Whitney McKnight

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]

CHICAGO – Probably the last thing on the minds of office-based physicians is whether they are running afoul of antitrust regulations.

However, according to Dr. Edward J. Diamond, a pulmonary specialist, a faculty member of the American College of Chest Physicians, and president of Suburban Lung Associates – a large network of pulmonary care offices near Chicago – physicians can add that to their list of concerns about the Affordable Care Act.

The danger zone, according to Dr. Diamond, is what’s known as "clinical integration": pooling patient and protocol data for the purpose of meeting the ACA’s data-driven call on providers to improve care and lower costs. This can be achieved for less when physicians in private practice band together, but it’s not as simple as a handshake, said Dr. Diamond.

The U.S. Department of Justice specifically defines clinical integration as a "network implementing an active and ongoing program to evaluate and modify practice patterns ... and create a high degree of interdependence and cooperation among the physicians to control costs and ensure quality..."

"You have to really adhere to this definition to avoid antitrust issues," said Dr. Diamond, who made his remarks at the annual meeting of the American College of Chest Physicians.

"The Statements of Antitrust Enforcement Policy in Health Care, issued jointly by the Federal Trade Commission and Department of Justice in 1996, carve out certain safety zones for physician network joint ventures," said Christopher Gordon, a specialist in health care antitrust law at Squire Sanders LLP in Washington.

Mr. Gordon said that the DOJ and the FTC "will typically not challenge an exclusive physician network joint venture where the participants share substantial financial risk and constitute 20% or less of the physicians in each specialty practicing in the relevant geographic market. Where the network is nonexclusive, that number rises to 30% or less."

If they are too large, or if they don’t keep to these predetermined percentages of competing physicians by specialty, groups of competing health care providers cooperating to make their ACA mandates could be in danger.

"Networks that fall outside these safety zones – either because they include a higher percentage of physicians or do not involve financial risk sharing – do not necessarily raise antitrust concerns, but instead will have their conduct reviewed under what is known as the "rule of reason" to determine whether, on balance, the conduct is anticompetitive or not," said Mr. Gordon.

"You have to be very careful you don’t end up accused of illegal collective bargaining," said Dr. Diamond. "There is a disconnect between what the Department of Justice and what the ACA are asking."

If not a disconnect, at least a proscribed field of play.

According to Mr. Gordon, providers have latitude in how they cooperate when it comes to developing clinical protocols and best practices, so long as that cooperation does not include pricing agreements among multiple, independent clinics. "Such conduct would arguably constitute a per se violation of the antitrust laws regardless of how small or big the clinics are," he said.

Although the justice department and the FTC are primarily focused on conduct that impacts commercial health insurance markets, fee schedules and reimbursements that are part of any Medicare Advantage plan are considered part of the marketplace, because these plans are offered by private insurers contracting with the federal government, Mr. Gordon said. Medicare proper, meanwhile, is unaffected by antitrust concerns because "its pricing is set by the government, so there is little or no risk that provider misconduct could impact those prices," he noted.

Whatever happens, said Dr. Diamond, to survive in the era of the ACA, providers who will thrive with clinical integration are those who can develop areas of expertise such as excellent electronic health record systems, which make them attractive partners to other clinics and health care facilities. "Be a friendly competitor," he said, Above all else, he added: "Embrace change."

Dr. Diamond reported having no disclosures.

[email protected]

CHICAGO – Accurate phenotyping, in the ascendant over the last decade, equates with more effectively targeted treatments for chronic obstructive pulmonary disease, according to a proponent of personalized pulmonary medicine.

"We know that COPD is not the same, but right now we are treating these patients as though one size fits all," Dr. Nicola A. Hanania of the Baylor College of Medicine, Houston, said in a packed session on COPD at the annual meeting of the American College of Chest Physicians.

Because phenotypes describe differences in individuals, they should have relevance to clinically meaningful outcomes. "In COPD, that relates to symptoms, exacerbation, disease progression, response to therapy, and survival," he said.

Potential phenotypes that have been identified according to clinical, physiologic, and radiologic criteria include chronic bronchitis, asthma/COPD overlap, frequent exacerbator, radiologic CT, and persistent systemic inflammation.

Chronic bronchitis

Chronic bronchitis tends to occur more in younger people who smoke. It also is characterized by more wheezing and thicker airway walls. Data presented by Dr. Hanania also showed that this phenotype has more frequent acute exacerbations (Chest 2011;140:1107-8).

In one study, 290 subjects deemed chronically bronchitic – chronic cough and phlegm lasting 3 months of every year for 2 consecutive years – were compared with 771 subjects who were not chronically bronchitic. Investigators found that patients in the first group had more frequent exacerbations per patient: 1.21-1.62 vs. 0.63-1.12 (P < .027). The first group also reported more severe exacerbations: 26.6% vs. 20% (P < .024) (Chest 2011;140:626-33).

Asthma/COPD overlap

"This is a phenotype that deserves more attention. We all have patients where we scratch our head, ‘Is this asthma, or is this COPD?’ " said Dr. Hanania. "We don’t really know because these patients are notoriously excluded from both asthma and COPD studies." He cited estimates suggesting that 13%-20% of COPD patients overlap with asthma (Arch. Bronconeumol. 2012;48:331-7).

Proposed diagnostic criteria for the overlap syndrome phenotype may include two major criteria: marked response to bronchodilators (>15% and >400 mL in forced expiratory volume in 1 second [FEV₁]), history of asthma if patient is younger than 40 years, and sputum eosinophilia. Overlap also can be diagnosed by one major criterion and two of the following: response to bronchodilation at least two separate times (>12% and >200 mL in FEV₁), history of atopy, and increased total serum IgE. At this time, he said, these criteria are based on expert opinion and on data, "but the clinical implications, once we do the homework, is that these patients deserve to be on antibiotics and corticosteroids early on."

Frequent exacerbator

Defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as two or more exacerbations per year, the frequent exacerbator phenotype was explained in the ECLIPSE study (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints), Dr. Hanania said, which showed that, although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype (N. Engl. J. Med. 2010; 363:1128-38).

Frequent exacerbators have higher-stage COPD, more severe obstruction, and more hospitalizations, Dr. Hanania noted.

In addition, the ECLIPSE investigators found that, in 2,138 patients, frequent exacerbator types had an odds ratio of 5.72 of having had an exacerbation in the previous year

Although there other risk factors implicating this phenotype, "the most important question to ask the patient is whether they have had an exacerbation in the previous year," he said. Chronic cough is another factor.

The clinical benefit to identifying the frequent exacerbator, according to Dr. Hanania, is that this group has a greater range of comorbidities, including more inflammation, heightened viral susceptibility, and increased cardiovascular risk, among other susceptibilities.

Using CT for phenotyping

Noting that radiologic phenotyping in COPD is more advanced than in asthma at this time, Dr. Hanania said that quantitative and visual assessment of CT radiographs is "promising" and has helped identify COPD subphenotypes such as emphysema because of accurate assessment of lung inflation, wall thickness, and other factors.

Identifying patients with bronchiectasis, pulmonary arterial enlargement, and acute exacerbations in COPD is also possible with CT radiography, making it possible to predict the different outcomes in each situation. "The clinical implication is that these patients tend to have more frequent exacerbation, worse lung function, and infection," he said, noting that nascent research using imaging to determine biomarkers in functional small airways disease also is occurring.

Systemic inflammation

In the ECLIPSE study, 2,164 COPD patients had an odds ratio of 2.23 for being a current smoker and had higher levels of inflammation, as determined using biomarkers such as C-reactive protein, compared with 337 smokers without COPD and 245 nonsmokers. At the 3-year follow-up, this group with persistently higher inflammation also was classified as having significantly higher all-cause mortality than the group with less inflammation (13% vs. 2%); exacerbation rates in this group were also persistently higher (1.5 vs. 0.9) (PLoS ONE 2012;7:e37483).

Therapeutic implications

Coupling these phenotypes with molecular descriptions of mechanisms and their underlying pathologies can lead to accurate, personalized treatment of COPD. "Phenotypes without clear implications for prognosis and treatment are of little clinical use," Dr. Hanania said, noting that longitudinal studies to validate these phenotypes are necessary.

"Research can help identify mechanisms and courses in different phenotypes, including gender differences," he concluded. "Examining therapeutic responses to different phenotypes can lead to future interventions."

Dr. Hanania disclosed several relationships with a variety of pharmaceutical and medical manufacturers, including Genentech, GlaxoSmithKline* and Astra Zeneca.

Beyond GOLD: A tale of two COPD guidelines

Both address severity and comorbidity, but only one COPD guideline takes into account the latest research on phenotyping in chronic obstructive pulmonary disease.

"The GOLD guidelines do not include clinical phenotypes," said Dr. Joan Soriano, a presenter at the meeting. "But the Spanish ones do."

In fact, there is really only one area where the two documents overlap, said Dr. Soriano: how they define COPD, and even that is not the same. "They both mention the fundamental aspect, which is airflow limitation, and also that the mechanism involved is inflammation," he said. The GOLD definition, however, recognizes the importance of comorbidities, which the Spanish guidelines address the role of tobacco and symptomology.

GOLD (Global Initiative for Chronic Obstructive Lung Disease) is an organization of health care professionals from around the world. "I am not a member of GOLD," Dr. Soriano told the packed session.

The Spanish guidelines are issued by SEPAR, the Spanish Society for Pneumology and Thoracic Surgery. Dr. Soriano is the director of epidemiology and clinical research at the International Center of Advanced Respiratory Medicine (CIMERA) in Palma, Spain.

How the two approach diagnosis also differs. The Spanish guidelines begin with the general COPD diagnosis, then move to the characterization and phenotype, then move to the severity of the disease. They are more specific about age (over 35 years), and have lower limit of normal (LLN) values for persons aged over 70 years and less than 50 years. The GOLD guidelines do not address LLN.

To characterize the disease specifically, the Spanish guidelines address the existence of phenotypes, according to Dr. Soriano, beginning with determining the frequency of exacerbation the patient has per year, and then classifying them eventually into four types: mixed, chronic bronchitis, emphysema, and exacerbator. The GOLD guidelines do not mention phenotypes.

When it comes to the multidimensional assessment of COPD, "the GOLD guidelines lump the mild with the severe spirometry. This is very hard for me to understand," he said. Other classification divergence includes that the Spanish guidelines consider the BODE index.

Treatment in the two guidelines begins similarly, but vectors off from there. "Basically, we are looking at the same trials, so the initial treatments should be short-acting bronchodilators," Dr. Soriano said, but because phenotyping allows for more targeted treatment, the Spanish guidelines offer more detailed treatment options.

In a paper coauthored by Dr. Soriano earlier this year, specific treatment per phenotype included phosphodiesterase-4 inhibitors only for those with chronic bronchitis, inhaled corticosteroids for overlap COPD-asthma, and bronchodilators for infrequent exacerbators (Eur. Respir. J. 2013;41:1252-6).

In the end, the guidelines might not follow the same trajectory, but each has value, he said. "Whatever guidelines you choose, don’t go back and forth. Pick one and use them."

Dr. Soriano reported relationships with Novartis Spain, AstraZeneca, Pfizer, and several other pharmaceutical and medical manufacturers.

[email protected]

*CORRECTION, 2/20/2014: An earlier version of this story misstated the name of GlaxoSmithKline.

CHICAGO – Accurate phenotyping, in the ascendant over the last decade, equates with more effectively targeted treatments for chronic obstructive pulmonary disease, according to a proponent of personalized pulmonary medicine.

"We know that COPD is not the same, but right now we are treating these patients as though one size fits all," Dr. Nicola A. Hanania of the Baylor College of Medicine, Houston, said in a packed session on COPD at the annual meeting of the American College of Chest Physicians.

Because phenotypes describe differences in individuals, they should have relevance to clinically meaningful outcomes. "In COPD, that relates to symptoms, exacerbation, disease progression, response to therapy, and survival," he said.

Potential phenotypes that have been identified according to clinical, physiologic, and radiologic criteria include chronic bronchitis, asthma/COPD overlap, frequent exacerbator, radiologic CT, and persistent systemic inflammation.

Chronic bronchitis

Chronic bronchitis tends to occur more in younger people who smoke. It also is characterized by more wheezing and thicker airway walls. Data presented by Dr. Hanania also showed that this phenotype has more frequent acute exacerbations (Chest 2011;140:1107-8).

In one study, 290 subjects deemed chronically bronchitic – chronic cough and phlegm lasting 3 months of every year for 2 consecutive years – were compared with 771 subjects who were not chronically bronchitic. Investigators found that patients in the first group had more frequent exacerbations per patient: 1.21-1.62 vs. 0.63-1.12 (P < .027). The first group also reported more severe exacerbations: 26.6% vs. 20% (P < .024) (Chest 2011;140:626-33).

Asthma/COPD overlap

"This is a phenotype that deserves more attention. We all have patients where we scratch our head, ‘Is this asthma, or is this COPD?’ " said Dr. Hanania. "We don’t really know because these patients are notoriously excluded from both asthma and COPD studies." He cited estimates suggesting that 13%-20% of COPD patients overlap with asthma (Arch. Bronconeumol. 2012;48:331-7).

Proposed diagnostic criteria for the overlap syndrome phenotype may include two major criteria: marked response to bronchodilators (>15% and >400 mL in forced expiratory volume in 1 second [FEV₁]), history of asthma if patient is younger than 40 years, and sputum eosinophilia. Overlap also can be diagnosed by one major criterion and two of the following: response to bronchodilation at least two separate times (>12% and >200 mL in FEV₁), history of atopy, and increased total serum IgE. At this time, he said, these criteria are based on expert opinion and on data, "but the clinical implications, once we do the homework, is that these patients deserve to be on antibiotics and corticosteroids early on."

Frequent exacerbator

Defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as two or more exacerbations per year, the frequent exacerbator phenotype was explained in the ECLIPSE study (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints), Dr. Hanania said, which showed that, although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype (N. Engl. J. Med. 2010; 363:1128-38).

Frequent exacerbators have higher-stage COPD, more severe obstruction, and more hospitalizations, Dr. Hanania noted.

In addition, the ECLIPSE investigators found that, in 2,138 patients, frequent exacerbator types had an odds ratio of 5.72 of having had an exacerbation in the previous year

Although there other risk factors implicating this phenotype, "the most important question to ask the patient is whether they have had an exacerbation in the previous year," he said. Chronic cough is another factor.

The clinical benefit to identifying the frequent exacerbator, according to Dr. Hanania, is that this group has a greater range of comorbidities, including more inflammation, heightened viral susceptibility, and increased cardiovascular risk, among other susceptibilities.

Using CT for phenotyping

Noting that radiologic phenotyping in COPD is more advanced than in asthma at this time, Dr. Hanania said that quantitative and visual assessment of CT radiographs is "promising" and has helped identify COPD subphenotypes such as emphysema because of accurate assessment of lung inflation, wall thickness, and other factors.

Identifying patients with bronchiectasis, pulmonary arterial enlargement, and acute exacerbations in COPD is also possible with CT radiography, making it possible to predict the different outcomes in each situation. "The clinical implication is that these patients tend to have more frequent exacerbation, worse lung function, and infection," he said, noting that nascent research using imaging to determine biomarkers in functional small airways disease also is occurring.

Systemic inflammation

In the ECLIPSE study, 2,164 COPD patients had an odds ratio of 2.23 for being a current smoker and had higher levels of inflammation, as determined using biomarkers such as C-reactive protein, compared with 337 smokers without COPD and 245 nonsmokers. At the 3-year follow-up, this group with persistently higher inflammation also was classified as having significantly higher all-cause mortality than the group with less inflammation (13% vs. 2%); exacerbation rates in this group were also persistently higher (1.5 vs. 0.9) (PLoS ONE 2012;7:e37483).

Therapeutic implications

Coupling these phenotypes with molecular descriptions of mechanisms and their underlying pathologies can lead to accurate, personalized treatment of COPD. "Phenotypes without clear implications for prognosis and treatment are of little clinical use," Dr. Hanania said, noting that longitudinal studies to validate these phenotypes are necessary.

"Research can help identify mechanisms and courses in different phenotypes, including gender differences," he concluded. "Examining therapeutic responses to different phenotypes can lead to future interventions."

Dr. Hanania disclosed several relationships with a variety of pharmaceutical and medical manufacturers, including Genentech, GlaxoSmithKline* and Astra Zeneca.

Beyond GOLD: A tale of two COPD guidelines

Both address severity and comorbidity, but only one COPD guideline takes into account the latest research on phenotyping in chronic obstructive pulmonary disease.

"The GOLD guidelines do not include clinical phenotypes," said Dr. Joan Soriano, a presenter at the meeting. "But the Spanish ones do."

In fact, there is really only one area where the two documents overlap, said Dr. Soriano: how they define COPD, and even that is not the same. "They both mention the fundamental aspect, which is airflow limitation, and also that the mechanism involved is inflammation," he said. The GOLD definition, however, recognizes the importance of comorbidities, which the Spanish guidelines address the role of tobacco and symptomology.

GOLD (Global Initiative for Chronic Obstructive Lung Disease) is an organization of health care professionals from around the world. "I am not a member of GOLD," Dr. Soriano told the packed session.

The Spanish guidelines are issued by SEPAR, the Spanish Society for Pneumology and Thoracic Surgery. Dr. Soriano is the director of epidemiology and clinical research at the International Center of Advanced Respiratory Medicine (CIMERA) in Palma, Spain.

How the two approach diagnosis also differs. The Spanish guidelines begin with the general COPD diagnosis, then move to the characterization and phenotype, then move to the severity of the disease. They are more specific about age (over 35 years), and have lower limit of normal (LLN) values for persons aged over 70 years and less than 50 years. The GOLD guidelines do not address LLN.

To characterize the disease specifically, the Spanish guidelines address the existence of phenotypes, according to Dr. Soriano, beginning with determining the frequency of exacerbation the patient has per year, and then classifying them eventually into four types: mixed, chronic bronchitis, emphysema, and exacerbator. The GOLD guidelines do not mention phenotypes.

When it comes to the multidimensional assessment of COPD, "the GOLD guidelines lump the mild with the severe spirometry. This is very hard for me to understand," he said. Other classification divergence includes that the Spanish guidelines consider the BODE index.

Treatment in the two guidelines begins similarly, but vectors off from there. "Basically, we are looking at the same trials, so the initial treatments should be short-acting bronchodilators," Dr. Soriano said, but because phenotyping allows for more targeted treatment, the Spanish guidelines offer more detailed treatment options.

In a paper coauthored by Dr. Soriano earlier this year, specific treatment per phenotype included phosphodiesterase-4 inhibitors only for those with chronic bronchitis, inhaled corticosteroids for overlap COPD-asthma, and bronchodilators for infrequent exacerbators (Eur. Respir. J. 2013;41:1252-6).

In the end, the guidelines might not follow the same trajectory, but each has value, he said. "Whatever guidelines you choose, don’t go back and forth. Pick one and use them."

Dr. Soriano reported relationships with Novartis Spain, AstraZeneca, Pfizer, and several other pharmaceutical and medical manufacturers.

[email protected]

*CORRECTION, 2/20/2014: An earlier version of this story misstated the name of GlaxoSmithKline.

CHICAGO – Accurate phenotyping, in the ascendant over the last decade, equates with more effectively targeted treatments for chronic obstructive pulmonary disease, according to a proponent of personalized pulmonary medicine.

"We know that COPD is not the same, but right now we are treating these patients as though one size fits all," Dr. Nicola A. Hanania of the Baylor College of Medicine, Houston, said in a packed session on COPD at the annual meeting of the American College of Chest Physicians.

Because phenotypes describe differences in individuals, they should have relevance to clinically meaningful outcomes. "In COPD, that relates to symptoms, exacerbation, disease progression, response to therapy, and survival," he said.

Potential phenotypes that have been identified according to clinical, physiologic, and radiologic criteria include chronic bronchitis, asthma/COPD overlap, frequent exacerbator, radiologic CT, and persistent systemic inflammation.

Chronic bronchitis

Chronic bronchitis tends to occur more in younger people who smoke. It also is characterized by more wheezing and thicker airway walls. Data presented by Dr. Hanania also showed that this phenotype has more frequent acute exacerbations (Chest 2011;140:1107-8).

In one study, 290 subjects deemed chronically bronchitic – chronic cough and phlegm lasting 3 months of every year for 2 consecutive years – were compared with 771 subjects who were not chronically bronchitic. Investigators found that patients in the first group had more frequent exacerbations per patient: 1.21-1.62 vs. 0.63-1.12 (P < .027). The first group also reported more severe exacerbations: 26.6% vs. 20% (P < .024) (Chest 2011;140:626-33).

Asthma/COPD overlap

"This is a phenotype that deserves more attention. We all have patients where we scratch our head, ‘Is this asthma, or is this COPD?’ " said Dr. Hanania. "We don’t really know because these patients are notoriously excluded from both asthma and COPD studies." He cited estimates suggesting that 13%-20% of COPD patients overlap with asthma (Arch. Bronconeumol. 2012;48:331-7).

Proposed diagnostic criteria for the overlap syndrome phenotype may include two major criteria: marked response to bronchodilators (>15% and >400 mL in forced expiratory volume in 1 second [FEV₁]), history of asthma if patient is younger than 40 years, and sputum eosinophilia. Overlap also can be diagnosed by one major criterion and two of the following: response to bronchodilation at least two separate times (>12% and >200 mL in FEV₁), history of atopy, and increased total serum IgE. At this time, he said, these criteria are based on expert opinion and on data, "but the clinical implications, once we do the homework, is that these patients deserve to be on antibiotics and corticosteroids early on."

Frequent exacerbator

Defined in the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines as two or more exacerbations per year, the frequent exacerbator phenotype was explained in the ECLIPSE study (Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints), Dr. Hanania said, which showed that, although exacerbations become more frequent and more severe as COPD progresses, the rate at which they occur appears to reflect an independent susceptibility phenotype (N. Engl. J. Med. 2010; 363:1128-38).

Frequent exacerbators have higher-stage COPD, more severe obstruction, and more hospitalizations, Dr. Hanania noted.

In addition, the ECLIPSE investigators found that, in 2,138 patients, frequent exacerbator types had an odds ratio of 5.72 of having had an exacerbation in the previous year

Although there other risk factors implicating this phenotype, "the most important question to ask the patient is whether they have had an exacerbation in the previous year," he said. Chronic cough is another factor.

The clinical benefit to identifying the frequent exacerbator, according to Dr. Hanania, is that this group has a greater range of comorbidities, including more inflammation, heightened viral susceptibility, and increased cardiovascular risk, among other susceptibilities.

Using CT for phenotyping

Noting that radiologic phenotyping in COPD is more advanced than in asthma at this time, Dr. Hanania said that quantitative and visual assessment of CT radiographs is "promising" and has helped identify COPD subphenotypes such as emphysema because of accurate assessment of lung inflation, wall thickness, and other factors.

Identifying patients with bronchiectasis, pulmonary arterial enlargement, and acute exacerbations in COPD is also possible with CT radiography, making it possible to predict the different outcomes in each situation. "The clinical implication is that these patients tend to have more frequent exacerbation, worse lung function, and infection," he said, noting that nascent research using imaging to determine biomarkers in functional small airways disease also is occurring.

Systemic inflammation

In the ECLIPSE study, 2,164 COPD patients had an odds ratio of 2.23 for being a current smoker and had higher levels of inflammation, as determined using biomarkers such as C-reactive protein, compared with 337 smokers without COPD and 245 nonsmokers. At the 3-year follow-up, this group with persistently higher inflammation also was classified as having significantly higher all-cause mortality than the group with less inflammation (13% vs. 2%); exacerbation rates in this group were also persistently higher (1.5 vs. 0.9) (PLoS ONE 2012;7:e37483).

Therapeutic implications

Coupling these phenotypes with molecular descriptions of mechanisms and their underlying pathologies can lead to accurate, personalized treatment of COPD. "Phenotypes without clear implications for prognosis and treatment are of little clinical use," Dr. Hanania said, noting that longitudinal studies to validate these phenotypes are necessary.

"Research can help identify mechanisms and courses in different phenotypes, including gender differences," he concluded. "Examining therapeutic responses to different phenotypes can lead to future interventions."

Dr. Hanania disclosed several relationships with a variety of pharmaceutical and medical manufacturers, including Genentech, GlaxoSmithKline* and Astra Zeneca.

Beyond GOLD: A tale of two COPD guidelines

Both address severity and comorbidity, but only one COPD guideline takes into account the latest research on phenotyping in chronic obstructive pulmonary disease.

"The GOLD guidelines do not include clinical phenotypes," said Dr. Joan Soriano, a presenter at the meeting. "But the Spanish ones do."

In fact, there is really only one area where the two documents overlap, said Dr. Soriano: how they define COPD, and even that is not the same. "They both mention the fundamental aspect, which is airflow limitation, and also that the mechanism involved is inflammation," he said. The GOLD definition, however, recognizes the importance of comorbidities, which the Spanish guidelines address the role of tobacco and symptomology.

GOLD (Global Initiative for Chronic Obstructive Lung Disease) is an organization of health care professionals from around the world. "I am not a member of GOLD," Dr. Soriano told the packed session.

The Spanish guidelines are issued by SEPAR, the Spanish Society for Pneumology and Thoracic Surgery. Dr. Soriano is the director of epidemiology and clinical research at the International Center of Advanced Respiratory Medicine (CIMERA) in Palma, Spain.

How the two approach diagnosis also differs. The Spanish guidelines begin with the general COPD diagnosis, then move to the characterization and phenotype, then move to the severity of the disease. They are more specific about age (over 35 years), and have lower limit of normal (LLN) values for persons aged over 70 years and less than 50 years. The GOLD guidelines do not address LLN.

To characterize the disease specifically, the Spanish guidelines address the existence of phenotypes, according to Dr. Soriano, beginning with determining the frequency of exacerbation the patient has per year, and then classifying them eventually into four types: mixed, chronic bronchitis, emphysema, and exacerbator. The GOLD guidelines do not mention phenotypes.

When it comes to the multidimensional assessment of COPD, "the GOLD guidelines lump the mild with the severe spirometry. This is very hard for me to understand," he said. Other classification divergence includes that the Spanish guidelines consider the BODE index.

Treatment in the two guidelines begins similarly, but vectors off from there. "Basically, we are looking at the same trials, so the initial treatments should be short-acting bronchodilators," Dr. Soriano said, but because phenotyping allows for more targeted treatment, the Spanish guidelines offer more detailed treatment options.

In a paper coauthored by Dr. Soriano earlier this year, specific treatment per phenotype included phosphodiesterase-4 inhibitors only for those with chronic bronchitis, inhaled corticosteroids for overlap COPD-asthma, and bronchodilators for infrequent exacerbators (Eur. Respir. J. 2013;41:1252-6).

In the end, the guidelines might not follow the same trajectory, but each has value, he said. "Whatever guidelines you choose, don’t go back and forth. Pick one and use them."

Dr. Soriano reported relationships with Novartis Spain, AstraZeneca, Pfizer, and several other pharmaceutical and medical manufacturers.

[email protected]

*CORRECTION, 2/20/2014: An earlier version of this story misstated the name of GlaxoSmithKline.

CHICAGO – Low doses of opioids titrated based on patient ratings of breathing difficulty are effective in managing refractory dyspnea, according to Dr. Donald Mahler.

Because refractory dyspnea is a neuromechanical dissociation, treating more than the pulmonary system can be beneficial, Dr. Mahler said at the annual meeting of the American College of Chest Physicians. "We have targets for the lungs to relieve dyspnea, but we may also have potential targets in the central nervous system that may also provide benefit."

Referring to published data from two randomized controlled studies about the effect of naloxone on blocking opioid signals in patients with COPD who reported breathlessness and perceived "unpleasantness" of dyspnea after exercise, Dr. Mahler said that endogenous opioids modulate the perception of dyspnea; exogenous opioids could therefore do the same (Eur. Respir. J. 2009;33:771-7 and COPD 2011;8:160-6).

Opioid receptors in the limbic system have 100 times greater binding density in the bronchioles and alveolar walls. "That may play a role when thinking about a nebulized approach," said Dr. Mahler of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. The number of side effects, including constipation, was lower with this approach, he added.

Because opioids are known to decrease respiratory drive, there is a "presumable" effect on corollary discharge, which can lead to less perception of breathlessness, according to Dr. Mahler. Narcotics’ dulling effect on the perception of pain and anxiety might also contribute. "Maybe by relieving symptoms, there’s less anxiety as a result," said Dr. Mahler.

He addressed concerns over the "double effect" whereby opioids used to lessen symptoms might actually hasten death in a patient with refractory dyspnea, saying the studies "don’t really support that." Dr. Mahler cited data indicating that higher doses of benzodiazepines used in withdrawal of life-sustaining treatment were not associated with a decreased time from withdrawal of life support to death (CHEST 2004;126:286-93).

As for respiratory depression, Dr. Mahler said he had reviewed 11 studies and found only one report of any change in oxygen saturation after opioid administration.

In deciding whether a patient should be given opioid therapy, Dr. Mahler said physicians should be sure that standard therapies are inadequate and that the risk/benefit ratio favors trial treatment. Establishing treatment goals and confirming that the patient and/or the patient’s family are on board with a trial of opioid treatment is key, he added.

To determine titration, physicians should ask the patients to rate their breathing difficulty. "This is a critical part of the assessment," said Dr. Mahler, noting that the level of breathlessness determines the dose and duration of action.

If dyspnea is episodic, he said, "it doesn’t make sense to administer a long-acting opioid" and so an immediate-release or short-acting form should be considered. If it’s constant, sustained release may be effective, he said.

Dr. Mahler, who said his presentation was related to the off-label use of morphine only, said that the important thing is to "titrate the opioid to achieve the lower effective dose based on the patient’s rating of the dyspnea." Adding an anxiolytic could also be considered, he said. "It’s pretty straightforward that you should discontinue the opioid if there is an unsatisfactory response or if there is an adverse effect."

Dr. Mahler disclosed ties with numerous pharmaceutical manufacturers and other medical organizations, including GlaxoSmithKline, Novartis, and Sunovion.

[email protected]

CHICAGO – Low doses of opioids titrated based on patient ratings of breathing difficulty are effective in managing refractory dyspnea, according to Dr. Donald Mahler.

Because refractory dyspnea is a neuromechanical dissociation, treating more than the pulmonary system can be beneficial, Dr. Mahler said at the annual meeting of the American College of Chest Physicians. "We have targets for the lungs to relieve dyspnea, but we may also have potential targets in the central nervous system that may also provide benefit."

Referring to published data from two randomized controlled studies about the effect of naloxone on blocking opioid signals in patients with COPD who reported breathlessness and perceived "unpleasantness" of dyspnea after exercise, Dr. Mahler said that endogenous opioids modulate the perception of dyspnea; exogenous opioids could therefore do the same (Eur. Respir. J. 2009;33:771-7 and COPD 2011;8:160-6).

Opioid receptors in the limbic system have 100 times greater binding density in the bronchioles and alveolar walls. "That may play a role when thinking about a nebulized approach," said Dr. Mahler of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. The number of side effects, including constipation, was lower with this approach, he added.

Because opioids are known to decrease respiratory drive, there is a "presumable" effect on corollary discharge, which can lead to less perception of breathlessness, according to Dr. Mahler. Narcotics’ dulling effect on the perception of pain and anxiety might also contribute. "Maybe by relieving symptoms, there’s less anxiety as a result," said Dr. Mahler.

He addressed concerns over the "double effect" whereby opioids used to lessen symptoms might actually hasten death in a patient with refractory dyspnea, saying the studies "don’t really support that." Dr. Mahler cited data indicating that higher doses of benzodiazepines used in withdrawal of life-sustaining treatment were not associated with a decreased time from withdrawal of life support to death (CHEST 2004;126:286-93).

As for respiratory depression, Dr. Mahler said he had reviewed 11 studies and found only one report of any change in oxygen saturation after opioid administration.

In deciding whether a patient should be given opioid therapy, Dr. Mahler said physicians should be sure that standard therapies are inadequate and that the risk/benefit ratio favors trial treatment. Establishing treatment goals and confirming that the patient and/or the patient’s family are on board with a trial of opioid treatment is key, he added.

To determine titration, physicians should ask the patients to rate their breathing difficulty. "This is a critical part of the assessment," said Dr. Mahler, noting that the level of breathlessness determines the dose and duration of action.

If dyspnea is episodic, he said, "it doesn’t make sense to administer a long-acting opioid" and so an immediate-release or short-acting form should be considered. If it’s constant, sustained release may be effective, he said.

Dr. Mahler, who said his presentation was related to the off-label use of morphine only, said that the important thing is to "titrate the opioid to achieve the lower effective dose based on the patient’s rating of the dyspnea." Adding an anxiolytic could also be considered, he said. "It’s pretty straightforward that you should discontinue the opioid if there is an unsatisfactory response or if there is an adverse effect."

Dr. Mahler disclosed ties with numerous pharmaceutical manufacturers and other medical organizations, including GlaxoSmithKline, Novartis, and Sunovion.

[email protected]

CHICAGO – Low doses of opioids titrated based on patient ratings of breathing difficulty are effective in managing refractory dyspnea, according to Dr. Donald Mahler.

Because refractory dyspnea is a neuromechanical dissociation, treating more than the pulmonary system can be beneficial, Dr. Mahler said at the annual meeting of the American College of Chest Physicians. "We have targets for the lungs to relieve dyspnea, but we may also have potential targets in the central nervous system that may also provide benefit."

Referring to published data from two randomized controlled studies about the effect of naloxone on blocking opioid signals in patients with COPD who reported breathlessness and perceived "unpleasantness" of dyspnea after exercise, Dr. Mahler said that endogenous opioids modulate the perception of dyspnea; exogenous opioids could therefore do the same (Eur. Respir. J. 2009;33:771-7 and COPD 2011;8:160-6).

Opioid receptors in the limbic system have 100 times greater binding density in the bronchioles and alveolar walls. "That may play a role when thinking about a nebulized approach," said Dr. Mahler of Dartmouth-Hitchcock Medical Center, Lebanon, N.H. The number of side effects, including constipation, was lower with this approach, he added.

Because opioids are known to decrease respiratory drive, there is a "presumable" effect on corollary discharge, which can lead to less perception of breathlessness, according to Dr. Mahler. Narcotics’ dulling effect on the perception of pain and anxiety might also contribute. "Maybe by relieving symptoms, there’s less anxiety as a result," said Dr. Mahler.

He addressed concerns over the "double effect" whereby opioids used to lessen symptoms might actually hasten death in a patient with refractory dyspnea, saying the studies "don’t really support that." Dr. Mahler cited data indicating that higher doses of benzodiazepines used in withdrawal of life-sustaining treatment were not associated with a decreased time from withdrawal of life support to death (CHEST 2004;126:286-93).

As for respiratory depression, Dr. Mahler said he had reviewed 11 studies and found only one report of any change in oxygen saturation after opioid administration.

In deciding whether a patient should be given opioid therapy, Dr. Mahler said physicians should be sure that standard therapies are inadequate and that the risk/benefit ratio favors trial treatment. Establishing treatment goals and confirming that the patient and/or the patient’s family are on board with a trial of opioid treatment is key, he added.

To determine titration, physicians should ask the patients to rate their breathing difficulty. "This is a critical part of the assessment," said Dr. Mahler, noting that the level of breathlessness determines the dose and duration of action.

If dyspnea is episodic, he said, "it doesn’t make sense to administer a long-acting opioid" and so an immediate-release or short-acting form should be considered. If it’s constant, sustained release may be effective, he said.

Dr. Mahler, who said his presentation was related to the off-label use of morphine only, said that the important thing is to "titrate the opioid to achieve the lower effective dose based on the patient’s rating of the dyspnea." Adding an anxiolytic could also be considered, he said. "It’s pretty straightforward that you should discontinue the opioid if there is an unsatisfactory response or if there is an adverse effect."

Dr. Mahler disclosed ties with numerous pharmaceutical manufacturers and other medical organizations, including GlaxoSmithKline, Novartis, and Sunovion.

[email protected]

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

ATLANTA – The addition of a comprehensive discharge protocol checklist and follow-up contact for bariatric surgery patients resulted in slightly longer hospital lengths of stay but significant reductions in readmissions.

"I feel the small amount of extra length of stay really supports the 46% overall decrease in readmissions. That’s pretty good," Sharon A. Krzyzanowski, RN, said at Obesity Week, presented by the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

To determine if the addition of discharge protocols had helped their bariatric surgery facility reduce the rate of 30-day readmissions, Ms. Krzyzanowski and her colleagues at the Celebration Health Florida Hospital in Orlando retrospectively analyzed patient data both pre- and post-implementation.

They compared the data of 224 Roux-en-Y gastric bypass (RYGB) patients before implementation of the protocols to 242 post-protocol RYGB patients; 125 pre-protocol laparoscopic gastric sleeve (LGS) patients to 178 post-protocol patients; and 100 gastric band patients admitted before the center had the protocols in place, vs. 50 such patients after the protocols.

Discharge protocols stipulated that patients must not be in extreme pain and were able to tolerate their pain medication; that they were not nauseous and were able to tolerate their nausea medication; and that they were able to comfortably drink a minimum of 30 ounces on the day of discharge. Respiratory values also had to be at "status quo," said Ms. Krzyzanowski. If patients did not meet any of those protocols, they were not discharged that day.

The second portion of the protocol that the researchers examined was post-discharge patient follow-up, either by phone or by e-mail. Under the protocol, a nurse contacted patients to discuss mental status, medications, postoperative regime, and any other questions the patients might have.

Patient readmissions were sorted according to reasons of technical concern, such as organ injury or leak; physical issues, such as an infection or a thromboembolic event; or general malaise, such as dehydration or benign abdominal pain.

The investigators determined that readmission rates in RYGB patients declined by 38.3%; 34.7% in LGS patients; and 100% in gastric banding patients.

The hospital length of stay in the RYGB group went from a pre-protocol average of 2.12 days to 2.50 days post protocol; in the LGS group, the average length of stay went from 1.93 to 2.10 average days.

The investigators found there was an overall reduction in readmissions of 46%. Readmissions associated with malaise were reduced from 6.5% to 2.9%; those associated with physical concerns were reduced from 2.9% to 2.1%, said Ms. Krzyzanowski. Technical readmissions did not change significantly.

During the question-and-answer portion of the presentation, Ms. Krzyzanowski said in response to a query about reimbursements for keeping patients an extra day, "As long as it’s documented why the patient is staying, insurance will review that and they will be fine. We have not had anybody denied for a third day."

Ms. Krzyzanowski, Dr. Kim, and Dr. Buffington reported no relevant disclosures.

[email protected]

Adults who don’t show symptoms of, or have risk factors for, early chronic kidney disease should not be screened for it, according to new guidelines from the American College of Physicians.

But the ACP’s recommendation prompted the American Society of Nephrology to counter with its own strong recommendation in favor of kidney disease screening regardless of a patient’s risk factors.

"There is no evidence that obtaining a ‘baseline creatinine’ level, or screening for renal dysfunction in asymptomatic individuals with no risk factors for kidney disease, improves outcomes for patients," said ACP President Molly Cooke in an interview.

The clinical practice guidelines are the first issued by the ACP for the screening, monitoring, and treatment of stage 1-3 chronic kidney disease in adults. Major risk factors for CKD in adults include diabetes, hypertension, and cardiovascular disease.

The ACP published the guidelines online in Annals of Internal Medicine 2013 Oct. 22 [doi:10.7326/0003-4819-159-12-201312170-00726]).

The college’s Clinical Guidelines Committee used Medline and Cochrane databases to systematically review all relevant data published between 1985 and November 2011. Outcomes assessed for the guidelines included all-cause mortality, cardiovascular events and disease, composite renal and vascular outcomes, end-stage renal disease, quality of life, physical function, and activities of daily living.

The investigators determined that there was not enough evidence to evaluate the benefits and harms of screening for early CKD, and so they recommended that clinicians not perform it.

The ACP specifically recommended against proteinuria testing in adults with or without diabetes and who are currently taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). That recommendation was a “reminder to physicians not to do tests that will not change patient management,” Dr. Cooke said. ACE inhibitors or ARBs are already the treatment for microalbuminuria, a form of low-grade proteinuria. “There is no evidence that monitoring proteinuria to assess the effects of pharmacological hypertension management produces better outcomes,” she added.

ASN: No screen? No way!

The ACP’s recommendations spurred an immediate rebuke from the American Society of Nephrology.

“Early detection is the key to preventing patients from progressing to relying on dialysis to stay alive,” Dr. Tod Ibrahim, the ASN’s executive director, said in a statement. “ASN and its nearly 15,000 members – all of whom are experts in kidney disease – are disappointed by ACP’s irresponsible recommendation.”

The lack of evidence on the benefits and harms of early CKD screening is precisely why physicians should test for early-stage CKD, according to ASN President Bruce Molitoris.

“One of the problems with CKD is we don’t have effective mechanisms to detect it early,” he said in an interview. “What we do have is screening for proteinuria, which is a very simple, extremely inexpensive test that can give great insight.”

As for proteinuria testing in adults taking ACE inhibitors or ARBs, there might be a more nuanced benefit, Dr. Molitoris explained. “It’s a little bit more incentive to increase compliance in a patient who is taking a medication for hypertension if you tell them they’re getting progressive kidney disease if they don’t control their blood pressure,” he said. “Not all patients with hypertension are started out on those first-line drugs,” he added.

The ACP endorses treating patients who have hypertension or stage 1-3 CKD with ACE inhibitors or ARBs, as well as giving patients with early CKD appropriate statin therapy to manage elevated levels of low-density lipoprotein. However, the college calls additional screening and treatment largely superfluous.

“For doctors who have been using a thiazide diuretic or a beta-blocker as their initial antihypertensive of choice, this guideline should change their practice,” said Dr. Cooke. However, because many practice “report cards” call for an annual urine microalbumin test in diabetic patients, many physicians perform the test on patients who are already on an ACE inhibitor or an ARB, she said.

“This guideline should prompt them to respond ‘test not indicated’ when it is requested,” Dr. Cooke said.

The ACP found no significant differences in outcomes between ACE inhibitors and ARBs, although it did note that the risk of adverse effects (cough, hyperkalemia, hypotension, and dialysis) significantly increased in combined ACE inhibitor and ARB therapy.

Meanwhile, the National Kidney Foundation recommends that anyone with diabetes, hypertension, cardiovascular disease, age over 60, or a family history of kidney failure have a blood test to estimate their glomerular filtration rate (GFR) and a urine test for proteinuria.

“The ACP guidelines looked at the clinical outcomes of CKD very differently than our guidelines did,” cautioned Sean Roach, spokesperson for the NKF, in an e-mail. The ACP put “CKD stages 1-3 together when they have markedly different risks of adverse outcomes, and [didn’t take] into account all of the patient safety issues that arise due to ignorance of a patient’s level of kidney function.

“We acknowledge that there have been no randomized trials of CKD screening,” Mr. Roach noted, “but our recommendations are based on extensive analysis of observational trials, clinical trials of diabetes and antihypertensive drugs, and clinical experience.”

Critics question CKD criteria

A recent U.S. Preventive Services Task Force (USPSTF) report took a position similar to the ACP’s, stating there is currently insufficient evidence to recommend general population-based screening. That report noted that although early screening could affect outcomes for people already diagnosed with conditions such as diabetes or hypertension, no evidence existed to show the benefits of early treatment in people without these risk factors.

The ASN swiftly responded. "We sent [the USPSTF] a letter asking them to reconsider," said Dr. Molitoris. "That was within the last 6 months. They came back with a ‘high recommendation’ for collecting more data to analyze the cost effectiveness of screening."

In 2002, the NFK-sponsored Kidney Disease: Improving Global Outcomes (KDIGO) released landmark guidelines on CKD. In a 2012 guidelines update, KDIGO kept the criteria it established in 2002 for CKD, including diagnostic thresholds of a GFR less than 60 mL/min per 1.73 m² and an albumin/creatinine ratio (ACR) of at least 30 mg/g. And it maintained its five-stage CKD classification system.

But it expanded the existing five-stage classification system to include two subcategories of grade 3 GFR categories – G3a, with a GFR of 45-59; and G3b, with a GFR of 30-44 – and three additional categories of albuminuria (Ann. Intern. Med. 2013;158:825-30).

Those CKD criteria raised eyebrows not just at the ACP, but also with some evidence-based medicine scholars. In an analysis published online earlier this year in BMJ, Dr. Roy Moynihan of the Centre for Research in Evidence-Based Practice, Robina, Australia, cited data that the GFR value used by KDIGO to determine early CKD falls within the normal range for men over age 60 and women over age 50.

By "labeling so many people at low risk of symptoms as having chronic kidney disease, the new definition axiomatically produces overdiagnosis," Dr. Moynihan and his colleagues cautioned (BMJ 2013;347:f4298).

Prior to the 2002 publication of the KDIGO criteria for CKD, according to Dr. Moynihan, the incidence rate for CKD in U.S. adults was estimated to be around 1.7%. After 2002, using the KDIGO criteria, it rose to 1 in 8 adults, or about 14% of the adult population.

"The controversial aspect around that is, at what point as your GFR decreases does it become abnormal?" cautioned Dr. Molitoris. "If you have a reduced GFR, and proteinuria, we know that’s abnormal. That’s why the screening for proteinuria is so important. If you just have a reduced GFR to a certain extent, it may be a normal aging process. That’s the European perspective, and I think they have a point there."

‘Different worldview’

While the ACP guidelines for CKD refer to the KDIGO criteria as their counterpoint, Dr. Cooke said she did not know what motivated KDIGO to expand the criteria. She suggested it might be the "different worldview" phenomenon that often occurs between subspecialists and generalists.

"It’s tempting to say, ‘Let’s just test everybody’s creatinine,’ " Dr. Cooke noted. "But it’s just like with prostate cancer screening: Once you start to factor in all the costs – and not just the money – of testing on that broad of a scale, it doesn’t [add up]."

But Dr. Molitoris countered that CKD screening is more akin to testing for cardiovascular disease.

"One could make the comparison to checking for cholesterol, only that’s invasive – that’s drawing blood," he said. "This is just taking urine, and yet, how many people do we screen for cholesterol? There is no risk in doing the proteinuria test. You collect the urine, put a stick into it, and read it. If it’s positive, then you will follow up with a more sophisticated chemical test." He also noted that false positives in proteinuria tests are rare.

The ACP guidelines offer physicians what it calls "high-value care advice": Skip early CKD screening, because in the absence of evidence that screening improves clinical outcomes, "testing will add costs, owing to both the screening test and additional follow-up tests (including those resulting from false-positive findings), increased medical visits, and costs of keeping or obtaining health insurance."

Dr. Molitoris disagreed, citing "the aggressive and silent nature" of kidney disease in all its stages.

"You have to think of the cost analysis as how many screenings you can do for the cost of one patient who goes on to need dialysis. That costs between $80,000 and $90,000 a year to maintain for every year [a patient is] on it," Dr. Molitoris explained. "You can do a lot of screening on that."

Dr. Cooke said the ACP was calling for a "middle ground" to bring the discussion back to what is best for the patient, not the practitioner.

"We are saying that unless the patient has a reason for you to be concerned, other than the fact that they are a human being, there is no reason to screen for CKD every year," she explained. "There is no evidence that diagnosing the average person on the street as stage 1 or 2 [CKD] does them any good if they don’t have any risk factors."

The American College of Physicians funded the guidelines. The guidelines’ authors had no relevant disclosures.

[email protected]

Adults who don’t show symptoms of, or have risk factors for, early chronic kidney disease should not be screened for it, according to new guidelines from the American College of Physicians.

But the ACP’s recommendation prompted the American Society of Nephrology to counter with its own strong recommendation in favor of kidney disease screening regardless of a patient’s risk factors.

"There is no evidence that obtaining a ‘baseline creatinine’ level, or screening for renal dysfunction in asymptomatic individuals with no risk factors for kidney disease, improves outcomes for patients," said ACP President Molly Cooke in an interview.

The clinical practice guidelines are the first issued by the ACP for the screening, monitoring, and treatment of stage 1-3 chronic kidney disease in adults. Major risk factors for CKD in adults include diabetes, hypertension, and cardiovascular disease.

The ACP published the guidelines online in Annals of Internal Medicine 2013 Oct. 22 [doi:10.7326/0003-4819-159-12-201312170-00726]).

The college’s Clinical Guidelines Committee used Medline and Cochrane databases to systematically review all relevant data published between 1985 and November 2011. Outcomes assessed for the guidelines included all-cause mortality, cardiovascular events and disease, composite renal and vascular outcomes, end-stage renal disease, quality of life, physical function, and activities of daily living.

The investigators determined that there was not enough evidence to evaluate the benefits and harms of screening for early CKD, and so they recommended that clinicians not perform it.

The ACP specifically recommended against proteinuria testing in adults with or without diabetes and who are currently taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). That recommendation was a “reminder to physicians not to do tests that will not change patient management,” Dr. Cooke said. ACE inhibitors or ARBs are already the treatment for microalbuminuria, a form of low-grade proteinuria. “There is no evidence that monitoring proteinuria to assess the effects of pharmacological hypertension management produces better outcomes,” she added.

ASN: No screen? No way!

The ACP’s recommendations spurred an immediate rebuke from the American Society of Nephrology.

“Early detection is the key to preventing patients from progressing to relying on dialysis to stay alive,” Dr. Tod Ibrahim, the ASN’s executive director, said in a statement. “ASN and its nearly 15,000 members – all of whom are experts in kidney disease – are disappointed by ACP’s irresponsible recommendation.”

The lack of evidence on the benefits and harms of early CKD screening is precisely why physicians should test for early-stage CKD, according to ASN President Bruce Molitoris.

“One of the problems with CKD is we don’t have effective mechanisms to detect it early,” he said in an interview. “What we do have is screening for proteinuria, which is a very simple, extremely inexpensive test that can give great insight.”

As for proteinuria testing in adults taking ACE inhibitors or ARBs, there might be a more nuanced benefit, Dr. Molitoris explained. “It’s a little bit more incentive to increase compliance in a patient who is taking a medication for hypertension if you tell them they’re getting progressive kidney disease if they don’t control their blood pressure,” he said. “Not all patients with hypertension are started out on those first-line drugs,” he added.

The ACP endorses treating patients who have hypertension or stage 1-3 CKD with ACE inhibitors or ARBs, as well as giving patients with early CKD appropriate statin therapy to manage elevated levels of low-density lipoprotein. However, the college calls additional screening and treatment largely superfluous.

“For doctors who have been using a thiazide diuretic or a beta-blocker as their initial antihypertensive of choice, this guideline should change their practice,” said Dr. Cooke. However, because many practice “report cards” call for an annual urine microalbumin test in diabetic patients, many physicians perform the test on patients who are already on an ACE inhibitor or an ARB, she said.

“This guideline should prompt them to respond ‘test not indicated’ when it is requested,” Dr. Cooke said.

The ACP found no significant differences in outcomes between ACE inhibitors and ARBs, although it did note that the risk of adverse effects (cough, hyperkalemia, hypotension, and dialysis) significantly increased in combined ACE inhibitor and ARB therapy.

Meanwhile, the National Kidney Foundation recommends that anyone with diabetes, hypertension, cardiovascular disease, age over 60, or a family history of kidney failure have a blood test to estimate their glomerular filtration rate (GFR) and a urine test for proteinuria.

“The ACP guidelines looked at the clinical outcomes of CKD very differently than our guidelines did,” cautioned Sean Roach, spokesperson for the NKF, in an e-mail. The ACP put “CKD stages 1-3 together when they have markedly different risks of adverse outcomes, and [didn’t take] into account all of the patient safety issues that arise due to ignorance of a patient’s level of kidney function.

“We acknowledge that there have been no randomized trials of CKD screening,” Mr. Roach noted, “but our recommendations are based on extensive analysis of observational trials, clinical trials of diabetes and antihypertensive drugs, and clinical experience.”

Critics question CKD criteria

A recent U.S. Preventive Services Task Force (USPSTF) report took a position similar to the ACP’s, stating there is currently insufficient evidence to recommend general population-based screening. That report noted that although early screening could affect outcomes for people already diagnosed with conditions such as diabetes or hypertension, no evidence existed to show the benefits of early treatment in people without these risk factors.

The ASN swiftly responded. "We sent [the USPSTF] a letter asking them to reconsider," said Dr. Molitoris. "That was within the last 6 months. They came back with a ‘high recommendation’ for collecting more data to analyze the cost effectiveness of screening."

In 2002, the NFK-sponsored Kidney Disease: Improving Global Outcomes (KDIGO) released landmark guidelines on CKD. In a 2012 guidelines update, KDIGO kept the criteria it established in 2002 for CKD, including diagnostic thresholds of a GFR less than 60 mL/min per 1.73 m² and an albumin/creatinine ratio (ACR) of at least 30 mg/g. And it maintained its five-stage CKD classification system.

But it expanded the existing five-stage classification system to include two subcategories of grade 3 GFR categories – G3a, with a GFR of 45-59; and G3b, with a GFR of 30-44 – and three additional categories of albuminuria (Ann. Intern. Med. 2013;158:825-30).

Those CKD criteria raised eyebrows not just at the ACP, but also with some evidence-based medicine scholars. In an analysis published online earlier this year in BMJ, Dr. Roy Moynihan of the Centre for Research in Evidence-Based Practice, Robina, Australia, cited data that the GFR value used by KDIGO to determine early CKD falls within the normal range for men over age 60 and women over age 50.

By "labeling so many people at low risk of symptoms as having chronic kidney disease, the new definition axiomatically produces overdiagnosis," Dr. Moynihan and his colleagues cautioned (BMJ 2013;347:f4298).

Prior to the 2002 publication of the KDIGO criteria for CKD, according to Dr. Moynihan, the incidence rate for CKD in U.S. adults was estimated to be around 1.7%. After 2002, using the KDIGO criteria, it rose to 1 in 8 adults, or about 14% of the adult population.

"The controversial aspect around that is, at what point as your GFR decreases does it become abnormal?" cautioned Dr. Molitoris. "If you have a reduced GFR, and proteinuria, we know that’s abnormal. That’s why the screening for proteinuria is so important. If you just have a reduced GFR to a certain extent, it may be a normal aging process. That’s the European perspective, and I think they have a point there."

‘Different worldview’

While the ACP guidelines for CKD refer to the KDIGO criteria as their counterpoint, Dr. Cooke said she did not know what motivated KDIGO to expand the criteria. She suggested it might be the "different worldview" phenomenon that often occurs between subspecialists and generalists.

"It’s tempting to say, ‘Let’s just test everybody’s creatinine,’ " Dr. Cooke noted. "But it’s just like with prostate cancer screening: Once you start to factor in all the costs – and not just the money – of testing on that broad of a scale, it doesn’t [add up]."

But Dr. Molitoris countered that CKD screening is more akin to testing for cardiovascular disease.

"One could make the comparison to checking for cholesterol, only that’s invasive – that’s drawing blood," he said. "This is just taking urine, and yet, how many people do we screen for cholesterol? There is no risk in doing the proteinuria test. You collect the urine, put a stick into it, and read it. If it’s positive, then you will follow up with a more sophisticated chemical test." He also noted that false positives in proteinuria tests are rare.

The ACP guidelines offer physicians what it calls "high-value care advice": Skip early CKD screening, because in the absence of evidence that screening improves clinical outcomes, "testing will add costs, owing to both the screening test and additional follow-up tests (including those resulting from false-positive findings), increased medical visits, and costs of keeping or obtaining health insurance."

Dr. Molitoris disagreed, citing "the aggressive and silent nature" of kidney disease in all its stages.

"You have to think of the cost analysis as how many screenings you can do for the cost of one patient who goes on to need dialysis. That costs between $80,000 and $90,000 a year to maintain for every year [a patient is] on it," Dr. Molitoris explained. "You can do a lot of screening on that."

Dr. Cooke said the ACP was calling for a "middle ground" to bring the discussion back to what is best for the patient, not the practitioner.

"We are saying that unless the patient has a reason for you to be concerned, other than the fact that they are a human being, there is no reason to screen for CKD every year," she explained. "There is no evidence that diagnosing the average person on the street as stage 1 or 2 [CKD] does them any good if they don’t have any risk factors."

The American College of Physicians funded the guidelines. The guidelines’ authors had no relevant disclosures.

[email protected]

Adults who don’t show symptoms of, or have risk factors for, early chronic kidney disease should not be screened for it, according to new guidelines from the American College of Physicians.

But the ACP’s recommendation prompted the American Society of Nephrology to counter with its own strong recommendation in favor of kidney disease screening regardless of a patient’s risk factors.

"There is no evidence that obtaining a ‘baseline creatinine’ level, or screening for renal dysfunction in asymptomatic individuals with no risk factors for kidney disease, improves outcomes for patients," said ACP President Molly Cooke in an interview.

The clinical practice guidelines are the first issued by the ACP for the screening, monitoring, and treatment of stage 1-3 chronic kidney disease in adults. Major risk factors for CKD in adults include diabetes, hypertension, and cardiovascular disease.

The ACP published the guidelines online in Annals of Internal Medicine 2013 Oct. 22 [doi:10.7326/0003-4819-159-12-201312170-00726]).

The college’s Clinical Guidelines Committee used Medline and Cochrane databases to systematically review all relevant data published between 1985 and November 2011. Outcomes assessed for the guidelines included all-cause mortality, cardiovascular events and disease, composite renal and vascular outcomes, end-stage renal disease, quality of life, physical function, and activities of daily living.

The investigators determined that there was not enough evidence to evaluate the benefits and harms of screening for early CKD, and so they recommended that clinicians not perform it.

The ACP specifically recommended against proteinuria testing in adults with or without diabetes and who are currently taking angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs). That recommendation was a “reminder to physicians not to do tests that will not change patient management,” Dr. Cooke said. ACE inhibitors or ARBs are already the treatment for microalbuminuria, a form of low-grade proteinuria. “There is no evidence that monitoring proteinuria to assess the effects of pharmacological hypertension management produces better outcomes,” she added.

ASN: No screen? No way!

The ACP’s recommendations spurred an immediate rebuke from the American Society of Nephrology.

“Early detection is the key to preventing patients from progressing to relying on dialysis to stay alive,” Dr. Tod Ibrahim, the ASN’s executive director, said in a statement. “ASN and its nearly 15,000 members – all of whom are experts in kidney disease – are disappointed by ACP’s irresponsible recommendation.”

The lack of evidence on the benefits and harms of early CKD screening is precisely why physicians should test for early-stage CKD, according to ASN President Bruce Molitoris.

“One of the problems with CKD is we don’t have effective mechanisms to detect it early,” he said in an interview. “What we do have is screening for proteinuria, which is a very simple, extremely inexpensive test that can give great insight.”

As for proteinuria testing in adults taking ACE inhibitors or ARBs, there might be a more nuanced benefit, Dr. Molitoris explained. “It’s a little bit more incentive to increase compliance in a patient who is taking a medication for hypertension if you tell them they’re getting progressive kidney disease if they don’t control their blood pressure,” he said. “Not all patients with hypertension are started out on those first-line drugs,” he added.

The ACP endorses treating patients who have hypertension or stage 1-3 CKD with ACE inhibitors or ARBs, as well as giving patients with early CKD appropriate statin therapy to manage elevated levels of low-density lipoprotein. However, the college calls additional screening and treatment largely superfluous.

“For doctors who have been using a thiazide diuretic or a beta-blocker as their initial antihypertensive of choice, this guideline should change their practice,” said Dr. Cooke. However, because many practice “report cards” call for an annual urine microalbumin test in diabetic patients, many physicians perform the test on patients who are already on an ACE inhibitor or an ARB, she said.

“This guideline should prompt them to respond ‘test not indicated’ when it is requested,” Dr. Cooke said.

The ACP found no significant differences in outcomes between ACE inhibitors and ARBs, although it did note that the risk of adverse effects (cough, hyperkalemia, hypotension, and dialysis) significantly increased in combined ACE inhibitor and ARB therapy.

Meanwhile, the National Kidney Foundation recommends that anyone with diabetes, hypertension, cardiovascular disease, age over 60, or a family history of kidney failure have a blood test to estimate their glomerular filtration rate (GFR) and a urine test for proteinuria.

“The ACP guidelines looked at the clinical outcomes of CKD very differently than our guidelines did,” cautioned Sean Roach, spokesperson for the NKF, in an e-mail. The ACP put “CKD stages 1-3 together when they have markedly different risks of adverse outcomes, and [didn’t take] into account all of the patient safety issues that arise due to ignorance of a patient’s level of kidney function.

“We acknowledge that there have been no randomized trials of CKD screening,” Mr. Roach noted, “but our recommendations are based on extensive analysis of observational trials, clinical trials of diabetes and antihypertensive drugs, and clinical experience.”

Critics question CKD criteria

A recent U.S. Preventive Services Task Force (USPSTF) report took a position similar to the ACP’s, stating there is currently insufficient evidence to recommend general population-based screening. That report noted that although early screening could affect outcomes for people already diagnosed with conditions such as diabetes or hypertension, no evidence existed to show the benefits of early treatment in people without these risk factors.

The ASN swiftly responded. "We sent [the USPSTF] a letter asking them to reconsider," said Dr. Molitoris. "That was within the last 6 months. They came back with a ‘high recommendation’ for collecting more data to analyze the cost effectiveness of screening."

In 2002, the NFK-sponsored Kidney Disease: Improving Global Outcomes (KDIGO) released landmark guidelines on CKD. In a 2012 guidelines update, KDIGO kept the criteria it established in 2002 for CKD, including diagnostic thresholds of a GFR less than 60 mL/min per 1.73 m² and an albumin/creatinine ratio (ACR) of at least 30 mg/g. And it maintained its five-stage CKD classification system.

But it expanded the existing five-stage classification system to include two subcategories of grade 3 GFR categories – G3a, with a GFR of 45-59; and G3b, with a GFR of 30-44 – and three additional categories of albuminuria (Ann. Intern. Med. 2013;158:825-30).

Those CKD criteria raised eyebrows not just at the ACP, but also with some evidence-based medicine scholars. In an analysis published online earlier this year in BMJ, Dr. Roy Moynihan of the Centre for Research in Evidence-Based Practice, Robina, Australia, cited data that the GFR value used by KDIGO to determine early CKD falls within the normal range for men over age 60 and women over age 50.

By "labeling so many people at low risk of symptoms as having chronic kidney disease, the new definition axiomatically produces overdiagnosis," Dr. Moynihan and his colleagues cautioned (BMJ 2013;347:f4298).

Prior to the 2002 publication of the KDIGO criteria for CKD, according to Dr. Moynihan, the incidence rate for CKD in U.S. adults was estimated to be around 1.7%. After 2002, using the KDIGO criteria, it rose to 1 in 8 adults, or about 14% of the adult population.

"The controversial aspect around that is, at what point as your GFR decreases does it become abnormal?" cautioned Dr. Molitoris. "If you have a reduced GFR, and proteinuria, we know that’s abnormal. That’s why the screening for proteinuria is so important. If you just have a reduced GFR to a certain extent, it may be a normal aging process. That’s the European perspective, and I think they have a point there."

‘Different worldview’

While the ACP guidelines for CKD refer to the KDIGO criteria as their counterpoint, Dr. Cooke said she did not know what motivated KDIGO to expand the criteria. She suggested it might be the "different worldview" phenomenon that often occurs between subspecialists and generalists.

"It’s tempting to say, ‘Let’s just test everybody’s creatinine,’ " Dr. Cooke noted. "But it’s just like with prostate cancer screening: Once you start to factor in all the costs – and not just the money – of testing on that broad of a scale, it doesn’t [add up]."

But Dr. Molitoris countered that CKD screening is more akin to testing for cardiovascular disease.

"One could make the comparison to checking for cholesterol, only that’s invasive – that’s drawing blood," he said. "This is just taking urine, and yet, how many people do we screen for cholesterol? There is no risk in doing the proteinuria test. You collect the urine, put a stick into it, and read it. If it’s positive, then you will follow up with a more sophisticated chemical test." He also noted that false positives in proteinuria tests are rare.

The ACP guidelines offer physicians what it calls "high-value care advice": Skip early CKD screening, because in the absence of evidence that screening improves clinical outcomes, "testing will add costs, owing to both the screening test and additional follow-up tests (including those resulting from false-positive findings), increased medical visits, and costs of keeping or obtaining health insurance."

Dr. Molitoris disagreed, citing "the aggressive and silent nature" of kidney disease in all its stages.

"You have to think of the cost analysis as how many screenings you can do for the cost of one patient who goes on to need dialysis. That costs between $80,000 and $90,000 a year to maintain for every year [a patient is] on it," Dr. Molitoris explained. "You can do a lot of screening on that."

Dr. Cooke said the ACP was calling for a "middle ground" to bring the discussion back to what is best for the patient, not the practitioner.

"We are saying that unless the patient has a reason for you to be concerned, other than the fact that they are a human being, there is no reason to screen for CKD every year," she explained. "There is no evidence that diagnosing the average person on the street as stage 1 or 2 [CKD] does them any good if they don’t have any risk factors."

The American College of Physicians funded the guidelines. The guidelines’ authors had no relevant disclosures.

[email protected]

ATLANTA – The thought of bariatric surgery for obese pediatric patients makes Dr. Sarah Barlow, lead author of recommendations on the prevention, assessment, and treatment of obesity, uncomfortable.

"I have a little bit of a love/hate relationship with bariatric surgery," said Dr. Barlow. For some young people, the procedure can be life altering, "but there is a big jump [from] a behavior-based intervention to bariatric surgery," she said at the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Her reservation hinges upon the question that runs specialtywide for physicians who treat obesity: Just who "owns" the disease?

"Is this a health care problem that needs to be taken care of by doctors, or is this a community problem, and this is all about prevention?" was Dr. Barlow’s rhetorical question. "There are a lot of barriers. There are a lot of players, but not really any reimbursement," she said.

In the case of bariatric surgery for children, Dr. Barlow said she wonders whether obese youngsters are sometimes pushed into having medical treatments in order to skirt reimbursement issues, or because it’s just one more item to tick off for guideline-laden office practitioners who have limited time with patients but an ever-increasing list of precautionary pearls they are meant to dispense?

"The hate part of my relationship is that the bariatric results are so wonderful that I feel people aren’t putting resources into intensive [nonsurgical] treatments," said Dr. Barlow. "I think it’s an option that should be on the table, but I think that medication and behavioral interventions and other tertiary care type interventions should be considered," she noted, adding that bariatric surgery is certainly not the answer to severe obesity in a 10-year-old.

Dr. Barlow is the lead author of the oft-cited Expert Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity, published by the American Academy of Pediatrics in 2007, and jointly sponsored by the American Medical Association, the U.S. Health Resources and Service Administration, and the Centers for Disease Control and Prevention. The recommendations emphasize behavior modifications with techniques such as motivational interviewing and culturally oriented nutritional counseling.

However, while pediatricians are willing to talk to patients about eating habits and exercise, said Dr. Barlow, the discussion is "very superficial. It gets lost in the ultralong list of anticipatory guidance that has to get done in a very short time frame."

As for reimbursements, it is unclear whether the Affordable Care Act will help or hurt pediatricians faced with an obesity epidemic in their patients, but it may help, said Dr. Barlow of Baylor College of Medicine, Houston. The legislation emphasizes research, improved access to primary care, and community-oriented health care initiatives as ways that awareness may be raised, she noted.

As for the ACA’s impact on reimbursements, she said, "I believe the ACA says anything that the U.S. Preventative Services Task Force promotes should be covered." The group’s 2010 report said there is little evidence of impact from moderate to intensive behavior-based treatments, she added.

"The conclusion from that is that those kinds of programs should not be covered," said Dr. Barlow. "The question the task force was addressing was whether it was worth it [for pediatricians] to take the time to calculate [body mass index]. They want screening tests that are sensitive and once you have the answer, you can do something with."

When asked if the underlying problem will be identified any time soon, such as through genetics, food addiction, food environment, or lifestyle, Dr. Barlow said, "everyone wants to treat it as being black or white, using a very medical approach. But we just don’t know."

[email protected]

ATLANTA – The thought of bariatric surgery for obese pediatric patients makes Dr. Sarah Barlow, lead author of recommendations on the prevention, assessment, and treatment of obesity, uncomfortable.

"I have a little bit of a love/hate relationship with bariatric surgery," said Dr. Barlow. For some young people, the procedure can be life altering, "but there is a big jump [from] a behavior-based intervention to bariatric surgery," she said at the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Her reservation hinges upon the question that runs specialtywide for physicians who treat obesity: Just who "owns" the disease?

"Is this a health care problem that needs to be taken care of by doctors, or is this a community problem, and this is all about prevention?" was Dr. Barlow’s rhetorical question. "There are a lot of barriers. There are a lot of players, but not really any reimbursement," she said.

In the case of bariatric surgery for children, Dr. Barlow said she wonders whether obese youngsters are sometimes pushed into having medical treatments in order to skirt reimbursement issues, or because it’s just one more item to tick off for guideline-laden office practitioners who have limited time with patients but an ever-increasing list of precautionary pearls they are meant to dispense?

"The hate part of my relationship is that the bariatric results are so wonderful that I feel people aren’t putting resources into intensive [nonsurgical] treatments," said Dr. Barlow. "I think it’s an option that should be on the table, but I think that medication and behavioral interventions and other tertiary care type interventions should be considered," she noted, adding that bariatric surgery is certainly not the answer to severe obesity in a 10-year-old.

Dr. Barlow is the lead author of the oft-cited Expert Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity, published by the American Academy of Pediatrics in 2007, and jointly sponsored by the American Medical Association, the U.S. Health Resources and Service Administration, and the Centers for Disease Control and Prevention. The recommendations emphasize behavior modifications with techniques such as motivational interviewing and culturally oriented nutritional counseling.

However, while pediatricians are willing to talk to patients about eating habits and exercise, said Dr. Barlow, the discussion is "very superficial. It gets lost in the ultralong list of anticipatory guidance that has to get done in a very short time frame."

As for reimbursements, it is unclear whether the Affordable Care Act will help or hurt pediatricians faced with an obesity epidemic in their patients, but it may help, said Dr. Barlow of Baylor College of Medicine, Houston. The legislation emphasizes research, improved access to primary care, and community-oriented health care initiatives as ways that awareness may be raised, she noted.

As for the ACA’s impact on reimbursements, she said, "I believe the ACA says anything that the U.S. Preventative Services Task Force promotes should be covered." The group’s 2010 report said there is little evidence of impact from moderate to intensive behavior-based treatments, she added.

"The conclusion from that is that those kinds of programs should not be covered," said Dr. Barlow. "The question the task force was addressing was whether it was worth it [for pediatricians] to take the time to calculate [body mass index]. They want screening tests that are sensitive and once you have the answer, you can do something with."

When asked if the underlying problem will be identified any time soon, such as through genetics, food addiction, food environment, or lifestyle, Dr. Barlow said, "everyone wants to treat it as being black or white, using a very medical approach. But we just don’t know."

[email protected]

ATLANTA – The thought of bariatric surgery for obese pediatric patients makes Dr. Sarah Barlow, lead author of recommendations on the prevention, assessment, and treatment of obesity, uncomfortable.

"I have a little bit of a love/hate relationship with bariatric surgery," said Dr. Barlow. For some young people, the procedure can be life altering, "but there is a big jump [from] a behavior-based intervention to bariatric surgery," she said at the Obesity Society and the American Society for Metabolic and Bariatric Surgery.

Her reservation hinges upon the question that runs specialtywide for physicians who treat obesity: Just who "owns" the disease?

"Is this a health care problem that needs to be taken care of by doctors, or is this a community problem, and this is all about prevention?" was Dr. Barlow’s rhetorical question. "There are a lot of barriers. There are a lot of players, but not really any reimbursement," she said.

In the case of bariatric surgery for children, Dr. Barlow said she wonders whether obese youngsters are sometimes pushed into having medical treatments in order to skirt reimbursement issues, or because it’s just one more item to tick off for guideline-laden office practitioners who have limited time with patients but an ever-increasing list of precautionary pearls they are meant to dispense?

"The hate part of my relationship is that the bariatric results are so wonderful that I feel people aren’t putting resources into intensive [nonsurgical] treatments," said Dr. Barlow. "I think it’s an option that should be on the table, but I think that medication and behavioral interventions and other tertiary care type interventions should be considered," she noted, adding that bariatric surgery is certainly not the answer to severe obesity in a 10-year-old.

Dr. Barlow is the lead author of the oft-cited Expert Recommendations Regarding the Prevention, Assessment, and Treatment of Child and Adolescent Overweight and Obesity, published by the American Academy of Pediatrics in 2007, and jointly sponsored by the American Medical Association, the U.S. Health Resources and Service Administration, and the Centers for Disease Control and Prevention. The recommendations emphasize behavior modifications with techniques such as motivational interviewing and culturally oriented nutritional counseling.

However, while pediatricians are willing to talk to patients about eating habits and exercise, said Dr. Barlow, the discussion is "very superficial. It gets lost in the ultralong list of anticipatory guidance that has to get done in a very short time frame."

As for reimbursements, it is unclear whether the Affordable Care Act will help or hurt pediatricians faced with an obesity epidemic in their patients, but it may help, said Dr. Barlow of Baylor College of Medicine, Houston. The legislation emphasizes research, improved access to primary care, and community-oriented health care initiatives as ways that awareness may be raised, she noted.

As for the ACA’s impact on reimbursements, she said, "I believe the ACA says anything that the U.S. Preventative Services Task Force promotes should be covered." The group’s 2010 report said there is little evidence of impact from moderate to intensive behavior-based treatments, she added.

"The conclusion from that is that those kinds of programs should not be covered," said Dr. Barlow. "The question the task force was addressing was whether it was worth it [for pediatricians] to take the time to calculate [body mass index]. They want screening tests that are sensitive and once you have the answer, you can do something with."

When asked if the underlying problem will be identified any time soon, such as through genetics, food addiction, food environment, or lifestyle, Dr. Barlow said, "everyone wants to treat it as being black or white, using a very medical approach. But we just don’t know."

[email protected]

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

WASHINGTON – One year out from surgery, gastric bypass, gastric sleeve, and gastric banding all showed considerable reductions in cardiac risk factors, but gastric bypass showed the greatest risk reduction of all three, as well as greater improvement in body mass index, according to a study presented at this year’s annual clinical congress of the American College of Surgeons.

Baseline and 1-year postoperative data were collected on 1,398 consecutive bariatric surgery patients by Christopher S. Crowe and his colleagues at Stanford (Calif.) University. The investigators sought to evaluate each type of surgery’s effect on biochemical cardiovascular risk factors. The follow-up rate at 12 months was 77%.

The values measured were hemoglobin A_1c, fasting insulin, high-density lipoprotein (HDL), low-density lipoprotein (LDL), total cholesterol, triglycerides, high-sensitivity C-reactive protein (CRP), homocysteine, and lipoprotein (a).

Across the three groups, bypass patients tended to be younger by 1-2 years (mean age of this group was 44.3 years), and they had a higher baseline body mass index on average.

Excess weight loss after 1 year averaged 75% in the bypass patients, 55% in the patients with a sleeve, and 40% in those with a band.

When analyzing laboratory values for each group, the investigators found that fasting insulin levels were notably improved in all three groups; but at an improvement rate of 67.0%, the bypass patients had more than double the improvement of the gastric-band patients, while the gastric-sleeve patients showed a 63.7% improvement rate.

The CRP levels also improved dramatically in the bypass patients (67.1%), especially when compared with the band (21.2%) and sleeve (26.3%) groups. In addition, the ratio between triglycerides and HDL, a strong predictor of cardiovascular events, was differentially most improved in the bypass patients (38.5%), although improvement was also seen in both band (20.6%) and sleeve (35.2%) groups.

The investigators also sought to correlate each bariatric procedure’s resultant weight loss to improvement in specific cardiac risk factors. Only bypass was found to have a correlate between weight loss and total cholesterol and LDL reduction.

The triglyceride/HDL ratio improved with weight loss in both the bypass and band surgical groups. However, patients over age 50 and with a BMI greater than 50 kg/m² had the least improvement in this ratio.

Reduction in CRP level was not found to be related to weight loss for any of the procedures, although CRP did improve substantially after all three operations, primarily in bypass patients. In response to a question from an audience member, Mr. Crowe, a medical student, said this was probably because of changes in patient lifestyle, diet, and medications, as well as smoking cessation, postoperatively.

"When someone comes in for a bariatric procedure, they’re not just receiving the surgery, they are changing a lot about their life," said Mr. Crowe. "Those changes could, in effect, decrease the CRP levels after surgery, without it being weight loss–dependent."

Mr. Crowe reported no relevant disclosures. His coinvestigators reported serving as consultants to Ethicon and Covidien.

[email protected]

WASHINGTON – Nonoperative prophylaxis for blunt solid abdominal organ trauma was found safe when given 48 hours post injury, according to data presented at the annual clinical congress of the American College of Surgeons.

Because updated guidelines for nonoperative management of solid abdominal organ injuries do not state an optimal time for initiation of prophylaxis, investigators, including presenter Caitlyn Harrison, a third-year medical student at the University of Arizona, Tucson, sought to determine how soon is too soon in this patient population.

Theorizing that there would be no difference in bleeding complications and failure rates associated with early venous thromboembolism (VTE) prevention, the investigators reviewed 7 years of patient data (2005-2011) from a single trauma center to compare the safety of early (less than 48 hours), intermediate (48-72 hours), and late (more than 72 hours) initiation of unfractionated heparin (5,000 units, subcutaneously, every 8 hours) in blunt abdominal injury patients.

Included for review were patients whose abdominal injuries were equal to or greater than 3 on the Abbreviated Injury Scale (AIS). Patients with head injuries that scored 3 or greater on the AIS and those who had been transferred were excluded.

A total of 116 patients were matched according to whether they had received early (n = 58; 67.2% male; mean age, 40 years), intermediate (n = 29; 69% male; mean age, 44.3 years), or late (n = 29; 72.4% male; mean age, 45 years) initiation of VTE prophylaxis.

They also were matched according to organs injured. The investigators found a preponderance of splenic injuries: 41.4% in the early group, 37.9% in the intermediate, and 45.2% in the late group.

The grade of injury and laboratory values including blood pressure and injury severity also were measured.

The researchers found that none of the patients in the intermediate or late groups reached the primary outcome of the need for a post-treatment blood transfusion, although 3.2% of the early group did, Ms. Harrison said.

No patients in any of the three groups required an operative intervention after nonoperative management, although 1.7% of the early group did require embolization, as did 3.4% each of the intermediate and late groups.

Similarly, while thromboembolisms were not found to have occurred in the early group, they did occur in the intermediate and late groups at a rate of 3.4% each. No mortality was recorded as an outcome in any of the three groups, she said, concluding that "early VTE prophylaxis is safe."

Ms. Harrison reported no relevant disclosures.

[email protected]

WASHINGTON – Nonoperative prophylaxis for blunt solid abdominal organ trauma was found safe when given 48 hours post injury, according to data presented at the annual clinical congress of the American College of Surgeons.

Because updated guidelines for nonoperative management of solid abdominal organ injuries do not state an optimal time for initiation of prophylaxis, investigators, including presenter Caitlyn Harrison, a third-year medical student at the University of Arizona, Tucson, sought to determine how soon is too soon in this patient population.

Theorizing that there would be no difference in bleeding complications and failure rates associated with early venous thromboembolism (VTE) prevention, the investigators reviewed 7 years of patient data (2005-2011) from a single trauma center to compare the safety of early (less than 48 hours), intermediate (48-72 hours), and late (more than 72 hours) initiation of unfractionated heparin (5,000 units, subcutaneously, every 8 hours) in blunt abdominal injury patients.

Included for review were patients whose abdominal injuries were equal to or greater than 3 on the Abbreviated Injury Scale (AIS). Patients with head injuries that scored 3 or greater on the AIS and those who had been transferred were excluded.

A total of 116 patients were matched according to whether they had received early (n = 58; 67.2% male; mean age, 40 years), intermediate (n = 29; 69% male; mean age, 44.3 years), or late (n = 29; 72.4% male; mean age, 45 years) initiation of VTE prophylaxis.

They also were matched according to organs injured. The investigators found a preponderance of splenic injuries: 41.4% in the early group, 37.9% in the intermediate, and 45.2% in the late group.

The grade of injury and laboratory values including blood pressure and injury severity also were measured.

The researchers found that none of the patients in the intermediate or late groups reached the primary outcome of the need for a post-treatment blood transfusion, although 3.2% of the early group did, Ms. Harrison said.

No patients in any of the three groups required an operative intervention after nonoperative management, although 1.7% of the early group did require embolization, as did 3.4% each of the intermediate and late groups.

Similarly, while thromboembolisms were not found to have occurred in the early group, they did occur in the intermediate and late groups at a rate of 3.4% each. No mortality was recorded as an outcome in any of the three groups, she said, concluding that "early VTE prophylaxis is safe."

Ms. Harrison reported no relevant disclosures.

[email protected]

WASHINGTON – Nonoperative prophylaxis for blunt solid abdominal organ trauma was found safe when given 48 hours post injury, according to data presented at the annual clinical congress of the American College of Surgeons.

Because updated guidelines for nonoperative management of solid abdominal organ injuries do not state an optimal time for initiation of prophylaxis, investigators, including presenter Caitlyn Harrison, a third-year medical student at the University of Arizona, Tucson, sought to determine how soon is too soon in this patient population.

Theorizing that there would be no difference in bleeding complications and failure rates associated with early venous thromboembolism (VTE) prevention, the investigators reviewed 7 years of patient data (2005-2011) from a single trauma center to compare the safety of early (less than 48 hours), intermediate (48-72 hours), and late (more than 72 hours) initiation of unfractionated heparin (5,000 units, subcutaneously, every 8 hours) in blunt abdominal injury patients.

Included for review were patients whose abdominal injuries were equal to or greater than 3 on the Abbreviated Injury Scale (AIS). Patients with head injuries that scored 3 or greater on the AIS and those who had been transferred were excluded.

A total of 116 patients were matched according to whether they had received early (n = 58; 67.2% male; mean age, 40 years), intermediate (n = 29; 69% male; mean age, 44.3 years), or late (n = 29; 72.4% male; mean age, 45 years) initiation of VTE prophylaxis.

They also were matched according to organs injured. The investigators found a preponderance of splenic injuries: 41.4% in the early group, 37.9% in the intermediate, and 45.2% in the late group.

The grade of injury and laboratory values including blood pressure and injury severity also were measured.

The researchers found that none of the patients in the intermediate or late groups reached the primary outcome of the need for a post-treatment blood transfusion, although 3.2% of the early group did, Ms. Harrison said.

No patients in any of the three groups required an operative intervention after nonoperative management, although 1.7% of the early group did require embolization, as did 3.4% each of the intermediate and late groups.

Similarly, while thromboembolisms were not found to have occurred in the early group, they did occur in the intermediate and late groups at a rate of 3.4% each. No mortality was recorded as an outcome in any of the three groups, she said, concluding that "early VTE prophylaxis is safe."

Ms. Harrison reported no relevant disclosures.

[email protected]

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

The addition of a transversus abdominis plane block to standard enhanced recovery pathway protocols decreased lengths of stay to less than 3 days in roughly two-thirds of patients who underwent laparoscopic colectomy, findings from a small study showed.

To determine the impact of a TAP block on rates of discharge for colorectal laparoscopic surgery, researchers at University Hospitals Case Medical Center in Cleveland observed 100 consecutive patients who underwent the elective procedure performed over a 1-year period by the same experienced laparoscopic colorectal surgeon. The TAP block was administered at the conclusion of the laparoscopic procedure.

The mean age of the study population was 60.5 years, and 62 were female. The mean body mass index was 28.4 kg/m². Surgical indications in two-thirds of patients included colorectal cancer or polyp. One-third of patients had an inflammatory condition such as diverticulitis, ulcerative colitis, or Crohn’s disease, said Dr. Joanne Favuzza and Dr. Conor P. Delaney (J. Am. Coll. Surg. 2013;217:503-6).

The investigators found that 62% of patients were discharged within 48 hours, with 27% being discharged on day 1. No operative mortality was reported, and only one patient experienced a complication post discharge. Two patients were readmitted, both having had lengths of stay exceeding 48 hours.

Incidence rates of complication or readmission were not significantly affected by the block. Eight patients experienced postoperative complications: one patient on the second day post surgery, another patient on the third day, and the rest after the fourth day. Three patients had complications involving the ileus or lower-bowel obstruction, four patients had anastomotic or gastrointestinal bleed, and one had a urinary tract infection.

"This study demonstrated that the addition of a TAP block to an established ERP can reproducibly reduce length of stay to less than 3 days," wrote Dr. Favuzza and Dr. Delaney, who also noted that a prospective randomized controlled trial is underway to further evaluate the benefits of TAP blocks to ERP in colorectal surgery.

Dr. Favuzza reported no relevant disclosures. Dr. Delaney is a paid a consultant to Adolor Corp., Ferring Pharmaceuticals, and Pacira Pharmaceuticals.

[email protected]

CHICAGO – Big Data promises better outcomes and cost savings but begs the question of how much privacy patients are willing to give up.

Via smart phones and cloud computing, hyperspecific information on individual patients can be gathered 24 hours a day, 7 days a week from GPS location, photographs, audio, and other forms of monitoring. Blood pressure, weight, and even pulse detection are already being tracked in some patients. Using advanced algorithms, patient alerts can identify those at risk and possibly allow early interventions that avoid critical events and reduce the cost of care.

"The question is, ‘How much do [patients] want to be monitored?’ " asked Dr. Burt Lesnick, FCCP, of Georgia Pediatric Pulmonary Associates, Atlanta, during a presentation at the annual meeting of the American College of Chest Physicians. Monitoring can assist patients in managing their illness; but empowerment that comes at the cost of constant surveillance "sounds very Orwellian," he said.

Dr. Lesnick has even observed the power of mobile technology to improve asthma control in his own practice. In two small controlled studies, he and his associates randomized a total of 100 children who had asthma and owned a cell phone into three groups. The control group did not receive any communication from the physician. The second group was surveyed by e-mail every 4 days to assess their asthma control scores. If responses indicated an increase in risk, the clinical staff would call the family to discuss the child’s risk status.

The third group also received the rolling assessments, as well as text messages that quizzed their asthma knowledge with true/false questions. Patients who answered the prompts correctly were rewarded with a text message, "You’re right!" and an explanation of why they were correct. If they answered incorrectly, they were told, "Not quite," and also given an explanation.

Dr. Lesnick’s first study included 40 children. In his second study, 60 children were randomized in similar fashion. However, an additional factor – whether patients had public or private insurance – also was used for randomization. Furthermore, the second study addressed whether the success of the combined assessment/knowledge group could be attributed to the increased volume of text messages in that group. The researchers examined whether the text messages created a "reminder" effect for the children to take their medications.

In each study, the groups given rolling assessments and education had significant improvements in forced expiratory flow (FEF25-75%) over baseline measures.

In the first study, the FEF25-75% scores rose from a baseline average of 74.3 plus or minus 31.4 to a poststudy average of 96.0 plus or minus 32.6 in the group given assessments and education. No statistically significant differences in FEF25-75% were seen in the other two groups. In the knowledge-only group, FEF25-75% scores increased from 78.2 plus or minus 32.0 to 84.2 plus or minus 31.7. In the control group, the FEF25-75% scores decreased from 91.1 plus or minus 26.6 to 73.5 plus or minus 27.5.

In the second study, which included equal numbers of children on public and private insurance, the FEF25-75% scores in the education group went from 51.3 plus or minus 21.0 at baseline to 65.5 plus or minus 25.7 at post study.

"Kids were much better reporters of their asthma symptoms with exercise than their parents were," Dr. Lesnick noted. "Not a great surprise, but an important point."

There was a direct correlation between children being put in charge of learning about and managing their asthma, versus relying on their parents to do it for them.

"We were getting them to be empowered ... because we were talking to them in their language: text messages. That’s how they communicate." said Dr. Lesnick.

But how much intrusion will patients be willing to accept in the future to gain "empowerment"? And how much of their information should be shared – and in what manner?

States are eager to use Big Data to drive down health care costs as they compete for federal health dollars based on quality improvements derived from this data, Dr. Lesnick noted. Meanwhile, private insurers are particularly interested in tracking who is most mindful of their health since aggregating this data helps to stratify risk.

Similar to how the auto insurance industry has recognized customers’ willingness to have devices installed in their cars to monitor their driving habits in exchange for lower premiums, health insurers are willing to bank on the notion that people who know they are under observation will change their behavior, Dr. Lesnick said.

Further, Big Data is being driven by health care consumers themselves, particularly younger generations for whom privacy is largely anachronistic, making "patient sensoring" by insurers actually not that hard to achieve, he said.

"There is this psyche out there of people who really want to be monitored," said Dr. Lesnick, citing the ascendency of smartphone watches and humidity sensor apps that allow users to track their exercise performance. These technologies suggest a future of vastly more mobile health or "mHealth" options.

"The Holy Grail is to get the information passively, with sensors all over your body," Dr. Lesnick said.

The encounter between privacy issues and advances in technology begs the questions: If privacy becomes a commodity, will health insurers profit from selling it? And, if our individual data adds to the collective knowledge base, is it our responsibility to give it away for free?

Up-and-coming generations may live according to an ethos whereby "all data should be out there, and it should be completely transparent," Dr. Lesnick said. "But is transparency always a good thing? I don’t know the answer."

[email protected]

CHICAGO – Big Data promises better outcomes and cost savings but begs the question of how much privacy patients are willing to give up.

Via smart phones and cloud computing, hyperspecific information on individual patients can be gathered 24 hours a day, 7 days a week from GPS location, photographs, audio, and other forms of monitoring. Blood pressure, weight, and even pulse detection are already being tracked in some patients. Using advanced algorithms, patient alerts can identify those at risk and possibly allow early interventions that avoid critical events and reduce the cost of care.

"The question is, ‘How much do [patients] want to be monitored?’ " asked Dr. Burt Lesnick, FCCP, of Georgia Pediatric Pulmonary Associates, Atlanta, during a presentation at the annual meeting of the American College of Chest Physicians. Monitoring can assist patients in managing their illness; but empowerment that comes at the cost of constant surveillance "sounds very Orwellian," he said.

Dr. Lesnick has even observed the power of mobile technology to improve asthma control in his own practice. In two small controlled studies, he and his associates randomized a total of 100 children who had asthma and owned a cell phone into three groups. The control group did not receive any communication from the physician. The second group was surveyed by e-mail every 4 days to assess their asthma control scores. If responses indicated an increase in risk, the clinical staff would call the family to discuss the child’s risk status.

The third group also received the rolling assessments, as well as text messages that quizzed their asthma knowledge with true/false questions. Patients who answered the prompts correctly were rewarded with a text message, "You’re right!" and an explanation of why they were correct. If they answered incorrectly, they were told, "Not quite," and also given an explanation.

Dr. Lesnick’s first study included 40 children. In his second study, 60 children were randomized in similar fashion. However, an additional factor – whether patients had public or private insurance – also was used for randomization. Furthermore, the second study addressed whether the success of the combined assessment/knowledge group could be attributed to the increased volume of text messages in that group. The researchers examined whether the text messages created a "reminder" effect for the children to take their medications.

In each study, the groups given rolling assessments and education had significant improvements in forced expiratory flow (FEF25-75%) over baseline measures.

In the first study, the FEF25-75% scores rose from a baseline average of 74.3 plus or minus 31.4 to a poststudy average of 96.0 plus or minus 32.6 in the group given assessments and education. No statistically significant differences in FEF25-75% were seen in the other two groups. In the knowledge-only group, FEF25-75% scores increased from 78.2 plus or minus 32.0 to 84.2 plus or minus 31.7. In the control group, the FEF25-75% scores decreased from 91.1 plus or minus 26.6 to 73.5 plus or minus 27.5.

In the second study, which included equal numbers of children on public and private insurance, the FEF25-75% scores in the education group went from 51.3 plus or minus 21.0 at baseline to 65.5 plus or minus 25.7 at post study.

"Kids were much better reporters of their asthma symptoms with exercise than their parents were," Dr. Lesnick noted. "Not a great surprise, but an important point."

There was a direct correlation between children being put in charge of learning about and managing their asthma, versus relying on their parents to do it for them.

"We were getting them to be empowered ... because we were talking to them in their language: text messages. That’s how they communicate." said Dr. Lesnick.

But how much intrusion will patients be willing to accept in the future to gain "empowerment"? And how much of their information should be shared – and in what manner?

States are eager to use Big Data to drive down health care costs as they compete for federal health dollars based on quality improvements derived from this data, Dr. Lesnick noted. Meanwhile, private insurers are particularly interested in tracking who is most mindful of their health since aggregating this data helps to stratify risk.

Similar to how the auto insurance industry has recognized customers’ willingness to have devices installed in their cars to monitor their driving habits in exchange for lower premiums, health insurers are willing to bank on the notion that people who know they are under observation will change their behavior, Dr. Lesnick said.

Further, Big Data is being driven by health care consumers themselves, particularly younger generations for whom privacy is largely anachronistic, making "patient sensoring" by insurers actually not that hard to achieve, he said.

"There is this psyche out there of people who really want to be monitored," said Dr. Lesnick, citing the ascendency of smartphone watches and humidity sensor apps that allow users to track their exercise performance. These technologies suggest a future of vastly more mobile health or "mHealth" options.

"The Holy Grail is to get the information passively, with sensors all over your body," Dr. Lesnick said.

The encounter between privacy issues and advances in technology begs the questions: If privacy becomes a commodity, will health insurers profit from selling it? And, if our individual data adds to the collective knowledge base, is it our responsibility to give it away for free?

Up-and-coming generations may live according to an ethos whereby "all data should be out there, and it should be completely transparent," Dr. Lesnick said. "But is transparency always a good thing? I don’t know the answer."

[email protected]

CHICAGO – Big Data promises better outcomes and cost savings but begs the question of how much privacy patients are willing to give up.

Via smart phones and cloud computing, hyperspecific information on individual patients can be gathered 24 hours a day, 7 days a week from GPS location, photographs, audio, and other forms of monitoring. Blood pressure, weight, and even pulse detection are already being tracked in some patients. Using advanced algorithms, patient alerts can identify those at risk and possibly allow early interventions that avoid critical events and reduce the cost of care.

"The question is, ‘How much do [patients] want to be monitored?’ " asked Dr. Burt Lesnick, FCCP, of Georgia Pediatric Pulmonary Associates, Atlanta, during a presentation at the annual meeting of the American College of Chest Physicians. Monitoring can assist patients in managing their illness; but empowerment that comes at the cost of constant surveillance "sounds very Orwellian," he said.

Dr. Lesnick has even observed the power of mobile technology to improve asthma control in his own practice. In two small controlled studies, he and his associates randomized a total of 100 children who had asthma and owned a cell phone into three groups. The control group did not receive any communication from the physician. The second group was surveyed by e-mail every 4 days to assess their asthma control scores. If responses indicated an increase in risk, the clinical staff would call the family to discuss the child’s risk status.

The third group also received the rolling assessments, as well as text messages that quizzed their asthma knowledge with true/false questions. Patients who answered the prompts correctly were rewarded with a text message, "You’re right!" and an explanation of why they were correct. If they answered incorrectly, they were told, "Not quite," and also given an explanation.

Dr. Lesnick’s first study included 40 children. In his second study, 60 children were randomized in similar fashion. However, an additional factor – whether patients had public or private insurance – also was used for randomization. Furthermore, the second study addressed whether the success of the combined assessment/knowledge group could be attributed to the increased volume of text messages in that group. The researchers examined whether the text messages created a "reminder" effect for the children to take their medications.

In each study, the groups given rolling assessments and education had significant improvements in forced expiratory flow (FEF25-75%) over baseline measures.

In the first study, the FEF25-75% scores rose from a baseline average of 74.3 plus or minus 31.4 to a poststudy average of 96.0 plus or minus 32.6 in the group given assessments and education. No statistically significant differences in FEF25-75% were seen in the other two groups. In the knowledge-only group, FEF25-75% scores increased from 78.2 plus or minus 32.0 to 84.2 plus or minus 31.7. In the control group, the FEF25-75% scores decreased from 91.1 plus or minus 26.6 to 73.5 plus or minus 27.5.

In the second study, which included equal numbers of children on public and private insurance, the FEF25-75% scores in the education group went from 51.3 plus or minus 21.0 at baseline to 65.5 plus or minus 25.7 at post study.

"Kids were much better reporters of their asthma symptoms with exercise than their parents were," Dr. Lesnick noted. "Not a great surprise, but an important point."

There was a direct correlation between children being put in charge of learning about and managing their asthma, versus relying on their parents to do it for them.

"We were getting them to be empowered ... because we were talking to them in their language: text messages. That’s how they communicate." said Dr. Lesnick.

But how much intrusion will patients be willing to accept in the future to gain "empowerment"? And how much of their information should be shared – and in what manner?

States are eager to use Big Data to drive down health care costs as they compete for federal health dollars based on quality improvements derived from this data, Dr. Lesnick noted. Meanwhile, private insurers are particularly interested in tracking who is most mindful of their health since aggregating this data helps to stratify risk.

Similar to how the auto insurance industry has recognized customers’ willingness to have devices installed in their cars to monitor their driving habits in exchange for lower premiums, health insurers are willing to bank on the notion that people who know they are under observation will change their behavior, Dr. Lesnick said.

Further, Big Data is being driven by health care consumers themselves, particularly younger generations for whom privacy is largely anachronistic, making "patient sensoring" by insurers actually not that hard to achieve, he said.

"There is this psyche out there of people who really want to be monitored," said Dr. Lesnick, citing the ascendency of smartphone watches and humidity sensor apps that allow users to track their exercise performance. These technologies suggest a future of vastly more mobile health or "mHealth" options.

"The Holy Grail is to get the information passively, with sensors all over your body," Dr. Lesnick said.

The encounter between privacy issues and advances in technology begs the questions: If privacy becomes a commodity, will health insurers profit from selling it? And, if our individual data adds to the collective knowledge base, is it our responsibility to give it away for free?

Up-and-coming generations may live according to an ethos whereby "all data should be out there, and it should be completely transparent," Dr. Lesnick said. "But is transparency always a good thing? I don’t know the answer."

[email protected]