Sneak Peek: Journal of Hospital Medicine

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Inpatient antimicrobial utilization measures are associated with antimicrobial stewardship activities and facility characteristics of Veterans Affairs medical centers

 

BACKGROUND: Antimicrobial stewardship programs (ASPs) have been advocated to improve antimicrobial utilization, but program implementation is variable.

OBJECTIVE: To determine associations of ASPs with facility characteristics and inpatient antimicrobial utilization measures in the Veterans Affairs (VA) system in 2012.

DESIGN: In 2012, the VA administered a survey on antimicrobial stewardship practices to designated ASP contacts at VA acute-care hospitals. From the survey, we identified 34 variables across three domains (evidence, organizational context, and facilitation) that were assessed, using multivariable LASSO (least absolute shrinkage and selection operator) regression, against four antimicrobial utilization measures: aggregate acute care antimicrobial use, antimicrobial use in patients with noninfectious primary discharge diagnoses, missed opportunities to convert from parenteral to oral antimicrobial therapy, and double anaerobic coverage.

SETTING: All 130 VA facilities with acute care services.

RESULTS: Variables associated with at least three favorable changes in antimicrobial utilization included presence of postgraduate physician/pharmacy training programs, number of antimicrobial-specific order sets, frequency of systematic de-escalation review, presence of pharmacists and/or infectious diseases (ID) attendings on acute care ward teams, and formal ID training of the lead ASP pharmacist. Variables associated with two unfavorable measures included bed size, the level of engagement with VA Antimicrobial Stewardship Task Force online resources, and utilization of antimicrobial stop orders.

CONCLUSIONS: Formalization of ASP processes and presence of pharmacy and ID expertise are associated with favorable utilization. Systematic de-escalation review and order set establishment may be high-yield interventions.

Also in JHM

High prevalence of inappropriate benzodiazepine and sedative hypnotic prescriptions among hospitalized older adults

AUTHORS: Elisabeth Anna Pek, MD, Andrew Remfry, MD, Ciara Pendrith, MSc, Chris Fan-Lun, BScPhm, R. Sacha Bhatia, MD, and Christine Soong, MD, MSc, SFHM

Incidence, predictors, and outcomes of hospital-acquired anemia

AUTHORS: Anil N. Makam, MD, MAS, Oanh K. Nguyen, MD, MAS, Christopher Clark, MPA, and Ethan A. Halm, MD, MPH

Association between radiologic incidental findings and resource utilization in patients admitted with chest pain in an urban medical center

AUTHORS: Venkat P. Gundareddy, MD, MPH, SFHM, Nisa M. Maruthur, MD, MHS, Abednego Chibungu, MD, Preetam Bollampally, MD, Regina Landis, MS, abd Shaker M. Eid, MD, MBA

Clinical utility of routine CBC testing in patients with community-acquired pneumonia

AUTHORS: Neelaysh Vukkadala, BS, and Andrew Auerbach, MD, MPH, SFHM

Overuse of troponin? A comprehensive evaluation of testing in a large hospital system

AUTHORS: Gibbs Wilson, MD, Kyler Barkley, MD, Kipp Slicker, DO, Robert Kowal, MD, PhD, Brandon Pope, PhD, and Jeffrey Michel, MD

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Inpatient antimicrobial utilization measures are associated with antimicrobial stewardship activities and facility characteristics of Veterans Affairs medical centers
Inpatient antimicrobial utilization measures are associated with antimicrobial stewardship activities and facility characteristics of Veterans Affairs medical centers

 

BACKGROUND: Antimicrobial stewardship programs (ASPs) have been advocated to improve antimicrobial utilization, but program implementation is variable.

OBJECTIVE: To determine associations of ASPs with facility characteristics and inpatient antimicrobial utilization measures in the Veterans Affairs (VA) system in 2012.

DESIGN: In 2012, the VA administered a survey on antimicrobial stewardship practices to designated ASP contacts at VA acute-care hospitals. From the survey, we identified 34 variables across three domains (evidence, organizational context, and facilitation) that were assessed, using multivariable LASSO (least absolute shrinkage and selection operator) regression, against four antimicrobial utilization measures: aggregate acute care antimicrobial use, antimicrobial use in patients with noninfectious primary discharge diagnoses, missed opportunities to convert from parenteral to oral antimicrobial therapy, and double anaerobic coverage.

SETTING: All 130 VA facilities with acute care services.

RESULTS: Variables associated with at least three favorable changes in antimicrobial utilization included presence of postgraduate physician/pharmacy training programs, number of antimicrobial-specific order sets, frequency of systematic de-escalation review, presence of pharmacists and/or infectious diseases (ID) attendings on acute care ward teams, and formal ID training of the lead ASP pharmacist. Variables associated with two unfavorable measures included bed size, the level of engagement with VA Antimicrobial Stewardship Task Force online resources, and utilization of antimicrobial stop orders.

CONCLUSIONS: Formalization of ASP processes and presence of pharmacy and ID expertise are associated with favorable utilization. Systematic de-escalation review and order set establishment may be high-yield interventions.

Also in JHM

High prevalence of inappropriate benzodiazepine and sedative hypnotic prescriptions among hospitalized older adults

AUTHORS: Elisabeth Anna Pek, MD, Andrew Remfry, MD, Ciara Pendrith, MSc, Chris Fan-Lun, BScPhm, R. Sacha Bhatia, MD, and Christine Soong, MD, MSc, SFHM

Incidence, predictors, and outcomes of hospital-acquired anemia

AUTHORS: Anil N. Makam, MD, MAS, Oanh K. Nguyen, MD, MAS, Christopher Clark, MPA, and Ethan A. Halm, MD, MPH

Association between radiologic incidental findings and resource utilization in patients admitted with chest pain in an urban medical center

AUTHORS: Venkat P. Gundareddy, MD, MPH, SFHM, Nisa M. Maruthur, MD, MHS, Abednego Chibungu, MD, Preetam Bollampally, MD, Regina Landis, MS, abd Shaker M. Eid, MD, MBA

Clinical utility of routine CBC testing in patients with community-acquired pneumonia

AUTHORS: Neelaysh Vukkadala, BS, and Andrew Auerbach, MD, MPH, SFHM

Overuse of troponin? A comprehensive evaluation of testing in a large hospital system

AUTHORS: Gibbs Wilson, MD, Kyler Barkley, MD, Kipp Slicker, DO, Robert Kowal, MD, PhD, Brandon Pope, PhD, and Jeffrey Michel, MD

 

BACKGROUND: Antimicrobial stewardship programs (ASPs) have been advocated to improve antimicrobial utilization, but program implementation is variable.

OBJECTIVE: To determine associations of ASPs with facility characteristics and inpatient antimicrobial utilization measures in the Veterans Affairs (VA) system in 2012.

DESIGN: In 2012, the VA administered a survey on antimicrobial stewardship practices to designated ASP contacts at VA acute-care hospitals. From the survey, we identified 34 variables across three domains (evidence, organizational context, and facilitation) that were assessed, using multivariable LASSO (least absolute shrinkage and selection operator) regression, against four antimicrobial utilization measures: aggregate acute care antimicrobial use, antimicrobial use in patients with noninfectious primary discharge diagnoses, missed opportunities to convert from parenteral to oral antimicrobial therapy, and double anaerobic coverage.

SETTING: All 130 VA facilities with acute care services.

RESULTS: Variables associated with at least three favorable changes in antimicrobial utilization included presence of postgraduate physician/pharmacy training programs, number of antimicrobial-specific order sets, frequency of systematic de-escalation review, presence of pharmacists and/or infectious diseases (ID) attendings on acute care ward teams, and formal ID training of the lead ASP pharmacist. Variables associated with two unfavorable measures included bed size, the level of engagement with VA Antimicrobial Stewardship Task Force online resources, and utilization of antimicrobial stop orders.

CONCLUSIONS: Formalization of ASP processes and presence of pharmacy and ID expertise are associated with favorable utilization. Systematic de-escalation review and order set establishment may be high-yield interventions.

Also in JHM

High prevalence of inappropriate benzodiazepine and sedative hypnotic prescriptions among hospitalized older adults

AUTHORS: Elisabeth Anna Pek, MD, Andrew Remfry, MD, Ciara Pendrith, MSc, Chris Fan-Lun, BScPhm, R. Sacha Bhatia, MD, and Christine Soong, MD, MSc, SFHM

Incidence, predictors, and outcomes of hospital-acquired anemia

AUTHORS: Anil N. Makam, MD, MAS, Oanh K. Nguyen, MD, MAS, Christopher Clark, MPA, and Ethan A. Halm, MD, MPH

Association between radiologic incidental findings and resource utilization in patients admitted with chest pain in an urban medical center

AUTHORS: Venkat P. Gundareddy, MD, MPH, SFHM, Nisa M. Maruthur, MD, MHS, Abednego Chibungu, MD, Preetam Bollampally, MD, Regina Landis, MS, abd Shaker M. Eid, MD, MBA

Clinical utility of routine CBC testing in patients with community-acquired pneumonia

AUTHORS: Neelaysh Vukkadala, BS, and Andrew Auerbach, MD, MPH, SFHM

Overuse of troponin? A comprehensive evaluation of testing in a large hospital system

AUTHORS: Gibbs Wilson, MD, Kyler Barkley, MD, Kipp Slicker, DO, Robert Kowal, MD, PhD, Brandon Pope, PhD, and Jeffrey Michel, MD

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Women less likely to be diagnosed with sleep disorders

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Women are less likely to be diagnosed with and treated for sleep-disordered breathing, despite having symptoms similar to those of men, a Swedish study showed.

In a survey of 10,854 subjects, 14% of women reported being diagnosed with obstructive sleep apnea (OSA), compared with 25% of men (P less than .001), and 9% of women reported having any OSA treatment, compared with 16% of men (Sleep Med. 2017. doi: 10.1016/j.sleep.2017.02.032).

Underdiagnosis of sleep-disordered breathing (SDB) in women may have dire consequences, as symptoms, specifically snoring and excessive daytime sleepiness (EDS), correlate with increased risk for hypertension and diabetes, regardless of gender, according to Eva Lindberg, PhD, professor in the department of medical sciences, respiratory, allergy, and sleep research at Uppsala (Sweden) University, and her colleagues.

The mean age of the patients at baseline was 41 years. Mean body mass index was 25.4 kg/m2 for men and 24 kg/m2 for women.

On initial testing, approximately three times the percentage of men reported having issues with snoring and no EDS, compared with women (19% vs. 6% respectively), while more women reported the opposite, EDS but no snoring (19% vs. 11%). A slightly larger percentage of men reported having both symptoms (7.3% vs. 4.5%).

Investigators hypothesized the disparity between women and men reporting problems with snoring may be caused by gender expectations.


“It is more probable that SDB is still assumed to be a condition associated predominantly with men, and women feel ashamed of reporting these symptoms and seeking medical advice,” said Dr. Lindberg and her coinvestigators. These gender expectations may “contribute to females being less inclined to seek medical advice due to SDB symptoms.”

In a follow-up survey conducted 11 years after the initial one, doctors found 1,716 and 319 patients had received a new diagnosis for hypertension and diabetes, respectively.

While incidence was greater in men than in women for both (hypertension: 18.6% vs. 15.8% [P less than .001] and 3.6 vs. 2.4% [P less than .001], respectively), the investigators found “after adjusting for BMI and snoring at baseline, none of these gender differences remained significant.”


Physicians’ perception of SDB is partially responsible for the number of women who go undiagnosed, according to the researchers. Because SDB is considered to occur predominantly in males, doctors may overlook symptoms in female patients that would otherwise be a cause for further testing, they noted.

“[Even] among health professionals, SDB is still usually attributed to a male population, and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings. ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators wrote.

“[Even] among health professionals, SDB is still usually attributed to a male population and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators claimed.

Dr. Lindberg and her team suggested engaging female patients more frequently about SDB symptoms, as well as referring patients with positive symptoms to participate in a sleep study.

The current study was limited by the nature of the data, which were self-reported. Patients were not surveyed via the Epworth Sleepiness Scale.

The study was funded by grants from the Norwegian Research Council, the Icelandic Research Council, Aarhus University, the Swedish Heart-Lung Foundation, and the Estonian Science Foundation.

The investigators reported no relevant financial disclosures.

ezimmerman@frontlinemedcom.com

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Krishna Sundar, MD, FCCP, comments: The authors discuss the important topic of differing expression of OSA in male versus female subjects that may lead to under-recognition of sleep apnea in women.
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Krishna Sundar, MD, FCCP, comments: The authors discuss the important topic of differing expression of OSA in male versus female subjects that may lead to under-recognition of sleep apnea in women.
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Dr. Krishna Sundar
Krishna Sundar, MD, FCCP, comments: The authors discuss the important topic of differing expression of OSA in male versus female subjects that may lead to under-recognition of sleep apnea in women.

 

Women are less likely to be diagnosed with and treated for sleep-disordered breathing, despite having symptoms similar to those of men, a Swedish study showed.

In a survey of 10,854 subjects, 14% of women reported being diagnosed with obstructive sleep apnea (OSA), compared with 25% of men (P less than .001), and 9% of women reported having any OSA treatment, compared with 16% of men (Sleep Med. 2017. doi: 10.1016/j.sleep.2017.02.032).

Underdiagnosis of sleep-disordered breathing (SDB) in women may have dire consequences, as symptoms, specifically snoring and excessive daytime sleepiness (EDS), correlate with increased risk for hypertension and diabetes, regardless of gender, according to Eva Lindberg, PhD, professor in the department of medical sciences, respiratory, allergy, and sleep research at Uppsala (Sweden) University, and her colleagues.

The mean age of the patients at baseline was 41 years. Mean body mass index was 25.4 kg/m2 for men and 24 kg/m2 for women.

On initial testing, approximately three times the percentage of men reported having issues with snoring and no EDS, compared with women (19% vs. 6% respectively), while more women reported the opposite, EDS but no snoring (19% vs. 11%). A slightly larger percentage of men reported having both symptoms (7.3% vs. 4.5%).

Investigators hypothesized the disparity between women and men reporting problems with snoring may be caused by gender expectations.


“It is more probable that SDB is still assumed to be a condition associated predominantly with men, and women feel ashamed of reporting these symptoms and seeking medical advice,” said Dr. Lindberg and her coinvestigators. These gender expectations may “contribute to females being less inclined to seek medical advice due to SDB symptoms.”

In a follow-up survey conducted 11 years after the initial one, doctors found 1,716 and 319 patients had received a new diagnosis for hypertension and diabetes, respectively.

While incidence was greater in men than in women for both (hypertension: 18.6% vs. 15.8% [P less than .001] and 3.6 vs. 2.4% [P less than .001], respectively), the investigators found “after adjusting for BMI and snoring at baseline, none of these gender differences remained significant.”


Physicians’ perception of SDB is partially responsible for the number of women who go undiagnosed, according to the researchers. Because SDB is considered to occur predominantly in males, doctors may overlook symptoms in female patients that would otherwise be a cause for further testing, they noted.

“[Even] among health professionals, SDB is still usually attributed to a male population, and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings. ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators wrote.

“[Even] among health professionals, SDB is still usually attributed to a male population and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators claimed.

Dr. Lindberg and her team suggested engaging female patients more frequently about SDB symptoms, as well as referring patients with positive symptoms to participate in a sleep study.

The current study was limited by the nature of the data, which were self-reported. Patients were not surveyed via the Epworth Sleepiness Scale.

The study was funded by grants from the Norwegian Research Council, the Icelandic Research Council, Aarhus University, the Swedish Heart-Lung Foundation, and the Estonian Science Foundation.

The investigators reported no relevant financial disclosures.

ezimmerman@frontlinemedcom.com

 

Women are less likely to be diagnosed with and treated for sleep-disordered breathing, despite having symptoms similar to those of men, a Swedish study showed.

In a survey of 10,854 subjects, 14% of women reported being diagnosed with obstructive sleep apnea (OSA), compared with 25% of men (P less than .001), and 9% of women reported having any OSA treatment, compared with 16% of men (Sleep Med. 2017. doi: 10.1016/j.sleep.2017.02.032).

Underdiagnosis of sleep-disordered breathing (SDB) in women may have dire consequences, as symptoms, specifically snoring and excessive daytime sleepiness (EDS), correlate with increased risk for hypertension and diabetes, regardless of gender, according to Eva Lindberg, PhD, professor in the department of medical sciences, respiratory, allergy, and sleep research at Uppsala (Sweden) University, and her colleagues.

The mean age of the patients at baseline was 41 years. Mean body mass index was 25.4 kg/m2 for men and 24 kg/m2 for women.

On initial testing, approximately three times the percentage of men reported having issues with snoring and no EDS, compared with women (19% vs. 6% respectively), while more women reported the opposite, EDS but no snoring (19% vs. 11%). A slightly larger percentage of men reported having both symptoms (7.3% vs. 4.5%).

Investigators hypothesized the disparity between women and men reporting problems with snoring may be caused by gender expectations.


“It is more probable that SDB is still assumed to be a condition associated predominantly with men, and women feel ashamed of reporting these symptoms and seeking medical advice,” said Dr. Lindberg and her coinvestigators. These gender expectations may “contribute to females being less inclined to seek medical advice due to SDB symptoms.”

In a follow-up survey conducted 11 years after the initial one, doctors found 1,716 and 319 patients had received a new diagnosis for hypertension and diabetes, respectively.

While incidence was greater in men than in women for both (hypertension: 18.6% vs. 15.8% [P less than .001] and 3.6 vs. 2.4% [P less than .001], respectively), the investigators found “after adjusting for BMI and snoring at baseline, none of these gender differences remained significant.”


Physicians’ perception of SDB is partially responsible for the number of women who go undiagnosed, according to the researchers. Because SDB is considered to occur predominantly in males, doctors may overlook symptoms in female patients that would otherwise be a cause for further testing, they noted.

“[Even] among health professionals, SDB is still usually attributed to a male population, and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings. ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators wrote.

“[Even] among health professionals, SDB is still usually attributed to a male population and female patients are therefore less frequently asked about the cardinal symptoms of snoring and sleepiness and do not therefore undergo sleep recordings ... Also, among patients with obesity hypoventilation syndrome, females are generally diagnosed when the disease is more advanced and significantly more frequently develop acute disease before achieving treatment,” the investigators claimed.

Dr. Lindberg and her team suggested engaging female patients more frequently about SDB symptoms, as well as referring patients with positive symptoms to participate in a sleep study.

The current study was limited by the nature of the data, which were self-reported. Patients were not surveyed via the Epworth Sleepiness Scale.

The study was funded by grants from the Norwegian Research Council, the Icelandic Research Council, Aarhus University, the Swedish Heart-Lung Foundation, and the Estonian Science Foundation.

The investigators reported no relevant financial disclosures.

ezimmerman@frontlinemedcom.com

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Key clinical point: Women are less likely to be tested for sleep disorders, a factor leading to underdiagnoses and potential long-term health risks.

Major finding: Women were less likely than were men to be diagnosed with sleep apnea (14% vs. 25%, P = .001) or given treatment for any kind of sleep disordered breathing (9% vs. 16%, P = .01).

Data source: Survey of 10,854 subjects: 4,962 men and 5,892 women, gathered from the European Community Respiratory Health Survey with subsequent follow-up.

Disclosures: The study was funded by grants from the Norwegian Research Council, the Icelandic Research Council, Aarhus University, the Swedish Heart-Lung Foundation, and the Estonian Science Foundation. The investigators report no relevant financial disclosures.

Oncology treatment errors: Emerging data shed light on risk factors, prevention

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– Accumulating evidence is helping researchers better understand why errors occur during the delivery of cancer treatment and how to prevent them. Findings from a trio of studies were reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Identifying causes of incidents in radiation therapy

In the first study, Greg D. Judy, MD, a radiation oncology resident at the University of North Carolina at Chapel Hill, and his colleagues retrospectively reviewed records in their institution’s reporting system, called Good Catch, to identify near-miss incidents (ones that didn’t reach the patient) and safety incidents (ones that did) among patients undergoing radiation therapy from October 2014 through April 2016.

Susan London/Frontline Medical News
Dr. Greg D. Judy
They compared patient, clinical, and treatment factors between 200 patients who had such incidents and 200 patients who did not. Each incident was assigned a root cause and was graded for severity (J Clin Oncol. 35, 2017 [suppl 8S; abstract 36]).

Multivariate analysis showed that patients had a significantly higher risk of near-miss or safety incidents if they had stage T2 disease (odds ratio, 3.3), were being treated for cancer involving the head and neck (5.2), or were receiving image-guided intensity-modulated radiation therapy (3.0) or daily imaging as part of their treatment (7.0), Dr. Judy reported.

“Head and neck site and image-guided IMRT [intensity-modulated radiation therapy] are complex entities: They have multiple steps in both the planning and delivery phase,” he said. “Daily imaging as well. It’s a much more complex process to do daily imaging for setup verification than it is to do once-a-week or even once-every-2-weeks setup verification.”

On the other hand, it was unclear why T2 stage was a risk factor. “We kind of hypothesized that it might be more of the disease site that really drives this, as you can have HPV-positive oropharyngeal cancer which usually has lower T stages and more advanced nodal stages, but even then, that’s a head and neck site and we usually use image-guided IMRT, which are both very complex entities,” he said. The most common root causes for the incidents were issues related to documentation and scheduling (29% each), followed by issues related to communication (22%), technical treatment planning (14%), and technical treatment delivery (6%).

Incidents having a communication root cause were more likely than were others to affect patients (P less than .001), and those having a technical treatment delivery root cause were more likely to have higher severity (P = .005).

“Like some other studies, we found really the key factor was the complexity of the treatment plan and complexity of the overall process that is the real driving factor. This is important to understand because it promotes the idea of developing a more dedicated and robust QA system for complex cases,” said Dr. Judy. “It also highlights the importance of a strong reporting system to support a safety culture, as well as promote the continuous learning improvements within a department.”

The national Radiation Oncology Incident Learning System (RO-ILS) has been developed by the American Society for Radiation Oncology (ASTRO). “This is gaining membership very rapidly, and it’s good because it facilitates cooperative research and also safety standards for our field,” he maintained.

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Dr. Joseph O. Jacobson
Invited discussant Joseph O. Jacobson, MD, chief quality officer and a senior physician at the Dana-Farber Cancer Institute in Boston, commended the authors for meeting their study goals of identifying predictor and root causes of incidents.

“I’ll argue that they did that for a variety of reasons,” he elaborated. “Strong and effective leadership by Dr. Larry Marks, who’s really created a departmental culture of safety in which people can feel free to speak up. They have this wonderful Good Catch program in place. And they have these simulation review huddles ... where people feel free to talk about what happened yesterday or today that may be relevant moving forward.”

As for the national RO-ILS initiative, “I would look out to the audience and say, why is it that we don’t have such a program in medical oncology?” Dr. Jacobson said. “It’s probably time for us to do this,” he maintained.

Reducing chemotherapy errors in pediatric oncology

In the second study, Brian D. Weiss, MD, associate director of safety and compliance at Cincinnati Children’s Hospital Medical Center, and his colleagues studied the impact of a safety initiative to prevent chemotherapy errors at their large urban pediatric academic center (J Clin Oncol 35, 2017 [suppl 8S; abstract 37]).

 

 

“Pediatric chemotherapy protocols are different from adult protocols. We dose based on age or weight or body surface area, and that can change within a protocol. You have to do adjustments every time they gain weight or grow some, which is different than for adult protocols,” he explained. “We have parents administering chemo at home. And the protocols most patients are on are very complicated, but there is no standardized format, so it makes crucial information for dose adjustments difficult to find.”

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Dr. Brian D. Weiss
Dr. Weiss and his colleagues created a multidisciplinary chemotherapy safety working group with a pediatric oncologist, inpatient and outpatient chemotherapy nurses, pharmacists, and an expert in quality improvement science methods.

The team successively implemented about half a dozen interventions, such as dedicated chemotherapy safety zones where staff were not to be disturbed while checking orders and ear protectors as a visual deterrent to interruptions; a new chemotherapy registered nurse role with a detailed list of responsibilities; an event-reporting system to supplement the center’s error-reporting system and capture events not reaching the patient (near-miss events); and a daily chemotherapy huddle to discuss errors in a nonpunitive setting and review upcoming chemotherapy for readiness.

In the 6 years after the start of the initiative, 105,187 chemotherapy doses were administered at the center and 998 errors occurred, including 250 errors that reached the patient, according to results reported at the symposium and recently published (J Oncol Pract. 2017 April;13:e329-e336).

At the 22-month mark, the rate of chemotherapy errors reaching the patient had fallen from 3.8 in 1,000 doses at baseline to 1.9 in 1,000 doses. The reduction has since persisted for more than 4 years and translates to an estimated 155 fewer predicted errors reaching the patient because of the initiative.

“The errors that reached the patient were more often administration and dispensing errors,” Dr. Weiss said. “About two-thirds of those errors that didn’t reach the patient – because they got caught by the pharmacists and the nurses – were prescription errors.

“Our chemotherapy huddle has certainly increased our reporting of errors. We also now use it for patients on clinical trials ... any patient getting PK [pharmacokinetics] or PD [pharmacodynamics] sampled within the next 24 hours is reviewed at that meeting. And our missed samples have gone down significantly,” he noted. “It’s allowed us to manage our bed space better because now everybody knows who’s definitely coming in the next day and who’s maybe coming in the next day.”

“We are a large urban academic pediatric medical center. Some of these things may seem difficult to translate [to smaller facilities], but I’m not sure they are,” concluded Dr. Weiss.

Dr. Jacobson, the discussant, noted that the initiative was in keeping with this health system’s longstanding “obsessive” focus on patient safety and commended its rigorousness in, for example, setting clear goals, focusing on key drivers [processes] needed for change, and selecting a good outcome metric.

“This is very successful project,” he said. The success can be attributed to “strong and effective organization and leadership, building a culture of safety at Cincinnati Children’s Hospital, and an important predefined measurement program and methodology.”

Building chemotherapy regimens more accurately

In the third study, a team led by Andrea Crespo, BSc, BScPhm, BCOP, an oncology pharmacist and member of the Systemic Treatment Team at Cancer Care Ontario, Toronto, studied errors introduced when chemotherapy regimens were moved from publications into orders used by centers in the province (J Clin Oncol. 35, 2017 [suppl 8S; abstract 51]).

 

 

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Andrea Crespo
“They depend on cognitive input at multiple points and are susceptible to human error. Computerized prescriptions are often given less attention and considered safe due to their validation by those who created them; this is often called automation complacency,” Ms. Crespo explained. “Errors related to inaccurate regimen creation have been reported ... There currently is no known guidance in oncology to ensure that ST-CPOE regimens are of high quality and built as intended.”

She and her colleagues asked all Ontario treatment centers to review their active chemotherapy regimens. Data were analyzed to determine whether the regimens were built as intended with respect to their component drugs and doses, leading to identification of any unintentional discrepancies with the original regimen.

A total of 33 centers performed the review, and the median number of regimens reviewed was 375 per center, Ms. Crespo reported.

Unintentional discrepancies in regimens were found at 27% of centers. The total number reported was 369 discrepancies, with a range from 2 to 198 per center.

All of the nine centers where discrepancies were found participated in the provincial ST-CPOE system, and most had for at least 20 years. Furthermore, eight of them used a team of at least two pharmacists and one oncologist to build their regimens. “So you can see that discrepancies occurred despite a fairly rigorous regimen-build process and many years of experience with the system,” she said.

Of the 369 total discrepancies, 41% were related to alignment with the Systemic Treatment Quality-Based Program regimen, and 32% were regimens flagged to be inactivated because of outdated information, new standards, or lack of use.

A detailed analysis of the remaining 27%, or 101 unintentional discrepancies, showed that the majority were due to missing information (35.6%) or missing drugs (13.9%), incorrect doses (10.9%), and incorrect or missing schedules (10.9%). Potential to cause harm was mild for 55%, moderate for 28%, and none for 17%.

“Corrective action has been taken to address the discrepancies identified,” said Ms. Crespo.

Only 6% of the 33 centers reported having an established regimen review and maintenance process in place before the study, but all now have such a process. In addition, some centers that did not find any regimen discrepancies nonetheless reported adding quality improvement activities, such as changes in the ways regimens were built and documented, and revising regimen names to facilitate accurate selection.

In discussing the study, Dr. Jacobson noted the low proportion of centers having an established process at baseline to ensure appropriate regimen maintenance and updates. “You might want to think to yourselves, the medical oncologists in the group, whether your center has such a process in place,” he proposed.

It is not yet known whether the project has met its goal of improving the quality and accuracy of oncology regimens in Ontario, he maintained. “We are going to have to invite [Ms. Crespo] back in a year or two to see whether that turns out to be true.” On the other hand, “clearly what they have achieved was the ability to measure the variance between what was intended and what was actually built.”

Chief among the reasons for success, again, “was a strong and effective leadership and organizational structure, not at the department level or hospital level, but across the entire province through Cancer Care Ontario,” Dr. Jacobson said. “It’s clear that they have a focus on quality and patient safety, and this measurement program that they have put in place turned out to be useful.”

Dr. Judy, Dr. Weiss, and Ms. Crespo disclosed that they had no relevant conflicts of interest.
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– Accumulating evidence is helping researchers better understand why errors occur during the delivery of cancer treatment and how to prevent them. Findings from a trio of studies were reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Identifying causes of incidents in radiation therapy

In the first study, Greg D. Judy, MD, a radiation oncology resident at the University of North Carolina at Chapel Hill, and his colleagues retrospectively reviewed records in their institution’s reporting system, called Good Catch, to identify near-miss incidents (ones that didn’t reach the patient) and safety incidents (ones that did) among patients undergoing radiation therapy from October 2014 through April 2016.

Susan London/Frontline Medical News
Dr. Greg D. Judy
They compared patient, clinical, and treatment factors between 200 patients who had such incidents and 200 patients who did not. Each incident was assigned a root cause and was graded for severity (J Clin Oncol. 35, 2017 [suppl 8S; abstract 36]).

Multivariate analysis showed that patients had a significantly higher risk of near-miss or safety incidents if they had stage T2 disease (odds ratio, 3.3), were being treated for cancer involving the head and neck (5.2), or were receiving image-guided intensity-modulated radiation therapy (3.0) or daily imaging as part of their treatment (7.0), Dr. Judy reported.

“Head and neck site and image-guided IMRT [intensity-modulated radiation therapy] are complex entities: They have multiple steps in both the planning and delivery phase,” he said. “Daily imaging as well. It’s a much more complex process to do daily imaging for setup verification than it is to do once-a-week or even once-every-2-weeks setup verification.”

On the other hand, it was unclear why T2 stage was a risk factor. “We kind of hypothesized that it might be more of the disease site that really drives this, as you can have HPV-positive oropharyngeal cancer which usually has lower T stages and more advanced nodal stages, but even then, that’s a head and neck site and we usually use image-guided IMRT, which are both very complex entities,” he said. The most common root causes for the incidents were issues related to documentation and scheduling (29% each), followed by issues related to communication (22%), technical treatment planning (14%), and technical treatment delivery (6%).

Incidents having a communication root cause were more likely than were others to affect patients (P less than .001), and those having a technical treatment delivery root cause were more likely to have higher severity (P = .005).

“Like some other studies, we found really the key factor was the complexity of the treatment plan and complexity of the overall process that is the real driving factor. This is important to understand because it promotes the idea of developing a more dedicated and robust QA system for complex cases,” said Dr. Judy. “It also highlights the importance of a strong reporting system to support a safety culture, as well as promote the continuous learning improvements within a department.”

The national Radiation Oncology Incident Learning System (RO-ILS) has been developed by the American Society for Radiation Oncology (ASTRO). “This is gaining membership very rapidly, and it’s good because it facilitates cooperative research and also safety standards for our field,” he maintained.

Susan London/Frontline Medical News
Dr. Joseph O. Jacobson
Invited discussant Joseph O. Jacobson, MD, chief quality officer and a senior physician at the Dana-Farber Cancer Institute in Boston, commended the authors for meeting their study goals of identifying predictor and root causes of incidents.

“I’ll argue that they did that for a variety of reasons,” he elaborated. “Strong and effective leadership by Dr. Larry Marks, who’s really created a departmental culture of safety in which people can feel free to speak up. They have this wonderful Good Catch program in place. And they have these simulation review huddles ... where people feel free to talk about what happened yesterday or today that may be relevant moving forward.”

As for the national RO-ILS initiative, “I would look out to the audience and say, why is it that we don’t have such a program in medical oncology?” Dr. Jacobson said. “It’s probably time for us to do this,” he maintained.

Reducing chemotherapy errors in pediatric oncology

In the second study, Brian D. Weiss, MD, associate director of safety and compliance at Cincinnati Children’s Hospital Medical Center, and his colleagues studied the impact of a safety initiative to prevent chemotherapy errors at their large urban pediatric academic center (J Clin Oncol 35, 2017 [suppl 8S; abstract 37]).

 

 

“Pediatric chemotherapy protocols are different from adult protocols. We dose based on age or weight or body surface area, and that can change within a protocol. You have to do adjustments every time they gain weight or grow some, which is different than for adult protocols,” he explained. “We have parents administering chemo at home. And the protocols most patients are on are very complicated, but there is no standardized format, so it makes crucial information for dose adjustments difficult to find.”

Susan London/Frontline Medical News
Dr. Brian D. Weiss
Dr. Weiss and his colleagues created a multidisciplinary chemotherapy safety working group with a pediatric oncologist, inpatient and outpatient chemotherapy nurses, pharmacists, and an expert in quality improvement science methods.

The team successively implemented about half a dozen interventions, such as dedicated chemotherapy safety zones where staff were not to be disturbed while checking orders and ear protectors as a visual deterrent to interruptions; a new chemotherapy registered nurse role with a detailed list of responsibilities; an event-reporting system to supplement the center’s error-reporting system and capture events not reaching the patient (near-miss events); and a daily chemotherapy huddle to discuss errors in a nonpunitive setting and review upcoming chemotherapy for readiness.

In the 6 years after the start of the initiative, 105,187 chemotherapy doses were administered at the center and 998 errors occurred, including 250 errors that reached the patient, according to results reported at the symposium and recently published (J Oncol Pract. 2017 April;13:e329-e336).

At the 22-month mark, the rate of chemotherapy errors reaching the patient had fallen from 3.8 in 1,000 doses at baseline to 1.9 in 1,000 doses. The reduction has since persisted for more than 4 years and translates to an estimated 155 fewer predicted errors reaching the patient because of the initiative.

“The errors that reached the patient were more often administration and dispensing errors,” Dr. Weiss said. “About two-thirds of those errors that didn’t reach the patient – because they got caught by the pharmacists and the nurses – were prescription errors.

“Our chemotherapy huddle has certainly increased our reporting of errors. We also now use it for patients on clinical trials ... any patient getting PK [pharmacokinetics] or PD [pharmacodynamics] sampled within the next 24 hours is reviewed at that meeting. And our missed samples have gone down significantly,” he noted. “It’s allowed us to manage our bed space better because now everybody knows who’s definitely coming in the next day and who’s maybe coming in the next day.”

“We are a large urban academic pediatric medical center. Some of these things may seem difficult to translate [to smaller facilities], but I’m not sure they are,” concluded Dr. Weiss.

Dr. Jacobson, the discussant, noted that the initiative was in keeping with this health system’s longstanding “obsessive” focus on patient safety and commended its rigorousness in, for example, setting clear goals, focusing on key drivers [processes] needed for change, and selecting a good outcome metric.

“This is very successful project,” he said. The success can be attributed to “strong and effective organization and leadership, building a culture of safety at Cincinnati Children’s Hospital, and an important predefined measurement program and methodology.”

Building chemotherapy regimens more accurately

In the third study, a team led by Andrea Crespo, BSc, BScPhm, BCOP, an oncology pharmacist and member of the Systemic Treatment Team at Cancer Care Ontario, Toronto, studied errors introduced when chemotherapy regimens were moved from publications into orders used by centers in the province (J Clin Oncol. 35, 2017 [suppl 8S; abstract 51]).

 

 

Susan London/Frontline Medical News
Andrea Crespo
“They depend on cognitive input at multiple points and are susceptible to human error. Computerized prescriptions are often given less attention and considered safe due to their validation by those who created them; this is often called automation complacency,” Ms. Crespo explained. “Errors related to inaccurate regimen creation have been reported ... There currently is no known guidance in oncology to ensure that ST-CPOE regimens are of high quality and built as intended.”

She and her colleagues asked all Ontario treatment centers to review their active chemotherapy regimens. Data were analyzed to determine whether the regimens were built as intended with respect to their component drugs and doses, leading to identification of any unintentional discrepancies with the original regimen.

A total of 33 centers performed the review, and the median number of regimens reviewed was 375 per center, Ms. Crespo reported.

Unintentional discrepancies in regimens were found at 27% of centers. The total number reported was 369 discrepancies, with a range from 2 to 198 per center.

All of the nine centers where discrepancies were found participated in the provincial ST-CPOE system, and most had for at least 20 years. Furthermore, eight of them used a team of at least two pharmacists and one oncologist to build their regimens. “So you can see that discrepancies occurred despite a fairly rigorous regimen-build process and many years of experience with the system,” she said.

Of the 369 total discrepancies, 41% were related to alignment with the Systemic Treatment Quality-Based Program regimen, and 32% were regimens flagged to be inactivated because of outdated information, new standards, or lack of use.

A detailed analysis of the remaining 27%, or 101 unintentional discrepancies, showed that the majority were due to missing information (35.6%) or missing drugs (13.9%), incorrect doses (10.9%), and incorrect or missing schedules (10.9%). Potential to cause harm was mild for 55%, moderate for 28%, and none for 17%.

“Corrective action has been taken to address the discrepancies identified,” said Ms. Crespo.

Only 6% of the 33 centers reported having an established regimen review and maintenance process in place before the study, but all now have such a process. In addition, some centers that did not find any regimen discrepancies nonetheless reported adding quality improvement activities, such as changes in the ways regimens were built and documented, and revising regimen names to facilitate accurate selection.

In discussing the study, Dr. Jacobson noted the low proportion of centers having an established process at baseline to ensure appropriate regimen maintenance and updates. “You might want to think to yourselves, the medical oncologists in the group, whether your center has such a process in place,” he proposed.

It is not yet known whether the project has met its goal of improving the quality and accuracy of oncology regimens in Ontario, he maintained. “We are going to have to invite [Ms. Crespo] back in a year or two to see whether that turns out to be true.” On the other hand, “clearly what they have achieved was the ability to measure the variance between what was intended and what was actually built.”

Chief among the reasons for success, again, “was a strong and effective leadership and organizational structure, not at the department level or hospital level, but across the entire province through Cancer Care Ontario,” Dr. Jacobson said. “It’s clear that they have a focus on quality and patient safety, and this measurement program that they have put in place turned out to be useful.”

Dr. Judy, Dr. Weiss, and Ms. Crespo disclosed that they had no relevant conflicts of interest.

 

– Accumulating evidence is helping researchers better understand why errors occur during the delivery of cancer treatment and how to prevent them. Findings from a trio of studies were reported at a symposium on quality care sponsored by the American Society of Clinical Oncology.

Identifying causes of incidents in radiation therapy

In the first study, Greg D. Judy, MD, a radiation oncology resident at the University of North Carolina at Chapel Hill, and his colleagues retrospectively reviewed records in their institution’s reporting system, called Good Catch, to identify near-miss incidents (ones that didn’t reach the patient) and safety incidents (ones that did) among patients undergoing radiation therapy from October 2014 through April 2016.

Susan London/Frontline Medical News
Dr. Greg D. Judy
They compared patient, clinical, and treatment factors between 200 patients who had such incidents and 200 patients who did not. Each incident was assigned a root cause and was graded for severity (J Clin Oncol. 35, 2017 [suppl 8S; abstract 36]).

Multivariate analysis showed that patients had a significantly higher risk of near-miss or safety incidents if they had stage T2 disease (odds ratio, 3.3), were being treated for cancer involving the head and neck (5.2), or were receiving image-guided intensity-modulated radiation therapy (3.0) or daily imaging as part of their treatment (7.0), Dr. Judy reported.

“Head and neck site and image-guided IMRT [intensity-modulated radiation therapy] are complex entities: They have multiple steps in both the planning and delivery phase,” he said. “Daily imaging as well. It’s a much more complex process to do daily imaging for setup verification than it is to do once-a-week or even once-every-2-weeks setup verification.”

On the other hand, it was unclear why T2 stage was a risk factor. “We kind of hypothesized that it might be more of the disease site that really drives this, as you can have HPV-positive oropharyngeal cancer which usually has lower T stages and more advanced nodal stages, but even then, that’s a head and neck site and we usually use image-guided IMRT, which are both very complex entities,” he said. The most common root causes for the incidents were issues related to documentation and scheduling (29% each), followed by issues related to communication (22%), technical treatment planning (14%), and technical treatment delivery (6%).

Incidents having a communication root cause were more likely than were others to affect patients (P less than .001), and those having a technical treatment delivery root cause were more likely to have higher severity (P = .005).

“Like some other studies, we found really the key factor was the complexity of the treatment plan and complexity of the overall process that is the real driving factor. This is important to understand because it promotes the idea of developing a more dedicated and robust QA system for complex cases,” said Dr. Judy. “It also highlights the importance of a strong reporting system to support a safety culture, as well as promote the continuous learning improvements within a department.”

The national Radiation Oncology Incident Learning System (RO-ILS) has been developed by the American Society for Radiation Oncology (ASTRO). “This is gaining membership very rapidly, and it’s good because it facilitates cooperative research and also safety standards for our field,” he maintained.

Susan London/Frontline Medical News
Dr. Joseph O. Jacobson
Invited discussant Joseph O. Jacobson, MD, chief quality officer and a senior physician at the Dana-Farber Cancer Institute in Boston, commended the authors for meeting their study goals of identifying predictor and root causes of incidents.

“I’ll argue that they did that for a variety of reasons,” he elaborated. “Strong and effective leadership by Dr. Larry Marks, who’s really created a departmental culture of safety in which people can feel free to speak up. They have this wonderful Good Catch program in place. And they have these simulation review huddles ... where people feel free to talk about what happened yesterday or today that may be relevant moving forward.”

As for the national RO-ILS initiative, “I would look out to the audience and say, why is it that we don’t have such a program in medical oncology?” Dr. Jacobson said. “It’s probably time for us to do this,” he maintained.

Reducing chemotherapy errors in pediatric oncology

In the second study, Brian D. Weiss, MD, associate director of safety and compliance at Cincinnati Children’s Hospital Medical Center, and his colleagues studied the impact of a safety initiative to prevent chemotherapy errors at their large urban pediatric academic center (J Clin Oncol 35, 2017 [suppl 8S; abstract 37]).

 

 

“Pediatric chemotherapy protocols are different from adult protocols. We dose based on age or weight or body surface area, and that can change within a protocol. You have to do adjustments every time they gain weight or grow some, which is different than for adult protocols,” he explained. “We have parents administering chemo at home. And the protocols most patients are on are very complicated, but there is no standardized format, so it makes crucial information for dose adjustments difficult to find.”

Susan London/Frontline Medical News
Dr. Brian D. Weiss
Dr. Weiss and his colleagues created a multidisciplinary chemotherapy safety working group with a pediatric oncologist, inpatient and outpatient chemotherapy nurses, pharmacists, and an expert in quality improvement science methods.

The team successively implemented about half a dozen interventions, such as dedicated chemotherapy safety zones where staff were not to be disturbed while checking orders and ear protectors as a visual deterrent to interruptions; a new chemotherapy registered nurse role with a detailed list of responsibilities; an event-reporting system to supplement the center’s error-reporting system and capture events not reaching the patient (near-miss events); and a daily chemotherapy huddle to discuss errors in a nonpunitive setting and review upcoming chemotherapy for readiness.

In the 6 years after the start of the initiative, 105,187 chemotherapy doses were administered at the center and 998 errors occurred, including 250 errors that reached the patient, according to results reported at the symposium and recently published (J Oncol Pract. 2017 April;13:e329-e336).

At the 22-month mark, the rate of chemotherapy errors reaching the patient had fallen from 3.8 in 1,000 doses at baseline to 1.9 in 1,000 doses. The reduction has since persisted for more than 4 years and translates to an estimated 155 fewer predicted errors reaching the patient because of the initiative.

“The errors that reached the patient were more often administration and dispensing errors,” Dr. Weiss said. “About two-thirds of those errors that didn’t reach the patient – because they got caught by the pharmacists and the nurses – were prescription errors.

“Our chemotherapy huddle has certainly increased our reporting of errors. We also now use it for patients on clinical trials ... any patient getting PK [pharmacokinetics] or PD [pharmacodynamics] sampled within the next 24 hours is reviewed at that meeting. And our missed samples have gone down significantly,” he noted. “It’s allowed us to manage our bed space better because now everybody knows who’s definitely coming in the next day and who’s maybe coming in the next day.”

“We are a large urban academic pediatric medical center. Some of these things may seem difficult to translate [to smaller facilities], but I’m not sure they are,” concluded Dr. Weiss.

Dr. Jacobson, the discussant, noted that the initiative was in keeping with this health system’s longstanding “obsessive” focus on patient safety and commended its rigorousness in, for example, setting clear goals, focusing on key drivers [processes] needed for change, and selecting a good outcome metric.

“This is very successful project,” he said. The success can be attributed to “strong and effective organization and leadership, building a culture of safety at Cincinnati Children’s Hospital, and an important predefined measurement program and methodology.”

Building chemotherapy regimens more accurately

In the third study, a team led by Andrea Crespo, BSc, BScPhm, BCOP, an oncology pharmacist and member of the Systemic Treatment Team at Cancer Care Ontario, Toronto, studied errors introduced when chemotherapy regimens were moved from publications into orders used by centers in the province (J Clin Oncol. 35, 2017 [suppl 8S; abstract 51]).

 

 

Susan London/Frontline Medical News
Andrea Crespo
“They depend on cognitive input at multiple points and are susceptible to human error. Computerized prescriptions are often given less attention and considered safe due to their validation by those who created them; this is often called automation complacency,” Ms. Crespo explained. “Errors related to inaccurate regimen creation have been reported ... There currently is no known guidance in oncology to ensure that ST-CPOE regimens are of high quality and built as intended.”

She and her colleagues asked all Ontario treatment centers to review their active chemotherapy regimens. Data were analyzed to determine whether the regimens were built as intended with respect to their component drugs and doses, leading to identification of any unintentional discrepancies with the original regimen.

A total of 33 centers performed the review, and the median number of regimens reviewed was 375 per center, Ms. Crespo reported.

Unintentional discrepancies in regimens were found at 27% of centers. The total number reported was 369 discrepancies, with a range from 2 to 198 per center.

All of the nine centers where discrepancies were found participated in the provincial ST-CPOE system, and most had for at least 20 years. Furthermore, eight of them used a team of at least two pharmacists and one oncologist to build their regimens. “So you can see that discrepancies occurred despite a fairly rigorous regimen-build process and many years of experience with the system,” she said.

Of the 369 total discrepancies, 41% were related to alignment with the Systemic Treatment Quality-Based Program regimen, and 32% were regimens flagged to be inactivated because of outdated information, new standards, or lack of use.

A detailed analysis of the remaining 27%, or 101 unintentional discrepancies, showed that the majority were due to missing information (35.6%) or missing drugs (13.9%), incorrect doses (10.9%), and incorrect or missing schedules (10.9%). Potential to cause harm was mild for 55%, moderate for 28%, and none for 17%.

“Corrective action has been taken to address the discrepancies identified,” said Ms. Crespo.

Only 6% of the 33 centers reported having an established regimen review and maintenance process in place before the study, but all now have such a process. In addition, some centers that did not find any regimen discrepancies nonetheless reported adding quality improvement activities, such as changes in the ways regimens were built and documented, and revising regimen names to facilitate accurate selection.

In discussing the study, Dr. Jacobson noted the low proportion of centers having an established process at baseline to ensure appropriate regimen maintenance and updates. “You might want to think to yourselves, the medical oncologists in the group, whether your center has such a process in place,” he proposed.

It is not yet known whether the project has met its goal of improving the quality and accuracy of oncology regimens in Ontario, he maintained. “We are going to have to invite [Ms. Crespo] back in a year or two to see whether that turns out to be true.” On the other hand, “clearly what they have achieved was the ability to measure the variance between what was intended and what was actually built.”

Chief among the reasons for success, again, “was a strong and effective leadership and organizational structure, not at the department level or hospital level, but across the entire province through Cancer Care Ontario,” Dr. Jacobson said. “It’s clear that they have a focus on quality and patient safety, and this measurement program that they have put in place turned out to be useful.”

Dr. Judy, Dr. Weiss, and Ms. Crespo disclosed that they had no relevant conflicts of interest.
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Key clinical point: Identifying and targeting risk factors for treatment errors in oncology can reduce their occurrence.

Major finding: Risk factors for radiation therapy near-miss and safety incidents were T2 stage, H&N site, and more complex techniques (odds ratios, 3.0-7.0). A quality improvement initiative halved the rate of chemotherapy errors reaching the patient from 3.8 to 1.9 per 1,000 doses. Twenty-seven percent of centers found unintentional discrepancies in their chemotherapy regimens, 83% with potential to cause harm.

Data source: A retrospective case-control study of 400 patients receiving radiation therapy, a longitudinal cohort study of a quality improvement initiative at an urban pediatric academic medical center involving administration of 105,187 chemotherapy doses, and a cohort study of 33 Ontario treatment centers that reviewed a median of 375 chemotherapy regimens.

Disclosures: Dr. Judy, Dr. Weiss, and Ms. Crespo disclosed that they had no relevant conflicts of interest.

Tools measuring oxygen desaturation produced disparate data

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WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.


The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.


AL  showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).


This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.


“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”


The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.


ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).


When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.


Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.


“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.


When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.


Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.

Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.


Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.


Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.

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Dr. Krishna Sundar
Krishna Sundar, MD, FCCP, comments: This article raises significant concerns about the role of different oximeters in contributing to the variation in hypopnea scoring.
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Dr. Krishna Sundar
Krishna Sundar, MD, FCCP, comments: This article raises significant concerns about the role of different oximeters in contributing to the variation in hypopnea scoring.
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Dr. Krishna Sundar
Krishna Sundar, MD, FCCP, comments: This article raises significant concerns about the role of different oximeters in contributing to the variation in hypopnea scoring.

 

WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.


The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.


AL  showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).


This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.


“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”


The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.


ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).


When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.


Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.


“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.


When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.


Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.

Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.


Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.


Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.

 

WASHINGTON – Oxygen desaturation index (ODI) scores showed significant variation across two software systems, a study showed.


The researchers assessed the ODI scores of 106 patients using the ResMed ApneaLink Plus system (AL) and the Compumedics Grael Profusion PSG3 system (Comp). “AL ODI values tended to be higher than Comp ODI values, but with significant variability,” they said.


AL  showed a bias of an additional 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) for ODI scores at 4% desaturation and a bias of an additional 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour) at 3% desaturation (J Clin Sleep Med. 2017;13[4]:599-605).


This may be problematic for physicians evaluating patients during sleep studies who rely on ODI scores at 3% and 4% desaturations to create accurate apnea severity assessments, the investigators said.


“[The] wide limits of agreement in our study highlight that clinicians cannot be confident that an ODI4% recorded in the AL is the same as that recorded in the Comp,” wrote Yvonne Ng, MBBS, of the department of lung and sleep medicine at Monash Health, Victoria, Australia, and her colleagues. “The differences are large enough to significantly affect diagnostic thresholds for OSA [obstructive sleep apnea] and, in particular, moderate-severe OSA.”


The researchers gathered data from patients undergoing sleep analysis at the Monash Medical Centre, who were, on average, 47 years of age, had a body mass index score of 32 kg/m2, and had an apnea hypopnea index (AHI) of 23.2.


ODI3% scores analyzed through Comp diagnosed 66 patients with OSA (ODI3% greater than or equal to 5 events per hour), while desaturation events analyzed through the AL system diagnosed 90 patients, a 36% increase over Comp (P = .0002).


When researchers tested for moderate to severe OSA (ODI3% greater than or equal to 15 events per hour), 32 patients were diagnosed using the Comp system, compared with 59 patients using the AL system.


Disparities in these measurements create uncertainty among clinicians, who rely on ODI measurements for scores that are accurate and can be easily replicated using an algorithm, the researchers said.


“The current work demonstrates that significantly more patients would receive a diagnosis of OSA, or more particularly, moderate-severe OSA, with the AL ODI, compared to the Comp ODI,” Dr. Ng and her colleagues wrote.


When sensitivity scores for Comp and AL were compared, AL ODI3% scores were significantly more sensitive than Comp, with sensitivity scores of 96% vs. 58%.


Using different fingers for measuring desaturation during the test or differences in algorithms used to assess ODI scores were possible sources of the disparities, the researchers noted.

Differences in internal processing between the two systems were the most likely causes of the discrepancies between the data collected using each system, they added.


Because there is no universal standard for ODI measurements, the researchers were unable to determine which system was more accurate.


Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.

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Key clinical point: Two software systems used for measuring patients’ oxygen desaturation indexes produced disparate results.

Major finding: ODI tests analyzed using the ResMed APneaLink Plus system vs. Compumedics Grael Profusion PSG3 system reported ODI4% bias = 4.4 events per hour (95% limits of agreement, –5.8 to 14.6 events per hour) and ODI3% bias = 7.1 events per hour (95% limits of agreement, –6.4 to 20.6 events per hour).

Data source: ODI test results for 106 participants in a sleep study at Monash Medical Centre.

Disclosures: Several of the researchers reported receiving financial support, research equipment, or consultancy fees from various entities.
 

No-shows

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Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for medical offices as a whole.

Why the higher rate? One reason is a lag between appointment and visit. Many dermatologists are booked well in advance, so, by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found other offices willing to see them sooner. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is highest when the patient is paying out-of-pocket for the visit.

Dr. Joseph S. Eastern
But the biggest reason is probably the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. Others may suffer from poor communication. For example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably-priced phone software is available from a variety of vendors to automate this process. You could also hire a teenager to do it after school each day.

Whenever possible, use cell phone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. Patients who have moved will often have a new home phone number, but their cell phone numbers will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

If your no-shows are incorrigible, consider charging them. One increasingly popular mechanism is a fee ($20 seems to be popular) that must be paid at the time of the next appointment before being seen. Some patients will respond to that by never showing up again. Fine. You need to reserve your appointment slots for patients who plan to keep them. Those more contrite will pay and, hopefully, learn their lesson. Give your receptionists the power to override the charge since there are, obviously, legitimate reasons for missing an appointment.

One physician in my area told me he seldom actually collects the fee, which is okay with him. “After all,” he said, “the purpose is not to generate income. It’s to encourage patients to keep their appointments.”

If you go this route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee and cannot be billed to insurance. Remind patients about it during reminder calls. If you have a high no-show rate for cosmetic and other noninsurance procedures, consider collecting a nonrefundable deposit in advance.

Above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses the visit for re-excision) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

All missed appointments should be documented in the patient’s record – it’s important clinical and medicolegal information. A second missed appointment should prompt a written warning that measures will be taken if it happens again. Make sure to spell out what those measures are, and stick to them. Habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

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Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for medical offices as a whole.

Why the higher rate? One reason is a lag between appointment and visit. Many dermatologists are booked well in advance, so, by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found other offices willing to see them sooner. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is highest when the patient is paying out-of-pocket for the visit.

Dr. Joseph S. Eastern
But the biggest reason is probably the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. Others may suffer from poor communication. For example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably-priced phone software is available from a variety of vendors to automate this process. You could also hire a teenager to do it after school each day.

Whenever possible, use cell phone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. Patients who have moved will often have a new home phone number, but their cell phone numbers will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

If your no-shows are incorrigible, consider charging them. One increasingly popular mechanism is a fee ($20 seems to be popular) that must be paid at the time of the next appointment before being seen. Some patients will respond to that by never showing up again. Fine. You need to reserve your appointment slots for patients who plan to keep them. Those more contrite will pay and, hopefully, learn their lesson. Give your receptionists the power to override the charge since there are, obviously, legitimate reasons for missing an appointment.

One physician in my area told me he seldom actually collects the fee, which is okay with him. “After all,” he said, “the purpose is not to generate income. It’s to encourage patients to keep their appointments.”

If you go this route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee and cannot be billed to insurance. Remind patients about it during reminder calls. If you have a high no-show rate for cosmetic and other noninsurance procedures, consider collecting a nonrefundable deposit in advance.

Above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses the visit for re-excision) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

All missed appointments should be documented in the patient’s record – it’s important clinical and medicolegal information. A second missed appointment should prompt a written warning that measures will be taken if it happens again. Make sure to spell out what those measures are, and stick to them. Habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

 

Of all the headaches inherent in a private medical practice, few are more frustrating than patients who make appointments and then fail to keep them.

No-shows are a problem for all physicians but especially for dermatologists. In one study, the no-show rate in dermatology offices averaged 10% – almost double the average for medical offices as a whole.

Why the higher rate? One reason is a lag between appointment and visit. Many dermatologists are booked well in advance, so, by the time the appointment arrives, some patients’ complaints will have resolved spontaneously, while other patients will have found other offices willing to see them sooner. Another reason is lack of insurance coverage. Studies have shown that the no-show rate is highest when the patient is paying out-of-pocket for the visit.

Dr. Joseph S. Eastern
But the biggest reason is probably the absence of a strong physician-patient relationship. Perhaps the patient sees a different doctor or physician assistant at each visit and doesn’t feel a particular bond with any of them. Some patients may perceive a lack of concern on the part of the physician. Others may suffer from poor communication. For example, patients frequently become frustrated that a chronic condition has not resolved, when it has not been clearly explained to them that such problems cannot be expected to resolve completely.

Whatever the reasons, no-shows are an economic and medicolegal liability. It is worth the considerable effort it often takes to minimize them.

Deal with simple forgetfulness by calling your patients the day before to remind them of their appointments. Reasonably-priced phone software is available from a variety of vendors to automate this process. You could also hire a teenager to do it after school each day.

Whenever possible, use cell phone numbers for reminder calls. Patients often aren’t home during the day, and many don’t listen to their messages when they come in. Patients who have moved will often have a new home phone number, but their cell phone numbers will be the same.

Decrease the wait for new appointments. Keep some slots open each week for new patients, who will often “shop around” for a faster appointment while they’re waiting for an appointment they already have elsewhere.

If your no-shows are incorrigible, consider charging them. One increasingly popular mechanism is a fee ($20 seems to be popular) that must be paid at the time of the next appointment before being seen. Some patients will respond to that by never showing up again. Fine. You need to reserve your appointment slots for patients who plan to keep them. Those more contrite will pay and, hopefully, learn their lesson. Give your receptionists the power to override the charge since there are, obviously, legitimate reasons for missing an appointment.

One physician in my area told me he seldom actually collects the fee, which is okay with him. “After all,” he said, “the purpose is not to generate income. It’s to encourage patients to keep their appointments.”

If you go this route, be sure to post notices in your office and on your website clearly delineating your policy. Emphasize that it is not a service fee and cannot be billed to insurance. Remind patients about it during reminder calls. If you have a high no-show rate for cosmetic and other noninsurance procedures, consider collecting a nonrefundable deposit in advance.

Above all, seek to maximize the strength of your physician-patient relationships. Try not to shuttle patients between different physicians or PAs, and make it clear that you are genuinely concerned about their health. Impress upon them the crucial role they play in their own care, which includes keeping all their appointments.

In our office, significant no-shows (for example, a patient with a melanoma who misses the visit for re-excision) receive a phone call and a certified letter, and their records go into a special file for close follow-up by the nursing staff.

All missed appointments should be documented in the patient’s record – it’s important clinical and medicolegal information. A second missed appointment should prompt a written warning that measures will be taken if it happens again. Make sure to spell out what those measures are, and stick to them. Habitual no-shows should be dismissed from your practice. You cannot afford them.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters and is a longtime monthly columnist for Dermatology News. Write to him at dermnews@frontlinemedcom.com.

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USPSTF discourages postmenopausal hormone therapy for prevention

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Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.

The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.

After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.

The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.

Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.

However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).

Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.

The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.

Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.

View the recommendations online at uspreventiveservicestaskforce.org.

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Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.

The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.

After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.

The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.

Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.

However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).

Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.

The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.

Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.

View the recommendations online at uspreventiveservicestaskforce.org.

 

Hormone therapy, in the form of estrogen combined with progestin, is not recommended to prevent chronic conditions such as heart disease and diabetes in postmenopausal women, according to updated draft recommendations from the U.S. Preventive Services Task Force. They also recommended against the use of estrogen alone in postmenopausal women who have had a hysterectomy.

The updated recommendations were published online May 16 on the U.S. Preventive Services Task Force website.

After considering new evidence in the last several years, the recommendations are essentially unchanged from the final recommendations published in 2012, according to a Task Force statement published with the recommendations. “The benefits of using menopausal hormone therapy to prevent chronic conditions like heart disease and diabetes do not outweigh the harms in women who have gone through menopause,” Maureen G. Phipps, MD, MPH, a task force member, said in the statement.

The draft recommendations were based on a review of 17 randomized clinical trials published through Aug. 1, 2016, that included data from the Women’s Health Initiative.

Women taking estrogen/progestin reported a significantly lower risk (per 10,000 women approximately 5 years) of colorectal cancer, diabetes, and fractures, compared with women on a placebo, wrote Gerald Gartlehner, MD, and his colleagues at the RTI International–University of North Carolina Evidence-Based Practice Center in Research Triangle Park, NC, in the evidence report accompanying the draft recommendations.

However, the risks for several other conditions were significantly higher among women on hormone therapy, compared with placebo, including invasive breast cancer (52 more cases), coronary heart disease (41 more cases) probable dementia (88 more cases), gallbladder disease (259 more cases), stroke (53 more cases), and venous thromboembolism (120 more cases). Additionally, urinary incontinence rates were higher after a 1-year follow up among women on hormone therapy (876 more cases/10,000 women).

Some evidence suggests that women who began hormone therapy closer to menopause might have a lower risk for developing cardiovascular complications, but the evidence is insufficient for firm conclusions, the researchers wrote.

The recommendations against hormone therapy do not apply to women younger than 50 years who have undergone oophorectomies or premature menopause, or to those considering hormone therapy to manage menopausal symptoms, according to the Task Force.

Public comments on the draft recommendations may be submitted on the Task Force website until June 12. The researchers had no financial conflicts to disclose.

View the recommendations online at uspreventiveservicestaskforce.org.

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Despite CVD risk, few internists screen for prior preeclampsia

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– Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.

Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).

“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Irene Lewnard
This is true, she said, despite that “preeclampsia meets or exceeds traditional risk factors for cardiovascular disease.” Preeclampsia can result in a two- to threefold elevation in risk for CVD, a figure in line with the increased risk seen for smokers and individuals with obesity or metabolic syndrome. However, the CVD risk for women who have had preterm preeclampsia may be eight or nine times higher than that seen in the general population, she said.

Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.

The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.

Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.

Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.

In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.

In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.

Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).

A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).

When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.

The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.

Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
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– Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.

Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).

“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Irene Lewnard
This is true, she said, despite that “preeclampsia meets or exceeds traditional risk factors for cardiovascular disease.” Preeclampsia can result in a two- to threefold elevation in risk for CVD, a figure in line with the increased risk seen for smokers and individuals with obesity or metabolic syndrome. However, the CVD risk for women who have had preterm preeclampsia may be eight or nine times higher than that seen in the general population, she said.

Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.

The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.

Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.

Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.

In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.

In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.

Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).

A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).

When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.

The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.

Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.

 

– Women who have preeclampsia are at increased risk for later cardiovascular disease, yet internists performing well-woman exams were unlikely to have asked their patients about a history of preeclampsia, a small study showed.

Just 21 of 89 women were asked about preeclampsia during a well-woman exam, while 88 of 89 were asked about diabetes or smoking history, and all 89 were asked about hypertension (P = .0002 for comparing preeclampsia to each individual comorbidity).

“There is a screening gap leading to missed opportunities to identify women at risk for cardiovascular disease,” Irene Lewnard, MD, said at the annual meeting of the American College of Obstetricians and Gynecologists.

Dr. Irene Lewnard
This is true, she said, despite that “preeclampsia meets or exceeds traditional risk factors for cardiovascular disease.” Preeclampsia can result in a two- to threefold elevation in risk for CVD, a figure in line with the increased risk seen for smokers and individuals with obesity or metabolic syndrome. However, the CVD risk for women who have had preterm preeclampsia may be eight or nine times higher than that seen in the general population, she said.

Dr. Lewnard and her colleagues at the Medical College of Wisconsin, Milwaukee, used a retrospective chart review to see whether internal medicine physicians were asking about preeclampsia as well as traditional CVD risk factors during well-woman exams.

The researchers looked at records from 89 women, aged 18-48 years, who had at least one prior delivery to see whether they were asked about preeclampsia. The review also assessed whether physicians had asked about traditional CVD risk factors: smoking, diabetes, and hypertension.

Of the 89 patients, 6 had a confirmed prior history of preeclampsia. The demographic characteristics and obstetric histories of these patients were not significantly different from those of the larger group. The mean patient age was about 35 years, and the average gravidity was three and parity was two.

Dr. Lewnard, an ob.gyn., and her colleagues looked at charts beginning Jan. 1, 2013, and ending May 31, 2016, after both the American Heart Association (AHA) and the American College of Obstetricians and Gynecologists (ACOG) had issued guidelines that recognized the elevated CVD risk for women with a history of preeclampsia.

In 2011, the AHA issued guidelines that preeclampsia should be listed along with gestational diabetes and gestational hypertension as risk factors for CVD. The AHA called for ob.gyns. to refer patients with these conditions to primary care physicians or cardiologists for follow-up, and recommended that providers include questions about pregnancy-related CVD risk factors when taking a history.

In 2013, ACOG recommended early screening for heart disease for women with a history of preterm or recurrent preeclampsia, to include a consideration for early assessment of blood pressure, body mass index, serum lipids, and fasting blood glucose. The group also recommended counseling on modifiable lifestyle factors for these patients.

Data from several large studies support preeclampsia’s status as an independent risk factor for CVD. A 2001 Norwegian study of more than 600,000 births found that, for women who had preeclampsia and were delivered at term, the relative risk for death from cardiovascular disease was 1.65. However, when women with preeclampsia gave birth before 37 weeks’ gestation, the relative risk for later death from CVD rose to 8.12 (BMJ. 2001;323[7323]:1213-7).

A 2007 systematic review and meta-analysis examined data from 3,488,160 women and found a relative risk of 2.16 for ischemic heart disease after an average 11.7 years of follow-up (BMJ 2007;335:974). Finally, a smaller 2010 California study of 14,403 women found a hazard ratio of 2.14 for CVD-related deaths for all women with a history of preeclampsia. For women whose preeclampsia began before 34 weeks’ gestation, that hazard ratio rose to 9.54 (Hypertension. 2010;56:166-71).

When Dr. Lewnard and her colleagues spoke with the internists who had participated in their study, several raised the point that there are not clear guidelines about how to incorporate a history of preeclampsia into risk calculators or treatment recommendations. This knowledge gap, she said, should be addressed, with an ultimate goal of establishing an interdisciplinary set of guidelines for counseling and management of women with prior preeclampsia.

The investigators are assessing whether adding prompts to the electronic medical record could increase the number of primary care physicians who include preeclampsia questions in their history taking.

Dr. Lewnard and her colleagues reported having no outside sources of funding and no conflicts of interest.
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Key clinical point: Fewer than one in four women were asked about preeclampsia history during well-woman exams with an internist.

Major finding: Of 89 women who received well-woman exams, 21 were asked about prior preeclampsia, while 88 were asked about diabetes and smoking, and 89, about hypertension (P = .0002).

Data source: A retrospective record review of 89 women receiving well-woman exams in the year after the American College of Obstetricians and Gynecologists issued CVD screening guidelines for prior preeclampsia.

Disclosures: The study authors reported having no outside sources of funding and no conflicts of interest.

Oral iron of no benefit in heart failure with iron deficiency

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High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.

Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.

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Intravenous iron repletion produces consistent clinical benefit in symptomatic HF patients with reduced left ventricular ejection fraction (LVEF) who also have iron deficiency. But repeated IV treatments are impractical for many patients, and clinicians have turned to prescribing oral iron supplements in the hope of achieving similar results. However, until now, no large randomized, controlled clinical trials have examined the effectiveness of the oral route of administration, Dr. Lewis and his associates noted.

The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.

These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.

The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).

In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.

In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.

This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.

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High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.

Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.

Saipg/iStockphoto
Intravenous iron repletion produces consistent clinical benefit in symptomatic HF patients with reduced left ventricular ejection fraction (LVEF) who also have iron deficiency. But repeated IV treatments are impractical for many patients, and clinicians have turned to prescribing oral iron supplements in the hope of achieving similar results. However, until now, no large randomized, controlled clinical trials have examined the effectiveness of the oral route of administration, Dr. Lewis and his associates noted.

The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.

These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.

The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).

In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.

In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.

This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.

 

High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure who also have iron deficiency, according to a report published online May 16 in JAMA.

Iron deficiency in patients with HF, regardless of their hemoglobin status, is associated with reduced functional capacity, poorer quality of life, and increased mortality. Iron plays a crucial role in the delivery and utilization of oxygen, and “cells with high-energy demands, including skeletal and cardiac myocytes, are particularly sensitive to depleted iron stores,” said Gregory D. Lewis, MD, of the pulmonary critical care unit of Massachusetts General Hospital, Boston, and his associates.

Saipg/iStockphoto
Intravenous iron repletion produces consistent clinical benefit in symptomatic HF patients with reduced left ventricular ejection fraction (LVEF) who also have iron deficiency. But repeated IV treatments are impractical for many patients, and clinicians have turned to prescribing oral iron supplements in the hope of achieving similar results. However, until now, no large randomized, controlled clinical trials have examined the effectiveness of the oral route of administration, Dr. Lewis and his associates noted.

The IRONOUT study was conducted at 23 U.S. medical centers, where outcomes after 16 weeks of oral iron therapy (150 mg twice daily) were compared against matching placebo in 225 patients. The median patient age was 63 years, and the median duration of HF was 5.7 years. Ischemic heart disease was the primary cause of HF in 78% of the study participants.

These patients had low LVEF and poor exercise capacity, despite having high rates of guideline-directed treatment with medications.

The primary endpoint was a change in peak oxygen uptake (peak VO2) at the conclusion of treatment, a measure that “reflects the multiple mechanisms by which iron repletion is expected to improve systemic oxygen delivery and utilization.” Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min), the investigators wrote (JAMA Pediatr. 2017 May 16. doi: 10.1001/jama.2017.5427).

In subgroup analyses, oral iron also failed to improve peak VO2 in any subgroup of patients: neither men nor women; neither those with decreased hemoglobin nor those with normal hemoglobin levels; nor patients with or without venous congestion at baseline. Oral iron also failed to improve secondary endpoints including 6-minute walk distance, quality of life scores, NT-proBNP levels, and ventilatory efficiency.

In contrast to previous studies of IV iron repletion, oral iron supplementation “produced minimal improvement in iron stores, implicating the route of administration rather than the strategy of iron repletion in the lack of clinical benefit,” Dr. Lewis and his associates said.

This study was funded by the National Heart, Lung, and Blood Institute, which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.

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Key clinical point: High-dose oral iron therapy doesn’t improve exercise capacity in the estimated 50% of patients with symptomatic heart failure and iron deficiency.

Major finding: Change in peak VO2 was not significantly different between the 111 participants who took oral iron supplements (+23 mL/min) and the 114 who took placebo (–2 mL/min).

Data source: A multicenter, randomized, double-blind, placebo-controlled phase II trial involving 225 patients treated for 16 weeks.

Disclosures: This study was funded by the National Heart, Lung, and Blood Institute (NCT02188784), which also conceived, designed, and conducted the trial. Dr. Lewis reported ties to Abbott, Novartis, Shape Systems, Stealth Bio Therapeutics, Ironwood, Cheetah Medical, Luitpold, and SoniVie. His associates reported ties to numerous industry sources.

Can prenatal choline lead to prevention of Alzheimer’s?

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As psychiatrists, we are the advocates for inserting the biological thread into the tapestry of understanding human behavior. Try as they may, other mental health professionals are not biologists at heart. Accordingly, psychiatrists bring important thoughtfulness to any consideration about mental health and wellness and about the treatment and prevention of problematic thoughts, feelings, and behaviors.

Throughout my career, my main focus has been on identifying strategies and treatments that can prevent mental illness. For example, I wrote a column about prevention for Clinical Psychiatry News from 2004 to 2011, and, as a member of the publication’s Editorial Advisory Board, I continue to try to steer our attention to biological aspects of prevention.

Dr. Carl C. Bell
David Satcher, MD, PhD, the 16th U.S. surgeon general, instructed me that there were two basic categories of prevention – biotechnical and psychosocial. A biotechnical prevention technique of flu prevention would be a flu shot, and a psychosocial prevention would be teaching people to wash their hands during the day and keep their fingers away from their noses, eyes, and mouths. Clearly, the psychosocial is more difficult to disseminate and implement.

Recently, I have been seeing psychiatric articles on fetal health and mental health, and, because I am excited about the prospect of understanding fetal alcohol exposure, I feel the need to share. A recent article in the American Journal of Psychiatry was provocatively entitled, “Fetal origins of mental health: The developmental origins of health and disease hypothesis (2016. doi: 10.1176/appi.2016.16020138).

Disappointedly, the authors overlooked the biology of fetal alcohol exposure and focused on how psychosocial issues of maternal anxiety, depression, and anxiety could influence neurodevelopment, which could affect mental health outcomes after birth. Of course, I thought, “What about fetal alcohol exposure?” Meanwhile, a commentary in JAMA Psychiatry entitled “Prenatal nutritional deficiency and psychosis: Where do we go from here?” referred to prenatal choline supplementation along with other supplements (2017;74(4):349-50).

When I first stumbled upon the high prevalence of fetal alcohol exposure in low-income African American populations, it occurred to me that, since choline was involved with the psychopathology of fetal alcohol spectrum disorders and acetylcholine seemed to be involved in the psychopathology of Alzheimer’s disease, there might be a relationship between the two (Psychiatric Serv. 2015 May 1. doi: 10.1176/appi.ps.201400162). Such possible links are especially intriguing in light of the Alzheimer’s Association suggestion that Alzheimer’s disease is a “silent epidemic” among African Americans. The association notes that the prevalence among African Americans ranges from 14% to 100% higher than among whites. The problem – how to make the connection, if there were one, between the adults I was seeing and fetal alcohol exposure – proved difficult, because the time between fetal health and adult mental illness was huge. The time from fetal health and geriatric Alzheimer’s disease was even greater.

However, modern biologic science came through again. Maternal choline supplementation has been touted as a potential prenatal treatment for Down syndrome and Alzheimer’s disease (Curr Alzheimer Res. 2016;13[1]:97-106). Using mice that are genetically altered to show the development of Down syndrome and Alzheimer’s disease changes in the brain at 6 months, allowing researchers to seek prevention strategies for this pathophysiology, researchers have found that maternal choline supplementation protects against basal forebrain cholinergic neuron degeneration seen in these animals.

Thus, it would seem the problem of choline deficiency in pregnancy, most exacerbated by fetal alcohol exposure, is preventable by increasing the amount of choline available during pregnancy. So, it makes sense to increase the amount of choline in prenatal vitamins, as it appears that this biotechnical intervention not only would reduce the scourge of fetal alcohol spectrum disorders but also of Alzheimer’s disease (J Fam Med Dis Prev. 2016 Nov 29;2[6]:1-3).

Finally, the Office of Juvenile Justice and Delinquency Prevention has finally released a paper – “Fetal alcohol spectrum disorders listening session report” – from a session held in June 2013 that documents the extent of the problem in juvenile justice facilities.

Unfortunately, many of us have abdicated our role as biologists. We’ve got evidence showing the power of prenatal choline. It is time to stop counting all of the problems that stem from deficiency of choline during pregnancy and start doing something about it.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

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As psychiatrists, we are the advocates for inserting the biological thread into the tapestry of understanding human behavior. Try as they may, other mental health professionals are not biologists at heart. Accordingly, psychiatrists bring important thoughtfulness to any consideration about mental health and wellness and about the treatment and prevention of problematic thoughts, feelings, and behaviors.

Throughout my career, my main focus has been on identifying strategies and treatments that can prevent mental illness. For example, I wrote a column about prevention for Clinical Psychiatry News from 2004 to 2011, and, as a member of the publication’s Editorial Advisory Board, I continue to try to steer our attention to biological aspects of prevention.

Dr. Carl C. Bell
David Satcher, MD, PhD, the 16th U.S. surgeon general, instructed me that there were two basic categories of prevention – biotechnical and psychosocial. A biotechnical prevention technique of flu prevention would be a flu shot, and a psychosocial prevention would be teaching people to wash their hands during the day and keep their fingers away from their noses, eyes, and mouths. Clearly, the psychosocial is more difficult to disseminate and implement.

Recently, I have been seeing psychiatric articles on fetal health and mental health, and, because I am excited about the prospect of understanding fetal alcohol exposure, I feel the need to share. A recent article in the American Journal of Psychiatry was provocatively entitled, “Fetal origins of mental health: The developmental origins of health and disease hypothesis (2016. doi: 10.1176/appi.2016.16020138).

Disappointedly, the authors overlooked the biology of fetal alcohol exposure and focused on how psychosocial issues of maternal anxiety, depression, and anxiety could influence neurodevelopment, which could affect mental health outcomes after birth. Of course, I thought, “What about fetal alcohol exposure?” Meanwhile, a commentary in JAMA Psychiatry entitled “Prenatal nutritional deficiency and psychosis: Where do we go from here?” referred to prenatal choline supplementation along with other supplements (2017;74(4):349-50).

When I first stumbled upon the high prevalence of fetal alcohol exposure in low-income African American populations, it occurred to me that, since choline was involved with the psychopathology of fetal alcohol spectrum disorders and acetylcholine seemed to be involved in the psychopathology of Alzheimer’s disease, there might be a relationship between the two (Psychiatric Serv. 2015 May 1. doi: 10.1176/appi.ps.201400162). Such possible links are especially intriguing in light of the Alzheimer’s Association suggestion that Alzheimer’s disease is a “silent epidemic” among African Americans. The association notes that the prevalence among African Americans ranges from 14% to 100% higher than among whites. The problem – how to make the connection, if there were one, between the adults I was seeing and fetal alcohol exposure – proved difficult, because the time between fetal health and adult mental illness was huge. The time from fetal health and geriatric Alzheimer’s disease was even greater.

However, modern biologic science came through again. Maternal choline supplementation has been touted as a potential prenatal treatment for Down syndrome and Alzheimer’s disease (Curr Alzheimer Res. 2016;13[1]:97-106). Using mice that are genetically altered to show the development of Down syndrome and Alzheimer’s disease changes in the brain at 6 months, allowing researchers to seek prevention strategies for this pathophysiology, researchers have found that maternal choline supplementation protects against basal forebrain cholinergic neuron degeneration seen in these animals.

Thus, it would seem the problem of choline deficiency in pregnancy, most exacerbated by fetal alcohol exposure, is preventable by increasing the amount of choline available during pregnancy. So, it makes sense to increase the amount of choline in prenatal vitamins, as it appears that this biotechnical intervention not only would reduce the scourge of fetal alcohol spectrum disorders but also of Alzheimer’s disease (J Fam Med Dis Prev. 2016 Nov 29;2[6]:1-3).

Finally, the Office of Juvenile Justice and Delinquency Prevention has finally released a paper – “Fetal alcohol spectrum disorders listening session report” – from a session held in June 2013 that documents the extent of the problem in juvenile justice facilities.

Unfortunately, many of us have abdicated our role as biologists. We’ve got evidence showing the power of prenatal choline. It is time to stop counting all of the problems that stem from deficiency of choline during pregnancy and start doing something about it.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

 

As psychiatrists, we are the advocates for inserting the biological thread into the tapestry of understanding human behavior. Try as they may, other mental health professionals are not biologists at heart. Accordingly, psychiatrists bring important thoughtfulness to any consideration about mental health and wellness and about the treatment and prevention of problematic thoughts, feelings, and behaviors.

Throughout my career, my main focus has been on identifying strategies and treatments that can prevent mental illness. For example, I wrote a column about prevention for Clinical Psychiatry News from 2004 to 2011, and, as a member of the publication’s Editorial Advisory Board, I continue to try to steer our attention to biological aspects of prevention.

Dr. Carl C. Bell
David Satcher, MD, PhD, the 16th U.S. surgeon general, instructed me that there were two basic categories of prevention – biotechnical and psychosocial. A biotechnical prevention technique of flu prevention would be a flu shot, and a psychosocial prevention would be teaching people to wash their hands during the day and keep their fingers away from their noses, eyes, and mouths. Clearly, the psychosocial is more difficult to disseminate and implement.

Recently, I have been seeing psychiatric articles on fetal health and mental health, and, because I am excited about the prospect of understanding fetal alcohol exposure, I feel the need to share. A recent article in the American Journal of Psychiatry was provocatively entitled, “Fetal origins of mental health: The developmental origins of health and disease hypothesis (2016. doi: 10.1176/appi.2016.16020138).

Disappointedly, the authors overlooked the biology of fetal alcohol exposure and focused on how psychosocial issues of maternal anxiety, depression, and anxiety could influence neurodevelopment, which could affect mental health outcomes after birth. Of course, I thought, “What about fetal alcohol exposure?” Meanwhile, a commentary in JAMA Psychiatry entitled “Prenatal nutritional deficiency and psychosis: Where do we go from here?” referred to prenatal choline supplementation along with other supplements (2017;74(4):349-50).

When I first stumbled upon the high prevalence of fetal alcohol exposure in low-income African American populations, it occurred to me that, since choline was involved with the psychopathology of fetal alcohol spectrum disorders and acetylcholine seemed to be involved in the psychopathology of Alzheimer’s disease, there might be a relationship between the two (Psychiatric Serv. 2015 May 1. doi: 10.1176/appi.ps.201400162). Such possible links are especially intriguing in light of the Alzheimer’s Association suggestion that Alzheimer’s disease is a “silent epidemic” among African Americans. The association notes that the prevalence among African Americans ranges from 14% to 100% higher than among whites. The problem – how to make the connection, if there were one, between the adults I was seeing and fetal alcohol exposure – proved difficult, because the time between fetal health and adult mental illness was huge. The time from fetal health and geriatric Alzheimer’s disease was even greater.

However, modern biologic science came through again. Maternal choline supplementation has been touted as a potential prenatal treatment for Down syndrome and Alzheimer’s disease (Curr Alzheimer Res. 2016;13[1]:97-106). Using mice that are genetically altered to show the development of Down syndrome and Alzheimer’s disease changes in the brain at 6 months, allowing researchers to seek prevention strategies for this pathophysiology, researchers have found that maternal choline supplementation protects against basal forebrain cholinergic neuron degeneration seen in these animals.

Thus, it would seem the problem of choline deficiency in pregnancy, most exacerbated by fetal alcohol exposure, is preventable by increasing the amount of choline available during pregnancy. So, it makes sense to increase the amount of choline in prenatal vitamins, as it appears that this biotechnical intervention not only would reduce the scourge of fetal alcohol spectrum disorders but also of Alzheimer’s disease (J Fam Med Dis Prev. 2016 Nov 29;2[6]:1-3).

Finally, the Office of Juvenile Justice and Delinquency Prevention has finally released a paper – “Fetal alcohol spectrum disorders listening session report” – from a session held in June 2013 that documents the extent of the problem in juvenile justice facilities.

Unfortunately, many of us have abdicated our role as biologists. We’ve got evidence showing the power of prenatal choline. It is time to stop counting all of the problems that stem from deficiency of choline during pregnancy and start doing something about it.

Dr. Bell is a staff psychiatrist at Jackson Park Hospital Family Medicine Clinic in Chicago, clinical psychiatrist emeritus in the department of psychiatry at the University of Illinois at Chicago, former president/CEO of Community Mental Health Council, and former director of the Institute for Juvenile Research (birthplace of child psychiatry), also in Chicago.

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Blood test could aid steroid decision in alcoholic hepatitis

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– Determining the ratio of neutrophils to leukocytes in the blood could help identify patients with alcoholic hepatitis that would and would not benefit from steroid treatment.

Patients who had a neutrophil to lymphocyte ratio (NLR) of between 5 and 8 before being treated with the corticosteroid prednisolone appeared to obtain a benefit versus no-steroid treatment (P = .007) while those with higher and lower NLR values did not, in an analysis presented at the International Liver Congress.

Martynasfoto/Thinkstock
If patients with only an NLR of 5-8 were treated with prednisolone, then this would give a survival of 84.6% at roughly 3 months, compared with 88.1% for patients with an NLR of less than 5 and 57.4% for patients with an NLR above 8 (P less than .0001).

This could potentially help clinicians avoid putting some patients through a futile trial of steroid therapy, study author Ewan H. Forrest, MD, explained in an interview at the meeting, which is sponsored by the European Association for the Study of the Liver (EASL).

“The traditional approach would be to give steroids to patients with severe alcoholic hepatitis, wait 7 days, see if they are getting better, and if so, keep them on the steroids,” Dr. Forrest of the liver unit at Glasgow Royal Infirmary observed. Conversely, if patients are not doing better then steroids should be stopped.

“What we are increasingly aware of is that not only do some people not do well with steroids but also they actually do considerably more badly,” Dr. Forrest cautioned.

Usually, the response to steroid treatment in alcoholic hepatitis is measured by changes in serum bilirubin after a week of treatment, but this, of course, exposes patients to a “futile course of treatment with a risk of complication such as sepsis,” Dr. Forrest and his coauthors noted in a a late-breaking poster.

Determining the NLR has already been shown to help predict the prognosis of patients with several diseases with an underlying inflammatory component, such as cardiovascular diseases and several types of cancer. It also has proven useful in patients with liver disease, although not specifically in alcoholic hepatitis before this study, Dr. Forrest observed.

Data on patients with alcoholic hepatitis who had participated in the multicenter, double-blind, randomized STOPAH trial were used to see if the baseline NLR could help stratify patients who would benefit from steroid therapy.

STOPAH had compared the use of prednisolone or pentoxifylline for the treatment of alcoholic hepatitis but found no benefit for the latter, although there was a possible benefit of steroids for improving overall survival, at least in the short term (N Engl J Med. 2015 Apr;372:1619-28).

Dr. Forrest noted that measurement of the lymphocyte count was not part of the original study design, so data to calculate the NLR were obtained retrospectively. As there had been little or no response to pentoxifylline in the trial, patients who had taken this drug were regarded as having had no treatment in the analysis.

In all, baseline NLR values could be worked out for 630 patients from the STOPAH trial, but 113 were excluded from further analysis as they met the prespecified exclusion criteria of gastrointestinal bleeding or sepsis.

Overall, a NLR of 5 or less, indicating milder liver disease, was associated with significantly better survival at 3 months than if the NLR was 5 or more (85.5% vs. 67.3%; P less than .0001), study findings suggested.

Dr. Forest noted that 29% of patients fell into the “sweet spot” of the NLR of between 5 and 8, where patients did benefit from steroids, but that the 23% of study subjects who had an NLR ratio above 8 did not. These patients may have had disease too severe to benefit from the prednisolone, he suggested, and tended to have a worse prognosis regardless. A baseline NLR greater than 8 was associated with acute kidney infection but not sepsis, the team found.

There was also no great effect of the steroid in the 48% of patients who had an NLR ratio less than 5, suggesting that maybe they had disease that was too mild to warrant such treatment and did well regardless.

Of course, these findings still need further validation, but they are “not far off” from clinical application, Dr. Forrest offered. Calculating the ratio is simple, can be done during a routine whole-blood cell count, and is potentially cost saving because it reduces the standard practice in the United Kingdom of giving “all-comers” 7 days of corticosteroid therapy as a trial to see if they get better, he said.

Dr. Forrest had no conflicts of interest to disclose.

 

 

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– Determining the ratio of neutrophils to leukocytes in the blood could help identify patients with alcoholic hepatitis that would and would not benefit from steroid treatment.

Patients who had a neutrophil to lymphocyte ratio (NLR) of between 5 and 8 before being treated with the corticosteroid prednisolone appeared to obtain a benefit versus no-steroid treatment (P = .007) while those with higher and lower NLR values did not, in an analysis presented at the International Liver Congress.

Martynasfoto/Thinkstock
If patients with only an NLR of 5-8 were treated with prednisolone, then this would give a survival of 84.6% at roughly 3 months, compared with 88.1% for patients with an NLR of less than 5 and 57.4% for patients with an NLR above 8 (P less than .0001).

This could potentially help clinicians avoid putting some patients through a futile trial of steroid therapy, study author Ewan H. Forrest, MD, explained in an interview at the meeting, which is sponsored by the European Association for the Study of the Liver (EASL).

“The traditional approach would be to give steroids to patients with severe alcoholic hepatitis, wait 7 days, see if they are getting better, and if so, keep them on the steroids,” Dr. Forrest of the liver unit at Glasgow Royal Infirmary observed. Conversely, if patients are not doing better then steroids should be stopped.

“What we are increasingly aware of is that not only do some people not do well with steroids but also they actually do considerably more badly,” Dr. Forrest cautioned.

Usually, the response to steroid treatment in alcoholic hepatitis is measured by changes in serum bilirubin after a week of treatment, but this, of course, exposes patients to a “futile course of treatment with a risk of complication such as sepsis,” Dr. Forrest and his coauthors noted in a a late-breaking poster.

Determining the NLR has already been shown to help predict the prognosis of patients with several diseases with an underlying inflammatory component, such as cardiovascular diseases and several types of cancer. It also has proven useful in patients with liver disease, although not specifically in alcoholic hepatitis before this study, Dr. Forrest observed.

Data on patients with alcoholic hepatitis who had participated in the multicenter, double-blind, randomized STOPAH trial were used to see if the baseline NLR could help stratify patients who would benefit from steroid therapy.

STOPAH had compared the use of prednisolone or pentoxifylline for the treatment of alcoholic hepatitis but found no benefit for the latter, although there was a possible benefit of steroids for improving overall survival, at least in the short term (N Engl J Med. 2015 Apr;372:1619-28).

Dr. Forrest noted that measurement of the lymphocyte count was not part of the original study design, so data to calculate the NLR were obtained retrospectively. As there had been little or no response to pentoxifylline in the trial, patients who had taken this drug were regarded as having had no treatment in the analysis.

In all, baseline NLR values could be worked out for 630 patients from the STOPAH trial, but 113 were excluded from further analysis as they met the prespecified exclusion criteria of gastrointestinal bleeding or sepsis.

Overall, a NLR of 5 or less, indicating milder liver disease, was associated with significantly better survival at 3 months than if the NLR was 5 or more (85.5% vs. 67.3%; P less than .0001), study findings suggested.

Dr. Forest noted that 29% of patients fell into the “sweet spot” of the NLR of between 5 and 8, where patients did benefit from steroids, but that the 23% of study subjects who had an NLR ratio above 8 did not. These patients may have had disease too severe to benefit from the prednisolone, he suggested, and tended to have a worse prognosis regardless. A baseline NLR greater than 8 was associated with acute kidney infection but not sepsis, the team found.

There was also no great effect of the steroid in the 48% of patients who had an NLR ratio less than 5, suggesting that maybe they had disease that was too mild to warrant such treatment and did well regardless.

Of course, these findings still need further validation, but they are “not far off” from clinical application, Dr. Forrest offered. Calculating the ratio is simple, can be done during a routine whole-blood cell count, and is potentially cost saving because it reduces the standard practice in the United Kingdom of giving “all-comers” 7 days of corticosteroid therapy as a trial to see if they get better, he said.

Dr. Forrest had no conflicts of interest to disclose.

 

 

 

– Determining the ratio of neutrophils to leukocytes in the blood could help identify patients with alcoholic hepatitis that would and would not benefit from steroid treatment.

Patients who had a neutrophil to lymphocyte ratio (NLR) of between 5 and 8 before being treated with the corticosteroid prednisolone appeared to obtain a benefit versus no-steroid treatment (P = .007) while those with higher and lower NLR values did not, in an analysis presented at the International Liver Congress.

Martynasfoto/Thinkstock
If patients with only an NLR of 5-8 were treated with prednisolone, then this would give a survival of 84.6% at roughly 3 months, compared with 88.1% for patients with an NLR of less than 5 and 57.4% for patients with an NLR above 8 (P less than .0001).

This could potentially help clinicians avoid putting some patients through a futile trial of steroid therapy, study author Ewan H. Forrest, MD, explained in an interview at the meeting, which is sponsored by the European Association for the Study of the Liver (EASL).

“The traditional approach would be to give steroids to patients with severe alcoholic hepatitis, wait 7 days, see if they are getting better, and if so, keep them on the steroids,” Dr. Forrest of the liver unit at Glasgow Royal Infirmary observed. Conversely, if patients are not doing better then steroids should be stopped.

“What we are increasingly aware of is that not only do some people not do well with steroids but also they actually do considerably more badly,” Dr. Forrest cautioned.

Usually, the response to steroid treatment in alcoholic hepatitis is measured by changes in serum bilirubin after a week of treatment, but this, of course, exposes patients to a “futile course of treatment with a risk of complication such as sepsis,” Dr. Forrest and his coauthors noted in a a late-breaking poster.

Determining the NLR has already been shown to help predict the prognosis of patients with several diseases with an underlying inflammatory component, such as cardiovascular diseases and several types of cancer. It also has proven useful in patients with liver disease, although not specifically in alcoholic hepatitis before this study, Dr. Forrest observed.

Data on patients with alcoholic hepatitis who had participated in the multicenter, double-blind, randomized STOPAH trial were used to see if the baseline NLR could help stratify patients who would benefit from steroid therapy.

STOPAH had compared the use of prednisolone or pentoxifylline for the treatment of alcoholic hepatitis but found no benefit for the latter, although there was a possible benefit of steroids for improving overall survival, at least in the short term (N Engl J Med. 2015 Apr;372:1619-28).

Dr. Forrest noted that measurement of the lymphocyte count was not part of the original study design, so data to calculate the NLR were obtained retrospectively. As there had been little or no response to pentoxifylline in the trial, patients who had taken this drug were regarded as having had no treatment in the analysis.

In all, baseline NLR values could be worked out for 630 patients from the STOPAH trial, but 113 were excluded from further analysis as they met the prespecified exclusion criteria of gastrointestinal bleeding or sepsis.

Overall, a NLR of 5 or less, indicating milder liver disease, was associated with significantly better survival at 3 months than if the NLR was 5 or more (85.5% vs. 67.3%; P less than .0001), study findings suggested.

Dr. Forest noted that 29% of patients fell into the “sweet spot” of the NLR of between 5 and 8, where patients did benefit from steroids, but that the 23% of study subjects who had an NLR ratio above 8 did not. These patients may have had disease too severe to benefit from the prednisolone, he suggested, and tended to have a worse prognosis regardless. A baseline NLR greater than 8 was associated with acute kidney infection but not sepsis, the team found.

There was also no great effect of the steroid in the 48% of patients who had an NLR ratio less than 5, suggesting that maybe they had disease that was too mild to warrant such treatment and did well regardless.

Of course, these findings still need further validation, but they are “not far off” from clinical application, Dr. Forrest offered. Calculating the ratio is simple, can be done during a routine whole-blood cell count, and is potentially cost saving because it reduces the standard practice in the United Kingdom of giving “all-comers” 7 days of corticosteroid therapy as a trial to see if they get better, he said.

Dr. Forrest had no conflicts of interest to disclose.

 

 

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Key clinical point: Calculating the neutrophil to leukocyte ratio (NLR) could save some patients with alcoholic hepatitis from having steroid therapy.

Major finding: 90-day survival was 85.5% vs. 67.3%, (P less than .0001), comparing an NLR less than 5 with an NLR of 5 or greater in all patients.

Data source: 513 patients with alcoholic hepatitis who had participated in the multicenter, double-blind, randomized STOPAH trial.

Disclosures: Dr. Forrest had no conflicts of interest to disclose.