User login
After the Global Initiative for Chronic Obstructive Lung Disease released updated recommendations for grading COPD patients’ level of disease in November of 2016, Imran Iftikhar, MD, tried to incorporate them into his practice, but he encountered problems.
For one thing, the new classification system, which became known as GOLD 2017, uncoupled spirometry results from the ABCD treatment algorithm. “I found it wasn’t really helping me in terms of prognostication or COPD management,” said Dr. Iftikhar, section chief of pulmonary and critical care at Emory Saint Joseph’s Hospital, Atlanta. “Although the purpose of the GOLD classification was not really meant for prognostication, most practicing physicians are frequently asked about prognosis by patients, and I am not sure if the 2017 reclassification really helps with that.”
The GOLD 2017 classification simplified the chronic obstructive pulmonary disease staging that was available from 2011 to 2015 from three variables (spirometry thresholds, exacerbation risk, and dyspnea scale) to two variables (exacerbation risk and dyspnea scale). In the 2017 report, authors of the new guidelines characterized forced expiratory volume in 1 second (FEV1) as “a poor predictor of disease status” and proposed that clinicians derive ABCD groups exclusively from patient symptoms and their exacerbations. FEV1 is an “important parameter at the population level” in predicting hospitalization and mortality, the authors wrote, but keeping results separate “acknowledges the limitations of FEV1 in making treatment decisions for individualized patient care and highlights the importance of patient symptoms and exacerbation risks in guiding therapies in COPD.”
According to Meilan Han, MD, MS, a member of the GOLD Science Committee, since release of the 2017 guidelines, “clinicians have indicated that they like the flexibility the system provides in separating spirometry, symptoms, and exacerbation risk as this more accurately reflects the heterogeneity we see in the COPD patient population.” Nevertheless, how this approach influences long-term outcomes remains unclear.
Daniel Ouellette, MD, FCCP, a pulmonologist with the Henry Ford Health System in Detroit, described the GOLD 2017 criteria as “a good step forward” but said he wasn’t sure if the optimal or perfect tool exists for categorizing COPD patients’ level of disease.
“I think what we see is an effort to use all of these criteria to help us better treat our patients. I think ,” he said in an interview.
“All guidelines need to be modified as further research becomes available. I think that the frontiers of this area are going to be to incorporate new elements such as tobacco history, more emphasis on clinical signs and symptoms, and use of markers other than spirometry, such as eosinophil count, to categorize patients with COPD,” Dr. Ouellette added.
In an analysis of the GOLD 2017 criteria applied to 819 COPD patients in Spain and the United States, published online Nov. 3, 2017, in the American Journal of Respiratory and Critical Care Medicine, Carlos Cabrera López, MD, and his colleagues concluded that the mortality risk was better predicted by the 2015 GOLD classification system than by the 2017 iteration (Am J Respir Crit Care Med. 2018 Feb. doi: 10.101164/rccm.201707-1363OC).
The distribution of Charlson index scores also changed. Whereas group D was higher than B in 2015, they became similar in the 2017 system. For her part, Dr. Han emphasized that the primary goal of the GOLD ABCD classification system is to categorize patients with respect to treatment groups. “Current therapy targets symptoms and exacerbations, which are the key current elements of the classification schema,” she said in an interview. “The results of the Cabrera Lopez analysis are not necessarily unexpected, as FEV1 is associated with mortality.”
In a prospective, multicenter analysis, Portuguese researchers compared the performance of GOLD 2011 and 2017 in terms of how 200 COPD patients were reclassified, the level of agreement between the two iterations, and the performance of each to predict future exacerbations (COPD. 2018 Feb;15[1]; 21-6). They found that about half of patients classified as GOLD D under the 2011 guidelines became classified as GOLD B when the 2017 version was used, and the extent of agreement between the two iterations was moderate (P less than .001). They also found that the two versions of the guidelines were equivalently effective at predicting exacerbations (69.7% vs. 67.6% in the 2011 and 2017 iterations, respectively). In addition, patients who met the criteria for a GOLD B grouping in the 2017 iteration exacerbated 17% more often and had a lower percent predicted post bronchodilator FEV1 than did those who met the criteria for a GOLD B classification under the 2011 guidelines.
Dr. Han, who is also an associate professor of medicine at the University of Michigan Hospital, acknowledged that GOLD 2017 has resulted in the reclassification of some previously group D patients as group B patients. “Our primary goal is to aid clinicians with the diagnosis and management of patients with COPD,” she said. “We look forward to additional data coming in from ongoing clinical trials that will provide longer term data to further refine treatment algorithms.”
In a recent study of more than 33,000 Danish patients older than age 30 with COPD, researchers led by Anne Gedebjerg, MD, found that the GOLD 2017 ABCD classification did not predict all-cause and respiratory mortality more accurately than previous GOLD iterations from 2007 and 2011. Area under the curve for all-cause mortality was 0.61 for GOLD 2007, 0.61 for GOLD 2011, and 0.63 for GOLD 2017, while the area under the curve for respiratory mortality was 0.64 for GOLD 2007, 0.63 for GOLD 2011, and 0.65 for GOLD 2017 (Lancet Respir Med. 2018 Jan;6[3]:204-12).
However, when the spirometric stages 1-4 were combined with the A to D groupings based on symptoms and exacerbations, the 2017 classification predicted mortality with greater accuracy, compared with previous iterations (P less than .0001). “My practice is very much like this paper,” Dr. Iftikhar said. “I use both the spirometric grade and the ABCD grouping to specify which ‘group’ and ‘grade’ my patient belongs to. I think future investigators need to combine ABCD with spirometry classification to see how we can improve the classification system.”
In a commentary published in the same issue of the Lancet Respiratory Medicine as the large Danish study, Joan B. Soriano, MD, PhD, wrote that the 2011 GOLD guideline’s collapse of four spirometric thresholds (greater than 80%, 50%-80%, 30%-50%, and less than 30%) into just two (greater than 50% or 50% or less) “reduced the system’s ability to inform and predict mortality from the short term up to 10 years” (Lancet Respir Med. 2018 Jan;6[3]:165-6).
Lung function remains the best available biomarker for life expectancy in both patients with COPD and the general population,” wrote Dr. Soriano, a respiratory medicine researcher based in Madrid, Spain.
Additional important outcomes
Dr. Ouellette noted that while mortality is an important outcome for COPD patients, it’s not the only outcome of interest. “In addition to [trying to] help people live longer, which is certainly a desirable goal, we also want to make people be able to be more functional during their life, have fewer hospitalizations, and have less of a need of other types of supportive medical care for worsening of their disease,” he said. “The fact that the current guidelines don’t improve mortality more than the previous ones may not be a negative thing. It may tell us that the previous guidelines already did a pretty good job of helping us to improve mortality.”
Dr. Ouellette was quick to add that none of inhaled drugs currently available to treat COPD have been conclusively shown to improve mortality. “The only things we know that improve mortality for COPD patients are quitting smoking and using oxygen if a patient meets predefined goals for oxygen,” he said. “So the fact that GOLD criteria doesn’t improve mortality shouldn’t make us think that it’s not a useful tool. We already know that the medicines may not help people live longer.”
Dr. Han pointed out that spirometry “is still used to further clarify the choice of therapy recommended based on the nature and degree of airflow obstruction in light of severity of patient symptoms. The data are still designed to be used in conjunction to personalize therapy for patients.”
She added that the GOLD Science Committee “welcomes additional data analyses so that future recommendations can be further refined.”
Dr. Han disclosed that she has consulted for Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline. She has also received in-kind research support from Novartis and Sunovion.
Dr. Iftikhar reported having no financial disclosures. Dr. Ouellette is a member of CHEST® Physician’s editorial advisory board. He disclosed being part of a federally funded study being carried out by the Patient-Centered Outcomes Research Institute.
There was no industry involvement in the GOLD 2017 report, but many of its authors and board members had pharmaceutical company ties, and GOLD’s treatment advice relies on data from industry-sponsored studies.
After the Global Initiative for Chronic Obstructive Lung Disease released updated recommendations for grading COPD patients’ level of disease in November of 2016, Imran Iftikhar, MD, tried to incorporate them into his practice, but he encountered problems.
For one thing, the new classification system, which became known as GOLD 2017, uncoupled spirometry results from the ABCD treatment algorithm. “I found it wasn’t really helping me in terms of prognostication or COPD management,” said Dr. Iftikhar, section chief of pulmonary and critical care at Emory Saint Joseph’s Hospital, Atlanta. “Although the purpose of the GOLD classification was not really meant for prognostication, most practicing physicians are frequently asked about prognosis by patients, and I am not sure if the 2017 reclassification really helps with that.”
The GOLD 2017 classification simplified the chronic obstructive pulmonary disease staging that was available from 2011 to 2015 from three variables (spirometry thresholds, exacerbation risk, and dyspnea scale) to two variables (exacerbation risk and dyspnea scale). In the 2017 report, authors of the new guidelines characterized forced expiratory volume in 1 second (FEV1) as “a poor predictor of disease status” and proposed that clinicians derive ABCD groups exclusively from patient symptoms and their exacerbations. FEV1 is an “important parameter at the population level” in predicting hospitalization and mortality, the authors wrote, but keeping results separate “acknowledges the limitations of FEV1 in making treatment decisions for individualized patient care and highlights the importance of patient symptoms and exacerbation risks in guiding therapies in COPD.”
According to Meilan Han, MD, MS, a member of the GOLD Science Committee, since release of the 2017 guidelines, “clinicians have indicated that they like the flexibility the system provides in separating spirometry, symptoms, and exacerbation risk as this more accurately reflects the heterogeneity we see in the COPD patient population.” Nevertheless, how this approach influences long-term outcomes remains unclear.
Daniel Ouellette, MD, FCCP, a pulmonologist with the Henry Ford Health System in Detroit, described the GOLD 2017 criteria as “a good step forward” but said he wasn’t sure if the optimal or perfect tool exists for categorizing COPD patients’ level of disease.
“I think what we see is an effort to use all of these criteria to help us better treat our patients. I think ,” he said in an interview.
“All guidelines need to be modified as further research becomes available. I think that the frontiers of this area are going to be to incorporate new elements such as tobacco history, more emphasis on clinical signs and symptoms, and use of markers other than spirometry, such as eosinophil count, to categorize patients with COPD,” Dr. Ouellette added.
In an analysis of the GOLD 2017 criteria applied to 819 COPD patients in Spain and the United States, published online Nov. 3, 2017, in the American Journal of Respiratory and Critical Care Medicine, Carlos Cabrera López, MD, and his colleagues concluded that the mortality risk was better predicted by the 2015 GOLD classification system than by the 2017 iteration (Am J Respir Crit Care Med. 2018 Feb. doi: 10.101164/rccm.201707-1363OC).
The distribution of Charlson index scores also changed. Whereas group D was higher than B in 2015, they became similar in the 2017 system. For her part, Dr. Han emphasized that the primary goal of the GOLD ABCD classification system is to categorize patients with respect to treatment groups. “Current therapy targets symptoms and exacerbations, which are the key current elements of the classification schema,” she said in an interview. “The results of the Cabrera Lopez analysis are not necessarily unexpected, as FEV1 is associated with mortality.”
In a prospective, multicenter analysis, Portuguese researchers compared the performance of GOLD 2011 and 2017 in terms of how 200 COPD patients were reclassified, the level of agreement between the two iterations, and the performance of each to predict future exacerbations (COPD. 2018 Feb;15[1]; 21-6). They found that about half of patients classified as GOLD D under the 2011 guidelines became classified as GOLD B when the 2017 version was used, and the extent of agreement between the two iterations was moderate (P less than .001). They also found that the two versions of the guidelines were equivalently effective at predicting exacerbations (69.7% vs. 67.6% in the 2011 and 2017 iterations, respectively). In addition, patients who met the criteria for a GOLD B grouping in the 2017 iteration exacerbated 17% more often and had a lower percent predicted post bronchodilator FEV1 than did those who met the criteria for a GOLD B classification under the 2011 guidelines.
Dr. Han, who is also an associate professor of medicine at the University of Michigan Hospital, acknowledged that GOLD 2017 has resulted in the reclassification of some previously group D patients as group B patients. “Our primary goal is to aid clinicians with the diagnosis and management of patients with COPD,” she said. “We look forward to additional data coming in from ongoing clinical trials that will provide longer term data to further refine treatment algorithms.”
In a recent study of more than 33,000 Danish patients older than age 30 with COPD, researchers led by Anne Gedebjerg, MD, found that the GOLD 2017 ABCD classification did not predict all-cause and respiratory mortality more accurately than previous GOLD iterations from 2007 and 2011. Area under the curve for all-cause mortality was 0.61 for GOLD 2007, 0.61 for GOLD 2011, and 0.63 for GOLD 2017, while the area under the curve for respiratory mortality was 0.64 for GOLD 2007, 0.63 for GOLD 2011, and 0.65 for GOLD 2017 (Lancet Respir Med. 2018 Jan;6[3]:204-12).
However, when the spirometric stages 1-4 were combined with the A to D groupings based on symptoms and exacerbations, the 2017 classification predicted mortality with greater accuracy, compared with previous iterations (P less than .0001). “My practice is very much like this paper,” Dr. Iftikhar said. “I use both the spirometric grade and the ABCD grouping to specify which ‘group’ and ‘grade’ my patient belongs to. I think future investigators need to combine ABCD with spirometry classification to see how we can improve the classification system.”
In a commentary published in the same issue of the Lancet Respiratory Medicine as the large Danish study, Joan B. Soriano, MD, PhD, wrote that the 2011 GOLD guideline’s collapse of four spirometric thresholds (greater than 80%, 50%-80%, 30%-50%, and less than 30%) into just two (greater than 50% or 50% or less) “reduced the system’s ability to inform and predict mortality from the short term up to 10 years” (Lancet Respir Med. 2018 Jan;6[3]:165-6).
Lung function remains the best available biomarker for life expectancy in both patients with COPD and the general population,” wrote Dr. Soriano, a respiratory medicine researcher based in Madrid, Spain.
Additional important outcomes
Dr. Ouellette noted that while mortality is an important outcome for COPD patients, it’s not the only outcome of interest. “In addition to [trying to] help people live longer, which is certainly a desirable goal, we also want to make people be able to be more functional during their life, have fewer hospitalizations, and have less of a need of other types of supportive medical care for worsening of their disease,” he said. “The fact that the current guidelines don’t improve mortality more than the previous ones may not be a negative thing. It may tell us that the previous guidelines already did a pretty good job of helping us to improve mortality.”
Dr. Ouellette was quick to add that none of inhaled drugs currently available to treat COPD have been conclusively shown to improve mortality. “The only things we know that improve mortality for COPD patients are quitting smoking and using oxygen if a patient meets predefined goals for oxygen,” he said. “So the fact that GOLD criteria doesn’t improve mortality shouldn’t make us think that it’s not a useful tool. We already know that the medicines may not help people live longer.”
Dr. Han pointed out that spirometry “is still used to further clarify the choice of therapy recommended based on the nature and degree of airflow obstruction in light of severity of patient symptoms. The data are still designed to be used in conjunction to personalize therapy for patients.”
She added that the GOLD Science Committee “welcomes additional data analyses so that future recommendations can be further refined.”
Dr. Han disclosed that she has consulted for Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline. She has also received in-kind research support from Novartis and Sunovion.
Dr. Iftikhar reported having no financial disclosures. Dr. Ouellette is a member of CHEST® Physician’s editorial advisory board. He disclosed being part of a federally funded study being carried out by the Patient-Centered Outcomes Research Institute.
There was no industry involvement in the GOLD 2017 report, but many of its authors and board members had pharmaceutical company ties, and GOLD’s treatment advice relies on data from industry-sponsored studies.
After the Global Initiative for Chronic Obstructive Lung Disease released updated recommendations for grading COPD patients’ level of disease in November of 2016, Imran Iftikhar, MD, tried to incorporate them into his practice, but he encountered problems.
For one thing, the new classification system, which became known as GOLD 2017, uncoupled spirometry results from the ABCD treatment algorithm. “I found it wasn’t really helping me in terms of prognostication or COPD management,” said Dr. Iftikhar, section chief of pulmonary and critical care at Emory Saint Joseph’s Hospital, Atlanta. “Although the purpose of the GOLD classification was not really meant for prognostication, most practicing physicians are frequently asked about prognosis by patients, and I am not sure if the 2017 reclassification really helps with that.”
The GOLD 2017 classification simplified the chronic obstructive pulmonary disease staging that was available from 2011 to 2015 from three variables (spirometry thresholds, exacerbation risk, and dyspnea scale) to two variables (exacerbation risk and dyspnea scale). In the 2017 report, authors of the new guidelines characterized forced expiratory volume in 1 second (FEV1) as “a poor predictor of disease status” and proposed that clinicians derive ABCD groups exclusively from patient symptoms and their exacerbations. FEV1 is an “important parameter at the population level” in predicting hospitalization and mortality, the authors wrote, but keeping results separate “acknowledges the limitations of FEV1 in making treatment decisions for individualized patient care and highlights the importance of patient symptoms and exacerbation risks in guiding therapies in COPD.”
According to Meilan Han, MD, MS, a member of the GOLD Science Committee, since release of the 2017 guidelines, “clinicians have indicated that they like the flexibility the system provides in separating spirometry, symptoms, and exacerbation risk as this more accurately reflects the heterogeneity we see in the COPD patient population.” Nevertheless, how this approach influences long-term outcomes remains unclear.
Daniel Ouellette, MD, FCCP, a pulmonologist with the Henry Ford Health System in Detroit, described the GOLD 2017 criteria as “a good step forward” but said he wasn’t sure if the optimal or perfect tool exists for categorizing COPD patients’ level of disease.
“I think what we see is an effort to use all of these criteria to help us better treat our patients. I think ,” he said in an interview.
“All guidelines need to be modified as further research becomes available. I think that the frontiers of this area are going to be to incorporate new elements such as tobacco history, more emphasis on clinical signs and symptoms, and use of markers other than spirometry, such as eosinophil count, to categorize patients with COPD,” Dr. Ouellette added.
In an analysis of the GOLD 2017 criteria applied to 819 COPD patients in Spain and the United States, published online Nov. 3, 2017, in the American Journal of Respiratory and Critical Care Medicine, Carlos Cabrera López, MD, and his colleagues concluded that the mortality risk was better predicted by the 2015 GOLD classification system than by the 2017 iteration (Am J Respir Crit Care Med. 2018 Feb. doi: 10.101164/rccm.201707-1363OC).
The distribution of Charlson index scores also changed. Whereas group D was higher than B in 2015, they became similar in the 2017 system. For her part, Dr. Han emphasized that the primary goal of the GOLD ABCD classification system is to categorize patients with respect to treatment groups. “Current therapy targets symptoms and exacerbations, which are the key current elements of the classification schema,” she said in an interview. “The results of the Cabrera Lopez analysis are not necessarily unexpected, as FEV1 is associated with mortality.”
In a prospective, multicenter analysis, Portuguese researchers compared the performance of GOLD 2011 and 2017 in terms of how 200 COPD patients were reclassified, the level of agreement between the two iterations, and the performance of each to predict future exacerbations (COPD. 2018 Feb;15[1]; 21-6). They found that about half of patients classified as GOLD D under the 2011 guidelines became classified as GOLD B when the 2017 version was used, and the extent of agreement between the two iterations was moderate (P less than .001). They also found that the two versions of the guidelines were equivalently effective at predicting exacerbations (69.7% vs. 67.6% in the 2011 and 2017 iterations, respectively). In addition, patients who met the criteria for a GOLD B grouping in the 2017 iteration exacerbated 17% more often and had a lower percent predicted post bronchodilator FEV1 than did those who met the criteria for a GOLD B classification under the 2011 guidelines.
Dr. Han, who is also an associate professor of medicine at the University of Michigan Hospital, acknowledged that GOLD 2017 has resulted in the reclassification of some previously group D patients as group B patients. “Our primary goal is to aid clinicians with the diagnosis and management of patients with COPD,” she said. “We look forward to additional data coming in from ongoing clinical trials that will provide longer term data to further refine treatment algorithms.”
In a recent study of more than 33,000 Danish patients older than age 30 with COPD, researchers led by Anne Gedebjerg, MD, found that the GOLD 2017 ABCD classification did not predict all-cause and respiratory mortality more accurately than previous GOLD iterations from 2007 and 2011. Area under the curve for all-cause mortality was 0.61 for GOLD 2007, 0.61 for GOLD 2011, and 0.63 for GOLD 2017, while the area under the curve for respiratory mortality was 0.64 for GOLD 2007, 0.63 for GOLD 2011, and 0.65 for GOLD 2017 (Lancet Respir Med. 2018 Jan;6[3]:204-12).
However, when the spirometric stages 1-4 were combined with the A to D groupings based on symptoms and exacerbations, the 2017 classification predicted mortality with greater accuracy, compared with previous iterations (P less than .0001). “My practice is very much like this paper,” Dr. Iftikhar said. “I use both the spirometric grade and the ABCD grouping to specify which ‘group’ and ‘grade’ my patient belongs to. I think future investigators need to combine ABCD with spirometry classification to see how we can improve the classification system.”
In a commentary published in the same issue of the Lancet Respiratory Medicine as the large Danish study, Joan B. Soriano, MD, PhD, wrote that the 2011 GOLD guideline’s collapse of four spirometric thresholds (greater than 80%, 50%-80%, 30%-50%, and less than 30%) into just two (greater than 50% or 50% or less) “reduced the system’s ability to inform and predict mortality from the short term up to 10 years” (Lancet Respir Med. 2018 Jan;6[3]:165-6).
Lung function remains the best available biomarker for life expectancy in both patients with COPD and the general population,” wrote Dr. Soriano, a respiratory medicine researcher based in Madrid, Spain.
Additional important outcomes
Dr. Ouellette noted that while mortality is an important outcome for COPD patients, it’s not the only outcome of interest. “In addition to [trying to] help people live longer, which is certainly a desirable goal, we also want to make people be able to be more functional during their life, have fewer hospitalizations, and have less of a need of other types of supportive medical care for worsening of their disease,” he said. “The fact that the current guidelines don’t improve mortality more than the previous ones may not be a negative thing. It may tell us that the previous guidelines already did a pretty good job of helping us to improve mortality.”
Dr. Ouellette was quick to add that none of inhaled drugs currently available to treat COPD have been conclusively shown to improve mortality. “The only things we know that improve mortality for COPD patients are quitting smoking and using oxygen if a patient meets predefined goals for oxygen,” he said. “So the fact that GOLD criteria doesn’t improve mortality shouldn’t make us think that it’s not a useful tool. We already know that the medicines may not help people live longer.”
Dr. Han pointed out that spirometry “is still used to further clarify the choice of therapy recommended based on the nature and degree of airflow obstruction in light of severity of patient symptoms. The data are still designed to be used in conjunction to personalize therapy for patients.”
She added that the GOLD Science Committee “welcomes additional data analyses so that future recommendations can be further refined.”
Dr. Han disclosed that she has consulted for Boehringer Ingelheim, AstraZeneca, and GlaxoSmithKline. She has also received in-kind research support from Novartis and Sunovion.
Dr. Iftikhar reported having no financial disclosures. Dr. Ouellette is a member of CHEST® Physician’s editorial advisory board. He disclosed being part of a federally funded study being carried out by the Patient-Centered Outcomes Research Institute.
There was no industry involvement in the GOLD 2017 report, but many of its authors and board members had pharmaceutical company ties, and GOLD’s treatment advice relies on data from industry-sponsored studies.