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SSTI guidelines stress diagnostic skill, careful treatment
New practice guidelines on skin and soft tissue infections from the Infectious Diseases Society of America stress careful clinical attention to the type of infection, the epidemiological setting in which the infection occurred, the health status of the patient, and the selection and dosage of the most appropriate treatment agents.
The guidelines, published online June 18 in Clinical Infectious Diseases (doi:10.1093/cid/ciu296), update those issued by IDSA in 2005 and cover everything from preventing infections caused by animal bites in healthy hosts to life-threatening infections in immunocompromised patients. They also emphasize accurate identification of pathogens, stressing that clinical presentations can be very similar.
"This is not one of those guidelines that boils complex issues down to a choice between a couple of different drugs or combinations of drugs," said Dr. Dennis Stevens of the Department of Veterans Affairs in Boise, Idaho, the guidelines’ lead author. "Skin and soft tissue infections [SSTIs] have multiple causes and different presentations, depending upon the immune status of the host. Here it’s much more complicated and really requires an astute physician to consider a number of things."
The guidelines, drafted by a 10-member panel, offer a novel algorithm for management of nonpurulent and purulent infections that aims to define a pathway for mild, moderate, and severe infections in each category. For example, no antibiotic is recommended for a purulent infection – only incision and drainage – if the patient has no signs of systemic involvement.
For moderate cases of purulent infection with some systemic involvement, incision and drainage should be followed by culture and sensitivity testing, the guidelines say, listing two antibiotics, trimethoprim-sulfamethoxazole and doxycycline, as appropriate for empiric treatment, while trimethoprim-sulfamethoxazole is recommended if the pathogen is found to be methicillin-resistant Staphylococcus aureus (MRSA) and dicloxacillin or cephalexin if it is methicillin-susceptible S. aureus (MSSA).
The purpose of the algorithm, expressed in the guidelines in chart form, "is to make the physician think," Dr. Stevens said in an interview. "There is a huge move to try and monitor antibiotic stewardship to prevent resistance, and we’re just trying to get the clinician to think of tier 1, tier 2, and tier 3 approaches, depending not only on the bug, but on how sick the patient is. Instead of a knee-jerk approach treating everybody with highly expensive IV antibiotics, [the algorithm] provides a clear pathway to treat appropriately."
In people with an abscess who have failed antibiotic treatment, are immunocompromised, or have fever and elevated white blood cell counts or other evidence of severe infection, "we’re not going to gamble," Dr. Stevens said, adding that the guidelines recommend prompt treatment using "an antibiotic that gets all of these organisms, including resistant ones." Newly approved agents dalbavancin and tedizolid are effective in treating SSTIs caused by MRSA, the guidelines note.
The guidelines are intended for use by clinicians in emergency departments, family practice, internal medicine, general surgery, orthopedics, gynecology, dermatology, infectious disease, and oncology.
Another algorithm charted in the guidelines covers wound infections following surgeries, which can involve multiple pathogens. The algorithm provides simple clinical clues as to which require antibiotics, a simple opening of the suture line, "or a full-court press for the kind of devastating infections that occur within the first 48 hours," Dr. Stevens said. Additional recommendations address infections that can occur in individuals receiving treatment for cancer or receiving immunosuppressant medications, or those who have had an organ transplant or who have HIV/AIDS.
Immunocompromised patients, Dr. Stevens said, are among the most challenging to treat because they may have a history of extensive antibiotic exposure, are likely to have infections with resistant bacteria, and often see involvement with fungal and parasitic agents that might be considered innocuous in normal individuals. "This is the first time physicians will have some decent guidelines about how to approach the problem of skin and soft tissue infections in these kinds of patients," he noted.
The guidelines’ development was funded by the IDSA. Dr. Stevens reported no conflicts of interest. Panel member Alan L. Bisno disclosed receiving honoraria from UpToDate, while five other members – Dr. Henry F. Chambers, Dr. E. Patchen Dellinger, Dr. Ellie J. C. Goldstein, Dr. Sherwood L. Gorbach, and Dr. Sheldon L. Kaplan – disclosed financial relationships with pharmaceutical manufacturers.
Skin and soft tissue infections are one of the most common causes for patient evaluation in emergency departments and are common reasons for consultations by surgeons. SSTIs occur across a broad continuum of severity and often require only antimicrobial therapy (such as cellulitis), but they may be fulminate and life-threatening necrotizing infections that require aggressive surgical intervention. The guidelines provided by a distinguished group of clinicians from the Infectious Diseases Society of America provide an excellent organizational framework to understand this heterogenous collection of infections and provide a meaningful structure to direct management.
Several points in these guidelines deserve emphasis. First, considerable discussion in the guidelines has focused on the immunocompromised patient with SSTIs, and appropriately so. A broader consideration might have been to also include those patients with health care-associated exposure in addition to clinical immunosuppression. About 40 million hospitalizations occur annually in the United State, which makes over 3 million patients within 30 days of discharge. A larger number of patients have had recent antibiotic exposure. About 1.5 million patients are in chronic care facilities and nearly 500,000 are receiving chronic hemodialysis. Accordingly, immunocompromised and health care-associated patient exposures require that assumptions about the microbiology of SSTIs have "sensitivity" to the resistant pathogens (such as MRSA) not traditionally typical of community-acquired infections.
Second, the guidelines refer to the use of Gram stains for directing antimicrobial therapy. Although the Gram stain does not have the high-technology flare of contemporary health care, it remains a useful tool in differentiating pathogens, especially in necrotizing SSTIs.
Of the major microbiological presentations of necrotizing SSTIs, Streptococcus pyogenes is a gram-positive cocci in chains, Staphylococcus aureus is a gram-positive cocci in clusters, Clostridium perfringens is a gram-positive rod, and polymicrobial infections will have an assortment of different morphologic and gram-staining characteristics in identified bacteria. Aeromonas hydrophilia and Vibrio vulnificus will appear as gram-negative rods in those necrotizing SSTIs associated with fresh or salt-water recreational exposure. The Gram stain provides immediate direction for therapy when culture results will often be too late for a meaningful impact on patient care. Unfortunately, many hospitals have abandoned the use of Gram stains for clinical specimens.
Finally, prompt diagnosis of necrotizing SSTIs is essential. A cause of potentially preventable morbidity and deaths is a delay in the recognition of necrotizing SSTIs and the need for urgent surgical debridement. Necrotizing SSTIs are common issues in medicolegal actions because of the issue of failure to make the timely diagnosis. The hallmark of necrotizing SSTIs is pain out of proportion to the inciting injury. Trivial cutaneous injuries that are associated with an advancing perimeter of palpable tenderness and induration are necrotizing SSTIs until proven otherwise. Importantly, S. pyogenes in particular is associated with "metastatic" infection. Patients with soft-tissue contusions, joint effusions, and even fractures may have blood-borne streptococcal contamination of the injury site and yield a necrotizing infection without any cutaneous source of microbial contamination.
Because monitoring the progression of SSTIs is so important in differentiating necrotizing infections, I would only take to task the recommendation for the use of corticosteroids in treatment of cellulitic infections. Pharmacologic immunosuppression of the patient with an active SSTI in the interest of providing symptomatic relief compromises the clinical evaluation of disease progression.
In summary, the guidelines and the two algorithms for managing community-acquired and surgical incision infections are very useful for providing surgical clinicians direction in patient management. The increased incidence of S. aureus-associated necrotizing SSTIs and the emergence of community-associated MRSA over the last 20 years indicate that this is a dynamic area with changing characteristics. The changing pattern of pathogens and antimicrobial choices require a more frequent updating of these important guidelines for patient management.
Dr. Donald E. Fry is an ACS Fellow, executive vice-president for clinical outcomes management of MPA Inc. of Chicago, adjunct professor of surgery at the Northwestern University in Chicago, and professor emeritus of surgery at the University of New Mexico. He is a fellow of the Infectious Diseases Society of America, a past president of the Surgical Infection Society, and associate editor of the journal Surgical Infections.
Skin and soft tissue infections are one of the most common causes for patient evaluation in emergency departments and are common reasons for consultations by surgeons. SSTIs occur across a broad continuum of severity and often require only antimicrobial therapy (such as cellulitis), but they may be fulminate and life-threatening necrotizing infections that require aggressive surgical intervention. The guidelines provided by a distinguished group of clinicians from the Infectious Diseases Society of America provide an excellent organizational framework to understand this heterogenous collection of infections and provide a meaningful structure to direct management.
Several points in these guidelines deserve emphasis. First, considerable discussion in the guidelines has focused on the immunocompromised patient with SSTIs, and appropriately so. A broader consideration might have been to also include those patients with health care-associated exposure in addition to clinical immunosuppression. About 40 million hospitalizations occur annually in the United State, which makes over 3 million patients within 30 days of discharge. A larger number of patients have had recent antibiotic exposure. About 1.5 million patients are in chronic care facilities and nearly 500,000 are receiving chronic hemodialysis. Accordingly, immunocompromised and health care-associated patient exposures require that assumptions about the microbiology of SSTIs have "sensitivity" to the resistant pathogens (such as MRSA) not traditionally typical of community-acquired infections.
Second, the guidelines refer to the use of Gram stains for directing antimicrobial therapy. Although the Gram stain does not have the high-technology flare of contemporary health care, it remains a useful tool in differentiating pathogens, especially in necrotizing SSTIs.
Of the major microbiological presentations of necrotizing SSTIs, Streptococcus pyogenes is a gram-positive cocci in chains, Staphylococcus aureus is a gram-positive cocci in clusters, Clostridium perfringens is a gram-positive rod, and polymicrobial infections will have an assortment of different morphologic and gram-staining characteristics in identified bacteria. Aeromonas hydrophilia and Vibrio vulnificus will appear as gram-negative rods in those necrotizing SSTIs associated with fresh or salt-water recreational exposure. The Gram stain provides immediate direction for therapy when culture results will often be too late for a meaningful impact on patient care. Unfortunately, many hospitals have abandoned the use of Gram stains for clinical specimens.
Finally, prompt diagnosis of necrotizing SSTIs is essential. A cause of potentially preventable morbidity and deaths is a delay in the recognition of necrotizing SSTIs and the need for urgent surgical debridement. Necrotizing SSTIs are common issues in medicolegal actions because of the issue of failure to make the timely diagnosis. The hallmark of necrotizing SSTIs is pain out of proportion to the inciting injury. Trivial cutaneous injuries that are associated with an advancing perimeter of palpable tenderness and induration are necrotizing SSTIs until proven otherwise. Importantly, S. pyogenes in particular is associated with "metastatic" infection. Patients with soft-tissue contusions, joint effusions, and even fractures may have blood-borne streptococcal contamination of the injury site and yield a necrotizing infection without any cutaneous source of microbial contamination.
Because monitoring the progression of SSTIs is so important in differentiating necrotizing infections, I would only take to task the recommendation for the use of corticosteroids in treatment of cellulitic infections. Pharmacologic immunosuppression of the patient with an active SSTI in the interest of providing symptomatic relief compromises the clinical evaluation of disease progression.
In summary, the guidelines and the two algorithms for managing community-acquired and surgical incision infections are very useful for providing surgical clinicians direction in patient management. The increased incidence of S. aureus-associated necrotizing SSTIs and the emergence of community-associated MRSA over the last 20 years indicate that this is a dynamic area with changing characteristics. The changing pattern of pathogens and antimicrobial choices require a more frequent updating of these important guidelines for patient management.
Dr. Donald E. Fry is an ACS Fellow, executive vice-president for clinical outcomes management of MPA Inc. of Chicago, adjunct professor of surgery at the Northwestern University in Chicago, and professor emeritus of surgery at the University of New Mexico. He is a fellow of the Infectious Diseases Society of America, a past president of the Surgical Infection Society, and associate editor of the journal Surgical Infections.
Skin and soft tissue infections are one of the most common causes for patient evaluation in emergency departments and are common reasons for consultations by surgeons. SSTIs occur across a broad continuum of severity and often require only antimicrobial therapy (such as cellulitis), but they may be fulminate and life-threatening necrotizing infections that require aggressive surgical intervention. The guidelines provided by a distinguished group of clinicians from the Infectious Diseases Society of America provide an excellent organizational framework to understand this heterogenous collection of infections and provide a meaningful structure to direct management.
Several points in these guidelines deserve emphasis. First, considerable discussion in the guidelines has focused on the immunocompromised patient with SSTIs, and appropriately so. A broader consideration might have been to also include those patients with health care-associated exposure in addition to clinical immunosuppression. About 40 million hospitalizations occur annually in the United State, which makes over 3 million patients within 30 days of discharge. A larger number of patients have had recent antibiotic exposure. About 1.5 million patients are in chronic care facilities and nearly 500,000 are receiving chronic hemodialysis. Accordingly, immunocompromised and health care-associated patient exposures require that assumptions about the microbiology of SSTIs have "sensitivity" to the resistant pathogens (such as MRSA) not traditionally typical of community-acquired infections.
Second, the guidelines refer to the use of Gram stains for directing antimicrobial therapy. Although the Gram stain does not have the high-technology flare of contemporary health care, it remains a useful tool in differentiating pathogens, especially in necrotizing SSTIs.
Of the major microbiological presentations of necrotizing SSTIs, Streptococcus pyogenes is a gram-positive cocci in chains, Staphylococcus aureus is a gram-positive cocci in clusters, Clostridium perfringens is a gram-positive rod, and polymicrobial infections will have an assortment of different morphologic and gram-staining characteristics in identified bacteria. Aeromonas hydrophilia and Vibrio vulnificus will appear as gram-negative rods in those necrotizing SSTIs associated with fresh or salt-water recreational exposure. The Gram stain provides immediate direction for therapy when culture results will often be too late for a meaningful impact on patient care. Unfortunately, many hospitals have abandoned the use of Gram stains for clinical specimens.
Finally, prompt diagnosis of necrotizing SSTIs is essential. A cause of potentially preventable morbidity and deaths is a delay in the recognition of necrotizing SSTIs and the need for urgent surgical debridement. Necrotizing SSTIs are common issues in medicolegal actions because of the issue of failure to make the timely diagnosis. The hallmark of necrotizing SSTIs is pain out of proportion to the inciting injury. Trivial cutaneous injuries that are associated with an advancing perimeter of palpable tenderness and induration are necrotizing SSTIs until proven otherwise. Importantly, S. pyogenes in particular is associated with "metastatic" infection. Patients with soft-tissue contusions, joint effusions, and even fractures may have blood-borne streptococcal contamination of the injury site and yield a necrotizing infection without any cutaneous source of microbial contamination.
Because monitoring the progression of SSTIs is so important in differentiating necrotizing infections, I would only take to task the recommendation for the use of corticosteroids in treatment of cellulitic infections. Pharmacologic immunosuppression of the patient with an active SSTI in the interest of providing symptomatic relief compromises the clinical evaluation of disease progression.
In summary, the guidelines and the two algorithms for managing community-acquired and surgical incision infections are very useful for providing surgical clinicians direction in patient management. The increased incidence of S. aureus-associated necrotizing SSTIs and the emergence of community-associated MRSA over the last 20 years indicate that this is a dynamic area with changing characteristics. The changing pattern of pathogens and antimicrobial choices require a more frequent updating of these important guidelines for patient management.
Dr. Donald E. Fry is an ACS Fellow, executive vice-president for clinical outcomes management of MPA Inc. of Chicago, adjunct professor of surgery at the Northwestern University in Chicago, and professor emeritus of surgery at the University of New Mexico. He is a fellow of the Infectious Diseases Society of America, a past president of the Surgical Infection Society, and associate editor of the journal Surgical Infections.
New practice guidelines on skin and soft tissue infections from the Infectious Diseases Society of America stress careful clinical attention to the type of infection, the epidemiological setting in which the infection occurred, the health status of the patient, and the selection and dosage of the most appropriate treatment agents.
The guidelines, published online June 18 in Clinical Infectious Diseases (doi:10.1093/cid/ciu296), update those issued by IDSA in 2005 and cover everything from preventing infections caused by animal bites in healthy hosts to life-threatening infections in immunocompromised patients. They also emphasize accurate identification of pathogens, stressing that clinical presentations can be very similar.
"This is not one of those guidelines that boils complex issues down to a choice between a couple of different drugs or combinations of drugs," said Dr. Dennis Stevens of the Department of Veterans Affairs in Boise, Idaho, the guidelines’ lead author. "Skin and soft tissue infections [SSTIs] have multiple causes and different presentations, depending upon the immune status of the host. Here it’s much more complicated and really requires an astute physician to consider a number of things."
The guidelines, drafted by a 10-member panel, offer a novel algorithm for management of nonpurulent and purulent infections that aims to define a pathway for mild, moderate, and severe infections in each category. For example, no antibiotic is recommended for a purulent infection – only incision and drainage – if the patient has no signs of systemic involvement.
For moderate cases of purulent infection with some systemic involvement, incision and drainage should be followed by culture and sensitivity testing, the guidelines say, listing two antibiotics, trimethoprim-sulfamethoxazole and doxycycline, as appropriate for empiric treatment, while trimethoprim-sulfamethoxazole is recommended if the pathogen is found to be methicillin-resistant Staphylococcus aureus (MRSA) and dicloxacillin or cephalexin if it is methicillin-susceptible S. aureus (MSSA).
The purpose of the algorithm, expressed in the guidelines in chart form, "is to make the physician think," Dr. Stevens said in an interview. "There is a huge move to try and monitor antibiotic stewardship to prevent resistance, and we’re just trying to get the clinician to think of tier 1, tier 2, and tier 3 approaches, depending not only on the bug, but on how sick the patient is. Instead of a knee-jerk approach treating everybody with highly expensive IV antibiotics, [the algorithm] provides a clear pathway to treat appropriately."
In people with an abscess who have failed antibiotic treatment, are immunocompromised, or have fever and elevated white blood cell counts or other evidence of severe infection, "we’re not going to gamble," Dr. Stevens said, adding that the guidelines recommend prompt treatment using "an antibiotic that gets all of these organisms, including resistant ones." Newly approved agents dalbavancin and tedizolid are effective in treating SSTIs caused by MRSA, the guidelines note.
The guidelines are intended for use by clinicians in emergency departments, family practice, internal medicine, general surgery, orthopedics, gynecology, dermatology, infectious disease, and oncology.
Another algorithm charted in the guidelines covers wound infections following surgeries, which can involve multiple pathogens. The algorithm provides simple clinical clues as to which require antibiotics, a simple opening of the suture line, "or a full-court press for the kind of devastating infections that occur within the first 48 hours," Dr. Stevens said. Additional recommendations address infections that can occur in individuals receiving treatment for cancer or receiving immunosuppressant medications, or those who have had an organ transplant or who have HIV/AIDS.
Immunocompromised patients, Dr. Stevens said, are among the most challenging to treat because they may have a history of extensive antibiotic exposure, are likely to have infections with resistant bacteria, and often see involvement with fungal and parasitic agents that might be considered innocuous in normal individuals. "This is the first time physicians will have some decent guidelines about how to approach the problem of skin and soft tissue infections in these kinds of patients," he noted.
The guidelines’ development was funded by the IDSA. Dr. Stevens reported no conflicts of interest. Panel member Alan L. Bisno disclosed receiving honoraria from UpToDate, while five other members – Dr. Henry F. Chambers, Dr. E. Patchen Dellinger, Dr. Ellie J. C. Goldstein, Dr. Sherwood L. Gorbach, and Dr. Sheldon L. Kaplan – disclosed financial relationships with pharmaceutical manufacturers.
New practice guidelines on skin and soft tissue infections from the Infectious Diseases Society of America stress careful clinical attention to the type of infection, the epidemiological setting in which the infection occurred, the health status of the patient, and the selection and dosage of the most appropriate treatment agents.
The guidelines, published online June 18 in Clinical Infectious Diseases (doi:10.1093/cid/ciu296), update those issued by IDSA in 2005 and cover everything from preventing infections caused by animal bites in healthy hosts to life-threatening infections in immunocompromised patients. They also emphasize accurate identification of pathogens, stressing that clinical presentations can be very similar.
"This is not one of those guidelines that boils complex issues down to a choice between a couple of different drugs or combinations of drugs," said Dr. Dennis Stevens of the Department of Veterans Affairs in Boise, Idaho, the guidelines’ lead author. "Skin and soft tissue infections [SSTIs] have multiple causes and different presentations, depending upon the immune status of the host. Here it’s much more complicated and really requires an astute physician to consider a number of things."
The guidelines, drafted by a 10-member panel, offer a novel algorithm for management of nonpurulent and purulent infections that aims to define a pathway for mild, moderate, and severe infections in each category. For example, no antibiotic is recommended for a purulent infection – only incision and drainage – if the patient has no signs of systemic involvement.
For moderate cases of purulent infection with some systemic involvement, incision and drainage should be followed by culture and sensitivity testing, the guidelines say, listing two antibiotics, trimethoprim-sulfamethoxazole and doxycycline, as appropriate for empiric treatment, while trimethoprim-sulfamethoxazole is recommended if the pathogen is found to be methicillin-resistant Staphylococcus aureus (MRSA) and dicloxacillin or cephalexin if it is methicillin-susceptible S. aureus (MSSA).
The purpose of the algorithm, expressed in the guidelines in chart form, "is to make the physician think," Dr. Stevens said in an interview. "There is a huge move to try and monitor antibiotic stewardship to prevent resistance, and we’re just trying to get the clinician to think of tier 1, tier 2, and tier 3 approaches, depending not only on the bug, but on how sick the patient is. Instead of a knee-jerk approach treating everybody with highly expensive IV antibiotics, [the algorithm] provides a clear pathway to treat appropriately."
In people with an abscess who have failed antibiotic treatment, are immunocompromised, or have fever and elevated white blood cell counts or other evidence of severe infection, "we’re not going to gamble," Dr. Stevens said, adding that the guidelines recommend prompt treatment using "an antibiotic that gets all of these organisms, including resistant ones." Newly approved agents dalbavancin and tedizolid are effective in treating SSTIs caused by MRSA, the guidelines note.
The guidelines are intended for use by clinicians in emergency departments, family practice, internal medicine, general surgery, orthopedics, gynecology, dermatology, infectious disease, and oncology.
Another algorithm charted in the guidelines covers wound infections following surgeries, which can involve multiple pathogens. The algorithm provides simple clinical clues as to which require antibiotics, a simple opening of the suture line, "or a full-court press for the kind of devastating infections that occur within the first 48 hours," Dr. Stevens said. Additional recommendations address infections that can occur in individuals receiving treatment for cancer or receiving immunosuppressant medications, or those who have had an organ transplant or who have HIV/AIDS.
Immunocompromised patients, Dr. Stevens said, are among the most challenging to treat because they may have a history of extensive antibiotic exposure, are likely to have infections with resistant bacteria, and often see involvement with fungal and parasitic agents that might be considered innocuous in normal individuals. "This is the first time physicians will have some decent guidelines about how to approach the problem of skin and soft tissue infections in these kinds of patients," he noted.
The guidelines’ development was funded by the IDSA. Dr. Stevens reported no conflicts of interest. Panel member Alan L. Bisno disclosed receiving honoraria from UpToDate, while five other members – Dr. Henry F. Chambers, Dr. E. Patchen Dellinger, Dr. Ellie J. C. Goldstein, Dr. Sherwood L. Gorbach, and Dr. Sheldon L. Kaplan – disclosed financial relationships with pharmaceutical manufacturers.
FROM CLINICAL INFECTIOUS DISEASES
FDA approves tedizolid for acute bacterial skin infections
Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.
Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.
At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.
Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.
One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm2 in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.
The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.
Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.
Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.
Sivextro is marketed by Cubist Pharmaceuticals.
Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.
Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.
At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.
Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.
One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm2 in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.
The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.
Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.
Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.
Sivextro is marketed by Cubist Pharmaceuticals.
Tedizolid, an oxazolidinone antibacterial drug, has been approved as an intravenous and oral treatment for acute bacterial skin and skin structure infections caused by gram positive bacteria, the Food and Drug Administration announced on June 20.
Tedizolid (Sivextro) is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant and methicillin-susceptible strains of Staphylococcus aureus, various streptococcus species, and Enterococcus faecalis.
At a meeting in March, the FDA’s Anti-infective Drugs Advisory Committee unanimously recommended that tedizolid be approved. The drug is the second new antibacterial drug to be approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved dalbavancin (Dalvance) to treat patients with ABSSSI caused by Staphylococcus aureus and various streptococcus species. Both drugs were designated as qualified infectious disease products, allowing them an additional 5 years of marketing exclusivity.
Tedizolid’s safety and efficacy were evaluated and shown to be as effective as linezolid in two clinical trials with 1,315 adults randomly assigned to receive tedizolid or linezolid.
One of the phase III studies, the ESTABLISH-2 study, an international, randomized study, compared 6 days of treatment with intravenous tedizolid to 10 days of treatment with IV linezolid in 666 patients with acute bacterial skin and skin structure infections, with the option of switching to oral treatment. The lesions were at least 75 cm2 in size, and were known to be or were suspected to be associated with gram-positive bacteria. Half the patients had cellulitis, 20% had a major cutaneous abscess, and about 30% had an infected wound; about 27% had MRSA.
The primary endpoint, an early clinical response (at least a 20% reduction in the lesion area 48-72 hours after starting treatment), was achieved by 85% of those treated with tedizolid and by 83% of those treated with linezolid, a difference that met the non-inferiority margin. Clinical responses were also similar at 7-14 days. At late follow-up, 18-25 days after the end of treatment, outcomes of MRSA infections "matched the overall results," according to the study, which was published online in the Lancet Infectious Diseases.
Fewer patients on tedizolid (16%) developed gastrointestinal-related adverse events than those on linezolid (20%); otherwise, treatment- associated adverse events were similar in the two groups.
Tedizolid has not been evaluated in neutropenic patients, so alternative therapies should be considered, the FDA said in its statement announcing the approval.
Sivextro is marketed by Cubist Pharmaceuticals.
Point/Counterpoint: Is accreditation necessary to maintain quality in bariatric surgery?
Yes: Accreditation is why bariatric surgery outcomes are so good.
In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.
Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.
Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).
The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).
If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).
A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.
The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.
The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.
We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.
Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.
Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.
Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.
No: The data do not show that outcomes are better in COEs.
The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.
I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.
A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.
We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.
In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.
We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.
Medicare eliminated their facility accreditation requirement for bariatric surgery last September.
My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.
We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.
We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.
Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.
Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.
Yes: Accreditation is why bariatric surgery outcomes are so good.
In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.
Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.
Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).
The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).
If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).
A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.
The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.
The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.
We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.
Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.
Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.
Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.
No: The data do not show that outcomes are better in COEs.
The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.
I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.
A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.
We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.
In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.
We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.
Medicare eliminated their facility accreditation requirement for bariatric surgery last September.
My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.
We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.
We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.
Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.
Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.
Yes: Accreditation is why bariatric surgery outcomes are so good.
In the early days of bariatric surgery, there were very high mortality rates, up to 21% at 1 year in some studies. Because of that level of risk to patients, accreditation was implemented. Currently, mortality rates for bariatric surgery are at 0.15%, an extraordinary achievement in less than a decade. There are now 729 accredited hospitals in the United States, and that number says much about the level of access for patients. It is not unfettered access to bariatric surgery that is important, but rather access by patients to quality care. That’s what matters at the end of the day.
Accreditation isn’t keeping patients from gaining access to bariatric surgery. The bigger problem in access is making sure the federal and state health exchanges provide coverage for bariatric surgery among the essential health benefits. Fewer than half the states have this coverage.
Since accreditation started, there have been six studies with findings supporting it and three with findings that did not. Among the papers supporting it, Flum et al. is most persuasive because it looks at the Medicare population before and after the implementation of accreditation. It shows a big improvement in deaths, complications, and readmissions after the accreditation mandate despite an increase in the number of patients undergoing bariatric surgery (Ann. Surg. 2011;254:860-5).
The question that always comes up is whether it is volume (the number of cases you’re doing) or accreditation that matters for outcomes. A 2013 study found that accreditation status rendered a benefit independent of volume (Surg. Endosc. 2013;27:4539-46).
If we look at the three papers that found against accreditation, I would dismiss one study because it preceded the accreditation movement (Arch. Surg. 2009;144:319-25).
A study of Michigan patients reported similar complication rates at Centers of Excellence (COEs) and non-COEs (JAMA 2010;304:435-42). The problem with that study is that all of the hospitals in the study essentially are COEs, with the same components that come out of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP). They have a registry. They have volume requirements. They have quality improvement. So, essentially, they’re all COEs, and I’m glad that they embrace the same concepts that we espouse.
The final paper, by Dr. Dimick, takes an econometric approach using differences within differences analysis, which means you look at the differential rate of change to see if the experimental group (in this case, the Medicare population) is different in some way from the control group (non-Medicare). Here’s the problem: That is not a true control. Non-Medicare patients were exposed to accreditation. All of the major insurers embraced accreditation then and continue to do so.
The paper didn’t look at mortality and failure to rescue patients from complications (JAMA 2013;309:792-9). Even though mortality may be low, it still matters. It’s what I would call a sentinel event. It’s become so rare that when it happens, it’s a signal of an issue around quality. We see improvements in both the Medicare and non-Medicare populations. Do two rights make a wrong? Does that mean that accreditation doesn’t work? I think it points out that we’re seeing important changes for the better for all groups.
We presented findings at the American Surgical Association this year showing that accredited hospitals had lower total charges with lower rates of complications, mortality, and failure to rescue. What accreditation provides is a safety net. If something goes wrong, the difference is the ability to recover from complications. There was not a big difference between accredited and non-accredited hospitals in complications in general, but a bigger difference in mortality. Mortality still counts. Failure to rescue is a very important metric that we all need to pay attention to.
Some of our other data show a halo effect from accreditation. In the accredited centers, outcomes were better for non-bariatric procedures. Why? Because they had more experience with obese patients. It’s a collateral benefit.
Without accreditation, I wonder what will happen at hospitals that aren’t required to be accredited. Will they still have the registry? Will they still have the resources they need? Not everybody has the advantages that Michigan has with major insurer support to pay for accreditation efforts. And it’s critical that we have those data. You can’t manage what you don’t measure. Accreditation is vital for bariatric surgery.
Dr. Morton is director of both bariatric surgery and surgical quality at Stanford (Calif.) University Medical Center. He disclosed financial associations with Vivus, Covidien, and Ethicon.
No: The data do not show that outcomes are better in COEs.
The Centers of Excellence has evolved into the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP), which is an outcomes benchmarking and quality improvement program. So we are, in many ways, looking in the rear-view mirror when we talk about whether or not the historical accreditation process improved outcomes.
I’m going to make two arguments against the historical way it was done. The first argument is that limiting care to Centers of Excellence (COEs) as they were defined had very little benefit on outcomes and may have caused some harm.
A lot of the data out there to evaluate the COE program are a little misleading. They looked at Medicare data for outcomes before and after the Medicare COE mandate was put in place requiring that bariatric surgery be performed in a COE to qualify for coverage. The problem with that is the outcomes are improving so quickly that you can’t just do a before and after study. You need to adjust for that time frame to make sure you’re not getting a spurious finding.
We did a study comparing improvement trends for any complications, serious complications, and reoperations before and after Medicare implemented its coverage decision. Surgeons were already getting better before that. There was no change in the trajectory of improvements when the policy was implemented. We concluded that the policy that selectively referred patients to Centers of Excellence didn’t have any benefit (JAMA 2013;309:792-9). We originally included mortality in our analysis but deaths were so rare that it didn’t meet power specifications set by the journal.
In that paper, we did a head-to-head comparison of COEs vs. non-COEs in 12 large states. It’s hard to do a randomized controlled trial for this, so we did an instrumental variable analysis, a sophisticated analysis that takes out a lot of the unmeasured confounding in selection bias. We found that there was no benefit to having bariatric surgery in a COE.
We noticed that many hospitals that traditionally served minorities did not achieve accreditation. One can assume that’s because they probably didn’t have the resources to participate in the program. After the policy was implemented, the rate of bariatric surgery in minorities dropped substantially, whereas it went up in non-minority patients (JAMA 2013;310:1399-1400). So, there’s potential evidence of harm with these policies.
Medicare eliminated their facility accreditation requirement for bariatric surgery last September.
My second argument is that we could be doing something so much better than accreditation to improve bariatric surgery outcomes. Michigan’s approach is a large quality improvement collaborative funded by Blue Cross Blue Shield. We’re using lessons learned in Michigan to implement change on a broader scale without the involvement of payers. We have 70 surgeons and 32 bariatric surgery programs benchmarking outcomes and using those in strategic ways to learn from each other, hopefully improving everybody’s outcomes.
We standardized venous thromboembolism (VTE) prophylaxis across the state and implemented decision support. VTE rates fell by half. We saw a 90% improvement in mortality and a 24% drop in overall complications. Yes, bariatric surgery centers everywhere were improving at that same time, but when we compared Michigan hospitals participating in our collaborative to non-Michigan hospitals, we saw steeper declines in adverse outcomes in Michigan. That’s very robust evidence that this approach is effective for improving perioperative care.
We have launched a technical skill initiative in which surgeons participating in the collaborative give us a video of a typical procedure that gets rated in a blinded fashion by their peers. We just got funded to use these videos in a coaching program to help surgeons in Michigan improve our technique.
Doing this kind of collaborative work doesn’t take a ton of money. It does take time, strategy, and social capital – developing networks of surgeons that work together and learn together. The historical Centers of Excellence program wasn’t a bad idea, but it wasn’t correlated with perioperative outcomes, and it did have harms.
Dr. Dimick is chief of minimally invasive surgery at the University of Michigan Health System, Ann Arbor. He disclosed being a stockholder in ArborMetrix.
Tests pinpoint primary sources of neuroendocrine bowel, pancreatic metastases
BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.
By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.
"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.
In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.
The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).
The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).
The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.
They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.
The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.
They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).
In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.
When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.
As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.
The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.
"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.
In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.
Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.
The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.
BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.
By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.
"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.
In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.
The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).
The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).
The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.
They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.
The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.
They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).
In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.
When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.
As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.
The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.
"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.
In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.
Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.
The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.
BOSTON – With a little chemical or genetic snooping, or both, clinicians may be able to pinpoint the source of nearly all metastatic neuroendocrine tumors of the small bowel or pancreas.
By looking at expression patterns of four genes, investigators were able to determine that a surgically obtained metastatic neuroendocrine tumor (NET) originated in the small bowel with more than 96% accuracy, and, with the use of an immunohistochemistry algorithm, they identified the pancreas as the primary source of metastases in 10 of 10 cases.
"All the NETs that were misclassified by one method were correctly identified by the other method," said Dr. Jessica Maxwell of the department of surgery at the University of Iowa Hospitals and Clinics in Iowa City.
In about 15%-20% of cases of metastatic NETs, the primary tumor site is unknown, but is most likely to be in the small bowel or pancreas. Failure to identify the primary tumor site, despite optimal work-up, could delay referral for surgery or complicate choice of systemic medical therapies, she said at the annual meeting of the American Association of Endocrine Surgeons.
The authors tested the mettle of immunohistochemistry and gene expression classification (GEC) methods on 136 metastatic NETs collected intraoperatively from 97 patients with small-bowel NETs (38 with metastases to liver and 59 with metastases to lymph nodes) and 39 with pancreatic NETs (17 liver and 22 lymph node metastases).
The GEC uses quantitative or "real-time" polymerase chain reaction (qPCR) to evaluate expression of four key genes, encoding for the secretin receptor (SCTR), oxytocin receptor (OXTR), bombesin-like receptor-3 (BRS3), and opioid receptor kappa-1 (OPRK1).
The differential patterns of gene expression mark the metastases as originating either in the pancreas or small bowel.
They also tested a two-tiered immunohistochemistry algorithm using the markers CDX2, PAX6, and ISLET1 for tier 1, and PrAP, PRm NESP55, and PDX1 in tier 2. They tested the algorithm on six primary tumors and validated their findings on 37 metastases.
The immunohistochemistry method can identify a primary tumor site with as few as three markers, but if the findings are indeterminate, the addition of the four tier 2 markers can help to nail down the tumor site, Dr. Maxwell said.
They found that the GEC accurately identified 94 of 97 small bowel NETs (96.9%), and 34 of 39 pancreatic NETS (87.2%).
In contrast, the immunohistochemistry algorithm correctly identified the primary site in 23 of 27 small bowel metastases (85.2%), and in 10 of 10 (100%) pancreatic metastases.
When the methods were compared head to head in 27 metastases, GEC had a 96.2% overall accuracy and immunohistochemistry an 85.2% accuracy.
As noted before, the methods were complementary, with all NETs misclassified by one method called accurately by the other.
The investigators suggest that because the methods are highly accurate and complementary, they may best be used sequentially, starting with immunohistochemistry which is both inexpensive and widely available, and if immunohistochemistry fails, moving on to GEC.
"Sequential use allows for identification of nearly all metastatic neuroendocrine tumors from small bowel or pancreatic sites," Dr. Maxwell said.
In the discussion, Dr. Eren Berber of the Center for Endocrine Surgery at the Cleveland Clinic, who was not involved in the study, questioned whether knowing the primary site had any practical implications for surgeons.
Dr. Maxwell noted that some pancreatic NETs are not detected by preoperative studies and that given the risks of pancreatectomy or pancreaticoduodenectomy, accurately identifying the source of an NET may be helpful for patient counseling and preoperative planning.
The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.
AT AAES 2014
Key clinical point: Gene expression can be used to identify the primary source of neuroendocrine small bowel and pancreatic metastases.
Major finding: Gene expression classification accurately identified the primary source of 94 of 97 small bowel neuroendocrine tumor metastases, (96.9%), and 34 of 39 pancreatic metastases (87.2%).
Data source: Retrospective single institution study of metastases from 136 patients with neuroendocrine tumors.
Disclosures: The study was supported by a grant from the National Institutes of Health. Dr. Maxwell and Dr. Berber reported having no financial disclosures.
Bariatric surgery found to reduce risk of AF in morbidly obese patients
SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.
"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.
In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"
Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.
Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).
After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.
Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."
The researchers reported no financial conflicts of interest.
SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.
"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.
In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"
Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.
Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).
After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.
Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."
The researchers reported no financial conflicts of interest.
SAN FRANCISCO – Bariatric surgery appears to have a preventive effect on the incidence of atrial fibrillation in patients who are morbidly obese, results from a study of more than 400 patients showed.
"Bariatric surgery is a preventative measure that obese patients may choose to take and our study shows that the surgery helps them not only lose weight, but also reduces their risk of developing a serious cardiac condition, like AF," Dr. Yong-Mei Cha, professor of medicine at Mayo Clinic, Rochester, Minn., said in a prepared statement.
In an interview at the annual scientific sessions of the Heart Rhythm Society, Dr. John D. Day, a Murray, Utah–based electrophysiologist and cardiologist who was not involved in the research, characterized the findings as "a message of hope. Too often here in the United States people get a diagnosis of AF and they feel like it’s going to be with them the rest of their lives. The message of hope is that AF – if aggressive lifestyle changes are made early on – is a potentially reversible condition. This study showed that point. And this was just by eliminating the weight. How much more powerful would it be if they made comprehensive lifestyle changes that include more physical activity, dietary changes, and stress reduction?"
Dr. Cha and her associates retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery. One electrophysiologist reviewed the medical records and the diagnosis of AF was documented by ECG or ambulatory monitors. The researchers collected metabolic profiles at baseline and at follow-up.
Of the 438 patients, 326 (74%) underwent bariatric surgery while the remaining 112 were managed medically and served as the control group. At baseline, BMI was significantly greater in the surgery group compared with the control group (a mean of 46.9 vs. 43.2 kg/m2, respectively), but the prevalence of AF was similar between the two groups (3.7 vs. 4.5%).
After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of the surgery group, compared with 12.5% in the control group, a difference that reached statistical significance. The surgery group also had a significant reduction in BMI and improvements in their metabolic profiles, compared with the control group.
Dr. Day said that the study’s single-center, retrospective design is a limitation, as is the fact that bariatric surgery "is pretty extreme; you can’t offer it to everybody. But [the findings] fit in line with current data. We know that obesity is a powerful risk factor for atrial fibrillation."
The researchers reported no financial conflicts of interest.
AT HEART RHYTHM 2014
Key clinical point: Weight loss achieved through bariatric surgery may prevent atrial fibrillation in morbidly obese patients.
Major finding: After a mean follow-up of 7.2 years, new onset of AF occurred in 3.1% of morbidly obese patients who underwent bariatric surgery, compared with 12.5% of their counterparts who were treated medically, a statistically significant difference.
Data source: Retrospectively evaluated data from 438 patients in Olmsted County, Minn., who had a body mass index of 40 kg/m2 or higher and were considered good candidates for bariatric surgery.
Disclosures: The researchers reported no financial conflicts of interest.
Naloxegol cut opioid-associated constipation without impairing pain relief
Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.
Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.
Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.
The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.
The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.
"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.
The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.
Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).
"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."
There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.
There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.
Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.
Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.
AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.
Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.
Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.
Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.
The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.
The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.
"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.
The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.
Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).
"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."
There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.
There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.
Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.
Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.
AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.
Treatment with opioid receptor-antagonist naloxegol significantly improved opioid-associated constipation, compared with placebo, without affecting pain scores or daily opioid requirements, according to data from two identical double-blind studies.
Outpatients with noncancer pain who were given 25 mg of naloxegol showed a significantly shorter time to first spontaneous bowel movement after treatment, compared with those given placebo – a median time of 5.9 hours and 12 hours in the two studies, compared with 35.8 hours and 37.2 hours with placebo, according to a study published online June 4 in the New England Journal of Medicine.
Treatment with naloxegol was also associated with a significantly greater number of spontaneous bowel movements over the course of the 12-week study period, compared with placebo, and an increase in the mean number of days per week with one or more spontaneous bowel movements.
The Food and Drug Administration is currently considering whether to approve naloxegol; the agency is expected to decide by Sept. 16, 2014.
The two phase III randomized, controlled studies were nearly identical in size – one including 652 individuals with opioid-induced constipation, and the other including 700 – and entirely identical in design: Participants were randomized to receive either 25 mg or 12.5 mg of naloxegol daily, or placebo.
"In both studies, naloxegol at a dose of 25 mg was associated with an increased rate of response (10-15 percentage points higher than the response with placebo) over a period of 12 weeks," wrote Dr. William D. Chey of the University of Michigan Health System, Ann Arbor, and his colleagues.
The higher dose of naloxegol also was associated with more significant improvements in severity of straining, stool consistency, and the frequency of days with complete, spontaneous bowel movements.
Naloxegol’s benefits were even greater among individuals who had previously failed to respond to laxatives before study enrollment, which accounted for 71% of participants, a prespecified subgroup analysis showed (N. Engl. J. Med. 2014 June 4 [doi:10.1056/NEJMoa1310246]).
"In clinical practice, osmotic and stimulant laxatives are likely to be used before more expensive prescription medications," the researchers wrote. "Thus, the finding that naloxegol proved beneficial in patients who had persistent symptoms of opioid-induced constipation despite using standard laxatives is of potential importance."
There were some dose-related side effects observed in the naloxegol group, including abdominal pain, nausea, diarrhea, and vomiting, occurring soon after initiation of treatment. But most of these effects were mild to moderate.
There had been concern about potential cardiovascular side effects, which had been observed previously with alvimopan, another peripherally-acting mu-opioid antagonist. However the incidence of major cardiovascular events was rare and similar across both active and placebo groups.
Researchers found no significant interaction between naloxegol treatment and daily opioid dose, and there also were no significant differences in the mean change from baseline in pain scores.
Around half of the patients enrolled were taking opioids for back pain, while other reasons included arthritis, joint pain, or fibromyalgia. On average, participants had been taking opioids for 3.65 years.
AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies, including AstraZeneca.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: Naloxegol improves opioid-induced constipation without affecting pain relief.
Major finding: Treatment with naloxegol was associated with a significantly shorter time to first spontaneous bowel movement, a significantly greater number of spontaneous bowel movements, and an increase in the mean number of days per week with one or more spontaneous bowel movements, compared with placebo.
Data source: Two identical 12-week, phase III, double-blind, randomized, controlled trials in a total of 1,352 patients with opioid-associated constipation.
Disclosures: AstraZeneca supported the study, and the authors declared a range of grants, consultancies, and other financial relationships with several pharmaceutical companies including AstraZeneca.
Type 2 diabetes remits in some bariatric surgery patients
In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.
Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.
The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.
"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.
The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.
By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.
Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).
Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.
The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.
Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.
"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.
The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.
In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.
Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.
The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.
"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.
The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.
By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.
Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).
Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.
The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.
Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.
"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.
The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.
In a group of moderately obese patients with type 2 diabetes, Roux-en-Y gastric bypass and laparoscopic adjustable gastric banding resulted in complete disease remission in 17% and 23%, respectively.
Partial remission was significantly more common among the Roux-en-Y patients, with 50% achieving it, compared with 27% of the gastric banding patients, Dr. Anita Courcoulas and her colleagues reported in the June 4 online issue of JAMA Surgery (JAMA Surg. 2014 [doi:10.1001/jamasurg.2014.467]). There were no partial or complete remissions in the study’s third arm – a year-long intensive lifestyle-management program.
The results are encouraging, but because the study had only 69 patients with just 1 year of follow-up, "no definitive conclusions can be drawn," about the durability of disease remission, Dr. Courcoulas, a bariatric surgeon at the University of Pittsburgh Medical Center, and her associates wrote.
"Nevertheless, the [lifestyle management arm] had no remission, so these results suggest that the gastric banding procedure – low risk and potentially reversible – may have a place as a treatment option for patients with low body mass index and type 2 diabetes. Further studies will be needed to confirm these results," the investigators wrote.
The patients were an average of 47 years old, with a mean body mass index (BMI) of 35 kg/m2. The mean duration of type 2 diabetes was 6 years. The average HbA1c was 8%. Almost all were taking some kind of antidiabetic medication; 40 were on oral drugs, and 26 were taking insulin.
By 1 year, there were no cases of partial or complete remission in the lifestyle intervention group. In the Roux-en-Y group, 50% experienced a partial remission and 17% a complete remission. In the gastric banding group, 27% experienced a partial remission and 23% a complete remission.
Patients in the Roux-en-Y group lost significantly more weight than those in the banding or lifestyle groups (27% vs. 17% and 10% respectively). HbA1c improved significantly more in the Roux-en-Y group than in the banding or lifestyle groups as well. Significantly more surgical patients than lifestyle patients were able to be off all antidiabetic medications (58% vs. 36% and 4%, respectively).
Surgical safety was good, with six patients needing one additional hospital night for nausea or glucose management. One banding patient needed a port replacement, and three others had minor clinical problems. There were three serious adverse events, including an anastomotic ulcer in one Roux-en-Y patient and dehydration requiring a hospital stay in two gastric banding patients.
The study also highlighted some of the problems with accruing and retaining patients in weight loss trials, the investigators noted. Of 667 screened patients, 69 (10%) were randomized. Of these, seven refused their assigned treatment, and one was excluded from treatment on the procedure day. Six had incomplete follow-up and five – all in the lifestyle intervention arm – withdrew by 6 months.
Because the planned 12-month follow-up was too short to allow any conclusions about the stability of diabetes remission in treated patients, longer follow-up is crucial and will require considerable financial investments.
"These important feasibility issues – the need for targeted screening, the thorough assessment of clinical equipoise to reduce the likelihood of postrandomization dropout, the challenging retention in the [lifestyle] arm, and funding – raise a number of concerns for the scalability of this type of study to a larger multicenter trial. For this reason, pursuing alternative methods to obtain high-order evidence regarding outcomes of surgical vs. nonsurgical treatment may be more reasonable for people with a relatively low BMI," they said.
The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.
FROM JAMA SURGERY
Key clinical point: Bariatric surgery was linked to type 2 diabetes remission in some moderately obese patients.
Major finding: Complete remission occurred in 17% of Roux-en-Y bypass patients and 23% of gastric banding patients, but in none of those assigned to a lifestyle intervention.
Data source: The three-way randomized trial of 69 patients.
Disclosures: The study was funded by the National Institutes of Health. Dr. Courcoulas disclosed financial relationships with Covidien, EndoGastric Solutions, Nutrisystem, and Ethicon J&J Healthcare. Some of the other authors disclosed financial relationships with a variety of pharmaceutical companies.
FDA approves generic celecoxib
The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.
Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.
Information about the availability of generic celecoxib is available from the companies.
On Twitter @maryjodales
The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.
Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.
Information about the availability of generic celecoxib is available from the companies.
On Twitter @maryjodales
The first generic versions of celecoxib received approval May 30 by the Food and Drug Administration.
Teva Pharmaceutical Industries received approval to market celecoxib capsules in 50 mg, 100 mg, 200 mg, and 400 mg strengths, and has 180-day exclusivity on the 100 mg, 200 mg, and 400 mg strength products. Mylan Pharmaceuticals received approval to market 50 mg celecoxib capsules.
Citing the importance of "affordable treatment options for chronic conditions," Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, added in a written statement, the assurance "that these FDA-approved generic drugs have met our rigorous approval standards." Generic prescription drugs approved by the FDA are of the same strength as brand-name drugs, and generic drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs.
As with its trade version Celebrex and all nonsteroidal anti-inflammatory drugs, the two new generics will carry a boxed warning in their prescribing information regarding the risks of heart attack or stroke and serious gastrointestinal bleeding. These labels also will note that risk is increased for patients who have heart disease or heart disease risk factors, as it is for patients who take NSAIDs for prolonged periods of time.
Information about the availability of generic celecoxib is available from the companies.
On Twitter @maryjodales
Prevention bundle led to drop in postoperative pressure ulcers
BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.
Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.
Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.
More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.
The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.
Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).
The components of the program included:
• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.
• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.
• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.
• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.
The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).
During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.
The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.
Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.
Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.
Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.
BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.
Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.
Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.
More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.
The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.
Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).
The components of the program included:
• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.
• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.
• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.
• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.
The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).
During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.
The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.
Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.
Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.
Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.
BALTIMORE – Implementing a bundle of preventive interventions led to a significant drop in pressure ulcers acquired during hospitalization among high-risk surgical patients, according to a prospective study.
Moreover, the beneficial effect of the program was sustained for more than a year after the program was implemented, reported Dr. Sylvia Martinez of Baylor College of Medicine and the Michael E. DeBakey VA Medical Center in Houston.
Dr. Martinez pointed out that strategies used to prevent hospital-acquired pressure ulcers are not standardized, and that in an effort to improve quality of care, save money, and reduce mortality, the Centers for Medicare & Medicaid Services no longer reimburses medical facilities for stage III and IV hospital-acquired pressure ulcers.
More than 7,000 high-risk patients were included in the study. During the 6 months before the plan was implemented at the medical center, the mean pressure ulcer rate overall was 3.37, dropping to 1.45 during the 6 months after implementation, a significant difference (P = .004). At 18 months, the rate was 0.89. During this time, the mean rates of hospital-acquired pressure ulcers in the entire VA system did not significantly change, ranging from 1.68 to 1.85, Dr. Martinez reported at the annual meeting of the Surgical Infection Society.
The study was done to address the relatively high rate of pressure ulcers in the medical center’s surgical service. Dr. Martinez and her associates evaluated the impact of an evidence-based hospital-acquired pressure ulcer prevention bundle, developed by an interdisciplinary team.
Patients were classified as high risk if they met at least two of four criteria (age greater than 62 years, albumin less than 3.5 g/dL, ASA score greater than 3, and surgery lasting for more than 3 hours).
The components of the program included:
• Comprehensive skin assessment and documentation and identification of any ulcers on admission, transfer, and discharge.
• Use of operating room beds with pressure redistributing mattresses, with careful positioning and padding of pressure points.
• Turning of patients every 2 hours with pressure point relief via wedges, heel pads, and pillows, as well as massages of bony prominences.
• Assessment of patients for pressure ulcers on daily rounds (led by the unit nurse manager) and use of daily checklists in high-risk patients.
The pressure ulcer rate was calculated by the number of discharged acute-care patients with a stage II or greater hospital-acquired pressure ulcer, divided by number patient days in the hospital (the discharge date minus the admission date for all discharged acute-care patients who were hospitalized for at least 48 hours).
During the period studied, 21,377 operations were performed. Almost 5,000 (4,692) were during the 6-month period prior to implementation of the program, from January to June 2012, and 16,685 were done in the 18 months after implementation (including 4,461 during the first 6 months). Overall, 34% of the patients were determined to be at high risk.
The rates dropped significantly in different parts of the surgical service: In the surgical intensive care unit, the rate dropped from 2.93 before implementation to 1.25 at 6 months and 0.86 at 18 months post implementation. In the surgical wards, the rate dropped from 2.93 to 0.83 at 6 months, and was 0.86 at 18 months.
Implementation of this bundle "may decrease hospital-acquired pressure ulcer rates in high risk surgical patients," with sustained lower rates, which "can lead to decreased costs, complications, and length of stay, and improved quality of life for our patients," Dr. Martinez concluded.
Among the study’s limitations were that it was conducted at one hospital and it did not evaluate which elements of the prevention bundle were most important, she said.
Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.
AT THE SIS ANNUAL MEETING
Key clinical point: Use preventive measures to reduce pressure ulcers in high-risk surgical patients.
Major finding: The rate of pressure ulcers acquired during hospitalization dropped from 3.37 during the 6 months before a prevention bundle was implemented to 0.89 18 months afterward.
Data source: A prospective study of surgical patients at high risk for developing bedsores, comparing rates of hospital-acquired pressure ulcers 6 and 18 months after preventive interventions with the 6-month period beforehand.
Disclosures: Dr. Martinez had no disclosures. The study was funded by the U.S. Department of Veterans Affairs.
FDA approves dalbavancin for acute bacterial skin infections
Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
Dalbavancin is the first drug with a Qualified Infectious Disease Product designation to be approved by the Food and Drug Administration.
On May 23, the agency approved dalbavancin (Dalvance) for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus. The drug, which is given intravenously, is effective for methicillin-susceptible and methicillin-resistant strains as well as Streptococcus pyogenes.
Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, dalbavancin was granted Qualified Infectious Disease Product designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections, according to a statement issued by the FDA.
As part of its QIDP designation, dalbavancin was given priority review and qualifies for an additional 5 years of marketing exclusivity, in addition to the exclusivity period already provided by the Food, Drug and Cosmetic Act.
Dalbavancin was shown to be as safe and effective as vancomycin for the treatment of ABSSSI in two clinical trials with a total of 1,289 adults who had ABSSSI and were randomly assigned to one of the two drugs.
The most common side effects identified in the clinical trials were nausea, headache and diarrhea. More participants in the dalbavancin group had elevated liver enzymes.
Dalvance is marketed by Durata Therapeutics.
