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Accuracy and Sources of Images From Direct Google Image Searches for Common Dermatology Terms
To the Editor:
Prior studies have assessed the quality of text-based dermatology information on the Internet using traditional search engine queries.1 However, little is understood about the sources, accuracy, and quality of online dermatology images derived from direct image searches. Previous work has shown that direct search engine image queries were largely accurate for 3 pediatric dermatology diagnosis searches: atopic dermatitis, lichen striatus, and subcutaneous fat necrosis.2 We assessed images obtained for common dermatologic conditions from a Google image search (GIS) compared to a traditional text-based Google web search (GWS).
Image results for 32 unique dermatologic search terms were analyzed (Table 1). These search terms were selected using the results of a prior study that identified the most common dermatologic diagnoses that led users to the 2 most popular dermatology-specific websites worldwide: the American Academy of Dermatology (www.aad.org) and DermNet New Zealand (www.dermnetnz.org).3 The Alexa directory (www.alexa.com), a large publicly available Internet analytics resource, was used to determine the most common dermatology search terms that led a user to either www.dermnetnz.org or www.aad.org. In addition, searches for the 3 most common types of skin cancer—melanoma, squamous cell carcinoma, and basal cell carcinoma—were included. Each term was entered into a GIS and a GWS. The first 10 results, which represent 92% of the websites ultimately visited by users,4 were analyzed. The source, diagnostic accuracy, and Fitzpatrick skin type of the images was determined. Website sources were organized into 11 categories. All data collection occurred within a 1-week period in August 2015.
A total of 320 images were analyzed. In the GIS, private websites (36%), dermatology association websites (28%), and general health information websites (10%) were the 3 most common sources. In the GWS, health information websites (35%), private websites (21%), and dermatology association websites (20%) accounted for the most common sources (Table 2). The majority of images were of Fitzpatrick skin types I and II (89%) and nearly all images were diagnostically accurate (98%). There was no statistically significant difference in accuracy of diagnosis between physician-associated websites (100% accuracy) versus nonphysician-associated sites (98% accuracy, P=.25).
Our results showed high diagnostic accuracy among the top GIS results for common dermatology search terms. Diagnostic accuracy did not vary between websites that were physician associated versus those that were not. Our results are comparable to the reported accuracy of online dermatologic health information.1 In GIS results, the majority of images were provided by private websites, whereas the top websites in GWS results were health information websites.
Only 1% of images were of Fitzpatrick skin types VI and VII. Presentation of skin diseases is remarkably different based on the patient’s skin type.5 The shortage of readily accessible images of skin of color is in line with the lack of familiarity physicians and trainees have with dermatologic conditions in ethnic skin.6
Based on the results from this analysis, providers and patients searching for dermatologic conditions via a direct GIS should be cognizant of several considerations. Although our results showed that GIS was accurate, the searcher should note that image-based searches are not accompanied by relevant text that can help confirm relevancy and accuracy. Image searches depend on textual tags added by the source website. Websites that represent dermatological associations and academic centers can add an additional layer of confidence for users. Patients and clinicians also should be aware that the consideration of a patient’s Fitzpatrick skin type is critical when assessing the relevancy of a GIS result. In conclusion, search results via GIS queries are accurate for the dermatological diagnoses tested but may be lacking in skin of color variations, suggesting a potential unmet need based on our growing ethnic skin population.
- Jensen JD, Dunnick CA, Arbuckle HA, et al. Dermatology information on the Internet: an appraisal by dermatologists and dermatology residents. J Am Acad Dermatol. 2010;63:1101-1103.
- Cutrone M, Grimalt R. Dermatological image search engines on the Internet: do they work? J Eur Acad Dermatol Venereol. 2007;21:175-177.
- Xu S, Nault A, Bhatia A. Search and engagement analysis of association websites representing dermatologists—implications and opportunities for web visibility and patient education: website rankings of dermatology associations. Pract Dermatol. In press.
- comScore releases July 2015 U.S. desktop search engine rankings [press release]. Reston, VA: comScore, Inc; August 14, 2015. http://www.comscore.com/Insights/Market-Rankings/comScore-Releases-July-2015-U.S.-Desktop-Search-Engine-Rankings. Accessed October 18, 2016.
- Kundu RV, Patterson S. Dermatologic conditions in skin of color: part I. special considerations for common skin disorders. Am Fam Physician. 2013;87:850-856.
- Nijhawan RI, Jacob SE, Woolery-Lloyd H. Skin of color education in dermatology residency programs: does residency training reflect the changing demographics of the United States? J Am Acad Dermatol. 2008;59:615-618.
To the Editor:
Prior studies have assessed the quality of text-based dermatology information on the Internet using traditional search engine queries.1 However, little is understood about the sources, accuracy, and quality of online dermatology images derived from direct image searches. Previous work has shown that direct search engine image queries were largely accurate for 3 pediatric dermatology diagnosis searches: atopic dermatitis, lichen striatus, and subcutaneous fat necrosis.2 We assessed images obtained for common dermatologic conditions from a Google image search (GIS) compared to a traditional text-based Google web search (GWS).
Image results for 32 unique dermatologic search terms were analyzed (Table 1). These search terms were selected using the results of a prior study that identified the most common dermatologic diagnoses that led users to the 2 most popular dermatology-specific websites worldwide: the American Academy of Dermatology (www.aad.org) and DermNet New Zealand (www.dermnetnz.org).3 The Alexa directory (www.alexa.com), a large publicly available Internet analytics resource, was used to determine the most common dermatology search terms that led a user to either www.dermnetnz.org or www.aad.org. In addition, searches for the 3 most common types of skin cancer—melanoma, squamous cell carcinoma, and basal cell carcinoma—were included. Each term was entered into a GIS and a GWS. The first 10 results, which represent 92% of the websites ultimately visited by users,4 were analyzed. The source, diagnostic accuracy, and Fitzpatrick skin type of the images was determined. Website sources were organized into 11 categories. All data collection occurred within a 1-week period in August 2015.
A total of 320 images were analyzed. In the GIS, private websites (36%), dermatology association websites (28%), and general health information websites (10%) were the 3 most common sources. In the GWS, health information websites (35%), private websites (21%), and dermatology association websites (20%) accounted for the most common sources (Table 2). The majority of images were of Fitzpatrick skin types I and II (89%) and nearly all images were diagnostically accurate (98%). There was no statistically significant difference in accuracy of diagnosis between physician-associated websites (100% accuracy) versus nonphysician-associated sites (98% accuracy, P=.25).
Our results showed high diagnostic accuracy among the top GIS results for common dermatology search terms. Diagnostic accuracy did not vary between websites that were physician associated versus those that were not. Our results are comparable to the reported accuracy of online dermatologic health information.1 In GIS results, the majority of images were provided by private websites, whereas the top websites in GWS results were health information websites.
Only 1% of images were of Fitzpatrick skin types VI and VII. Presentation of skin diseases is remarkably different based on the patient’s skin type.5 The shortage of readily accessible images of skin of color is in line with the lack of familiarity physicians and trainees have with dermatologic conditions in ethnic skin.6
Based on the results from this analysis, providers and patients searching for dermatologic conditions via a direct GIS should be cognizant of several considerations. Although our results showed that GIS was accurate, the searcher should note that image-based searches are not accompanied by relevant text that can help confirm relevancy and accuracy. Image searches depend on textual tags added by the source website. Websites that represent dermatological associations and academic centers can add an additional layer of confidence for users. Patients and clinicians also should be aware that the consideration of a patient’s Fitzpatrick skin type is critical when assessing the relevancy of a GIS result. In conclusion, search results via GIS queries are accurate for the dermatological diagnoses tested but may be lacking in skin of color variations, suggesting a potential unmet need based on our growing ethnic skin population.
To the Editor:
Prior studies have assessed the quality of text-based dermatology information on the Internet using traditional search engine queries.1 However, little is understood about the sources, accuracy, and quality of online dermatology images derived from direct image searches. Previous work has shown that direct search engine image queries were largely accurate for 3 pediatric dermatology diagnosis searches: atopic dermatitis, lichen striatus, and subcutaneous fat necrosis.2 We assessed images obtained for common dermatologic conditions from a Google image search (GIS) compared to a traditional text-based Google web search (GWS).
Image results for 32 unique dermatologic search terms were analyzed (Table 1). These search terms were selected using the results of a prior study that identified the most common dermatologic diagnoses that led users to the 2 most popular dermatology-specific websites worldwide: the American Academy of Dermatology (www.aad.org) and DermNet New Zealand (www.dermnetnz.org).3 The Alexa directory (www.alexa.com), a large publicly available Internet analytics resource, was used to determine the most common dermatology search terms that led a user to either www.dermnetnz.org or www.aad.org. In addition, searches for the 3 most common types of skin cancer—melanoma, squamous cell carcinoma, and basal cell carcinoma—were included. Each term was entered into a GIS and a GWS. The first 10 results, which represent 92% of the websites ultimately visited by users,4 were analyzed. The source, diagnostic accuracy, and Fitzpatrick skin type of the images was determined. Website sources were organized into 11 categories. All data collection occurred within a 1-week period in August 2015.
A total of 320 images were analyzed. In the GIS, private websites (36%), dermatology association websites (28%), and general health information websites (10%) were the 3 most common sources. In the GWS, health information websites (35%), private websites (21%), and dermatology association websites (20%) accounted for the most common sources (Table 2). The majority of images were of Fitzpatrick skin types I and II (89%) and nearly all images were diagnostically accurate (98%). There was no statistically significant difference in accuracy of diagnosis between physician-associated websites (100% accuracy) versus nonphysician-associated sites (98% accuracy, P=.25).
Our results showed high diagnostic accuracy among the top GIS results for common dermatology search terms. Diagnostic accuracy did not vary between websites that were physician associated versus those that were not. Our results are comparable to the reported accuracy of online dermatologic health information.1 In GIS results, the majority of images were provided by private websites, whereas the top websites in GWS results were health information websites.
Only 1% of images were of Fitzpatrick skin types VI and VII. Presentation of skin diseases is remarkably different based on the patient’s skin type.5 The shortage of readily accessible images of skin of color is in line with the lack of familiarity physicians and trainees have with dermatologic conditions in ethnic skin.6
Based on the results from this analysis, providers and patients searching for dermatologic conditions via a direct GIS should be cognizant of several considerations. Although our results showed that GIS was accurate, the searcher should note that image-based searches are not accompanied by relevant text that can help confirm relevancy and accuracy. Image searches depend on textual tags added by the source website. Websites that represent dermatological associations and academic centers can add an additional layer of confidence for users. Patients and clinicians also should be aware that the consideration of a patient’s Fitzpatrick skin type is critical when assessing the relevancy of a GIS result. In conclusion, search results via GIS queries are accurate for the dermatological diagnoses tested but may be lacking in skin of color variations, suggesting a potential unmet need based on our growing ethnic skin population.
- Jensen JD, Dunnick CA, Arbuckle HA, et al. Dermatology information on the Internet: an appraisal by dermatologists and dermatology residents. J Am Acad Dermatol. 2010;63:1101-1103.
- Cutrone M, Grimalt R. Dermatological image search engines on the Internet: do they work? J Eur Acad Dermatol Venereol. 2007;21:175-177.
- Xu S, Nault A, Bhatia A. Search and engagement analysis of association websites representing dermatologists—implications and opportunities for web visibility and patient education: website rankings of dermatology associations. Pract Dermatol. In press.
- comScore releases July 2015 U.S. desktop search engine rankings [press release]. Reston, VA: comScore, Inc; August 14, 2015. http://www.comscore.com/Insights/Market-Rankings/comScore-Releases-July-2015-U.S.-Desktop-Search-Engine-Rankings. Accessed October 18, 2016.
- Kundu RV, Patterson S. Dermatologic conditions in skin of color: part I. special considerations for common skin disorders. Am Fam Physician. 2013;87:850-856.
- Nijhawan RI, Jacob SE, Woolery-Lloyd H. Skin of color education in dermatology residency programs: does residency training reflect the changing demographics of the United States? J Am Acad Dermatol. 2008;59:615-618.
- Jensen JD, Dunnick CA, Arbuckle HA, et al. Dermatology information on the Internet: an appraisal by dermatologists and dermatology residents. J Am Acad Dermatol. 2010;63:1101-1103.
- Cutrone M, Grimalt R. Dermatological image search engines on the Internet: do they work? J Eur Acad Dermatol Venereol. 2007;21:175-177.
- Xu S, Nault A, Bhatia A. Search and engagement analysis of association websites representing dermatologists—implications and opportunities for web visibility and patient education: website rankings of dermatology associations. Pract Dermatol. In press.
- comScore releases July 2015 U.S. desktop search engine rankings [press release]. Reston, VA: comScore, Inc; August 14, 2015. http://www.comscore.com/Insights/Market-Rankings/comScore-Releases-July-2015-U.S.-Desktop-Search-Engine-Rankings. Accessed October 18, 2016.
- Kundu RV, Patterson S. Dermatologic conditions in skin of color: part I. special considerations for common skin disorders. Am Fam Physician. 2013;87:850-856.
- Nijhawan RI, Jacob SE, Woolery-Lloyd H. Skin of color education in dermatology residency programs: does residency training reflect the changing demographics of the United States? J Am Acad Dermatol. 2008;59:615-618.
Practice Points
- Direct Google image searches largely deliver accurate results for common dermatological diagnoses.
- Greater effort should be made to include more publicly available images for dermatological diseases in darker skin types.
Optimal MPE management requires early pulmonology referral
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary.
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary.
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
LOS ANGELES – About half of patients with symptomatic malignant pleural effusions at McGill University Health Centre in Montreal had unnecessary procedures and hospital admissions before definitive treatment with chemical pleurodesis or indwelling pleural catheters, according to researchers.
Instead of chest taps to relieve symptoms followed by referrals for definitive treatment, some patients got chest tubes – without pleurodesis – after presenting to the emergency department and being referred to radiology; they were then admitted to the hospital for a few days while the tubes were in place. In short, cancer patients were wasting what time they had left on medical care they didn’t need, and incurring unnecessary costs, said lead investigator Benjamin Shieh, MD, formerly at McGill but now an interventional pulmonology fellow at the University of Calgary.
McGill is a tertiary care center able to perform both definitive procedures, so “we should be a center of excellence. I imagine there are similar situations” at other hospitals, especially those without the resources of McGill, Dr. Shieh said at the annual meeting of the American College of Chest Physicians.
McGill has taken several steps to address the problem, including early ED referral to the pulmonology service and discouraging radiology from placing chest tubes for malignant pleural effusions (MPE). “I think we can avoid a big proportion of hospitalizations for MPE, and certainly a proportion of repeat [ED] visits,” said senior author Anne Gonzalez, MD, an attending pulmonologist at McGill.
The investigators looked into the issue after noting that a lot of their MPE cases had been hospitalized with chest tubes. They reviewed 72 symptomatic MPE cases in 69 patients treated in 2014 and 2015. Management was ideal in 36 cases (50%), meaning that, prior to definitive treatment, patients had no more than two pleural taps for symptom relief, no more than one ED visit, no chest tubes without pleurodesis, and no hospitalizations. “We thought this would be reasonable to try to achieve for MPE,” since there’s no definition of ideal management, Dr. Shieh said.
Nonideal patients had a mean of 2.5 pleural procedures – almost twice the number in the ideal group – before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed in 27 cases (38%) for an average of 3.7 days; 28 cases (39%) were hospitalized. Nonideal patients were far more likely to present first to the ED, and ED presentations were more likely to get chest tubes and be admitted. All the cases were eventually treated definitively, 68 with indwelling pleural catheters and 4 by thoracoscopic talc insufflation. Time from initial presentation to definitive palliation was about 1 month in both groups. The investigators didn’t consider rate of effusion recurrence, which might help explain why the ideal group wasn’t treated sooner; they might not have needed it. The higher number of ED visits in the nonideal group suggests that they may have had quicker recurrences, and should have been treated sooner, Dr. Gonzalez said.
The patients were 70 years old, on average, and about 60% were women. Lung and breast were the most common cancers.
There was no industry funding for the work, and the investigators had no disclosures.
AT CHEST 2016
Key clinical point:
Major finding: Those patients had a mean of 2.5 pleural procedures before definitive palliation, with no respiratory consult beforehand. Chest tubes were placed for an average of 3.7 days.
Data source: Review of 72 MPE cases in 69 patients.
Disclosures: There was no industry funding for the work, and the investigators had no disclosures.
POEM procedure effective over the long term in achalasia
The therapeutic endoscopic procedure per-oral endoscopic myotomy (POEM) is safe and has a high clinical success rate at 2 years in patients with the rare esophageal motility disorder achalasia, according to results of the longest follow-up study to date.
The research team said that achalasia is characterized by the loss of enteric neurons, which results in impaired relaxation of the lower esophageal sphincter and absence of esophageal peristalsis.
The newer procedure, called POEM, is based on a technique of submucosal endoscopy and endoscopic myotomy. However, while short-term studies have shown it to be safe and effective for achalasia, long-term data have been limited.
“As achalasia is a chronic disease with a risk of recurrence of symptoms after treatment, long-term efficacy, rather than short-term data, is important for decision making surrounding the optimal therapeutic modalities,” wrote the investigators, led by Saowanee Ngamruengphong, MD, of Johns Hopkins Hospital, Baltimore (Gastrointest Endosc. 2016. doi: 10.1016/j.gie.2016.09.017).
The study involved 205 patients with achalasia from 10 centers in the United States, Europe, and Asia. Patients were included in the study if they had at least 2 years of follow-up data available.
Results showed that the overall clinical success – defined by a decrease in Eckardt score to 3 or lower – for the procedure was 91% at 2 years. The Eckardt score (maximum 12) is a composite measure of frequency of symptoms and severity of weight loss.
Overall, 18 patients (8.8%) were considered to have clinical failure (Eckardt score greater than 3) after POEM.
A history of prior pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23).
The researchers noted that the therapeutic success of POEM decreased over time as the clinical success rate of the procedure at 6 months’ follow-up had been 98%.
This is consistent with findings from other studies and also with other procedures such as Heller myotomy and pneumatic dilation.
“After POEM or other standard therapies, patients with achalasia require ongoing follow-up to assess recurrent symptoms with additional evaluation and treatment when indicated,” they wrote.
In terms of safety, the researchers reported procedure-related adverse events in 8.2% of patients, with one patient requiring surgical intervention.
Abnormal esophageal acid exposure and reflux esophagitis were also documented in 37.5% and 18% of patients, respectively.
Multivariate analysis revealed that full-thickness myotomy was independently associated with postoperative reflux esophagitis (adjusted OR, 3.99; 95% CI, 1.16-13.68; P = .002).
The authors noted that while reflux was common after POEM, almost all patients could be successfully treated with proton pump inhibitors.
“Prospective randomized studies comparing POEM and current standard therapy are awaited, but in the meantime, it can be considered an effective alternative option for patients with achalasia where expertise is available,” they concluded.
The therapeutic endoscopic procedure per-oral endoscopic myotomy (POEM) is safe and has a high clinical success rate at 2 years in patients with the rare esophageal motility disorder achalasia, according to results of the longest follow-up study to date.
The research team said that achalasia is characterized by the loss of enteric neurons, which results in impaired relaxation of the lower esophageal sphincter and absence of esophageal peristalsis.
The newer procedure, called POEM, is based on a technique of submucosal endoscopy and endoscopic myotomy. However, while short-term studies have shown it to be safe and effective for achalasia, long-term data have been limited.
“As achalasia is a chronic disease with a risk of recurrence of symptoms after treatment, long-term efficacy, rather than short-term data, is important for decision making surrounding the optimal therapeutic modalities,” wrote the investigators, led by Saowanee Ngamruengphong, MD, of Johns Hopkins Hospital, Baltimore (Gastrointest Endosc. 2016. doi: 10.1016/j.gie.2016.09.017).
The study involved 205 patients with achalasia from 10 centers in the United States, Europe, and Asia. Patients were included in the study if they had at least 2 years of follow-up data available.
Results showed that the overall clinical success – defined by a decrease in Eckardt score to 3 or lower – for the procedure was 91% at 2 years. The Eckardt score (maximum 12) is a composite measure of frequency of symptoms and severity of weight loss.
Overall, 18 patients (8.8%) were considered to have clinical failure (Eckardt score greater than 3) after POEM.
A history of prior pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23).
The researchers noted that the therapeutic success of POEM decreased over time as the clinical success rate of the procedure at 6 months’ follow-up had been 98%.
This is consistent with findings from other studies and also with other procedures such as Heller myotomy and pneumatic dilation.
“After POEM or other standard therapies, patients with achalasia require ongoing follow-up to assess recurrent symptoms with additional evaluation and treatment when indicated,” they wrote.
In terms of safety, the researchers reported procedure-related adverse events in 8.2% of patients, with one patient requiring surgical intervention.
Abnormal esophageal acid exposure and reflux esophagitis were also documented in 37.5% and 18% of patients, respectively.
Multivariate analysis revealed that full-thickness myotomy was independently associated with postoperative reflux esophagitis (adjusted OR, 3.99; 95% CI, 1.16-13.68; P = .002).
The authors noted that while reflux was common after POEM, almost all patients could be successfully treated with proton pump inhibitors.
“Prospective randomized studies comparing POEM and current standard therapy are awaited, but in the meantime, it can be considered an effective alternative option for patients with achalasia where expertise is available,” they concluded.
The therapeutic endoscopic procedure per-oral endoscopic myotomy (POEM) is safe and has a high clinical success rate at 2 years in patients with the rare esophageal motility disorder achalasia, according to results of the longest follow-up study to date.
The research team said that achalasia is characterized by the loss of enteric neurons, which results in impaired relaxation of the lower esophageal sphincter and absence of esophageal peristalsis.
The newer procedure, called POEM, is based on a technique of submucosal endoscopy and endoscopic myotomy. However, while short-term studies have shown it to be safe and effective for achalasia, long-term data have been limited.
“As achalasia is a chronic disease with a risk of recurrence of symptoms after treatment, long-term efficacy, rather than short-term data, is important for decision making surrounding the optimal therapeutic modalities,” wrote the investigators, led by Saowanee Ngamruengphong, MD, of Johns Hopkins Hospital, Baltimore (Gastrointest Endosc. 2016. doi: 10.1016/j.gie.2016.09.017).
The study involved 205 patients with achalasia from 10 centers in the United States, Europe, and Asia. Patients were included in the study if they had at least 2 years of follow-up data available.
Results showed that the overall clinical success – defined by a decrease in Eckardt score to 3 or lower – for the procedure was 91% at 2 years. The Eckardt score (maximum 12) is a composite measure of frequency of symptoms and severity of weight loss.
Overall, 18 patients (8.8%) were considered to have clinical failure (Eckardt score greater than 3) after POEM.
A history of prior pneumatic dilation was associated with long-term treatment failure (odds ratio, 3.41; 95% confidence interval, 1.25-9.23).
The researchers noted that the therapeutic success of POEM decreased over time as the clinical success rate of the procedure at 6 months’ follow-up had been 98%.
This is consistent with findings from other studies and also with other procedures such as Heller myotomy and pneumatic dilation.
“After POEM or other standard therapies, patients with achalasia require ongoing follow-up to assess recurrent symptoms with additional evaluation and treatment when indicated,” they wrote.
In terms of safety, the researchers reported procedure-related adverse events in 8.2% of patients, with one patient requiring surgical intervention.
Abnormal esophageal acid exposure and reflux esophagitis were also documented in 37.5% and 18% of patients, respectively.
Multivariate analysis revealed that full-thickness myotomy was independently associated with postoperative reflux esophagitis (adjusted OR, 3.99; 95% CI, 1.16-13.68; P = .002).
The authors noted that while reflux was common after POEM, almost all patients could be successfully treated with proton pump inhibitors.
“Prospective randomized studies comparing POEM and current standard therapy are awaited, but in the meantime, it can be considered an effective alternative option for patients with achalasia where expertise is available,” they concluded.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: The therapeutic endoscopic procedure per-oral endoscopic myotomy (POEM) has a high clinical success rate at 2 years in patients with achalasia.
Main finding: Overall clinical success for the procedure – defined by a decrease in Eckardt score to 3 or lower – was 91% at 2 years’ follow-up.
Data source: Retrospective study of 205 patients with achalasia from 10 centers across the United States, Europe, and Asia.
Disclosures: Several of the authors are consultants for Medtronic, Boston Scientific, and Sandhill Scientific, but no conflicts of interest were declared in relation to the current paper.
Targeting HER1/2 falls flat in bladder cancer trial
Patients with metastatic urothelial bladder cancer (UBC) overexpressing HER1 or HER2 did not benefit from a course of lapatinib maintenance therapy following chemotherapy, a U.K.-based research group reported.
The phase III study, led by Thomas Powles, MD, of Queen Mary University of London, randomized 232 patients (mean age 71, about 75% male) with HER1- or HER2-positive metastatic UBC who had not progressed during platinum-based chemotherapy to placebo or lapatinib (Tykerb), an oral medication that targets HER1 and HER2 and is marketed for use in some breast cancers. The lapatinib-treated group saw no significant gains in either progression-free (PFS) or overall survival (OS), Dr. Powles and associates reported (J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2015.66.3468).
The median PFS for patients receiving lapatinib 1,500 mg daily was 4.5 months, compared with 5.1 months for the placebo group (hazard ratio, 1.07; 95% CI, 0.81-1.43; P = .63), while OS after chemotherapy was 12.6 and 12 months, respectively (HR 0.96; 95% CI, 0.70-1.31; P = .80). A subgroup of patients strongly positive for either or both receptors did not see significant OS or PFS benefit associated with lapatinib, a finding that the investigators said reinforced a lack of benefit.
While previous studies have indicated roles for both HER1 and HER2 in bladder cancer progression, targeting them “may not be of clinical benefit in UBC,” Dr. Powles and his colleagues wrote.
Patients with metastatic UBC have short overall survival following first-line chemotherapy, and few proven second-line treatment options exist besides additional chemotherapy, whose benefit is controversial, the researchers noted.
Despite this trial’s negative result for postchemotherapy maintenance treatment with lapatinib, Dr. Powles and his colleagues said their study, which screened 446 patients with metastatic UBC before randomizing slightly more than half, nonetheless shed some light on this difficult-to-treat patient group, including identifying three prognostic factors associated with poor outcome: radiologic progression during chemotherapy, visceral metastasis, and poor performance status. Also, they noted, 61% of the screened patients received cisplatin chemotherapy, and 48% had visceral metastasis, “which gives some insight into the current population of patients who receive chemotherapy.”
GlaxoSmithKline and Cancer Research U.K. sponsored the study. Dr. Powles and several coauthors disclosed financial support from GlaxoSmithKline and other pharmaceutical firms.
Patients with metastatic urothelial bladder cancer (UBC) overexpressing HER1 or HER2 did not benefit from a course of lapatinib maintenance therapy following chemotherapy, a U.K.-based research group reported.
The phase III study, led by Thomas Powles, MD, of Queen Mary University of London, randomized 232 patients (mean age 71, about 75% male) with HER1- or HER2-positive metastatic UBC who had not progressed during platinum-based chemotherapy to placebo or lapatinib (Tykerb), an oral medication that targets HER1 and HER2 and is marketed for use in some breast cancers. The lapatinib-treated group saw no significant gains in either progression-free (PFS) or overall survival (OS), Dr. Powles and associates reported (J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2015.66.3468).
The median PFS for patients receiving lapatinib 1,500 mg daily was 4.5 months, compared with 5.1 months for the placebo group (hazard ratio, 1.07; 95% CI, 0.81-1.43; P = .63), while OS after chemotherapy was 12.6 and 12 months, respectively (HR 0.96; 95% CI, 0.70-1.31; P = .80). A subgroup of patients strongly positive for either or both receptors did not see significant OS or PFS benefit associated with lapatinib, a finding that the investigators said reinforced a lack of benefit.
While previous studies have indicated roles for both HER1 and HER2 in bladder cancer progression, targeting them “may not be of clinical benefit in UBC,” Dr. Powles and his colleagues wrote.
Patients with metastatic UBC have short overall survival following first-line chemotherapy, and few proven second-line treatment options exist besides additional chemotherapy, whose benefit is controversial, the researchers noted.
Despite this trial’s negative result for postchemotherapy maintenance treatment with lapatinib, Dr. Powles and his colleagues said their study, which screened 446 patients with metastatic UBC before randomizing slightly more than half, nonetheless shed some light on this difficult-to-treat patient group, including identifying three prognostic factors associated with poor outcome: radiologic progression during chemotherapy, visceral metastasis, and poor performance status. Also, they noted, 61% of the screened patients received cisplatin chemotherapy, and 48% had visceral metastasis, “which gives some insight into the current population of patients who receive chemotherapy.”
GlaxoSmithKline and Cancer Research U.K. sponsored the study. Dr. Powles and several coauthors disclosed financial support from GlaxoSmithKline and other pharmaceutical firms.
Patients with metastatic urothelial bladder cancer (UBC) overexpressing HER1 or HER2 did not benefit from a course of lapatinib maintenance therapy following chemotherapy, a U.K.-based research group reported.
The phase III study, led by Thomas Powles, MD, of Queen Mary University of London, randomized 232 patients (mean age 71, about 75% male) with HER1- or HER2-positive metastatic UBC who had not progressed during platinum-based chemotherapy to placebo or lapatinib (Tykerb), an oral medication that targets HER1 and HER2 and is marketed for use in some breast cancers. The lapatinib-treated group saw no significant gains in either progression-free (PFS) or overall survival (OS), Dr. Powles and associates reported (J Clin Oncol. 2016 Oct 31. doi: 10.1200/JCO.2015.66.3468).
The median PFS for patients receiving lapatinib 1,500 mg daily was 4.5 months, compared with 5.1 months for the placebo group (hazard ratio, 1.07; 95% CI, 0.81-1.43; P = .63), while OS after chemotherapy was 12.6 and 12 months, respectively (HR 0.96; 95% CI, 0.70-1.31; P = .80). A subgroup of patients strongly positive for either or both receptors did not see significant OS or PFS benefit associated with lapatinib, a finding that the investigators said reinforced a lack of benefit.
While previous studies have indicated roles for both HER1 and HER2 in bladder cancer progression, targeting them “may not be of clinical benefit in UBC,” Dr. Powles and his colleagues wrote.
Patients with metastatic UBC have short overall survival following first-line chemotherapy, and few proven second-line treatment options exist besides additional chemotherapy, whose benefit is controversial, the researchers noted.
Despite this trial’s negative result for postchemotherapy maintenance treatment with lapatinib, Dr. Powles and his colleagues said their study, which screened 446 patients with metastatic UBC before randomizing slightly more than half, nonetheless shed some light on this difficult-to-treat patient group, including identifying three prognostic factors associated with poor outcome: radiologic progression during chemotherapy, visceral metastasis, and poor performance status. Also, they noted, 61% of the screened patients received cisplatin chemotherapy, and 48% had visceral metastasis, “which gives some insight into the current population of patients who receive chemotherapy.”
GlaxoSmithKline and Cancer Research U.K. sponsored the study. Dr. Powles and several coauthors disclosed financial support from GlaxoSmithKline and other pharmaceutical firms.
FROM JOURNAL OF CLINICAL ONCOLOGY
Key clinical point: Treatment with lapatinib after chemotherapy does not improve survival in people with HER1- or HER2-positive metastatic urothelial bladder cancer.
Major finding: Median progression-free survival for lapatinib was 4.5 months (95% CI, 2.8-5.4), compared with 5.1 (95% CI, 3.0-5.8) for placebo (HR, 1.07; 95% CI, 0.81-1.43; P = .063).
Data source: A randomized, placebo-controlled trial in which 232 patients with HER1- or HER2-positive disease were assigned treatment with lapatinib (n = 116) or placebo (n = 116) after platinum-based chemotherapy.
Disclosures: GlaxoSmithKline and Cancer Research U.K. sponsored the study. Dr. Powles and several coauthors disclosed financial support from GlaxoSmithKline and other pharmaceutical firms.
PBC patients show brain abnormalities before cirrhosis occurs
Brain abnormalities associated with primary biliary cholangitis (PBC) can be observed via magnetic resonance imaging before significant liver damage occurs, according to V.B.P. Grover, MD, and associates at the Liver Unit and Robert Steiner MRI Unit, MRC Clinical Sciences Centre, Imperial College London.
In a study of 13 newly diagnosed precirrhotic PBC patients and 17 healthy volunteers, mean magnetization transfer ratios (MTR) were lower in the thalamus, putamen, and head of caudate in PBC patients, compared with the control group, with the greatest difference seen in the thalamus. Severity of PBC symptoms did not have any significant effect on MTR.
An increase in the apparent diffusion coefficient was seen in the thalamus of PBC patients; however, no significant difference in cerebral metabolite ratios or pallidal index was observed. No correlation between neuroimaging data, lab data, symptom severity scores, or age was observed.
“Larger scale, and in particular linear studies, will be needed to explore the relationship of this change to symptoms and its response to therapies such as UDCA [ursodeoxycholic acid] and OCA [obeticholic acid]. The presence of brain change so early in the disease process would, however, suggest that the current step-up approach to therapy in which treatment change follows failure of a therapy type may allow the progressive accumulation of brain injury whilst waiting for adequate therapeutic response,” the investigators concluded.
Find the full study in Alimentary Pharmacology & Therapeutics (doi: 10.1111/apt.13797).
Brain abnormalities associated with primary biliary cholangitis (PBC) can be observed via magnetic resonance imaging before significant liver damage occurs, according to V.B.P. Grover, MD, and associates at the Liver Unit and Robert Steiner MRI Unit, MRC Clinical Sciences Centre, Imperial College London.
In a study of 13 newly diagnosed precirrhotic PBC patients and 17 healthy volunteers, mean magnetization transfer ratios (MTR) were lower in the thalamus, putamen, and head of caudate in PBC patients, compared with the control group, with the greatest difference seen in the thalamus. Severity of PBC symptoms did not have any significant effect on MTR.
An increase in the apparent diffusion coefficient was seen in the thalamus of PBC patients; however, no significant difference in cerebral metabolite ratios or pallidal index was observed. No correlation between neuroimaging data, lab data, symptom severity scores, or age was observed.
“Larger scale, and in particular linear studies, will be needed to explore the relationship of this change to symptoms and its response to therapies such as UDCA [ursodeoxycholic acid] and OCA [obeticholic acid]. The presence of brain change so early in the disease process would, however, suggest that the current step-up approach to therapy in which treatment change follows failure of a therapy type may allow the progressive accumulation of brain injury whilst waiting for adequate therapeutic response,” the investigators concluded.
Find the full study in Alimentary Pharmacology & Therapeutics (doi: 10.1111/apt.13797).
Brain abnormalities associated with primary biliary cholangitis (PBC) can be observed via magnetic resonance imaging before significant liver damage occurs, according to V.B.P. Grover, MD, and associates at the Liver Unit and Robert Steiner MRI Unit, MRC Clinical Sciences Centre, Imperial College London.
In a study of 13 newly diagnosed precirrhotic PBC patients and 17 healthy volunteers, mean magnetization transfer ratios (MTR) were lower in the thalamus, putamen, and head of caudate in PBC patients, compared with the control group, with the greatest difference seen in the thalamus. Severity of PBC symptoms did not have any significant effect on MTR.
An increase in the apparent diffusion coefficient was seen in the thalamus of PBC patients; however, no significant difference in cerebral metabolite ratios or pallidal index was observed. No correlation between neuroimaging data, lab data, symptom severity scores, or age was observed.
“Larger scale, and in particular linear studies, will be needed to explore the relationship of this change to symptoms and its response to therapies such as UDCA [ursodeoxycholic acid] and OCA [obeticholic acid]. The presence of brain change so early in the disease process would, however, suggest that the current step-up approach to therapy in which treatment change follows failure of a therapy type may allow the progressive accumulation of brain injury whilst waiting for adequate therapeutic response,” the investigators concluded.
Find the full study in Alimentary Pharmacology & Therapeutics (doi: 10.1111/apt.13797).
FROM ALIMENTARY PHARMACOLOGY & THERAPEUTICS
Doctors have at least seven APM options in 2017
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
Physicians will have several options to choose from when it comes to advanced alternative payment models (APMs) in 2017.
In an Oct. 25 release, the Centers for Medicare & Medicaid Services announced seven models that will be considered advanced APMs in 2017, including the new Oncology Care Model with two-sided risk. Other advanced APM choices will include:
• Comprehensive Primary Care Plus (CPC+).
• Comprehensive ESRD Care Model (Large Dialysis Organization [LDO] arrangement).
• Comprehensive ESRD Care Model (non-LDO arrangement).
• Medicare Shared Savings Program Accountable Care Organizations (ACOs) – Track 2.
• Medicare Shared Savings Program ACOs – Track 3.
• Next Generation ACO Model.
For the 2017 performance year, CMS estimates that 70,000-120,000 clinicians will participate in an advanced APM. In 2018, more than 125,000 clinicians will likely participate, according to CMS. The agency plans to reopen applications for new practices in the Comprehensive Primary Care Plus (CPC+) model and the Next Generation ACO model for the 2018 performance year.
Other models available for the 2018 performance year will include:
• ACO – Track 1+.
• New voluntary bundled payment model.
• Comprehensive Care for Joint Replacement Payment Model (Certified Electronic Health Record Technology [CEHRT] track).
• Advancing Care Coordination through Episode Payment Models – Track 1 (CEHRT).
For performance years 2017 and 2018, participation requirements will apply only to Medicare payments and physicians who treat Medicare patients. Starting in 2019, clinicians may also meet an alternative standard for advanced APMs that will include non-Medicare payments and patients.
“With these new opportunities, CMS expects that by the 2018 performance period, 25% of clinicians in the Quality Payment Program will earn incentive payments by being a part of these advanced models,” Patrick Conway, MD, CMS deputy administrator said in a statement. “Thanks to MACRA and the Innovation Center, we’re striving to see more Medicare patients benefit from better care when they visit their doctor for a knee replacement, receive cancer treatment, or have a coordinated care team manage their complex conditions.”
CMS is accepting feedback from physicians on the Quality Payment Program final rule until Dec. 17. Doctors can submit their comments and suggestions electronically through the CMS e-Regulation website.
AGA supports physician-focused payment models (PFPMs) tailored to the practice and goals of GIs through the development of episodes of care. We appreciate that CMS has provided flexibility to allow more physicians to be eligible to participate in APMs and are hopeful that there will be new options in the future for gastroenterologists to demonstrate their value and maximize their earnings under APMs.
[email protected]
On Twitter @legal_med
AGA Resource
AGA is committed to preparing you for success in possible new reimbursement environments. Learn more about bundled and episode payment models at http://www.gastro.org/practice-management/quality/bundled-payment-options.
Mitral valve disease often missed in pulmonary hypertension
LOS ANGELES – Dyspnea in pulmonary hypertension is caused by mitral valve disease until proven otherwise, according to Paul Forfia, MD, director of pulmonary hypertension, right heart failure, and pulmonary thromboendarterectomy at Temple University, Philadelphia.
Although mitral valve disease is a well-recognized cause of pulmonary hypertension, its significance is often underestimated in practice.
“Whether the valve is regurgitant or stenotic makes absolutely no difference. When you delay” repair or replacement, “the patient keeps getting sicker,” he said. In time, “everyone is standing around wringing their hands going, ‘Oh my god, what are we going to do? Are you serious? Fix the valve.’ We see this type of patient a couple times a month,” Dr. Forfia said at the American College of Chest Physicians annual meeting.
“I have seen lifesaving mitral valve surgery put off for many years in patients with pulmonary hypertension, when all they needed was to have their valve fixed,” he said.
Whatever the case, pulmonologists who want the valve fixed often end up playing patient ping pong with cardiologists who want the hypertension controlled beforehand, but “if I treat the pulmonary circulation first, all I am going to do is unmask the left heart failure. There will be no functional improvement whatsoever,” Dr. Forfia said.
Surgery is the best solution as long as patients are well enough to recover. “With pulmonary hypertension in the setting of severe mitral valve regurgitation or stenosis, whether the pulmonary hypertension is related to passive left heart congestion or associated with pulmonary arteriopathy, the only sensible option is to correct the underlying valvular abnormality,” he said. The surgery should be done at an institution capable of managing postop pulmonary arteriopathy, if present.
The ping pong solution is to send patients to an expert pulmonology center; the mitral valve problem will be spotted right away.
“There is no pulmonary pressure cutoff that should prohibit surgery” in patients able to recover. “There is no such thing as a pulmonary artery pressure too high to be explained by mitral valve disease. The pulmonary pressure can be as high as it wants to be. You will get nowhere by thinking the pressure is too high to address the valve,” Dr. Forfia said.
Often “you hear, ‘I’m afraid the person is going to die on the table.’ I always say ‘if the patient is not going to die on the table, they are going to die in their living room of progressive heart failure because you [didn’t] fix their valve. I have never had a patient with pulmonary hypertension not separate from cardiopulmonary bypass. It’s a myth,” he said.
When there’s a “question if the dyspnea is coming from the mitral valve, we routinely use exercise right heart catheterization to probe the situation. We have a recumbent bike in the cath lab. You’ll often provoke significant left heart congestion with a low workload. It’s very revealing to the significance of mitral valve disease,” he said.
Aortic valve disease is also missed in pulmonary hypertension. “It’s not [a] similar” problem; “it’s the same” problem, Dr. Forfia said.
Dr. Forfia is a consultant for Bayer, Actelion, and United Therapeutics.
LOS ANGELES – Dyspnea in pulmonary hypertension is caused by mitral valve disease until proven otherwise, according to Paul Forfia, MD, director of pulmonary hypertension, right heart failure, and pulmonary thromboendarterectomy at Temple University, Philadelphia.
Although mitral valve disease is a well-recognized cause of pulmonary hypertension, its significance is often underestimated in practice.
“Whether the valve is regurgitant or stenotic makes absolutely no difference. When you delay” repair or replacement, “the patient keeps getting sicker,” he said. In time, “everyone is standing around wringing their hands going, ‘Oh my god, what are we going to do? Are you serious? Fix the valve.’ We see this type of patient a couple times a month,” Dr. Forfia said at the American College of Chest Physicians annual meeting.
“I have seen lifesaving mitral valve surgery put off for many years in patients with pulmonary hypertension, when all they needed was to have their valve fixed,” he said.
Whatever the case, pulmonologists who want the valve fixed often end up playing patient ping pong with cardiologists who want the hypertension controlled beforehand, but “if I treat the pulmonary circulation first, all I am going to do is unmask the left heart failure. There will be no functional improvement whatsoever,” Dr. Forfia said.
Surgery is the best solution as long as patients are well enough to recover. “With pulmonary hypertension in the setting of severe mitral valve regurgitation or stenosis, whether the pulmonary hypertension is related to passive left heart congestion or associated with pulmonary arteriopathy, the only sensible option is to correct the underlying valvular abnormality,” he said. The surgery should be done at an institution capable of managing postop pulmonary arteriopathy, if present.
The ping pong solution is to send patients to an expert pulmonology center; the mitral valve problem will be spotted right away.
“There is no pulmonary pressure cutoff that should prohibit surgery” in patients able to recover. “There is no such thing as a pulmonary artery pressure too high to be explained by mitral valve disease. The pulmonary pressure can be as high as it wants to be. You will get nowhere by thinking the pressure is too high to address the valve,” Dr. Forfia said.
Often “you hear, ‘I’m afraid the person is going to die on the table.’ I always say ‘if the patient is not going to die on the table, they are going to die in their living room of progressive heart failure because you [didn’t] fix their valve. I have never had a patient with pulmonary hypertension not separate from cardiopulmonary bypass. It’s a myth,” he said.
When there’s a “question if the dyspnea is coming from the mitral valve, we routinely use exercise right heart catheterization to probe the situation. We have a recumbent bike in the cath lab. You’ll often provoke significant left heart congestion with a low workload. It’s very revealing to the significance of mitral valve disease,” he said.
Aortic valve disease is also missed in pulmonary hypertension. “It’s not [a] similar” problem; “it’s the same” problem, Dr. Forfia said.
Dr. Forfia is a consultant for Bayer, Actelion, and United Therapeutics.
LOS ANGELES – Dyspnea in pulmonary hypertension is caused by mitral valve disease until proven otherwise, according to Paul Forfia, MD, director of pulmonary hypertension, right heart failure, and pulmonary thromboendarterectomy at Temple University, Philadelphia.
Although mitral valve disease is a well-recognized cause of pulmonary hypertension, its significance is often underestimated in practice.
“Whether the valve is regurgitant or stenotic makes absolutely no difference. When you delay” repair or replacement, “the patient keeps getting sicker,” he said. In time, “everyone is standing around wringing their hands going, ‘Oh my god, what are we going to do? Are you serious? Fix the valve.’ We see this type of patient a couple times a month,” Dr. Forfia said at the American College of Chest Physicians annual meeting.
“I have seen lifesaving mitral valve surgery put off for many years in patients with pulmonary hypertension, when all they needed was to have their valve fixed,” he said.
Whatever the case, pulmonologists who want the valve fixed often end up playing patient ping pong with cardiologists who want the hypertension controlled beforehand, but “if I treat the pulmonary circulation first, all I am going to do is unmask the left heart failure. There will be no functional improvement whatsoever,” Dr. Forfia said.
Surgery is the best solution as long as patients are well enough to recover. “With pulmonary hypertension in the setting of severe mitral valve regurgitation or stenosis, whether the pulmonary hypertension is related to passive left heart congestion or associated with pulmonary arteriopathy, the only sensible option is to correct the underlying valvular abnormality,” he said. The surgery should be done at an institution capable of managing postop pulmonary arteriopathy, if present.
The ping pong solution is to send patients to an expert pulmonology center; the mitral valve problem will be spotted right away.
“There is no pulmonary pressure cutoff that should prohibit surgery” in patients able to recover. “There is no such thing as a pulmonary artery pressure too high to be explained by mitral valve disease. The pulmonary pressure can be as high as it wants to be. You will get nowhere by thinking the pressure is too high to address the valve,” Dr. Forfia said.
Often “you hear, ‘I’m afraid the person is going to die on the table.’ I always say ‘if the patient is not going to die on the table, they are going to die in their living room of progressive heart failure because you [didn’t] fix their valve. I have never had a patient with pulmonary hypertension not separate from cardiopulmonary bypass. It’s a myth,” he said.
When there’s a “question if the dyspnea is coming from the mitral valve, we routinely use exercise right heart catheterization to probe the situation. We have a recumbent bike in the cath lab. You’ll often provoke significant left heart congestion with a low workload. It’s very revealing to the significance of mitral valve disease,” he said.
Aortic valve disease is also missed in pulmonary hypertension. “It’s not [a] similar” problem; “it’s the same” problem, Dr. Forfia said.
Dr. Forfia is a consultant for Bayer, Actelion, and United Therapeutics.
EXPERT ANALYSIS FROM CHEST 2016
Weight loss procedure is linked to subsequent substance misuse
NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.
“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.
LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),
After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.
In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.
But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.
After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.
The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.
With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.
Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.
“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.
She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.
John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.
“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.
Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.
The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.
“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.
LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),
After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.
In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.
But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.
After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.
The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.
With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.
Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.
“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.
She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.
John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.
“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.
Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.
The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
NEW ORLEANS – Severely obese patients who undergo Roux-en-Y gastric bypass surgery are subsequently at sharply increased risk for new-onset alcohol use disorder as well as for treatment of substance use disorder, compared with others who opt for a laparoscopic adjustable banding procedure for weight loss, Wendy C. King, PhD, reported at a meeting presented by the Obesity Society of America and the American Society for Metabolic and Bariatric Surgery.
This new finding from the NIH-sponsored Longitudinal Assessment of Bariatric Surgery–2 study (LABS-2) has important implications for clinical practice.
“Patients considering bariatric surgery really should be informed of this surgery-specific risk. Also, alcohol use disorder screening, evaluation, intervention, and referral should be incorporated as part of regular presurgical and definitely also postoperative care. And because many patients don’t return to their surgeon for long-term postoperative care, it’s important that clinicians in primary care and other specialties are really looking for this problem in long-term follow-up,” said Dr. King, an epidemiologist at the University of Pittsburgh.
LABS-2 is an observational cohort study of patients undergoing first-time bariatric surgery at 10 participating U.S. hospitals, all of which have academic ties and are rated as bariatric surgery centers of excellence. Dr. King presented 5-year postsurgical follow-up data on 1,481 patients who had Roux-en-Y gastric bypass (RYGB) and 522 with laparoscopic adjustable gastric banding (LAGB). Independently of their regular clinical care visits, participants were assessed annually for their alcohol use and its consequences using the Alcohol Use Disorders Identification Test (AUDIT), use of illicit drugs within the past year, and whether they had undergone hospitalization or counseling for alcohol or drug problems. A score of 8 or more points on the AUDIT was deemed an indication of symptoms of alcohol use disorder (AUD),
After eliminating from consideration the 7% of patients with AUD symptoms at baseline, the cumulative incidence of AUD symptoms in the RYGB patients climbed from zero to 20.8% by the end of the fifth year of follow-up. Treatment for a substance use disorder occurred in 3.5% of RYGB patients during their first 5 years postsurgery, and 7.5% admitted to illicit drug use, said Dr. King.
In contrast, the cumulative incidence of AUD symptoms through 5 years in the LAGB patients was only 11.3%, less than 1% underwent treatment for a substance use disorder, and 4.9% said they had used illicit drugs.
But LABS-2 is not a randomized trial. Patients chose their bariatric procedure together with their surgeon. For this reason, it was important to perform a multivariate regression analysis adjusted for sociodemographics, social support, psychiatric treatment, lifetime history of psychiatric hospitalization, baseline smoking and alcohol consumption, and other potential confounders.
After performing this statistical exercise, the RYGB patients remained at an adjusted 2.05-fold increased risk of AUD symptoms, compared with the LAGB patients, as well as at 3.83-fold greater risk of treatment for a substance use disorder.
The 1.6-fold increased rate of illicit drug use in the RYGB group didn’t achieve statistical significance. Moreover, on closer examination, most of this illicit drug use involved marijuana, and its use in the post–bariatric surgery population appeared to mirror secular trends in the United States as a whole, according to Dr. King.
With her coinvestigators, Dr. King searched for presurgical risk factors that might predict postsurgical substance misuse. Perhaps the most interesting finding concerned the factors that weren’t predictive, including education, unemployment, score on the Beck Depression Inventory, SF-36 mental component summary score, race, marital status, binge eating, loss of control eating, and body mass index.
Lower social support prior to surgery was associated with increased risk for developing AUD symptoms during the first 5 years after bariatric surgery. Younger age and smoking at baseline were associated with increased rates of postoperative AUD symptoms, substance use disorder treatment, and illicit drug use. A history of psychiatric treatment was associated with increased rates of substance use disorder treatment and illicit drug use.
“That could indicate greater medical surveillance among those patients or greater willingness to get treatment, since they’d had treatment for other psychiatric issues in the past,” Dr. King speculated.
She described the study’s strengths as its large size, geographically diverse patient population, unusually high retention over time, compared with other bariatric surgery studies, and the use of AUDIT, a validated and reliable screening tool. The major limitations are that investigators didn’t inquire about illicit use of opioids and benzodiazepines, and recipients of gastric sleeve procedures weren’t included in the long-term follow-up analysis because LABS-2 began before the gastric sleeve boomed in popularity.
John M. Morton, MD, a former president of the American Society for Metabolic and Bariatric Surgery, predicted that a similar study that included gastric sleeve patients would show them to have the same unremarkable postoperative rates of substance misuse as the LAGB group.
“I want to emphasize that this increased incidence of alcohol problems in the Roux-en-Y gastric bypass patients is maybe not so much a psychological issue as it is a physiologic one,” added Dr. Morton, chief of bariatric and minimally invasive surgery at Stanford (Calif.) School of Medicine.
Dr. King agreed. “Just in the last year and a half there have been some great pharmacokinetic studies showing that the Roux-en-Y affects alcohol metabolism and absorption, as well as studies in rodent models that suggest alcohol produces increased neurobiologic reward,” she noted.
The LABS-2 study is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. King reported having no relevant financial interests.
AT OBESITY WEEK 2016
Key clinical point:
Major finding: In the first 5 years following bariatric surgery, patients who underwent Roux-en-Y gastric bypass were twice as likely to develop new-onset alcohol use disorder and nearly four times more likely to be treated for substance use disorder, compared with recipients of laparoscopic gastric banding.
Data source: The LABS-2 study is an observational cohort study involving more than 2,000 patients in long-term follow-up after undergoing Roux-en-Y gastric bypass or laparoscopic adjustable banding.
Disclosures: LABS-2 is funded by the National Institute of Diabetes and Digestive and Kidney Diseases. The presenter reported having no relevant financial interests.
Bezlotoxumab reduces CDI recurrence across antibiotic subgroups
NEW ORLEANS – The monoclonal antibody bezlotoxumab significantly reduces the risk of Clostridium difficile infection (CDI) recurrence in adults receiving standard of care antibiotic treatment, regardless of whether that treatment is with metronidazole, vancomycin, or fidaxomicin, according to an analysis of data from the MODIFY I and II trials.
The global, randomized, double-blind, placebo-controlled trials demonstrated that bezlotoxumab was safe and effective for preventing CDI recurrence, and the current prespecified analysis further showed that choice of standard of care antibiotic therapy did not affect the outcomes, Erik R. Dubberke, MD, of Washington University in St. Louis, reported at IDWeek, an annual scientific meeting on infectious diseases.
Consistent with the overall study results, clinical cure rates were similar with bezlotoxumab and placebo, regardless of the standard of care antibiotic received (80% vs. 80.3%, respectively, overall; 81% vs. 81.3% in the metronidazole group; 78.5% vs. 79.6% in the vancomycin group; and 86.7% vs. 76.9% in the fidaxomicin group), he said.
However, CDI recurrence rates were lower among those who received bezlotoxumab, compared with those who received placebo in all three standard of care subgroups, with 10%, 15%, and 12% fewer bezlotoxumab vs. placebo patients experiencing recurrence in the metronidazole, vancomycin, and fidaxomicin groups, respectively, and 12% fewer experiencing recurrence overall.
The primary endpoint of CDI recurrence was defined in the studies as a new episode of diarrhea (at least three unformed stools in 24 hours) and a positive stool test for toxigenic C. difficile after clinical cure of the baseline CDI episode. Clinical cure was defined as standard of care antibiotics given for 14 days or less and no diarrhea for 2 consecutive days after completing standard of care treatment.
Of note, the patients in the vancomycin group were older and sicker, and had more risk factors for CDI, he said, noting, for example, that 57% of vancomycin patients were aged at least 65 years and 33% were aged at least 75 years, vs. 46% and 26% for metronidazole, respectively, and 46% and 18% for fidaxomicin; 72% of vancomycin patients were inpatients, compared with 65% and 50% of metronidazole and fidaxomicin patients.
Further, 19% of vancomycin patients, vs. 13% and 14% of metronidazole and fidaxomicin patients met criteria for severe CDI.
The findings of the current analysis are important, because the incidence of CDI recurrence is about 25%, and the risk increases with each subsequent recurrence, Dr. Dubberke said, concluding that this novel, nonantibiotic approach to prevention of CDI recurrence using bezlotoxumab, which recently received Food and Drug Administration approval for this indication, is of benefit for reducing that risk, regardless of the antibiotic used as part of standard of care therapy for CDI.
Dr. Dubberke reported serving as an investigator, adviser and/or consultant for Merck, Rebiotix, Sanofi Pasteur, and Summit, and receiving consultant fees and/or grant/research support from these companies.
NEW ORLEANS – The monoclonal antibody bezlotoxumab significantly reduces the risk of Clostridium difficile infection (CDI) recurrence in adults receiving standard of care antibiotic treatment, regardless of whether that treatment is with metronidazole, vancomycin, or fidaxomicin, according to an analysis of data from the MODIFY I and II trials.
The global, randomized, double-blind, placebo-controlled trials demonstrated that bezlotoxumab was safe and effective for preventing CDI recurrence, and the current prespecified analysis further showed that choice of standard of care antibiotic therapy did not affect the outcomes, Erik R. Dubberke, MD, of Washington University in St. Louis, reported at IDWeek, an annual scientific meeting on infectious diseases.
Consistent with the overall study results, clinical cure rates were similar with bezlotoxumab and placebo, regardless of the standard of care antibiotic received (80% vs. 80.3%, respectively, overall; 81% vs. 81.3% in the metronidazole group; 78.5% vs. 79.6% in the vancomycin group; and 86.7% vs. 76.9% in the fidaxomicin group), he said.
However, CDI recurrence rates were lower among those who received bezlotoxumab, compared with those who received placebo in all three standard of care subgroups, with 10%, 15%, and 12% fewer bezlotoxumab vs. placebo patients experiencing recurrence in the metronidazole, vancomycin, and fidaxomicin groups, respectively, and 12% fewer experiencing recurrence overall.
The primary endpoint of CDI recurrence was defined in the studies as a new episode of diarrhea (at least three unformed stools in 24 hours) and a positive stool test for toxigenic C. difficile after clinical cure of the baseline CDI episode. Clinical cure was defined as standard of care antibiotics given for 14 days or less and no diarrhea for 2 consecutive days after completing standard of care treatment.
Of note, the patients in the vancomycin group were older and sicker, and had more risk factors for CDI, he said, noting, for example, that 57% of vancomycin patients were aged at least 65 years and 33% were aged at least 75 years, vs. 46% and 26% for metronidazole, respectively, and 46% and 18% for fidaxomicin; 72% of vancomycin patients were inpatients, compared with 65% and 50% of metronidazole and fidaxomicin patients.
Further, 19% of vancomycin patients, vs. 13% and 14% of metronidazole and fidaxomicin patients met criteria for severe CDI.
The findings of the current analysis are important, because the incidence of CDI recurrence is about 25%, and the risk increases with each subsequent recurrence, Dr. Dubberke said, concluding that this novel, nonantibiotic approach to prevention of CDI recurrence using bezlotoxumab, which recently received Food and Drug Administration approval for this indication, is of benefit for reducing that risk, regardless of the antibiotic used as part of standard of care therapy for CDI.
Dr. Dubberke reported serving as an investigator, adviser and/or consultant for Merck, Rebiotix, Sanofi Pasteur, and Summit, and receiving consultant fees and/or grant/research support from these companies.
NEW ORLEANS – The monoclonal antibody bezlotoxumab significantly reduces the risk of Clostridium difficile infection (CDI) recurrence in adults receiving standard of care antibiotic treatment, regardless of whether that treatment is with metronidazole, vancomycin, or fidaxomicin, according to an analysis of data from the MODIFY I and II trials.
The global, randomized, double-blind, placebo-controlled trials demonstrated that bezlotoxumab was safe and effective for preventing CDI recurrence, and the current prespecified analysis further showed that choice of standard of care antibiotic therapy did not affect the outcomes, Erik R. Dubberke, MD, of Washington University in St. Louis, reported at IDWeek, an annual scientific meeting on infectious diseases.
Consistent with the overall study results, clinical cure rates were similar with bezlotoxumab and placebo, regardless of the standard of care antibiotic received (80% vs. 80.3%, respectively, overall; 81% vs. 81.3% in the metronidazole group; 78.5% vs. 79.6% in the vancomycin group; and 86.7% vs. 76.9% in the fidaxomicin group), he said.
However, CDI recurrence rates were lower among those who received bezlotoxumab, compared with those who received placebo in all three standard of care subgroups, with 10%, 15%, and 12% fewer bezlotoxumab vs. placebo patients experiencing recurrence in the metronidazole, vancomycin, and fidaxomicin groups, respectively, and 12% fewer experiencing recurrence overall.
The primary endpoint of CDI recurrence was defined in the studies as a new episode of diarrhea (at least three unformed stools in 24 hours) and a positive stool test for toxigenic C. difficile after clinical cure of the baseline CDI episode. Clinical cure was defined as standard of care antibiotics given for 14 days or less and no diarrhea for 2 consecutive days after completing standard of care treatment.
Of note, the patients in the vancomycin group were older and sicker, and had more risk factors for CDI, he said, noting, for example, that 57% of vancomycin patients were aged at least 65 years and 33% were aged at least 75 years, vs. 46% and 26% for metronidazole, respectively, and 46% and 18% for fidaxomicin; 72% of vancomycin patients were inpatients, compared with 65% and 50% of metronidazole and fidaxomicin patients.
Further, 19% of vancomycin patients, vs. 13% and 14% of metronidazole and fidaxomicin patients met criteria for severe CDI.
The findings of the current analysis are important, because the incidence of CDI recurrence is about 25%, and the risk increases with each subsequent recurrence, Dr. Dubberke said, concluding that this novel, nonantibiotic approach to prevention of CDI recurrence using bezlotoxumab, which recently received Food and Drug Administration approval for this indication, is of benefit for reducing that risk, regardless of the antibiotic used as part of standard of care therapy for CDI.
Dr. Dubberke reported serving as an investigator, adviser and/or consultant for Merck, Rebiotix, Sanofi Pasteur, and Summit, and receiving consultant fees and/or grant/research support from these companies.
AT IDWEEK 2016
Key clinical point:
Major finding: 12% fewer bezlotoxumab vs. placebo patients experienced CDI recurrence.
Data source: A prespecified analysis of data from 1,554 subjects from the MODIFY I and II trials.
Disclosures: Dr. Dubberke reported serving as an investigator, adviser, and/or consultant for Merck, Rebiotix, Sanofi Pasteur, and Summit, and receiving consultant fees and/or grant/research support from these companies.
Diabetes, stroke linked to recurrent C. difficile
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
AGA Resource
AGA offers information to educate your patients about C. difficile and fecal microbiota transplant. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
AGA Resource
AGA offers information to educate your patients about C. difficile and fecal microbiota transplant. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.
LAS VEGAS – Diabetes and stroke are risk factors for recurrent Clostridium difficile infection (CDI), with stroke patients at about 10 times the risk of recurrence.
The underlying cause for the association is a mystery, but one-sided paralysis is one possibility. “A lot of stroke patients may be hemiplegic, and they may be bedridden, so that may be a risk factor by itself. It’s something that may need to be studied in the future,” Alan Putrus, MD, a gastroenterology fellow at St. John Providence Hospital, Detroit, said in an interview.
CDI recurrence rates range from 5% to 47%, depending on the institution. Although risk factors of initial CDI have been well defined, few studies have looked at risk factors associated with recurrence.
In order to get at the question, the researchers conducted a study of 108 initial CDIs and 113 recurrences at two urban and one suburban hospital. Patients who experienced recurrence were matched 1:1 to age- and gender-matched controls with no recurrent CDI.
CDI recurrence rates were 16.5% and 15.9% in the two urban hospitals, and 14.9% in the suburban hospital.
Logistic regression revealed risk factors associated with CDI recurrence, including diabetes (odds ratio, 1.91; 95% confidence interval, 1.05-3.47; P = .04), stroke (OR, 9.73; 95% CI, 1.15-82.35; P = .04), exposure to proton pump inhibitors in the past 3 months (OR, 1.82; 95% CI, 1.03-3.23; P = .04), and admission to an intensive care unit in the past 3 months (OR, 1.95; 95% CI, 1.0-3.83; P = .04).
The results suggest that diabetes and especially stroke may be important risk factors for CDI recurrence, and their presence should prompt physicians to alter patient care accordingly, according to Dr. Putrus.
He stressed the importance of antibiotic stewardship. “Once you find a certain bug or pathogen, try to deescalate the antibiotics as soon as you can. If a patient is diabetic, controlling their blood sugar may also help,” Dr. Putrus said.
Finally, physicians should consider whether proton pump inhibitors are really necessary. Some patients start on PPIs but remain on the drugs long after symptoms have abated. “A lot of patients just have some discomfort in their abdomen, and they never stop taking it. They keep refilling it. So that’s a problem,” said Dr. Putrus.
Dr. Putrus has declared no conflicts of interest.
AGA Resource
AGA offers information to educate your patients about C. difficile and fecal microbiota transplant. Learn more at http://www.gastro.org/patient-care/conditions-diseases/clostridium-difficile-infection.
AT ACG 2016
Key clinical point:
Major finding: Diabetes, stroke, and a history of PPI use were all associated with higher risks of recurrence.
Data source: Case-control, retrospective study.
Disclosures: Dr. Putrus has declared no conflicts of interest.