Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.

This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.

For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).

It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.

Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.

Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.

This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.

For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).

It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.

Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.

Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

Over the last 50 years, we have witnessed some incredible advancements that have vastly improved maternal and fetal outcomes, even in the face of the most complex obstetrical dilemmas. As our practice and the research continues to evolve, it is increasingly important that we carefully review our practice standards to ensure that every woman and her baby receives the most up-to-date medical care.

This month’s Master Class highlights a critical area of obstetrics where the convergence of technology, clinical observation, and research stimulated a change in practice guidelines: the use of the labor curve to monitor normal versus abnormal labor. Until quite recently, ob.gyns. had based labor criteria on the “Friedman Curve,” first established in the mid-1950s, and supported by other smaller and less comprehensive studies. This work was adopted by the American College of Obstetricians and Gynecologists.

For more than half a century, we used these parameters to determine if a woman had entered active-phase arrest, and to make the very important decision of whether to perform a cesarean section. However, work in the early 2000s strongly suggested that the old criteria no longer applied to the full course of labor in contemporary patients (Am J Obstet Gynecol. 2002 Oct;187[4]:824-8). A 2010 comprehensive study showed that we needed to consider a new approach to labor management (Am J Obstet Gynecol. 2010 Oct;203[4]:326.e1-326.e10).

It may seem incredible that it took such a long time to update our thinking about what constitutes normal versus abnormal labor progression. However, we must keep in mind that many studies supported the original labor curve, and advanced tools to assess fetal health during labor were just being developed. The first commercially available fetal heart rate monitor would not be produced until 1968, and debates about the utility of these devices would continue into the early 1990s.

Additionally, our patient population has changed. As we have discussed in previous columns, the incidence and severity of other chronic conditions, such as diabetes and obesity, has increased significantly and deeply impacted labor progression.

Just as technology has advanced and our patients’ needs have changed, so, too, must our practice standards. We have invited Dr. Alison G. Cahill, associate professor and chief of the division of maternal-fetal medicine in the department of obstetrics and gynecology at Washington University, St. Louis, to discuss the importance and implications of the new labor curve.

Dr. Reece, who specializes in maternal-fetal medicine, is vice president for medical affairs at the University of Maryland, Baltimore, as well as the John Z. and Akiko K. Bowers Distinguished Professor and dean of the school of medicine. Dr. Reece said he had no relevant financial disclosures. He is the medical editor of this column. Contact him at [email protected].

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!

Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.

We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.

Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.

Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.

Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.

A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.

In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”

Infection control is everyone’s responsibility and we all need to work together toward this common goal.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!

Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.

We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.

Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.

Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.

Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.

A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.

In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”

Infection control is everyone’s responsibility and we all need to work together toward this common goal.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

Big things come in small packages, very small – so small they may even be invisible to the naked eye. Take for instance a huge infection causing multiorgan system failure, disseminated intravascular coagulation, even septic shock refractory to high-dose pressors. This catastrophe may be the end result of exposure to tiny pathogenic microbes that can take down an otherwise healthy 300-pound man, tout suite!

Microorganisms are everywhere. We can’t live without them, but we can’t live with certain ones either. Unless you live in a bubble you are going to be exposed to countless bacteria each and every day. They are in the air we breathe, the water we drink, the beds we sleep in. While it is a given that we all will be continuously exposed to bacteria, having a well-considered strategy to curtail the spread of disease can dramatically decrease the risk that we, our families, and our patients are needlessly exposed to potentially life-threatening organisms.

We all know we are to wash our hands on the way in, and out, of patients’ rooms. This practice is our front line of defense against the spread of numerous potentially lethal diseases. Yet, many clinicians, as well as ancillary hospital personnel, repeatedly fail to abide by this rule, thinking that ‘this one time won’t hurt anything.’ Whether it’s the nurse who rushes into a patient’s room to stop a beeping IV pole or the doctor who eyes a family member in the room and makes a beeline to discuss the discharge plan, all of us have been guilty of entering or leaving a patient’s room without following appropriate infection control standards.

Or, how many times have you followed the protocol meticulously, at least initially, and removed your gown and gloves and washed your hands on your way out the door when the patient remembers another question, or asks you to hand him something that leads to more contact with him or his surroundings? You already washed your hands once, so must you really do it again? After all, what is the likelihood that you pick up (or pass along) any germs anyway? Sometimes, more than we realize. Something as simple as handing a patient his nurses’ call button can expose us to enough C. difficile spores to cause infection in us or others we come into contact with unwittingly. So wash those hands, and wash them again if you touch anything in a patient’s room, even if it is not the patient himself.

Direct observation (AKA “Secret Santas”) can provide invaluable information about adherence to hand hygiene among health care workers and providing feedback is key. This can be unit based, group based, and even provider based. Once collected, this information should be used to drive changes in behavior, which could be punitive or positive; each hospital should decide how to best use its data.

Visitor contact is another important issue and not everyone agrees on how to enforce, or whether to even try to enforce, infection control procedures. The Society for Healthcare Epidemiology of America (SHEA) has several helpful pocket guidelines to address this and other infection control issues. For instance, the society recommends that hospitals consider adopting guidelines to minimize horizontal transmission by visitors, though these guidelines should be feasible to enforce. Factors such as the specific organism and its potential to cause harm are important to consider when developing these guidelines. For instance, the spouse of a patient admitted with influenza has likely already been exposed, and postexposure prophylaxis may be more feasible to her than wearing an uncomfortable mask during an 8-hour hospital visit.

A pharmacy stewardship program is another invaluable infection control tool. With this model, a group of pharmacists, under the direction of an infectious disease specialist, reviews culture results daily and makes recommendations to the physician regarding narrowing antibiotic coverage. I greatly appreciate receiving calls to notify me that the final culture results are in long before I would have actually seen them myself. This allows me to adjust antibiotics in a timely fashion, thus reducing the emergence of drug-resistant organisms or precipitating an unnecessary case of C. difficile.

In addition, written guidelines should be established for indwelling catheters, both urinary and venous. The indication for continued use should be reassessed daily; a computer alert that requires a response is very helpful, as is a call from the friendly floor nurse asking, “Does this patient really still need his catheter?”

Infection control is everyone’s responsibility and we all need to work together toward this common goal.

Dr. Hester is a hospitalist at Baltimore-Washington Medical Center in Glen Burnie, Md. She is the creator of the Patient Whiz, a patient-engagement app for iOS. Reach her at [email protected].

PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

PHILADELPHIA—The Society of Hospital Medicine (SHM) is pleased to announce the introduction of a dedicated billing code for hospitalists by the Centers for Medicare & Medicaid Services (CMS). This decision comes in response to concerted advocacy efforts from SHM for CMS to recognize the specialty. This is a monumental step for hospital medicine, which continues to be the fastest growing medical specialty in the United States with over 48,000 practitioners identifying as hospitalists, growing from approximately 1,000 in the mid-1990s.

“We see each day that hospitalists are driving positive change in healthcare, and this recognition by CMS affirms that hospital medicine is growing both in scope and impact,” notes Laurence Wellikson, MD, MHM, CEO of SHM. “The ability for hospital medicine practitioners to differentiate themselves from providers in other specialties will have a huge impact, particularly for upcoming value-based or pay-for-performance programs.”

Until now, hospitalists could only compare performance to that of practitioners in internal medicine or another related specialty. This new billing code will allow hospitalists to appropriately benchmark and focus improvement efforts with others in the hospital medicine specialty, facilitating more accurate comparisons and fairer assessments of hospitalist performance.

Despite varied training backgrounds, hospitalists have become focused within their own unique specialty, dedicated to providing care to hospitalized patients and working toward high-quality, patient-centered care in the hospital. They have developed institutional-based skills that differentiate them from practitioners in other specialties, such as internal and family medicine. Their specialized expertise includes improving both the efficiency and safety of care for hospitalized patients and the ability to manage and innovate in a hospital’s team-based environment.

This momentous decision coincides with the twenty-year anniversary of the coining of the term ‘hospitalist’ by Robert Wachter, MD, MHM, and Lee Goldman, MD in the New England Journal of Medicine. In recognition of this anniversary, SHM introduced a year-long celebration, the “Year of the Hospitalist,” to commemorate the specialty’s continued success and bright future.

“We have known who we are for years, and the special role that hospitalists play in the well-being of our patients, communities and health systems,” explains Brian Harte, MD, SFHM, president-elect of SHM. “The hospitalist provider code will provide Medicare and other players in the healthcare system an important new tool to better understand and acknowledge the critical role we play in the care of hospitalized patients nationwide.”

Lisa Zoks is SHM's Vice-President of Communications.

ABOUT SHM

Representing the fastest growing specialty in modern healthcare, SHM is the leading medical society for more than 48,000 hospitalists and their patients. SHM is dedicated to promoting the highest quality care for all hospitalized patients and overall excellence in the practice of hospital medicine through quality improvement, education, advocacy and research. Over the past decade, studies have shown that hospitalists can contribute to decreased patient lengths of stay, reductions in hospital costs and readmission rates, and increased patient satisfaction.

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

ORLANDO – Statins administered perioperatively offered no protection against acute kidney injury following cardiac surgery, according to new results of a 5-year randomized clinical trial.

The findings held true whether or not patients were naive to statins; serum creatinine levels actually increased significantly more for statin-naive patients given atorvastatin than those given placebo.

The study was stopped early for patients naive to statins because increased acute kidney injury was seen in those patients who had chronic kidney disease (eGFR less than 60 mL/min/1.73 m²), and was subsequently stopped early for futility for all patients.

“De novo initiation of daily perioperative atorvastatin treatment did not reduce the incidence of AKI or reduce the increase in serum creatinine concentration associated with cardiac surgery,” wrote Dr. Frederic T. Billings IV, professor of medicine at Vanderbilt University, Nashville, Tenn., and his collaborators. The findings (JAMA 2016 Feb 23. doi: 10.1001/jama.2016.0548) were published concurrently with his presentation at the Critical Care Congress, sponsored by the Society for Critical Care Medicine.

In what Dr. Phil B. Fontanarosa, executive editor of JAMA and comoderator of the late-breaking trials session at the meeting, described as “really an elegant clinical trial,” Dr. Billings and his collaborators enrolled 615 patients over 5 years at Vanderbilt University Medical Center.

Patients undergoing elective coronary artery bypass grafting, valvular heart surgery, or ascending aortic surgery were eligible. Patients were excluded if they had prior statin intolerance, acute coronary syndrome, or liver dysfunction; were taking potent CYP3A4 inhibitors or cyclosporine; were receiving renal replacement therapy or had a kidney transplant; or were pregnant.

Both patients currently on a statin and patients naive to statins were recruited. Statin-naive patients received 80 mg atorvastatin the day before surgery, and then 40 mg of atorvastatin on the day of surgery and daily following surgery, or a matched placebo regimen.

Patients who were already on a statin received the study drug only on days that they would not have received a statin if treated according to the current standard of care. It was deemed unethical to allow those patients to receive placebo during and after surgery, since observational studies suggested that doing so might increase their potential for AKI.

For those patients already on a statin, this meant that they stayed on their usual regimen until the day of surgery, and then were randomized to receive either 80 mg of atorvastatin on the day of surgery and 40 mg of atorvastatin the day after surgery, or a matching placebo regimen.

For both groups, the study drug was given at least 3 hours before surgery on the day of surgery.

Randomization was stratified for prior statin use, for chronic kidney disease, and by history of diabetes. The 199 patients naive to statins and the 416 already on a statin were similar in demographic and health characteristics. Median age was 67 years, 188 (30.6%) were women; 202 participants (32.8%) had diabetes.

The primary outcome measure was diagnosis of AKI, defined as an increase of 0.3 mg/dL in serum creatinine, or beginning renal replacement therapy within 48 hours of surgery. Baseline serum creatinine was measured no more than 7 days prior to surgery.

AKI occurred in 64 of 308 patients (20.8%) in the atorvastatin group, and in 60 of 307 patients (19.5%) receiving placebo overall (P = .75). For those naive to statins, 21.6% of the atorvastatin group and 13.4% of the placebo group developed AKI (P = .15). Overall, 179 enrolled patients had CKD, and the incidence of AKI did not significantly differ in the atorvastatin and the placebo arms of this subgroup.

The subpopulation of participants with CKD who were statin naive (n = 36), however, saw an increased incidence of AKI with atorvastatin compared to placebo. AKI occurred in 9 of 17 patients (52.9%) given atorvastatin, and in 3 of 19 (15.8%) given placebo group (RR, 3.35[95% confidence interval 0.12 to 10.05]; P = .03). “It should be noted that the number of patients in this subgroup was particularly small, leading to a wide confidence interval and an increased chance of type 1 error,” said Dr. Billings.

Secondary outcome measures were maximum increase in creatinine concentration from baseline through postop day 2, delirium in the ICU, degree of myocardial injury, and incidence of postoperative pneumonia, atrial fibrillation, or stroke. Perioperative atorvastatin administration did not affect any of these endpoints.

The safety analysis showed no indications of increased risk of skeletal muscle or liver injury with perioperative atorvastatin use.

In the real world, “Most patients presenting for cardiac surgery … are already taking statins, and in the current study there was little evidence that continuation or withdrawal from statin treatment on the day of surgery and postoperative day 1 affects AKI,” wrote Dr. Billings and his coauthors.

Study limitations included its single-center design, and the use of AKI criteria that may not be sensitive to late-developing AKI. Also, for enrolled patients who were already on statins, statin exposure was not reduced in comparison with usual care.

After the presentation, Dr. Billings reported that the researchers also collected information about other biomarkers that may signal AKI, including IgM. He and his collaborators plan later publication of those data after a full analysis.

The National Institutes of Health and the Vanderbilt University Medical Center department of anesthesiology funded the study. Dr. Brown reported receiving grants from Shire Pharmaceuticals and New Haven Pharmaceuticals, and personal fees from Novartis Pharmaceuticals and Alnylam Pharmaceuticals. The other authors reported no conflicts of interest.

[email protected]

On Twitter @karioakes

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

NEW ORLEANS – Treatment with fingolimod improved gait impairment in treatment-naive multiple sclerosis (MS) patients and those on a previous first-line therapy in a small, single-center study.

“Fingolimod [Gilenya] is the first disease-modifying treatment shown to improve gait impairment in MS,” commented Dr. Soledad Pérez-Sánchez of Virgen Macarena University Hospital, Seville, Spain, who presented the study as a poster at the meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.

©solitude72/iStockphoto

The investigators also found that patients who were unsuccessfully treated with natalizumab (Tysabri) prior to fingolimod did not improve their gait during the course of the 6-month study. Natalizumab is a second-line drug in Spain, and fingolimod is a second-line therapy there as well, except in cases of aggressive onset of disease, according to the investigators.

Of 36 patients in the study, 24 were treatment-naïve/first-line patients (17 females and 7 males; mean age, 38.25 years), with the remaining 12 (9 females, 3 males; mean age, 44.25 years) having been treated with natalizumab. The mean duration of MS was 11.2 years in the naïve/first-line group and 17.9 years in patients on natalizumab prior to fingolimod. The mean Extended Disability Status Scale score in the two groups was similar at 3.79 and 3.38, respectively.

The investigators measured gait profile changes during fingolimod treatment with the Gaitrite Electronic System, which comprises an electronic pathway equipped with sensors designed to measure the timing and position of walking. The measurement parameters included velocity, ambulation time, and functional ambulation profile (FAP), the time to move unassisted through five common environmental terrains.

All patients completed the walking test prior to treatment and 3 months after treatment. At 6 months, 20 naïve/first-line patients and 11 patients previously on natalizumab completed the test. For each group of patients, the results prior to treatment and 3 months after were statistically similar. But significant differences were evident for naïve/first-line patients between the 3- and 6-month measures of velocity (89.10±31.03 to 100.70±23.75 cm/s; P = .01) and FAP (82.81±16.93 to 91.95±9.02 seconds; P = .01). These measurements trended toward significance when the values prior to treatment and 6 months after treatment were compared (P = .096, .077, and .065, in the same respective order).

Patients who had been treated with natalizumab did not display appreciable changes in velocity, ambulation time, and FAP.

“Our study shows that fingolimod improves gait impairment in naïve patients and those switched from first-line therapy. Our data are consistent with other clinical measures published so far which have pointed to better outcomes with fingolimod in naïve/first-line patients than in natalizumab-switched patients,” Dr. Pérez-Sánchez and her colleagues said.

The single-center study design and small number of patients limit any conclusions on the use of fingolimod as a gait-improving therapy in MS until further studies are completed, according to the researchers.

Funding was provided by Novartis. Dr. Pérez-Sánchez had no disclosures.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Drug release in a cancer cell

Image courtesy of PNAS

DNA origami nanostructures may be used to overcome drug resistance in acute myeloid leukemia (AML), according to preclinical research published in the journal Small.

Researchers found they could create these nanostructures in 10 minutes and load them with the anthracycline daunorubicin.

When the team introduced the structures to daunorubicin-resistant AML cells, the drug delivery vehicles entered the cells via endocytosis.

This allowed the drug to bypass defenses in the cell membrane that are effective against the free drug.

Once the nanostructures broke down, daunorubicin flooded the cells and killed them off.

Other research groups have used this delivery technique to overcome drug resistance in solid tumors, but this is the first time researchers have shown the same technique works on drug-resistant leukemia cells.

To create the DNA origami nanostructures, the researchers used the genome of a common bacteriophage and synthetic strands that were designed to fold up the bacteriophage DNA.

Although the folded-up shape performs a function, the DNA itself does not, explained Patrick Halley, a graduate student at The Ohio State University in Columbus.

“[T]he DNA capsule doesn’t do anything except hold a shape,” Halley said. “It’s just a static, rigid structure that carries things. It doesn’t encode any proteins or do anything else that we normally think of DNA as doing.”

The researchers tested the DNA origami nanostructures in AML cell lines that had developed resistance to daunorubicin. When molecules of daunorubicin enter these cells, the cells recognize the drug molecules and eject them through openings in the cell wall.

“Cancer cells have novel ways of resisting drugs, like these ‘pumps,’ and the exciting part of packaging the drug this way is that we can circumvent those defenses so that the drug accumulates in the cancer cell and causes it to die,” said John Byrd, MD, of The Ohio State University.

“Potentially, we can also tailor these structures to make them deliver drugs selectively to cancer cells and not to other parts of the body where they can cause side effects.”

In tests, the resistant AML cells effectively absorbed molecules of daunorubicin when they were hidden inside the rod-shaped nanostructures.

The researchers tracked the nanostructures inside the cells using fluorescent tags. Each structure measures about 15 nanometers wide and 100 nanometers long, and each has 4 hollow, open-ended interior compartments.

Study author Christopher Lucas, PhD, of The Ohio State University, said the design of the nanostructures maximizes the surface area available to carry the drug.

“The way daunorubicin works is it tucks into the cancer cell’s DNA and prevents it from replicating,” Dr Lucas said. “So we designed a capsule structure that would have lots of accessible DNA base-pairs for it to tuck into. When the capsule breaks down, the drug molecules are freed to flood the cell.”

The researchers said they designed the nanostructures to be strong and stable so they wouldn’t fully disintegrate and release the bulk of the drug until it was too late for the cells to eject them.

And that’s what the team observed with a fluorescence microscope. The cells drew the nanostructures into the organelles that would normally digest them (if they were food).

When the nanostructures broke down, the drug flooded the cells and caused them to disintegrate. Most cells died within the first 15 hours after consuming the nanostructures.

“DNA origami nanostructures have a lot of potential for drug delivery, not just for making effective drug delivery vehicles, but enabling new ways to study drug delivery,” said Carlos Castro, PhD, of The Ohio State University.

“For instance, we can vary the shape or mechanical stiffness of a structure very precisely and see how that affects entry into cells.”

Dr Castro said he hopes to create a streamlined and economically viable process for building DNA origami nanostructures as part of a modular drug delivery system.

Dr Byrd said the technique should work on most any form of drug-resistant cancer if further research shows it can be translated to animal models.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Cancer patient

receiving treatment

Photo by Rhoda Baer

A new report suggests African Americans (AAs) have significantly lower rates of most hematologic malignancies than non-Hispanic white (NHW) individuals in the US.

AAs of both sexes had significantly lower rates of leukemia, Hodgkin lymphoma (HL), and non-Hodgkin lymphoma (NHL) than NHWs, but the rate of myeloma was significantly higher among AAs.

The death rates for these malignancies followed the same patterns, with the exception of HL. There was no significant difference in HL mortality between AAs and NHWs of either sex.

These findings can be found in the report, “Cancer Statistics for African Americans, 2016,” appearing in CA: A Cancer Journal for Clinicians.

To compile this report, the researchers used data from the Surveillance, Epidemiology, and End Results program and the Centers for Disease Control and Prevention’s National Program of Cancer Registries.

Incidence

For part of the report, the researchers compared the incidence of cancers between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

Among females, the incidence of leukemia was 8.6 per 100,000 in AAs and 10.7 per 100,000 in NHWs (P<0.05). Among males, the incidence was 13.2 per 100,000 in AAs and 17.7 per 100,000 in NHWs (P<0.05).

The incidence of HL in females was 2.4 per 100,000 in AAs and 2.7 per 100,000 in NHWs (P<0.05). The incidence of HL in males was 3.2 per 100,000 in AAs and 3.4 per 100,000 in NHWs (P<0.05).

The incidence of NHL in females was 12.0 per 100,000 in AAs and 16.6 per 100,000 in NHWs (P<0.05). The incidence of NHL in males was 17.2 per 100,000 in AAs and 24.1 per 100,000 in NHWs (P<0.05).

The incidence of myeloma in females was 11.1 per 100,000 in AAs and 4.3 per 100,000 in NHWs (P<0.05). The incidence of myeloma in males was 14.8 per 100,000 in AAs and 7.0 per 100,000 in NHWs (P<0.05).

Mortality

The researchers also compared cancer mortality between AAs and NHWs (divided by gender) for the period from 2008 to 2012.

The death rate for female leukemia patients was 4.8 per 100,000 in AAs and 5.4 per 100,000 in NHWs (P<0.05). The death rate for male leukemia patients was 8.1 per 100,000 in AAs and 9.9 per 100,000 in NHWs (P<0.05).

The death rate for female HL patients was 0.3 per 100,000 for both AAs and NHWs. The death rate for male HL patients was 0.4 per 100,000 for AAs and 0.5 per 100,000 in NHWs (not significant).

The death rate for female NHL patients was 3.6 per 100,000 in AAs and 5.0 per 100,000 in NHWs (P<0.05). The death rate for male NHL patients was 5.9 per 100,000 in AAs and 8.3 per 100,000 in NHWs (P<0.05).

The death rate for female myeloma patients was 5.4 per 100,000 in AAs and 2.4 per 100,000 in NHWs (P<0.05). The death rate for male myeloma patients was 7.8 per 100,000 in AAs and 4.0 per 100,000 in NHWs (P<0.05).

The researchers noted that the reasons for the higher rates of myeloma and myeloma death among AAs are, at present, unknown.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

Excellent communication between physicians and patients is a crucial element of hospital quality, but it’s also an ongoing challenge for many institutions. One physician wondered whether letting patients read their physicians’ notes could help.

“I wanted to find new methods to improve patient understanding of their medical care plan,” says Craig Weinert, MD, MPH, medical director for adult inpatient services at the University of Minnesota Medical Center and author of “Giving Doctors’ Daily Progress Notes to Hospitalized Patients and Families to Improve Patient Experience” in the American Journal of Medical Quality. “It seemed logical to me that giving patients access to the same information that all the other members of the healthcare team were reading would improve communication. This is the overall hypothesis of the Open Notes movement.”

Another reason Dr. Weinert pursued the study: In his clinical job as an intensivist, he encounters frequent disagreements with patients’ families regarding prognosis and goals of care.

“No one has figured out how to increase the alignment of prognosis between the family and the medical team,” Dr. Weinert says. “I think having the families read the doctors’ notes, where the issues with poor-prognosis multi-organ failure are repeatedly spelled out, might help families more quickly grasp the futility of continuing care.”

During the study, hospitalized patients or family members on six wards of a university hospital received a printed copy of their medical team’s daily progress notes. Surveys afterward showed 74% to 86% of patients and family members responded favorably. Physicians were mostly satisfied, too.

“Most doctors, at the end of the study, thought that Open Notes went better than they had predicted,” Dr. Weinert says.

Complete transparency of medical records is the future of medicine, he says. It’s what patients want, “especially the younger generation.”

“Over the next 10 years,” he says, “I predict ... all [electronic medical record] vendors will have electronic portals that allow clinic and hospitalized patients access to almost everything in the EMR.”

Reference

1. Weinert C. Giving doctors’ daily progress notes to hospitalized patients and families to improve patient experience. Am J Med Qual. 2015. doi:10.1177/1062860615610424.

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."

(Reuters Health) - Elderly patients hospitalized for cancer surgery are more likely to have complications afterward compared to the middle-aged, particularly when they have several other health problems, a U.S. study suggests.

Overall, almost one in 10 adults age 55 and older had at least one post-operative issue like delirium, dehydration, falls, fractures, pressure ulcers or unusual weight loss, the study of nearly 1 million cancer surgery patients found.

These setbacks were even more common when patients were at least 65 years old, had two or more other serious health problems in addition to malignancies, or had surgeries for tumors of the digestive system or nearby organs.

But the odds were worst for people over 75 - about 46 percent of them had at least one complication, compared with 22 percent of adults aged 55 to 64.

"With the population aging, it's becoming increasingly important to consider not only the survival benefits of cancer surgery but the impact on functionality, vitality and quality of life," said lead study author Dr. Hung-Jui Tan, a researcher in urologic oncology at the University of California, Los Angeles.

While the events studied here are specific to the initial hospitalization, they can carry potential long-term ramifications," Tan added by email.

To see how age influences the risk of post-operative complications, Tan and colleagues reviewed hospital admission records for a nationwide sample of 940,000 adults age 55 and older who had cancer surgery from 2009 to 2011.

Compared with patients who were under age 65, those who were 65 to 74 years old were 23 percent more likely to have complications, while the over-75 group had 66 percent higher odds, researchers report in the Journal of Clinical Oncology.

Complications were most likely when patients were having surgery for cancers of the bladder, ovary, colon, rectum, pancreas or stomach.

After suffering post-operative setbacks, patients were also more likely to have further complications during their hospital stay, to remain in the hospital longer and to have more costly care. They were also more likely to die in the hospital and less likely to be discharged to home.

One limitation of the study is its reliance on administrative claims data, which is designed for billing purposes and might not always reflect the nuances of patients' medical conditions, the authors note. In addition, it's possible that some complications may have resulted from conditions patients had before they arrived at the hospital for cancer surgery.

The study can't prove that advanced age directly causes post-operative problems. But the findings suggest doctors and patients should consider these potential risks when deciding the best course of treatment, Tan said.

Patients should also understand that not all complications are equally devastating to quality of life. Dehydration and weight loss, for example, are nutritional problems that might be treated with fluids, noted Dr. Siri Rostoft, a geriatric medicine researcher at Oslo University Hospital in Norway.

"Cancer is often a lethal disease if left untreated that causes conditions such as bleeding, obstruction of the intestines, and pain," Rostoft, who wasn't involved in the study, said by email. "Not treating patients may be worse for their quality of life than operating."

Still, the findings add to a growing body of data on post-operative complications that may help doctors and patients decide if the potential benefits of surgery outweigh the possible risks, Dr. Steven Cunningham, a researcher at Saint Agnes Hospital and Cancer Institute in Baltimore who wasn't involved in the study, said by email.

Complications in the study were more likely at non-teaching hospitals and facilities that did fewer cancer surgeries, a factor that patients should also consider when they have a choice about where to go for surgery, noted Dr. Kwok-Leung Cheung, a researcher at the University of Nottingham in the U.K. and member of the surgical task force for the International Society of Geriatric Oncology.

Knowing when not to operate also matters, Cheung, who wasn't involved in the study, added by email.

"The surgeon should seriously consider the intensity of surgery, which has been identified as one of the important factors with post operative problems," Cheung added. "The use of minimally invasive techniques including laparoscopic and robotic surgery should be considered wherever appropriate."