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Report: Hospitalists Can Trim Wasteful Healthcare Spending
An author of a report that estimates the national cost of unnecessary or wasteful healthcare at $750 billion per year hopes its findings will serve as a platform for hospitalists to spearhead improvements in healthcare delivery in the U.S.
The Institute of Medicine report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America" [PDF], offers 10 broad recommendations that include reforming payment, adopting digital infrastructure, and simplifying transitional care. The paper was published earlier this month by a national committee of healthcare leaders, including Gary Kaplan, MD, FACP, FACMPE, FACPE, chairman and chief executive officer of Virginia Mason Health System in Seattle.
"The hospitalist is in a very unique position," Dr. Kaplan says. "They really are at the nexus of what we see as several of our key recommendations going forward."
In particular, Dr. Kaplan notes that healthcare delivery organizations should develop, implement, and fine-tune their "systems, engineering tools and process-improvement methods." Making such changes would help to "eliminate inefficiencies, remove unnecessary burdens on clinicians and staff, enhance patient experience, and improve patient health outcomes," he says.
"The hospitalists and the care teams with which the hospitalist connects are very critical to streamlining operations," Dr. Kaplan adds.
Many of the report's complaints about unnecessary testing, poor communication, and inefficient care delivery dovetail with the quality initiatives and practice-management improvements HM groups already push, Dr. Kaplan adds. To advance healthcare delivery's evolution, hospitalists should view the task of reform as an opportunity, not a challenge.
"There are very powerful opportunities for the hospitalist now to have great impact," he says. "To not just be the passive participants in a broken and dysfunctional system, but in many ways, [to be] one of the architects of an improved care system going forward."
An author of a report that estimates the national cost of unnecessary or wasteful healthcare at $750 billion per year hopes its findings will serve as a platform for hospitalists to spearhead improvements in healthcare delivery in the U.S.
The Institute of Medicine report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America" [PDF], offers 10 broad recommendations that include reforming payment, adopting digital infrastructure, and simplifying transitional care. The paper was published earlier this month by a national committee of healthcare leaders, including Gary Kaplan, MD, FACP, FACMPE, FACPE, chairman and chief executive officer of Virginia Mason Health System in Seattle.
"The hospitalist is in a very unique position," Dr. Kaplan says. "They really are at the nexus of what we see as several of our key recommendations going forward."
In particular, Dr. Kaplan notes that healthcare delivery organizations should develop, implement, and fine-tune their "systems, engineering tools and process-improvement methods." Making such changes would help to "eliminate inefficiencies, remove unnecessary burdens on clinicians and staff, enhance patient experience, and improve patient health outcomes," he says.
"The hospitalists and the care teams with which the hospitalist connects are very critical to streamlining operations," Dr. Kaplan adds.
Many of the report's complaints about unnecessary testing, poor communication, and inefficient care delivery dovetail with the quality initiatives and practice-management improvements HM groups already push, Dr. Kaplan adds. To advance healthcare delivery's evolution, hospitalists should view the task of reform as an opportunity, not a challenge.
"There are very powerful opportunities for the hospitalist now to have great impact," he says. "To not just be the passive participants in a broken and dysfunctional system, but in many ways, [to be] one of the architects of an improved care system going forward."
An author of a report that estimates the national cost of unnecessary or wasteful healthcare at $750 billion per year hopes its findings will serve as a platform for hospitalists to spearhead improvements in healthcare delivery in the U.S.
The Institute of Medicine report, "Best Care at Lower Cost: The Path to Continuously Learning Health Care in America" [PDF], offers 10 broad recommendations that include reforming payment, adopting digital infrastructure, and simplifying transitional care. The paper was published earlier this month by a national committee of healthcare leaders, including Gary Kaplan, MD, FACP, FACMPE, FACPE, chairman and chief executive officer of Virginia Mason Health System in Seattle.
"The hospitalist is in a very unique position," Dr. Kaplan says. "They really are at the nexus of what we see as several of our key recommendations going forward."
In particular, Dr. Kaplan notes that healthcare delivery organizations should develop, implement, and fine-tune their "systems, engineering tools and process-improvement methods." Making such changes would help to "eliminate inefficiencies, remove unnecessary burdens on clinicians and staff, enhance patient experience, and improve patient health outcomes," he says.
"The hospitalists and the care teams with which the hospitalist connects are very critical to streamlining operations," Dr. Kaplan adds.
Many of the report's complaints about unnecessary testing, poor communication, and inefficient care delivery dovetail with the quality initiatives and practice-management improvements HM groups already push, Dr. Kaplan adds. To advance healthcare delivery's evolution, hospitalists should view the task of reform as an opportunity, not a challenge.
"There are very powerful opportunities for the hospitalist now to have great impact," he says. "To not just be the passive participants in a broken and dysfunctional system, but in many ways, [to be] one of the architects of an improved care system going forward."
ITL: Physician Reviews of HM-Relevant Research
Clinical question: What is the optimal duration of oral ciprofloxacin in women with acute community-acquired pyelonephritis?
Background: Despite being a commonly encountered infection, there are little data on the appropriate duration of therapy for acute pyelonephritis in women.
Study design: Prospective, randomized, open-labeled, double-blinded, noninferiority trial.
Setting: Twenty-one infectious diseases centers in Sweden.
Synopsis: Two hundred forty-eight women aged 18 or older with a presumed diagnosis of pyelonephritis were randomized to treatment with seven or 14 days of oral ciprofloxacin 500 mg twice daily. One hundred fifty-six per protocol patients were analyzed, and short-term clinical cure was shown to be noninferior, with cure of 97% in the seven-day group and 96% in the 14-day group (90% confidence interval -6.5-4.8, P=0.004). Results were also shown to be valid for older women and those with more severe infections. With growing concerns of antibiotic resistance and adverse drug events, using shorter courses of antibiotics has come into favor. The authors warn that these findings should not be extrapolated to other classes of antibiotics.
Bottom line: Treatment of community-acquired acute pyelonephritis in women with ciprofloxacin 500 mg twice daily for seven days is not inferior to 14 days.
Citation: Sandberg T, Skoog G, Hermansson AB, et al. Ciprofloxacin for 7 days versus 14 days in women with acute pyelonephritis: a randomised, open-label and double-blind, placebo-controlled, non-inferiority trial. Lancet. 2012; Jun 20: [Epub ahead of print].
Read more of our physician reviews of recent, HM-relevant literature.
Clinical question: What is the optimal duration of oral ciprofloxacin in women with acute community-acquired pyelonephritis?
Background: Despite being a commonly encountered infection, there are little data on the appropriate duration of therapy for acute pyelonephritis in women.
Study design: Prospective, randomized, open-labeled, double-blinded, noninferiority trial.
Setting: Twenty-one infectious diseases centers in Sweden.
Synopsis: Two hundred forty-eight women aged 18 or older with a presumed diagnosis of pyelonephritis were randomized to treatment with seven or 14 days of oral ciprofloxacin 500 mg twice daily. One hundred fifty-six per protocol patients were analyzed, and short-term clinical cure was shown to be noninferior, with cure of 97% in the seven-day group and 96% in the 14-day group (90% confidence interval -6.5-4.8, P=0.004). Results were also shown to be valid for older women and those with more severe infections. With growing concerns of antibiotic resistance and adverse drug events, using shorter courses of antibiotics has come into favor. The authors warn that these findings should not be extrapolated to other classes of antibiotics.
Bottom line: Treatment of community-acquired acute pyelonephritis in women with ciprofloxacin 500 mg twice daily for seven days is not inferior to 14 days.
Citation: Sandberg T, Skoog G, Hermansson AB, et al. Ciprofloxacin for 7 days versus 14 days in women with acute pyelonephritis: a randomised, open-label and double-blind, placebo-controlled, non-inferiority trial. Lancet. 2012; Jun 20: [Epub ahead of print].
Read more of our physician reviews of recent, HM-relevant literature.
Clinical question: What is the optimal duration of oral ciprofloxacin in women with acute community-acquired pyelonephritis?
Background: Despite being a commonly encountered infection, there are little data on the appropriate duration of therapy for acute pyelonephritis in women.
Study design: Prospective, randomized, open-labeled, double-blinded, noninferiority trial.
Setting: Twenty-one infectious diseases centers in Sweden.
Synopsis: Two hundred forty-eight women aged 18 or older with a presumed diagnosis of pyelonephritis were randomized to treatment with seven or 14 days of oral ciprofloxacin 500 mg twice daily. One hundred fifty-six per protocol patients were analyzed, and short-term clinical cure was shown to be noninferior, with cure of 97% in the seven-day group and 96% in the 14-day group (90% confidence interval -6.5-4.8, P=0.004). Results were also shown to be valid for older women and those with more severe infections. With growing concerns of antibiotic resistance and adverse drug events, using shorter courses of antibiotics has come into favor. The authors warn that these findings should not be extrapolated to other classes of antibiotics.
Bottom line: Treatment of community-acquired acute pyelonephritis in women with ciprofloxacin 500 mg twice daily for seven days is not inferior to 14 days.
Citation: Sandberg T, Skoog G, Hermansson AB, et al. Ciprofloxacin for 7 days versus 14 days in women with acute pyelonephritis: a randomised, open-label and double-blind, placebo-controlled, non-inferiority trial. Lancet. 2012; Jun 20: [Epub ahead of print].
Read more of our physician reviews of recent, HM-relevant literature.
DNA Alone Inadequate to Identify HPV-Related Cancers
Testing for the presence of human papillomavirus DNA alone, especially using polymerase chain reaction methods, is not adequate to identify which head and neck squamous cell carcinomas are caused by the virus, according to two studies published online Sept. 18 in Cancer Research.
Identifying HPV-driven malignancies is important because they respond better to treatment and have better outcomes than those unrelated to HPV infection. Indeed, treatment of head and neck squamous cell carcinoma (HNSCC) may soon be guided by the tumor’s HPV status, since trials are now underway to determine whether de-escalation of chemo- and radiotherapy is safe and effective in such patients.
At present, however, the biomarkers that are best suited to making this identification are unclear.
Case Series Assesses Biomarkers
In the first study, researchers assessed the usefulness of four biomarkers in determining which HNSCCs in a case series were driven by HPV. They began by examining fresh-frozen tumor biopsy samples from 199 German adults diagnosed as having oropharyngeal squamous cell cancer between 1990 and 2008.
The four biomarkers were HPV-16 viral load, viral oncogene RNA (E6 and E7), p16INK4a, and RNA patterns similar to those characteristic of cervical carcinomas (CxCa RNA), said Dr. Dana Holzinger of the German Cancer Research Center at Heidelberg (Germany) University and her associates.
The simple presence of HPV DNA in a tumor sample was found to be a poor indicator of prognosis, likely because it often signaled past HPV infections or recent oral exposure, rather than active HPV infection that progressed to malignancy, the investigators said (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-11-3934]).
Instead, "we showed that high viral load and a cancer-specific pattern of viral gene expression are most suited to identify patients with HPV-driven tumors among patients with oropharyngeal cancer. Viral expression pattern is a completely new marker in this field, and viral load has hardly been analyzed before," Dr. Holzinger said in a press statement accompanying the publication of these findings.
"Once standardized assays for these markers, applicable in routine clinical laboratories, are established, they will allow precise identification" of cancers that are or are not HPV-driven, which will in turn influence prognosis and treatment, she added.
Results Back Combination Approach
In the second study, Dr. Caihua Liang of Brown University, Providence, R.I., and her associates examined 488 HNSCC samples as well as serum samples collected in a population-based study in the Boston area during 1999-2003.
As in the first study, these investigators found that the mere presence of HPV-16 DNA in these tumors, particularly when detected by PCR analysis, did not accurately predict overall survival or progression-free survival.
Instead, "our study strongly suggests that the combination of detection of HPV-16 DNA in HNSCC tumors [plus] p16 immunostaining with E6/E7 antibodies represents the most clinically valuable surrogate marker for the identification of patients . . . who have a better prognosis," they said (Cancer Res. 2012 Sept. 28 [doi: 10.1158/0008-5472.CAN-11-3277]).
"Assessment of HPV DNA using polymerase chain reaction methods as a biomarker in individual head and neck cancers is a poor predictor of outcome, and is also poorly associated with antibody response indicative of exposure and/or infection by HPV," senior author Dr. Karl T. Kelsey added in the press statement.
"We may not be diagnosing these tumors as accurately and precisely as we need to for adjusting treatments," said Dr. Kelsey, a professor in the department of epidemiology and the department of pathology and laboratory medicine at Brown University.
Dr. Holzinger’s study was funded in part by the European Commission, BMBG/HGAF-Canceropole Grand-Est, and the German Research Foundation. Her associates reported ties to Qiagen and Roche. Dr. Liang’s study was supported by the National Institutes of Health and the Flight Attendant Medical Research Institute, and one associate reported ties to Bristol-Myers Squibb.
Both of these studies demonstrate that the HPV DNA status of head and neck squamous cell carcinomas should be interpreted with caution, said Dr. Eduardo Mendez.
"Further testing to confirm HPV active infection may be warranted, particularly in consideration of de-escalation regimens," he said. In addition, other prognostic factors should be taken into account, such as tumor classification and lymph node status.
Dr. Mendez is at the University of Washington/Fred Hutchinson Cancer Research Center, Seattle. He reported ties to Intuitive Surgical. These remarks were taken from his commentary accompanying Dr. Holzinger’s and Dr. Liang’s reports (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-12-3285]).
Both of these studies demonstrate that the HPV DNA status of head and neck squamous cell carcinomas should be interpreted with caution, said Dr. Eduardo Mendez.
"Further testing to confirm HPV active infection may be warranted, particularly in consideration of de-escalation regimens," he said. In addition, other prognostic factors should be taken into account, such as tumor classification and lymph node status.
Dr. Mendez is at the University of Washington/Fred Hutchinson Cancer Research Center, Seattle. He reported ties to Intuitive Surgical. These remarks were taken from his commentary accompanying Dr. Holzinger’s and Dr. Liang’s reports (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-12-3285]).
Both of these studies demonstrate that the HPV DNA status of head and neck squamous cell carcinomas should be interpreted with caution, said Dr. Eduardo Mendez.
"Further testing to confirm HPV active infection may be warranted, particularly in consideration of de-escalation regimens," he said. In addition, other prognostic factors should be taken into account, such as tumor classification and lymph node status.
Dr. Mendez is at the University of Washington/Fred Hutchinson Cancer Research Center, Seattle. He reported ties to Intuitive Surgical. These remarks were taken from his commentary accompanying Dr. Holzinger’s and Dr. Liang’s reports (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-12-3285]).
Testing for the presence of human papillomavirus DNA alone, especially using polymerase chain reaction methods, is not adequate to identify which head and neck squamous cell carcinomas are caused by the virus, according to two studies published online Sept. 18 in Cancer Research.
Identifying HPV-driven malignancies is important because they respond better to treatment and have better outcomes than those unrelated to HPV infection. Indeed, treatment of head and neck squamous cell carcinoma (HNSCC) may soon be guided by the tumor’s HPV status, since trials are now underway to determine whether de-escalation of chemo- and radiotherapy is safe and effective in such patients.
At present, however, the biomarkers that are best suited to making this identification are unclear.
Case Series Assesses Biomarkers
In the first study, researchers assessed the usefulness of four biomarkers in determining which HNSCCs in a case series were driven by HPV. They began by examining fresh-frozen tumor biopsy samples from 199 German adults diagnosed as having oropharyngeal squamous cell cancer between 1990 and 2008.
The four biomarkers were HPV-16 viral load, viral oncogene RNA (E6 and E7), p16INK4a, and RNA patterns similar to those characteristic of cervical carcinomas (CxCa RNA), said Dr. Dana Holzinger of the German Cancer Research Center at Heidelberg (Germany) University and her associates.
The simple presence of HPV DNA in a tumor sample was found to be a poor indicator of prognosis, likely because it often signaled past HPV infections or recent oral exposure, rather than active HPV infection that progressed to malignancy, the investigators said (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-11-3934]).
Instead, "we showed that high viral load and a cancer-specific pattern of viral gene expression are most suited to identify patients with HPV-driven tumors among patients with oropharyngeal cancer. Viral expression pattern is a completely new marker in this field, and viral load has hardly been analyzed before," Dr. Holzinger said in a press statement accompanying the publication of these findings.
"Once standardized assays for these markers, applicable in routine clinical laboratories, are established, they will allow precise identification" of cancers that are or are not HPV-driven, which will in turn influence prognosis and treatment, she added.
Results Back Combination Approach
In the second study, Dr. Caihua Liang of Brown University, Providence, R.I., and her associates examined 488 HNSCC samples as well as serum samples collected in a population-based study in the Boston area during 1999-2003.
As in the first study, these investigators found that the mere presence of HPV-16 DNA in these tumors, particularly when detected by PCR analysis, did not accurately predict overall survival or progression-free survival.
Instead, "our study strongly suggests that the combination of detection of HPV-16 DNA in HNSCC tumors [plus] p16 immunostaining with E6/E7 antibodies represents the most clinically valuable surrogate marker for the identification of patients . . . who have a better prognosis," they said (Cancer Res. 2012 Sept. 28 [doi: 10.1158/0008-5472.CAN-11-3277]).
"Assessment of HPV DNA using polymerase chain reaction methods as a biomarker in individual head and neck cancers is a poor predictor of outcome, and is also poorly associated with antibody response indicative of exposure and/or infection by HPV," senior author Dr. Karl T. Kelsey added in the press statement.
"We may not be diagnosing these tumors as accurately and precisely as we need to for adjusting treatments," said Dr. Kelsey, a professor in the department of epidemiology and the department of pathology and laboratory medicine at Brown University.
Dr. Holzinger’s study was funded in part by the European Commission, BMBG/HGAF-Canceropole Grand-Est, and the German Research Foundation. Her associates reported ties to Qiagen and Roche. Dr. Liang’s study was supported by the National Institutes of Health and the Flight Attendant Medical Research Institute, and one associate reported ties to Bristol-Myers Squibb.
Testing for the presence of human papillomavirus DNA alone, especially using polymerase chain reaction methods, is not adequate to identify which head and neck squamous cell carcinomas are caused by the virus, according to two studies published online Sept. 18 in Cancer Research.
Identifying HPV-driven malignancies is important because they respond better to treatment and have better outcomes than those unrelated to HPV infection. Indeed, treatment of head and neck squamous cell carcinoma (HNSCC) may soon be guided by the tumor’s HPV status, since trials are now underway to determine whether de-escalation of chemo- and radiotherapy is safe and effective in such patients.
At present, however, the biomarkers that are best suited to making this identification are unclear.
Case Series Assesses Biomarkers
In the first study, researchers assessed the usefulness of four biomarkers in determining which HNSCCs in a case series were driven by HPV. They began by examining fresh-frozen tumor biopsy samples from 199 German adults diagnosed as having oropharyngeal squamous cell cancer between 1990 and 2008.
The four biomarkers were HPV-16 viral load, viral oncogene RNA (E6 and E7), p16INK4a, and RNA patterns similar to those characteristic of cervical carcinomas (CxCa RNA), said Dr. Dana Holzinger of the German Cancer Research Center at Heidelberg (Germany) University and her associates.
The simple presence of HPV DNA in a tumor sample was found to be a poor indicator of prognosis, likely because it often signaled past HPV infections or recent oral exposure, rather than active HPV infection that progressed to malignancy, the investigators said (Cancer Res. 2012 Sept. 18 [doi: 10.1158/0008-5472.CAN-11-3934]).
Instead, "we showed that high viral load and a cancer-specific pattern of viral gene expression are most suited to identify patients with HPV-driven tumors among patients with oropharyngeal cancer. Viral expression pattern is a completely new marker in this field, and viral load has hardly been analyzed before," Dr. Holzinger said in a press statement accompanying the publication of these findings.
"Once standardized assays for these markers, applicable in routine clinical laboratories, are established, they will allow precise identification" of cancers that are or are not HPV-driven, which will in turn influence prognosis and treatment, she added.
Results Back Combination Approach
In the second study, Dr. Caihua Liang of Brown University, Providence, R.I., and her associates examined 488 HNSCC samples as well as serum samples collected in a population-based study in the Boston area during 1999-2003.
As in the first study, these investigators found that the mere presence of HPV-16 DNA in these tumors, particularly when detected by PCR analysis, did not accurately predict overall survival or progression-free survival.
Instead, "our study strongly suggests that the combination of detection of HPV-16 DNA in HNSCC tumors [plus] p16 immunostaining with E6/E7 antibodies represents the most clinically valuable surrogate marker for the identification of patients . . . who have a better prognosis," they said (Cancer Res. 2012 Sept. 28 [doi: 10.1158/0008-5472.CAN-11-3277]).
"Assessment of HPV DNA using polymerase chain reaction methods as a biomarker in individual head and neck cancers is a poor predictor of outcome, and is also poorly associated with antibody response indicative of exposure and/or infection by HPV," senior author Dr. Karl T. Kelsey added in the press statement.
"We may not be diagnosing these tumors as accurately and precisely as we need to for adjusting treatments," said Dr. Kelsey, a professor in the department of epidemiology and the department of pathology and laboratory medicine at Brown University.
Dr. Holzinger’s study was funded in part by the European Commission, BMBG/HGAF-Canceropole Grand-Est, and the German Research Foundation. Her associates reported ties to Qiagen and Roche. Dr. Liang’s study was supported by the National Institutes of Health and the Flight Attendant Medical Research Institute, and one associate reported ties to Bristol-Myers Squibb.
FROM CANCER RESEARCH
Major Finding: The simple presence of HPV DNA in tumor samples did not accurately identify which cancers were driven by active HPV infection, and thus did not predict which would show the greatest response to treatment.
Data Source: Two analyses were used to assess the prognostic accuracy of various biomarkers in tumor samples from adults with head and neck squamous cell carcinoma.
Disclosures: Dr. Holzinger’s study was funded in part by the European Commission, BMBG/HGAF-Canceropole Grand-Est, and the German Research Foundation. Her associates reported ties to Qiagen and Roche. Dr. Liang’s study was supported by the National Institutes of Health and the Flight Attendant Medical Research Institute, and one associate reported ties to Bristol-Myers Squibb.
Noroviruses Affecting Diverse Populations
SAN FRANCISCO – As the availability of more sensitive diagnostic methods such as reverse transcription-polymerase chain reaction testing become more widespread, noroviruses are increasingly being recognized as important enteric pathogens in diverse populations.
"In the past, much of our knowledge about noroviruses has been hindered because we don’t have a good animal model or method for culturing norovirus," Dr. Hoonmo L. Koo said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. "The majority of our current understanding has come from studying human outbreaks, volunteer challenge studies, and evaluating surrogate caliciviruses such as feline and murine caliciviruses, which don’t cause human infection but can be cultured."
Noroviruses (NoVs) are classified into five genetic groups based on their RNA capsid sequences, with genogroup I (GI) and genogroup II (GII) NoVs causing the most human NoV infections. GII.4 NoV strains are the predominant circulating genotype in the United States and worldwide, said Dr. Koo of Baylor College of Medicine, Houston. As reverse transcription-polymerase chain reaction testing (RT-PCR) has become more available in recent years, NoVs "are now recognized as the most definable common cause of acute nonbacterial gastroenteritis worldwide," he said. "They account for approximately half of all food-borne illness in the United States.
"Each year, NoVs cause about 21 million cases of infection in the United States. They occur throughout the year, but they peak in the winter season."
NoV outbreaks are common in children, travelers, restaurant patrons, military personnel, patients, and health care staff at hospitals, nursing homes, and other medical facilities. Dr. Koo and his associates conducted an 8.5-year surveillance study at Texas Children’s Hospital (TCH) investigating NoV, rotavirus (RV), and adenovirus prevalence at the facility before and after introduction of the RV vaccine in 2006. The study evaluated 8,173 stool samples from inpatients and outpatients at TCH from February 2002 to June 2010. The samples were evaluated for RV by antigen detection or electron microscopy and adenoviruses by electron microscopy. In addition, a subset of 3,222 stools were evaluated for NoV by RT-PCR (J. Ped. Infect. Dis. 2012 Aug. 3 [doi:10.1093/jpids/pis070]).
"We found that RV prevalence decreased significantly after the introduction of the RV vaccine in 2006," Dr. Koo said at the meeting, which was sponsored by the American Society for Microbiology. "In more recent years, it decreased from about 9% in 2007 to 3% in 2010." At the same time, he continued, "NoV prevalence increased in 2004 and was consistently between 11% and 17% from 2004 to 2010. There was no significant increase in NoV prevalence after the RV vaccine was introduced in 2006."
The researchers concluded that NoVs have emerged as the most common viral gastroenteritis pathogen at TCH, which is one of the largest pediatric hospitals in the United States. "We believe that as RV prevalence continues to decline with vaccination, NoVs will soon eclipse rotaviruses as the most important cause of pediatric gastroenteritis in the United States and other countries where the RV vaccine is successfully administered," Dr. Koo said.
In a separate study, he and his associates evaluated stools from 571 international travelers who acquired diarrhea in Guatemala, India, and Mexico (J. Clin. Microbiol. 2010;48:1673-6). NoVs were identified in 10% of cases of travelers’ diarrhea, and overall were the second most common pathogen following diarrheagenic Escherichia coli. "We concluded that NoVs are important pathogens of travelers’ diarrhea in multiple developing regions of the world," Dr. Koo said. "However, there was significant variation evident in the prevalence of NoV diarrhea and in the predominant genogroup infecting the travelers, depending on the specific geographic location and time period we looked at."
Immunocompromised patients also have been affected by NoVs. One report described 12 hematopoietic stem cell transplant patients with NoV gastroenteritis who were hospitalized for a median of 73 days (Clin. Infect. Dis. 2009;49:1069-71). Half of the patients required supplemental feeding with enteral or parenteral nutrition, and two patients died: one secondary to malnutrition and chronic NoV gastroenteritis. "Future areas of NoV study include further defining the burden of disease in pediatric and immunocompromised populations," Dr. Koo said. "We need development of sensitive diagnostic assays that can be used by clinical laboratories. Unfortunately, the ELISA assay that we have now for NoV detection is relatively insensitive, and most clinical laboratories cannot perform RT-PCR. We need effective therapeutic agents to be developed, and we need an effective NoV vaccine."
Results from a recent randomized, double-blind, placebo-controlled trial of an investigational NoV vaccine found a significantly lower frequency of viral gastroenteritis among vaccine recipients, compared with placebo recipients (37% vs. 69%, respectively; P = .006). It was found to be safe and well tolerated, and no severe adverse events were reported (N. Engl. J. Med. 2011;365:2178-87). "The vaccine was also found to be immunogenic, with 70% of vaccine recipients producing a fourfold rise in serum total antibody and serum IgA," Dr. Koo said. "However, there are significant challenges to the development of NoV vaccines. In the NEJM study, the frequency and magnitude of serum antibody response with the vaccine was lower than what’s been observed with natural infection. Previous studies have shown that acquired immunity with natural infection may be short-lived: less than 2 years. So how long will the vaccine protection last?"
Another challenge, he said, is that antibodies are only cross-protective within the same genogroup. "Future NoV vaccines will need to be composed of both GI and GII virus–like particles (VLPs)," he said. "Finally, significant antigenic diversity of noroviruses and the constant antigenic drift may require active surveillance similar to what we have for influenza viruses, where we are constantly surveying what strains are in the community and changing the composition of vaccine VLP strains to represent these important community strains."
Dr. Koo disclosed that he has received research support from the National Institute of Diabetes and Digestive and Kidney Diseases, and the Baylor College of Medicine Center for Globalization.
SAN FRANCISCO – As the availability of more sensitive diagnostic methods such as reverse transcription-polymerase chain reaction testing become more widespread, noroviruses are increasingly being recognized as important enteric pathogens in diverse populations.
"In the past, much of our knowledge about noroviruses has been hindered because we don’t have a good animal model or method for culturing norovirus," Dr. Hoonmo L. Koo said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. "The majority of our current understanding has come from studying human outbreaks, volunteer challenge studies, and evaluating surrogate caliciviruses such as feline and murine caliciviruses, which don’t cause human infection but can be cultured."
Noroviruses (NoVs) are classified into five genetic groups based on their RNA capsid sequences, with genogroup I (GI) and genogroup II (GII) NoVs causing the most human NoV infections. GII.4 NoV strains are the predominant circulating genotype in the United States and worldwide, said Dr. Koo of Baylor College of Medicine, Houston. As reverse transcription-polymerase chain reaction testing (RT-PCR) has become more available in recent years, NoVs "are now recognized as the most definable common cause of acute nonbacterial gastroenteritis worldwide," he said. "They account for approximately half of all food-borne illness in the United States.
"Each year, NoVs cause about 21 million cases of infection in the United States. They occur throughout the year, but they peak in the winter season."
NoV outbreaks are common in children, travelers, restaurant patrons, military personnel, patients, and health care staff at hospitals, nursing homes, and other medical facilities. Dr. Koo and his associates conducted an 8.5-year surveillance study at Texas Children’s Hospital (TCH) investigating NoV, rotavirus (RV), and adenovirus prevalence at the facility before and after introduction of the RV vaccine in 2006. The study evaluated 8,173 stool samples from inpatients and outpatients at TCH from February 2002 to June 2010. The samples were evaluated for RV by antigen detection or electron microscopy and adenoviruses by electron microscopy. In addition, a subset of 3,222 stools were evaluated for NoV by RT-PCR (J. Ped. Infect. Dis. 2012 Aug. 3 [doi:10.1093/jpids/pis070]).
"We found that RV prevalence decreased significantly after the introduction of the RV vaccine in 2006," Dr. Koo said at the meeting, which was sponsored by the American Society for Microbiology. "In more recent years, it decreased from about 9% in 2007 to 3% in 2010." At the same time, he continued, "NoV prevalence increased in 2004 and was consistently between 11% and 17% from 2004 to 2010. There was no significant increase in NoV prevalence after the RV vaccine was introduced in 2006."
The researchers concluded that NoVs have emerged as the most common viral gastroenteritis pathogen at TCH, which is one of the largest pediatric hospitals in the United States. "We believe that as RV prevalence continues to decline with vaccination, NoVs will soon eclipse rotaviruses as the most important cause of pediatric gastroenteritis in the United States and other countries where the RV vaccine is successfully administered," Dr. Koo said.
In a separate study, he and his associates evaluated stools from 571 international travelers who acquired diarrhea in Guatemala, India, and Mexico (J. Clin. Microbiol. 2010;48:1673-6). NoVs were identified in 10% of cases of travelers’ diarrhea, and overall were the second most common pathogen following diarrheagenic Escherichia coli. "We concluded that NoVs are important pathogens of travelers’ diarrhea in multiple developing regions of the world," Dr. Koo said. "However, there was significant variation evident in the prevalence of NoV diarrhea and in the predominant genogroup infecting the travelers, depending on the specific geographic location and time period we looked at."
Immunocompromised patients also have been affected by NoVs. One report described 12 hematopoietic stem cell transplant patients with NoV gastroenteritis who were hospitalized for a median of 73 days (Clin. Infect. Dis. 2009;49:1069-71). Half of the patients required supplemental feeding with enteral or parenteral nutrition, and two patients died: one secondary to malnutrition and chronic NoV gastroenteritis. "Future areas of NoV study include further defining the burden of disease in pediatric and immunocompromised populations," Dr. Koo said. "We need development of sensitive diagnostic assays that can be used by clinical laboratories. Unfortunately, the ELISA assay that we have now for NoV detection is relatively insensitive, and most clinical laboratories cannot perform RT-PCR. We need effective therapeutic agents to be developed, and we need an effective NoV vaccine."
Results from a recent randomized, double-blind, placebo-controlled trial of an investigational NoV vaccine found a significantly lower frequency of viral gastroenteritis among vaccine recipients, compared with placebo recipients (37% vs. 69%, respectively; P = .006). It was found to be safe and well tolerated, and no severe adverse events were reported (N. Engl. J. Med. 2011;365:2178-87). "The vaccine was also found to be immunogenic, with 70% of vaccine recipients producing a fourfold rise in serum total antibody and serum IgA," Dr. Koo said. "However, there are significant challenges to the development of NoV vaccines. In the NEJM study, the frequency and magnitude of serum antibody response with the vaccine was lower than what’s been observed with natural infection. Previous studies have shown that acquired immunity with natural infection may be short-lived: less than 2 years. So how long will the vaccine protection last?"
Another challenge, he said, is that antibodies are only cross-protective within the same genogroup. "Future NoV vaccines will need to be composed of both GI and GII virus–like particles (VLPs)," he said. "Finally, significant antigenic diversity of noroviruses and the constant antigenic drift may require active surveillance similar to what we have for influenza viruses, where we are constantly surveying what strains are in the community and changing the composition of vaccine VLP strains to represent these important community strains."
Dr. Koo disclosed that he has received research support from the National Institute of Diabetes and Digestive and Kidney Diseases, and the Baylor College of Medicine Center for Globalization.
SAN FRANCISCO – As the availability of more sensitive diagnostic methods such as reverse transcription-polymerase chain reaction testing become more widespread, noroviruses are increasingly being recognized as important enteric pathogens in diverse populations.
"In the past, much of our knowledge about noroviruses has been hindered because we don’t have a good animal model or method for culturing norovirus," Dr. Hoonmo L. Koo said at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. "The majority of our current understanding has come from studying human outbreaks, volunteer challenge studies, and evaluating surrogate caliciviruses such as feline and murine caliciviruses, which don’t cause human infection but can be cultured."
Noroviruses (NoVs) are classified into five genetic groups based on their RNA capsid sequences, with genogroup I (GI) and genogroup II (GII) NoVs causing the most human NoV infections. GII.4 NoV strains are the predominant circulating genotype in the United States and worldwide, said Dr. Koo of Baylor College of Medicine, Houston. As reverse transcription-polymerase chain reaction testing (RT-PCR) has become more available in recent years, NoVs "are now recognized as the most definable common cause of acute nonbacterial gastroenteritis worldwide," he said. "They account for approximately half of all food-borne illness in the United States.
"Each year, NoVs cause about 21 million cases of infection in the United States. They occur throughout the year, but they peak in the winter season."
NoV outbreaks are common in children, travelers, restaurant patrons, military personnel, patients, and health care staff at hospitals, nursing homes, and other medical facilities. Dr. Koo and his associates conducted an 8.5-year surveillance study at Texas Children’s Hospital (TCH) investigating NoV, rotavirus (RV), and adenovirus prevalence at the facility before and after introduction of the RV vaccine in 2006. The study evaluated 8,173 stool samples from inpatients and outpatients at TCH from February 2002 to June 2010. The samples were evaluated for RV by antigen detection or electron microscopy and adenoviruses by electron microscopy. In addition, a subset of 3,222 stools were evaluated for NoV by RT-PCR (J. Ped. Infect. Dis. 2012 Aug. 3 [doi:10.1093/jpids/pis070]).
"We found that RV prevalence decreased significantly after the introduction of the RV vaccine in 2006," Dr. Koo said at the meeting, which was sponsored by the American Society for Microbiology. "In more recent years, it decreased from about 9% in 2007 to 3% in 2010." At the same time, he continued, "NoV prevalence increased in 2004 and was consistently between 11% and 17% from 2004 to 2010. There was no significant increase in NoV prevalence after the RV vaccine was introduced in 2006."
The researchers concluded that NoVs have emerged as the most common viral gastroenteritis pathogen at TCH, which is one of the largest pediatric hospitals in the United States. "We believe that as RV prevalence continues to decline with vaccination, NoVs will soon eclipse rotaviruses as the most important cause of pediatric gastroenteritis in the United States and other countries where the RV vaccine is successfully administered," Dr. Koo said.
In a separate study, he and his associates evaluated stools from 571 international travelers who acquired diarrhea in Guatemala, India, and Mexico (J. Clin. Microbiol. 2010;48:1673-6). NoVs were identified in 10% of cases of travelers’ diarrhea, and overall were the second most common pathogen following diarrheagenic Escherichia coli. "We concluded that NoVs are important pathogens of travelers’ diarrhea in multiple developing regions of the world," Dr. Koo said. "However, there was significant variation evident in the prevalence of NoV diarrhea and in the predominant genogroup infecting the travelers, depending on the specific geographic location and time period we looked at."
Immunocompromised patients also have been affected by NoVs. One report described 12 hematopoietic stem cell transplant patients with NoV gastroenteritis who were hospitalized for a median of 73 days (Clin. Infect. Dis. 2009;49:1069-71). Half of the patients required supplemental feeding with enteral or parenteral nutrition, and two patients died: one secondary to malnutrition and chronic NoV gastroenteritis. "Future areas of NoV study include further defining the burden of disease in pediatric and immunocompromised populations," Dr. Koo said. "We need development of sensitive diagnostic assays that can be used by clinical laboratories. Unfortunately, the ELISA assay that we have now for NoV detection is relatively insensitive, and most clinical laboratories cannot perform RT-PCR. We need effective therapeutic agents to be developed, and we need an effective NoV vaccine."
Results from a recent randomized, double-blind, placebo-controlled trial of an investigational NoV vaccine found a significantly lower frequency of viral gastroenteritis among vaccine recipients, compared with placebo recipients (37% vs. 69%, respectively; P = .006). It was found to be safe and well tolerated, and no severe adverse events were reported (N. Engl. J. Med. 2011;365:2178-87). "The vaccine was also found to be immunogenic, with 70% of vaccine recipients producing a fourfold rise in serum total antibody and serum IgA," Dr. Koo said. "However, there are significant challenges to the development of NoV vaccines. In the NEJM study, the frequency and magnitude of serum antibody response with the vaccine was lower than what’s been observed with natural infection. Previous studies have shown that acquired immunity with natural infection may be short-lived: less than 2 years. So how long will the vaccine protection last?"
Another challenge, he said, is that antibodies are only cross-protective within the same genogroup. "Future NoV vaccines will need to be composed of both GI and GII virus–like particles (VLPs)," he said. "Finally, significant antigenic diversity of noroviruses and the constant antigenic drift may require active surveillance similar to what we have for influenza viruses, where we are constantly surveying what strains are in the community and changing the composition of vaccine VLP strains to represent these important community strains."
Dr. Koo disclosed that he has received research support from the National Institute of Diabetes and Digestive and Kidney Diseases, and the Baylor College of Medicine Center for Globalization.
AT THE ANNUAL INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Primary Care Physicians Don't Get Patients Well
(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)
The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.
One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?
Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.
Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.
However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.
Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.
To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"
It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.
Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.
On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.
Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.
These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.
If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.
This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.
Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.
Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.
The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.
(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)
The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.
One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?
Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.
Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.
However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.
Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.
To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"
It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.
Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.
On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.
Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.
These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.
If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.
This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.
Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.
Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.
The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.
(Editor's Note: Read Dr. George Andros' introduction to this installment of Veith's Viewpoint.)
The Affordable Care Act (ACA) has the laudable goals of extending health care insurance coverage and reducing overall health care costs. However, hidden in the more than 2400 pages of this bill are a number of provisions, many still unrecognized, which will have detrimental effects on our national economy and the quality of care our health system delivers to society.
One such damaging initiative within the ACA is the thrust to increase the reimbursement for primary care providers and to compensate for this increase by decreasing reimbursement to specialty care providers. Is this a good thing?
Yes, we will need more primary care physicians to do what they do for our increasingly elderly population. The ACA will provide a financial incentive to increase the numbers of such physicians. And yes, health care costs are spiraling upward, and part of this spiral is due to the over-utilization of coronary, carotid and lower extremity stents and other procedures in patients who are not benefited by them or who are actually harmed by them.
Such over-utilization was recently documented in the lead article on the front page of the New York Times (August 7, 2012). This over-utilization of specialty care may be diminished somewhat if the guilty specialists receive less compensation per case.
However, the decreased specialist reimbursement may also have the paradoxical effect of prompting the unethical specialists to do even more unnecessary cases to maintain their incomes. There should be better, more direct ways to stop unnecessary procedures than shifting specialist reimbursement to primary care physicians.
Restoring ethical behavior to physicians and considering how best to modify the reimbursement system to be a disincentive to such bad practices are beyond the scope of this commentary. However, we should examine more carefully the negative effects and unintended consequences of shifting specialist reimbursement to primary care providers.
To do this we have to examine the question: "Who today gets patients who are really sick with an organic problem well?"
It is not primary care physicians. They play valuable roles in preventive medicine, in providing simple care, in comforting and reassuring patients while their self-limited disease runs its course, in recognizing serious illness, and in directing patients to appropriate specialists when needed.
Many of these functions, although very valuable and necessary, could be fulfilled by a trained nurse practitioner or a physician’s assistant and do not require a highly paid primary care physician.
On the other hand, in today’s high tech and complicated medical world, it is the highly trained medical specialist who gets patients well when they have a serious life- or limb-threatening illness. Such skilled specialists can place a coronary stent to prevent or treat an otherwise fatal or disabling myocardial infarction.
Other specialists can ablate a focus of an otherwise fatal cardiac arrhythmia. Still others can exclude an aortic aneurysm before or after it ruptures, or revascularize and save a severely ischemic limb. Other specialists can remove a variety of cancers, reconstruct a destroyed hip or fix other serious problems within the head, chest, abdomen or other parts of the body.
These skilled specialists have to work hard and devote years and long hours to be trained and to maintain their skills. They have to be available 24/7 to provide emergency treatment when minutes and hours make a difference, and they have to take the risks of failure including exposure to medical liability. For these skills, risks and their commitment, they deserve to be highly compensated in keeping with other professions that have similar requirements.
If reimbursement to such specialists is diminished, clearly the level of care that they provide – the care that really makes a difference to patients – will also be diminished. We will be sacrificing the geese that lay the golden eggs of medicine in the U. S. today, and health care will suffer.
This unintended consequence of diminished specialist reimbursement has occurred in other countries where specialists are underpaid.
Thus, as we go about the difficult task of reforming our health care system, decreasing unnecessary procedures and cutting overall costs, we must be sure to preserve what is great about our system and some of the exemplary care it provides. Most of this care is delivered by specialists, and we must be careful to continue to motivate them appropriately.
Dr. Veith is Professor of Surgery at New York University Medical Center and the Cleveland Clinic. He is an associate medical editor for Vascular Specialist.
The ideas and opinions expressed in Vascular Specialist do not necessarily reflect those of the Society or Publisher.
Promising C. difficile Antibiotic in Pipeline
SAN FRANCISCO – Those desperate for new treatments for Clostridium difficile infection may want to keep an eye on the experimental oral antibiotic cadazolid, which looked promising in an early-phase trial, according to Daniela Baldoni, Pharm.D.
Cadazolid produced low systemic exposure with high concentrations at the desired site – the colon – and was well tolerated in 64 healthy men who received up to 3,000 mg b.i.d. for 10 days, she reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Dr. Baldoni is employed by Actelion Pharmaceuticals, the company that is developing cadazolid.
The study randomized nonsmoking men to either the drug (single or multiple doses of cadazolid) or placebo. All subjects remained in the clinic for observation for 120 hours after the last dose.
In the single-dose group, 30 fasting subjects received a single dose of 30, 100, 300, 1,000, or 3,000 mg cadazolid and 10 subjects received matching placebo. After a wash-out period of 8-15 days, the six subjects who had taken 300 mg received a second dose of 300 mg after eating instead of after fasting. In the multiple-dose group, 18 subjects took 300, 1,000, or 3,000 mg of cadazolid twice a day and 6 received matching placebo for 10 days.
Taking cadazolid with food appeared to increase the rate and extent of drug absorption by two- to fivefold. Blood samples showed low systemic exposure after single or multiple doses, with a minor, twofold increase in cadazolid in plasma after 10 days for all doses in the twice-a-day group, Dr. Baldoni reported at the meeting, sponsored by the American Society for Microbiology.
Negligible recovery of unchanged cadazolid in urine samples and the fact that most of the dose was recovered in feces suggests that treatment produced high concentrations at the colon. In fecal samples collected during days 6 and 10 of treatment, the mean cumulative recovery of unchanged cadazolid in feces was between 87% and 94%.
There were no significant changes in vital signs, ECG results, or laboratory parameters compared with baseline measurements, and no drug-related serious adverse events. All subjects completed the study except one man in the 100-mg single-dose subgroup who withdrew consent for reasons unrelated to adverse events.
The dose or duration of treatment did not seem to affect the number of adverse events.
In the single-dose group, 8 of 30 subjects on cadazolid (27%) and 4 of 10 on placebo (40%) reported adverse events, most commonly headache and diarrhea. Four subjects on cadazolid (13%) and two on placebo (20%) reported headache, and three subjects on cadazolid (10%) and one on placebo (10%) reported diarrhea.
In the twice-a-day dosing group, 7 of 18 subjects on cadazolid (39%) and 1 of 6 subjects on placebo (17%) reported adverse events, most commonly headache in 5 subjects on cadazolid (28%) and 1 subject on placebo (17%).
Subjects were aged 45-60 years and had a body mass index of 18-32 kg/m2.
C. difficile is the most common cause of antibiotic-associated infectious diarrhea, especially among the elderly. The mainstays of treating C. difficile–associated infection, metronidazole or vancomycin, fail in approximately 20%-45% of patients.
Cadazolid is in the oxazolidinone class of antibiotics. Its mechanism of action consists mainly of bacterial protein-synthesis inhibition.
Dr. Baldoni and most of her coinvestigators are employees of Actelion Pharmaceuticals, which funded the study.
SAN FRANCISCO – Those desperate for new treatments for Clostridium difficile infection may want to keep an eye on the experimental oral antibiotic cadazolid, which looked promising in an early-phase trial, according to Daniela Baldoni, Pharm.D.
Cadazolid produced low systemic exposure with high concentrations at the desired site – the colon – and was well tolerated in 64 healthy men who received up to 3,000 mg b.i.d. for 10 days, she reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Dr. Baldoni is employed by Actelion Pharmaceuticals, the company that is developing cadazolid.
The study randomized nonsmoking men to either the drug (single or multiple doses of cadazolid) or placebo. All subjects remained in the clinic for observation for 120 hours after the last dose.
In the single-dose group, 30 fasting subjects received a single dose of 30, 100, 300, 1,000, or 3,000 mg cadazolid and 10 subjects received matching placebo. After a wash-out period of 8-15 days, the six subjects who had taken 300 mg received a second dose of 300 mg after eating instead of after fasting. In the multiple-dose group, 18 subjects took 300, 1,000, or 3,000 mg of cadazolid twice a day and 6 received matching placebo for 10 days.
Taking cadazolid with food appeared to increase the rate and extent of drug absorption by two- to fivefold. Blood samples showed low systemic exposure after single or multiple doses, with a minor, twofold increase in cadazolid in plasma after 10 days for all doses in the twice-a-day group, Dr. Baldoni reported at the meeting, sponsored by the American Society for Microbiology.
Negligible recovery of unchanged cadazolid in urine samples and the fact that most of the dose was recovered in feces suggests that treatment produced high concentrations at the colon. In fecal samples collected during days 6 and 10 of treatment, the mean cumulative recovery of unchanged cadazolid in feces was between 87% and 94%.
There were no significant changes in vital signs, ECG results, or laboratory parameters compared with baseline measurements, and no drug-related serious adverse events. All subjects completed the study except one man in the 100-mg single-dose subgroup who withdrew consent for reasons unrelated to adverse events.
The dose or duration of treatment did not seem to affect the number of adverse events.
In the single-dose group, 8 of 30 subjects on cadazolid (27%) and 4 of 10 on placebo (40%) reported adverse events, most commonly headache and diarrhea. Four subjects on cadazolid (13%) and two on placebo (20%) reported headache, and three subjects on cadazolid (10%) and one on placebo (10%) reported diarrhea.
In the twice-a-day dosing group, 7 of 18 subjects on cadazolid (39%) and 1 of 6 subjects on placebo (17%) reported adverse events, most commonly headache in 5 subjects on cadazolid (28%) and 1 subject on placebo (17%).
Subjects were aged 45-60 years and had a body mass index of 18-32 kg/m2.
C. difficile is the most common cause of antibiotic-associated infectious diarrhea, especially among the elderly. The mainstays of treating C. difficile–associated infection, metronidazole or vancomycin, fail in approximately 20%-45% of patients.
Cadazolid is in the oxazolidinone class of antibiotics. Its mechanism of action consists mainly of bacterial protein-synthesis inhibition.
Dr. Baldoni and most of her coinvestigators are employees of Actelion Pharmaceuticals, which funded the study.
SAN FRANCISCO – Those desperate for new treatments for Clostridium difficile infection may want to keep an eye on the experimental oral antibiotic cadazolid, which looked promising in an early-phase trial, according to Daniela Baldoni, Pharm.D.
Cadazolid produced low systemic exposure with high concentrations at the desired site – the colon – and was well tolerated in 64 healthy men who received up to 3,000 mg b.i.d. for 10 days, she reported in a poster presentation at the annual Interscience Conference on Antimicrobial Agents and Chemotherapy. Dr. Baldoni is employed by Actelion Pharmaceuticals, the company that is developing cadazolid.
The study randomized nonsmoking men to either the drug (single or multiple doses of cadazolid) or placebo. All subjects remained in the clinic for observation for 120 hours after the last dose.
In the single-dose group, 30 fasting subjects received a single dose of 30, 100, 300, 1,000, or 3,000 mg cadazolid and 10 subjects received matching placebo. After a wash-out period of 8-15 days, the six subjects who had taken 300 mg received a second dose of 300 mg after eating instead of after fasting. In the multiple-dose group, 18 subjects took 300, 1,000, or 3,000 mg of cadazolid twice a day and 6 received matching placebo for 10 days.
Taking cadazolid with food appeared to increase the rate and extent of drug absorption by two- to fivefold. Blood samples showed low systemic exposure after single or multiple doses, with a minor, twofold increase in cadazolid in plasma after 10 days for all doses in the twice-a-day group, Dr. Baldoni reported at the meeting, sponsored by the American Society for Microbiology.
Negligible recovery of unchanged cadazolid in urine samples and the fact that most of the dose was recovered in feces suggests that treatment produced high concentrations at the colon. In fecal samples collected during days 6 and 10 of treatment, the mean cumulative recovery of unchanged cadazolid in feces was between 87% and 94%.
There were no significant changes in vital signs, ECG results, or laboratory parameters compared with baseline measurements, and no drug-related serious adverse events. All subjects completed the study except one man in the 100-mg single-dose subgroup who withdrew consent for reasons unrelated to adverse events.
The dose or duration of treatment did not seem to affect the number of adverse events.
In the single-dose group, 8 of 30 subjects on cadazolid (27%) and 4 of 10 on placebo (40%) reported adverse events, most commonly headache and diarrhea. Four subjects on cadazolid (13%) and two on placebo (20%) reported headache, and three subjects on cadazolid (10%) and one on placebo (10%) reported diarrhea.
In the twice-a-day dosing group, 7 of 18 subjects on cadazolid (39%) and 1 of 6 subjects on placebo (17%) reported adverse events, most commonly headache in 5 subjects on cadazolid (28%) and 1 subject on placebo (17%).
Subjects were aged 45-60 years and had a body mass index of 18-32 kg/m2.
C. difficile is the most common cause of antibiotic-associated infectious diarrhea, especially among the elderly. The mainstays of treating C. difficile–associated infection, metronidazole or vancomycin, fail in approximately 20%-45% of patients.
Cadazolid is in the oxazolidinone class of antibiotics. Its mechanism of action consists mainly of bacterial protein-synthesis inhibition.
Dr. Baldoni and most of her coinvestigators are employees of Actelion Pharmaceuticals, which funded the study.
AT THE ANNUAL INTERSCIENCE CONFERENCE ON ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
Major Finding: The experimental antibiotic cadazolid concentrated in feces with low systemic exposure and few side effects after single doses or twice-a-day dosing for 10 days.
Data Source: Data are from a randomized, placebo-controlled study in 64 healthy, nonsmoking men.
Disclosures: Dr. Baldoni and most of her coinvestigators are employees of Actelion Pharmaceuticals, which funded the study.
Gastric Bypass Benefits Persist at 6 Years' Follow-Up
Both weight loss and its associated improvements in cardiovascular and metabolic risk factors persisted for 6 years in most of the 418 severely obese adults who underwent Roux-en-Y gastric bypass surgery in a prospective study published in the Sept. 19 JAMA.
Despite some weight regain over time, surgery patients showed a mean weight loss of 28% at 6-year follow-up, as well as higher remission rates for diabetes, dyslipidemia, and hypertension, compared with the two control groups, said Ted D. Adams, Ph.D., of the department of internal medicine, University of Utah, Salt Lake City, and his associates.
"Considering the 5%-9% weight loss at 1 year with only 2%-6% weight loss after 4 years of intensive lifestyle-based and medication-based therapy, the weight-loss maintenance of 28% ... in our Utah study is quite significant," they noted.
The study involved severely obese adults with a body mass index of 35 kg/m2 or higher (mean BMI 45.9 kg/m2), of whom 82% were women and 96% were white. In addition to the patients who underwent either open or laparoscopic gastric bypass, there were 417 obese subjects in the first control group who were assessed for the surgery at the same time as the intervention group but did not have the surgery, and 321 obese subjects in the second control group who were randomly selected from a population-based sample of Utah residents.
Subjects in the control groups did not receive any weight-loss intervention as part of the study but were free to pursue it on their own. Over time, 101 of the subjects from both control groups chose to have bariatric surgery.
In the surgical group, mean weight loss was 35% at 2 years and 28% at 6 years, representing a 7% regain over time. By comparison, neither control group showed any significant weight loss or regain.
Diabetes remitted in 75% of the bypass group at 2 years, decreasing to 62% at 6 years. Despite the recurrence of diabetes in some patients, this long-term remission rate was dramatically better than the remission rates in the control groups (8% and 6%, respectively).
Similarly, the proportion of bypass patients who developed index diabetes during follow-up was markedly lower in the bypass group (2%) than in either control group (17% and 15%, respectively).
Remission of hypertension also was greater 6 years after bypass surgery (42%) than in the control groups (18% and 9%, respectively). Rates of high LDL cholesterol and triglycerides followed the same pattern, Dr. Adams and his colleagues wrote (JAMA 2012;308:1122-31).
Importantly, the weight loss and the concurrent improvement in cardiovascular and metabolic risk factors did not improve mortality. There were 29 deaths: 12 in the bypass group (3%); 14 in the first control group (3%); and 3 in the second control group (1%).
Notably, suicide was significantly more common in the bypass patients than in the control subjects. There were four suicides and three poisonings "of undetermined intention" overall, and six of these seven events occurred in bypass patients. The reason for this excess in the surgery group is unknown, but it is consistent with the finding that the mental component of the SF-36 fails to improve during follow-up, even though the physical component improves markedly among gastric bypass patients.
Other investigators have postulated that bariatric surgery precipitates profound changes "that may generate tension and pose special social, psychological, and lifestyle challenges. Preoperative and postoperative psychological assessment of social and emotional status related to post–bariatric surgical expectations and the potential risk of self-destructive behavior might be warranted," Dr. Adams and his associates said.
The rate of perioperative complications was 3% in the surgery group, and there were 38 hospitalizations for bypass-related indications.
This study was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. Dr. Adams’s associates reported ties to Vivus, Orexigen, GlaxoSmithKline, Health Outcome Solutions, and Ethicon Endo-Surgery.
Dr. Adams and his associates show that, despite some weight regain and some recurrence of diabetes, "the control of comorbid conditions remained very good" several years after severely obese patients underwent gastric bypass surgery, said Dr. Anita P. Courcoulas.
Most weight-loss studies are limited by very high dropout rates, so it was remarkable that follow-up was 96% in the intervention group in this study. "These findings are important because they show in a Roux-en-Y cohort and control group with nearly complete follow-up at 6 years that weight loss and associated health benefits ... are durable," she noted.
Anita P. Courcoulas, M.D., is in the department of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center. She reported ties to Ethicon, Endogastric Solutions, Pfizer, Allergan, Stryker Endoscopy, Covidien, and Nutrisystem. These remarks were taken from her editorial comment accompanying the report (JAMA 2012;308:1160-1).
Dr. Adams and his associates show that, despite some weight regain and some recurrence of diabetes, "the control of comorbid conditions remained very good" several years after severely obese patients underwent gastric bypass surgery, said Dr. Anita P. Courcoulas.
Most weight-loss studies are limited by very high dropout rates, so it was remarkable that follow-up was 96% in the intervention group in this study. "These findings are important because they show in a Roux-en-Y cohort and control group with nearly complete follow-up at 6 years that weight loss and associated health benefits ... are durable," she noted.
Anita P. Courcoulas, M.D., is in the department of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center. She reported ties to Ethicon, Endogastric Solutions, Pfizer, Allergan, Stryker Endoscopy, Covidien, and Nutrisystem. These remarks were taken from her editorial comment accompanying the report (JAMA 2012;308:1160-1).
Dr. Adams and his associates show that, despite some weight regain and some recurrence of diabetes, "the control of comorbid conditions remained very good" several years after severely obese patients underwent gastric bypass surgery, said Dr. Anita P. Courcoulas.
Most weight-loss studies are limited by very high dropout rates, so it was remarkable that follow-up was 96% in the intervention group in this study. "These findings are important because they show in a Roux-en-Y cohort and control group with nearly complete follow-up at 6 years that weight loss and associated health benefits ... are durable," she noted.
Anita P. Courcoulas, M.D., is in the department of minimally invasive bariatric and general surgery at the University of Pittsburgh Medical Center. She reported ties to Ethicon, Endogastric Solutions, Pfizer, Allergan, Stryker Endoscopy, Covidien, and Nutrisystem. These remarks were taken from her editorial comment accompanying the report (JAMA 2012;308:1160-1).
Both weight loss and its associated improvements in cardiovascular and metabolic risk factors persisted for 6 years in most of the 418 severely obese adults who underwent Roux-en-Y gastric bypass surgery in a prospective study published in the Sept. 19 JAMA.
Despite some weight regain over time, surgery patients showed a mean weight loss of 28% at 6-year follow-up, as well as higher remission rates for diabetes, dyslipidemia, and hypertension, compared with the two control groups, said Ted D. Adams, Ph.D., of the department of internal medicine, University of Utah, Salt Lake City, and his associates.
"Considering the 5%-9% weight loss at 1 year with only 2%-6% weight loss after 4 years of intensive lifestyle-based and medication-based therapy, the weight-loss maintenance of 28% ... in our Utah study is quite significant," they noted.
The study involved severely obese adults with a body mass index of 35 kg/m2 or higher (mean BMI 45.9 kg/m2), of whom 82% were women and 96% were white. In addition to the patients who underwent either open or laparoscopic gastric bypass, there were 417 obese subjects in the first control group who were assessed for the surgery at the same time as the intervention group but did not have the surgery, and 321 obese subjects in the second control group who were randomly selected from a population-based sample of Utah residents.
Subjects in the control groups did not receive any weight-loss intervention as part of the study but were free to pursue it on their own. Over time, 101 of the subjects from both control groups chose to have bariatric surgery.
In the surgical group, mean weight loss was 35% at 2 years and 28% at 6 years, representing a 7% regain over time. By comparison, neither control group showed any significant weight loss or regain.
Diabetes remitted in 75% of the bypass group at 2 years, decreasing to 62% at 6 years. Despite the recurrence of diabetes in some patients, this long-term remission rate was dramatically better than the remission rates in the control groups (8% and 6%, respectively).
Similarly, the proportion of bypass patients who developed index diabetes during follow-up was markedly lower in the bypass group (2%) than in either control group (17% and 15%, respectively).
Remission of hypertension also was greater 6 years after bypass surgery (42%) than in the control groups (18% and 9%, respectively). Rates of high LDL cholesterol and triglycerides followed the same pattern, Dr. Adams and his colleagues wrote (JAMA 2012;308:1122-31).
Importantly, the weight loss and the concurrent improvement in cardiovascular and metabolic risk factors did not improve mortality. There were 29 deaths: 12 in the bypass group (3%); 14 in the first control group (3%); and 3 in the second control group (1%).
Notably, suicide was significantly more common in the bypass patients than in the control subjects. There were four suicides and three poisonings "of undetermined intention" overall, and six of these seven events occurred in bypass patients. The reason for this excess in the surgery group is unknown, but it is consistent with the finding that the mental component of the SF-36 fails to improve during follow-up, even though the physical component improves markedly among gastric bypass patients.
Other investigators have postulated that bariatric surgery precipitates profound changes "that may generate tension and pose special social, psychological, and lifestyle challenges. Preoperative and postoperative psychological assessment of social and emotional status related to post–bariatric surgical expectations and the potential risk of self-destructive behavior might be warranted," Dr. Adams and his associates said.
The rate of perioperative complications was 3% in the surgery group, and there were 38 hospitalizations for bypass-related indications.
This study was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. Dr. Adams’s associates reported ties to Vivus, Orexigen, GlaxoSmithKline, Health Outcome Solutions, and Ethicon Endo-Surgery.
Both weight loss and its associated improvements in cardiovascular and metabolic risk factors persisted for 6 years in most of the 418 severely obese adults who underwent Roux-en-Y gastric bypass surgery in a prospective study published in the Sept. 19 JAMA.
Despite some weight regain over time, surgery patients showed a mean weight loss of 28% at 6-year follow-up, as well as higher remission rates for diabetes, dyslipidemia, and hypertension, compared with the two control groups, said Ted D. Adams, Ph.D., of the department of internal medicine, University of Utah, Salt Lake City, and his associates.
"Considering the 5%-9% weight loss at 1 year with only 2%-6% weight loss after 4 years of intensive lifestyle-based and medication-based therapy, the weight-loss maintenance of 28% ... in our Utah study is quite significant," they noted.
The study involved severely obese adults with a body mass index of 35 kg/m2 or higher (mean BMI 45.9 kg/m2), of whom 82% were women and 96% were white. In addition to the patients who underwent either open or laparoscopic gastric bypass, there were 417 obese subjects in the first control group who were assessed for the surgery at the same time as the intervention group but did not have the surgery, and 321 obese subjects in the second control group who were randomly selected from a population-based sample of Utah residents.
Subjects in the control groups did not receive any weight-loss intervention as part of the study but were free to pursue it on their own. Over time, 101 of the subjects from both control groups chose to have bariatric surgery.
In the surgical group, mean weight loss was 35% at 2 years and 28% at 6 years, representing a 7% regain over time. By comparison, neither control group showed any significant weight loss or regain.
Diabetes remitted in 75% of the bypass group at 2 years, decreasing to 62% at 6 years. Despite the recurrence of diabetes in some patients, this long-term remission rate was dramatically better than the remission rates in the control groups (8% and 6%, respectively).
Similarly, the proportion of bypass patients who developed index diabetes during follow-up was markedly lower in the bypass group (2%) than in either control group (17% and 15%, respectively).
Remission of hypertension also was greater 6 years after bypass surgery (42%) than in the control groups (18% and 9%, respectively). Rates of high LDL cholesterol and triglycerides followed the same pattern, Dr. Adams and his colleagues wrote (JAMA 2012;308:1122-31).
Importantly, the weight loss and the concurrent improvement in cardiovascular and metabolic risk factors did not improve mortality. There were 29 deaths: 12 in the bypass group (3%); 14 in the first control group (3%); and 3 in the second control group (1%).
Notably, suicide was significantly more common in the bypass patients than in the control subjects. There were four suicides and three poisonings "of undetermined intention" overall, and six of these seven events occurred in bypass patients. The reason for this excess in the surgery group is unknown, but it is consistent with the finding that the mental component of the SF-36 fails to improve during follow-up, even though the physical component improves markedly among gastric bypass patients.
Other investigators have postulated that bariatric surgery precipitates profound changes "that may generate tension and pose special social, psychological, and lifestyle challenges. Preoperative and postoperative psychological assessment of social and emotional status related to post–bariatric surgical expectations and the potential risk of self-destructive behavior might be warranted," Dr. Adams and his associates said.
The rate of perioperative complications was 3% in the surgery group, and there were 38 hospitalizations for bypass-related indications.
This study was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. Dr. Adams’s associates reported ties to Vivus, Orexigen, GlaxoSmithKline, Health Outcome Solutions, and Ethicon Endo-Surgery.
FROM JAMA
Major Finding: Six years after undergoing gastric bypass, patients showed a mean weight loss of 28%, a diabetes remission rate of 62%, a hypertension remission rate of 42%, and improved lipid profiles.
Data Source: A prospective case-control study involving 1,156 severely obese adults, comparing outcomes at long-term follow-up between 418 who had undergone Roux-en-Y gastric bypass and 738 who had not.
Disclosures: This study was supported by the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Center for Research Resources. Dr. Adams’s associates reported ties to Vivus, Orexigen, GlaxoSmithKline, Health Outcome Solutions, and Ethicon Endo-Surgery.
Avoiding Harmful Palliative Chemotherapy Treatment in the End of Life
Avoiding Harmful Palliative Chemotherapy Treatment in the End of Life: Development of a Brief Patient-Completed Questionnaire for Routine Assessment of Performance Status
Ulla Näppä, RN, MSc
Abstract
Background
Earlier studies have shown that up to 43% of patients with incurable cancer are treated with palliative chemotherapy in the last month of their lives. Although pretreatment blood tests are acceptable, the patient's general condition may not permit further palliative chemotherapy treatment (PCT). Presently, there is no patient self-assessment tool available to monitor performance status during PCT.
Objectives
To describe the development process of the Performance Status in Palliative Chemotherapy (PSPC) questionnaire, and the testing of its psychometric properties.
Methods
The questionnaire was developed by the authors based on the Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) scale as well as their clinical experience with PCT. Adult patients who were diagnosed with epithelial cancers (n = 118) were enrolled to test the PSPC questionnaire for reliability, sensitivity for change, and validity.
Results
After stepwise modifications of the PSPC questionnaire, psychometric tests revealed acceptable values for reliability (via a test-retest method), sensitivity for change (via a comparison of patients with progressive disease over time), and validity (via a comparison of the PSPC vs the Edmonton Symptom Assessment System [ESAS]).
Limitations
At this stage of questionnaire development, we are unable to conclude whether the PSPC is superior to the conventional ECOG PSR in the evaluation of performance status and the prediction of chemotherapy response.
Conclusion
Psychometric tests suggest that the PSPC questionnaire may be a useful patient-completed tool in the late stages of cancer disease to routinely monitor performance status in palliative chemotherapy treatments so as to minimize the risk of inflicting more harm than good.
*For a PDF of the full article and accompanying commentary by Dr Jamie von Roenn, click on the links to the left of this introduction.
Avoiding Harmful Palliative Chemotherapy Treatment in the End of Life: Development of a Brief Patient-Completed Questionnaire for Routine Assessment of Performance Status
Ulla Näppä, RN, MSc
Abstract
Background
Earlier studies have shown that up to 43% of patients with incurable cancer are treated with palliative chemotherapy in the last month of their lives. Although pretreatment blood tests are acceptable, the patient's general condition may not permit further palliative chemotherapy treatment (PCT). Presently, there is no patient self-assessment tool available to monitor performance status during PCT.
Objectives
To describe the development process of the Performance Status in Palliative Chemotherapy (PSPC) questionnaire, and the testing of its psychometric properties.
Methods
The questionnaire was developed by the authors based on the Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) scale as well as their clinical experience with PCT. Adult patients who were diagnosed with epithelial cancers (n = 118) were enrolled to test the PSPC questionnaire for reliability, sensitivity for change, and validity.
Results
After stepwise modifications of the PSPC questionnaire, psychometric tests revealed acceptable values for reliability (via a test-retest method), sensitivity for change (via a comparison of patients with progressive disease over time), and validity (via a comparison of the PSPC vs the Edmonton Symptom Assessment System [ESAS]).
Limitations
At this stage of questionnaire development, we are unable to conclude whether the PSPC is superior to the conventional ECOG PSR in the evaluation of performance status and the prediction of chemotherapy response.
Conclusion
Psychometric tests suggest that the PSPC questionnaire may be a useful patient-completed tool in the late stages of cancer disease to routinely monitor performance status in palliative chemotherapy treatments so as to minimize the risk of inflicting more harm than good.
*For a PDF of the full article and accompanying commentary by Dr Jamie von Roenn, click on the links to the left of this introduction.
Avoiding Harmful Palliative Chemotherapy Treatment in the End of Life: Development of a Brief Patient-Completed Questionnaire for Routine Assessment of Performance Status
Ulla Näppä, RN, MSc
Abstract
Background
Earlier studies have shown that up to 43% of patients with incurable cancer are treated with palliative chemotherapy in the last month of their lives. Although pretreatment blood tests are acceptable, the patient's general condition may not permit further palliative chemotherapy treatment (PCT). Presently, there is no patient self-assessment tool available to monitor performance status during PCT.
Objectives
To describe the development process of the Performance Status in Palliative Chemotherapy (PSPC) questionnaire, and the testing of its psychometric properties.
Methods
The questionnaire was developed by the authors based on the Eastern Cooperative Oncology Group Performance Status Rating (ECOG PSR) scale as well as their clinical experience with PCT. Adult patients who were diagnosed with epithelial cancers (n = 118) were enrolled to test the PSPC questionnaire for reliability, sensitivity for change, and validity.
Results
After stepwise modifications of the PSPC questionnaire, psychometric tests revealed acceptable values for reliability (via a test-retest method), sensitivity for change (via a comparison of patients with progressive disease over time), and validity (via a comparison of the PSPC vs the Edmonton Symptom Assessment System [ESAS]).
Limitations
At this stage of questionnaire development, we are unable to conclude whether the PSPC is superior to the conventional ECOG PSR in the evaluation of performance status and the prediction of chemotherapy response.
Conclusion
Psychometric tests suggest that the PSPC questionnaire may be a useful patient-completed tool in the late stages of cancer disease to routinely monitor performance status in palliative chemotherapy treatments so as to minimize the risk of inflicting more harm than good.
*For a PDF of the full article and accompanying commentary by Dr Jamie von Roenn, click on the links to the left of this introduction.
The Essential Elements of an ACO
"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford
As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?
There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:
• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.
Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.
Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.
• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.
• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.
For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.
• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.
Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.
To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.
• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.
• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.
According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."
• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.
• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.
Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.
For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.
"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford
As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?
There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:
• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.
Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.
Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.
• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.
• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.
For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.
• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.
Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.
To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.
• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.
• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.
According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."
• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.
• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.
Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.
For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.
"Clinical transformation has less to do with technical capabilities and more with the ability to effect cultural change." –Gary Edmiston and David Wofford
As we’ve demonstrated in previous columns, there’s plenty of potential for primary care physicians who embrace the concept of the accountable care organization. But what characteristics and capabilities are critical to ensuring that the promise of ACOs is realized in real – and sustainable – organizations?
There are at least eight elements that are fundamental to the success of an ACO – and they should be part of every physician’s decision-making checklist when you consider forming or joining an ACO:
• A culture of teamwork. The most important element, yet the one most difficult for physicians to attain, is a team-oriented culture with a deeply held, shared commitment to reorganize care to achieve higher quality at lower cost.
Physician attitudes favor autonomy and individualism over collaboration. These attitudes are inculcated in clinical training and reinforced daily in care delivery. Physicians need to understand that the level of involvement needed to effect changes in quality and cost is much different than just banding together for contracting purposes.
Furthermore, physicians tend to be cynical about prior "next best things," such as HMOs, gatekeeping, and capitation, and they have little experience with, or time for, organizational-level strategic planning.
• Primary care physicians. As Harold Miller of the Center for Healthcare Quality and Payment Reform asserts, "It seems clear that in order to be accountable for the health and health care of a broad population of patients, an accountable care organization must have one or more primary care practices playing a central role." This need is logical when you examine the highest-impact targets identified for ACOs: prevention and wellness; chronic disease management; reduced hospitalizations; improved care transitions across the current fragmented system; and multispecialty comanagement of complex patients.
• Adequate administrative capabilities. There are three essential infrastructure functional capabilities: performance measurement; financial administration; and clinical direction.
For example, ACOs qualifying under the Medicare Shared Savings Program must have a leadership and management structure that includes clinical and administrative systems that align with the aims of the Shared Savings Program. The ACO must have an infrastructure capable of promoting evidence-based medicine and beneficiary engagement, reporting on quality and cost metrics, and coordinating care.
• Adequate financial incentives. Three tiers of financial income models are available to ACOs: upside-bonus-only shared savings; a hybrid of limited-upside and limited-downside shared savings and penalty; and full-upside and full-downside capitation.
Shared savings is emerging as the common initial preference of start-up ACOs. If quality and patient satisfaction are enhanced or maintained, and if there are savings relative to the predicted costs for the assigned patient population, then a portion (commonly 50%) of those savings is shared with the ACO.
To maximize incentives, the savings pool should be divided in proportion to the level of contribution of each ACO participant. If primary care has especially high medical home management responsibility, this responsibility may be accompanied by the addition of a flat per member/per month payment.
• Health information technology and data. ACO data are usually a combination of quality, efficiency, and patient-satisfaction measures. These data will usually have outcomes and process measures. Nationally accepted benchmarks are emerging. Three categories of data needs exist for an ACO: baseline data; performance measurement data; and data as a clinical tool. The ACO will need the capability to move data across the continuum of care in a meaningful way, often termed "health information exchange" capability.
• Best practices across the continuum of care. Another essential element of a successful ACO is the ability to translate evidence-based medical principles into best practices in actual clinical care.
According to the Advisory Board Company’s "Moving Toward Accountable Care" project, "The best bet for achieving returns from integration is to prioritize initiatives specifically targeting waste and inefficiency caused by fragmentation in today’s delivery system, unnecessary spending relating to substandard clinical coordination, aggravated with the complexity of navigating episodes of care, and unwanted variations in clinical outcomes driven by lack of adherence to best clinical practice."
• Patient engagement. Patient engagement is another essential element. Unfortunately, many of today’s health care consumers erroneously believe that more is better – especially when they are not "paying" for it, insurance is. It is difficult to accept a compensation model based on improved patient population health when that is dramatically affected by a variable outside of your control: patient adherence.
• Scale-sufficient patient population. It is okay, even desirable, to start small or "walk before you run." However, potential ACOs often overlook the requirement that there needs to be a minimal critical mass of patients to justify the time and infrastructure investment for the ACO. The Medicare Shared Savings Program, for example, requires that an ACO have a minimum of 5,000 beneficiaries assigned to the ACO.
Investing the time now to assess an organization’s ability to deliver on these eight elements will pay off later for primary care physicians who are ready to build or join an ACO.
For more information on the topics covered here, visit www.smithlaw.com/publications/ACOG.pdf.
Mr. Bobbitt is a senior partner and head of the Health Law Group at the Smith Anderson law firm in Raleigh, N.C. He has many years’ experience helping physicians form integrated delivery systems. He has spoken and written nationally to primary care physicians on the strategies and practicalities of forming or joining ACOs. This article is meant to be educational and does not constitute legal advice. For additional information, readers may contact Mr. Bobbitt at [email protected] or at 919-821-6612.
ONLINE EXCLUSIVE: Lehigh Valley Health Network Team Members Discuss Teach-Back
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