr. Tamma and her associates said.
Twenty percent of hospitalized adults given antibiotics develop adverse drug events, including GI, nephrotoxic, hematologic, cardiac, and neurotoxic effects, according to a report in JAMA Internal Medicine.
This high frequency of adverse reactions “may not be recognized by clinicians because [these events] have varied manifestations, clinicians may be unaware of the risks associated with specific antibiotic agents, or because they occur after patients are discharged from the hospital,” said Pranita D. Tamma, MD, of the division of pediatric infectious diseases, Johns Hopkins University, Baltimore, and her associates.
They assessed antibiotic-associated adverse drug events in all 1,488 adults admitted to four general medicine services at a single medical center during a 9-month period and given at least 24 hours of any antibiotic therapy. The most common indications for antibiotics were urinary tract infections (12%), skin and soft-tissue infections (8%), and community-acquired pneumonia (7%).
Perhaps as important, the researchers noted, 19% of these adverse drug events were attributed to unnecessary antibiotics – drugs given for conditions for which they were not clinically indicated according to the hospital’s own antibiotic guidelines. These included asymptomatic bacteriuria, aspiration pneumonitis, and heart failure (JAMA Intern. Med. 2017 June 12. doi: 10.1001/jamainternmed.2017.1938).
The most common adverse reactions that developed within 30 days were GI, renal, and hematologic abnormalities. Neurotoxic effects included encephalopathy and seizures; cardiotoxic effects included QTc prolongation. Less frequent adverse events included anaphylaxis, daptomycin-associated myositis, trimethoprim/sulfamethoxazole-associated pancreatitis, linezolid-associated neuropathy, and ciprofloxacin-related tendinitis. The most common adverse reactions that developed within 90 days were C. difficile infections and infections involving multidrug-resistant organisms.
“Our findings underscore the importance of avoiding unnecessary antibiotic prescribing to reduce the harm that can result from antibiotic-associated adverse drug events,” Dr. Tamma and her associates said.
FROM JAMA INTERNAL MEDICINE
Key clinical point: Among hospitalized adults given antibiotics, 20% develop adverse reactions, including GI, nephrotoxic, hematologic, cardiac, and neurotoxic effects.
Major finding: Among 1,488 patients, 298 (20%) developed 324 adverse reactions to antibiotics – 73% during hospitalization and 27% after discharge – requiring prolonged hospitalization; a subsequent hospitalization; an ED visit; or additional lab tests, ECGs, or imaging studies.
Data source: A single-center retrospective cohort study involving all 1,488 general medicine inpatients admitted during a 9-month period who received any antibiotic for at least 24 hours.
Disclosures: This study was supported by Pfizer Independent Grants for Learning and Change and the Joint Commission. Dr. Tamma and her associates reported having no relevant financial disclosures.
Liver disease doubles risk of colorectal cancer
Chronic liver disease appears to double the risk of colorectal cancer (CRC), even after patients undergo liver transplantation, according to a report published in Gastrointestinal Endoscopy.
“Strict surveillance for colorectal cancer is warranted in this patient population,” said Yuga Komaki, MD, of the section of gastroenterology, hepatology, and nutrition, University of Chicago, and associates.
One prominent chronic liver disease, primary sclerosing cholangitis, is known to raise the risk of CRC, which “is mainly attributed to the concurrence of inflammatory bowel disease.” In addition, whether liver transplantation mitigates that risk remains “controversial,” the investigators noted.
To assess whether chronic liver disease impacts CRC risk, they performed a systematic review and meta-analysis of the literature, examining data from 55 observational studies involving 55,991 participants. Case patients had a variety of chronic liver diseases, including primary sclerosing cholangitis, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, and alcoholic liver damage.
Overall, the pooled standardized incidence ratio of CRC was 2.06 among patients with liver disease, compared with control subjects. It was highest in the subgroup of patients with primary sclerosing cholangitis at 6.70, the investigators said (Gastrointest. Endosc. 2017;86:93-104).
CRC risk appeared to be slightly higher among patients who had cirrhosis than among those who had hepatitis, “suggesting that advanced liver damage may lead to higher risks of CRC. This is not surprising because advanced liver damage can cause systemic alterations in immunity that may precipitate malignant transformation,” Dr. Komaki and associates noted.
The pooled standardized incidence ratio of CRC remained elevated at 2.16 among patients who underwent liver transplantation for a variety of causes. It is possible that their exposure to immunosuppressive therapy plays a role in elevating this risk, the researchers added.
“We propose that patients with chronic hepatitis and cirrhosis require a screening colonoscopy every 5 years, as opposed to the 10-year interval in the general population. Patients undergoing liver transplant should have a colonoscopy before the transplant and, subsequently, should undergo colonoscopy at 5-year intervals,” Dr. Komaki and associates said.
They added that the sixfold increase in CRC risk among patients with PSC “justifies the present recommendation of annual surveillance colonoscopy that should be continued after transplant.”
Chronic liver disease appears to double the risk of colorectal cancer (CRC), even after patients undergo liver transplantation, according to a report published in Gastrointestinal Endoscopy.
“Strict surveillance for colorectal cancer is warranted in this patient population,” said Yuga Komaki, MD, of the section of gastroenterology, hepatology, and nutrition, University of Chicago, and associates.
One prominent chronic liver disease, primary sclerosing cholangitis, is known to raise the risk of CRC, which “is mainly attributed to the concurrence of inflammatory bowel disease.” In addition, whether liver transplantation mitigates that risk remains “controversial,” the investigators noted.
To assess whether chronic liver disease impacts CRC risk, they performed a systematic review and meta-analysis of the literature, examining data from 55 observational studies involving 55,991 participants. Case patients had a variety of chronic liver diseases, including primary sclerosing cholangitis, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, and alcoholic liver damage.
Overall, the pooled standardized incidence ratio of CRC was 2.06 among patients with liver disease, compared with control subjects. It was highest in the subgroup of patients with primary sclerosing cholangitis at 6.70, the investigators said (Gastrointest. Endosc. 2017;86:93-104).
CRC risk appeared to be slightly higher among patients who had cirrhosis than among those who had hepatitis, “suggesting that advanced liver damage may lead to higher risks of CRC. This is not surprising because advanced liver damage can cause systemic alterations in immunity that may precipitate malignant transformation,” Dr. Komaki and associates noted.
The pooled standardized incidence ratio of CRC remained elevated at 2.16 among patients who underwent liver transplantation for a variety of causes. It is possible that their exposure to immunosuppressive therapy plays a role in elevating this risk, the researchers added.
“We propose that patients with chronic hepatitis and cirrhosis require a screening colonoscopy every 5 years, as opposed to the 10-year interval in the general population. Patients undergoing liver transplant should have a colonoscopy before the transplant and, subsequently, should undergo colonoscopy at 5-year intervals,” Dr. Komaki and associates said.
They added that the sixfold increase in CRC risk among patients with PSC “justifies the present recommendation of annual surveillance colonoscopy that should be continued after transplant.”
Chronic liver disease appears to double the risk of colorectal cancer (CRC), even after patients undergo liver transplantation, according to a report published in Gastrointestinal Endoscopy.
“Strict surveillance for colorectal cancer is warranted in this patient population,” said Yuga Komaki, MD, of the section of gastroenterology, hepatology, and nutrition, University of Chicago, and associates.
One prominent chronic liver disease, primary sclerosing cholangitis, is known to raise the risk of CRC, which “is mainly attributed to the concurrence of inflammatory bowel disease.” In addition, whether liver transplantation mitigates that risk remains “controversial,” the investigators noted.
To assess whether chronic liver disease impacts CRC risk, they performed a systematic review and meta-analysis of the literature, examining data from 55 observational studies involving 55,991 participants. Case patients had a variety of chronic liver diseases, including primary sclerosing cholangitis, viral hepatitis, autoimmune hepatitis, primary biliary cirrhosis, and alcoholic liver damage.
Overall, the pooled standardized incidence ratio of CRC was 2.06 among patients with liver disease, compared with control subjects. It was highest in the subgroup of patients with primary sclerosing cholangitis at 6.70, the investigators said (Gastrointest. Endosc. 2017;86:93-104).
CRC risk appeared to be slightly higher among patients who had cirrhosis than among those who had hepatitis, “suggesting that advanced liver damage may lead to higher risks of CRC. This is not surprising because advanced liver damage can cause systemic alterations in immunity that may precipitate malignant transformation,” Dr. Komaki and associates noted.
The pooled standardized incidence ratio of CRC remained elevated at 2.16 among patients who underwent liver transplantation for a variety of causes. It is possible that their exposure to immunosuppressive therapy plays a role in elevating this risk, the researchers added.
“We propose that patients with chronic hepatitis and cirrhosis require a screening colonoscopy every 5 years, as opposed to the 10-year interval in the general population. Patients undergoing liver transplant should have a colonoscopy before the transplant and, subsequently, should undergo colonoscopy at 5-year intervals,” Dr. Komaki and associates said.
They added that the sixfold increase in CRC risk among patients with PSC “justifies the present recommendation of annual surveillance colonoscopy that should be continued after transplant.”
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Chronic liver disease appears to double the risk of colorectal cancer, even after patients undergo liver transplantation.
Major finding: The pooled standardized incidence ratio of colorectal cancer was 2.06 among patients with liver disease, compared with control subjects.
Data source: A meta-analysis of 50 observational studies (55,991 participants) that examined the rate of colorectal cancer in patients with a variety of liver diseases.
Disclosures: No specific sponsor was identified for this study. Dr. Komaki reported receiving research support from the Children’s Cancer Association of Japan. Dr. Komaki and associates reported having no other relevant financial disclosures.
USPSTF recommends screening children, adolescents for obesity
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
This USPSTF recommendation simply confirms what pediatric clinicians always do in the everyday care for children and adolescents: monitor growth, counsel on healthy lifestyles, and refer for specialized care when appropriate.
Intensive behavioral interventions are impractical for many families and frequently aren’t covered by insurance. At best, implementing this recommendation will have only a modest effect on obesity in the United States. At worst, it could divert attention and resources away from population-health approaches to prevention and toward weight management programs that are not well equipped to meet the demand and very often don’t exist within local communities.
Improving neighborhood walkability, increasing the availability of healthy foods, and providing safe physical spaces would be more effective at reducing childhood obesity, as would improving school nutrition and curtailing the marketing of sugar-sweetened drinks and other unhealthy foods to children.
Rachel L. J. Thornton, MD, PhD, Raquel G. Hernandez, MD, MPH; Tina L. Cheng, MD, MPH, are in the department of pediatrics at Johns Hopkins University, Baltimore. They reported having no relevant financial disclosures. They made these remarks in an editorial accompanying the USPSTF report (JAMA. 2017;317:2378-80).
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
Children and adolescents aged 6 years and older should be screened for obesity and referred to comprehensive, intensive behavioral interventions with at least 26 hours of intervention contact, according to a U.S. Preventive Services Task Force Recommendation Statement that was published online June 20 in JAMA.
This updated recommendation is largely consistent with the previous 2010 recommendation “but includes the word ‘adolescents’ to further clarify the population to which this recommendation applies,” according to a press release accompanying the Recommendation Statement and the Evidence Report on which it is based.
The behavioral interventions that proved most beneficial included at least 26 hours of contact over a period of 2-12 months. Those that included 52 or more hours of contact achieved even greater weight loss, as well as some improvements in cardiovascular and metabolic risk factors (JAMA. 2017 Jun 20. doi: 10.1001/jama.2017.6803).
In general, children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
The components of these comprehensive interventions varied, but the most successful ones included sessions involving both the child and the parent (separately, together, or both); offered both family and group sessions; provided education regarding healthy eating, exercising, and reading food labels; encouraged stimulus-control measures such as limiting access to unhealthy foods and limiting screen time (that is, physical inactivity); and included supervised physical activity. Additional beneficial components are assisting patients to identify and accomplish goals, self-monitor, and problem-solve, as well as teaching them coping skills and addressing their body image.
In contrast to behavioral interventions, pharmacotherapy was not endorsed by the USPSTF. The current evidence was deemed inadequate to determine whether the slight weight loss achieved with pharmacotherapy is clinically significant and whether it outweighs the harms of the medications.
The two agents currently used in this regard are metformin, which is not Food and Drug Administration–approved for this purpose, and orlistat, which is approved for patients aged 12 years and older. Orlistat in particular frequently causes adverse events including fatty or oily stools, abdominal pain or cramping, flatus with stool discharge, and fecal incontinence, Dr. Grossman and his associates said.
The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at https://www.uspreventiveservicestaskforce.org/Page/Name/conflict-of-interest-disclosures.
Letter to the Editor
It is not surprising that there are so many overweight and obese children, despite the fact that in order to prevent bad feelings, children have to be much more overweight than adults to be classified as obese or overweight.
If one is waiting until age 6 years to screen for obesity, that horse will be long out of the barn. The problem begins when the rapid weight gain of infants does not slow down in the 2nd and 3rd years of life. This is also when bad food choices and eating habits often begin.
The other problem is that body mass index is a terrible tool and so is any indicator that tries to define obesity using only height and weight. None of these distinguish between the muscular child and the slender child with a large belly. Waist to height or body volume measurements are far better indicators.
Lastly, parents have come to see the mildly overweight child as the norm because so many children are. Until parents see pictures of children from a few decades ago and are educated as to what normal looks like, we will have great difficulty making a dent in this problem.
Richard H. Feuille Jr., MD
FROM JAMA
Key clinical point: with at least 26 hours of contact.
Major finding: Children and adolescents who received intensive behavioral intervention showed absolute reductions in BMI z scores of 0.20 and maintained their baseline weight within approximately 5 pounds, while control subjects showed small or no reductions in BMI z scores and typically gained a mean of 5-17 pounds.
Data source: A review of the literature since the previous USPSTF recommendation statement in 2010, including 45 studies of lifestyle-based interventions involving 7,099 overweight and obese children.
Disclosures: The USPSTF is an independent voluntary group supported by the U.S. Agency for Healthcare Research and Quality as mandated by Congress. The authors’ conflicts of interest are available at www.uspreventiveservicestaskforce.org.
Brexanolone appears effective for severe postpartum depression
A single 60-hour infusion of brexanolone dramatically and rapidly improves severe postpartum depression with minimal adverse effects, a small manufacturer-conducted phase II trial suggests.
Brexanolone is a proprietary formulation of allopregnanolone, the major metabolite of progesterone and a potent modulator of synaptic and extrasynaptic gamma-aminobutyric acid type A (GABAA) receptors that has demonstrated profound benefits for anxiety and depression symptoms in animal models. Plasma levels of allopregnanolone rise to a peak during the third trimester of pregnancy, then abruptly fall after childbirth. “Failure of GABAA receptors to adapt to these changes at parturition has been postulated to have a role in triggering postpartum depression,” said Stephen Kanes, MD, of Sage Therapeutics, Cambridge, Mass., and his associates.
They assessed the drug’s effects in 21 women hospitalized for severe postpartum depression at 11 U.S. medical centers during a 5-month period. The study participants, who had Hamilton Rating Scale for Depression (HAM-D) scores of 26 or higher at baseline, randomized to receive a 60-hour infusion of brexanolone (10 patients) or a matching placebo (11 patients) in a double-blind fashion.
The primary outcome measure – mean reduction in HAM-D score at the end of the 60-hour infusion – was 21.0 points with brexanolone, significantly greater than the 8.8 point reduction seen with placebo. Women in the active-treatment group began showing a marked improvement within 24 hours of beginning the infusion, which was maintained throughout the week of treatment, as well as for the succeeding 30 days of follow-up.
Of the 10 patients, 7 receiving brexanolone (70%), compared with only 1 of those receiving placebo (9%), achieved remission of depression (HAM-D score of 7 or less) by the end of treatment. That remission occurred within 24 hours of beginning the infusion in six of the women in the brexanolone group. Moreover, improvement extended beyond the core depressive symptoms, with women in the active-treatment group also showing rapid and marked improvement on Clinical Global Impression–Improvement Scale scores, the investigators said (Lancet. 2017 Jun 12. doi: 10.1016/S0140-67369(17)31264-3).
Two women who received brexanolone admitted that, at baseline, they’d had active suicidal ideation with a specific plan and intent. Neither was suicidal after treatment.
Brexanolone was well-tolerated, with no serious adverse events or treatment discontinuations. Fewer patients who received active treatment (4) than placebo (8) reported mild adverse events. The most frequently reported adverse effects of brexanolone were dizziness and somnolence.
Among the limitations cited by the investigators was the use of a “very strict definition of postpartum depression” (HAM-D scores greater than or equal to 26).
Dr. Kanes and his associates reported that a phase III study currently underway is looking into the possible use of brexanolone in women with “varying degrees of severity.”
“Our findings provide the first placebo-controlled clinical support for the role of extrasynaptic GABAA receptors in the modulation of mood and affective states in any clinical population. The large effect size seen in this trial contrasts with that observed in studies of currently available and widely used antidepressants, including [selective serotonin reuptake inhibitors], [selective norepinephrine reuptake inhibitors], and tricyclics,” Dr. Kanes and his associates noted.
The impressive findings by Kanes et al., even though based on a very small sample of patients, are promising for new mothers who have postpartum depression and for the clinicians who treat them, wrote Ian Jones, PhD, in an editorial comment accompanying Dr. Kanes’s report (Lancet. 2017 Jun 12. doi:10.1016/S0140-6736(17)31546-5).
Now, the pressing need is for larger phase III trials to replicate these results in postpartum depression. After that, researchers can address whether brexanolone is effective for other psychiatric conditions triggered by childbirth, such as postpartum psychosis, or even for a wider spectrum of reproductive- and endocrine-related mood disorders such as those related to menstruation and menopause. Eventually, brexanolone or similar agents may even prove helpful in preventing postpartum depression in women at high risk for the disorder.
“Those of us hoping for the development of effective pharmacological treatments that specifically target postpartum depression have, like our patients, felt in a dark place,” Dr. Jones wrote. “With the very encouraging results of this trial, perhaps we can begin to see the first glimpses of light.”
Dr. Jones is affiliated with the National Centre for Mental Health and the MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff (Wales) University. He reported having no relevant financial disclosures.
The impressive findings by Kanes et al., even though based on a very small sample of patients, are promising for new mothers who have postpartum depression and for the clinicians who treat them, wrote Ian Jones, PhD, in an editorial comment accompanying Dr. Kanes’s report (Lancet. 2017 Jun 12. doi:10.1016/S0140-6736(17)31546-5).
Now, the pressing need is for larger phase III trials to replicate these results in postpartum depression. After that, researchers can address whether brexanolone is effective for other psychiatric conditions triggered by childbirth, such as postpartum psychosis, or even for a wider spectrum of reproductive- and endocrine-related mood disorders such as those related to menstruation and menopause. Eventually, brexanolone or similar agents may even prove helpful in preventing postpartum depression in women at high risk for the disorder.
“Those of us hoping for the development of effective pharmacological treatments that specifically target postpartum depression have, like our patients, felt in a dark place,” Dr. Jones wrote. “With the very encouraging results of this trial, perhaps we can begin to see the first glimpses of light.”
Dr. Jones is affiliated with the National Centre for Mental Health and the MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff (Wales) University. He reported having no relevant financial disclosures.
The impressive findings by Kanes et al., even though based on a very small sample of patients, are promising for new mothers who have postpartum depression and for the clinicians who treat them, wrote Ian Jones, PhD, in an editorial comment accompanying Dr. Kanes’s report (Lancet. 2017 Jun 12. doi:10.1016/S0140-6736(17)31546-5).
Now, the pressing need is for larger phase III trials to replicate these results in postpartum depression. After that, researchers can address whether brexanolone is effective for other psychiatric conditions triggered by childbirth, such as postpartum psychosis, or even for a wider spectrum of reproductive- and endocrine-related mood disorders such as those related to menstruation and menopause. Eventually, brexanolone or similar agents may even prove helpful in preventing postpartum depression in women at high risk for the disorder.
“Those of us hoping for the development of effective pharmacological treatments that specifically target postpartum depression have, like our patients, felt in a dark place,” Dr. Jones wrote. “With the very encouraging results of this trial, perhaps we can begin to see the first glimpses of light.”
Dr. Jones is affiliated with the National Centre for Mental Health and the MRC Centre for Neuropsychiatric Genetics and Genomics at Cardiff (Wales) University. He reported having no relevant financial disclosures.
A single 60-hour infusion of brexanolone dramatically and rapidly improves severe postpartum depression with minimal adverse effects, a small manufacturer-conducted phase II trial suggests.
Brexanolone is a proprietary formulation of allopregnanolone, the major metabolite of progesterone and a potent modulator of synaptic and extrasynaptic gamma-aminobutyric acid type A (GABAA) receptors that has demonstrated profound benefits for anxiety and depression symptoms in animal models. Plasma levels of allopregnanolone rise to a peak during the third trimester of pregnancy, then abruptly fall after childbirth. “Failure of GABAA receptors to adapt to these changes at parturition has been postulated to have a role in triggering postpartum depression,” said Stephen Kanes, MD, of Sage Therapeutics, Cambridge, Mass., and his associates.
They assessed the drug’s effects in 21 women hospitalized for severe postpartum depression at 11 U.S. medical centers during a 5-month period. The study participants, who had Hamilton Rating Scale for Depression (HAM-D) scores of 26 or higher at baseline, randomized to receive a 60-hour infusion of brexanolone (10 patients) or a matching placebo (11 patients) in a double-blind fashion.
The primary outcome measure – mean reduction in HAM-D score at the end of the 60-hour infusion – was 21.0 points with brexanolone, significantly greater than the 8.8 point reduction seen with placebo. Women in the active-treatment group began showing a marked improvement within 24 hours of beginning the infusion, which was maintained throughout the week of treatment, as well as for the succeeding 30 days of follow-up.
Of the 10 patients, 7 receiving brexanolone (70%), compared with only 1 of those receiving placebo (9%), achieved remission of depression (HAM-D score of 7 or less) by the end of treatment. That remission occurred within 24 hours of beginning the infusion in six of the women in the brexanolone group. Moreover, improvement extended beyond the core depressive symptoms, with women in the active-treatment group also showing rapid and marked improvement on Clinical Global Impression–Improvement Scale scores, the investigators said (Lancet. 2017 Jun 12. doi: 10.1016/S0140-67369(17)31264-3).
Two women who received brexanolone admitted that, at baseline, they’d had active suicidal ideation with a specific plan and intent. Neither was suicidal after treatment.
Brexanolone was well-tolerated, with no serious adverse events or treatment discontinuations. Fewer patients who received active treatment (4) than placebo (8) reported mild adverse events. The most frequently reported adverse effects of brexanolone were dizziness and somnolence.
Among the limitations cited by the investigators was the use of a “very strict definition of postpartum depression” (HAM-D scores greater than or equal to 26).
Dr. Kanes and his associates reported that a phase III study currently underway is looking into the possible use of brexanolone in women with “varying degrees of severity.”
“Our findings provide the first placebo-controlled clinical support for the role of extrasynaptic GABAA receptors in the modulation of mood and affective states in any clinical population. The large effect size seen in this trial contrasts with that observed in studies of currently available and widely used antidepressants, including [selective serotonin reuptake inhibitors], [selective norepinephrine reuptake inhibitors], and tricyclics,” Dr. Kanes and his associates noted.
A single 60-hour infusion of brexanolone dramatically and rapidly improves severe postpartum depression with minimal adverse effects, a small manufacturer-conducted phase II trial suggests.
Brexanolone is a proprietary formulation of allopregnanolone, the major metabolite of progesterone and a potent modulator of synaptic and extrasynaptic gamma-aminobutyric acid type A (GABAA) receptors that has demonstrated profound benefits for anxiety and depression symptoms in animal models. Plasma levels of allopregnanolone rise to a peak during the third trimester of pregnancy, then abruptly fall after childbirth. “Failure of GABAA receptors to adapt to these changes at parturition has been postulated to have a role in triggering postpartum depression,” said Stephen Kanes, MD, of Sage Therapeutics, Cambridge, Mass., and his associates.
They assessed the drug’s effects in 21 women hospitalized for severe postpartum depression at 11 U.S. medical centers during a 5-month period. The study participants, who had Hamilton Rating Scale for Depression (HAM-D) scores of 26 or higher at baseline, randomized to receive a 60-hour infusion of brexanolone (10 patients) or a matching placebo (11 patients) in a double-blind fashion.
The primary outcome measure – mean reduction in HAM-D score at the end of the 60-hour infusion – was 21.0 points with brexanolone, significantly greater than the 8.8 point reduction seen with placebo. Women in the active-treatment group began showing a marked improvement within 24 hours of beginning the infusion, which was maintained throughout the week of treatment, as well as for the succeeding 30 days of follow-up.
Of the 10 patients, 7 receiving brexanolone (70%), compared with only 1 of those receiving placebo (9%), achieved remission of depression (HAM-D score of 7 or less) by the end of treatment. That remission occurred within 24 hours of beginning the infusion in six of the women in the brexanolone group. Moreover, improvement extended beyond the core depressive symptoms, with women in the active-treatment group also showing rapid and marked improvement on Clinical Global Impression–Improvement Scale scores, the investigators said (Lancet. 2017 Jun 12. doi: 10.1016/S0140-67369(17)31264-3).
Two women who received brexanolone admitted that, at baseline, they’d had active suicidal ideation with a specific plan and intent. Neither was suicidal after treatment.
Brexanolone was well-tolerated, with no serious adverse events or treatment discontinuations. Fewer patients who received active treatment (4) than placebo (8) reported mild adverse events. The most frequently reported adverse effects of brexanolone were dizziness and somnolence.
Among the limitations cited by the investigators was the use of a “very strict definition of postpartum depression” (HAM-D scores greater than or equal to 26).
Dr. Kanes and his associates reported that a phase III study currently underway is looking into the possible use of brexanolone in women with “varying degrees of severity.”
“Our findings provide the first placebo-controlled clinical support for the role of extrasynaptic GABAA receptors in the modulation of mood and affective states in any clinical population. The large effect size seen in this trial contrasts with that observed in studies of currently available and widely used antidepressants, including [selective serotonin reuptake inhibitors], [selective norepinephrine reuptake inhibitors], and tricyclics,” Dr. Kanes and his associates noted.
FROM THE LANCET
Key clinical point: A single 60-hour infusion of brexanolone dramatically and rapidly improved severe postpartum depression with minimal adverse effects in a small manufacturer-conducted phase II trial.
Major finding: The primary outcome measure – mean reduction in HAM-D score at the end of the 60-hour infusion – was 21.0 points with brexanolone vs. 8.8 points with placebo.
Data source: A multicenter, double-blind, randomized controlled trial involving 21 women with severe postpartum depression.
Disclosures: This study was funded by Sage Therapeutics, maker of brexanolone, which also was involved in the study design, collection,and interpretation of the data and the writing of the report. Dr. Kanes is an employee of Sage Therapeutics, and several of his associates reported being employees of or consultants for the company.
Relatives of NAFLD patients: 12-fold higher risk
Asymptomatic first-degree relatives of patients who have nonalcoholic fatty liver disease with cirrhosis are at a 12-fold higher risk for advanced liver fibrosis compared with the general population, according to a report published online June 19 in the Journal of Clinical Investigation.
If this preliminary but robust association is confirmed in further research, it may well change clinical practice. First-degree relatives would likely require screening for advanced fibrosis, and those found to have it would likely need continued surveillance for hepatocellular carcinoma.
They noted that previous studies have suggested a familial component to NAFLD, and decided to assess the risk of advanced fibrosis in first-degree relatives of patients who had NAFLD plus cirrhosis. The investigators used noninvasive imaging techniques – MRI-PDFF (MRI proton density fat fraction) and MRE (magnetic resonance elastography) – to quantify liver fat and liver fibrosis in 26 patients who had NAFLD plus cirrhosis, 39 of their first-degree relatives who were asymptomatic, 69 community-dwelling adults who did not have NAFLD or cirrhosis, and 69 of their first-degree relatives.
The primary outcome measure, the prevalence of advanced liver fibrosis, was 18% among first-degree relatives of patients who had NAFLD plus cirrhosis. This was markedly greater than the prevalence of advanced fibrosis among first-degree relatives of unaffected adults (1.4%).
The odds ratio of having advanced fibrosis among first-degree relatives of affected patients was 14.9, compared with the control population. When the data were adjusted to account for age, sex, body mass index, and diabetes status, the OR remained statistically and clinically significant at 12.5, Dr. Caussy and her associates said (doi.org/10.1172/JCI93465).
This study was limited in that it was a single-center investigation and used advanced MRI techniques that may not be routinely available at other centers. In addition, since it was cross-sectional in design, long-term outcomes, such as the development of hepatocellular carcinoma and survival rates, could not be assessed.
“Despite these limitations, we believe that this study provides important data that require validation in larger studies to then change clinical practice guidelines to screen first-degree relatives of patients with NAFLD with cirrhosis,” the investigators added.
The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences supported the study. Dr. Caussy and her associates reported having no relevant financial disclosures.
Asymptomatic first-degree relatives of patients who have nonalcoholic fatty liver disease with cirrhosis are at a 12-fold higher risk for advanced liver fibrosis compared with the general population, according to a report published online June 19 in the Journal of Clinical Investigation.
If this preliminary but robust association is confirmed in further research, it may well change clinical practice. First-degree relatives would likely require screening for advanced fibrosis, and those found to have it would likely need continued surveillance for hepatocellular carcinoma.
They noted that previous studies have suggested a familial component to NAFLD, and decided to assess the risk of advanced fibrosis in first-degree relatives of patients who had NAFLD plus cirrhosis. The investigators used noninvasive imaging techniques – MRI-PDFF (MRI proton density fat fraction) and MRE (magnetic resonance elastography) – to quantify liver fat and liver fibrosis in 26 patients who had NAFLD plus cirrhosis, 39 of their first-degree relatives who were asymptomatic, 69 community-dwelling adults who did not have NAFLD or cirrhosis, and 69 of their first-degree relatives.
The primary outcome measure, the prevalence of advanced liver fibrosis, was 18% among first-degree relatives of patients who had NAFLD plus cirrhosis. This was markedly greater than the prevalence of advanced fibrosis among first-degree relatives of unaffected adults (1.4%).
The odds ratio of having advanced fibrosis among first-degree relatives of affected patients was 14.9, compared with the control population. When the data were adjusted to account for age, sex, body mass index, and diabetes status, the OR remained statistically and clinically significant at 12.5, Dr. Caussy and her associates said (doi.org/10.1172/JCI93465).
This study was limited in that it was a single-center investigation and used advanced MRI techniques that may not be routinely available at other centers. In addition, since it was cross-sectional in design, long-term outcomes, such as the development of hepatocellular carcinoma and survival rates, could not be assessed.
“Despite these limitations, we believe that this study provides important data that require validation in larger studies to then change clinical practice guidelines to screen first-degree relatives of patients with NAFLD with cirrhosis,” the investigators added.
The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences supported the study. Dr. Caussy and her associates reported having no relevant financial disclosures.
Asymptomatic first-degree relatives of patients who have nonalcoholic fatty liver disease with cirrhosis are at a 12-fold higher risk for advanced liver fibrosis compared with the general population, according to a report published online June 19 in the Journal of Clinical Investigation.
If this preliminary but robust association is confirmed in further research, it may well change clinical practice. First-degree relatives would likely require screening for advanced fibrosis, and those found to have it would likely need continued surveillance for hepatocellular carcinoma.
They noted that previous studies have suggested a familial component to NAFLD, and decided to assess the risk of advanced fibrosis in first-degree relatives of patients who had NAFLD plus cirrhosis. The investigators used noninvasive imaging techniques – MRI-PDFF (MRI proton density fat fraction) and MRE (magnetic resonance elastography) – to quantify liver fat and liver fibrosis in 26 patients who had NAFLD plus cirrhosis, 39 of their first-degree relatives who were asymptomatic, 69 community-dwelling adults who did not have NAFLD or cirrhosis, and 69 of their first-degree relatives.
The primary outcome measure, the prevalence of advanced liver fibrosis, was 18% among first-degree relatives of patients who had NAFLD plus cirrhosis. This was markedly greater than the prevalence of advanced fibrosis among first-degree relatives of unaffected adults (1.4%).
The odds ratio of having advanced fibrosis among first-degree relatives of affected patients was 14.9, compared with the control population. When the data were adjusted to account for age, sex, body mass index, and diabetes status, the OR remained statistically and clinically significant at 12.5, Dr. Caussy and her associates said (doi.org/10.1172/JCI93465).
This study was limited in that it was a single-center investigation and used advanced MRI techniques that may not be routinely available at other centers. In addition, since it was cross-sectional in design, long-term outcomes, such as the development of hepatocellular carcinoma and survival rates, could not be assessed.
“Despite these limitations, we believe that this study provides important data that require validation in larger studies to then change clinical practice guidelines to screen first-degree relatives of patients with NAFLD with cirrhosis,” the investigators added.
The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences supported the study. Dr. Caussy and her associates reported having no relevant financial disclosures.
FROM THE JOURNAL OF CLINICAL INVESTIGATION
Key clinical point: First-degree relatives of patients who have nonalcoholic fatty liver disease with cirrhosis are at a 12-fold higher risk of advanced liver fibrosis compared with the general population.
Major finding: The adjusted odds ratio of having advanced fibrosis among first-degree relatives of affected patients was 12.5, compared with the control population.
Data source: A cross-sectional cohort study involving 25 probands with NAFLD + cirrhosis, 39 first-degree relatives, and 69 control pairs of relatives from the general population.
Disclosures: The National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Environmental Health Sciences supported the study. Dr. Caussy and her associates reported having no relevant financial disclosures.
Urgent surgery said to deserve separate classification
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
Urgent surgery deserves a separate classification from elective surgery and emergency surgery for assessments of healthcare quality and performance, because the three types of surgery have distinct morbidity and mortality profiles, according to a report published in JAMA Surgery.
Current methods of assessing pay-for-performance reimbursement, surgical outcomes, and value-based care programs all classify surgeries as either elective or emergent procedures. They do not account for the many surgeries that are instead urgent – performed after a trial of nonoperative conservative management or after patients with acute disease processes undergo a brief period of medical optimization.
Common examples of surgeries that occupy this middle ‘urgent’ ground between elective and emergent procedures are those done for cholecystitis, adhesive small-bowel obstruction, and acute diverticulitis, said Matthew G. Mullen, MD, and his associates at the University of Virginia Health System, Charlottesville.
Such urgent surgeries should not be lumped together with elective surgeries, as they usually are at present, because they carry substantially higher complication rates and mortality. “At a time when reimbursement is contingent on value-based outcomes reporting and performance, it is imperative to ensure that appropriate risk adjustment is performed,” the researchers stated.
“Surgeons who commonly operate on an urgent basis, including many acute-care and emergency general surgeons, are at risk of being penalized” in Medicare’s value-based reimbursement for their services.
“These surgeons may even unfairly be labeled as poor performers by current outcome reporting guidelines,” the investigators noted.
Morbidity and mortality rates associated with the “substantial” population of patients undergoing urgent surgery have not been well-studied until now. Dr. Mullen and his associates examined the issue using information from a national database, the American College of Surgeons’ National Quality Improvement Program Participant Use File. They focused on 173,643 general surgeries performed at 435 hospitals during a 1-year period: 130,235 (75%) were categorized as elective, 20,816 (12%) as urgent (nonelective and nonemergency), and 22,592 (13%) as emergency procedures.
Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality. These rates are much greater than those of elective surgeries (6.7% and 0.4%, respectively), even though urgent surgeries typically fall into the category of “elective.” In fact, the morbidity and mortality rates for urgent surgeries closely approached those of emergency surgeries (13.8% and 3.7%, respectively), the investigators said (JAMA Surg. 2017 May 10 [doi:10.1001/jamasurg.2017.0918]).
In this cohort, patients in the “urgent” surgery category had the highest preoperative rates of congestive heart failure, chronic obstructive pulmonary disease, diabetes, hemodialysis, corticosteroid use, and disseminated cancer – all factors that markedly elevate mortality and morbidity risks.
“We have identified operative urgency as a key consideration for patient risk stratification. If this issue is not recognized, quality outcome reporting and value-based reimbursement will continue to incentivize operating on an elective basis and will make surgeons more reluctant to operate on patients who urgently require care,” Dr. Mullen and his associates said. And such delays in surgical intervention could further increase patient morbidity and mortality.
This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
FROM JAMA SURGERY
Key clinical point: Urgent surgery deserves a separate classification from elective and emergency surgeries for assessments of healthcare quality and performance.
Major finding: Urgent general surgeries carried a 12.3% rate of morbidity and a 2.3% rate of mortality, approximately double the morbidity rate and 6 times the mortality rate of elective surgeries (6.7% and 0.4%, respectively).
Data source: A retrospective analysis of outcomes for 173,643 general surgeries performed during a 1-year period at 435 hospitals across U.S.
Disclosures: This study was supported by the National Institutes of Health. Dr. Mullen and his associates reported having no relevant financial disclosures.
Laparoscopic colectomy cost savings linked to surgeon experience
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach, according to a study published in the Annals of Surgery.
Many studies have demonstrated that compared with the open surgery, the laparoscopic approach reduces the cost of major abdominal operations including colectomy by as much as 50%. These savings are attributed to the shorter length of stay and lower complication rate associated with laparoscopic surgery.
“The present study underscores and clarifies the complex relationship between surgeon experience, postoperative complications, and healthcare payments. It builds on prior analyses of surgical cohorts that demonstrate an association of higher complication rates with significantly increased total episode payments,” the investigators wrote.
To assess payments for laparoscopic vs. open colectomy, they performed a population-based analysis of information in a national Medicare database regarding 182,852 procedures done in 2010-2012. They included payments for complications, readmissions, and postacute care as well as for the surgery and hospital stay.
To examine any possible effects of the surgeons’ experience on the resulting costs, the data were divided into quartiles of experience with laparoscopy. The investigators then compared surgeons with the least experience (the lowest quartile), the most experience (the highest quartile), and intermediate experience (the two middle quartiles).
Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312). In contrast, among surgeons with the most experience, payments were substantially lower for laparoscopic ($20,476) than for open colectomy ($23,793).
This difference was attributed to the less experienced surgeons’ higher complication rates; higher readmission rates; and greater need for postacute care services, such as discharging the patient to a skilled nursing facility rather than home, the investigators said (Ann Surg. 2017 May 25. doi: 10.1097/SLA.0000000000002312).
These findings demonstrate that “the financial benefits of laparoscopy are only realized when the surgeon has appropriate experience or proficiency.” They have important implications, highlighting the need for more rigorous credentialing standards for individual surgeons and for improving continuing medical education through more extensive proctoring or coaching to enhance surgical skills, Dr. Sheetz and his associates said.
The study results also “make a business case for investing in the training and retraining of surgeons in practice,” they added
“New procedures are continually introduced into practice, and surgeons need to take the time to learn them safely. Taking time to learn new procedures is expensive. Increasing the number of surgeons at a given hospital who are, however, proficient with complex laparoscopy has an important beneficial impact on the financial bottom line for hospitals and health care payers,” the investigators noted.
This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
FROM THE ANNALS OF SURGERY
Key clinical point: Laparoscopic colectomy is less expensive than open colectomy only when it is performed by surgeons experienced with the laparoscopic approach.
Major finding: Among the surgeons with the least experience in laparoscopy, Medicare payments were actually higher for laparoscopic ($26,915) than for open colectomy ($23,312).
Data source: An analysis of Medicare payment data for 182,852 patients who had laparoscopic or open colectomy in 2010-2012.
Disclosures: This study was supported by The National Institutes of Health. Dr. Sheetz and his associates reported having no relevant financial disclosures.
Rural patients less likely to have bariatric surgery
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
Obese patients living in rural areas of West Virginia were substantially less likely than were their urban and suburban counterparts to have bariatric surgery, according to findings from a study comparing outcomes in two patient groups.
This discrepancy is attributed to a difference between rural and nonrural patients in type of insurance coverage. In this 2-year study, rural patients were nearly five times more likely to be covered by West Virginia Medicaid than were patients living in nonrural areas of the state, said Kristie L. Bergmann, PhD, of the department of behavioral medicine and psychiatry, West Virginia University, Morgantown, and her associates. The findings were published in Surgery for Obesity and Related Diseases (2017;13[4]:632-6), the journal of the American Society for Metabolic and Bariatric Surgery.
Previous research has identified rural patients’ lack of insurance as a barrier to health care. “Our results suggest that insurance denial represents a successive barrier. Despite being insured, rural individuals may be barred from surgery if insurance carriers do not offer it as a covered benefit, deny approval, or require indomitable prerequisites for surgery,” Dr. Bergmann and her associates said.
They examined the associations among rural status, access to bariatric surgery, and surgical outcomes in West Virginia in part because the state’s residents “have been consistently ranked as the most obese population in the United States, with approximately 35.1% of residents meeting criteria for obesity.” West Virginia also has the highest rates of diabetes (13%) and hypertension (41%) in the United States.
At the same time, rural populations are known to have decreased access to all forms of health care and specifically to bariatric surgery. This makes rural West Virginians “a particularly vulnerable population of interest,” the investigators said.
They performed a retrospective cohort study involving 122 obese patients seeking bariatric surgery at their university’s medical center during 2012-2014. A total of 97% of these patients were white, 83% were women, and the mean age was 47 years. Only 82 of the 122 study participants underwent bariatric surgery: 77 had Roux-en-Y gastric bypass and 5 had sleeve gastrectomy.
Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference. When Medicaid patients were excluded from the analysis, nonrural status no longer predicted the use of bariatric surgery.
Moreover, when Medicaid coverage was controlled for, rural status had no effect on the effectiveness of bariatric surgery. Patients residing in rural areas had the same attendance at follow-up visits and the same reduction in body mass index at 6 months and at 12 months as did nonrural patients.
In addition, patients who had higher levels of education and who worked full-time were more likely to undergo bariatric surgery, but overall, rural patients were more likely to have comorbidities, disability, and lower rates of full-time work. “An argument can be made that rural individuals may have a greater medical need for bariatric surgery, as obesity and associated health conditions may contribute to lower rates of employment. Unfortunately, barring these patients from receiving care may reinforce a cycle of disability and declining health status,” Dr. Bergmann and her associates noted.
This study was limited in that it had a relatively small sample size, particularly in analyses that excluded Medicaid recipients. It also had a follow-up of only 1 year, so longer-term outcomes of bariatric surgery could not be assessed. “Our sample is also predominantly Caucasian and may have unique culturally-based characteristics” that limit the generalizability of the study findings, they added.
No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.
FROM SURGERY FOR OBESITY AND RELATED DISEASES
Key clinical point: Obese patients living in rural areas of West Virginia are substantially less likely than are their urban and suburban counterparts to have bariatric surgery.
Major finding: Rural residents were significantly less likely to undergo bariatric surgery than were nonrural patients, but coverage by West Virginia Medicaid explained 83.6% of this difference.
Data source: A retrospective single-center cohort study involving 122 obese West Virginians seeking bariatric surgery in 2012-2014.
Disclosures: No specific sponsor was cited for this study. Dr. Bergmann and her associates reported having no relevant financial disclosures.