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Sharon Worcester is an award-winning medical journalist for MDedge News. She has been with the company since 1996, first as the Southeast Bureau Chief (1996-2009) when the company was known as International Medical News Group, then as a freelance writer (2010-2015) before returning as a reporter in 2015. She previously worked as a daily newspaper reporter covering health and local government. Sharon currently reports primarily on oncology and hematology. She has a BA from Eckerd College and an MA in Mass Communication/Print Journalism from the University of Florida. Connect with her via LinkedIn and follow her on twitter @SW_MedReporter.
Uveal melanoma: NCCN provides first pathway-based guidelines
ORLANDO – Uveal melanoma has little in common with it’s cutaneous namesake, and its distinct characteristics necessitated the development of specific guidelines for diagnosis and management, which were released earlier this year by the National Comprehensive Cancer Network (NCCN).
Unlike cutaneous melanoma, uveal melanoma is usually treated with radiotherapy rather than surgery, and primary treatment is based on tumor size, according to Christopher A. Barker, MD, a radiation oncologist and director of clinical investigations in the department of radiation at Memorial Sloan Kettering Cancer Center, New York.
Further, molecular testing aids in prognosis in uveal melanoma but not in predicting treatment response as it can in cutaneous disease, and recurrences of uveal melanoma are typically distant – usually occurring in the liver – rather than in the skin or lymph nodes as with cutaneous melanoma.
These and other diagnosis- and treatment-related issues are outlined in the new guidelines, which are the first developed by the NCCN for uveal melanoma.
Guidelines exist in several countries, including Australia, the United Kingdom, Canada, and the United States (published by The American Brachytherapy Society), but until now none have provided pathway-based strategies for the management of all stages of this rare disease that affects about 1 in 200,000 Americans, typically Caucasians in their 50s, 60s, or 70s, Dr. Barker, a member of the NCCN Melanoma guidelines panel and the uveal melanoma subcommittee, said at the NCCN’s annual meeting where he presented the guidelines.
The median age of diagnosis is 60 years, he noted.
The NCCN guidelines specifically address melanoma arising in the choroid and ciliary body of the uvea. The choroid is the predominant site of uveal melanoma origin, and tumors arising there may involve the ciliary body as well, although the latter is a rare site of melanoma origin. The iris is also a rare site of origin, and tumors arising there are typically indolent in nature and thus are not part of the new guidelines, he explained.
Risk factors include choroidal nevi, ocular melanocytosis, and familial uveal melanoma associated with germline BAP1 mutation, neurofibromatosis, or dysplastic nevus syndrome; cutaneous melanoma is not a risk factor, he said.
The guidelines address clinical presentation, diagnostic work-up, and staging; primary treatments; and metastatic risks and follow-up imaging.
Presentation, diagnosis, and staging
About two-thirds of patients with uveal melanoma present because of changes in their vision, and about a third present with no new symptoms and are diagnosed during routine evaluation, Dr. Barker said.
“History and physical exam, and specifically attention to any prior malignancies, is important,” he said. “A comprehensive eye examination is absolutely vital to the evaluation and staging of patients with uveal melanoma.”
Numerous additional testing options, including autofluorescence of the ocular fundus, retinal fluorescein angiography of the ocular fundus, and transillumination, among others, are listed in the guidelines, which note that MRI is sometimes needed to confirm diagnosis.
Biopsies, however, are generally only performed to confirm diagnosis if needed or for prognostic analysis for risk stratification.
Staging is determined mainly by tumor size, which is known to be associated with outcomes in patients with uveal melanoma, and is based on criteria from both the Collaborative Ocular Melanoma Study (COMS) staging system and the American Joint Committee on Cancer (AJCC) staging manual, Dr. Barker said.
The COMS system was developed based on separate studies of small, medium, and large tumors and helped define primary tumor management and establish existing standards of care. The AJCC system was developed subsequently and focuses more on tumor features that may improve clinical predictions.
Primary treatments
Options for primary treatment for small tumors (largest diameter 5-16 mm and thickness less than 2.5 mm) include plaque brachytherapy, partical beam radiation, and laser ablation in highly select patients. For medium tumors (18mm or less at largest diameter and thickness of 2.5-10 mm), they include plaque brachytherapy, particle beam radiation, and enucleation, according to the guidelines.
Large tumors can be treated with radiotherapy (preferably particle beam radiation, Dr. Barker said) or enucleation. Large tumors are those greater than 18mm with any thickness, those with thickness greater than 10mm with any diameter, and those with thickness greater than 8mm with optic nerve involvement.
In patients for whom surgical removal is selected, “ there are a few unusual situations where additional local adjuvant therapy might be considered,” Dr. Barker said, explaining, for example, that the presence of microscopically positive or close margins after enucleation without evidence of gross residual disease in the orbit may be observed or may warrant map biopsy and/or particle beam or photon beam radiotherapy to the orbit.
For visible extraocular tumors or suspicion of gross disease in the orbit, biopsy of the extraocular tissue is recommended when possible, along with either intraoperative cryotherapy, orbital exenteration, or particle beam or photon beam radiotherapy to the orbit, he added.
Metastatic risks and follow-up imaging
Recent studies, including Cancer Genome Atlas Research Network studies, have elucidated the genomics of both uveal and cutaneous melanomas, and they show “a completely different mutation spectrum” for uveal melanoma, Dr. Barker said.
These genomic studies demonstrate that cutaneous melanoma involves mutations that predict response to certain treatments, while those found in uveal melanoma do not, but they are, however, associated with the probability of metastasis, he said.
For example, various studies have shown that BRAF mutation in cutaneous melanoma predicts response to RAF or MEK inhibition and that the overall number of mutations in cutaneous melanoma may predict response to immunotherapy.
In uveal melanoma, alterations in ElFAX1, SF3B1, or BAP1 have been shown to indicate low, intermediate, and high risk of metastasis, respectively.
Other factors associated with the risk of metastasis after primary tumor treatment in uveal melanoma include clinical factors (tumor size, ciliary body involvement, and extraocular extension); histopathologic factors (spindle or epithelioid cell type); and cytogenetics (status of chromosomes 3, 6, and 8), he said.
An AJCC Ophthalmic Oncology Task Force study published in 2015, for example, showed that the 5-year metastasis-free survival was 97% for AJCC stage T1 disease, 85% for stage T2, 77% for stage T3, and 61% for stage T4. T-stage modifiers, which are based on particular tumor characteristics, such as ciliary body involvement (CBI) and extraocular extension (EXE), were also associated with the risk of distant metastasis: 5-year metastasis-free survival was 90%, 72%, 54% and 33% for AJCC T_a (no CBI or EXE), T_b (CBI only), T_c (EXE only), and T_d tumors (CBI and EXE), respectively.
Follow-up imaging after primary tumor treatment should be based on the most likely site of metastatic recurrence, which is the liver in 90% of uveal melanoma metastases.
“For this reason, surveillance of high-risk patients with uveal melanoma should include specific imaging of the liver,” Dr. Barker said, who noted that the NCCN risk stratification–based surveillance guidelines categorize patients as either low, medium, or high risk for metastasis based on the various characteristics that can affect risk.
“These risk groups help clinicians identify how often imaging should be performed in their surveillance strategy,” he said, adding that those who are high risk based on BAP1 mutation, PRAME mutation, CBI, or EXE, for example, should undergo imaging to evaluate signs or symptoms every 3-6 months for 5 years, every 6-12 months for 10 years, and then as clinically indicated thereafter.
The guideline calls for less stringent imaging for low- and medium-risk patients.
“Now, what happens when distant metastases are identified? Unfortunately there is no single systemic therapy that has proven to be most effective for uveal melanoma,” he said. “For this reason, the NCCN guideline encourages clinical trial participation whenever possible for patients who develop distant metastasis.”
This is because drugs effective for cutaneous melanoma are far less effective for uveal melanoma, but do elicit response in some patients and can be considered, he explained.
“Moreover, because the liver is the site of metastasis most often, and is often the exclusive site of metastasis, liver metastasis–directed therapy is considered part of the management of patients with uveal melanoma,” he said, adding that this can involve resection, ablation, chemo/radio embolization, or regional perfusion.”
The NCCN Uveal Melanoma Guidelines were developed by a panel of experts from various institutions based on the available evidence and on consensus; they are category 2A (based on lower-level evidence with uniform NCCN consensus that the intervention is appropriate).
Dr. Barker reported receiving clinical research support from Amgen, Bristol-Myers Squibb, Elekta, Merck, University of California San Francisco, and University of Florida Health Cancer Center Orlando, and serving as an advisor, consultant, or expert witness for Pfizer.
ORLANDO – Uveal melanoma has little in common with it’s cutaneous namesake, and its distinct characteristics necessitated the development of specific guidelines for diagnosis and management, which were released earlier this year by the National Comprehensive Cancer Network (NCCN).
Unlike cutaneous melanoma, uveal melanoma is usually treated with radiotherapy rather than surgery, and primary treatment is based on tumor size, according to Christopher A. Barker, MD, a radiation oncologist and director of clinical investigations in the department of radiation at Memorial Sloan Kettering Cancer Center, New York.
Further, molecular testing aids in prognosis in uveal melanoma but not in predicting treatment response as it can in cutaneous disease, and recurrences of uveal melanoma are typically distant – usually occurring in the liver – rather than in the skin or lymph nodes as with cutaneous melanoma.
These and other diagnosis- and treatment-related issues are outlined in the new guidelines, which are the first developed by the NCCN for uveal melanoma.
Guidelines exist in several countries, including Australia, the United Kingdom, Canada, and the United States (published by The American Brachytherapy Society), but until now none have provided pathway-based strategies for the management of all stages of this rare disease that affects about 1 in 200,000 Americans, typically Caucasians in their 50s, 60s, or 70s, Dr. Barker, a member of the NCCN Melanoma guidelines panel and the uveal melanoma subcommittee, said at the NCCN’s annual meeting where he presented the guidelines.
The median age of diagnosis is 60 years, he noted.
The NCCN guidelines specifically address melanoma arising in the choroid and ciliary body of the uvea. The choroid is the predominant site of uveal melanoma origin, and tumors arising there may involve the ciliary body as well, although the latter is a rare site of melanoma origin. The iris is also a rare site of origin, and tumors arising there are typically indolent in nature and thus are not part of the new guidelines, he explained.
Risk factors include choroidal nevi, ocular melanocytosis, and familial uveal melanoma associated with germline BAP1 mutation, neurofibromatosis, or dysplastic nevus syndrome; cutaneous melanoma is not a risk factor, he said.
The guidelines address clinical presentation, diagnostic work-up, and staging; primary treatments; and metastatic risks and follow-up imaging.
Presentation, diagnosis, and staging
About two-thirds of patients with uveal melanoma present because of changes in their vision, and about a third present with no new symptoms and are diagnosed during routine evaluation, Dr. Barker said.
“History and physical exam, and specifically attention to any prior malignancies, is important,” he said. “A comprehensive eye examination is absolutely vital to the evaluation and staging of patients with uveal melanoma.”
Numerous additional testing options, including autofluorescence of the ocular fundus, retinal fluorescein angiography of the ocular fundus, and transillumination, among others, are listed in the guidelines, which note that MRI is sometimes needed to confirm diagnosis.
Biopsies, however, are generally only performed to confirm diagnosis if needed or for prognostic analysis for risk stratification.
Staging is determined mainly by tumor size, which is known to be associated with outcomes in patients with uveal melanoma, and is based on criteria from both the Collaborative Ocular Melanoma Study (COMS) staging system and the American Joint Committee on Cancer (AJCC) staging manual, Dr. Barker said.
The COMS system was developed based on separate studies of small, medium, and large tumors and helped define primary tumor management and establish existing standards of care. The AJCC system was developed subsequently and focuses more on tumor features that may improve clinical predictions.
Primary treatments
Options for primary treatment for small tumors (largest diameter 5-16 mm and thickness less than 2.5 mm) include plaque brachytherapy, partical beam radiation, and laser ablation in highly select patients. For medium tumors (18mm or less at largest diameter and thickness of 2.5-10 mm), they include plaque brachytherapy, particle beam radiation, and enucleation, according to the guidelines.
Large tumors can be treated with radiotherapy (preferably particle beam radiation, Dr. Barker said) or enucleation. Large tumors are those greater than 18mm with any thickness, those with thickness greater than 10mm with any diameter, and those with thickness greater than 8mm with optic nerve involvement.
In patients for whom surgical removal is selected, “ there are a few unusual situations where additional local adjuvant therapy might be considered,” Dr. Barker said, explaining, for example, that the presence of microscopically positive or close margins after enucleation without evidence of gross residual disease in the orbit may be observed or may warrant map biopsy and/or particle beam or photon beam radiotherapy to the orbit.
For visible extraocular tumors or suspicion of gross disease in the orbit, biopsy of the extraocular tissue is recommended when possible, along with either intraoperative cryotherapy, orbital exenteration, or particle beam or photon beam radiotherapy to the orbit, he added.
Metastatic risks and follow-up imaging
Recent studies, including Cancer Genome Atlas Research Network studies, have elucidated the genomics of both uveal and cutaneous melanomas, and they show “a completely different mutation spectrum” for uveal melanoma, Dr. Barker said.
These genomic studies demonstrate that cutaneous melanoma involves mutations that predict response to certain treatments, while those found in uveal melanoma do not, but they are, however, associated with the probability of metastasis, he said.
For example, various studies have shown that BRAF mutation in cutaneous melanoma predicts response to RAF or MEK inhibition and that the overall number of mutations in cutaneous melanoma may predict response to immunotherapy.
In uveal melanoma, alterations in ElFAX1, SF3B1, or BAP1 have been shown to indicate low, intermediate, and high risk of metastasis, respectively.
Other factors associated with the risk of metastasis after primary tumor treatment in uveal melanoma include clinical factors (tumor size, ciliary body involvement, and extraocular extension); histopathologic factors (spindle or epithelioid cell type); and cytogenetics (status of chromosomes 3, 6, and 8), he said.
An AJCC Ophthalmic Oncology Task Force study published in 2015, for example, showed that the 5-year metastasis-free survival was 97% for AJCC stage T1 disease, 85% for stage T2, 77% for stage T3, and 61% for stage T4. T-stage modifiers, which are based on particular tumor characteristics, such as ciliary body involvement (CBI) and extraocular extension (EXE), were also associated with the risk of distant metastasis: 5-year metastasis-free survival was 90%, 72%, 54% and 33% for AJCC T_a (no CBI or EXE), T_b (CBI only), T_c (EXE only), and T_d tumors (CBI and EXE), respectively.
Follow-up imaging after primary tumor treatment should be based on the most likely site of metastatic recurrence, which is the liver in 90% of uveal melanoma metastases.
“For this reason, surveillance of high-risk patients with uveal melanoma should include specific imaging of the liver,” Dr. Barker said, who noted that the NCCN risk stratification–based surveillance guidelines categorize patients as either low, medium, or high risk for metastasis based on the various characteristics that can affect risk.
“These risk groups help clinicians identify how often imaging should be performed in their surveillance strategy,” he said, adding that those who are high risk based on BAP1 mutation, PRAME mutation, CBI, or EXE, for example, should undergo imaging to evaluate signs or symptoms every 3-6 months for 5 years, every 6-12 months for 10 years, and then as clinically indicated thereafter.
The guideline calls for less stringent imaging for low- and medium-risk patients.
“Now, what happens when distant metastases are identified? Unfortunately there is no single systemic therapy that has proven to be most effective for uveal melanoma,” he said. “For this reason, the NCCN guideline encourages clinical trial participation whenever possible for patients who develop distant metastasis.”
This is because drugs effective for cutaneous melanoma are far less effective for uveal melanoma, but do elicit response in some patients and can be considered, he explained.
“Moreover, because the liver is the site of metastasis most often, and is often the exclusive site of metastasis, liver metastasis–directed therapy is considered part of the management of patients with uveal melanoma,” he said, adding that this can involve resection, ablation, chemo/radio embolization, or regional perfusion.”
The NCCN Uveal Melanoma Guidelines were developed by a panel of experts from various institutions based on the available evidence and on consensus; they are category 2A (based on lower-level evidence with uniform NCCN consensus that the intervention is appropriate).
Dr. Barker reported receiving clinical research support from Amgen, Bristol-Myers Squibb, Elekta, Merck, University of California San Francisco, and University of Florida Health Cancer Center Orlando, and serving as an advisor, consultant, or expert witness for Pfizer.
ORLANDO – Uveal melanoma has little in common with it’s cutaneous namesake, and its distinct characteristics necessitated the development of specific guidelines for diagnosis and management, which were released earlier this year by the National Comprehensive Cancer Network (NCCN).
Unlike cutaneous melanoma, uveal melanoma is usually treated with radiotherapy rather than surgery, and primary treatment is based on tumor size, according to Christopher A. Barker, MD, a radiation oncologist and director of clinical investigations in the department of radiation at Memorial Sloan Kettering Cancer Center, New York.
Further, molecular testing aids in prognosis in uveal melanoma but not in predicting treatment response as it can in cutaneous disease, and recurrences of uveal melanoma are typically distant – usually occurring in the liver – rather than in the skin or lymph nodes as with cutaneous melanoma.
These and other diagnosis- and treatment-related issues are outlined in the new guidelines, which are the first developed by the NCCN for uveal melanoma.
Guidelines exist in several countries, including Australia, the United Kingdom, Canada, and the United States (published by The American Brachytherapy Society), but until now none have provided pathway-based strategies for the management of all stages of this rare disease that affects about 1 in 200,000 Americans, typically Caucasians in their 50s, 60s, or 70s, Dr. Barker, a member of the NCCN Melanoma guidelines panel and the uveal melanoma subcommittee, said at the NCCN’s annual meeting where he presented the guidelines.
The median age of diagnosis is 60 years, he noted.
The NCCN guidelines specifically address melanoma arising in the choroid and ciliary body of the uvea. The choroid is the predominant site of uveal melanoma origin, and tumors arising there may involve the ciliary body as well, although the latter is a rare site of melanoma origin. The iris is also a rare site of origin, and tumors arising there are typically indolent in nature and thus are not part of the new guidelines, he explained.
Risk factors include choroidal nevi, ocular melanocytosis, and familial uveal melanoma associated with germline BAP1 mutation, neurofibromatosis, or dysplastic nevus syndrome; cutaneous melanoma is not a risk factor, he said.
The guidelines address clinical presentation, diagnostic work-up, and staging; primary treatments; and metastatic risks and follow-up imaging.
Presentation, diagnosis, and staging
About two-thirds of patients with uveal melanoma present because of changes in their vision, and about a third present with no new symptoms and are diagnosed during routine evaluation, Dr. Barker said.
“History and physical exam, and specifically attention to any prior malignancies, is important,” he said. “A comprehensive eye examination is absolutely vital to the evaluation and staging of patients with uveal melanoma.”
Numerous additional testing options, including autofluorescence of the ocular fundus, retinal fluorescein angiography of the ocular fundus, and transillumination, among others, are listed in the guidelines, which note that MRI is sometimes needed to confirm diagnosis.
Biopsies, however, are generally only performed to confirm diagnosis if needed or for prognostic analysis for risk stratification.
Staging is determined mainly by tumor size, which is known to be associated with outcomes in patients with uveal melanoma, and is based on criteria from both the Collaborative Ocular Melanoma Study (COMS) staging system and the American Joint Committee on Cancer (AJCC) staging manual, Dr. Barker said.
The COMS system was developed based on separate studies of small, medium, and large tumors and helped define primary tumor management and establish existing standards of care. The AJCC system was developed subsequently and focuses more on tumor features that may improve clinical predictions.
Primary treatments
Options for primary treatment for small tumors (largest diameter 5-16 mm and thickness less than 2.5 mm) include plaque brachytherapy, partical beam radiation, and laser ablation in highly select patients. For medium tumors (18mm or less at largest diameter and thickness of 2.5-10 mm), they include plaque brachytherapy, particle beam radiation, and enucleation, according to the guidelines.
Large tumors can be treated with radiotherapy (preferably particle beam radiation, Dr. Barker said) or enucleation. Large tumors are those greater than 18mm with any thickness, those with thickness greater than 10mm with any diameter, and those with thickness greater than 8mm with optic nerve involvement.
In patients for whom surgical removal is selected, “ there are a few unusual situations where additional local adjuvant therapy might be considered,” Dr. Barker said, explaining, for example, that the presence of microscopically positive or close margins after enucleation without evidence of gross residual disease in the orbit may be observed or may warrant map biopsy and/or particle beam or photon beam radiotherapy to the orbit.
For visible extraocular tumors or suspicion of gross disease in the orbit, biopsy of the extraocular tissue is recommended when possible, along with either intraoperative cryotherapy, orbital exenteration, or particle beam or photon beam radiotherapy to the orbit, he added.
Metastatic risks and follow-up imaging
Recent studies, including Cancer Genome Atlas Research Network studies, have elucidated the genomics of both uveal and cutaneous melanomas, and they show “a completely different mutation spectrum” for uveal melanoma, Dr. Barker said.
These genomic studies demonstrate that cutaneous melanoma involves mutations that predict response to certain treatments, while those found in uveal melanoma do not, but they are, however, associated with the probability of metastasis, he said.
For example, various studies have shown that BRAF mutation in cutaneous melanoma predicts response to RAF or MEK inhibition and that the overall number of mutations in cutaneous melanoma may predict response to immunotherapy.
In uveal melanoma, alterations in ElFAX1, SF3B1, or BAP1 have been shown to indicate low, intermediate, and high risk of metastasis, respectively.
Other factors associated with the risk of metastasis after primary tumor treatment in uveal melanoma include clinical factors (tumor size, ciliary body involvement, and extraocular extension); histopathologic factors (spindle or epithelioid cell type); and cytogenetics (status of chromosomes 3, 6, and 8), he said.
An AJCC Ophthalmic Oncology Task Force study published in 2015, for example, showed that the 5-year metastasis-free survival was 97% for AJCC stage T1 disease, 85% for stage T2, 77% for stage T3, and 61% for stage T4. T-stage modifiers, which are based on particular tumor characteristics, such as ciliary body involvement (CBI) and extraocular extension (EXE), were also associated with the risk of distant metastasis: 5-year metastasis-free survival was 90%, 72%, 54% and 33% for AJCC T_a (no CBI or EXE), T_b (CBI only), T_c (EXE only), and T_d tumors (CBI and EXE), respectively.
Follow-up imaging after primary tumor treatment should be based on the most likely site of metastatic recurrence, which is the liver in 90% of uveal melanoma metastases.
“For this reason, surveillance of high-risk patients with uveal melanoma should include specific imaging of the liver,” Dr. Barker said, who noted that the NCCN risk stratification–based surveillance guidelines categorize patients as either low, medium, or high risk for metastasis based on the various characteristics that can affect risk.
“These risk groups help clinicians identify how often imaging should be performed in their surveillance strategy,” he said, adding that those who are high risk based on BAP1 mutation, PRAME mutation, CBI, or EXE, for example, should undergo imaging to evaluate signs or symptoms every 3-6 months for 5 years, every 6-12 months for 10 years, and then as clinically indicated thereafter.
The guideline calls for less stringent imaging for low- and medium-risk patients.
“Now, what happens when distant metastases are identified? Unfortunately there is no single systemic therapy that has proven to be most effective for uveal melanoma,” he said. “For this reason, the NCCN guideline encourages clinical trial participation whenever possible for patients who develop distant metastasis.”
This is because drugs effective for cutaneous melanoma are far less effective for uveal melanoma, but do elicit response in some patients and can be considered, he explained.
“Moreover, because the liver is the site of metastasis most often, and is often the exclusive site of metastasis, liver metastasis–directed therapy is considered part of the management of patients with uveal melanoma,” he said, adding that this can involve resection, ablation, chemo/radio embolization, or regional perfusion.”
The NCCN Uveal Melanoma Guidelines were developed by a panel of experts from various institutions based on the available evidence and on consensus; they are category 2A (based on lower-level evidence with uniform NCCN consensus that the intervention is appropriate).
Dr. Barker reported receiving clinical research support from Amgen, Bristol-Myers Squibb, Elekta, Merck, University of California San Francisco, and University of Florida Health Cancer Center Orlando, and serving as an advisor, consultant, or expert witness for Pfizer.
EXPERT ANALYSIS FROM THE NCCN ANNUAL CONFERENCE
GBS in T2DM patients: Study highlights pros and cons, need for better patient selection
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
ORLANDO – , according to a nationwide, matched, observational cohort study in Sweden.
After 9 years of follow-up, all-cause mortality was 49% lower among 5,321 patients with T2DM compared with 5,321 matched control (183 vs. 351 deaths; hazard ratio, 0.51), as has been reported in prior studies, Vasileios Liakopoulos, MD, of the University of Gothenburg (Sweden) reported at the annual scientific sessions of the American Diabetes Association.
Cardiovascular disease (CVD) risk was 34% lower (108 vs. 150 patients; HR, 0.66), fatal CVD risk was 66% lower (21 vs. 64 patients; HR, 0.34), acute myocardial infarction risk was 45% lower (51 vs. 85 events; HR, 0.55) congestive heart failure risk was 51% lower (109 vs. 225 events; HR, 0.49), and cancer risk was 22% lower (153 vs. 188 cases; HR, 0.78) in cases vs. controls, respectively.
“[As for] the diagnoses that related to diabetes, hyperglycemia was lower by 66%, admission to the hospital due to amputation was 49% lower, and we also found something relatively new – that renal disease was lower by 42%,” Dr. Liakopoulos said.
Renal disease occurred in 105 cases vs. 187 controls (HR, 0.58), with the difference between the groups intensifying after the third year of follow-up, he noted.
However, numerous adverse events occurred more often in case patients, he said.
For example, hospitalizations for psychiatric disorders were increased by 33% (317 vs. 268; HR, 1.33), alcohol-related diagnoses were nearly threefold higher (180 vs. 65; HR, 2.90), malnutrition occurred nearly three times more often (128 vs. 46 patients; HR, 2.81), and anemia occurred nearly twice as often (84 vs. 46 cases; HR, 1.92) in cases vs. controls.
Of course, all the surgery-related adverse events occurred more often in the case patients, but interestingly, those events – which included things like gastrointestinal surgery other than gastric bypass, abdominal pain, gallstones/pancreatitis, gastrointestinal ulcers and reflux, and bowel obstruction – did not occur more often in case patients than in gastric bypass patients without diabetes in other studies, he noted.
The findings were based on merged data from the Scandinavian Obesity Surgery Registry, the Swedish National Diabetes Register, and other national databases, and persons with T2DM who had undergone gastric bypass surgery between 2007 and 2013 were matched by propensity score (based on sex, age, body mass index, and calendar time from the beginning of the study) with obese individuals who were not surgically treated for obesity. The risks of postoperative outcomes were assessed using a Cox regression model adjusted for sex, age, body mass index, and socioeconomic status, Dr. Liakopoulos said.
This study, though limited by its observational nature, minor differences in patient characteristics between the cases and controls, and potential residual confounding, confirms the benefits of gastric bypass surgery in obese patients with T2DM but also characterizes an array of both short- and long-term adverse events after bariatric surgery in these patients, he said.
“The beneficial effects of gastric bypass have been presented in terms of weight reduction, improvements in risk factors and cardiovascular disease, and mortality reduction in people with or without diabetes,” he said, noting, however, that only a few reports have addressed long-term incidence of complications after gastric bypass – and type 2 diabetes has only been addressed in small randomized studies or in low proportions in large prospective studies.
“[Based on the findings] we suggest better selection of patients for bariatric surgery, and we think improved long-term postoperative monitoring might further improve the results of such treatment,” he concluded.
Dr. Liakopoulos reported having no disclosures.
SOURCE: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
REPORTING FROM ADA 2018
Key clinical point: Bariatric surgery lowers mortality, CVD, and renal and other risks in obese T2DM patients but also has high complication rates.
Major finding: All-cause mortality, CVD, and renal disease risks were 49%, 34%, and 42% lower, respectively, in cases vs. controls.
Study details: A matched observational cohort study of 5,321 cases and 5,321 controls.
Disclosures: Dr. Liakopoulos reported having no disclosures.
Source: Liakopoulos V et al. ADA 2018, Abstract 131-OR.
Natural history is comparable for astrovirus, sapovirus, norovirus
ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.
Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.
The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.
The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.
Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.
The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).
Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.
“Most AsV cases present with both vomiting and diarrhea; most SaV cases present with vomiting and only approximately half with diarrhea,” the investigators wrote.
APPETITE study participants were enrolled from the EDs of two large children’s hospitals from December 2014 to May 2018. All were tested for 18 enteric pathogens and information on patient symptoms, medications, and potential exposures at enrollment and at 14 days was provided by patients and parents/guardians.
“We compared the natural histories of AsV and SaV to that of NoV, and found that all are comparable. These data provide a clearer picture than previously available of the duration and intensity of cardinal gastroenteritis symptoms associated with AsV and SaV infections,” they concluded.
Dr. Tarr reported having no financial disclosures.
ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.
Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.
The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.
The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.
Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.
The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).
Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.
“Most AsV cases present with both vomiting and diarrhea; most SaV cases present with vomiting and only approximately half with diarrhea,” the investigators wrote.
APPETITE study participants were enrolled from the EDs of two large children’s hospitals from December 2014 to May 2018. All were tested for 18 enteric pathogens and information on patient symptoms, medications, and potential exposures at enrollment and at 14 days was provided by patients and parents/guardians.
“We compared the natural histories of AsV and SaV to that of NoV, and found that all are comparable. These data provide a clearer picture than previously available of the duration and intensity of cardinal gastroenteritis symptoms associated with AsV and SaV infections,” they concluded.
Dr. Tarr reported having no financial disclosures.
ATLANTA – Astrovirus and sapovirus in children visiting the ED with acute gastroenteritis have a similar natural history, which is also similar to that of norovirus, according to findings from a prospective cohort study.
Thanks to the increased use of molecular diagnostic testing, astrovirus and sapovirus (AsV and SaV) recently gained new appreciation as a cause of gastroenteritis, but little is known about their natural history.
The current findings from the Alberta Provincial Pediatric Enteric Infection Team (APPETITE) study provide some longitudinal insight regarding that history, Gillian A. M. Tarr, PhD, of the University of Calgary (Alta.), and her colleagues noted in a poster presentation at the International Conference on Emerging Infectious Diseases.
The investigators tested rectal swabs and stool samples from 2,590 children under age 18 years who had experienced at least three episodes of diarrhea and/or vomiting in 24 hours. AsV was detected in 84 children (3.2%), SaV was detected in 229 (8.8%), and norovirus (NoV) was detected in 655 (25%). After excluding those with coinfection, a total of 54, 144, and 478 children with AsV, SaV, and NoV, respectively, were included.
Vomiting occurred in 83%, 92%, and 98%; diarrhea occurred in 94%, 79% and 75%; and blood was present in the stool in 4.0%, 7.0%, and 3.5%, of those with AsV, SaV, and NoV, respectively, they reported.
The median maximal vomiting episodes per day was slightly lower for AsV versus SaV and NoV (about 3 vs. 5 and 7, respectively); the median maximal diarrhea episodes was slightly higher for AsV (about 5 vs. 4 for both SaV and NoV).
Vomiting duration was similar for AsV and SaV (about 3 days) and slightly longer than for NoV (about 2 days); median diarrhea duration was about 5 days for all three viruses.
“Most AsV cases present with both vomiting and diarrhea; most SaV cases present with vomiting and only approximately half with diarrhea,” the investigators wrote.
APPETITE study participants were enrolled from the EDs of two large children’s hospitals from December 2014 to May 2018. All were tested for 18 enteric pathogens and information on patient symptoms, medications, and potential exposures at enrollment and at 14 days was provided by patients and parents/guardians.
“We compared the natural histories of AsV and SaV to that of NoV, and found that all are comparable. These data provide a clearer picture than previously available of the duration and intensity of cardinal gastroenteritis symptoms associated with AsV and SaV infections,” they concluded.
Dr. Tarr reported having no financial disclosures.
REPORTING FROM ICEID 2018
Key clinical point:
Major finding: Vomiting lasted about 3 days for astrovirus and sapovirus and 2 days for norovirus; diarrhea lasted about 5 days for all three viruses.
Study details: A prospective cohort study of 2,590 children.
Disclosures: Dr. Tarr reported having no financial disclosures.
Study suggests “alarming” diabetes med discontinuation
ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.
The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.
Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.
Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.
“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.
Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).
Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.
They had a mean age of 55 years, with 28% aged 45-54 years and 35% aged 55-64 years. About 46% were women, and all had at least one diagnosis for type 2 diabetes mellitus during the study period and at least one outpatient pharmacy claim for a type 2 diabetes medication that was prescribed to be taken for at least 30 days.
“As you would expect, far and away the majority [68%] were given metformin,” Dr. Latts said.
Other prescribed treatments after the initial diagnosis included sulfonylureas (7%), insulin (6%), dipeptidyl peptidase–4 inhibitors (6%), sodium-glucose cotransporter 2 inhibitors (1.5%), and a variety of combination treatments – typically metformin plus sulfonylureas (5%).
This study provides real-world evidence that a majority of patients with type 2 diabetes discontinue their treatment within 1 year – an important finding given that medication persistence is imperative for successful treatment, Dr. Latts said. She noted that prior research has shown treatment discontinuation of prescribed medication within the first year is common for a number of chronic disease treatments and is associated with poor clinical outcomes.
“If you treat diabetes, this is alarming,” she said. “These are people who should be on a diabetes med, their doctor probably thinks they’re on a diabetes med, and they’re not taking it.”
The findings are limited by factors associated with the use of administrative claims data, such as possible coding inaccuracies and missed cases in which patients paid out of pocket for medications through low-cost pharmacy offers, as well as by the 12-month window used for the study. She added that the findings may not be generalizable to uninsured or Medicare patients.
Nevertheless, the findings are concerning and may reflect misunderstandings among patients about the need to refill prescriptions after the initial supply runs out, or may relate to side effects that patients don’t report to their physicians, Sherita Golden, MD, of Johns Hopkins University, Baltimore, said during a question-and-answer period following Dr. Latts’ presentation.
“I do treat patients with diabetes so I am very alarmed,” she said, adding that there is a need to improve communication between patients and physicians about treatment and side effects.
Dr. Latts reported relationships with Medtronic, Novo Nordisk, and Sanofi. Her coauthors from IBM Watson and the ADA all reported having no financial disclosures.
SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.
ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.
The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.
Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.
Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.
“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.
Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).
Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.
They had a mean age of 55 years, with 28% aged 45-54 years and 35% aged 55-64 years. About 46% were women, and all had at least one diagnosis for type 2 diabetes mellitus during the study period and at least one outpatient pharmacy claim for a type 2 diabetes medication that was prescribed to be taken for at least 30 days.
“As you would expect, far and away the majority [68%] were given metformin,” Dr. Latts said.
Other prescribed treatments after the initial diagnosis included sulfonylureas (7%), insulin (6%), dipeptidyl peptidase–4 inhibitors (6%), sodium-glucose cotransporter 2 inhibitors (1.5%), and a variety of combination treatments – typically metformin plus sulfonylureas (5%).
This study provides real-world evidence that a majority of patients with type 2 diabetes discontinue their treatment within 1 year – an important finding given that medication persistence is imperative for successful treatment, Dr. Latts said. She noted that prior research has shown treatment discontinuation of prescribed medication within the first year is common for a number of chronic disease treatments and is associated with poor clinical outcomes.
“If you treat diabetes, this is alarming,” she said. “These are people who should be on a diabetes med, their doctor probably thinks they’re on a diabetes med, and they’re not taking it.”
The findings are limited by factors associated with the use of administrative claims data, such as possible coding inaccuracies and missed cases in which patients paid out of pocket for medications through low-cost pharmacy offers, as well as by the 12-month window used for the study. She added that the findings may not be generalizable to uninsured or Medicare patients.
Nevertheless, the findings are concerning and may reflect misunderstandings among patients about the need to refill prescriptions after the initial supply runs out, or may relate to side effects that patients don’t report to their physicians, Sherita Golden, MD, of Johns Hopkins University, Baltimore, said during a question-and-answer period following Dr. Latts’ presentation.
“I do treat patients with diabetes so I am very alarmed,” she said, adding that there is a need to improve communication between patients and physicians about treatment and side effects.
Dr. Latts reported relationships with Medtronic, Novo Nordisk, and Sanofi. Her coauthors from IBM Watson and the ADA all reported having no financial disclosures.
SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.
ORLANDO – Most patients with type 2 diabetes mellitus stop taking their medication within a year, and nearly one-third stop within the first 3 months, a retrospective analysis of claims data for more than 324,000 patients suggests.
The findings in this population of commercially insured adults are startling and highlight a need for interventions to improve treatment persistence, according to Lisa Latts, MD, deputy chief health officer for IBM Watson Health in Cambridge, Mass.
Dr. Latts and her colleagues reviewed medication claims data for 324,136 patients with at least one diagnosis for type 2 diabetes mellitus and one outpatient pharmacy claim for a type 2 diabetes medication after at least 12 prior months without such a claim.
Of those patients, 58% discontinued treatment within 12 months, 31% discontinued within the first 3 months, and 44% discontinued within 6 months, Dr. Latts reported at the annual scientific sessions of the American Diabetes Association.
“Less than half of those patients who discontinued had a restart within the following year. So what we’re seeing here is a huge percentage of individuals who had a diagnosis of type 2 diabetes, were prescribed a medication, and then did not continue the medication,” she said.
Of those who discontinued within the 12-month follow-up, 27% restarted therapy within 60 days and 39% restarted therapy anytime during the 12-month follow-up (mean treatment gap, 107 days). Of those who discontinued by 3 months, 45% restarted within a year (mean treatment gap, 112 days), and of those who discontinued by 6 months, 44% restarted within a year (mean treatment gap, 119 days).
Patients included in the review, which was a collaborative effort of IBM Watson Health and the ADA, had at least 12 months of continuous enrollment in the Truven Health MarketScan Commercial and Medicare Supplemental Databases between 2013 and 2017, before and after the therapy initiation date.
They had a mean age of 55 years, with 28% aged 45-54 years and 35% aged 55-64 years. About 46% were women, and all had at least one diagnosis for type 2 diabetes mellitus during the study period and at least one outpatient pharmacy claim for a type 2 diabetes medication that was prescribed to be taken for at least 30 days.
“As you would expect, far and away the majority [68%] were given metformin,” Dr. Latts said.
Other prescribed treatments after the initial diagnosis included sulfonylureas (7%), insulin (6%), dipeptidyl peptidase–4 inhibitors (6%), sodium-glucose cotransporter 2 inhibitors (1.5%), and a variety of combination treatments – typically metformin plus sulfonylureas (5%).
This study provides real-world evidence that a majority of patients with type 2 diabetes discontinue their treatment within 1 year – an important finding given that medication persistence is imperative for successful treatment, Dr. Latts said. She noted that prior research has shown treatment discontinuation of prescribed medication within the first year is common for a number of chronic disease treatments and is associated with poor clinical outcomes.
“If you treat diabetes, this is alarming,” she said. “These are people who should be on a diabetes med, their doctor probably thinks they’re on a diabetes med, and they’re not taking it.”
The findings are limited by factors associated with the use of administrative claims data, such as possible coding inaccuracies and missed cases in which patients paid out of pocket for medications through low-cost pharmacy offers, as well as by the 12-month window used for the study. She added that the findings may not be generalizable to uninsured or Medicare patients.
Nevertheless, the findings are concerning and may reflect misunderstandings among patients about the need to refill prescriptions after the initial supply runs out, or may relate to side effects that patients don’t report to their physicians, Sherita Golden, MD, of Johns Hopkins University, Baltimore, said during a question-and-answer period following Dr. Latts’ presentation.
“I do treat patients with diabetes so I am very alarmed,” she said, adding that there is a need to improve communication between patients and physicians about treatment and side effects.
Dr. Latts reported relationships with Medtronic, Novo Nordisk, and Sanofi. Her coauthors from IBM Watson and the ADA all reported having no financial disclosures.
SOURCE: Latts L et al. ADA 2018, Abstract 135-OR.
REPORTING FROM ADA 2018
Key clinical point:
Major finding: In total, 58% of patients discontinued treatment within 12 months, and just 39% of those patients restarted within 1 year.
Study details: An analysis of claims data for more than 324,000 patients.
Disclosures: Dr. Latts reported relationships with Medtronic, Novo Nordisk, and Sanofi. Her coauthors from IBM Watson and the American Diabetes Association all reported having no financial disclosures.
Source: Latts L et al. ADA 2018, Abstract 135-OR.
Zika virus infection: Novel assay extends diagnostic window
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
ATLANTA – A novel pyrosequencing (PSQ)–based reverse-transcription polymerase chain reaction (RT-PCR) assay improves and expands diagnostic capabilities for Zika virus infection, according to findings in 60 patients diagnosed with the virus in 2016 and 2017.
The PSQ assay provides rapid, specific, and cost-effective detection of the virus in tissues of congenital and pregnancy-associated infections, and, compared with serum-based assays, extends the time frame for Zika virus detection, Julu Bhatnagar, PhD, reported in a presentation at the International Conference on Emerging Infectious Diseases.
Dr. Bhatnagar and her colleagues from the Centers for Disease Control and Prevention in Atlanta developed the assay and evaluated it using RNA extracted from formalin-fixed, paraffin-embedded placental/fetal tissues from 53 women with varying pregnancy outcomes, and brain tissues from seven infants with microcephaly who died. In all of the tissue samples, which were received between January 2016 and August 2017, Zika virus was previously identified by conventional RT-PCR and Sanger sequencing.
The PSQ assay detected and sequence confirmed Zika virus in tissues from all 60 patients, whereas 40 negative control samples, including tissues from dengue- and chikungunya virus–confirmed cases, all tested negative.
In addition, the PSQ assay detected Zika virus in placental tissues from three other cases that were previously negative by the conventional tissue-based RT-PCR, thereby demonstrating better sensitivity of the PSQ assay in comparison to conventional tissue RT-PCR, said Dr. Bhatnagar, who is molecular pathology team leader in the Infectious Diseases Pathology Branch, Division of High-Consequence Pathogens and Pathology at the CDC’s National Center for Emerging and Zoonotic Infectious Diseases.
“Importantly, PSQ results can be obtained in 1 day and at half the cost of Sanger sequencing,” she said.
The findings are important because Zika virus infection during pregnancy can cause microcephaly and is associated with pregnancy loss. Laboratory diagnosis of the virus is challenging for pregnancy-associated infections because of the short duration of viremia, she explained.
However, prolonged detection of Zika virus RNA in placental, fetal, and neonatal brain tissue has been reported.
Dr. Bhatnagar was the first author on a 2016 study published in Emerging Infectious Diseases that provided confirmation of the linkage of Zika virus with microcephaly and that suggested its association with adverse pregnancy outcomes and provided evidence of Zika virus replication and persistence in fetal brain and placenta.
“This article highlights the value of tissue analysis to expand opportunities to diagnose Zika virus congenital and pregnancy-associated infections and to enhance the understanding of mechanism of Zika virus intrauterine transmission and pathogenesis,” she and her colleagues wrote in that article. “In addition, the tissue-based RT-PCRs extend the time frame for Zika virus detection and particularly help to establish a diagnosis retrospectively, enabling pregnant women and their health care providers to identify the cause of severe microcephaly or fetal loss.”
Those findings led to the hypothesis that the PSQ assay evaluated in the current study would provide better opportunities for detection, particularly in cases where serum RT-PCR or serologic testing is negative because of testing performed outside the optimal testing window, she said.
Indeed, the novel assay not only allows for an extended time frame for Zika virus detection, it also provides insights into viral tissue tropism and persistence, she noted.
According to the CDC, no local mosquito-borne Zika virus transmissions have been reported in the continental United States in 2018, but transmission is still a threat internationally, and those traveling outside of the continental United States should find out if they are traveling to an area with risk of Zika.
Dr. Bhatnagar reported having no disclosures.
SOURCE: Bhatnagar J et al. ICEID 2018, Abstract O1.
REPORTING FROM ICEID 2018
Key clinical point: A novel assay extends the time frame for diagnosing Zika virus infection.
Major finding: The PSQ assay detected and sequence confirmed Zika virus in all 60 samples; 40 negative control samples all tested negative.
Study details: An analysis of 60 tissue samples using a novel assay.
Disclosures: Dr. Bhatnagar reported having no disclosures.
Source: Bhatnagar J et al. ICEID 2018, Abstract O1.
Review protocols, follow reprocessing guidelines to cut device-related HAIs
ATLANTA – Ongoing vigilance regarding the role of and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).
A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.
He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.
Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).
“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.
In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.
“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.
Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.
In some cases there was disciplinary action or oversight for health care professionals, he added.
Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.
A number of lessons can be learned from these and other investigations, he added.
“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”
In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.
Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”
“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.
Dr. Benowitz reported having no disclosures.
[email protected]
SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.
ATLANTA – Ongoing vigilance regarding the role of and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).
A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.
He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.
Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).
“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.
In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.
“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.
Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.
In some cases there was disciplinary action or oversight for health care professionals, he added.
Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.
A number of lessons can be learned from these and other investigations, he added.
“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”
In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.
Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”
“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.
Dr. Benowitz reported having no disclosures.
[email protected]
SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.
ATLANTA – Ongoing vigilance regarding the role of and transmission of antimicrobial-resistant pathogen is needed, according to Isaac Benowitz, MD, of the Centers for Disease Control and Prevention’s Division of Healthcare Quality Promotion (DHQP).
A review of records from the DHQP, which investigates and responds to infections and related adverse events in health care settings upon invitation, showed that in 2017 environmental pathogens were most often the triggers for these investigations, said Dr. Benowitz, a medical epidemiologist.
He reviewed internal records for consultations with state and local health departments involving medical devices and collected data on health care setting, pathogen, investigation findings including possible exposure or transmission, and public health actions.
Of 285 consultations, 48 involved a specific medical device or general medical device reprocessing, he said, noting that most of those 48 were in an acute care hospital (63%) or clinic (19%).
“The most frequent pathogens noted in these consultations were nontuberculous mycobacteria at 21%, Candida species ... at 10%, and Burkholderia species ... at 8%,” he said, noting that a wide variety of devices were implicated.
In the inpatient setting these devices included ventilators, dialysis machines, breast pumps, central lines, and respiratory therapy equipment. In the outpatient setting they included glucometers and opthalmic equipment.
“In many settings we saw issues with endoscopes, including duodenoscopes, but also bronchoscopes,” he added.
Actions taken as part of the investigations included medical device recalls, improved infection control and reprocessing procedures, and patient notification, education, guidance, testing, and treatment.
In some cases there was disciplinary action or oversight for health care professionals, he added.
Investigations identified medical devices contaminated in manufacturing, incorrect reprocessing of endoscopes or ventilators, and inappropriate medical device use or reuse, he said.
A number of lessons can be learned from these and other investigations, he added.
“First, devices can be reservoirs and transmission vectors for health care–associated infections. Second, health care facilities, health care facility staff, and public health partners should take opportunities to review protocols and the practices within those protocol,” he said. “These are opportunities to strengthen infection control practices even in the absence of documented transmission.”
In fact, in most of the investigations he discussed, transmission was rarely confirmed to be associated with a medical device. This was largely because of a lack of “epidemiological rigor,” but associations between health care–associated infections and medical devices “are still quite meaningful and often actionable,” he said.
Dr. Benowitz stressed the importance of engaging public health partners to discuss findings and actions, explaining that “what may look like a single-facility issue may have a very different perspective when you realize that there’s a similar issue at another facility elsewhere.”
“For all devices, it’s important to ensure adherence to the device reprocessing guidelines, “ he added, noting that these include a combination of facility protocols, manufacturer instructions for use, and guidance from organizations like the Food and Drug Administration and the CDC.
Dr. Benowitz reported having no disclosures.
[email protected]
SOURCE: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.
REPORTING FROM ICEID 2018
Key clinical point: Medical devices can be reservoirs and transmission vectors for health care–associated infections.
Major finding: Of 285 consultations, 48 involved medical devices or device reprocessing.
Study details: A review of records from 285 consultations
Disclosures: Dr. Benowitz reported having no disclosures
Source: Benowitz I et al. ICEID 2018, Oral Abstract Presentation E2.
Cutaneous lesions? Consider C. diphtheriae in those with foreign travel
ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.
The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”
Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”
The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.
The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.
The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.
The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.
Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.
Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.
Ms. Griffith reported having no disclosures.
ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.
The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”
Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”
The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.
The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.
The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.
The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.
Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.
Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.
Ms. Griffith reported having no disclosures.
ATLANTA – Seven cases of imported Corynebacterium diphtheriae in Minnesota highlight the importance of maintaining suspicion that cutaneous lesions in individuals with recent travel to endemic countries might be associated with C. diphtheriae infection.
The cases also underscore the importance of referring C. diphtheriae isolates to state health departments for confirmatory testing, Jayne Griffith, of the Minnesota Department of Health, and her colleagues reported in a poster at the International Conference on Emerging Infectious Diseases.
“C. diphtheriae infections was not clinically suspected in any of these case-patients. All infections were initially identified solely by [matrix-assisted laser desorption/ionization time-of-flight spectrometry] testing performed at the clinical institutions,” the investigators wrote. “Confirmation and further toxigenicity testing allowed for prompt case investigation and public health response, preventing disease spread.”
Infections caused by toxigenic C. diphtheriae are rare in the United States because of widespread vaccination, but remain endemic in countries with suboptimal vaccine coverage. For this reason, infection is a concern for unvaccinated individuals traveling to diphtheria-endemic countries as well as for those who have contact with people from these areas. The investigators noted that “infections are primarily respiratory or cutaneous; respiratory infections can be life-threatening and cutaneous wounds may serve as a reservoir from which bacteria can be transmitted to susceptible contacts.”
The Minnesota cases involved patients who presented with cutaneous ulcers between 2014 and 2017. The Minnesota Department of Health confirmed C. diphtheriae status by culture after the initial identification at private institutions or providers using matrix-assisted laser desorption/ionization time-of-flight spectrometry. Isolates were sent to the Centers for Disease Control and Prevention Pertussis and Diphtheria Laboratory for biotyping and confirmation of toxigenicity.
The CDC confirmed that isolates from two patients were toxigenic C. diphtheriae biotype mitis. The remaining cases were nontoxigenic diphtheria, including C. diphtheriae mitis (three case-patients, including one who also had Staphylococcus aureus, and another who also had methicillin-resistant S. aureus) and two case-patients with C. diphtheriae belfanti.
The patients with toxigenic infection included a 35-year-old woman who developed an abdominal boil after spending months in Somalia, and a 48-year-old man who cut his leg while in Ethiopia.
The patients with nontoxigenic infection included four foreign-born individuals ranging in age from 7 to 66 years and one 24-year-old man from the United States. One of the foreign-born individuals had immigrated from a diphtheria-endemic country 3 months prior to his diagnosis, but none of the remaining four had traveled outside the United States in the 6 months prior to infection onset. One, however, lived in a home with family members who traveled frequently to eastern Africa. The vaccination status of these patients was unknown.
Contact tracing was conducted and prophylactic antibiotics were recommended as appropriate. Vaccination was recommended when a case-patient and/or contact was inadequately immunized.
Both patients with toxigenic infection experienced wound healing after appropriate antibiotic therapy.
Ms. Griffith reported having no disclosures.
REPORTING FROM ICEID 2018
Key clinical point: Corynebacterium diphtheriae should be considered in individuals who present with cutaneous lesions after traveling to diphtheria-endemic countries.
Major finding: Refer suspect C. diphtheriae isolates to state health departments.
Study details: A review of seven C. diphtheriae cases.
Disclosures: Ms. Griffith reported having no disclosures.
United Kingdom experience provides important lessons for controlling C. auris outbreaks
ATLANTA – The persistence and transmission of Candida auris in health care settings appears to be dependent on environmental survival, underscoring the need for careful investigation of the environment – and, in particular, multiuse patient equipment.
That’s the key lesson from one of the largest outbreaks of the emerging, multidrug-resistant pathogen to date, David Eyre, DPhil, said at the International Conference on Emerging Infectious Diseases.
“Our experience at Oxford began with a Public Health England alert, which closely followed a similar alert from the [Centers for Disease Control and Prevention] in the summer of 2016,” Dr. Eyre of the University of Oxford (England) said during an update on the epidemiology of the outbreak and the successful, multipronged effort to control it.
The outbreak, which occurred in the neurosciences intensive care unit of Oxford University Hospitals beginning in early 2015, was detected in 2016 when a cluster of C. auris infections was identified and traced to the unit. An intensive patient and environmental screening program was established, isolation protocols were used for patients who tested positive, enhanced cleaning processes were initiated, and equipment was removed and replaced with single-use equipment when possible.
“We also worked quite closely with our staff to raise awareness,” he said, adding that colonized patients who were undergoing a surgical procedure received single-dose antifungal prophylaxis prior to the procedure.
A case-control study was conducted, and after the researchers used multivariate logistic regression to control for length of stay, patient physiology, and biomarkers, exposure to multiuse skin surface axillary temperature monitoring was shown to be one of the strongest independent predictors of C. auris colonization and infection (odds ratio 6.80), he said, adding that antifungal exposure was also a significant risk factor, but only 5% of patients had received antifungals.
The axillary probes were then removed from the environment. As of April 2017 (when the probes were removed), 66 patients had been colonized or infected, and an additional 10 cases occurred after the probes were removed, with the last case occurring in November 2017.
Seven of the 76 cases involved invasive infection, and 1 patient died several months after hospital discharge, Dr. Eyre said.
The patient screening processes allowed for estimation of colonization time (approximately 2 months), and also allowed for whole-genome sequencing of 79 samples from 43 patients, 6 environmental isolates, and 2 isolates from regional surveillance, Dr. Eyre said.
All outbreak sequences formed a single genetic cluster within the C. auris South African clade, and were found to have been introduced to Oxford around 2012 or 2013, with about six mutations per year, or “roughly 12 million base pairs in total,” he said, adding that both patients and temperature probes were colonized with multiple strains, and there was “close mixing” between the two.
This pattern changed following removal of the temperature probes, but it took some time.
“However, from November [2017] onward – so that’s now 291 days ... we’ve not had another new patient isolate, and that’s not only no invasive infection, but also no colonization despite continuing the screening program,” he said.
According to the CDC, C. auris is “an emerging fungus that presents a serious global health threat” because of its often multidrug-resistant nature, difficulty identifying the pathogen using standard laboratory methods, and the risk for misidentification in labs without specific technology, which could lead to inappropriate management.
“It has caused outbreaks in health care settings. For this reason, it is important to quickly identify C. auris in a hospitalized patient so that health care facilities can take special precautions to stop its spread,” a CDC page on C. auris states. “CDC encourages all U.S. laboratory staff who identify C. auris to notify their state or local public health authorities and CDC at [email protected].”
Dr. Eyre reported having no disclosures.
SOURCE: Eyre D et al. ICEID 2018 Oral Abstract Presentation.
ATLANTA – The persistence and transmission of Candida auris in health care settings appears to be dependent on environmental survival, underscoring the need for careful investigation of the environment – and, in particular, multiuse patient equipment.
That’s the key lesson from one of the largest outbreaks of the emerging, multidrug-resistant pathogen to date, David Eyre, DPhil, said at the International Conference on Emerging Infectious Diseases.
“Our experience at Oxford began with a Public Health England alert, which closely followed a similar alert from the [Centers for Disease Control and Prevention] in the summer of 2016,” Dr. Eyre of the University of Oxford (England) said during an update on the epidemiology of the outbreak and the successful, multipronged effort to control it.
The outbreak, which occurred in the neurosciences intensive care unit of Oxford University Hospitals beginning in early 2015, was detected in 2016 when a cluster of C. auris infections was identified and traced to the unit. An intensive patient and environmental screening program was established, isolation protocols were used for patients who tested positive, enhanced cleaning processes were initiated, and equipment was removed and replaced with single-use equipment when possible.
“We also worked quite closely with our staff to raise awareness,” he said, adding that colonized patients who were undergoing a surgical procedure received single-dose antifungal prophylaxis prior to the procedure.
A case-control study was conducted, and after the researchers used multivariate logistic regression to control for length of stay, patient physiology, and biomarkers, exposure to multiuse skin surface axillary temperature monitoring was shown to be one of the strongest independent predictors of C. auris colonization and infection (odds ratio 6.80), he said, adding that antifungal exposure was also a significant risk factor, but only 5% of patients had received antifungals.
The axillary probes were then removed from the environment. As of April 2017 (when the probes were removed), 66 patients had been colonized or infected, and an additional 10 cases occurred after the probes were removed, with the last case occurring in November 2017.
Seven of the 76 cases involved invasive infection, and 1 patient died several months after hospital discharge, Dr. Eyre said.
The patient screening processes allowed for estimation of colonization time (approximately 2 months), and also allowed for whole-genome sequencing of 79 samples from 43 patients, 6 environmental isolates, and 2 isolates from regional surveillance, Dr. Eyre said.
All outbreak sequences formed a single genetic cluster within the C. auris South African clade, and were found to have been introduced to Oxford around 2012 or 2013, with about six mutations per year, or “roughly 12 million base pairs in total,” he said, adding that both patients and temperature probes were colonized with multiple strains, and there was “close mixing” between the two.
This pattern changed following removal of the temperature probes, but it took some time.
“However, from November [2017] onward – so that’s now 291 days ... we’ve not had another new patient isolate, and that’s not only no invasive infection, but also no colonization despite continuing the screening program,” he said.
According to the CDC, C. auris is “an emerging fungus that presents a serious global health threat” because of its often multidrug-resistant nature, difficulty identifying the pathogen using standard laboratory methods, and the risk for misidentification in labs without specific technology, which could lead to inappropriate management.
“It has caused outbreaks in health care settings. For this reason, it is important to quickly identify C. auris in a hospitalized patient so that health care facilities can take special precautions to stop its spread,” a CDC page on C. auris states. “CDC encourages all U.S. laboratory staff who identify C. auris to notify their state or local public health authorities and CDC at [email protected].”
Dr. Eyre reported having no disclosures.
SOURCE: Eyre D et al. ICEID 2018 Oral Abstract Presentation.
ATLANTA – The persistence and transmission of Candida auris in health care settings appears to be dependent on environmental survival, underscoring the need for careful investigation of the environment – and, in particular, multiuse patient equipment.
That’s the key lesson from one of the largest outbreaks of the emerging, multidrug-resistant pathogen to date, David Eyre, DPhil, said at the International Conference on Emerging Infectious Diseases.
“Our experience at Oxford began with a Public Health England alert, which closely followed a similar alert from the [Centers for Disease Control and Prevention] in the summer of 2016,” Dr. Eyre of the University of Oxford (England) said during an update on the epidemiology of the outbreak and the successful, multipronged effort to control it.
The outbreak, which occurred in the neurosciences intensive care unit of Oxford University Hospitals beginning in early 2015, was detected in 2016 when a cluster of C. auris infections was identified and traced to the unit. An intensive patient and environmental screening program was established, isolation protocols were used for patients who tested positive, enhanced cleaning processes were initiated, and equipment was removed and replaced with single-use equipment when possible.
“We also worked quite closely with our staff to raise awareness,” he said, adding that colonized patients who were undergoing a surgical procedure received single-dose antifungal prophylaxis prior to the procedure.
A case-control study was conducted, and after the researchers used multivariate logistic regression to control for length of stay, patient physiology, and biomarkers, exposure to multiuse skin surface axillary temperature monitoring was shown to be one of the strongest independent predictors of C. auris colonization and infection (odds ratio 6.80), he said, adding that antifungal exposure was also a significant risk factor, but only 5% of patients had received antifungals.
The axillary probes were then removed from the environment. As of April 2017 (when the probes were removed), 66 patients had been colonized or infected, and an additional 10 cases occurred after the probes were removed, with the last case occurring in November 2017.
Seven of the 76 cases involved invasive infection, and 1 patient died several months after hospital discharge, Dr. Eyre said.
The patient screening processes allowed for estimation of colonization time (approximately 2 months), and also allowed for whole-genome sequencing of 79 samples from 43 patients, 6 environmental isolates, and 2 isolates from regional surveillance, Dr. Eyre said.
All outbreak sequences formed a single genetic cluster within the C. auris South African clade, and were found to have been introduced to Oxford around 2012 or 2013, with about six mutations per year, or “roughly 12 million base pairs in total,” he said, adding that both patients and temperature probes were colonized with multiple strains, and there was “close mixing” between the two.
This pattern changed following removal of the temperature probes, but it took some time.
“However, from November [2017] onward – so that’s now 291 days ... we’ve not had another new patient isolate, and that’s not only no invasive infection, but also no colonization despite continuing the screening program,” he said.
According to the CDC, C. auris is “an emerging fungus that presents a serious global health threat” because of its often multidrug-resistant nature, difficulty identifying the pathogen using standard laboratory methods, and the risk for misidentification in labs without specific technology, which could lead to inappropriate management.
“It has caused outbreaks in health care settings. For this reason, it is important to quickly identify C. auris in a hospitalized patient so that health care facilities can take special precautions to stop its spread,” a CDC page on C. auris states. “CDC encourages all U.S. laboratory staff who identify C. auris to notify their state or local public health authorities and CDC at [email protected].”
Dr. Eyre reported having no disclosures.
SOURCE: Eyre D et al. ICEID 2018 Oral Abstract Presentation.
REPORTING FROM ICEID 2018
Key clinical point:
Major finding: Ten additional cases occurred in the 7 months after the axillary probes were removed from the environment.
Study details: A review of the epidemiology and control of a C. auris outbreak affecting 76 patients.
Disclosures: Dr. Eyre reported having no disclosures.
Source: Eyre D et al. ICEID 2018 Oral Abstract Presentation.
Patient transfers between hospitals contribute substantially to CDI burden
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
The AGA Fecal Microbiota Transplantation (FMT) National Registry will assess short- and long-term patient outcomes associated with FMT. Learn more at http://ow.ly/WdQE30lBuSu
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
The AGA Fecal Microbiota Transplantation (FMT) National Registry will assess short- and long-term patient outcomes associated with FMT. Learn more at http://ow.ly/WdQE30lBuSu
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
The AGA Fecal Microbiota Transplantation (FMT) National Registry will assess short- and long-term patient outcomes associated with FMT. Learn more at http://ow.ly/WdQE30lBuSu
REPORTING FROM ICEID 2018
Key clinical point: Patient sharing among hospitals contributes substantially to Clostridium difficile infection (CDI) rates.
Major finding: Patient transfers account for 7.6% of the overall CDI burden.
Study details: A statistical analysis to estimate interhospital CDI transmissions.
Disclosures: Dr. Sewell reported that he had no disclosures.
Patient transfers between hospitals contribute substantially to CDI burden
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
ATLANTA – Patient sharing among hospital facilities contributed substantially to the overall Clostridium difficile infection rate, an analysis of interhospital contamination effects showed.
In fact, 7.6% of all Clostridium difficile infection (CDI) cases at the nearly 400 California hospitals included in the study were directly attributable to the patient-sharing network, Daniel Sewell, PhD, reported at the International Conference on Emerging Infectious Diseases.
“The methods that we employed allowed us to estimate the expected increase in CDI cases due to transfers as a function of the CDI rate at the hospital from which those patients were brought. These transfer patients were responsible for about 3.06 times the number of CDI cases as a normal patient,” said Dr. Sewell, a biostatistician at the University of Iowa, Iowa City.
The findings, which underscored the importance of regional (rather than local) efforts to minimize the spread of health care–associated infections, are based on an analysis of 27,200,873 hospital admissions and 532,320 same-day patient transfers identified from the Healthcare Cost and Utilization Project California State Inpatient Database for 2005-2011.
Transfer networks based on the monthly average number of patients discharged from one hospital and admitted to another on the same day were constructed, and the monthly average number of CDI cases per hospital were considered, along with hospital-level characteristics such as patient length of stay, age, and number of diagnoses. Network autocorrelation models that help eliminate bias were then used to assess the contamination effects between hospitals, he explained.
This led to development of an equation that can be used to determine the expected number of CDI cases in a hospital as a function of the number of transfers coming in and the contamination level of the source hospitals. The ability to calculate the expected number of CDI cases in this fashion is an important factor for the success of regional versus local intervention efforts, which are increasingly thought to be important for reducing health care–associated infections.
“If we want to design a coordinated or regional approach, we’ve got to have a much better understanding of the role that patient transfers have in these diseases,” Dr. Sewell said.
As most hospitals included in the study had a low CDI rate and a low transfer rate, the CDIs attributable to transfers represent a minority of cases, but they are a substantial minority, he said, noting that the main concern is with the “perfect storm” of high CDI rate plus high transfer rate.
The methodological approach used in this study to estimate CDI rates can be used for any health care–associated infection of interest, he added.
Dr. Sewell reported that he had no disclosures.
REPORTING FROM ICEID 2018
Key clinical point: Patient sharing among hospitals contributes substantially to Clostridium difficile infection (CDI) rates.
Major finding: Patient transfers account for 7.6% of the overall CDI burden.
Study details: A statistical analysis to estimate interhospital CDI transmissions.
Disclosures: Dr. Sewell reported that he had no disclosures.