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Task force affirms value of colorectal cancer screening
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
“The USPSTF should be applauded for taking a global approach to a screening recommendation,” wrote Dr. David F. Ransohoff and Dr. Harold C. Sox in an accompanying editorial (JAMA. 2016 Jun;315:2529-31). “Clinicians and patients will understand the importance of screening and making an informed choice among the seven strategies,” they said. However, “the lack of a statement indicating that the Task Force recommends specific tests or strategies leaves some ambiguity about whether private insurance must cover each of the specific tests,” they noted. The Task Force recognizes the many variables that impact screening in clinical practice, such as variations in the accuracy of imaging and stool-based screening tests, the commentators wrote.
“The Task Force appears to believe that the most important of these moving parts is the likelihood that the patient will actually undergo screening with a test that has been deemed ‘acceptable.’ The predictors of submitting to different colorectal cancer screening procedures are not known, so the Task Force could not expect the modeling teams to list the predictors of success for each screening procedure. Instead, they provide population-based information about the consequences of the strategies that, together with the patient’s preferences, can inform a shared decision.”
Dr. Ransohoff is affiliated with the University of North Carolina, Chapel Hill, and has had no financial relationships with colorectal cancer–related product manufacturers since 2002. Dr. Sox is affiliated with the Geisel School of Medicine in Hanover, N.H., and had no current relevant financial conflicts to disclose.
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
Colorectal cancer screening by a variety of methods is worthwhile and recommended for all adults aged 50-75 years, according to the latest recommendations from the U.S. Preventive Services Task Force. The USPSTF statement and summary of evidence were published in JAMA on June 15.
In addition, the USPSTF recommended selective screening for older adults aged 76-85 years, depending on their health status and screening history.
A team of researchers led by Dr. Jennifer S. Lin of Kaiser Permanente in Portland, Ore., reviewed studies on colorectal cancer screening published between Jan.1, 2008, and Dec. 31, 2014, with surveillance continuing through Feb. 23, 2016 (JAMA. 2016 Jun;315:2576-94 [doi: 10.1001/jama.2016.3332]). The USPSTF’s last recommendations on colorectal cancer screening were released in 2008.
“Although CRC screening has a large body of supporting evidence, additional research is still needed to weigh the relative benefits and harms of each test within a program of screening” for average-risk adults, the researchers noted.
The final recommendation statement includes three screening options that carry over from the 2008 guidelines: colonoscopy, sigmoidoscopy, and fecal immunochemical testing (FIT) with occult blood.
Other options now recommended include computed tomographic colonography (CTC), fecal immunochemical tests with DNA (FIT-DNA), guaiac-based fecal occult blood testing (gFOBT), and sigmoidoscopy plus FIT.
Some highlights from the analysis: Four randomized trials including 458,002 patients showed that one-time or two-time screening with flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73, the researchers wrote.
In addition, the researchers found that CTC had 73%-98% sensitivity and 89%-91% specificity to detect adenomas 6 mm and larger, compared with colonoscopy in seven studies. However, the risk of harm from low-dose ionizing radiation remains a consideration.
For diagnostic accuracy, colonoscopy showed per-person sensitivity of 89%-98% for adenomas 10 mm or larger, and 75%-93% for adenomas 6 mm or larger, in studies comparing it with CTC or as an adjunct to CTC. However, studies showing applicability to community practices were limited.
Fecal immunochemical tests (FITs) showed sensitivity ranging from 73% to 88% and specificity from 90% to 96%.
Data from five randomized, controlled trials evaluating multiple rounds of biennial screening using gFOBT showed a significant reduction in colorectal cancer mortality, from a relative risk of 0.91 at 19.5 years to a relative risk of 0.78 at 30 years.
Colonoscopy remains the standard by which other tests are assessed, although it has the highest risk of procedural complications, the researchers said. Three new randomized, controlled trials involving screening colonoscopy in average-risk adults scheduled for completion in 2021, 2026, and 2027, may yield more information on incidence and mortality, they added.
The evidence report and review was limited by its focus on average-risk adults; it did not address factors including screening for high-risk adults, availability and access to tests, potential risks of overdiagnosis, and overuse of screening after adenoma detection, the researchers said. In addition, “data are still needed on the differential uptake of and adherence to screening modalities and on continued adherence to repeated rounds of screening and diagnostic follow-up to screening over longer periods,” they said. However, they concluded, “colonoscopy, flexible sigmoidoscopy, CTC, and various stool tests have differing levels of evidence to support their use in CRC screening, ability to detect CRC and precursor lesions, and risk of serious adverse events in average-risk adults.”
The researchers had no relevant financial conflicts to disclose. The research was supported by the Agency for Healthcare Research and Quality under a contract with the U.S. Preventive Services Task Force.
The final recommendation statement is available online at USPSTF.
FROM JAMA
Key clinical point: Colorectal cancer screening is recommended for all adults aged 50-75 years, and several screening methods are supported by evidence-based research.
Major finding: In four randomized trials including 458,002 patients, one- or two-time screening via flexible sigmoidoscopy was associated with decreased mortality from colorectal cancer, compared with no screening, for an incidence rate ratio of 0.73.
Data source: Studies were selected based on searches of MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials.
Disclosures: The researchers had no relevant financial conflicts to disclose. The research was supported by AHRQ under a contract with the USPSTF.
TNF Blocker Safety May Differ in RA and Psoriasis Patients
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
TNF blocker safety may differ in RA and psoriasis patients
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Rheumatoid arthritis patients on anti–tumor necrosis factor medications had approximately twice the rate of serious adverse events as did psoriasis patients on the same medications, based on data from a pair of prospective studies of about 4,000 adults.
The findings were published online in the British Journal of Dermatology.
“Current trends are to extrapolate the abundant literature existing on the safety of TNF antagonists in RA to define safety management for psoriasis,” wrote Dr. Ignacio García-Doval of the Fundación Academia Española de Dermatología y Venereología, Madrid, and colleagues. However, data on the similarity of risk associated with anti-TNF medications in RA and psoriasis are limited, the investigators said (BJD. 2016. doi: 10.1111/bjd.14776).
The researchers compared data from two similarly designed, overlapping prospective safety registry studies of anti-TNF medications in RA patients (the BIOBADASER study) and psoriasis patients (the BIOBADADERM study).
In the cohort of 3,171 RA patients, the researchers identified 1,248 serious or fatal adverse events during 16,230 person-years of follow-up; in the cohort of 946 psoriasis patients, they identified 124 serious or fatal adverse events during 2,760 person-years of follow-up. The resulting incidence rate ratio of psoriasis to RA was 0.6. The increased risk of serious adverse events for RA patients compared with psoriasis patients remained after the investigators controlled for confounding factors including age, sex, treatments, and comorbid conditions including hypertension, diabetes, hypercholesterolemia, and methotrexate therapy, for a hazard ratio of 0.54.
Moreover, the types of serious adverse events were different between the RA and psoriasis groups. Among those with RA, the rates of serious infections, cardiac disorders, respiratory disorders, and infusion reactions were significantly greater among those with RA, while psoriatic patients “had more skin and subcutaneous tissue disorders and hepatobiliary disorders,” the researchers noted.
By contrast, “rates of nonserious adverse events cannot be compared between the two cohorts,” because of differences in definitions, they pointed out. These differences resulted in a nonserious adverse event rate that was more than twice as high in the psoriasis group as in the RA group (582.2 events per 1,000 patient-years vs. 242.8 events per 1,000 patient-years).
Based on the findings, “published safety results of TNF-antagonists in RA cannot be fully extrapolated to psoriasis, as patients with RA have a higher risk and a different pattern of serious adverse events,” they concluded.
The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: TNF-antagonists provoke different adverse events in patients with RA than in those with psoriasis, and safety data should be extrapolated with caution.
Major finding: The risk of serious adverse events associated with anti-TNF therapy was approximately twice as high in RA patients as in psoriasis patients (hazard ratio, 0.54).
Data source: A pair of prospective studies including 4,117 adults with RA or psoriasis who received anti-TNF agents.
Disclosures: The BIOBADADERM project is promoted by the Fundación Academia Española de Dermatología y Venereología, which is supported by the Spanish Medicines and Health Products Agency and by multiple pharmaceutical companies. BIOBADASER received funding from Fundacion Española de Reumatología and the Spanish Medicines and Health Products Agency and grants from numerous pharmaceutical companies. Lead author Dr. Garcia-Doval disclosed travel grants for congresses from Merck/Schering-Plough Pharmaceuticals, Pfizer, and Janssen; the remaining two authors disclosed being a speaker and/or a consultant for several companies, including AbbVie.
Midodrine cuts ICU days in septic shock patients
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
Septic shock patients who received midodrine needed significantly fewer intravenous vasopressors during recovery and had shorter hospital stays, based on data from a retrospective study of 275 adults at a single tertiary care center.
In many institutions, policy dictates that patients must remain in the ICU as long as they need intravenous vasopressors, wrote Dr. Micah R. Whitson of North Shore-LIJ Health System in New Hyde Park, N.Y., and colleagues. “One solution to this problem may be replacement of IV vasopressors with an oral agent.”
“Midodrine facilitated earlier patient transfer from the ICU and more efficient allocation of ICU resources,” the researchers wrote (Chest. 2016;149[6]:1380-83).
The researchers compared data on 135 patients treated with midodrine in addition to an intravenous vasopressor and 140 patients treated with an intravenous vasopressor alone.
Overall, patients given midodrine received intravenous vasopressors for 2.9 days while the other group received intravenous vasopressors for 3.8 days, a significant 24% difference. Hospital length of stay was not significantly different, averaging 22 days in the midodrine group and 24 days in the intravenous vasopressor–only group. However, ICU length of stay averaged 7.5 days in the midodrine group and 9.4 days in the vasopressor-only group, a significant 20% reduction. Further, the midodrine group was significantly less likely to reinstitute intravenous vasopressors than the intravenous vasopressor–only group (5.2% vs. 15%, respectively). ICU and hospital mortality rates were not significantly different between the two groups, Dr. Whitson and associates reported.
Patients in the midodrine group received a starting dose of 10 mg every 8 hours, which was increased incrementally until they no longer needed intravenous vasopressors. The maximum midodrine dose in the study was 18.7 mg every 8 hours, and the average duration of use was 6 days.
The patients’ average age was 65 years in the intravenous vasopressor group and 69 years in the midodrine group. Other demographic factors did not significantly differ between the two groups.
One patient discontinued midodrine before discontinuing an intravenous vasopressor because of bradycardia, which resolved without additional treatment.
The findings were limited by the observational nature of the study and the use of data from a single center, the investigators noted. The results, however, support the safety of midodrine and the study “lays the groundwork for a prospective, randomized controlled trial that will examine efficacy, starting dose, escalation, tapering and appropriate patient selection for midodrine use during recovery from septic shock,” they said.
The researchers had no financial conflicts to disclose.
FROM CHEST
Key clinical point: Midodrine may reduce ICU length of stay by reducing the need for intravenous vasopressors in patients recovering from septic shock.
Major finding: The mean intravenous vasopressor duration was 2.9 days for patients who received midodrine vs. 3.8 days for controls who received intravenous vasopressors alone.
Data source: A retrospective study involving 275 patients that was conducted in a single medical intensive care unit.
Disclosures: The researchers had no financial conflicts to disclose.
Experts endorse metabolic surgery for diabetes intervention
Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.
Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).
The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.
The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.
The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.
“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”
The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.
However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.
The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.
“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.
However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.
“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .
Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.
“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.
However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.
“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .
Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.
“The new guidelines provide much needed guidance for general practitioners, endocrinologists, and diabetes specialists about the use of metabolic surgery in the treatment of obese patients with type 2 diabetes,” wrote Dr. William T. Cefalu and colleagues in an accompanying editorial.
However, “one of the many issues that remains unanswered for metabolic surgery pertains to the exact mechanism of action. Specifically, we now recognize that postoperative improvements in metabolic control occur rapidly and out of proportion to weight loss, yet the physiological and molecular mechanisms underlying these beneficial glycemic effects remain incompletely elucidated,” they wrote. In addition, “before we can fully appreciate the role of metabolic surgery in becoming a readily available, viable option in our treatment algorithm and expand the appropriate candidate pool, we need to fully understand the efficacy, complications, long-term clinical outcomes, and costs. In particular, it will be important to clarify the financial implications to patients, providers, and insurers (both private and government sectors) and to appreciate that these barriers may be hard to overcome in resource poor areas of the world,” they said.
“It is an exciting time for those of us in diabetes research, and the ability to be part of a paradigm change in the understanding, approach, and management of the disease will keep us focused on the next steps to address the larger issue of prevention,” they noted (Diabetes Care. 2016;39:857-60. doi:10.2337/dc16-0686) .
Dr. Cefalu is affiliated with the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, La. He disclosed financial relationships with multiple companies including AstraZeneca, Janssen, MannKind Corp., Intarcia Therapeutics, and Sanofi.
Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.
Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).
The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.
The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.
The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.
“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”
The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.
However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.
The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.
Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus, according to an international consensus statement from 48 clinicians and scholars issued after the Second Diabetes Surgery Summit held as part of the World Congress on Interventional Therapies for Type 2 Diabetes in London in 2015.
Current treatment plans for patients with type 2 diabetes do no include bariatric/metabolic surgery, despite increasing evidence of improved glycemic control and reduced cardiovascular risk factors in surgically treated patients, wrote Dr. Francesco Rubino and colleagues on behalf of members of the Second Diabetes Surgery Summit (DSS-II). The guidelines were endorsed by 45 global medical and scientific societies at the time of publication. The statement was published in a special edition of Diabetes Care (Diabetes Care. 2016;39:861-77. doi:10.2337/dc16-0236).
The guidelines recommend metabolic surgery for patients with type 2 diabetes who have class III obesity (defined as a body mass index of at least 40 kg/m2) or class II obesity (defined as a BMI of 35 kg/m2-39.9 kg/m2). In addition, metabolic surgery should be considered as a option for those patients with type 2 diabetes whose BMI falls within the 30 kg/m2-34.9 kg/m2 range if hyperglycemia remains uncontrolled after treatment attempts with oral or injectable medications. For Asian patients, the BMI thresholds for surgery should be reduced by 2.5 kg/m2, the researchers noted.
The conclusions are based on a review of published evidence on metabolic surgery and type 2 diabetes from January 1, 2005, through September 30, 2015.
The researchers assessed the evidence based on factors including long-term effects of surgery on glycemic control, effectiveness of surgery compared with nonsurgical interventions, comparisons of surgical procedures, and effects of surgery on diabetes complications, cardiovascular risk factors, and mortality. They also considered the short- and long-term safety of different procedures. The recommendations offer guidance on patient selection, pre- and postoperative workups, choice of procedure, and defining goals and success of surgery.
“The success of metabolic surgery needs to be defined in the larger context of comprehensive diabetes care plans,” the researchers noted. “Metabolic surgery should be considered a means to achieve the glycemic control necessary to reduce risk of microvascular complications and CVD.”
The researchers acknowledged that complications from metabolic surgery may require reoperations and rehospitalizations. Other limitations include a lack of evidence in several areas including: cost-effectiveness, optimal nutrition management after surgery, postoperative lifestyle interventions, and long-term effects of surgery, and further research is needed.
However, “there is now sufficient clinical and mechanistic evidence to support inclusion of GI surgery among antidiabetes interventions for people with type 2 diabetes and obesity,” the researchers said. They called for collaboration between clinicians and regulators to recognize the potential value of metabolic surgery for type 2 diabetes and develop appropriate reimbursement plans.
The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.
FROM DIABETES CARE
Key clinical point: Metabolic surgery should be recommended for obese patients with type 2 diabetes mellitus.
Major finding: Surgery is recommended for patients with type 2 diabetes who have a BMI of 35 kg/m2 or higher and should be considered for patients with a BMI of 30 kg/m2-34.9 kg/m2 with uncontrolled hyperglycemia.
Data source: Published evidence on metabolic surgery and type 2 diabetes identified on Medline between January 1, 2005 and September 30, 2015.
Disclosures: The DSS-II and WCITD 2015 were sponsored by the International Diabetes Society Task Force, King’s College London, King’s College Hospital, Johnson & Johnson, Medtronic, Medimmune, Fractyl, DIAMOND MetaCure, Gore, Novo Nordisk, and NGM Biopharmaceuticals. The researchers reported no relevant conflicts.
Early HIV testing tempers transmission
Early and aggressive HIV testing may reduce HIV incidence, according to a data analysis of new HIV diagnoses in San Diego.
From 2006 to 2012, an average of 471 new HIV diagnoses were made in San Diego County annually. Given the increased risk of HIV transmission from recently infected individuals, the San Diego Department of Public Health designed an early testing program to screen those persons at high risk of HIV, wrote Dr. Sanjay R. Mehta of the University of California, San Diego, and colleagues, in Clinical Infectious Diseases (Clin Infect Dis. 2016 May 11. doi:10.1093/cid/ciw161).
HIV testing in San Diego between 1998 and 2012 was relatively stable, and ranged from approximately 9,236 tests in 2006 to approximately 16,797 in 1999. However, the expanded testing program – implemented in late 2011 – resulted in 39,688 tests performed in 2012, and the Early Test identified an average of 17 acute HIV infections (20% of Early Test diagnoses) and 21 early infections (24% of Early Test diagnoses) per year between 2008 and 2012.
Two zip codes in the central region of San Diego County associated with the gay community had the highest prevalence of HIV infection. Zip codes 92103 and 92104 had the highest net HIV importation of all the county zip codes, and several neighboring zip codes had the highest net exportation. “This suggested increased HIV transmission chain termination in the 92103 and 92104 zip codes, areas targeted by the Early Test program,” the researchers said.
“Our analysis demonstrated that the observed decrease in incident diagnoses was associated with the steady increase in testing by the Early Test program and not with an appreciable increase in ART uptake or effectiveness or a decrease in other STIs in the community,” Dr. Mehta and his colleagues added.
The study was supported in part by a grant from the National Institutes of Health. Dr. Mehta had no financial conflicts to disclose.
Early and aggressive HIV testing may reduce HIV incidence, according to a data analysis of new HIV diagnoses in San Diego.
From 2006 to 2012, an average of 471 new HIV diagnoses were made in San Diego County annually. Given the increased risk of HIV transmission from recently infected individuals, the San Diego Department of Public Health designed an early testing program to screen those persons at high risk of HIV, wrote Dr. Sanjay R. Mehta of the University of California, San Diego, and colleagues, in Clinical Infectious Diseases (Clin Infect Dis. 2016 May 11. doi:10.1093/cid/ciw161).
HIV testing in San Diego between 1998 and 2012 was relatively stable, and ranged from approximately 9,236 tests in 2006 to approximately 16,797 in 1999. However, the expanded testing program – implemented in late 2011 – resulted in 39,688 tests performed in 2012, and the Early Test identified an average of 17 acute HIV infections (20% of Early Test diagnoses) and 21 early infections (24% of Early Test diagnoses) per year between 2008 and 2012.
Two zip codes in the central region of San Diego County associated with the gay community had the highest prevalence of HIV infection. Zip codes 92103 and 92104 had the highest net HIV importation of all the county zip codes, and several neighboring zip codes had the highest net exportation. “This suggested increased HIV transmission chain termination in the 92103 and 92104 zip codes, areas targeted by the Early Test program,” the researchers said.
“Our analysis demonstrated that the observed decrease in incident diagnoses was associated with the steady increase in testing by the Early Test program and not with an appreciable increase in ART uptake or effectiveness or a decrease in other STIs in the community,” Dr. Mehta and his colleagues added.
The study was supported in part by a grant from the National Institutes of Health. Dr. Mehta had no financial conflicts to disclose.
Early and aggressive HIV testing may reduce HIV incidence, according to a data analysis of new HIV diagnoses in San Diego.
From 2006 to 2012, an average of 471 new HIV diagnoses were made in San Diego County annually. Given the increased risk of HIV transmission from recently infected individuals, the San Diego Department of Public Health designed an early testing program to screen those persons at high risk of HIV, wrote Dr. Sanjay R. Mehta of the University of California, San Diego, and colleagues, in Clinical Infectious Diseases (Clin Infect Dis. 2016 May 11. doi:10.1093/cid/ciw161).
HIV testing in San Diego between 1998 and 2012 was relatively stable, and ranged from approximately 9,236 tests in 2006 to approximately 16,797 in 1999. However, the expanded testing program – implemented in late 2011 – resulted in 39,688 tests performed in 2012, and the Early Test identified an average of 17 acute HIV infections (20% of Early Test diagnoses) and 21 early infections (24% of Early Test diagnoses) per year between 2008 and 2012.
Two zip codes in the central region of San Diego County associated with the gay community had the highest prevalence of HIV infection. Zip codes 92103 and 92104 had the highest net HIV importation of all the county zip codes, and several neighboring zip codes had the highest net exportation. “This suggested increased HIV transmission chain termination in the 92103 and 92104 zip codes, areas targeted by the Early Test program,” the researchers said.
“Our analysis demonstrated that the observed decrease in incident diagnoses was associated with the steady increase in testing by the Early Test program and not with an appreciable increase in ART uptake or effectiveness or a decrease in other STIs in the community,” Dr. Mehta and his colleagues added.
The study was supported in part by a grant from the National Institutes of Health. Dr. Mehta had no financial conflicts to disclose.
FROM CLINICAL INFECTIOUS DISEASES
Key clinical point: Early HIV diagnosis via a primary infection screening reduced new HIV diagnoses overall in San Diego County.
Major finding: Early HIV testing identified an annual average of 17 acute and 21 early infections.
Data source: A regression analysis of new HIV diagnoses in San Diego County from 2006 to 2012.
Disclosures: The study was supported in part by a grant from the National Institutes of Health. Dr. Mehta had no financial conflicts to disclose.
Less education tied to more anxiety
Adults with less than a high school education are more than twice as likely as are those with high school degrees to have reported an anxiety disorder in the past year, according to the National Survey on Drug Use and Health’s 2008 to 2012 Mental Health Surveillance Study (MHSS), published June 2.
The data identified anxiety disorders in 13% of non–high school graduates vs. 5% of high school graduates. Adults with at least a college degree had the lowest rates of past year anxiety (4.3%). The MHSS estimated that approximately 13 million adults in the United States had at least one anxiety disorder within the past year.
“Although the MHSS results cannot be used to determine whether anxiety stopped people from finishing high school, having an anxiety disorder can lower the odds of graduating from high school and the odds of attending college,” the researchers wrote. The findings emphasize the need to support people with anxiety to help them remain in school and succeed, they added.
The findings were published in the Center for Behavioral Health Statistics and Quality Report. Read the full study here.
Adults with less than a high school education are more than twice as likely as are those with high school degrees to have reported an anxiety disorder in the past year, according to the National Survey on Drug Use and Health’s 2008 to 2012 Mental Health Surveillance Study (MHSS), published June 2.
The data identified anxiety disorders in 13% of non–high school graduates vs. 5% of high school graduates. Adults with at least a college degree had the lowest rates of past year anxiety (4.3%). The MHSS estimated that approximately 13 million adults in the United States had at least one anxiety disorder within the past year.
“Although the MHSS results cannot be used to determine whether anxiety stopped people from finishing high school, having an anxiety disorder can lower the odds of graduating from high school and the odds of attending college,” the researchers wrote. The findings emphasize the need to support people with anxiety to help them remain in school and succeed, they added.
The findings were published in the Center for Behavioral Health Statistics and Quality Report. Read the full study here.
Adults with less than a high school education are more than twice as likely as are those with high school degrees to have reported an anxiety disorder in the past year, according to the National Survey on Drug Use and Health’s 2008 to 2012 Mental Health Surveillance Study (MHSS), published June 2.
The data identified anxiety disorders in 13% of non–high school graduates vs. 5% of high school graduates. Adults with at least a college degree had the lowest rates of past year anxiety (4.3%). The MHSS estimated that approximately 13 million adults in the United States had at least one anxiety disorder within the past year.
“Although the MHSS results cannot be used to determine whether anxiety stopped people from finishing high school, having an anxiety disorder can lower the odds of graduating from high school and the odds of attending college,” the researchers wrote. The findings emphasize the need to support people with anxiety to help them remain in school and succeed, they added.
The findings were published in the Center for Behavioral Health Statistics and Quality Report. Read the full study here.
FROM THE CBHSQ REPORT
Antiretroviral therapy inadequate against arterial inflammation
Combined antiretroviral therapy (ART) significantly reduced viral load from 4.3 copies/mL to 1.3 copies/mL in a study of a dozen treatment-naive HIV-infected adults after 6 months. However, arterial inflammation, as measured by aortic target-background ratio (TBR), did not improve significantly, wrote Dr. Markella V. Zanni of Harvard Medical School, Boston, and colleagues.
The patients received a combination regimen including elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Arterial inflammation was assessed via fludeoxyglucose F 18 positron emission tomography.
The findings affirm the overall benefits of ART, but suggest that ART alone may not be enough to prevent cardiovascular disease in HIV patients in the short term, the researchers wrote.
“Complementary strategies to further improve immune activation indices and arterial inflammation – including statins and other immunomodulatory strategies – may be needed in addition to ART,” the researchers noted. “Future studies are needed to elucidate the relationship between arterial inflammation, atherogenesis, and myocardial infarction in HIV,” they added (JAMA Cardiol. 2016 May 25. doi: 10.1001/jamacardio.2016.0846). Read the study here.
Combined antiretroviral therapy (ART) significantly reduced viral load from 4.3 copies/mL to 1.3 copies/mL in a study of a dozen treatment-naive HIV-infected adults after 6 months. However, arterial inflammation, as measured by aortic target-background ratio (TBR), did not improve significantly, wrote Dr. Markella V. Zanni of Harvard Medical School, Boston, and colleagues.
The patients received a combination regimen including elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Arterial inflammation was assessed via fludeoxyglucose F 18 positron emission tomography.
The findings affirm the overall benefits of ART, but suggest that ART alone may not be enough to prevent cardiovascular disease in HIV patients in the short term, the researchers wrote.
“Complementary strategies to further improve immune activation indices and arterial inflammation – including statins and other immunomodulatory strategies – may be needed in addition to ART,” the researchers noted. “Future studies are needed to elucidate the relationship between arterial inflammation, atherogenesis, and myocardial infarction in HIV,” they added (JAMA Cardiol. 2016 May 25. doi: 10.1001/jamacardio.2016.0846). Read the study here.
Combined antiretroviral therapy (ART) significantly reduced viral load from 4.3 copies/mL to 1.3 copies/mL in a study of a dozen treatment-naive HIV-infected adults after 6 months. However, arterial inflammation, as measured by aortic target-background ratio (TBR), did not improve significantly, wrote Dr. Markella V. Zanni of Harvard Medical School, Boston, and colleagues.
The patients received a combination regimen including elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate. Arterial inflammation was assessed via fludeoxyglucose F 18 positron emission tomography.
The findings affirm the overall benefits of ART, but suggest that ART alone may not be enough to prevent cardiovascular disease in HIV patients in the short term, the researchers wrote.
“Complementary strategies to further improve immune activation indices and arterial inflammation – including statins and other immunomodulatory strategies – may be needed in addition to ART,” the researchers noted. “Future studies are needed to elucidate the relationship between arterial inflammation, atherogenesis, and myocardial infarction in HIV,” they added (JAMA Cardiol. 2016 May 25. doi: 10.1001/jamacardio.2016.0846). Read the study here.
FROM JAMA CARDIOLOGY
Rooming in cuts costs and improves care for neonatal abstinence syndrome
A neonatal abstinence syndrome program that focused on rooming in significantly decreased hospital costs, drug use, and length of hospital stay, based on data from a program in a single hospital in a rural academic tertiary care center.
“The aim of this project was to improve the care of opioid-exposed newborns by involving families, standardizing assessment and treatment, and transitioning to rooming-in for the full hospital stay,” reported Dr. Alison Volpe Holmes of the Geisel School of Medicine at Dartmouth, Hanover, N.H., and colleagues.
The researchers reviewed data from 163 newborns with neonatal abstinence syndrome (NAS) treated at Children’s Hospital at Dartmouth-Hitchcock between March 2012 and February 2015. Between the preintervention period and the study’s end, cumulative morphine exposure per infant dropped from 13.7 mg to 6.6 mg, length of hospital stay for newborns needing pharmacologic care dropped from 16.9 days to 12.3 days, and the average cost for newborns needing pharmacologic care dropped from $19,737 to $8,755. No adverse events were reported during the study period.
“We reduced system costs by more than half by caring for infants with prenatal opioid exposure and NAS in a rooming-in model, safely eliminating the use of critical care beds for this condition,” they noted.
Read the full study in Pediatrics (2016;137[6]:e20152929).
A neonatal abstinence syndrome program that focused on rooming in significantly decreased hospital costs, drug use, and length of hospital stay, based on data from a program in a single hospital in a rural academic tertiary care center.
“The aim of this project was to improve the care of opioid-exposed newborns by involving families, standardizing assessment and treatment, and transitioning to rooming-in for the full hospital stay,” reported Dr. Alison Volpe Holmes of the Geisel School of Medicine at Dartmouth, Hanover, N.H., and colleagues.
The researchers reviewed data from 163 newborns with neonatal abstinence syndrome (NAS) treated at Children’s Hospital at Dartmouth-Hitchcock between March 2012 and February 2015. Between the preintervention period and the study’s end, cumulative morphine exposure per infant dropped from 13.7 mg to 6.6 mg, length of hospital stay for newborns needing pharmacologic care dropped from 16.9 days to 12.3 days, and the average cost for newborns needing pharmacologic care dropped from $19,737 to $8,755. No adverse events were reported during the study period.
“We reduced system costs by more than half by caring for infants with prenatal opioid exposure and NAS in a rooming-in model, safely eliminating the use of critical care beds for this condition,” they noted.
Read the full study in Pediatrics (2016;137[6]:e20152929).
A neonatal abstinence syndrome program that focused on rooming in significantly decreased hospital costs, drug use, and length of hospital stay, based on data from a program in a single hospital in a rural academic tertiary care center.
“The aim of this project was to improve the care of opioid-exposed newborns by involving families, standardizing assessment and treatment, and transitioning to rooming-in for the full hospital stay,” reported Dr. Alison Volpe Holmes of the Geisel School of Medicine at Dartmouth, Hanover, N.H., and colleagues.
The researchers reviewed data from 163 newborns with neonatal abstinence syndrome (NAS) treated at Children’s Hospital at Dartmouth-Hitchcock between March 2012 and February 2015. Between the preintervention period and the study’s end, cumulative morphine exposure per infant dropped from 13.7 mg to 6.6 mg, length of hospital stay for newborns needing pharmacologic care dropped from 16.9 days to 12.3 days, and the average cost for newborns needing pharmacologic care dropped from $19,737 to $8,755. No adverse events were reported during the study period.
“We reduced system costs by more than half by caring for infants with prenatal opioid exposure and NAS in a rooming-in model, safely eliminating the use of critical care beds for this condition,” they noted.
Read the full study in Pediatrics (2016;137[6]:e20152929).
FROM PEDIATRICS
Competitive surgical outcomes observed at critical access hospitals
Thirty-day mortality rates for several common operations were not significantly different for patients seen at “critical access” hospitals, compared with larger high-volume facilities, according to a study using a large, national Medicare database.
The findings suggest that such procedures can be performed safely in smaller, rural hospitals. The Medicare Provider Analysis and Review (MEDPAR) file was used by investigators to examine data from 2009 through 2013 on more than 1 million patients at both types of facilities. The findings were published in JAMA on May 17.
The study was important to conduct for two reasons, coauthors Dr. Andrew Ibrahim and Dr. Justin Dimick of the University of Michigan, Ann Arbor, said in an interview.
“First, this study helps inform important policy decision making regarding rural access to surgery. Critical access hospitals receive more than $9 billion dollars annually from Medicare under payment provisions established in the Medicare Rural Hospital Flexibility Program to help keep them financially viable,” they said. “Plans to modify and even eliminate this program have been proposed largely based on studies demonstrating lower quality of care for common medical conditions (such as heart failure, pneumonia, or heart attack.) This study provides important information about common surgical procedures done in these same hospitals,” they stated.
“Second, this study gives us a better understanding of how to ensure safe surgical care without limiting access for common procedures. We have years of research demonstrating that relatively rare, complex operations (such as open heart operations and cancer resections) should be centralized to high-volume centers where patients travel to obtain their care,” the researchers said. “On the other end of the spectrum, this paper describes common, less complex operations where it is safe for patients to stay at their local hospital without the burden of traveling. This is particularly important now as large health case systems are consolidating and developing strategies to regionalize procedures within their network,” they noted.
The researchers and their colleagues reviewed data from 28,512 patients treated at critical access hospitals and 1,603,392 seen at non–critical access hospitals (JAMA 2016;315:2095-2103. doi:10.1001/jama.2016.5618). The patients underwent one of four surgeries: appendectomy, cholecystectomy, colectomy, or hernia repair.
After the researchers controlled for confounding variables, 30-day mortality rates were not significantly different among patients at critical access and non–critical access hospitals (5.4% vs. 5.6%), although the rates of serious complications were significantly lower in critical access vs. non–critical access hospitals (6.5 vs. 14%). In addition, Medicare expenses were significantly lower at critical access vs. non–critical access hospitals after factoring in risk-adjustment and price standardization ($14,450 vs. $15,845).
Overall, patients treated at critical access hospitals were significantly less likely than were those seen at non–critical access hospitals to have chronic medical problems including heart failure (8% vs. 10%), diabetes (20% vs. 22%), obesity (7% vs. 11%), and two or more comorbidities (60% vs. 70%). The average age of the patients was 77 years, and approximately half were women.
The findings on 30-day mortality and Medicare expenses contradict previous studies of nonsurgical admissions in critical access and non–critical access settings, the researchers noted. However, patients were less likely to proceed to post–acute care facilities from critical access hospitals compared with non–critical access hospitals.
“Based on information about admissions for common medical problems to these hospitals having higher mortality rates and decreased compliance with process measures, we thought this might be the same for surgical admissions,” the researchers said in the interview. “Our findings, however, show that critical access hospitals perform well for common surgical admissions with no difference in their risk-adjusted 30-day mortality rates.”
The results were limited by the use of administrative data, the potential overestimation of complication rates, and the lack of data on younger patients. The data illustrate how new payment models might impact critical care facilities, but several areas of research should be explored, the investigators said.
“First, we need a better understanding of how these small rural hospitals appear to be providing safe care at lower costs. Our data suggest it may be related to patient-selection, but even when we accounted for that in our models they still perform well,” they explained.
“Second, as many of these hospitals may in fact close in the next year, studies will be needed to inform how this might impact cost and access to rural surgical care. Finally, there are many other operations that we do not yet understand if they should be centralized to a large urban hospital, of if they are safe to be done in small hospital settings. As large health care systems continue to consolidate, each one will need a ‘health care systems architect’ to help organize how surgical services should be centralized or decentralized across their network to optimize both quality and access,” they added.
Dr. Ibrahim has received funding from the Robert Wood Johnson Foundation and the U.S. Department of Veterans Affairs. Dr. Justin Dimick has a financial interest in ArborMetrix Inc. and has received funds from the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as honoraria from Stanford University, Emory University, and the University of Texas.
Thirty-day mortality rates for several common operations were not significantly different for patients seen at “critical access” hospitals, compared with larger high-volume facilities, according to a study using a large, national Medicare database.
The findings suggest that such procedures can be performed safely in smaller, rural hospitals. The Medicare Provider Analysis and Review (MEDPAR) file was used by investigators to examine data from 2009 through 2013 on more than 1 million patients at both types of facilities. The findings were published in JAMA on May 17.
The study was important to conduct for two reasons, coauthors Dr. Andrew Ibrahim and Dr. Justin Dimick of the University of Michigan, Ann Arbor, said in an interview.
“First, this study helps inform important policy decision making regarding rural access to surgery. Critical access hospitals receive more than $9 billion dollars annually from Medicare under payment provisions established in the Medicare Rural Hospital Flexibility Program to help keep them financially viable,” they said. “Plans to modify and even eliminate this program have been proposed largely based on studies demonstrating lower quality of care for common medical conditions (such as heart failure, pneumonia, or heart attack.) This study provides important information about common surgical procedures done in these same hospitals,” they stated.
“Second, this study gives us a better understanding of how to ensure safe surgical care without limiting access for common procedures. We have years of research demonstrating that relatively rare, complex operations (such as open heart operations and cancer resections) should be centralized to high-volume centers where patients travel to obtain their care,” the researchers said. “On the other end of the spectrum, this paper describes common, less complex operations where it is safe for patients to stay at their local hospital without the burden of traveling. This is particularly important now as large health case systems are consolidating and developing strategies to regionalize procedures within their network,” they noted.
The researchers and their colleagues reviewed data from 28,512 patients treated at critical access hospitals and 1,603,392 seen at non–critical access hospitals (JAMA 2016;315:2095-2103. doi:10.1001/jama.2016.5618). The patients underwent one of four surgeries: appendectomy, cholecystectomy, colectomy, or hernia repair.
After the researchers controlled for confounding variables, 30-day mortality rates were not significantly different among patients at critical access and non–critical access hospitals (5.4% vs. 5.6%), although the rates of serious complications were significantly lower in critical access vs. non–critical access hospitals (6.5 vs. 14%). In addition, Medicare expenses were significantly lower at critical access vs. non–critical access hospitals after factoring in risk-adjustment and price standardization ($14,450 vs. $15,845).
Overall, patients treated at critical access hospitals were significantly less likely than were those seen at non–critical access hospitals to have chronic medical problems including heart failure (8% vs. 10%), diabetes (20% vs. 22%), obesity (7% vs. 11%), and two or more comorbidities (60% vs. 70%). The average age of the patients was 77 years, and approximately half were women.
The findings on 30-day mortality and Medicare expenses contradict previous studies of nonsurgical admissions in critical access and non–critical access settings, the researchers noted. However, patients were less likely to proceed to post–acute care facilities from critical access hospitals compared with non–critical access hospitals.
“Based on information about admissions for common medical problems to these hospitals having higher mortality rates and decreased compliance with process measures, we thought this might be the same for surgical admissions,” the researchers said in the interview. “Our findings, however, show that critical access hospitals perform well for common surgical admissions with no difference in their risk-adjusted 30-day mortality rates.”
The results were limited by the use of administrative data, the potential overestimation of complication rates, and the lack of data on younger patients. The data illustrate how new payment models might impact critical care facilities, but several areas of research should be explored, the investigators said.
“First, we need a better understanding of how these small rural hospitals appear to be providing safe care at lower costs. Our data suggest it may be related to patient-selection, but even when we accounted for that in our models they still perform well,” they explained.
“Second, as many of these hospitals may in fact close in the next year, studies will be needed to inform how this might impact cost and access to rural surgical care. Finally, there are many other operations that we do not yet understand if they should be centralized to a large urban hospital, of if they are safe to be done in small hospital settings. As large health care systems continue to consolidate, each one will need a ‘health care systems architect’ to help organize how surgical services should be centralized or decentralized across their network to optimize both quality and access,” they added.
Dr. Ibrahim has received funding from the Robert Wood Johnson Foundation and the U.S. Department of Veterans Affairs. Dr. Justin Dimick has a financial interest in ArborMetrix Inc. and has received funds from the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as honoraria from Stanford University, Emory University, and the University of Texas.
Thirty-day mortality rates for several common operations were not significantly different for patients seen at “critical access” hospitals, compared with larger high-volume facilities, according to a study using a large, national Medicare database.
The findings suggest that such procedures can be performed safely in smaller, rural hospitals. The Medicare Provider Analysis and Review (MEDPAR) file was used by investigators to examine data from 2009 through 2013 on more than 1 million patients at both types of facilities. The findings were published in JAMA on May 17.
The study was important to conduct for two reasons, coauthors Dr. Andrew Ibrahim and Dr. Justin Dimick of the University of Michigan, Ann Arbor, said in an interview.
“First, this study helps inform important policy decision making regarding rural access to surgery. Critical access hospitals receive more than $9 billion dollars annually from Medicare under payment provisions established in the Medicare Rural Hospital Flexibility Program to help keep them financially viable,” they said. “Plans to modify and even eliminate this program have been proposed largely based on studies demonstrating lower quality of care for common medical conditions (such as heart failure, pneumonia, or heart attack.) This study provides important information about common surgical procedures done in these same hospitals,” they stated.
“Second, this study gives us a better understanding of how to ensure safe surgical care without limiting access for common procedures. We have years of research demonstrating that relatively rare, complex operations (such as open heart operations and cancer resections) should be centralized to high-volume centers where patients travel to obtain their care,” the researchers said. “On the other end of the spectrum, this paper describes common, less complex operations where it is safe for patients to stay at their local hospital without the burden of traveling. This is particularly important now as large health case systems are consolidating and developing strategies to regionalize procedures within their network,” they noted.
The researchers and their colleagues reviewed data from 28,512 patients treated at critical access hospitals and 1,603,392 seen at non–critical access hospitals (JAMA 2016;315:2095-2103. doi:10.1001/jama.2016.5618). The patients underwent one of four surgeries: appendectomy, cholecystectomy, colectomy, or hernia repair.
After the researchers controlled for confounding variables, 30-day mortality rates were not significantly different among patients at critical access and non–critical access hospitals (5.4% vs. 5.6%), although the rates of serious complications were significantly lower in critical access vs. non–critical access hospitals (6.5 vs. 14%). In addition, Medicare expenses were significantly lower at critical access vs. non–critical access hospitals after factoring in risk-adjustment and price standardization ($14,450 vs. $15,845).
Overall, patients treated at critical access hospitals were significantly less likely than were those seen at non–critical access hospitals to have chronic medical problems including heart failure (8% vs. 10%), diabetes (20% vs. 22%), obesity (7% vs. 11%), and two or more comorbidities (60% vs. 70%). The average age of the patients was 77 years, and approximately half were women.
The findings on 30-day mortality and Medicare expenses contradict previous studies of nonsurgical admissions in critical access and non–critical access settings, the researchers noted. However, patients were less likely to proceed to post–acute care facilities from critical access hospitals compared with non–critical access hospitals.
“Based on information about admissions for common medical problems to these hospitals having higher mortality rates and decreased compliance with process measures, we thought this might be the same for surgical admissions,” the researchers said in the interview. “Our findings, however, show that critical access hospitals perform well for common surgical admissions with no difference in their risk-adjusted 30-day mortality rates.”
The results were limited by the use of administrative data, the potential overestimation of complication rates, and the lack of data on younger patients. The data illustrate how new payment models might impact critical care facilities, but several areas of research should be explored, the investigators said.
“First, we need a better understanding of how these small rural hospitals appear to be providing safe care at lower costs. Our data suggest it may be related to patient-selection, but even when we accounted for that in our models they still perform well,” they explained.
“Second, as many of these hospitals may in fact close in the next year, studies will be needed to inform how this might impact cost and access to rural surgical care. Finally, there are many other operations that we do not yet understand if they should be centralized to a large urban hospital, of if they are safe to be done in small hospital settings. As large health care systems continue to consolidate, each one will need a ‘health care systems architect’ to help organize how surgical services should be centralized or decentralized across their network to optimize both quality and access,” they added.
Dr. Ibrahim has received funding from the Robert Wood Johnson Foundation and the U.S. Department of Veterans Affairs. Dr. Justin Dimick has a financial interest in ArborMetrix Inc. and has received funds from the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as honoraria from Stanford University, Emory University, and the University of Texas.
FROM JAMA
Key clinical point: Common surgical procedures can be performed at smaller hospitals safety and cost-effectively for appropriate patients.
Major finding: Thirty-day mortality rates were similar among patients at critical access and non–critical access hospitals (5.4% vs. 5.6%).
Data source: A cross-sectional, retrospective review of 1,631,904 Medicare beneficiary admissions for appendectomy, cholecystectomy, colectomy, or hernia repair.
Disclosures: Dr. Ibrahim has received funding from the Robert Wood Johnson Foundation and the U.S. Department of Veterans Affairs; coauthor Dr. Dennis Dimick has a financial interest in ArborMetrix Inc. and has received funds from the Agency for Healthcare Research and Quality and the National Institutes of Health, as well as honoraria from Stanford University, Emory University, and the University of Texas.
