AT THE STS ANNUAL MEETING

HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.

The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).

“Surgeons in the STS database do an excellent job taking care of these patients,” Dr. Onaitis, a thoracic surgeon at the University of California, San Diego, said in an interview. “The current survival model will allow surgeons to better estimate long-term survival of each individual patient. In addition, future analyses will identify subgroups of patients that may benefit from specific surgical approaches and procedures.”

For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.

Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).

Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).

After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).

“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”

Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m² (HR, 1.58).

Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.

[email protected]

 

AT THE STS ANNUAL MEETING

HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.

The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).

“Surgeons in the STS database do an excellent job taking care of these patients,” Dr. Onaitis, a thoracic surgeon at the University of California, San Diego, said in an interview. “The current survival model will allow surgeons to better estimate long-term survival of each individual patient. In addition, future analyses will identify subgroups of patients that may benefit from specific surgical approaches and procedures.”

For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.

Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).

Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).

After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).

“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”

Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m² (HR, 1.58).

Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.

[email protected]

 

AT THE STS ANNUAL MEETING

HOUSTON – Although certain medical factors predict long-term survival in patients over age 65 years with lung cancer, advanced age and disease stage are especially strong predictors, results from a large analysis of national data demonstrated.

The findings, which were presented by Mark Onaitis, MD, at the annual meeting of the Society of Thoracic Surgeons, come from a novel effort to pair Medicare data with files from the STS General Thoracic Surgery Database (GTSD).

“Surgeons in the STS database do an excellent job taking care of these patients,” Dr. Onaitis, a thoracic surgeon at the University of California, San Diego, said in an interview. “The current survival model will allow surgeons to better estimate long-term survival of each individual patient. In addition, future analyses will identify subgroups of patients that may benefit from specific surgical approaches and procedures.”

For the current study, he and his associates linked GTSD data to Medicare data on 29,899 patients who underwent lung cancer resection from 2002 to 2013. They used Cox proportional hazards modeling to create a long-term survival model and used statistically significant univariate factors and known clinical predictors of outcome to perform variable selection.

Dr. Onaitis reported that the median age of patients was 73 years and that 52% were female. Of the 29,899 patients, 805 had a missing pathologic stage. Of the 29,094 patients not missing a pathologic stage, 69% were stage I, 18% stage II, 11% stage III, and 2% stage IV. Two-thirds of patients (66%) underwent lobectomy, followed by wedge resection (17%), segmentectomy (7%), bilobectomy (3%), pneumonectomy (3%), and sleeve lobectomy (1%). A thoracoscopic approach was performed in nearly half of resections (47%).

Cox analysis revealed the following strong negative predictors of long-term survival: having stage III or IV-V disease (hazard ratio, 1.23 and 1.37, respectively), being age 70-74 (HR, 1.19), 75-80 (HR, 1.40), or 80 and older (HR, 1.90).

After controlling for disease stage, the following procedures were associated with increased hazard of death, compared with lobectomy: wedge resection (HR, 1.22), segmentectomy (HR, 1.10), bilobectomy (HR, 1.30), and pneumonectomy (HR, 1.58). In addition, video-assisted thoracoscopic surgery was associated with improved long-term survival, compared with thoracotomy (HR, 0.86).

“Given the large number of patients and the excellent quality of the data, it was not surprising that age and stage and known medical conditions affect long-term survival,” Dr. Onaitis commented. “The deleterious effects of sublobar operations and open [as opposed to thoracoscopic or VATS] approach were more pronounced than expected.”

Other modifiable predictive factors include being a past or current smoker (HR, 1.35 and HR, 1.54, respectively) and having a body mass index below 18.5 kg/m² (HR, 1.58).

Dr. Onaitis acknowledged certain limitations of the study, including its retrospective design. “Because the study involves linkage of STS data to Medicare data, the findings may not be applicable to patients less than 65 years of age,” he added. He reported having no financial disclosures.

[email protected]

 

HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.

While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.

“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”

In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.

James M. Meza, MD, the John W. Kirklin/David Ashburn Fellow at the Congenital Heart Surgeons’ Society Data Center at The Hospital for Sick Children, Toronto, collected the data and presented the study findings at the meeting. The investigators used multiphase parametric hazard analysis to determine overall survival after Norwood and after S2P. Next, the researchers identified risk factors for death after Norwood and after S2P and used both risk-adjusted models to determine cumulative survival at 4 years post-Norwood for all patients, through Norwood and S2P. The optimal timing of S2P was determined by plotting nomograms of 4-year, risk-adjusted, post-Norwood survival vs. age at S2P.

S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.

Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).

Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).

The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.

“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”

Dr. Jaquiss and Dr. Meza reported having no financial disclosures.

[email protected]

 

HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.

While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.

“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”

In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.

James M. Meza, MD, the John W. Kirklin/David Ashburn Fellow at the Congenital Heart Surgeons’ Society Data Center at The Hospital for Sick Children, Toronto, collected the data and presented the study findings at the meeting. The investigators used multiphase parametric hazard analysis to determine overall survival after Norwood and after S2P. Next, the researchers identified risk factors for death after Norwood and after S2P and used both risk-adjusted models to determine cumulative survival at 4 years post-Norwood for all patients, through Norwood and S2P. The optimal timing of S2P was determined by plotting nomograms of 4-year, risk-adjusted, post-Norwood survival vs. age at S2P.

S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.

Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).

Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).

The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.

“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”

Dr. Jaquiss and Dr. Meza reported having no financial disclosures.

[email protected]

 

HOUSTON – The optimal timing of stage 2 palliation after the Norwood operation depends on certain patient-specific risk factors, but in most cases should be done around 3-4 months of age, results from a multi-center study show.

While previous studies have investigated whether early stage-2 palliation (S2P) can be performed without increased post-S2P mortality, the effect of the timing of S2P on post-Norwood mortality remains unknown, Robert “Jake” Jaquiss, MD, said in an interview in advance of the annual meeting of the Society of Thoracic Surgeons.

“There has been a lot of dispute about how early is too early for S2P,” said Dr. Jaquiss, the study’s senior author, who is professor and division chief of pediatric cardiothoracic surgery at the University of Texas Southwestern Medical Center. “That is one of the few things that is in the control of the doctor. Most of the rest of the decisions are based entirely on the condition of the patient and the patient’s specific anatomy. So the timing of S2P is something that we can truly define most always. What we want to find out is, what is the ideal timing? How early is too early? Is there such a thing as too late?”

In an effort to determine the optimal timing of S2P that both minimizes pre-S2P attrition and maximizes long-term post-S2P survival, Dr. Jaquiss and his associates at 19 other institutions evaluated data from 534 neonates diagnosed with left ventricular outflow tract obstruction that precluded adequate systemic cardiac output through the aortic valve who initially underwent a Norwood operation from 2005 to 2016.

James M. Meza, MD, the John W. Kirklin/David Ashburn Fellow at the Congenital Heart Surgeons’ Society Data Center at The Hospital for Sick Children, Toronto, collected the data and presented the study findings at the meeting. The investigators used multiphase parametric hazard analysis to determine overall survival after Norwood and after S2P. Next, the researchers identified risk factors for death after Norwood and after S2P and used both risk-adjusted models to determine cumulative survival at 4 years post-Norwood for all patients, through Norwood and S2P. The optimal timing of S2P was determined by plotting nomograms of 4-year, risk-adjusted, post-Norwood survival vs. age at S2P.

S2P was performed in 377 patients (71%) at a mean age of 5.4 months, while 115 (22%) died after Norwood, and the rest underwent biventricular repair or heart transplantation. After S2P, 38 (10%) died, 248 (66%) underwent Fontan, and the rest were alive awaiting Fontan or underwent heart transplantation.

Risk factors for death after Norwood included requiring pre-Norwood extracorporeal membrane oxygenation (P less than .0001), birth weight of less than 2.5 kg (P less than .0001), modified Blalock-Taussig shunt vs. a right ventricle to pulmonary artery conduit (P = .0003), larger baseline right pulmonary artery diameter (P = .0002), smaller baseline mitral valve diameter (P = .0002), smaller baseline tricuspid valve diameter (P = .0001), and nonwhite race (P = .03).

Risk factors for death after S2P included lower oxygen saturation at pre-S2P clinic visit (P = .02), having moderate or severe pre-S2P right ventricular dysfunction (P = .007), younger age at S2P (P = .03), and longer post-Norwood hospital length of stay (P = .03).

The risk-adjusted, 4-year, post-Norwood survival was 72%, with a confidence interval of 67%-75%. When plotted vs. the age at S2P, risk-adjusted, 4-year, post-Norwood survival for the 534 patients was maximized by S2P at 3-6 months of age. At the same time, risk-adjusted, 4-year survival in low-risk infants was compromised only by undergoing S2P earlier than 3 months of age. In high-risk infants, survival was severely compromised, especially when undergoing S2P earlier than 6 months of age.

“The results reinforced intuitions or expectations that most of the investigators already had,” Dr. Jaquiss said. “But we are in an era where evidence-based medicine is much preferable to intuition-based medicine. I’m very confident in the findings we have. I feel more confident in suggesting that we should be planning these surgeries around 3-4 months of age in usual-risk children and also more confident in suggesting that we need to consider transplantation earlier in children who are perceived to be at high risk. There is some hope [by clinicians in] some centers that you can convert a high-risk prognosis to a lower or intermediate risk prognosis by doing the S2P earlier or at some alternative time. Our data suggests that would not be helpful.”

Dr. Jaquiss and Dr. Meza reported having no financial disclosures.

[email protected]

 

SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Bruce Jancin/Frontline Medical News

But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

[email protected]

 

SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Bruce Jancin/Frontline Medical News

But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

[email protected]

 

SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.

Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.

Bruce Jancin/Frontline Medical News

But while the outcomes of myectomy are significantly better than for septal ablation when the two procedures are done in high-volume centers, the national study showed that 80% of myectomies performed in the United States during 2003-2011 actually took place at centers doing fewer than 20 cases in total over that 9-year period. And in-hospital mortality and other key outcomes in those low-volume centers were far, far worse than when the surgery was done at one of the nation’s roughly two dozen hypertrophic cardiomyopathy centers of excellence recognized by the Hypertrophic Cardiomyopathy Association.

Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).

“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.

Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.

At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.

“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”

In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.

“One in four treated patients will not benefit,” the cardiologist emphasized.

The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.

When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.

Dr. Nishimura reported having no financial conflicts.

 

[email protected]

 

HOLLYWOOD, FLA. – Imaging obtained at nontertiary trauma centers probably doesn’t tell the whole story of a trauma patent’s injuries, according to a new retrospective study.

Repeat scans done at a Level 1 trauma center identified new injuries in 76% of patients who were transferred, Morgan Bonds, MD, reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma. About half of these previously unobserved injuries were considered clinically significant, said Dr. Bonds, a surgical resident at the University of Oklahoma, Oklahoma City.

Her study examined imaging and clinical assessment of 203 trauma patients who were initially worked up at a nontertiary trauma center (NTC), and then transferred to the Level 1 University of Oklahoma tertiary trauma Center (TTC). The facility’s primary radiologist reviewed all of the initial CT scans while blinded to the NTC interpretation. The initial scans and interpretations were then compared with those done at the TTC.

The team split imaging and interpretation disconnects into four categories:

• Type A errors: A missed injury on the NTC scan. “This represents the expertise and experience of our primary radiologist,” Dr. Bonds said.

• Type B errors: Missed injuries on scans where NTC radiologists saw other injuries that the TTC radiologist did not confirm. “This represents the experience of our radiologist and also the inexperience and overreaction of the NTC radiologists.

• Type C errors: New injuries seen on additional TTC imaging of the same body area. “This represents the quality of the image.”

• Type D errors: New injuries found upon any new imaging, whether of a previously scanned or newly scanned body area. “This represents quality of work-up – the decision of the trauma team to more fully investigate the patient’s injuries, as well as the quality of the CT tech performing the scan.”

During the study period, 203 patients presented at the TTC with prior scans conducted at an NTC.

The mean age of the patients was 43 years; most (67%) were men. The mean Injury Severity Score was 16; 97% had experienced blunt trauma. Shock was present in 3% and a traumatic brain injury in 8%. Repeat scans were most common for neck and cervical spine injuries (54%) and thoracic/lumbar spine injuries (53%) and least common for chest injuries (32%).

An inadequate NTC work-up as judged by the TTC attending was the most common reason for getting new images (76%). Poor image quality was the next most common reason (31%).

Among the 203 patients, 99 (49%) had a type A error. Of these injuries missed on the initial scan, 90% were considered to be clinically significant.

Type B errors occurred in 15% of patients.

Type C errors (new injuries in different body area) occurred in 54% of patients and, of these, 76% were considered clinically significant. Type D errors (new injuries seen in any imaging of any area) occurred in 73% of patients.

“This study confirms that images are often repeated or completed after having images done at nontertiary trauma centers,” Dr. Bonds said. “Relying on NTC image interpretation can lead to undertreating our patients. One potential solution to this issue could be image sharing between NTCs and TTCs. This might reduce both the rate of missed injuries and the need for repeat scans.”

Dr. Bonds had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

 

HOLLYWOOD, FLA. – Imaging obtained at nontertiary trauma centers probably doesn’t tell the whole story of a trauma patent’s injuries, according to a new retrospective study.

Repeat scans done at a Level 1 trauma center identified new injuries in 76% of patients who were transferred, Morgan Bonds, MD, reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma. About half of these previously unobserved injuries were considered clinically significant, said Dr. Bonds, a surgical resident at the University of Oklahoma, Oklahoma City.

Her study examined imaging and clinical assessment of 203 trauma patients who were initially worked up at a nontertiary trauma center (NTC), and then transferred to the Level 1 University of Oklahoma tertiary trauma Center (TTC). The facility’s primary radiologist reviewed all of the initial CT scans while blinded to the NTC interpretation. The initial scans and interpretations were then compared with those done at the TTC.

The team split imaging and interpretation disconnects into four categories:

• Type A errors: A missed injury on the NTC scan. “This represents the expertise and experience of our primary radiologist,” Dr. Bonds said.

• Type B errors: Missed injuries on scans where NTC radiologists saw other injuries that the TTC radiologist did not confirm. “This represents the experience of our radiologist and also the inexperience and overreaction of the NTC radiologists.

• Type C errors: New injuries seen on additional TTC imaging of the same body area. “This represents the quality of the image.”

• Type D errors: New injuries found upon any new imaging, whether of a previously scanned or newly scanned body area. “This represents quality of work-up – the decision of the trauma team to more fully investigate the patient’s injuries, as well as the quality of the CT tech performing the scan.”

During the study period, 203 patients presented at the TTC with prior scans conducted at an NTC.

The mean age of the patients was 43 years; most (67%) were men. The mean Injury Severity Score was 16; 97% had experienced blunt trauma. Shock was present in 3% and a traumatic brain injury in 8%. Repeat scans were most common for neck and cervical spine injuries (54%) and thoracic/lumbar spine injuries (53%) and least common for chest injuries (32%).

An inadequate NTC work-up as judged by the TTC attending was the most common reason for getting new images (76%). Poor image quality was the next most common reason (31%).

Among the 203 patients, 99 (49%) had a type A error. Of these injuries missed on the initial scan, 90% were considered to be clinically significant.

Type B errors occurred in 15% of patients.

Type C errors (new injuries in different body area) occurred in 54% of patients and, of these, 76% were considered clinically significant. Type D errors (new injuries seen in any imaging of any area) occurred in 73% of patients.

“This study confirms that images are often repeated or completed after having images done at nontertiary trauma centers,” Dr. Bonds said. “Relying on NTC image interpretation can lead to undertreating our patients. One potential solution to this issue could be image sharing between NTCs and TTCs. This might reduce both the rate of missed injuries and the need for repeat scans.”

Dr. Bonds had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

 

HOLLYWOOD, FLA. – Imaging obtained at nontertiary trauma centers probably doesn’t tell the whole story of a trauma patent’s injuries, according to a new retrospective study.

Repeat scans done at a Level 1 trauma center identified new injuries in 76% of patients who were transferred, Morgan Bonds, MD, reported at the annual scientific assembly of the Eastern Association for the Surgery of Trauma. About half of these previously unobserved injuries were considered clinically significant, said Dr. Bonds, a surgical resident at the University of Oklahoma, Oklahoma City.

Her study examined imaging and clinical assessment of 203 trauma patients who were initially worked up at a nontertiary trauma center (NTC), and then transferred to the Level 1 University of Oklahoma tertiary trauma Center (TTC). The facility’s primary radiologist reviewed all of the initial CT scans while blinded to the NTC interpretation. The initial scans and interpretations were then compared with those done at the TTC.

The team split imaging and interpretation disconnects into four categories:

• Type A errors: A missed injury on the NTC scan. “This represents the expertise and experience of our primary radiologist,” Dr. Bonds said.

• Type B errors: Missed injuries on scans where NTC radiologists saw other injuries that the TTC radiologist did not confirm. “This represents the experience of our radiologist and also the inexperience and overreaction of the NTC radiologists.

• Type C errors: New injuries seen on additional TTC imaging of the same body area. “This represents the quality of the image.”

• Type D errors: New injuries found upon any new imaging, whether of a previously scanned or newly scanned body area. “This represents quality of work-up – the decision of the trauma team to more fully investigate the patient’s injuries, as well as the quality of the CT tech performing the scan.”

During the study period, 203 patients presented at the TTC with prior scans conducted at an NTC.

The mean age of the patients was 43 years; most (67%) were men. The mean Injury Severity Score was 16; 97% had experienced blunt trauma. Shock was present in 3% and a traumatic brain injury in 8%. Repeat scans were most common for neck and cervical spine injuries (54%) and thoracic/lumbar spine injuries (53%) and least common for chest injuries (32%).

An inadequate NTC work-up as judged by the TTC attending was the most common reason for getting new images (76%). Poor image quality was the next most common reason (31%).

Among the 203 patients, 99 (49%) had a type A error. Of these injuries missed on the initial scan, 90% were considered to be clinically significant.

Type B errors occurred in 15% of patients.

Type C errors (new injuries in different body area) occurred in 54% of patients and, of these, 76% were considered clinically significant. Type D errors (new injuries seen in any imaging of any area) occurred in 73% of patients.

“This study confirms that images are often repeated or completed after having images done at nontertiary trauma centers,” Dr. Bonds said. “Relying on NTC image interpretation can lead to undertreating our patients. One potential solution to this issue could be image sharing between NTCs and TTCs. This might reduce both the rate of missed injuries and the need for repeat scans.”

Dr. Bonds had no financial disclosures.

[email protected]

On Twitter @Alz_Gal

Targeting RUNX1 could combat glucocorticoid resistance in patients with lymphoma, according to research published in the Journal of Cellular Biochemistry.

Researchers found an over activity of RUNX1 in lymphoma cells interfered with sphingolipids and caused cells to become resistant to dexamethasone.

Dexamethasone works, in part, through the control of sphingolipid enzymes, which play a role in instructing cells to live or die.

Specifically, the researchers said they found that ectopic expression of RUNX1 in lymphoma cells consistently perturbs the sphingolipid rheostat and confers increased resistance to glucocorticoid-mediated apoptosis.

The team also described the mechanism of cross-talk between glucocorticoid and sphingolipid metabolism through the enzyme Sgpp1.

The researchers said dexamethasone induces expression of Sgpp1 in T-lymphoma cells and drives cell death, which is reduced by partial knockdown of Sgpp1 with short hairpin RNA or direct transcriptional repression of Sgpp1 by ectopic RUNX1.

These findings suggest that drugs targeting RUNX1 may be able to reverse glucocorticoid resistance in lymphoma patients.

“The possibility of making existing therapies more active and specific by combining [them] with drugs that inhibit RUNX is a new and exciting prospect,” said study author James Neil, of The University of Glasgow in Scotland.

“Our collaborators in the US have recently developed drugs that inhibit RUNX, and we plan to test these with existing therapies in blood cancers where MYC and RUNX are both implicated, including multiple myeloma and Burkitt lymphoma.”

An earlier study by Dr Neil and his colleagues suggested that RUNX1 was a potential therapeutic target in MYC-driven lymphomas.

Targeting RUNX1 could combat glucocorticoid resistance in patients with lymphoma, according to research published in the Journal of Cellular Biochemistry.

Researchers found an over activity of RUNX1 in lymphoma cells interfered with sphingolipids and caused cells to become resistant to dexamethasone.

Dexamethasone works, in part, through the control of sphingolipid enzymes, which play a role in instructing cells to live or die.

Specifically, the researchers said they found that ectopic expression of RUNX1 in lymphoma cells consistently perturbs the sphingolipid rheostat and confers increased resistance to glucocorticoid-mediated apoptosis.

The team also described the mechanism of cross-talk between glucocorticoid and sphingolipid metabolism through the enzyme Sgpp1.

The researchers said dexamethasone induces expression of Sgpp1 in T-lymphoma cells and drives cell death, which is reduced by partial knockdown of Sgpp1 with short hairpin RNA or direct transcriptional repression of Sgpp1 by ectopic RUNX1.

These findings suggest that drugs targeting RUNX1 may be able to reverse glucocorticoid resistance in lymphoma patients.

“The possibility of making existing therapies more active and specific by combining [them] with drugs that inhibit RUNX is a new and exciting prospect,” said study author James Neil, of The University of Glasgow in Scotland.

“Our collaborators in the US have recently developed drugs that inhibit RUNX, and we plan to test these with existing therapies in blood cancers where MYC and RUNX are both implicated, including multiple myeloma and Burkitt lymphoma.”

An earlier study by Dr Neil and his colleagues suggested that RUNX1 was a potential therapeutic target in MYC-driven lymphomas.

Targeting RUNX1 could combat glucocorticoid resistance in patients with lymphoma, according to research published in the Journal of Cellular Biochemistry.

Researchers found an over activity of RUNX1 in lymphoma cells interfered with sphingolipids and caused cells to become resistant to dexamethasone.

Dexamethasone works, in part, through the control of sphingolipid enzymes, which play a role in instructing cells to live or die.

Specifically, the researchers said they found that ectopic expression of RUNX1 in lymphoma cells consistently perturbs the sphingolipid rheostat and confers increased resistance to glucocorticoid-mediated apoptosis.

The team also described the mechanism of cross-talk between glucocorticoid and sphingolipid metabolism through the enzyme Sgpp1.

The researchers said dexamethasone induces expression of Sgpp1 in T-lymphoma cells and drives cell death, which is reduced by partial knockdown of Sgpp1 with short hairpin RNA or direct transcriptional repression of Sgpp1 by ectopic RUNX1.

These findings suggest that drugs targeting RUNX1 may be able to reverse glucocorticoid resistance in lymphoma patients.

“The possibility of making existing therapies more active and specific by combining [them] with drugs that inhibit RUNX is a new and exciting prospect,” said study author James Neil, of The University of Glasgow in Scotland.

“Our collaborators in the US have recently developed drugs that inhibit RUNX, and we plan to test these with existing therapies in blood cancers where MYC and RUNX are both implicated, including multiple myeloma and Burkitt lymphoma.”

An earlier study by Dr Neil and his colleagues suggested that RUNX1 was a potential therapeutic target in MYC-driven lymphomas.

Researchers say they have engineered “superhemophobic” titanium surfaces that could be used to create implantable medical devices that don’t pose a risk of thrombosis.

The team described this work in Advanced Healthcare Materials.

The undesirable interaction of blood with foreign materials is an ongoing problem in medical research, said study author Ketul Popat, PhD, of Colorado State University in Fort Collins, Colorado.

He and his colleagues noted that, when implanted medical devices come in contact with blood, platelet adhesion and activation occur, which may lead to thrombosis and device failure.

“If we can design materials where blood barely contacts the surface, there is virtually no chance of clotting, which is a coordinated set of events,” Dr Popat said. “Here, we’re targeting the prevention of the first set of events.”

Dr Popat and his colleagues started with sheets of titanium, which are commonly used in medical devices. The team then grew chemically altered surfaces that act as barriers between the titanium and blood.

They analyzed variations of titanium surfaces, including different textures and chemistries, and compared the extent of platelet adhesion and activation.

These experiments revealed that fluorinated nanotubes offered the best protection against clotting.

Having implantable medical devices that repel blood might seem counterintuitive, the researchers noted, as biomedical scientists often use materials with an affinity to blood to make them biologically compatible.

“What we are doing is the exact opposite,” said study author Arun Kota, PhD, of Colorado State University.

“We are taking a material that blood hates to come in contact with, in order to make it compatible with blood.”

In essence, the titanium surface is so repellent that blood is “tricked” into “believing” there’s virtually no foreign material there at all.

Growing a surface and testing it in the lab is only the beginning, the researchers said. They want to continue examining other clotting factors, and eventually, to test real medical devices.

Researchers say they have engineered “superhemophobic” titanium surfaces that could be used to create implantable medical devices that don’t pose a risk of thrombosis.

The team described this work in Advanced Healthcare Materials.

The undesirable interaction of blood with foreign materials is an ongoing problem in medical research, said study author Ketul Popat, PhD, of Colorado State University in Fort Collins, Colorado.

He and his colleagues noted that, when implanted medical devices come in contact with blood, platelet adhesion and activation occur, which may lead to thrombosis and device failure.

“If we can design materials where blood barely contacts the surface, there is virtually no chance of clotting, which is a coordinated set of events,” Dr Popat said. “Here, we’re targeting the prevention of the first set of events.”

Dr Popat and his colleagues started with sheets of titanium, which are commonly used in medical devices. The team then grew chemically altered surfaces that act as barriers between the titanium and blood.

They analyzed variations of titanium surfaces, including different textures and chemistries, and compared the extent of platelet adhesion and activation.

These experiments revealed that fluorinated nanotubes offered the best protection against clotting.

Having implantable medical devices that repel blood might seem counterintuitive, the researchers noted, as biomedical scientists often use materials with an affinity to blood to make them biologically compatible.

“What we are doing is the exact opposite,” said study author Arun Kota, PhD, of Colorado State University.

“We are taking a material that blood hates to come in contact with, in order to make it compatible with blood.”

In essence, the titanium surface is so repellent that blood is “tricked” into “believing” there’s virtually no foreign material there at all.

Growing a surface and testing it in the lab is only the beginning, the researchers said. They want to continue examining other clotting factors, and eventually, to test real medical devices.

Researchers say they have engineered “superhemophobic” titanium surfaces that could be used to create implantable medical devices that don’t pose a risk of thrombosis.

The team described this work in Advanced Healthcare Materials.

The undesirable interaction of blood with foreign materials is an ongoing problem in medical research, said study author Ketul Popat, PhD, of Colorado State University in Fort Collins, Colorado.

He and his colleagues noted that, when implanted medical devices come in contact with blood, platelet adhesion and activation occur, which may lead to thrombosis and device failure.

“If we can design materials where blood barely contacts the surface, there is virtually no chance of clotting, which is a coordinated set of events,” Dr Popat said. “Here, we’re targeting the prevention of the first set of events.”

Dr Popat and his colleagues started with sheets of titanium, which are commonly used in medical devices. The team then grew chemically altered surfaces that act as barriers between the titanium and blood.

They analyzed variations of titanium surfaces, including different textures and chemistries, and compared the extent of platelet adhesion and activation.

These experiments revealed that fluorinated nanotubes offered the best protection against clotting.

Having implantable medical devices that repel blood might seem counterintuitive, the researchers noted, as biomedical scientists often use materials with an affinity to blood to make them biologically compatible.

“What we are doing is the exact opposite,” said study author Arun Kota, PhD, of Colorado State University.

“We are taking a material that blood hates to come in contact with, in order to make it compatible with blood.”

In essence, the titanium surface is so repellent that blood is “tricked” into “believing” there’s virtually no foreign material there at all.

Growing a surface and testing it in the lab is only the beginning, the researchers said. They want to continue examining other clotting factors, and eventually, to test real medical devices.

According to the National Academy of Medicine (NAM), health literacy is “the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions.”¹ Studies suggest that millions of patients have inadequate health literacy and cannot make fully informed decisions because of this lack of knowledge.^2-4 A 2007 National Patient Safety Foundation report calculated that inadequate health literacy burdens the U.S. health care system with an additional $106 to $238 billion annually.⁵

In 2014, the American Diabetes Association reported that diabetes affects 29.1 million Americans (9.3%) and that by 2050 1 in 3 Americans will have diabetes.⁶ People with diabetes have health care costs 2.3 times higher than the cost for nondiabetic patients. The cost of taking care of patients with diabetes annually is about $245 billion.⁶ Without interventions that address health literacy and effective self-management to reduce the risks of complications and comorbidity, health care costs related to diabetes will continue to increase.

Literature Review

According to a U.S. Department of Education assessment on adult health literacy in 2003, 88% of adults in the U.S. have inadequate health literacy.² About 90 million Americans lack health literacy skills, according to a 2004 NAM report.³ Heinrich, who conducted a review of U.S. studies on health literacy, concluded that about 25% of Americans have low health literacy.⁴

The Newest Vital Sign Tool

The Newest Vital Sign (NVS) tool is a free tool developed by Pfizer (New York, NY) for assessing health literacy. Participants are asked 6 questions about nutrition based on an ice cream nutrition label (Figure). The researcher records the participant’s responses, which accommodates participants who may have difficulty reading. The tool is scored from 0 to 6. A score of below 4 indicates the possibility of limited health literacy.⁷ This test can be completed in about 3 minutes, is widely accepted, and provides results comparable to more extensive literacy tests.⁸ A study conducted by Welch and colleagues suggested the NVS tool is both cost and time efficient.⁹ Ryan and colleagues found that 98% of patients in their study (n = 289) did not have objections to taking the NVS assessment.¹⁰

Escobedo and Weismuller’s study used the NVS health literacy tool to assess the health literacy of renal patients.³ In 2004, about 50,000 American patients with diabetes began treatment for kidney failure due to diabetes complications.⁶ Escobedo and Weismuller found that patients with diabetes with limited health literacy knowledge are more likely to be hospitalized, thus increasing health care costs.³ In addition, they discovered that these patients demonstrated poor adherence to prescribed treatment protocols. Welch, VanGeest, and Caskey conducted a case study on time, cost, and clinical utilization of the NVS health literacy tool and found that a patient’s lack of health literacy was linked to limited participation in personal medical decisions.^7,9 Patient’s lack of knowledge was associated with delays in seeking treatment, poor self-management of the disease, and more hospital admissions.

Health Literacy and Diabetes

Studies specific to diabetes and inadequate health literacy support the premise that better health literacy leads to improved patient outcomes. Using the NVS tool, Heinrich conducted a study of the health literacy of 54 patients with diabetes in a primary care setting. The study showed that 65% had inadequate health literacy and that patients with diabetes with inadequate health literacy were more likely to have poor glycemic control compared with patients with diabetes and adequate health literacy levels.⁴ McCleary-Jones examined diet, foot care, and exercise of 50 African American participants with diabetes from a community health center, finding a positive relationship between health literacy and diabetes knowledge.¹¹

Long and Gambling conducted a 2-year prospective, observational study that incorporated motivational interviewing and patient-centered care into a self-management program, examining the effectiveness of scheduled phone interventions to assist patients with diabetes in the management of their disease.¹² The interventions used structured and consistent questions supported by a protocol and script that examined medication adherence and lifestyle choices. Long and Gambling concluded that “the findings demonstrate not only changes in the depth and detail of diabetes-related knowledge and confidence, but also enhanced competence in translating knowledge into every day self-care.”¹² These researchers concluded that increased knowledge translated into better patient self-management of their disease. The Long and Gambling study included general self-management characteristics of monitoring HbA_1c, diet, exercise, medication management, and general self-care. These researchers contend that diabetes self-management education must be a long-term endeavor to promote change.¹²

Mendoza and Rosenburg’s meta-analysis on self-management programs for diabetes and chronic conditions found a statistically significant 0.81% reduction in hemoglobin A_1c (HbA_1c). Characteristics of self-management programs that were linked to improved outcomes included nurse and provider education on medications, diet and/or exercise, and demonstrated use of motivational interviewing and biofeedback. Mendoza and Rosenburg suggested motivational interviewing focuses on the patient’s perspective and facilitates the process that the patient uses to assess their needs and to think about possible solutions.¹³ Mulimba and Bryo-Daniel found that motivational interviewing is a valuable tool for primary care nurses’ health promotion practice, and Thompson and colleagues found that it was effective in changing behavior.^14,15

 

Nurse’s Role in Health Literacy

Nurses play a vital role in educating and securing adherence of patients in the management of their disease(s).¹³ In addition to educating patients, families, and friends of the family, nurses assist with helping them make informed decisions.¹⁶ The VHA uses the Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) to teach health care staff about diabetes self-management education (DSME). Tisdel and colleagues found that DSME established through telemedicine or clinical mentoring improved patient outcomes.¹⁷ Mendoza and Rosenburgfound nurse-led DSME was linked to minimizing cardiovascular risk factors and improvements in HbA_1c.¹³

Background

Staunton Community Based Outpatient Clinic (CBOC) in rural Virginia is a primary care clinic that serves veterans in the surrounding area. About one-fourth of the Staunton patients have diabetes. According to June 2014 data from the VHA Support Service Center, the physician at the Staunton CBOC was responsible for 946 patients (225 with diabetes) and the nurse practitioner was responsible for 707 (184 with diabetes). The VHA Support Service Center 2014 data indicated that veterans with poorly self-managed diabetes were at increased risk for poor outcomes, such as kidney failure, cardiovascular disease, and limb amputation. Veterans with diabetes use the emergency department more often and are admitted to the hospital more often than are veterans who do not have diabetes.¹⁸

Methods

The primary objective of this pilot study was to explore whether weekly structured nursing education sessions lasting 45 minutes and subsequent follow-up weekly conferences would improve their HbA_1c for veterans identified as having ≥ 9 HbA_1c and ≤ 3 health literacy score on the NVS 7 study assessment. Most recent HbA_1c prior to beginning the study was used to identify potential participants. After completion of 12 weekly education interventions, an additional HbA_1c was obtained.

The Salem VAMC and Eastern Mennonite University Institutional Review Board approved the study. Veterans’ questions were answered prior to signing consent forms. All data collected were kept confidential.

Veterans with ≥ 9 HbA_1c were evaluated for possible participation. Forty-nine veterans met the criteria to participate in this pilot study. Exclusion criteria included diagnosis of any cognitive disorder, such as dementia, Alzheimer disease, or memory impairment. In addition, veterans unwilling or unable to commit to weekly follow-up sessions were excluded. The veterans eligible for participation were contacted by telephone, and 9 agreed to participate in the pilot study. Inclusion criteria included those aged ≥ 18 years and a diagnosis of diabetes with most recent HbA_1c of ≥ 9 and a score of < 4 on the NVS health literacy assessment. After taking the NVS health literacy assessment, 6 of the 9 participants qualified to continue in the study.

Education interventions included assessing medication adherence, discussing diet, reviewing physical activity for the previous week (based on diet and activity logs), and reviewing home blood glucose monitoring. Weekly education sessions were either face-to-face or by telephone. This choice was given to accommodate veterans who may have had transportation issues. A total of 12 weekly appointments were scheduled for each participant, and education was directed at the specific needs and goals of each participant. Interventions for education were based on those found in previous studies.^13,14,18,19

Data Collection and Analysis

All 6 participants were white male veterans who were diagnosed with diabetes for at least 3 years. Their ages ranged from 59 to 72. Three participants were service connected for diabetes and 3 were not. One participant dropped from the study after completing 4 appointments, stating he was just too busy to be available for a weekly appointment. Another participant completed 6 appointments and removed himself from the study due to time constraints. The 4 participants who completed the pilot study were followed for 12 weeks by a registered nurse (RN), and all had reductions in their HbA_1c.

Participants were assessed at weekly appointments using a predetermined template for medication adherence, diet, activity, and blood glucose monitoring. Responses of the participants guided the education interventions to meet the individual veteran’s learning needs. For example, one veteran was given specific education on carbohydrate counting and another was educated on how to read food labels. Participants were also encouraged to express satisfaction, frustration, anger, or other emotions in managing their chronic illness. The premise for spending additional time with the veteran was to promote positive self-management behaviors as recommended by Radhakrishnan.¹⁹

Veterans who completed the study stated that the education interventions positively impacted their health status. One veteran was able to delay dialysis due to self-directed improvement in his lifestyle (exercising and watching his diet), which improved his HbA_1c. This veteran attributed his health improvement to the individualized education sessions with the RN and knowing he had to be accountable to someone. Additionally, it was found there was a strong familial-social component to diabetes self-management. Several veterans were knowledgeable about diabetes self-management as evidenced by their responses to weekly questions. However, disease management for these veterans was strongly impacted by family and life events.

One veteran did not manage his disease for an entire week due to “being busy with a death in the family and planning for a wedding.” This veteran took his medication but did not check his blood glucose or monitor his diet. Another veteran spoke of eating ice cream and other concentrated sweets because his young grandson was with him for the week. A third veteran was able to manage his diet better when his wife packed snacks for him but when left to his own accord did not do well with his food selection. Even though these veterans understood how to effectively manage their diabetes, they may have chosen to inconsistently translate that knowledge into practice if they perceive those familial-social forces to be more important or more powerful.

 

Discussion

The findings from this small pilot study from a single clinic cannot be generalized. However, this pilot study adds to the literature of the positive impact of individualized, structured, tailored nursing interventions delivered with careful consideration of the participants’ personal goals and health care needs for diabetes self-management.

Participants monitored home blood glucose levels, diet, and activity and maintained adherence with prescribed diabetes medications. The HbA_1c level for participants decreased by the end of the program. During the course of the pilot study a pharmacist managed the veterans’ medications. Participant 1 began a new medication regimen the first day of the study. Previously, the patient was self-regulating his medication. However, during the 12-week study, he had no medication adjustments. Participant 4 had several increases to his insulin dose (insulin aspart protamine and insulin aspart rdna origin) during the course of the study. Participants 5 and 6 had no medication adjustments during the study.

Even though participants had medication adjustments, which contributed to the HbA_1c decrease, they became more aware of the medical need to control their blood sugar through the one-on-one education provided. Although there was variation in the depth and detail that participants maintained their food/activity log and home blood glucose monitoring, all participants agreed that they were more likely to be adherent with prescribed self-monitoring “knowing they were going to have to report self-monitoring information” to the RN.

Health care professionals may not realize the impact of familial-social events on blood glucose control. Veterans in this study found that having weekly sessions with the RN helped them through such events, even though they did not adhere strictly to their regimen. One suggestion is having veterans anticipate future familial-social events that may trigger nonadherence to their diabetes health plan and then discuss those events with the health care professional.

Future Research

This small exploratory pilot study has implications for future research. Increasing the study’s sample size and using a control group is recommended to compare veterans who have an educational intervention with those that do not and the impact it has on blood glucose control. The study was limited to 1 CBOC. Incorporating additional CBOCs could increase the sample size. Additionally, although this study was only 3 months in duration, a longer study could reveal significant patterns of change over time as well as the long-term benefit of a tailored educational intervention. In addition, adjusting the study inclusion criteria of > 9 HbA_1c to include those with > 8 HbA_1c also may increase the sample size.

Limited financial resources for the study could have negatively impacted the sample size. Incorporating recruitment or advertising strategy may increase the number of participants. Research also is needed on education interventions with a diverse group of male and female veterans that extends beyond 3 months. Exploring the value of including the veteran’s family in the education sessions is needed. Finally, this study examined only diabetes education. Researchers need to consider other diseases and the value of individualized education.

Limitations


Limitations included a small sample size and no control group. Due to the study’s small sample size, extrapolating data from it becomes difficult. However, this pilot study sets the groundwork for other researchers to expand the importance of education interventions and health literacy. Recruitment was challenging since an eligibility criterion was the NVS score, and patients were sometimes difficult to contact.⁷ The pilot study started with 6 white male participants but only 4 finished. During the course of the pilot study, 1 veteran had medication adjustments as part of routine care and 1 veteran had medication adjustments prior to the study, which could have altered the HbA_1c results.

In hindsight, using the NVS to assess both prestudy with poststudy health literacy scores would have provided additional information about the education intervention. There is possible bias because the researcher was a VAMC employee, and the RN that implemented the interventions had previously worked with the patients.

 

Conclusion

Although this is a small descriptive pilot study, it adds to the body of research on the value of nurse-driven interventions to help veterans manage diabetes by enhancing their health literacy. It also raises questions and opportunities for further research into the power of familial-social influences on a veteran’s willingness to manage their diabetes. The majority of veterans who declined to participate in this study, even though they qualified, stated that they would “not follow any recommendations.” Further investigation is needed about why some veterans elect not to obtain help that could positively impact their health and possibly extend their life. Additionally, scientific quantitative and qualitative research is needed to evaluate the statistical significance between health care literacy and educational intervention on patient adherence among individuals diagnosed with diabetes.

According to the National Academy of Medicine (NAM), health literacy is “the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions.”¹ Studies suggest that millions of patients have inadequate health literacy and cannot make fully informed decisions because of this lack of knowledge.^2-4 A 2007 National Patient Safety Foundation report calculated that inadequate health literacy burdens the U.S. health care system with an additional $106 to $238 billion annually.⁵

In 2014, the American Diabetes Association reported that diabetes affects 29.1 million Americans (9.3%) and that by 2050 1 in 3 Americans will have diabetes.⁶ People with diabetes have health care costs 2.3 times higher than the cost for nondiabetic patients. The cost of taking care of patients with diabetes annually is about $245 billion.⁶ Without interventions that address health literacy and effective self-management to reduce the risks of complications and comorbidity, health care costs related to diabetes will continue to increase.

Literature Review

According to a U.S. Department of Education assessment on adult health literacy in 2003, 88% of adults in the U.S. have inadequate health literacy.² About 90 million Americans lack health literacy skills, according to a 2004 NAM report.³ Heinrich, who conducted a review of U.S. studies on health literacy, concluded that about 25% of Americans have low health literacy.⁴

The Newest Vital Sign Tool

The Newest Vital Sign (NVS) tool is a free tool developed by Pfizer (New York, NY) for assessing health literacy. Participants are asked 6 questions about nutrition based on an ice cream nutrition label (Figure). The researcher records the participant’s responses, which accommodates participants who may have difficulty reading. The tool is scored from 0 to 6. A score of below 4 indicates the possibility of limited health literacy.⁷ This test can be completed in about 3 minutes, is widely accepted, and provides results comparable to more extensive literacy tests.⁸ A study conducted by Welch and colleagues suggested the NVS tool is both cost and time efficient.⁹ Ryan and colleagues found that 98% of patients in their study (n = 289) did not have objections to taking the NVS assessment.¹⁰

Escobedo and Weismuller’s study used the NVS health literacy tool to assess the health literacy of renal patients.³ In 2004, about 50,000 American patients with diabetes began treatment for kidney failure due to diabetes complications.⁶ Escobedo and Weismuller found that patients with diabetes with limited health literacy knowledge are more likely to be hospitalized, thus increasing health care costs.³ In addition, they discovered that these patients demonstrated poor adherence to prescribed treatment protocols. Welch, VanGeest, and Caskey conducted a case study on time, cost, and clinical utilization of the NVS health literacy tool and found that a patient’s lack of health literacy was linked to limited participation in personal medical decisions.^7,9 Patient’s lack of knowledge was associated with delays in seeking treatment, poor self-management of the disease, and more hospital admissions.

Health Literacy and Diabetes

Studies specific to diabetes and inadequate health literacy support the premise that better health literacy leads to improved patient outcomes. Using the NVS tool, Heinrich conducted a study of the health literacy of 54 patients with diabetes in a primary care setting. The study showed that 65% had inadequate health literacy and that patients with diabetes with inadequate health literacy were more likely to have poor glycemic control compared with patients with diabetes and adequate health literacy levels.⁴ McCleary-Jones examined diet, foot care, and exercise of 50 African American participants with diabetes from a community health center, finding a positive relationship between health literacy and diabetes knowledge.¹¹

Long and Gambling conducted a 2-year prospective, observational study that incorporated motivational interviewing and patient-centered care into a self-management program, examining the effectiveness of scheduled phone interventions to assist patients with diabetes in the management of their disease.¹² The interventions used structured and consistent questions supported by a protocol and script that examined medication adherence and lifestyle choices. Long and Gambling concluded that “the findings demonstrate not only changes in the depth and detail of diabetes-related knowledge and confidence, but also enhanced competence in translating knowledge into every day self-care.”¹² These researchers concluded that increased knowledge translated into better patient self-management of their disease. The Long and Gambling study included general self-management characteristics of monitoring HbA_1c, diet, exercise, medication management, and general self-care. These researchers contend that diabetes self-management education must be a long-term endeavor to promote change.¹²

Mendoza and Rosenburg’s meta-analysis on self-management programs for diabetes and chronic conditions found a statistically significant 0.81% reduction in hemoglobin A_1c (HbA_1c). Characteristics of self-management programs that were linked to improved outcomes included nurse and provider education on medications, diet and/or exercise, and demonstrated use of motivational interviewing and biofeedback. Mendoza and Rosenburg suggested motivational interviewing focuses on the patient’s perspective and facilitates the process that the patient uses to assess their needs and to think about possible solutions.¹³ Mulimba and Bryo-Daniel found that motivational interviewing is a valuable tool for primary care nurses’ health promotion practice, and Thompson and colleagues found that it was effective in changing behavior.^14,15

 

Nurse’s Role in Health Literacy

Nurses play a vital role in educating and securing adherence of patients in the management of their disease(s).¹³ In addition to educating patients, families, and friends of the family, nurses assist with helping them make informed decisions.¹⁶ The VHA uses the Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) to teach health care staff about diabetes self-management education (DSME). Tisdel and colleagues found that DSME established through telemedicine or clinical mentoring improved patient outcomes.¹⁷ Mendoza and Rosenburgfound nurse-led DSME was linked to minimizing cardiovascular risk factors and improvements in HbA_1c.¹³

Background

Staunton Community Based Outpatient Clinic (CBOC) in rural Virginia is a primary care clinic that serves veterans in the surrounding area. About one-fourth of the Staunton patients have diabetes. According to June 2014 data from the VHA Support Service Center, the physician at the Staunton CBOC was responsible for 946 patients (225 with diabetes) and the nurse practitioner was responsible for 707 (184 with diabetes). The VHA Support Service Center 2014 data indicated that veterans with poorly self-managed diabetes were at increased risk for poor outcomes, such as kidney failure, cardiovascular disease, and limb amputation. Veterans with diabetes use the emergency department more often and are admitted to the hospital more often than are veterans who do not have diabetes.¹⁸

Methods

The primary objective of this pilot study was to explore whether weekly structured nursing education sessions lasting 45 minutes and subsequent follow-up weekly conferences would improve their HbA_1c for veterans identified as having ≥ 9 HbA_1c and ≤ 3 health literacy score on the NVS 7 study assessment. Most recent HbA_1c prior to beginning the study was used to identify potential participants. After completion of 12 weekly education interventions, an additional HbA_1c was obtained.

The Salem VAMC and Eastern Mennonite University Institutional Review Board approved the study. Veterans’ questions were answered prior to signing consent forms. All data collected were kept confidential.

Veterans with ≥ 9 HbA_1c were evaluated for possible participation. Forty-nine veterans met the criteria to participate in this pilot study. Exclusion criteria included diagnosis of any cognitive disorder, such as dementia, Alzheimer disease, or memory impairment. In addition, veterans unwilling or unable to commit to weekly follow-up sessions were excluded. The veterans eligible for participation were contacted by telephone, and 9 agreed to participate in the pilot study. Inclusion criteria included those aged ≥ 18 years and a diagnosis of diabetes with most recent HbA_1c of ≥ 9 and a score of < 4 on the NVS health literacy assessment. After taking the NVS health literacy assessment, 6 of the 9 participants qualified to continue in the study.

Education interventions included assessing medication adherence, discussing diet, reviewing physical activity for the previous week (based on diet and activity logs), and reviewing home blood glucose monitoring. Weekly education sessions were either face-to-face or by telephone. This choice was given to accommodate veterans who may have had transportation issues. A total of 12 weekly appointments were scheduled for each participant, and education was directed at the specific needs and goals of each participant. Interventions for education were based on those found in previous studies.^13,14,18,19

Data Collection and Analysis

All 6 participants were white male veterans who were diagnosed with diabetes for at least 3 years. Their ages ranged from 59 to 72. Three participants were service connected for diabetes and 3 were not. One participant dropped from the study after completing 4 appointments, stating he was just too busy to be available for a weekly appointment. Another participant completed 6 appointments and removed himself from the study due to time constraints. The 4 participants who completed the pilot study were followed for 12 weeks by a registered nurse (RN), and all had reductions in their HbA_1c.

Participants were assessed at weekly appointments using a predetermined template for medication adherence, diet, activity, and blood glucose monitoring. Responses of the participants guided the education interventions to meet the individual veteran’s learning needs. For example, one veteran was given specific education on carbohydrate counting and another was educated on how to read food labels. Participants were also encouraged to express satisfaction, frustration, anger, or other emotions in managing their chronic illness. The premise for spending additional time with the veteran was to promote positive self-management behaviors as recommended by Radhakrishnan.¹⁹

Veterans who completed the study stated that the education interventions positively impacted their health status. One veteran was able to delay dialysis due to self-directed improvement in his lifestyle (exercising and watching his diet), which improved his HbA_1c. This veteran attributed his health improvement to the individualized education sessions with the RN and knowing he had to be accountable to someone. Additionally, it was found there was a strong familial-social component to diabetes self-management. Several veterans were knowledgeable about diabetes self-management as evidenced by their responses to weekly questions. However, disease management for these veterans was strongly impacted by family and life events.

One veteran did not manage his disease for an entire week due to “being busy with a death in the family and planning for a wedding.” This veteran took his medication but did not check his blood glucose or monitor his diet. Another veteran spoke of eating ice cream and other concentrated sweets because his young grandson was with him for the week. A third veteran was able to manage his diet better when his wife packed snacks for him but when left to his own accord did not do well with his food selection. Even though these veterans understood how to effectively manage their diabetes, they may have chosen to inconsistently translate that knowledge into practice if they perceive those familial-social forces to be more important or more powerful.

 

Discussion

The findings from this small pilot study from a single clinic cannot be generalized. However, this pilot study adds to the literature of the positive impact of individualized, structured, tailored nursing interventions delivered with careful consideration of the participants’ personal goals and health care needs for diabetes self-management.

Participants monitored home blood glucose levels, diet, and activity and maintained adherence with prescribed diabetes medications. The HbA_1c level for participants decreased by the end of the program. During the course of the pilot study a pharmacist managed the veterans’ medications. Participant 1 began a new medication regimen the first day of the study. Previously, the patient was self-regulating his medication. However, during the 12-week study, he had no medication adjustments. Participant 4 had several increases to his insulin dose (insulin aspart protamine and insulin aspart rdna origin) during the course of the study. Participants 5 and 6 had no medication adjustments during the study.

Even though participants had medication adjustments, which contributed to the HbA_1c decrease, they became more aware of the medical need to control their blood sugar through the one-on-one education provided. Although there was variation in the depth and detail that participants maintained their food/activity log and home blood glucose monitoring, all participants agreed that they were more likely to be adherent with prescribed self-monitoring “knowing they were going to have to report self-monitoring information” to the RN.

Health care professionals may not realize the impact of familial-social events on blood glucose control. Veterans in this study found that having weekly sessions with the RN helped them through such events, even though they did not adhere strictly to their regimen. One suggestion is having veterans anticipate future familial-social events that may trigger nonadherence to their diabetes health plan and then discuss those events with the health care professional.

Future Research

This small exploratory pilot study has implications for future research. Increasing the study’s sample size and using a control group is recommended to compare veterans who have an educational intervention with those that do not and the impact it has on blood glucose control. The study was limited to 1 CBOC. Incorporating additional CBOCs could increase the sample size. Additionally, although this study was only 3 months in duration, a longer study could reveal significant patterns of change over time as well as the long-term benefit of a tailored educational intervention. In addition, adjusting the study inclusion criteria of > 9 HbA_1c to include those with > 8 HbA_1c also may increase the sample size.

Limited financial resources for the study could have negatively impacted the sample size. Incorporating recruitment or advertising strategy may increase the number of participants. Research also is needed on education interventions with a diverse group of male and female veterans that extends beyond 3 months. Exploring the value of including the veteran’s family in the education sessions is needed. Finally, this study examined only diabetes education. Researchers need to consider other diseases and the value of individualized education.

Limitations


Limitations included a small sample size and no control group. Due to the study’s small sample size, extrapolating data from it becomes difficult. However, this pilot study sets the groundwork for other researchers to expand the importance of education interventions and health literacy. Recruitment was challenging since an eligibility criterion was the NVS score, and patients were sometimes difficult to contact.⁷ The pilot study started with 6 white male participants but only 4 finished. During the course of the pilot study, 1 veteran had medication adjustments as part of routine care and 1 veteran had medication adjustments prior to the study, which could have altered the HbA_1c results.

In hindsight, using the NVS to assess both prestudy with poststudy health literacy scores would have provided additional information about the education intervention. There is possible bias because the researcher was a VAMC employee, and the RN that implemented the interventions had previously worked with the patients.

 

Conclusion

Although this is a small descriptive pilot study, it adds to the body of research on the value of nurse-driven interventions to help veterans manage diabetes by enhancing their health literacy. It also raises questions and opportunities for further research into the power of familial-social influences on a veteran’s willingness to manage their diabetes. The majority of veterans who declined to participate in this study, even though they qualified, stated that they would “not follow any recommendations.” Further investigation is needed about why some veterans elect not to obtain help that could positively impact their health and possibly extend their life. Additionally, scientific quantitative and qualitative research is needed to evaluate the statistical significance between health care literacy and educational intervention on patient adherence among individuals diagnosed with diabetes.

According to the National Academy of Medicine (NAM), health literacy is “the degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions.”¹ Studies suggest that millions of patients have inadequate health literacy and cannot make fully informed decisions because of this lack of knowledge.^2-4 A 2007 National Patient Safety Foundation report calculated that inadequate health literacy burdens the U.S. health care system with an additional $106 to $238 billion annually.⁵

In 2014, the American Diabetes Association reported that diabetes affects 29.1 million Americans (9.3%) and that by 2050 1 in 3 Americans will have diabetes.⁶ People with diabetes have health care costs 2.3 times higher than the cost for nondiabetic patients. The cost of taking care of patients with diabetes annually is about $245 billion.⁶ Without interventions that address health literacy and effective self-management to reduce the risks of complications and comorbidity, health care costs related to diabetes will continue to increase.

Literature Review

According to a U.S. Department of Education assessment on adult health literacy in 2003, 88% of adults in the U.S. have inadequate health literacy.² About 90 million Americans lack health literacy skills, according to a 2004 NAM report.³ Heinrich, who conducted a review of U.S. studies on health literacy, concluded that about 25% of Americans have low health literacy.⁴

The Newest Vital Sign Tool

The Newest Vital Sign (NVS) tool is a free tool developed by Pfizer (New York, NY) for assessing health literacy. Participants are asked 6 questions about nutrition based on an ice cream nutrition label (Figure). The researcher records the participant’s responses, which accommodates participants who may have difficulty reading. The tool is scored from 0 to 6. A score of below 4 indicates the possibility of limited health literacy.⁷ This test can be completed in about 3 minutes, is widely accepted, and provides results comparable to more extensive literacy tests.⁸ A study conducted by Welch and colleagues suggested the NVS tool is both cost and time efficient.⁹ Ryan and colleagues found that 98% of patients in their study (n = 289) did not have objections to taking the NVS assessment.¹⁰

Escobedo and Weismuller’s study used the NVS health literacy tool to assess the health literacy of renal patients.³ In 2004, about 50,000 American patients with diabetes began treatment for kidney failure due to diabetes complications.⁶ Escobedo and Weismuller found that patients with diabetes with limited health literacy knowledge are more likely to be hospitalized, thus increasing health care costs.³ In addition, they discovered that these patients demonstrated poor adherence to prescribed treatment protocols. Welch, VanGeest, and Caskey conducted a case study on time, cost, and clinical utilization of the NVS health literacy tool and found that a patient’s lack of health literacy was linked to limited participation in personal medical decisions.^7,9 Patient’s lack of knowledge was associated with delays in seeking treatment, poor self-management of the disease, and more hospital admissions.

Health Literacy and Diabetes

Studies specific to diabetes and inadequate health literacy support the premise that better health literacy leads to improved patient outcomes. Using the NVS tool, Heinrich conducted a study of the health literacy of 54 patients with diabetes in a primary care setting. The study showed that 65% had inadequate health literacy and that patients with diabetes with inadequate health literacy were more likely to have poor glycemic control compared with patients with diabetes and adequate health literacy levels.⁴ McCleary-Jones examined diet, foot care, and exercise of 50 African American participants with diabetes from a community health center, finding a positive relationship between health literacy and diabetes knowledge.¹¹

Long and Gambling conducted a 2-year prospective, observational study that incorporated motivational interviewing and patient-centered care into a self-management program, examining the effectiveness of scheduled phone interventions to assist patients with diabetes in the management of their disease.¹² The interventions used structured and consistent questions supported by a protocol and script that examined medication adherence and lifestyle choices. Long and Gambling concluded that “the findings demonstrate not only changes in the depth and detail of diabetes-related knowledge and confidence, but also enhanced competence in translating knowledge into every day self-care.”¹² These researchers concluded that increased knowledge translated into better patient self-management of their disease. The Long and Gambling study included general self-management characteristics of monitoring HbA_1c, diet, exercise, medication management, and general self-care. These researchers contend that diabetes self-management education must be a long-term endeavor to promote change.¹²

Mendoza and Rosenburg’s meta-analysis on self-management programs for diabetes and chronic conditions found a statistically significant 0.81% reduction in hemoglobin A_1c (HbA_1c). Characteristics of self-management programs that were linked to improved outcomes included nurse and provider education on medications, diet and/or exercise, and demonstrated use of motivational interviewing and biofeedback. Mendoza and Rosenburg suggested motivational interviewing focuses on the patient’s perspective and facilitates the process that the patient uses to assess their needs and to think about possible solutions.¹³ Mulimba and Bryo-Daniel found that motivational interviewing is a valuable tool for primary care nurses’ health promotion practice, and Thompson and colleagues found that it was effective in changing behavior.^14,15

 

Nurse’s Role in Health Literacy

Nurses play a vital role in educating and securing adherence of patients in the management of their disease(s).¹³ In addition to educating patients, families, and friends of the family, nurses assist with helping them make informed decisions.¹⁶ The VHA uses the Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) to teach health care staff about diabetes self-management education (DSME). Tisdel and colleagues found that DSME established through telemedicine or clinical mentoring improved patient outcomes.¹⁷ Mendoza and Rosenburgfound nurse-led DSME was linked to minimizing cardiovascular risk factors and improvements in HbA_1c.¹³

Background

Staunton Community Based Outpatient Clinic (CBOC) in rural Virginia is a primary care clinic that serves veterans in the surrounding area. About one-fourth of the Staunton patients have diabetes. According to June 2014 data from the VHA Support Service Center, the physician at the Staunton CBOC was responsible for 946 patients (225 with diabetes) and the nurse practitioner was responsible for 707 (184 with diabetes). The VHA Support Service Center 2014 data indicated that veterans with poorly self-managed diabetes were at increased risk for poor outcomes, such as kidney failure, cardiovascular disease, and limb amputation. Veterans with diabetes use the emergency department more often and are admitted to the hospital more often than are veterans who do not have diabetes.¹⁸

Methods

The primary objective of this pilot study was to explore whether weekly structured nursing education sessions lasting 45 minutes and subsequent follow-up weekly conferences would improve their HbA_1c for veterans identified as having ≥ 9 HbA_1c and ≤ 3 health literacy score on the NVS 7 study assessment. Most recent HbA_1c prior to beginning the study was used to identify potential participants. After completion of 12 weekly education interventions, an additional HbA_1c was obtained.

The Salem VAMC and Eastern Mennonite University Institutional Review Board approved the study. Veterans’ questions were answered prior to signing consent forms. All data collected were kept confidential.

Veterans with ≥ 9 HbA_1c were evaluated for possible participation. Forty-nine veterans met the criteria to participate in this pilot study. Exclusion criteria included diagnosis of any cognitive disorder, such as dementia, Alzheimer disease, or memory impairment. In addition, veterans unwilling or unable to commit to weekly follow-up sessions were excluded. The veterans eligible for participation were contacted by telephone, and 9 agreed to participate in the pilot study. Inclusion criteria included those aged ≥ 18 years and a diagnosis of diabetes with most recent HbA_1c of ≥ 9 and a score of < 4 on the NVS health literacy assessment. After taking the NVS health literacy assessment, 6 of the 9 participants qualified to continue in the study.

Education interventions included assessing medication adherence, discussing diet, reviewing physical activity for the previous week (based on diet and activity logs), and reviewing home blood glucose monitoring. Weekly education sessions were either face-to-face or by telephone. This choice was given to accommodate veterans who may have had transportation issues. A total of 12 weekly appointments were scheduled for each participant, and education was directed at the specific needs and goals of each participant. Interventions for education were based on those found in previous studies.^13,14,18,19

Data Collection and Analysis

All 6 participants were white male veterans who were diagnosed with diabetes for at least 3 years. Their ages ranged from 59 to 72. Three participants were service connected for diabetes and 3 were not. One participant dropped from the study after completing 4 appointments, stating he was just too busy to be available for a weekly appointment. Another participant completed 6 appointments and removed himself from the study due to time constraints. The 4 participants who completed the pilot study were followed for 12 weeks by a registered nurse (RN), and all had reductions in their HbA_1c.

Participants were assessed at weekly appointments using a predetermined template for medication adherence, diet, activity, and blood glucose monitoring. Responses of the participants guided the education interventions to meet the individual veteran’s learning needs. For example, one veteran was given specific education on carbohydrate counting and another was educated on how to read food labels. Participants were also encouraged to express satisfaction, frustration, anger, or other emotions in managing their chronic illness. The premise for spending additional time with the veteran was to promote positive self-management behaviors as recommended by Radhakrishnan.¹⁹

Veterans who completed the study stated that the education interventions positively impacted their health status. One veteran was able to delay dialysis due to self-directed improvement in his lifestyle (exercising and watching his diet), which improved his HbA_1c. This veteran attributed his health improvement to the individualized education sessions with the RN and knowing he had to be accountable to someone. Additionally, it was found there was a strong familial-social component to diabetes self-management. Several veterans were knowledgeable about diabetes self-management as evidenced by their responses to weekly questions. However, disease management for these veterans was strongly impacted by family and life events.

One veteran did not manage his disease for an entire week due to “being busy with a death in the family and planning for a wedding.” This veteran took his medication but did not check his blood glucose or monitor his diet. Another veteran spoke of eating ice cream and other concentrated sweets because his young grandson was with him for the week. A third veteran was able to manage his diet better when his wife packed snacks for him but when left to his own accord did not do well with his food selection. Even though these veterans understood how to effectively manage their diabetes, they may have chosen to inconsistently translate that knowledge into practice if they perceive those familial-social forces to be more important or more powerful.

 

Discussion

The findings from this small pilot study from a single clinic cannot be generalized. However, this pilot study adds to the literature of the positive impact of individualized, structured, tailored nursing interventions delivered with careful consideration of the participants’ personal goals and health care needs for diabetes self-management.

Participants monitored home blood glucose levels, diet, and activity and maintained adherence with prescribed diabetes medications. The HbA_1c level for participants decreased by the end of the program. During the course of the pilot study a pharmacist managed the veterans’ medications. Participant 1 began a new medication regimen the first day of the study. Previously, the patient was self-regulating his medication. However, during the 12-week study, he had no medication adjustments. Participant 4 had several increases to his insulin dose (insulin aspart protamine and insulin aspart rdna origin) during the course of the study. Participants 5 and 6 had no medication adjustments during the study.

Even though participants had medication adjustments, which contributed to the HbA_1c decrease, they became more aware of the medical need to control their blood sugar through the one-on-one education provided. Although there was variation in the depth and detail that participants maintained their food/activity log and home blood glucose monitoring, all participants agreed that they were more likely to be adherent with prescribed self-monitoring “knowing they were going to have to report self-monitoring information” to the RN.

Health care professionals may not realize the impact of familial-social events on blood glucose control. Veterans in this study found that having weekly sessions with the RN helped them through such events, even though they did not adhere strictly to their regimen. One suggestion is having veterans anticipate future familial-social events that may trigger nonadherence to their diabetes health plan and then discuss those events with the health care professional.

Future Research

This small exploratory pilot study has implications for future research. Increasing the study’s sample size and using a control group is recommended to compare veterans who have an educational intervention with those that do not and the impact it has on blood glucose control. The study was limited to 1 CBOC. Incorporating additional CBOCs could increase the sample size. Additionally, although this study was only 3 months in duration, a longer study could reveal significant patterns of change over time as well as the long-term benefit of a tailored educational intervention. In addition, adjusting the study inclusion criteria of > 9 HbA_1c to include those with > 8 HbA_1c also may increase the sample size.

Limited financial resources for the study could have negatively impacted the sample size. Incorporating recruitment or advertising strategy may increase the number of participants. Research also is needed on education interventions with a diverse group of male and female veterans that extends beyond 3 months. Exploring the value of including the veteran’s family in the education sessions is needed. Finally, this study examined only diabetes education. Researchers need to consider other diseases and the value of individualized education.

Limitations


Limitations included a small sample size and no control group. Due to the study’s small sample size, extrapolating data from it becomes difficult. However, this pilot study sets the groundwork for other researchers to expand the importance of education interventions and health literacy. Recruitment was challenging since an eligibility criterion was the NVS score, and patients were sometimes difficult to contact.⁷ The pilot study started with 6 white male participants but only 4 finished. During the course of the pilot study, 1 veteran had medication adjustments as part of routine care and 1 veteran had medication adjustments prior to the study, which could have altered the HbA_1c results.

In hindsight, using the NVS to assess both prestudy with poststudy health literacy scores would have provided additional information about the education intervention. There is possible bias because the researcher was a VAMC employee, and the RN that implemented the interventions had previously worked with the patients.

 

Conclusion

Although this is a small descriptive pilot study, it adds to the body of research on the value of nurse-driven interventions to help veterans manage diabetes by enhancing their health literacy. It also raises questions and opportunities for further research into the power of familial-social influences on a veteran’s willingness to manage their diabetes. The majority of veterans who declined to participate in this study, even though they qualified, stated that they would “not follow any recommendations.” Further investigation is needed about why some veterans elect not to obtain help that could positively impact their health and possibly extend their life. Additionally, scientific quantitative and qualitative research is needed to evaluate the statistical significance between health care literacy and educational intervention on patient adherence among individuals diagnosed with diabetes.

 

High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.

“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”

Carpe89/ThinkStock

In an effort to determine the prevalence and frequency of cigarette smoking and EVP use among high school students, and associations between health-risk behaviors and both cigarette smoking and EVP use, Dr. Demissie of the division of adolescent and school health at the Centers for Disease Control and Prevention and her associates evaluated results from the self-administered 2015 national Youth Risk Behavior Survey, which involves a nationally representative sample of public and private school students in grades 9-12 in the 50 states and the District of Columbia. The study sample included 15,624 students who were classified into four exclusive categories of smoking and EVP use based on 30-day use: nonuse, cigarette smoking only, EVP use only, and dual use (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-2921).

Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.

Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
 

• Engage in a physical fight (prevalence ratio range, 1.7-2.9).

• Attempt suicide (PR range, 1.9-4.0).

• Currently drink alcohol (PR range, 2.6-3.3).

• Currently use marijuana (PR range, 3.5-5.2).

• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).

• Be currently sexually active (PR range, 1.9-2.3).

“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”

Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”

They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.

The investigators reported having no relevant financial disclosures.

[email protected]

 

High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.

“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”

Carpe89/ThinkStock

In an effort to determine the prevalence and frequency of cigarette smoking and EVP use among high school students, and associations between health-risk behaviors and both cigarette smoking and EVP use, Dr. Demissie of the division of adolescent and school health at the Centers for Disease Control and Prevention and her associates evaluated results from the self-administered 2015 national Youth Risk Behavior Survey, which involves a nationally representative sample of public and private school students in grades 9-12 in the 50 states and the District of Columbia. The study sample included 15,624 students who were classified into four exclusive categories of smoking and EVP use based on 30-day use: nonuse, cigarette smoking only, EVP use only, and dual use (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-2921).

Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.

Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
 

• Engage in a physical fight (prevalence ratio range, 1.7-2.9).

• Attempt suicide (PR range, 1.9-4.0).

• Currently drink alcohol (PR range, 2.6-3.3).

• Currently use marijuana (PR range, 3.5-5.2).

• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).

• Be currently sexually active (PR range, 1.9-2.3).

“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”

Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”

They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.

The investigators reported having no relevant financial disclosures.

[email protected]

 

High school students who use electronic vapor products (EVPs), whether alone or in combination with cigarette smoking, are more likely to engage in violence, substance abuse, and other high-risk behaviors, compared with nonusers, according to the results of a national survey.

“Given that EVPs are relatively new to the U.S. marketplace, little is known about the use of these products in the context of other health behaviors, which can persist throughout life and contribute to significant morbidity and mortality during adolescence and adulthood,” Zewditu Demissie, PhD, and her associates wrote in a study published online in the Jan. 23, 2017, issue of Pediatrics. They went on to note that to date, “studies on the association between EVPs and health-risk behaviors among adolescents and young adults has been limited to examining the associations between e-cigarette and substance use. These studies have found that use of e-cigarettes was associated with alcohol use, binge drinking, and marijuana use.”

Carpe89/ThinkStock

In an effort to determine the prevalence and frequency of cigarette smoking and EVP use among high school students, and associations between health-risk behaviors and both cigarette smoking and EVP use, Dr. Demissie of the division of adolescent and school health at the Centers for Disease Control and Prevention and her associates evaluated results from the self-administered 2015 national Youth Risk Behavior Survey, which involves a nationally representative sample of public and private school students in grades 9-12 in the 50 states and the District of Columbia. The study sample included 15,624 students who were classified into four exclusive categories of smoking and EVP use based on 30-day use: nonuse, cigarette smoking only, EVP use only, and dual use (Pediatrics. 2017 Jan 23. doi: 10.1542/peds.2016-2921).

Of the 15,624 respondents, 74% reported that they did not smoke cigarettes or use EVPs, while 3% smoked cigarettes only, 16% used EVPs only, and 8% used both cigarettes and EVPs.

Compared with nonusers, cigarette-only smokers, EVP-only users, and dual users were significantly more likely to:
 

• Engage in a physical fight (prevalence ratio range, 1.7-2.9).

• Attempt suicide (PR range, 1.9-4.0).

• Currently drink alcohol (PR range, 2.6-3.3).

• Currently use marijuana (PR range, 3.5-5.2).

• Report nonmedical use of prescription drugs (PR range, 2.3-4.1).

• Be currently sexually active (PR range, 1.9-2.3).

“Engaging in health-risk behaviors did not generally differ between EVP-only users and cigarette-only smokers,” the researchers wrote. “However, cigarette-only smokers were significantly more likely than EVP-only users to attempt suicide, ever use synthetic marijuana, have four or more lifetime sexual partners, drink soda three or more times/day, and be physically active less than 7 days in the 7 days before the survey.”

Dr. Demissie and her associates concluded that the findings “underscore the importance of comprehensive efforts to address health-risk behaviors among adolescents, including prevention strategies focused on all forms of tobacco use, including EVPs. Additionally, educational and counseling efforts focusing on the harms associated with adolescent tobacco use, including EVPs, are critical.”

They acknowledged certain limitations of the study, including its observational design and the fact that Youth Risk Behavior Survey data are self-reported.

The investigators reported having no relevant financial disclosures.

[email protected]

 

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field, clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. As the charitable arm of the American Gastroenterological Association (AGA), the AGA Research Foundation contributes to this tradition of discovery to combat the continued lower quality of life and suffering brought on by digestive diseases.

AGA Institute

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. The foundation provides a key source of funding at a critical juncture in a young investigators’ career.

“Using this award, I plan to study the cytoskeletal intermediate filament proteins that are expressed in digestive-type epithelia, allowing me to better understand the molecular basis of GI diseases. My goal is to create a career in medical research and develop more ways to make biomedical research meaningful for clinical health-care professionals, and ultimately for patients,” said Rani Richardson, the 2016 AGA Investing in the Future Student Research Fellowship Award Recipient.
 

By joining others in donating to the AGA Research Foundation, you can help fill the funding gap and protect the next generation of investigators.

Help provide critical funding to young researchers today by making a donation to the AGA Research Foundation on the foundation’s website at www.gastro.org/contribute or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

 

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field, clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. As the charitable arm of the American Gastroenterological Association (AGA), the AGA Research Foundation contributes to this tradition of discovery to combat the continued lower quality of life and suffering brought on by digestive diseases.

AGA Institute

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. The foundation provides a key source of funding at a critical juncture in a young investigators’ career.

“Using this award, I plan to study the cytoskeletal intermediate filament proteins that are expressed in digestive-type epithelia, allowing me to better understand the molecular basis of GI diseases. My goal is to create a career in medical research and develop more ways to make biomedical research meaningful for clinical health-care professionals, and ultimately for patients,” said Rani Richardson, the 2016 AGA Investing in the Future Student Research Fellowship Award Recipient.
 

By joining others in donating to the AGA Research Foundation, you can help fill the funding gap and protect the next generation of investigators.

Help provide critical funding to young researchers today by making a donation to the AGA Research Foundation on the foundation’s website at www.gastro.org/contribute or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

 

Decades of research have revolutionized the care of many digestive disease patients. These patients, as well as everyone in the GI field, clinicians and researchers alike, have benefited from the discoveries of dedicated investigators, past and present. As the charitable arm of the American Gastroenterological Association (AGA), the AGA Research Foundation contributes to this tradition of discovery to combat the continued lower quality of life and suffering brought on by digestive diseases.

AGA Institute

The AGA Research Foundation’s mission is to raise funds to support young researchers in gastroenterology and hepatology. The foundation provides a key source of funding at a critical juncture in a young investigators’ career.

“Using this award, I plan to study the cytoskeletal intermediate filament proteins that are expressed in digestive-type epithelia, allowing me to better understand the molecular basis of GI diseases. My goal is to create a career in medical research and develop more ways to make biomedical research meaningful for clinical health-care professionals, and ultimately for patients,” said Rani Richardson, the 2016 AGA Investing in the Future Student Research Fellowship Award Recipient.
 

By joining others in donating to the AGA Research Foundation, you can help fill the funding gap and protect the next generation of investigators.

Help provide critical funding to young researchers today by making a donation to the AGA Research Foundation on the foundation’s website at www.gastro.org/contribute or by mail to 4930 Del Ray Avenue, Bethesda, MD 20814.

 

CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.

The association was independent of sociodemographic factors, comorbidities, and use of diuretics.

If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.

Brian Hoyle/Frontline Medical News

This retrospective analysis involved 3,551 study participants in the Dallas Heart Study who had serum magnesium measured at their baseline visit. Of these, CKD did not develop in 3,245 subjects and did develop in 306 subjects. Both groups could be stratified according to low, medium, and high serum magnesium. In the non-CKD group, the low (736 subjects), medium (1,461), and high (1,048) tertiles of serum magnesium comprised. The respective numbers in the CKD group were 118, 109, and 79 subjects.

In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.

Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.

Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.

The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.

The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.

 

CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.

The association was independent of sociodemographic factors, comorbidities, and use of diuretics.

If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.

Brian Hoyle/Frontline Medical News

This retrospective analysis involved 3,551 study participants in the Dallas Heart Study who had serum magnesium measured at their baseline visit. Of these, CKD did not develop in 3,245 subjects and did develop in 306 subjects. Both groups could be stratified according to low, medium, and high serum magnesium. In the non-CKD group, the low (736 subjects), medium (1,461), and high (1,048) tertiles of serum magnesium comprised. The respective numbers in the CKD group were 118, 109, and 79 subjects.

In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.

Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.

Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.

The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.

The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.

 

CHICAGO – Low levels of serum magnesium were associated with increased all-cause mortality, whether or not patients had chronic kidney disease, in a single center, retrospective study of 3,551 people.

The association was independent of sociodemographic factors, comorbidities, and use of diuretics.

If causality is shown, “magnesium supplementation could be a simple therapy to lessen the chance of death in CKD patients,” study investigator Silvia Ferrè, PhD, University of Texas Southwestern, Dallas, said in an interview regarding the results of the Dallas Heart Study, which was presented at the annual meeting of the American Society of Nephrology.

Brian Hoyle/Frontline Medical News

This retrospective analysis involved 3,551 study participants in the Dallas Heart Study who had serum magnesium measured at their baseline visit. Of these, CKD did not develop in 3,245 subjects and did develop in 306 subjects. Both groups could be stratified according to low, medium, and high serum magnesium. In the non-CKD group, the low (736 subjects), medium (1,461), and high (1,048) tertiles of serum magnesium comprised. The respective numbers in the CKD group were 118, 109, and 79 subjects.

In both groups, the subjects with low serum magnesium were younger, more likely to be female, had a higher body mass index, and were more burdened by comorbidities including type 2 diabetes mellitus and hypertension. Subjects without CKD and low serum magnesium were significantly more likely to use diuretics. Diuretic use was comparable in subjects with CKD regardless of serum magnesium level.

Irrespective of CKD status, survival was significantly lower in subjects with low serum magnesium in the median 12.3-year follow-up compared to the other two serum magnesium tertiles (P less than 0.001 and P equal to 0.03, respectively). Following adjustment for age, gender, race/ethnicity, body mass index, phosphorus, calcium, bicarbonate, albumin, intact parathyroid hormone, total cholesterol, high-density lipoprotein, and use of diuretics and supplements, low serum magnesium was independently associated with all-cause death in subjects with CKD (Hazard Ratio, 1.92; 9%% Confidence Interval, 1.03 to 3.59; P equal to 0.04) and those without CKD (HR, 1.43; 1.43; 95% CI, 0.95 to 2.15; P equal to 0.09), when compared to high serum magnesium as the referent.

Dr. Ferrè said that screening for serum magnesium and supplementation with magnesium as part of routine blood testing might improve survival. Low magnesium level alsonhas been linked with osteoporosis, diabetes, and cardiovascular disease.

The Dallas Heart Study was a multiethnic, population-based study involving 6,101 adults residing in Dallas County. The study, which ran from 2000 to the end of 2011, was designed to explore the early detection of cardiovascular disease and the social, behavioral, and environmental factors associated with risk, with the goal of interventions that can be provided at the community level.

The study sponsor was University of Texas Southwestern Medical Center. The study was funded by the National Institutes of Health and the Donald W. Reynolds Foundation. Dr. Ferrè reported having no financial disclosures.