Mixed Topics

Psoriasis patients with symptoms of psychological distress and depression reported lower satisfaction with their clinicians than did those without mental health comorbidities, according to a retrospective analysis of survey data.

The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.

“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.

The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.

The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.

The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.

After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).

“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.

Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.

“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.

The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.

The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.

SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.

Psoriasis patients with symptoms of psychological distress and depression reported lower satisfaction with their clinicians than did those without mental health comorbidities, according to a retrospective analysis of survey data.

The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.

“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.

The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.

The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.

The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.

After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).

“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.

Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.

“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.

The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.

The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.

SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.

Psoriasis patients with symptoms of psychological distress and depression reported lower satisfaction with their clinicians than did those without mental health comorbidities, according to a retrospective analysis of survey data.

The findings highlight the importance of clinicians being supportive and adaptable in their communication style when interacting with psoriasis patients with mental illness.

“This study aims to evaluate whether an association exists between a patient’s psychological state and the perception of patient-clinician encounters,” wrote Charlotte Read, MBBS, of Imperial College London, and April W. Armstrong, MD, MPH, of the University of Southern California, Los Angeles, in JAMA Dermatology.

The researchers retrospectively analyzed longitudinal data from over 8.8 million U.S. adults (unweighted, 652) with psoriasis who participated in the Medical Expenditure Panel Survey from 2004 to 2017. The nationally representative database includes various clinical information, such as data on patient demographics, health care use, and mental health comorbidities.

The primary outcome, patient satisfaction with their physician, was assessed using a patient-physician communication composite score. Mental health comorbidities were evaluated using standard questionnaires.

The mean age of study patients was 52.1 years (range, 0.7 years), and most were female (54%). In all, 73% of participants had no or mild psychological distress symptoms, and 27% had moderate or severe symptoms.

After analysis, the researchers found that patients with moderate psychological distress symptoms were 2.8 times more likely to report lower satisfaction with their physician than were those with no or mild symptoms (adjusted odds ratio, 2.8; P = .001). They also reported that patients with severe symptoms were more likely to report lower satisfaction (aOR, 2.3; P = .03).

“Patients with moderate or severe depression symptoms were less satisfied with their clinicians, compared with those with no or mild depression symptoms,” they further explained.

Based on the results, the coinvestigators emphasized the importance of bettering the patient experience for those with mental illness given the potential association with improved health outcomes.

“Because depressed patients can be more sensitive to negative communication, the clinician needs to be more conscious about using a positive and supportive communication style,” they recommended.

The authors acknowledged the inadequacy of evaluating clinician performance using patient satisfaction alone. As a result, the findings may not be generalizable to all clinical settings.

The study was funded by the National Psoriasis Foundation. Dr. Armstrong reported financial affiliations with several pharmaceutical companies.

SOURCE: Read C, Armstrong AW. JAMA Dermatol. 2020 May 6. doi: 10.1001/jamadermatol.2020.1054.

Potential risks of cardiac injury posed by coronavirus disease 2019 (COVID-19) infection warrant a cautious return-to-play for highly active people and competitive athletes who test positive, according to leading sports cardiologists.

To prevent cardiac injury, athletes should rest for at least 2 weeks after symptoms resolve, then undergo cardiac testing before returning high-level competitive sports, reported lead author Dermot Phelan, MD, PhD, of Atrium Health in Charlotte, N.C., and colleagues.

These recommendations, which were published in JAMA Cardiology, are part of a clinical algorithm that sorts athletes based on coronavirus test status and symptom severity. The algorithm offers a clear timeline for resumption of activity, with management decisions for symptomatic individuals based on additional diagnostics, such as high-sensitivity troponin testing and electrocardiogram.

Despite a scarcity of relevant clinical data, Dr. Phelan said that he and his colleagues wanted to offer their best recommendations to the athletic community, who had been reaching out for help.

“We were getting calls and messages from amateur and professional sporting organizations from around the country asking for guidance about what to do,” Dr. Phelan said. “So a number of us from the American College of Cardiology Sports and Exercise Council decided that we really should provide some guidance even in the absence of good, strong data, for what we feel is a reasonable approach.”

The recommendations were based on what is known of other viral infections, as well as risks posed by COVID-19 that may be worsened by athletic activity.

“We know that, when people have an active infection, vigorous exercise can lower immunity, and that can make the infection worse,” Dr. Phelan said. “That really applies very strongly in people who have had myocarditis. If you exercise when you have myocarditis, it actually increases viral replication and results in increased necrosis of the heart muscle. We really want to avoid exercising during that active infection phase.”

Myocarditis is one of the top causes of sudden cardiac death among young athletes, Dr. Phelan said, “so that’s a major concern for us.”

According to Dr. Phelan, existing data suggest a wide range of incidence of 7%-33% for cardiac injury among patients hospitalized for COVID-19. Even the low end of this range, at 7%, is significantly higher than the incidence rate of 1% found in patients with non–COVID-19 acute viral infections.

“This particular virus appears to cause more cardiac insults than other viruses,” Dr. Phelan said.

The incidence of cardiac injury among nonhospitalized patients remains unknown, leaving a wide knowledge gap that shaped the conservative nature of the present recommendations.

With more information, however, the guidance may “change dramatically,” Dr. Phelan said.

“If the data come back and show that no nonhospitalized patients got cardiac injury, then we would be much more comfortable allowing return to play without the need for cardiac testing,” he said.

Conversely, if cardiac injury is more common than anticipated, then more extensive testing may be needed, he added.

As the algorithm stands, high-sensitivity troponin testing and/or cardiac studies are recommended for all symptomatic athletes; if troponin levels are greater than the 99th percentile or a cardiac study is abnormal, then clinicians should follow return-to-play guidelines for myocarditis. For athletes with normal tests, slow resumption of activity is recommended, including close monitoring for clinical deterioration.

As Dr. Phelan discussed these recommendations in a broader context, he emphasized the need for caution, both preventively, and for cardiologists working with recovering athletes.

“For the early stage of this reentry into normal life while this is still an active pandemic, we need to be cautious,” Dr. Phelan said. “We need to follow the regular CDC guidelines, in terms of social distancing and handwashing, but we also need to consider that those people who have suffered from COVID-19 may have had cardiac injury. We don’t know that yet. But we need to be cautious with these individuals and test them before they return to high-level competitive sports.”

One author disclosed a relationship with the Atlanta Falcons.

SOURCE: Phelan D et al. JAMA Cardiology. 2020 Apr 13. doi: 10.1001/jamacardio.2020.2136.

Potential risks of cardiac injury posed by coronavirus disease 2019 (COVID-19) infection warrant a cautious return-to-play for highly active people and competitive athletes who test positive, according to leading sports cardiologists.

To prevent cardiac injury, athletes should rest for at least 2 weeks after symptoms resolve, then undergo cardiac testing before returning high-level competitive sports, reported lead author Dermot Phelan, MD, PhD, of Atrium Health in Charlotte, N.C., and colleagues.

These recommendations, which were published in JAMA Cardiology, are part of a clinical algorithm that sorts athletes based on coronavirus test status and symptom severity. The algorithm offers a clear timeline for resumption of activity, with management decisions for symptomatic individuals based on additional diagnostics, such as high-sensitivity troponin testing and electrocardiogram.

Despite a scarcity of relevant clinical data, Dr. Phelan said that he and his colleagues wanted to offer their best recommendations to the athletic community, who had been reaching out for help.

“We were getting calls and messages from amateur and professional sporting organizations from around the country asking for guidance about what to do,” Dr. Phelan said. “So a number of us from the American College of Cardiology Sports and Exercise Council decided that we really should provide some guidance even in the absence of good, strong data, for what we feel is a reasonable approach.”

The recommendations were based on what is known of other viral infections, as well as risks posed by COVID-19 that may be worsened by athletic activity.

“We know that, when people have an active infection, vigorous exercise can lower immunity, and that can make the infection worse,” Dr. Phelan said. “That really applies very strongly in people who have had myocarditis. If you exercise when you have myocarditis, it actually increases viral replication and results in increased necrosis of the heart muscle. We really want to avoid exercising during that active infection phase.”

Myocarditis is one of the top causes of sudden cardiac death among young athletes, Dr. Phelan said, “so that’s a major concern for us.”

According to Dr. Phelan, existing data suggest a wide range of incidence of 7%-33% for cardiac injury among patients hospitalized for COVID-19. Even the low end of this range, at 7%, is significantly higher than the incidence rate of 1% found in patients with non–COVID-19 acute viral infections.

“This particular virus appears to cause more cardiac insults than other viruses,” Dr. Phelan said.

The incidence of cardiac injury among nonhospitalized patients remains unknown, leaving a wide knowledge gap that shaped the conservative nature of the present recommendations.

With more information, however, the guidance may “change dramatically,” Dr. Phelan said.

“If the data come back and show that no nonhospitalized patients got cardiac injury, then we would be much more comfortable allowing return to play without the need for cardiac testing,” he said.

Conversely, if cardiac injury is more common than anticipated, then more extensive testing may be needed, he added.

As the algorithm stands, high-sensitivity troponin testing and/or cardiac studies are recommended for all symptomatic athletes; if troponin levels are greater than the 99th percentile or a cardiac study is abnormal, then clinicians should follow return-to-play guidelines for myocarditis. For athletes with normal tests, slow resumption of activity is recommended, including close monitoring for clinical deterioration.

As Dr. Phelan discussed these recommendations in a broader context, he emphasized the need for caution, both preventively, and for cardiologists working with recovering athletes.

“For the early stage of this reentry into normal life while this is still an active pandemic, we need to be cautious,” Dr. Phelan said. “We need to follow the regular CDC guidelines, in terms of social distancing and handwashing, but we also need to consider that those people who have suffered from COVID-19 may have had cardiac injury. We don’t know that yet. But we need to be cautious with these individuals and test them before they return to high-level competitive sports.”

One author disclosed a relationship with the Atlanta Falcons.

SOURCE: Phelan D et al. JAMA Cardiology. 2020 Apr 13. doi: 10.1001/jamacardio.2020.2136.

Potential risks of cardiac injury posed by coronavirus disease 2019 (COVID-19) infection warrant a cautious return-to-play for highly active people and competitive athletes who test positive, according to leading sports cardiologists.

To prevent cardiac injury, athletes should rest for at least 2 weeks after symptoms resolve, then undergo cardiac testing before returning high-level competitive sports, reported lead author Dermot Phelan, MD, PhD, of Atrium Health in Charlotte, N.C., and colleagues.

These recommendations, which were published in JAMA Cardiology, are part of a clinical algorithm that sorts athletes based on coronavirus test status and symptom severity. The algorithm offers a clear timeline for resumption of activity, with management decisions for symptomatic individuals based on additional diagnostics, such as high-sensitivity troponin testing and electrocardiogram.

Despite a scarcity of relevant clinical data, Dr. Phelan said that he and his colleagues wanted to offer their best recommendations to the athletic community, who had been reaching out for help.

“We were getting calls and messages from amateur and professional sporting organizations from around the country asking for guidance about what to do,” Dr. Phelan said. “So a number of us from the American College of Cardiology Sports and Exercise Council decided that we really should provide some guidance even in the absence of good, strong data, for what we feel is a reasonable approach.”

The recommendations were based on what is known of other viral infections, as well as risks posed by COVID-19 that may be worsened by athletic activity.

“We know that, when people have an active infection, vigorous exercise can lower immunity, and that can make the infection worse,” Dr. Phelan said. “That really applies very strongly in people who have had myocarditis. If you exercise when you have myocarditis, it actually increases viral replication and results in increased necrosis of the heart muscle. We really want to avoid exercising during that active infection phase.”

Myocarditis is one of the top causes of sudden cardiac death among young athletes, Dr. Phelan said, “so that’s a major concern for us.”

According to Dr. Phelan, existing data suggest a wide range of incidence of 7%-33% for cardiac injury among patients hospitalized for COVID-19. Even the low end of this range, at 7%, is significantly higher than the incidence rate of 1% found in patients with non–COVID-19 acute viral infections.

“This particular virus appears to cause more cardiac insults than other viruses,” Dr. Phelan said.

The incidence of cardiac injury among nonhospitalized patients remains unknown, leaving a wide knowledge gap that shaped the conservative nature of the present recommendations.

With more information, however, the guidance may “change dramatically,” Dr. Phelan said.

“If the data come back and show that no nonhospitalized patients got cardiac injury, then we would be much more comfortable allowing return to play without the need for cardiac testing,” he said.

Conversely, if cardiac injury is more common than anticipated, then more extensive testing may be needed, he added.

As the algorithm stands, high-sensitivity troponin testing and/or cardiac studies are recommended for all symptomatic athletes; if troponin levels are greater than the 99th percentile or a cardiac study is abnormal, then clinicians should follow return-to-play guidelines for myocarditis. For athletes with normal tests, slow resumption of activity is recommended, including close monitoring for clinical deterioration.

As Dr. Phelan discussed these recommendations in a broader context, he emphasized the need for caution, both preventively, and for cardiologists working with recovering athletes.

“For the early stage of this reentry into normal life while this is still an active pandemic, we need to be cautious,” Dr. Phelan said. “We need to follow the regular CDC guidelines, in terms of social distancing and handwashing, but we also need to consider that those people who have suffered from COVID-19 may have had cardiac injury. We don’t know that yet. But we need to be cautious with these individuals and test them before they return to high-level competitive sports.”

One author disclosed a relationship with the Atlanta Falcons.

SOURCE: Phelan D et al. JAMA Cardiology. 2020 Apr 13. doi: 10.1001/jamacardio.2020.2136.

To the Editor: I am very disappointed to continue receiving my copies of the Federal Practitioner in nonrecyclable plastic. As a health care professional, I am on the mailing list for numerous other medical publications, all of which seem to be able to utilize recyclable plastic wrappers. I hope you can rectify this problem, which is an embarrassment to me, a serviceconnected veteran.

C. William Kaiser, MD 

To the Editor: I am very disappointed to continue receiving my copies of the Federal Practitioner in nonrecyclable plastic. As a health care professional, I am on the mailing list for numerous other medical publications, all of which seem to be able to utilize recyclable plastic wrappers. I hope you can rectify this problem, which is an embarrassment to me, a serviceconnected veteran.

C. William Kaiser, MD 

To the Editor: I am very disappointed to continue receiving my copies of the Federal Practitioner in nonrecyclable plastic. As a health care professional, I am on the mailing list for numerous other medical publications, all of which seem to be able to utilize recyclable plastic wrappers. I hope you can rectify this problem, which is an embarrassment to me, a serviceconnected veteran.

C. William Kaiser, MD 

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Outstanding Service in Hospital Medicine

Efren Manjarrez, MD, SFHM, FACP, is an associate professor of clinical medicine at the University of Miami Miller School of Medicine, where he also serves as a hospitalist in the division of hospital medicine. His high-impact work at his home institution and through SHM has been extensive.

He founded the division of hospital medicine at the University of Miami in 2000 and later served as the division chief and patient safety officer. Dr. Manjarrez served in the prestigious role of course director for HM15 and as co-course director for the Adult Hospital Medicine Boot Camp.

One of his most enduring contributions is as an author of the white paper on hospitalist handoffs, published in the Journal of Hospital Medicine in 2009, which continues to be cited and validated. He was an assistant editor for the Journal of Hospital Medicine and continues to review articles for JHM. Dr. Manjarrez is also a senior fellow in hospital medicine.

Excellence in Research

Shoshana J. Herzig, MD, MPH, is the director of hospital medicine research at Beth Israel Deaconess Medical Center in Boston, where she also serves as a hospitalist. She is also an associate professor of medicine at Harvard Medical School, also in Boston.

She has published nearly 50 original peer-reviewed manuscripts in some of medicine’s top journals. Her impressive research, which primarily focuses on patterns of medication utilization and associated outcomes in hospitalized adults, has been cited more than 1,500 times in the medical literature.

In addition to her work on medication safety, she is also a site PI for the Hospital Medicine Research Network (HOMERuN), a nationwide collaborative of hospital medicine researchers.

Dr. Herzig has been a member of SHM since 2008 and has attended the annual conference every year since. She has served as an RIV abstract judge, was instrumental in developing SHM’s consensus statement on safe opioid prescribing, and has served as an editor for the Journal of Hospital Medicine since 2012 and has been a senior deputy editor since 2015.

Clinical Leadership for Physicians

Karen Smith, MD, MEd, SFHM, is the chief of the division of hospitalist medicine and past president of the medical staff at Children’s National Medical Center in Washington. She also serves as associate professor of pediatrics at the George Washington University School of Medicine. She has consistently worked to create a supportive environment in which to promote wellness among her staff and colleagues.

She was one of three founding faculty members of the division of hospital medicine at Children’s National, and under her leadership, the division has seen substantial growth. It has evolved from a single site to a comprehensive model of services, spanning six community hospitals and a specialty hospital for rehabilitation and subacute care.

To increase morale, Dr. Smith spearheaded the development of a virtual physician lounge. She reserved a conference room once a month and provided free lunch to medical staff members of different specialties. Its success led to the construction of a full-time lounge – all because of Dr. Smith’s perseverance and forward thinking.

She is a past member of SHM’s Pediatrics Committee and Hospital Quality and Patient Safety Committee and is a senior fellow in hospital medicine.

Excellence in Teaching

Kathleen M. Finn, MD, M.Phil, SFHM, is the senior associate program director for resident and faculty development in the Massachusetts General Hospital internal medicine residency program at Harvard Medical School, both in Boston, where she also is an assistant professor of medicine. She has excelled at teaching at all levels and in all kinds of settings, from clinical teaching on inpatient rounds, educating faculty through workshops to serving as course director for Hospital Medicine 2018 in Orlando. She constantly strives to think creatively and to teach in new ways and considers her career to be a synergy of all three domains in medical education: clinical teaching, leadership, and research.

Her interest in improving the art of inpatient teaching has also taken Dr. Finn into the medical education research space, where she has conducted and published several significant studies.

She was the codirector of the Boston chapter of SHM for 18 years and is well known for her dedication to SHM’s annual conference. She gained a reputation on the Annual Conference Committee for coming up with creative topics, including the Great Debate series.

Dr. Finn has previously served on the editorial board for the Journal of Hospital Medicine, where she continues to be a reviewer. She is a senior fellow in hospital medicine.

Excellence in Teaching

Juan Nicolás Lessing, MD, is an assistant professor of medicine within the division of hospital medicine at the Medical School at the University of Colorado at Denver, Aurora. He has dedicated himself to the teaching and study of clinical reasoning processes and has cocreated a resident clinical reasoning curriculum, which has been expended to all residency classes.

Dr. Lessing’s dedication to mentorship has been extraordinary. In fewer than 5 years, he has mentored more than 50 learners, resulting in 54 competitive abstracts, posters, and presentations. He has led more than 24 workshops and consistently sponsors junior colleagues to join him. In summary, he teaches learners how to learn rather than what to learn. Additionally, Dr. Lessing created and facilitated several impactful department-wide sessions on how we can learn from our mistakes to openly discuss missed diagnoses. He served as a co-PI on the LOOP study, a multicenter endeavor to provide real-time feedback to admitting residents on a patient’s clinical course, which was published in the Journal of Hospital Medicine.

Dr. Lessing has been actively involved with SHM since medical school, is a graduate of SHM’s Academic Hospitalist Academy, and serves on the executive board for the Rocky Mountain chapter of SHM.

Clinical Leadership for NPs/PAs

Ilaria Gadalla, DMSc, PA-C, is a hospitalist at Treasure Coast Hospitalists in Port St. Lucia, Fla., and also serves as the physician assistant department chair/program director at South University, where she supervises more than 40 PAs, medical directors, and administrative staff.

She continuously drives innovative projects for NPs and PAs to demonstrate excellence in collaboration by working closely with C-suite administration to expand QI (quality improvement) and education efforts. A prime example is the optimal communication system that she developed within her first week as a hospitalist in the Port St. Lucie area. Nursing, ED, and pharmacy staff had difficulty contacting hospitalists since the EMR would not reflect the assigned hospitalist, so she developed a simple contact sheet that included the hospitalist team each day. This method is still in use today.

Ms. Gadalla is the chair of SHM’s NP/PA special interest group who was integral in drafting the recent white paper on NP/PA integration and optimization.

Excellence in Humanitarian Services

Khaalisha Ajala, MD, MBA, is a hospitalist and associate site director for education at Grady Memorial Hospital in Atlanta. She cares for patients of diverse backgrounds directly and also has a deep-seeded passion for public health and patient education, always demonstrating how to bring this passion to trainee education.

Using her knowledge as an MBA, Dr. Ajala has designed, developed, and now maintains her own nonprofit agency, Heart Beats & Hip-Hop. Through this organization, she has hosted public health fairs to conduct health screenings in less-traditional local settings, where community members who may not have access to care can gain exposure to a health care provider.

More broadly, in the last year, she has made two journeys – one to Thailand and another to Ethiopia – to work with Emory trainees in educational and clinical efforts to help them engage the global community in health improvement. In Thailand, she taught students how to care for patients at risk for trafficking and sexual exploitation. While in Ethiopia, she served as an educator and clinical preceptor to Emory residents in the global health pathway, teaching them to care for high-risk patients at a local hospital.

With her active and unrelenting humanitarian efforts in mind, she was also chosen as a member of the executive council for SHM’s Care for Vulnerable Populations special interest group.

Diversity Leadership

Kimberly D. Manning, MD, FACP, FAAP, is a professor of medicine and the associate vice chair of diversity, equity and inclusion at the Emory University School of Medicine in Atlanta, where she also is a hospitalist at Grady Memorial Hospital. She demonstrates a strong passion for building and strengthening diverse clinical learning environments. This inspired her to promote cultural competency via lectures, curriculum development, and more.

Dr. Manning has designed a new educational modality – Bite-Sized Teaching (abbreviated “BST” and read as “BEAST”-Mode Teaching). This engages trainees as the teachers of their peers. As part of those sessions, Dr. Manning intentionally encourages and engages trainees from all backgrounds, including women, minorities, and trainees with varied ethnic and cultural perspectives.

Her leadership on the Emory Task Force on Diversity, Equity and Inclusion led her to be named the department of medicine’s first associate vice chair of diversity, equity and inclusion. Due in large part to her engagement, the medical school just admitted its largest class of underrepresented minorities, nearly doubling numbers from prior years.

She has received the 2018 AGCME Parker J. Palmer Courage to Teach Award and the 2019 Lifetime Achievement Award by the Association of Black Women Physicians. 

Leadership for Practice Manager

Douglas G. Philpot, MHA, MBA, MHR, FACHE, currently the hospitalist program director at Intermountain Healthcare in Salt Lake City, epitomizes excellence in practice management.

In mid-2018, Intermountain Healthcare transitioned to a new organizational structure that brought all medical and surgical operations under one leadership team. Prior to this reorganization, hospitalist groups were largely divided by the geographies they served, each operating independently.

After the reorganization, it was apparent that staffing structures among groups varied greatly. Dr. Philpot pored over the workload and billing data and determined the most efficient use of how to staff hospitalist providers. He recently created a program that allows all stakeholders to meet and discuss in an unbiased manner how and when to add resources to a given group. As a result, the team is better able to make smart decisions that translate into improved quality, better patient experience, a more engaged hospitalist group and improved financial decisions. This is a model that Intermountain is now looking to apply to other specialties.

Team Award in Quality Improvement

The Michigan Hospital Medicine Safety Consortium has been in place for a decade and has worked together to improve quality and safety for patients across Michigan and the nation. It has been led since its inception by Scott Flanders, MD, a hospitalist at the University of Michigan, Ann Arbor.

At each participating hospital, teams include hospitalists, infectious disease clinicians, interventional radiologists, nephrologists, nurses, pharmacists, administrators, and more. This integration ensures that the team’s work is highly relevant and generalizable for hospitals around the country.

Their initiatives have informed regulatory and guideline writing authorities in the United States and beyond. For example, findings from their venous thromboembolism project demonstrated that the majority of hospitalized patients do not benefit from VTE prophylaxis, but rather, targeted strategies to define those at high risk. In 2016, their work helped to prevent 852 VTEs in Michigan alone. This led to changes in national guidelines that now emphasize deimplementing pharmacologic VTE prophylaxis and focused risk-assessment in U.S. hospitals.

Their antimicrobial use initiative has led to a robust partnership between hospitalists, hospitals, and national partners, such as the Centers for Disease Control and Prevention. Early work has informed a key gap in stewardship – discharge antibiotic prescribing – which has been a focus for SHM, the CDC, and many others. Efforts have already led to a reduction in thousands of unnecessary antibiotic prescriptions in Michigan.

Junior Investigator Award

SHM’s Research Committee presents the Junior Investigator Award to recognize early-career hospitalist researchers who are leading the way in their field. We are pleased to present the HM20 Junior Investigator Award to Valerie Vaughn, MD, MSc.

Dr. Vaughn is an assistant professor and research scientist in the division of hospital medicine at the University of Michigan and Veterans Affairs Ann Arbor Healthcare System.

Her research is focused on engaging hospitalists in antibiotic prescribing, especially at discharge. She is the hospitalist lead for an initiative to improve antibiotic prescribing in 46 hospitals across Michigan. She has already made a national contribution to the field – two manuscripts that have received high praise and have been cited by the Joint Commission and the CDC in their updated recommendations for antibiotic stewardship. She has a grant from the Gordon and Betty Moore Foundation to study the role of diagnostic error in antibiotic overuse and just received a K08 career development award from the Agency for Healthcare Research and Quality to study methods to improve antibiotic prescribing at hospital discharge.

One of Dr. Vaughn’s career goals is to advance hospital medicine through mentoring the next generation of hospitalists. In 2017, she authored a manuscript titled “Mentee Missteps” in JAMA, which has been viewed nearly 40,000 times since publication. She continues to give talks on this topic and mentors clinical hospitalists on research projects to improve quality and safety.

Dr. Vaughn has worked closely with SHM and represents the society at the CDC’s Healthcare Infection Control Practices Advisory Committee quarterly meetings.

Certificate of Leadership in Hospital Medicine

The Certificate of Leadership in Hospital Medicine (CLHM) cultivates leadership skills in the context of specific hospital medicine challenges. This designation informs employers – or potential employers – with confidence that a candidate is equipped and ready to lead teams and grow an organization.

Charmaine Lewis, MD, MPH, FHM, CLHM, is the quality director for New Hanover Hospitalists in Wilmington, N.C., a role she has held for 7 years. She is also clinical assistant professor, department of medicine, University of North Carolina School of Medicine, Chapel Hill, serving as a mentor for internal medicine, surgery, and obstetrics residents completing projects in quality improvement.

While sitting on the CHF and readmissions committees at her institution, Dr. Lewis was asked why patients with heart failure came back to the hospital. This question launched an in-depth search for real-time and accurate data on heart failure patients in her institution. She worked with the Heart Failure Steering Committee to develop a process to close care gaps and document compliance to the ACC/AHA Get with the Guidelines: Heart Failure recommendations. She facilitated order set revisions, smart-phrase documentation in EPIC, and scripted bedside interdisciplinary rounding to facilitate compliance prior to patient discharge. She also created an end-user friendly dashboard to report compliance with medical leaders, and eventually this project was selected by the department of medicine as their annual quality goal.  The project has led to the improvement of CHF GWTG Composite Bundle compliance from 76% to 93%, and compliance with use of aldosterone antagonists from 22% to 85%.

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

Many planned randomized trials to test the efficacy of hydroxychloroquine or related drugs for preventing COVID-19 infection have, as of the end of April 2020, failed to include ECG assessment to either exclude people at the highest risk for possibly developing a life-threatening cardiac arrhythmia or to flag people who achieve a dangerous QTc interval on treatment, according to an analysis of the posted designs of several dozen studies.

“It is not only inexplicable, but also inexcusable that clinical investigators would dare to include healthy individuals in a clinical trial involving QT-prolonging medications without bothering to screen their electrocardiogram,” commented Sami Viskin, MD, an electrophysiologist at Tel Aviv Sourasky Medical Center. “The fact that we needed Dr. Gollob to ring this alarm is, itself, shocking,” he said in an interview.

“ECG screening is a good option to minimize the risk. You don’t eliminate the risk, but you can minimize it,” commented Arthur Wilde, MD, a cardiac electrophysiologist and professor of medicine at the Academic Medical Center in Amsterdam. Both Dr. Viskin and Dr. Wilde agreed with the QTc interval thresholds Dr. Gollob recommended using for excluding or discontinuing study participants.

In his commentary, Dr. Gollob estimated that if 85,000 otherwise healthy adults were randomized to received a drug that can increase the QTc interval, as many as about 3,400 people (4%) in the group could statistically be expected to have an especially high vulnerability to QT prolongation because of genetic variants they might carry that collectively have roughly this prevalence. In some people of African heritage, the prevalence of genetic risk for excessive QTc lengthening can be even higher, approaching about 10%, noted Dr. Wilde.

Dr. Gollob hoped the concerns he raised will prompt the organizers of many of these studies to revise their design, and he said he already knew of one study based in Toronto that recently added an ECG-monitoring strategy in response to the concerns he raised. He expressed optimism that more studies will follow.

“It’s a real issue to have these trials designed without ECG exclusions or monitoring. I’m glad that Dr. Gollob sent this warning, because he is right. ECG monitoring during treatment is important so you can stop the treatment in time,” Dr. Wilde said. Dr. Wilde also noted that many, if not most, of the studies listed on clinicaltrials.gov may not actually launch.

In April, representatives from several cardiology societies coauthored a document of considerations when using hydroxychloroquine, chloroquine, or azithromycin to treat patients with a diagnosed COVID-19 infection, and highlighted a QTc interval of 500 msec or greater as flagging patients who should no longer receive these drugs (J Am Coll Cardiol. 2020 Apr 10. doi: 10.1016/j.jacc.2020.04.016). For patients who do not yet have COVID-19 disease and the goal from treatment is prevention the potential efficacy of these drugs is reasonable to explore, but “does not exclude the need to minimize risk to research participants, especially when enrolling healthy subjects,” Dr. Gollob said.

Dr. Gollob, Dr. Viskin, and Dr. Wilde had no relevant financial disclosures.

[email protected]

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Traditionally at this time of year, everyone working in cancer turns their attention toward Chicago, and 40,000 or so travel to the city for the annual meeting of the American Society of Clinical Oncology (ASCO).

Not this year.

The McCormick Place convention center has been converted to a field hospital to cope with the ongoing COVID-19 pandemic. The cavernous meeting halls have been filled with makeshift wards with 750 acute care beds, as shown in a tweet from Toni Choueiri, MD, chief of genitourinary oncology at the Dana Farber Cancer Center in Boston.

But the annual meeting is still going ahead, having been transferred online.

“We have to remember that even though there’s a pandemic going on and people are dying every day from coronavirus, people are still dying every day from cancer,” Richard Schilsky, MD, PhD, chief medical officer at ASCO, told Medscape Medical News.

“This pandemic will end, but cancer will continue, and we need to be able to continue to get the most cutting edge scientific results out there to our members and our constituents so they can act on those results on behalf of their patients,” he said.

The ASCO Virtual Scientific Program will take place over the weekend of May 30-31.

“We’re certainly hoping that we’re going to deliver a program that features all of the most important science that would have been presented in person in Chicago,” Schilsky commented in an interview.

Most of the presentations will be prerecorded and then streamed, which “we hope will mitigate any of the technical glitches that could come from trying to do a live broadcast of the meeting,” he said.

There will be 250 oral and 2500 poster presentations in 24 disease-based and specialty tracks.

The majority of the abstracts will be released online on May 13. The majority of the on-demand content will be released on May 29. Some of the abstracts will be highlighted at ASCO press briefings and released on those two dates.

But some of the material will be made available only on the weekend of the meeting. The opening session, plenaries featuring late-breaking abstracts, special highlights sessions, and other clinical science symposia will be broadcast on Saturday, May 30, and Sunday, May 31 (the schedule for the weekend program is available on the ASCO meeting website).

Among the plenary presentations are some clinical results that are likely to change practice immediately, Schilsky predicted. These include data to be presented in the following abstracts:

• Abstract LBA4 on the KEYNOTE-177 study comparing immunotherapy using pembrolizumab (Keytruda, Merck & Co) with chemotherapy in patients with metastatic colorectal cancer whose tumors show microsatellite instability or mismatch repair deficiency;
• Abstract LBA5 on the ADAURA study exploring osimertinib (Tagrisso, AstraZeneca) as adjuvant therapy after complete tumor reseaction in patients with early-stage non–small cell lung cancer whose tumors are EGFR mutation positive;
• Abstract LBA1 on the JAVELIN Bladder 100 study exploring maintenance avelumab (Bavencio, Merck and Pfizer) with best supportive care after platinum-based first-line chemotherapy in patients with advanced urothelial carcinoma.

However, some of the material that would have been part of the annual meeting, which includes mostly educational sessions and invited talks, has been moved to another event, the ASCO Educational Program, to be held in August 2020.

“So I suppose, in the grand scheme of things, the meeting is going to be compressed a little bit,” Schilsky commented. “Obviously, we can’t deliver all the interactions that happen in the hallways and everywhere else at the meeting that really gives so much energy to the meeting, but, at this moment in our history, probably getting the science out there is what’s most important.”
 

Virtual exhibition hall

There will also be a virtual exhibition hall, which will open on May 29.

“Just as there is a typical exhibit hall in the convention center,” Schilsky commented, most of the companies that were planning to be in Chicago have “now transitioned to creating a virtual booth that people who are participating in the virtual meeting can visit.

“I don’t know exactly how each company is going to use their time and their virtual space, and that’s part of the whole learning process here to see how this whole experiment is going to work out,” he added.

Unlike some of the other conferences that have gone virtual, in which access has been made available to everyone for free, registration is still required for the ASCO meeting. But the society notes that the registration fee has been discounted for nonmembers and has been waived for ASCO members. Also, the fee covers both the Virtual Scientific Program in May and the ASCO Educational Program in August.

Registrants will have access to video and slide presentations, as well as discussant commentaries, for 180 days.

The article first appeared on Medscape.com.

Acute pyogenic vertebral osteomyelitis is often due to hematogenous spread of aerobic bacteria.^1-4 Conversely, only 0.5% of anaerobic bacteremias lead to osteomyelitis.⁵ Anaerobic osteomyelitis typically results from the contiguous spread of polymicrobial infections through breaks in the gut mucosal barrier and involves the vertebral bodies in only 2% to 5% of cases.^5,6 Although Bacteroides fragilis (B fragilis) is the most common anaerobic pathogen cultivated from blood, accounting for about half of all anaerobic blood isolates, it seldom leads to osteomyelitis.^1,2,7-11 We report an uncommon case of B fragilis bacteremia and vertebral osteomyelitis confounded by uncertainties in anaerobic identification and susceptibilities.

Case Presentation

A healthy-appearing male aged 55 years presented to the Naval Medical Center Portsmouth (NMCP) with subacute low back pain and fevers of 103 °F for > 3 weeks. While traveling 4 weeks prior, he completed a course of oseltamivir for influenza B infection; afterward, he was diagnosed with community-acquired pneumonia and treated with a dose of ceftriaxone and a 7-day course of doxycycline. The patient presented to the same facility a week later for low back pain and nonresolving respiratory symptoms, and his therapy was changed to azithromycin, cefuroxime, prednisone, and inhalers. Additionally, after being treated for influenza, he developed constipation and hematochezia for which he did not seek care. The hematochezia was similar to a previous episode from an anal fissure 1 year prior that resolved with stool softeners. When he was finally seen at NMCP after 3 weeks of worsening back pain and fevers, lumbosacral magnetic resonance imaging (MRI) demonstrated vertebral osteomyelitis and discitis at L4-L5 and admitted to the hospital (Figure 1).

After a fluoroscopy-guided biopsy of the L4 vertebral body on hospital day 1, the patient was started on cefepime and vancomycin. The biopsy sample was inoculated onto solid media (blood agar, chocolate agar, and MacConkey agar) and incubated at 36 °C for 24 hours in a 5% CO₂ atmosphere, as well as onto Shaedler agar with vitamin K and chopped meat glucose broth and incubated at 36 °C for 48 hours under anaerobic conditions. Metronidazole was added and vancomycin discontinued after 2 anaerobic blood culture vials obtained on hospital day 1, incubated in a Becton Dickinson BACTEC FX automated system, which demonstrated Gram-negative bacilli after 48 hours. The blood culture isolates demonstrated a > 99% probability of being identified as ß-lactamase positive Prevotella loescheii using Thermo Fischer Scientific RapID ANA II biochemical testing. Nitrocefinase discs were used to detect ß-lactamase activity.

The biopsy demonstrated nongranulomatous focal areas of necrotic bone and neutrophilia in a hematopoietic background consistent with acute osteomyelitis (Figure 2); on hospital day 4, ß-lactamase positive B fragilis grew from the bone culture. Additionally, 1 anaerobic vial from a surveillance blood culture set that was obtained on hospital day 3 grew ß-lactamasepositive B fragilis using the same identification methods. With these results he was thought to have a polymicrobial infection (B fragilis and Prevotella loescheii [P loescheii]) from a suspected bowel source based on his hematochezia and history of anal fissure. No aerobic, Gram-negative enterobacteriaceae were isolated, but he had previously been on cefuroxime, which has potential activity against these organisms, for ≥ 2 weeks prior to hospitalization and cultures. He was discharged on moxifloxacin and metronidazole pending final culture results, including requested anaerobic susceptibility testing.

At 1-week follow-up, both aerobic and anaerobic vials from surveillance blood cultures remained negative for any microbes, so antibiotics were deescalated to moxifloxacin monotherapy. However, after 3 days the patient was readmitted for increasing C-reactive protein (CRP) levels and intractable back pain with worsening bilateral radiculopathy. A repeat MRI demonstrated interval disease progression with near obliteration of the L4-L5 disc space and hyperenhancement of the prevertebral soft tissues and adjacent psoas musculature without focal rim-enhancing fluid collection (Figure 3). After repeat L4 biopsy, metronidazole was restarted and ertapenem added for enterobacteriaceae coverage, given the known B fragilis and potential suppression from previous cephalosporin therapy; moxifloxacin was discontinued. L4 biopsy cultures showed no growth, and CRP levels trended down from 154.2 mg/L (start of first admission) to 42.4 mg/L (start of second admission) to 14.9 mg/L (day of discharge) (reference range, 5-9.9 mg/L). He was discharged on ertapenem and metronidazole. He completed a 6-week course without further complication.

Discussion

In the era of growing antibiotic resistance patterns, antimicrobial stewardship programs recommend interventions to improve antimicrobial use through targeted narrow- spectrum antibiotics.¹² The Clinical and Laboratory Standards Institute (CLSI) maintains guidelines on the major indications for anaerobic antimicrobial susceptibility testing (AST) to help direct narrow-targeted antimicrobial therapy. However, in a 2008 practice survey Goldstein and colleagues reported that less than half of US hospitals performed anaerobic AST, and only 21% of these facilities did it in-house, while the remainder sent out their isolates for testing.^11-14 The CLSI major indications for AST include situations in which the selection of agents is important because of the (1) known resistance of a particular species; (2) confirmation of appropriate therapy for severe infections or for those that may require long-term therapy; (3) persistence of infection despite adequate treatment with an appropriate therapeutic regimen; and (4) difficulty in making empirical decisions based on precedent.¹⁴ Additionally, isolates from brain abscess, endocarditis, osteomyelitis, joint infection, infection of prosthetic devices or vascular grafts, bacteremia, and normally sterile body sites (unless contamination suspected) should be tested.¹⁴

Because of the lack of anaerobic AST, health care providers must base empiric treatment on reported sensitivities from the medical literature. Empiric selection of antimicrobials for anaerobic infections is made even more challenging by the increased rates of resistance reported in the literature, leading to recommendations to increase susceptibility testing to guide therapy.^13,15,16 Empiric therapy of deep-seated anaerobic infections may lead to use of inactive agents or overly broad-spectrum antibiotics. Current antimicrobial stewardship initiatives recognize the importance of narrow-spectrum antibiotics to minimize risk of adverse events and selective pressure for antimicrobial resistance.

Although we attempted to confirm the identification of the anaerobic isolates via commercially available methods, it was not until we performed genetic testing that we were able verify the isolates as B fragilis. Furthermore, earlier susceptibility testing would have allowed for more narrow-targeted antimicrobial therapy and could have potentially prevented our patient’s readmission and use of ertapenem, despite its > 98% susceptibility rates against B fragilis.^13,17

All of the B fragilis isolates carried the cepA gene, which is a cephalosporinase that encodes for resistance to cephalosporins and aminopenicillins but not to ß-lactam ß-lactamase inhibitor combinations.¹³ Although not a substitution for susceptibility analysis, genetic testing showed that all of the isolates carried a nonsynonymous mutation from serine to a phenylalanine at amino acid position 82 (S82F) in the gyrA gene. The S82F mutation has been implicated in fluoroquinolone resistance, via inhibition of substrate–target recognition and binding between fluoroquinolones and the target topoisomerase protein,¹⁸ and may potentially explain why our patient clinically worsened while on moxifloxacin monotherapy. Although moxifloxacin susceptibility was not performed, susceptibility rates remain highly variable, ranging from 50% to 70% for B fragilis.^13,15,16

It is important to note that the metronidazole the patient received during his first hospital admission could have sterilized the vertebral body without completely eradicating the microbe; thus could explain his clinical worsening while on moxifloxacin monotherapy despite no growth from the repeat biopsy culture. Our rationale for initially continuing moxifloxacin was based on its excellent bioavailability and bone penetration properties. Additionally, of the fluoroquinolones it has the most reliable anaerobic activity and is the only one recommended as monotherapy for complicated intraabdominal infections.¹⁹ However, guidelines recommend avoiding its use in patients who have received a fluoroquinolone in the past 90 days or at institutions with high rates of resistance. At our institution Escherichia coli has a > 90% susceptibility rate to fluoroquinolones. Given this rate and our concern that the patient had a polymicrobial infection, we felt that moxifloxacin would provide appropriate anaerobic and aerobic coverage, especially since he had no previous fluoroquinolone exposure.

Conclusions

We report a case of B fragilis bacteremia and vertebral osteomyelitis complicated by challenges in anaerobic identification and sensitivities that led to brief use of a possibly inactive antimicrobial and the subsequent use of carbapenem therapy, which may have been avoided if susceptibility testing were more readily available. This case led to changes in our hospital’s processing of anaerobic isolates to include susceptibility testing on request.

Acknowledgments

We thank Keith Thompson, MD (staff pathologist, Naval Medical Center Portsmouth Virginia), for providing the pathology images from the initial vertebral biopsy, and Dr. Kate Hinkle (director, Multidrug-Resistant Organism Repository and Surveillance Network, Silver Spring, Maryland ) for providing the whole genome sequencing results from the B fragilis isolates.

Acute pyogenic vertebral osteomyelitis is often due to hematogenous spread of aerobic bacteria.^1-4 Conversely, only 0.5% of anaerobic bacteremias lead to osteomyelitis.⁵ Anaerobic osteomyelitis typically results from the contiguous spread of polymicrobial infections through breaks in the gut mucosal barrier and involves the vertebral bodies in only 2% to 5% of cases.^5,6 Although Bacteroides fragilis (B fragilis) is the most common anaerobic pathogen cultivated from blood, accounting for about half of all anaerobic blood isolates, it seldom leads to osteomyelitis.^1,2,7-11 We report an uncommon case of B fragilis bacteremia and vertebral osteomyelitis confounded by uncertainties in anaerobic identification and susceptibilities.

Case Presentation

A healthy-appearing male aged 55 years presented to the Naval Medical Center Portsmouth (NMCP) with subacute low back pain and fevers of 103 °F for > 3 weeks. While traveling 4 weeks prior, he completed a course of oseltamivir for influenza B infection; afterward, he was diagnosed with community-acquired pneumonia and treated with a dose of ceftriaxone and a 7-day course of doxycycline. The patient presented to the same facility a week later for low back pain and nonresolving respiratory symptoms, and his therapy was changed to azithromycin, cefuroxime, prednisone, and inhalers. Additionally, after being treated for influenza, he developed constipation and hematochezia for which he did not seek care. The hematochezia was similar to a previous episode from an anal fissure 1 year prior that resolved with stool softeners. When he was finally seen at NMCP after 3 weeks of worsening back pain and fevers, lumbosacral magnetic resonance imaging (MRI) demonstrated vertebral osteomyelitis and discitis at L4-L5 and admitted to the hospital (Figure 1).

After a fluoroscopy-guided biopsy of the L4 vertebral body on hospital day 1, the patient was started on cefepime and vancomycin. The biopsy sample was inoculated onto solid media (blood agar, chocolate agar, and MacConkey agar) and incubated at 36 °C for 24 hours in a 5% CO₂ atmosphere, as well as onto Shaedler agar with vitamin K and chopped meat glucose broth and incubated at 36 °C for 48 hours under anaerobic conditions. Metronidazole was added and vancomycin discontinued after 2 anaerobic blood culture vials obtained on hospital day 1, incubated in a Becton Dickinson BACTEC FX automated system, which demonstrated Gram-negative bacilli after 48 hours. The blood culture isolates demonstrated a > 99% probability of being identified as ß-lactamase positive Prevotella loescheii using Thermo Fischer Scientific RapID ANA II biochemical testing. Nitrocefinase discs were used to detect ß-lactamase activity.

The biopsy demonstrated nongranulomatous focal areas of necrotic bone and neutrophilia in a hematopoietic background consistent with acute osteomyelitis (Figure 2); on hospital day 4, ß-lactamase positive B fragilis grew from the bone culture. Additionally, 1 anaerobic vial from a surveillance blood culture set that was obtained on hospital day 3 grew ß-lactamasepositive B fragilis using the same identification methods. With these results he was thought to have a polymicrobial infection (B fragilis and Prevotella loescheii [P loescheii]) from a suspected bowel source based on his hematochezia and history of anal fissure. No aerobic, Gram-negative enterobacteriaceae were isolated, but he had previously been on cefuroxime, which has potential activity against these organisms, for ≥ 2 weeks prior to hospitalization and cultures. He was discharged on moxifloxacin and metronidazole pending final culture results, including requested anaerobic susceptibility testing.

At 1-week follow-up, both aerobic and anaerobic vials from surveillance blood cultures remained negative for any microbes, so antibiotics were deescalated to moxifloxacin monotherapy. However, after 3 days the patient was readmitted for increasing C-reactive protein (CRP) levels and intractable back pain with worsening bilateral radiculopathy. A repeat MRI demonstrated interval disease progression with near obliteration of the L4-L5 disc space and hyperenhancement of the prevertebral soft tissues and adjacent psoas musculature without focal rim-enhancing fluid collection (Figure 3). After repeat L4 biopsy, metronidazole was restarted and ertapenem added for enterobacteriaceae coverage, given the known B fragilis and potential suppression from previous cephalosporin therapy; moxifloxacin was discontinued. L4 biopsy cultures showed no growth, and CRP levels trended down from 154.2 mg/L (start of first admission) to 42.4 mg/L (start of second admission) to 14.9 mg/L (day of discharge) (reference range, 5-9.9 mg/L). He was discharged on ertapenem and metronidazole. He completed a 6-week course without further complication.

Discussion

In the era of growing antibiotic resistance patterns, antimicrobial stewardship programs recommend interventions to improve antimicrobial use through targeted narrow- spectrum antibiotics.¹² The Clinical and Laboratory Standards Institute (CLSI) maintains guidelines on the major indications for anaerobic antimicrobial susceptibility testing (AST) to help direct narrow-targeted antimicrobial therapy. However, in a 2008 practice survey Goldstein and colleagues reported that less than half of US hospitals performed anaerobic AST, and only 21% of these facilities did it in-house, while the remainder sent out their isolates for testing.^11-14 The CLSI major indications for AST include situations in which the selection of agents is important because of the (1) known resistance of a particular species; (2) confirmation of appropriate therapy for severe infections or for those that may require long-term therapy; (3) persistence of infection despite adequate treatment with an appropriate therapeutic regimen; and (4) difficulty in making empirical decisions based on precedent.¹⁴ Additionally, isolates from brain abscess, endocarditis, osteomyelitis, joint infection, infection of prosthetic devices or vascular grafts, bacteremia, and normally sterile body sites (unless contamination suspected) should be tested.¹⁴

Because of the lack of anaerobic AST, health care providers must base empiric treatment on reported sensitivities from the medical literature. Empiric selection of antimicrobials for anaerobic infections is made even more challenging by the increased rates of resistance reported in the literature, leading to recommendations to increase susceptibility testing to guide therapy.^13,15,16 Empiric therapy of deep-seated anaerobic infections may lead to use of inactive agents or overly broad-spectrum antibiotics. Current antimicrobial stewardship initiatives recognize the importance of narrow-spectrum antibiotics to minimize risk of adverse events and selective pressure for antimicrobial resistance.

Although we attempted to confirm the identification of the anaerobic isolates via commercially available methods, it was not until we performed genetic testing that we were able verify the isolates as B fragilis. Furthermore, earlier susceptibility testing would have allowed for more narrow-targeted antimicrobial therapy and could have potentially prevented our patient’s readmission and use of ertapenem, despite its > 98% susceptibility rates against B fragilis.^13,17

All of the B fragilis isolates carried the cepA gene, which is a cephalosporinase that encodes for resistance to cephalosporins and aminopenicillins but not to ß-lactam ß-lactamase inhibitor combinations.¹³ Although not a substitution for susceptibility analysis, genetic testing showed that all of the isolates carried a nonsynonymous mutation from serine to a phenylalanine at amino acid position 82 (S82F) in the gyrA gene. The S82F mutation has been implicated in fluoroquinolone resistance, via inhibition of substrate–target recognition and binding between fluoroquinolones and the target topoisomerase protein,¹⁸ and may potentially explain why our patient clinically worsened while on moxifloxacin monotherapy. Although moxifloxacin susceptibility was not performed, susceptibility rates remain highly variable, ranging from 50% to 70% for B fragilis.^13,15,16

It is important to note that the metronidazole the patient received during his first hospital admission could have sterilized the vertebral body without completely eradicating the microbe; thus could explain his clinical worsening while on moxifloxacin monotherapy despite no growth from the repeat biopsy culture. Our rationale for initially continuing moxifloxacin was based on its excellent bioavailability and bone penetration properties. Additionally, of the fluoroquinolones it has the most reliable anaerobic activity and is the only one recommended as monotherapy for complicated intraabdominal infections.¹⁹ However, guidelines recommend avoiding its use in patients who have received a fluoroquinolone in the past 90 days or at institutions with high rates of resistance. At our institution Escherichia coli has a > 90% susceptibility rate to fluoroquinolones. Given this rate and our concern that the patient had a polymicrobial infection, we felt that moxifloxacin would provide appropriate anaerobic and aerobic coverage, especially since he had no previous fluoroquinolone exposure.

Conclusions

We report a case of B fragilis bacteremia and vertebral osteomyelitis complicated by challenges in anaerobic identification and sensitivities that led to brief use of a possibly inactive antimicrobial and the subsequent use of carbapenem therapy, which may have been avoided if susceptibility testing were more readily available. This case led to changes in our hospital’s processing of anaerobic isolates to include susceptibility testing on request.

Acknowledgments

We thank Keith Thompson, MD (staff pathologist, Naval Medical Center Portsmouth Virginia), for providing the pathology images from the initial vertebral biopsy, and Dr. Kate Hinkle (director, Multidrug-Resistant Organism Repository and Surveillance Network, Silver Spring, Maryland ) for providing the whole genome sequencing results from the B fragilis isolates.

Acute pyogenic vertebral osteomyelitis is often due to hematogenous spread of aerobic bacteria.^1-4 Conversely, only 0.5% of anaerobic bacteremias lead to osteomyelitis.⁵ Anaerobic osteomyelitis typically results from the contiguous spread of polymicrobial infections through breaks in the gut mucosal barrier and involves the vertebral bodies in only 2% to 5% of cases.^5,6 Although Bacteroides fragilis (B fragilis) is the most common anaerobic pathogen cultivated from blood, accounting for about half of all anaerobic blood isolates, it seldom leads to osteomyelitis.^1,2,7-11 We report an uncommon case of B fragilis bacteremia and vertebral osteomyelitis confounded by uncertainties in anaerobic identification and susceptibilities.

Case Presentation

A healthy-appearing male aged 55 years presented to the Naval Medical Center Portsmouth (NMCP) with subacute low back pain and fevers of 103 °F for > 3 weeks. While traveling 4 weeks prior, he completed a course of oseltamivir for influenza B infection; afterward, he was diagnosed with community-acquired pneumonia and treated with a dose of ceftriaxone and a 7-day course of doxycycline. The patient presented to the same facility a week later for low back pain and nonresolving respiratory symptoms, and his therapy was changed to azithromycin, cefuroxime, prednisone, and inhalers. Additionally, after being treated for influenza, he developed constipation and hematochezia for which he did not seek care. The hematochezia was similar to a previous episode from an anal fissure 1 year prior that resolved with stool softeners. When he was finally seen at NMCP after 3 weeks of worsening back pain and fevers, lumbosacral magnetic resonance imaging (MRI) demonstrated vertebral osteomyelitis and discitis at L4-L5 and admitted to the hospital (Figure 1).

After a fluoroscopy-guided biopsy of the L4 vertebral body on hospital day 1, the patient was started on cefepime and vancomycin. The biopsy sample was inoculated onto solid media (blood agar, chocolate agar, and MacConkey agar) and incubated at 36 °C for 24 hours in a 5% CO₂ atmosphere, as well as onto Shaedler agar with vitamin K and chopped meat glucose broth and incubated at 36 °C for 48 hours under anaerobic conditions. Metronidazole was added and vancomycin discontinued after 2 anaerobic blood culture vials obtained on hospital day 1, incubated in a Becton Dickinson BACTEC FX automated system, which demonstrated Gram-negative bacilli after 48 hours. The blood culture isolates demonstrated a > 99% probability of being identified as ß-lactamase positive Prevotella loescheii using Thermo Fischer Scientific RapID ANA II biochemical testing. Nitrocefinase discs were used to detect ß-lactamase activity.

The biopsy demonstrated nongranulomatous focal areas of necrotic bone and neutrophilia in a hematopoietic background consistent with acute osteomyelitis (Figure 2); on hospital day 4, ß-lactamase positive B fragilis grew from the bone culture. Additionally, 1 anaerobic vial from a surveillance blood culture set that was obtained on hospital day 3 grew ß-lactamasepositive B fragilis using the same identification methods. With these results he was thought to have a polymicrobial infection (B fragilis and Prevotella loescheii [P loescheii]) from a suspected bowel source based on his hematochezia and history of anal fissure. No aerobic, Gram-negative enterobacteriaceae were isolated, but he had previously been on cefuroxime, which has potential activity against these organisms, for ≥ 2 weeks prior to hospitalization and cultures. He was discharged on moxifloxacin and metronidazole pending final culture results, including requested anaerobic susceptibility testing.

At 1-week follow-up, both aerobic and anaerobic vials from surveillance blood cultures remained negative for any microbes, so antibiotics were deescalated to moxifloxacin monotherapy. However, after 3 days the patient was readmitted for increasing C-reactive protein (CRP) levels and intractable back pain with worsening bilateral radiculopathy. A repeat MRI demonstrated interval disease progression with near obliteration of the L4-L5 disc space and hyperenhancement of the prevertebral soft tissues and adjacent psoas musculature without focal rim-enhancing fluid collection (Figure 3). After repeat L4 biopsy, metronidazole was restarted and ertapenem added for enterobacteriaceae coverage, given the known B fragilis and potential suppression from previous cephalosporin therapy; moxifloxacin was discontinued. L4 biopsy cultures showed no growth, and CRP levels trended down from 154.2 mg/L (start of first admission) to 42.4 mg/L (start of second admission) to 14.9 mg/L (day of discharge) (reference range, 5-9.9 mg/L). He was discharged on ertapenem and metronidazole. He completed a 6-week course without further complication.

Discussion

In the era of growing antibiotic resistance patterns, antimicrobial stewardship programs recommend interventions to improve antimicrobial use through targeted narrow- spectrum antibiotics.¹² The Clinical and Laboratory Standards Institute (CLSI) maintains guidelines on the major indications for anaerobic antimicrobial susceptibility testing (AST) to help direct narrow-targeted antimicrobial therapy. However, in a 2008 practice survey Goldstein and colleagues reported that less than half of US hospitals performed anaerobic AST, and only 21% of these facilities did it in-house, while the remainder sent out their isolates for testing.^11-14 The CLSI major indications for AST include situations in which the selection of agents is important because of the (1) known resistance of a particular species; (2) confirmation of appropriate therapy for severe infections or for those that may require long-term therapy; (3) persistence of infection despite adequate treatment with an appropriate therapeutic regimen; and (4) difficulty in making empirical decisions based on precedent.¹⁴ Additionally, isolates from brain abscess, endocarditis, osteomyelitis, joint infection, infection of prosthetic devices or vascular grafts, bacteremia, and normally sterile body sites (unless contamination suspected) should be tested.¹⁴

Because of the lack of anaerobic AST, health care providers must base empiric treatment on reported sensitivities from the medical literature. Empiric selection of antimicrobials for anaerobic infections is made even more challenging by the increased rates of resistance reported in the literature, leading to recommendations to increase susceptibility testing to guide therapy.^13,15,16 Empiric therapy of deep-seated anaerobic infections may lead to use of inactive agents or overly broad-spectrum antibiotics. Current antimicrobial stewardship initiatives recognize the importance of narrow-spectrum antibiotics to minimize risk of adverse events and selective pressure for antimicrobial resistance.

Although we attempted to confirm the identification of the anaerobic isolates via commercially available methods, it was not until we performed genetic testing that we were able verify the isolates as B fragilis. Furthermore, earlier susceptibility testing would have allowed for more narrow-targeted antimicrobial therapy and could have potentially prevented our patient’s readmission and use of ertapenem, despite its > 98% susceptibility rates against B fragilis.^13,17

All of the B fragilis isolates carried the cepA gene, which is a cephalosporinase that encodes for resistance to cephalosporins and aminopenicillins but not to ß-lactam ß-lactamase inhibitor combinations.¹³ Although not a substitution for susceptibility analysis, genetic testing showed that all of the isolates carried a nonsynonymous mutation from serine to a phenylalanine at amino acid position 82 (S82F) in the gyrA gene. The S82F mutation has been implicated in fluoroquinolone resistance, via inhibition of substrate–target recognition and binding between fluoroquinolones and the target topoisomerase protein,¹⁸ and may potentially explain why our patient clinically worsened while on moxifloxacin monotherapy. Although moxifloxacin susceptibility was not performed, susceptibility rates remain highly variable, ranging from 50% to 70% for B fragilis.^13,15,16

It is important to note that the metronidazole the patient received during his first hospital admission could have sterilized the vertebral body without completely eradicating the microbe; thus could explain his clinical worsening while on moxifloxacin monotherapy despite no growth from the repeat biopsy culture. Our rationale for initially continuing moxifloxacin was based on its excellent bioavailability and bone penetration properties. Additionally, of the fluoroquinolones it has the most reliable anaerobic activity and is the only one recommended as monotherapy for complicated intraabdominal infections.¹⁹ However, guidelines recommend avoiding its use in patients who have received a fluoroquinolone in the past 90 days or at institutions with high rates of resistance. At our institution Escherichia coli has a > 90% susceptibility rate to fluoroquinolones. Given this rate and our concern that the patient had a polymicrobial infection, we felt that moxifloxacin would provide appropriate anaerobic and aerobic coverage, especially since he had no previous fluoroquinolone exposure.

Conclusions

We report a case of B fragilis bacteremia and vertebral osteomyelitis complicated by challenges in anaerobic identification and sensitivities that led to brief use of a possibly inactive antimicrobial and the subsequent use of carbapenem therapy, which may have been avoided if susceptibility testing were more readily available. This case led to changes in our hospital’s processing of anaerobic isolates to include susceptibility testing on request.

Acknowledgments

We thank Keith Thompson, MD (staff pathologist, Naval Medical Center Portsmouth Virginia), for providing the pathology images from the initial vertebral biopsy, and Dr. Kate Hinkle (director, Multidrug-Resistant Organism Repository and Surveillance Network, Silver Spring, Maryland ) for providing the whole genome sequencing results from the B fragilis isolates.

Xerostomia, the subjective sensation of dry mouth, is a common problem developed by geriatric patients. In practice, xerostomia can impair swallowing, speech, and oral hygiene, and if left unchecked, symptoms such as dysphagia and dysarthria can diminish patients’ quality of life (QOL). Salivary gland hypofunction (SGH) is the objective measure of decreased saliva production, determined by sialometry. Although xerostomia and SGH can coexist, the 2 conditions are not necessarily related.^1-4 For this discussion, the term xerostomia will denote dry mouth with or without a concomitant diagnosis of SGH.

Xerostomia is seen in a wide variety of patients with varied comorbidities. It is commonly associated with Sjögren syndrome and head and neck irradiation. The diagnosis and treatment of xerostomia often involves rheumatologists, dentists, otolaryngologists, and oncologists. Additionally, most of the scientific literature about this topic exists in dental journals, such as the Journal of the American Dental Association and the British Dental Journal. Rarer still are studies in the veteran population.⁵

Faced with increasing time pressure to treat the many chronic diseases affecting aging veterans, health care providers (HCPs) tend to deprioritize diagnosing dry mouth. To that point, saliva is often not considered in the same category as other bodily fluids. According to Mandel, “It lacks the drama of blood, the sincerity of sweat…[and] the emotional appeal of tears.”⁶ In reality, saliva plays a critical role in the oral-digestive tract and in swallowing. It contains the first digestive enzymes in the gastrointestinal tract and is key for maintaining homeostasis in the oral cavity.⁷ Decreased saliva production results in difficulties with speech and mastication as well as problems of dysphagia, esophageal dysfunction, dysgeusia, nutritional compromises, new and recurrent dental caries, candidiasis, glossitis, impaired use of dentures, halitosis, and susceptibility to mucosal injury.^7,8 Problems with the production of saliva may lead to loss of QOL, such as enjoying a meal or conversing with others.⁴

Although xerostomia is often associated with advanced age, it is more often explained by the diseases that afflict geriatric patients and the arsenal of medications used to treat them.^2,9-16 Polypharmacy, the simultaneous use of multiple drugs by a single patient for ≥ 1 conditions, is an independent risk factor for xerostomia regardless of the types of medication taken.¹⁶ From 2005 to 2011, older adults in the US significantly increased their prescription medication use and dietary supplements. More than one-third of older adults used ≥ 5 prescription medications concurrently, and two-thirds of older adults used combinations of prescribed medications, over-the-counter medications, and dietary supplements.¹⁷ Several drug classes have the capacity to induce xerostomia, such as antihypertensives, antiulcer agents, anticholinergics, and antidepressants.^2,5,12 Prevalence of dry mouth also can range from 10% to 46%, and women typically are more medicated and symptomatic.^{2,3,9,13,14,16} Xerostomia can also lead to depression and even reduce patients’ will to live.¹⁸ Despite xerostomia’s prevalence and impact on QOL, few patients report it as their chief symptom, and few physicians attempt to treat it.¹⁹

In order to target polypharmacy as a cause of dry mouth, the objectives for this study were to evaluate (1) the prevalence of xerostomia; (2) the relationship between xerostomia and other oral conditions; and (3) the impact of polypharmacy on dry mouth in a veteran population.

Methods

This is a retrospective cross-sectional study of all outpatient visits in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015) at the VA Palo Alto Health Care System (VAPAHCS), a tertiary care US Department of Veterans Affairs (VA) hospital. This study was approved by the Stanford University Institutional Review Board. All patients diagnosed with xerostomia in the 1-year study period were identified using ICD-9 diagnosis codes for dry mouth or disturbance of salivary gland secretion (527.7, 527.8, R68.2) and Systemized Nomenclature of Medicine Clinical Terms (SNOMED CT) codes covering dry mouth, xerostomia, aptyalism, absent salivary secretion, and disturbance of salivary secretion (87715008, 78948009). Data analysts in the VA Office of Business Analytics assisted in gathering data from the Veterans Information Systems and Technology Architecture (VistA) electronic health record.

The statistical analysis of that data was performed using Microsoft Excel. Age and gender distributions were determined for the patients. The relationship between xerostomia and the number and types of medications taken by patients also was examined. A previous Swedish study examining the link between dry mouth and quantities of medications used a scale ranging from 0 to ≥ 7 medications.¹⁶ The scale for this study was made wider to include the following groups: 0-2, 3-5, 6-8, 9-11, and ≥ 12 medications. Items that do not have xerogenic risks, such as medical supplies (eg, gloves, syringes, etc) and topical medications, were excluded from the analysis. Finally, the number of subjects with comorbid problems with speech, dentition, or swallowing (SDS) was recorded. Non-VA medications were included to capture any self- or externally prescribed xerogenic medications.

Results

Of the patients seen at VAPAHCS during FY 2015, 138 had a diagnostic code for xerostomia, including 129 men (93.5%) and 9 women (6.5%). The average (SD) age of this xerostomia cohort was 69.3 (12.6) years, and the 3 most common age groups were 60 to 69 years (37.7%), 70 to 79 years (28.3%), and 80 to 89 years (13.0%) (Table 1). Of those 138 patients with a xerostomia diagnosis, a majority (84; 60.9%) had at least 1 documented SDS problem (Table 2). Conversely, during FY 2015, although 4,971 patients seen at VAPAHCS had documented SDS problems, only 77 (1.5%) had a recorded diagnosis of xerostomia.

Of the 138 patients with xerostomia, 55 (39.9%) were taking ≥ 12 medications, more than twice as many patients as in any of the other groups studied (0-2, 3-5, 6-8, and 9-11 medications taken) (Table 3). On average, each patient with xerostomia filled prescriptions for 10.4 (SD, 7.2) different drugs. In this cohort of 138 patients diagnosed with xerostomia, antihypertensive medications or analgesics were taken by > 50% of patients, while statins, psychiatric medications, antibiotics, proton pump inhibitors, or drugs known to have anticholinergic activity were taken by > 40%. Antihistamines, anticonvulsants, diuretics, or inhaled respiratory agents were used by > 20% of the patients in this cohort (Table 4).

Data on each individual medication were split into 2 categories: the percentage of patients that filled ≥ 1 prescription for that drug, and the total number of prescriptions filled and/or refilled for that drug (ie, including all fills and refills made by individual patients). The 5 most widely used medications in this cohort were omeprazole (39.1%), docusate sodium (29.7%), gabapentin (29.7%), aspirin (27.5%), and hydrocodone/acetaminophen (26.1%) (Table 5). The 5 prescriptions that were cumulatively most filled and/or refilled were omeprazole (128), sildenafil citrate (108), gabapentin (101), hydrocodone/acetaminophen (100), and oxycodone (92) (Table 6). Though sildenafil citrate and oxycodone were among the most-filled prescriptions, these were not included in Table 5 as neither was taken by > 15% of the patients studied. These prescriptions were filled multiple times by a small subset of patients.

Regarding treatment for dry mouth, artificial saliva spray was one of the most widely used (23.2%) and the seventh most-filled prescription within this cohort (86). The only other medication taken by > 15% of patients in a formulation other than a tablet or capsule was chlorhexidine, a germicidal mouthwash used to improve oral care.

Discussion

Saliva is an essential component for the maintenance of normal oral health.^20,21 Decreased saliva production causes problems, including difficulties with speech, mastication, dysphagia, changes in taste, dental caries, impaired use of prostheses, recurrent infections, halitosis, deterioration of soft tissues, and compromised QOL.^22,23 Among patients with a diagnosed SDS abnormality who were seen at this facility during FY 2015, the prevalence of xerostomia was only 1.5%. However, the true prevalence and incidence of xerostomia among veterans is not known. Given the role of xerostomia as a common risk factor for SDS problems and the polypharmacy exhibited by those presented here with SDS problems, it is probable that xerostomia was underreported in this veteran cohort.

Additionally, although salivary acinar cells are known to atrophy with age, as is consistent with this xerostomia cohort’s average age (SD) of 69.3 (12.6) years, the development of dry mouth is a multifactorial process. The current scientific literature asserts that most salivary loss is due to local and systemic diseases, immunologic disorders, external radiation, and as was highlighted by this study, multiple prescription and nonprescription medications.^24-26

It has also been demonstrated previously that dry mouth complaints and low salivary flow rates are directly proportional to the number of medications taken by patients.^2,27-30 Polypharmacy is therefore an area of great interest, and ≥ 40 categories of xerogenic medications have been identified by investigators such as Sreebny and Schwartz.³¹ Among those, some of the most xerogenic medication classes include antihypertensives, antiulcer agents, anticholinergics, and antidepressants, are all very commonly consumed in this cohort of patients with dry mouth (58.7%, 42.0%, 47.1%, and 38.4%, respectively). The medication regimens within this cohort of veterans with xerostomia were prime examples of polypharmacy as each patient took an average (SD) of 10.4 (7.2) medications, 39.9% took ≥ 12, and 72.5% of patients with xerostomia were taking ≥ 6 prescription drugs during a 1-year period.

Given the dangers of polypharmacy, a more conservative approach to prescribing medications could feasibly help with preventing xerostomia and SGH. In practice, while clinicians try to avoid prescribing anticholinergics, antimuscarinics, and antihistaminergic drugs for geriatric patients, they are tasked with the complex management of medication adverse effects (AEs) when dealing with multiple health conditions. The clinicians’ primary responsibilities are to follow the standard of care and not to introduce unnecessary harm when managing patients, but they also must push for, stay abreast of, and conduct more basic research and clinical trials to inform, adjust, and improve our current standard.

Research into polypharmacy and its role in inducing dry mouth is ongoing. Twenty years ago, Thomson and colleagues identified reduced salivary flow in patients who used antianginals, thyroxine, diuretics, antidepressants, and medications for asthma, while only 5 years earlier Loesche and colleagues reported the role of antiulcer medications, such as proton pump inhibitors, in the development of xerostomia.^2,32 Within the past 5 years, Viljakainen and colleagues and Ohara and colleagues have echoed some of those findings by identifying associations between xerostomia and agents that impact digestive organs.^33,34 A strong association recently was identified between the use of antipsychotic drugs and xerostomia.³⁵ Additionally, when attributing xerostomia to polypharmacy, the interaction between medications is often overlooked in favor of considering the raw number of prescriptions taken. Whereas 1 medication alone may not have drying properties, combinations of medications might be more likely to induce xerostomia. Thomson and colleagues suggested such a situation regarding the interaction between thyroxine and diuretics.³⁶ Future studies should focus on identifying viable substitutes for existing medications that reduce risk for xerostomia without compromising the management of other serious conditions.

Treatment

Another pressing question for clinicians concerns artificial saliva. Although 23.2% of patients with dry mouth in this xerostomia cohort used artificial saliva, the efficacy of this treatment is still unproven. Saliva substitutes are often used by patients who cannot produce sufficient amounts of natural saliva. In practice, artificial saliva produces, at best, modest temporary improvement in dry mouth symptoms in up to 40% of patients. At worst, as put forth by the Cochrane Review, artificial saliva may be no better than placebo in treating dry mouth.^37,38 The volumes needed for symptom relief are large, ranging between 40 mL and 150 mL per day depending on the substitute’s composition. Saliva substitutes also must be reapplied throughout each day. This is particularly bothersome when patients must wake up repeatedly to reapply the treatment at night.³⁷ In short, these substances do not seem wholly effective in managing dry mouth, and other options must be made available to patients with refractory xerostomia when artificial saliva and lifestyle modifications fail.

For now, few alternatives exist. Chewing gums and lozenges help to stimulate salivary flow, as do muscarinic agonists like pilocarpine. Unfortunately, muscarinic agonists are seldom used due to cholinergic AEs. Humidifiers are effective in increasing nighttime moisture but are contraindicated in patients with dust mite allergies.³⁹ Reservoir-based devices with automated pumps funnel water and/or salivary substitutes from a fanny pack into patients’ mouths for lubrication.³⁷ Other more esoteric pharmacologic treatments include D-limonene, yohimbine, and amifostine, which purportedly protect salivary progenitor cells, increase peripheral cholinergic activity, and protect salivary glands from free-radical damage during radiation treatment, respectively. Although these agents have shown some promise, D-limonene is difficult to administer given the high dosage required for treatment, yohimbine hasn’t been seriously investigated for improving salivary secretion since 1997, and amifostine isn’t used widely due to its AE profile despite its US Food and Drug Administration approval for prevention of xerostomia.³⁹

Substance Abuse

The impact of smoking on xerostomia remains controversial. Some studies report an association between active smoking and xerostomia; others suggest that the local irritant effect of tobacco smoke may increase salivary gland output.^40,41 The same may be true for chronic alcohol use as there are no epidemiologic studies showing a causal relationship between alcohol use and xerostomia. Studies with rats that are chronically exposed to ethanol have found increased salivary flow rates.⁴² In the xerostomia cohort presented here, 30 patients (21.7%) had a documented history of substance misuse. That percentage is likely underestimated, as substance misuse is often underreported, and frequent use may not always constitute misuse. Therefore, nicotine exposure, alcohol exposure, illicit drug use, and vaping all should be considered during the workup of a patient with xerostomia.

Limitations

It is common for medications to remain in a patient’s health record long after that patient stops taking them. Developing methods to track when patients discontinue their prescriptions will be essential for clearing up uncertainty in our data and in other similar studies. This study also did not account for patients’ medication adherence and the duration of exposure to medications and illicit substances. Furthermore, the results of this veteran study are not easily generalizable as this cohort is disproportionately male, of advanced age, and especially prone to exhibiting both substance use and psychiatric diagnoses relative to the general population. As described by Viljakainen and colleagues, risk factors for xerostomia include advanced age, female gender, low body mass index (BMI), malnutrition, and depressive symptoms, but because the demographic scope of this veteran population was narrow, it was not possible to discern the impact of, for example, gender.³³ Data on variables like BMI, malnutrition, and depressive symptoms were not available. For this study, xerostomia could only be considered as an all-or-nothing phenomenon because the dataset did not describe different levels of dry mouth severity (eg, mild, moderate, severe).

Additionally, past polypharmacy studies have acknowledged an inability to tell whether xerostomia is mainly due to medications or to underlying medical conditions. For example, for emphysema, ß-adrenergic stimulation from bronchodilators could cause dry mouth by thickening saliva and decreasing salivary volume, but the pathophysiology and/or cardinal symptoms of emphysema, including chronic obstructive pulmonary disease-associated tachypnea, might contribute independently to dryness.

Though we can make inferences based on the medications taken by this cohort (eg, those taking antihypertensives have high blood pressure), this dataset did not explicitly detail comorbid conditions and ICD codes for chronic diseases that commonly arise with xerostomia. Those conditions, however, are of great clinical importance. Diabetes mellitus, HIV/AIDS, and, classically, Sjögren syndrome, all are known to cause dry mouth.⁴³ Identifying new conditions that co-occur with xerostomia would allow clinicians to describe the root causes of and risk factors for dry mouth and SDS conditions in greater detail. Patients with dry mouth without SDS problems in this dataset are of particular interest as closer examination of their medications and comorbid conditions could help us understand why some individuals and not others develop SDS problems. The subjects of how comorbidities contribute to dry mouth and how their influences can be judged independently from the effects of medications are of great interest to us and will be investigated rigorously in our future studies.

Conclusions

In this cohort, few patients with SDS problems had documentation of a concomitant xerostomia diagnosis. This could represent a true infrequency of dry mouth or more likely, an underrecognition by clinicians. Heightened physician awareness regarding the signs and symptoms of and risk factors for xerostomia is needed to improve providers’ ability to diagnose this condition. 

In particular, polypharmacy should be a major consideration when evaluating patients for xerostomia. This continues to be an important area of research, and some of the latest data on polypharmacy among older patients were compiled in a recent meta-analysis by Tan and colleagues. The authors of that systematic review reiterated the significant association between salivary gland hypofunction and the number of medications taken by patients. They also advocated for the creation of a risk score for medication-induced dry mouth to aid in medication management.⁴⁴ Per their recommendations, it is now as crucial as ever to consider the numbers and types of medications taken by patients, to discontinue unnecessary prescriptions when possible, and to continue developing new strategies for preventing and treating xerostomia.

Xerostomia, the subjective sensation of dry mouth, is a common problem developed by geriatric patients. In practice, xerostomia can impair swallowing, speech, and oral hygiene, and if left unchecked, symptoms such as dysphagia and dysarthria can diminish patients’ quality of life (QOL). Salivary gland hypofunction (SGH) is the objective measure of decreased saliva production, determined by sialometry. Although xerostomia and SGH can coexist, the 2 conditions are not necessarily related.^1-4 For this discussion, the term xerostomia will denote dry mouth with or without a concomitant diagnosis of SGH.

Xerostomia is seen in a wide variety of patients with varied comorbidities. It is commonly associated with Sjögren syndrome and head and neck irradiation. The diagnosis and treatment of xerostomia often involves rheumatologists, dentists, otolaryngologists, and oncologists. Additionally, most of the scientific literature about this topic exists in dental journals, such as the Journal of the American Dental Association and the British Dental Journal. Rarer still are studies in the veteran population.⁵

Faced with increasing time pressure to treat the many chronic diseases affecting aging veterans, health care providers (HCPs) tend to deprioritize diagnosing dry mouth. To that point, saliva is often not considered in the same category as other bodily fluids. According to Mandel, “It lacks the drama of blood, the sincerity of sweat…[and] the emotional appeal of tears.”⁶ In reality, saliva plays a critical role in the oral-digestive tract and in swallowing. It contains the first digestive enzymes in the gastrointestinal tract and is key for maintaining homeostasis in the oral cavity.⁷ Decreased saliva production results in difficulties with speech and mastication as well as problems of dysphagia, esophageal dysfunction, dysgeusia, nutritional compromises, new and recurrent dental caries, candidiasis, glossitis, impaired use of dentures, halitosis, and susceptibility to mucosal injury.^7,8 Problems with the production of saliva may lead to loss of QOL, such as enjoying a meal or conversing with others.⁴

Although xerostomia is often associated with advanced age, it is more often explained by the diseases that afflict geriatric patients and the arsenal of medications used to treat them.^2,9-16 Polypharmacy, the simultaneous use of multiple drugs by a single patient for ≥ 1 conditions, is an independent risk factor for xerostomia regardless of the types of medication taken.¹⁶ From 2005 to 2011, older adults in the US significantly increased their prescription medication use and dietary supplements. More than one-third of older adults used ≥ 5 prescription medications concurrently, and two-thirds of older adults used combinations of prescribed medications, over-the-counter medications, and dietary supplements.¹⁷ Several drug classes have the capacity to induce xerostomia, such as antihypertensives, antiulcer agents, anticholinergics, and antidepressants.^2,5,12 Prevalence of dry mouth also can range from 10% to 46%, and women typically are more medicated and symptomatic.^{2,3,9,13,14,16} Xerostomia can also lead to depression and even reduce patients’ will to live.¹⁸ Despite xerostomia’s prevalence and impact on QOL, few patients report it as their chief symptom, and few physicians attempt to treat it.¹⁹

In order to target polypharmacy as a cause of dry mouth, the objectives for this study were to evaluate (1) the prevalence of xerostomia; (2) the relationship between xerostomia and other oral conditions; and (3) the impact of polypharmacy on dry mouth in a veteran population.

Methods

This is a retrospective cross-sectional study of all outpatient visits in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015) at the VA Palo Alto Health Care System (VAPAHCS), a tertiary care US Department of Veterans Affairs (VA) hospital. This study was approved by the Stanford University Institutional Review Board. All patients diagnosed with xerostomia in the 1-year study period were identified using ICD-9 diagnosis codes for dry mouth or disturbance of salivary gland secretion (527.7, 527.8, R68.2) and Systemized Nomenclature of Medicine Clinical Terms (SNOMED CT) codes covering dry mouth, xerostomia, aptyalism, absent salivary secretion, and disturbance of salivary secretion (87715008, 78948009). Data analysts in the VA Office of Business Analytics assisted in gathering data from the Veterans Information Systems and Technology Architecture (VistA) electronic health record.

The statistical analysis of that data was performed using Microsoft Excel. Age and gender distributions were determined for the patients. The relationship between xerostomia and the number and types of medications taken by patients also was examined. A previous Swedish study examining the link between dry mouth and quantities of medications used a scale ranging from 0 to ≥ 7 medications.¹⁶ The scale for this study was made wider to include the following groups: 0-2, 3-5, 6-8, 9-11, and ≥ 12 medications. Items that do not have xerogenic risks, such as medical supplies (eg, gloves, syringes, etc) and topical medications, were excluded from the analysis. Finally, the number of subjects with comorbid problems with speech, dentition, or swallowing (SDS) was recorded. Non-VA medications were included to capture any self- or externally prescribed xerogenic medications.

Results

Of the patients seen at VAPAHCS during FY 2015, 138 had a diagnostic code for xerostomia, including 129 men (93.5%) and 9 women (6.5%). The average (SD) age of this xerostomia cohort was 69.3 (12.6) years, and the 3 most common age groups were 60 to 69 years (37.7%), 70 to 79 years (28.3%), and 80 to 89 years (13.0%) (Table 1). Of those 138 patients with a xerostomia diagnosis, a majority (84; 60.9%) had at least 1 documented SDS problem (Table 2). Conversely, during FY 2015, although 4,971 patients seen at VAPAHCS had documented SDS problems, only 77 (1.5%) had a recorded diagnosis of xerostomia.

Of the 138 patients with xerostomia, 55 (39.9%) were taking ≥ 12 medications, more than twice as many patients as in any of the other groups studied (0-2, 3-5, 6-8, and 9-11 medications taken) (Table 3). On average, each patient with xerostomia filled prescriptions for 10.4 (SD, 7.2) different drugs. In this cohort of 138 patients diagnosed with xerostomia, antihypertensive medications or analgesics were taken by > 50% of patients, while statins, psychiatric medications, antibiotics, proton pump inhibitors, or drugs known to have anticholinergic activity were taken by > 40%. Antihistamines, anticonvulsants, diuretics, or inhaled respiratory agents were used by > 20% of the patients in this cohort (Table 4).

Data on each individual medication were split into 2 categories: the percentage of patients that filled ≥ 1 prescription for that drug, and the total number of prescriptions filled and/or refilled for that drug (ie, including all fills and refills made by individual patients). The 5 most widely used medications in this cohort were omeprazole (39.1%), docusate sodium (29.7%), gabapentin (29.7%), aspirin (27.5%), and hydrocodone/acetaminophen (26.1%) (Table 5). The 5 prescriptions that were cumulatively most filled and/or refilled were omeprazole (128), sildenafil citrate (108), gabapentin (101), hydrocodone/acetaminophen (100), and oxycodone (92) (Table 6). Though sildenafil citrate and oxycodone were among the most-filled prescriptions, these were not included in Table 5 as neither was taken by > 15% of the patients studied. These prescriptions were filled multiple times by a small subset of patients.

Regarding treatment for dry mouth, artificial saliva spray was one of the most widely used (23.2%) and the seventh most-filled prescription within this cohort (86). The only other medication taken by > 15% of patients in a formulation other than a tablet or capsule was chlorhexidine, a germicidal mouthwash used to improve oral care.

Discussion

Saliva is an essential component for the maintenance of normal oral health.^20,21 Decreased saliva production causes problems, including difficulties with speech, mastication, dysphagia, changes in taste, dental caries, impaired use of prostheses, recurrent infections, halitosis, deterioration of soft tissues, and compromised QOL.^22,23 Among patients with a diagnosed SDS abnormality who were seen at this facility during FY 2015, the prevalence of xerostomia was only 1.5%. However, the true prevalence and incidence of xerostomia among veterans is not known. Given the role of xerostomia as a common risk factor for SDS problems and the polypharmacy exhibited by those presented here with SDS problems, it is probable that xerostomia was underreported in this veteran cohort.

Additionally, although salivary acinar cells are known to atrophy with age, as is consistent with this xerostomia cohort’s average age (SD) of 69.3 (12.6) years, the development of dry mouth is a multifactorial process. The current scientific literature asserts that most salivary loss is due to local and systemic diseases, immunologic disorders, external radiation, and as was highlighted by this study, multiple prescription and nonprescription medications.^24-26

It has also been demonstrated previously that dry mouth complaints and low salivary flow rates are directly proportional to the number of medications taken by patients.^2,27-30 Polypharmacy is therefore an area of great interest, and ≥ 40 categories of xerogenic medications have been identified by investigators such as Sreebny and Schwartz.³¹ Among those, some of the most xerogenic medication classes include antihypertensives, antiulcer agents, anticholinergics, and antidepressants, are all very commonly consumed in this cohort of patients with dry mouth (58.7%, 42.0%, 47.1%, and 38.4%, respectively). The medication regimens within this cohort of veterans with xerostomia were prime examples of polypharmacy as each patient took an average (SD) of 10.4 (7.2) medications, 39.9% took ≥ 12, and 72.5% of patients with xerostomia were taking ≥ 6 prescription drugs during a 1-year period.

Given the dangers of polypharmacy, a more conservative approach to prescribing medications could feasibly help with preventing xerostomia and SGH. In practice, while clinicians try to avoid prescribing anticholinergics, antimuscarinics, and antihistaminergic drugs for geriatric patients, they are tasked with the complex management of medication adverse effects (AEs) when dealing with multiple health conditions. The clinicians’ primary responsibilities are to follow the standard of care and not to introduce unnecessary harm when managing patients, but they also must push for, stay abreast of, and conduct more basic research and clinical trials to inform, adjust, and improve our current standard.

Research into polypharmacy and its role in inducing dry mouth is ongoing. Twenty years ago, Thomson and colleagues identified reduced salivary flow in patients who used antianginals, thyroxine, diuretics, antidepressants, and medications for asthma, while only 5 years earlier Loesche and colleagues reported the role of antiulcer medications, such as proton pump inhibitors, in the development of xerostomia.^2,32 Within the past 5 years, Viljakainen and colleagues and Ohara and colleagues have echoed some of those findings by identifying associations between xerostomia and agents that impact digestive organs.^33,34 A strong association recently was identified between the use of antipsychotic drugs and xerostomia.³⁵ Additionally, when attributing xerostomia to polypharmacy, the interaction between medications is often overlooked in favor of considering the raw number of prescriptions taken. Whereas 1 medication alone may not have drying properties, combinations of medications might be more likely to induce xerostomia. Thomson and colleagues suggested such a situation regarding the interaction between thyroxine and diuretics.³⁶ Future studies should focus on identifying viable substitutes for existing medications that reduce risk for xerostomia without compromising the management of other serious conditions.

Treatment

Another pressing question for clinicians concerns artificial saliva. Although 23.2% of patients with dry mouth in this xerostomia cohort used artificial saliva, the efficacy of this treatment is still unproven. Saliva substitutes are often used by patients who cannot produce sufficient amounts of natural saliva. In practice, artificial saliva produces, at best, modest temporary improvement in dry mouth symptoms in up to 40% of patients. At worst, as put forth by the Cochrane Review, artificial saliva may be no better than placebo in treating dry mouth.^37,38 The volumes needed for symptom relief are large, ranging between 40 mL and 150 mL per day depending on the substitute’s composition. Saliva substitutes also must be reapplied throughout each day. This is particularly bothersome when patients must wake up repeatedly to reapply the treatment at night.³⁷ In short, these substances do not seem wholly effective in managing dry mouth, and other options must be made available to patients with refractory xerostomia when artificial saliva and lifestyle modifications fail.

For now, few alternatives exist. Chewing gums and lozenges help to stimulate salivary flow, as do muscarinic agonists like pilocarpine. Unfortunately, muscarinic agonists are seldom used due to cholinergic AEs. Humidifiers are effective in increasing nighttime moisture but are contraindicated in patients with dust mite allergies.³⁹ Reservoir-based devices with automated pumps funnel water and/or salivary substitutes from a fanny pack into patients’ mouths for lubrication.³⁷ Other more esoteric pharmacologic treatments include D-limonene, yohimbine, and amifostine, which purportedly protect salivary progenitor cells, increase peripheral cholinergic activity, and protect salivary glands from free-radical damage during radiation treatment, respectively. Although these agents have shown some promise, D-limonene is difficult to administer given the high dosage required for treatment, yohimbine hasn’t been seriously investigated for improving salivary secretion since 1997, and amifostine isn’t used widely due to its AE profile despite its US Food and Drug Administration approval for prevention of xerostomia.³⁹

Substance Abuse

The impact of smoking on xerostomia remains controversial. Some studies report an association between active smoking and xerostomia; others suggest that the local irritant effect of tobacco smoke may increase salivary gland output.^40,41 The same may be true for chronic alcohol use as there are no epidemiologic studies showing a causal relationship between alcohol use and xerostomia. Studies with rats that are chronically exposed to ethanol have found increased salivary flow rates.⁴² In the xerostomia cohort presented here, 30 patients (21.7%) had a documented history of substance misuse. That percentage is likely underestimated, as substance misuse is often underreported, and frequent use may not always constitute misuse. Therefore, nicotine exposure, alcohol exposure, illicit drug use, and vaping all should be considered during the workup of a patient with xerostomia.

Limitations

It is common for medications to remain in a patient’s health record long after that patient stops taking them. Developing methods to track when patients discontinue their prescriptions will be essential for clearing up uncertainty in our data and in other similar studies. This study also did not account for patients’ medication adherence and the duration of exposure to medications and illicit substances. Furthermore, the results of this veteran study are not easily generalizable as this cohort is disproportionately male, of advanced age, and especially prone to exhibiting both substance use and psychiatric diagnoses relative to the general population. As described by Viljakainen and colleagues, risk factors for xerostomia include advanced age, female gender, low body mass index (BMI), malnutrition, and depressive symptoms, but because the demographic scope of this veteran population was narrow, it was not possible to discern the impact of, for example, gender.³³ Data on variables like BMI, malnutrition, and depressive symptoms were not available. For this study, xerostomia could only be considered as an all-or-nothing phenomenon because the dataset did not describe different levels of dry mouth severity (eg, mild, moderate, severe).

Additionally, past polypharmacy studies have acknowledged an inability to tell whether xerostomia is mainly due to medications or to underlying medical conditions. For example, for emphysema, ß-adrenergic stimulation from bronchodilators could cause dry mouth by thickening saliva and decreasing salivary volume, but the pathophysiology and/or cardinal symptoms of emphysema, including chronic obstructive pulmonary disease-associated tachypnea, might contribute independently to dryness.

Though we can make inferences based on the medications taken by this cohort (eg, those taking antihypertensives have high blood pressure), this dataset did not explicitly detail comorbid conditions and ICD codes for chronic diseases that commonly arise with xerostomia. Those conditions, however, are of great clinical importance. Diabetes mellitus, HIV/AIDS, and, classically, Sjögren syndrome, all are known to cause dry mouth.⁴³ Identifying new conditions that co-occur with xerostomia would allow clinicians to describe the root causes of and risk factors for dry mouth and SDS conditions in greater detail. Patients with dry mouth without SDS problems in this dataset are of particular interest as closer examination of their medications and comorbid conditions could help us understand why some individuals and not others develop SDS problems. The subjects of how comorbidities contribute to dry mouth and how their influences can be judged independently from the effects of medications are of great interest to us and will be investigated rigorously in our future studies.

Conclusions

In this cohort, few patients with SDS problems had documentation of a concomitant xerostomia diagnosis. This could represent a true infrequency of dry mouth or more likely, an underrecognition by clinicians. Heightened physician awareness regarding the signs and symptoms of and risk factors for xerostomia is needed to improve providers’ ability to diagnose this condition. 

In particular, polypharmacy should be a major consideration when evaluating patients for xerostomia. This continues to be an important area of research, and some of the latest data on polypharmacy among older patients were compiled in a recent meta-analysis by Tan and colleagues. The authors of that systematic review reiterated the significant association between salivary gland hypofunction and the number of medications taken by patients. They also advocated for the creation of a risk score for medication-induced dry mouth to aid in medication management.⁴⁴ Per their recommendations, it is now as crucial as ever to consider the numbers and types of medications taken by patients, to discontinue unnecessary prescriptions when possible, and to continue developing new strategies for preventing and treating xerostomia.

Xerostomia, the subjective sensation of dry mouth, is a common problem developed by geriatric patients. In practice, xerostomia can impair swallowing, speech, and oral hygiene, and if left unchecked, symptoms such as dysphagia and dysarthria can diminish patients’ quality of life (QOL). Salivary gland hypofunction (SGH) is the objective measure of decreased saliva production, determined by sialometry. Although xerostomia and SGH can coexist, the 2 conditions are not necessarily related.^1-4 For this discussion, the term xerostomia will denote dry mouth with or without a concomitant diagnosis of SGH.

Xerostomia is seen in a wide variety of patients with varied comorbidities. It is commonly associated with Sjögren syndrome and head and neck irradiation. The diagnosis and treatment of xerostomia often involves rheumatologists, dentists, otolaryngologists, and oncologists. Additionally, most of the scientific literature about this topic exists in dental journals, such as the Journal of the American Dental Association and the British Dental Journal. Rarer still are studies in the veteran population.⁵

Faced with increasing time pressure to treat the many chronic diseases affecting aging veterans, health care providers (HCPs) tend to deprioritize diagnosing dry mouth. To that point, saliva is often not considered in the same category as other bodily fluids. According to Mandel, “It lacks the drama of blood, the sincerity of sweat…[and] the emotional appeal of tears.”⁶ In reality, saliva plays a critical role in the oral-digestive tract and in swallowing. It contains the first digestive enzymes in the gastrointestinal tract and is key for maintaining homeostasis in the oral cavity.⁷ Decreased saliva production results in difficulties with speech and mastication as well as problems of dysphagia, esophageal dysfunction, dysgeusia, nutritional compromises, new and recurrent dental caries, candidiasis, glossitis, impaired use of dentures, halitosis, and susceptibility to mucosal injury.^7,8 Problems with the production of saliva may lead to loss of QOL, such as enjoying a meal or conversing with others.⁴

Although xerostomia is often associated with advanced age, it is more often explained by the diseases that afflict geriatric patients and the arsenal of medications used to treat them.^2,9-16 Polypharmacy, the simultaneous use of multiple drugs by a single patient for ≥ 1 conditions, is an independent risk factor for xerostomia regardless of the types of medication taken.¹⁶ From 2005 to 2011, older adults in the US significantly increased their prescription medication use and dietary supplements. More than one-third of older adults used ≥ 5 prescription medications concurrently, and two-thirds of older adults used combinations of prescribed medications, over-the-counter medications, and dietary supplements.¹⁷ Several drug classes have the capacity to induce xerostomia, such as antihypertensives, antiulcer agents, anticholinergics, and antidepressants.^2,5,12 Prevalence of dry mouth also can range from 10% to 46%, and women typically are more medicated and symptomatic.^{2,3,9,13,14,16} Xerostomia can also lead to depression and even reduce patients’ will to live.¹⁸ Despite xerostomia’s prevalence and impact on QOL, few patients report it as their chief symptom, and few physicians attempt to treat it.¹⁹

In order to target polypharmacy as a cause of dry mouth, the objectives for this study were to evaluate (1) the prevalence of xerostomia; (2) the relationship between xerostomia and other oral conditions; and (3) the impact of polypharmacy on dry mouth in a veteran population.

Methods

This is a retrospective cross-sectional study of all outpatient visits in fiscal year (FY) 2015 (October 1, 2014 to September 30, 2015) at the VA Palo Alto Health Care System (VAPAHCS), a tertiary care US Department of Veterans Affairs (VA) hospital. This study was approved by the Stanford University Institutional Review Board. All patients diagnosed with xerostomia in the 1-year study period were identified using ICD-9 diagnosis codes for dry mouth or disturbance of salivary gland secretion (527.7, 527.8, R68.2) and Systemized Nomenclature of Medicine Clinical Terms (SNOMED CT) codes covering dry mouth, xerostomia, aptyalism, absent salivary secretion, and disturbance of salivary secretion (87715008, 78948009). Data analysts in the VA Office of Business Analytics assisted in gathering data from the Veterans Information Systems and Technology Architecture (VistA) electronic health record.

The statistical analysis of that data was performed using Microsoft Excel. Age and gender distributions were determined for the patients. The relationship between xerostomia and the number and types of medications taken by patients also was examined. A previous Swedish study examining the link between dry mouth and quantities of medications used a scale ranging from 0 to ≥ 7 medications.¹⁶ The scale for this study was made wider to include the following groups: 0-2, 3-5, 6-8, 9-11, and ≥ 12 medications. Items that do not have xerogenic risks, such as medical supplies (eg, gloves, syringes, etc) and topical medications, were excluded from the analysis. Finally, the number of subjects with comorbid problems with speech, dentition, or swallowing (SDS) was recorded. Non-VA medications were included to capture any self- or externally prescribed xerogenic medications.

Results

Of the patients seen at VAPAHCS during FY 2015, 138 had a diagnostic code for xerostomia, including 129 men (93.5%) and 9 women (6.5%). The average (SD) age of this xerostomia cohort was 69.3 (12.6) years, and the 3 most common age groups were 60 to 69 years (37.7%), 70 to 79 years (28.3%), and 80 to 89 years (13.0%) (Table 1). Of those 138 patients with a xerostomia diagnosis, a majority (84; 60.9%) had at least 1 documented SDS problem (Table 2). Conversely, during FY 2015, although 4,971 patients seen at VAPAHCS had documented SDS problems, only 77 (1.5%) had a recorded diagnosis of xerostomia.

Of the 138 patients with xerostomia, 55 (39.9%) were taking ≥ 12 medications, more than twice as many patients as in any of the other groups studied (0-2, 3-5, 6-8, and 9-11 medications taken) (Table 3). On average, each patient with xerostomia filled prescriptions for 10.4 (SD, 7.2) different drugs. In this cohort of 138 patients diagnosed with xerostomia, antihypertensive medications or analgesics were taken by > 50% of patients, while statins, psychiatric medications, antibiotics, proton pump inhibitors, or drugs known to have anticholinergic activity were taken by > 40%. Antihistamines, anticonvulsants, diuretics, or inhaled respiratory agents were used by > 20% of the patients in this cohort (Table 4).

Data on each individual medication were split into 2 categories: the percentage of patients that filled ≥ 1 prescription for that drug, and the total number of prescriptions filled and/or refilled for that drug (ie, including all fills and refills made by individual patients). The 5 most widely used medications in this cohort were omeprazole (39.1%), docusate sodium (29.7%), gabapentin (29.7%), aspirin (27.5%), and hydrocodone/acetaminophen (26.1%) (Table 5). The 5 prescriptions that were cumulatively most filled and/or refilled were omeprazole (128), sildenafil citrate (108), gabapentin (101), hydrocodone/acetaminophen (100), and oxycodone (92) (Table 6). Though sildenafil citrate and oxycodone were among the most-filled prescriptions, these were not included in Table 5 as neither was taken by > 15% of the patients studied. These prescriptions were filled multiple times by a small subset of patients.

Regarding treatment for dry mouth, artificial saliva spray was one of the most widely used (23.2%) and the seventh most-filled prescription within this cohort (86). The only other medication taken by > 15% of patients in a formulation other than a tablet or capsule was chlorhexidine, a germicidal mouthwash used to improve oral care.

Discussion

Saliva is an essential component for the maintenance of normal oral health.^20,21 Decreased saliva production causes problems, including difficulties with speech, mastication, dysphagia, changes in taste, dental caries, impaired use of prostheses, recurrent infections, halitosis, deterioration of soft tissues, and compromised QOL.^22,23 Among patients with a diagnosed SDS abnormality who were seen at this facility during FY 2015, the prevalence of xerostomia was only 1.5%. However, the true prevalence and incidence of xerostomia among veterans is not known. Given the role of xerostomia as a common risk factor for SDS problems and the polypharmacy exhibited by those presented here with SDS problems, it is probable that xerostomia was underreported in this veteran cohort.

Additionally, although salivary acinar cells are known to atrophy with age, as is consistent with this xerostomia cohort’s average age (SD) of 69.3 (12.6) years, the development of dry mouth is a multifactorial process. The current scientific literature asserts that most salivary loss is due to local and systemic diseases, immunologic disorders, external radiation, and as was highlighted by this study, multiple prescription and nonprescription medications.^24-26

It has also been demonstrated previously that dry mouth complaints and low salivary flow rates are directly proportional to the number of medications taken by patients.^2,27-30 Polypharmacy is therefore an area of great interest, and ≥ 40 categories of xerogenic medications have been identified by investigators such as Sreebny and Schwartz.³¹ Among those, some of the most xerogenic medication classes include antihypertensives, antiulcer agents, anticholinergics, and antidepressants, are all very commonly consumed in this cohort of patients with dry mouth (58.7%, 42.0%, 47.1%, and 38.4%, respectively). The medication regimens within this cohort of veterans with xerostomia were prime examples of polypharmacy as each patient took an average (SD) of 10.4 (7.2) medications, 39.9% took ≥ 12, and 72.5% of patients with xerostomia were taking ≥ 6 prescription drugs during a 1-year period.

Given the dangers of polypharmacy, a more conservative approach to prescribing medications could feasibly help with preventing xerostomia and SGH. In practice, while clinicians try to avoid prescribing anticholinergics, antimuscarinics, and antihistaminergic drugs for geriatric patients, they are tasked with the complex management of medication adverse effects (AEs) when dealing with multiple health conditions. The clinicians’ primary responsibilities are to follow the standard of care and not to introduce unnecessary harm when managing patients, but they also must push for, stay abreast of, and conduct more basic research and clinical trials to inform, adjust, and improve our current standard.

Research into polypharmacy and its role in inducing dry mouth is ongoing. Twenty years ago, Thomson and colleagues identified reduced salivary flow in patients who used antianginals, thyroxine, diuretics, antidepressants, and medications for asthma, while only 5 years earlier Loesche and colleagues reported the role of antiulcer medications, such as proton pump inhibitors, in the development of xerostomia.^2,32 Within the past 5 years, Viljakainen and colleagues and Ohara and colleagues have echoed some of those findings by identifying associations between xerostomia and agents that impact digestive organs.^33,34 A strong association recently was identified between the use of antipsychotic drugs and xerostomia.³⁵ Additionally, when attributing xerostomia to polypharmacy, the interaction between medications is often overlooked in favor of considering the raw number of prescriptions taken. Whereas 1 medication alone may not have drying properties, combinations of medications might be more likely to induce xerostomia. Thomson and colleagues suggested such a situation regarding the interaction between thyroxine and diuretics.³⁶ Future studies should focus on identifying viable substitutes for existing medications that reduce risk for xerostomia without compromising the management of other serious conditions.

Treatment

Another pressing question for clinicians concerns artificial saliva. Although 23.2% of patients with dry mouth in this xerostomia cohort used artificial saliva, the efficacy of this treatment is still unproven. Saliva substitutes are often used by patients who cannot produce sufficient amounts of natural saliva. In practice, artificial saliva produces, at best, modest temporary improvement in dry mouth symptoms in up to 40% of patients. At worst, as put forth by the Cochrane Review, artificial saliva may be no better than placebo in treating dry mouth.^37,38 The volumes needed for symptom relief are large, ranging between 40 mL and 150 mL per day depending on the substitute’s composition. Saliva substitutes also must be reapplied throughout each day. This is particularly bothersome when patients must wake up repeatedly to reapply the treatment at night.³⁷ In short, these substances do not seem wholly effective in managing dry mouth, and other options must be made available to patients with refractory xerostomia when artificial saliva and lifestyle modifications fail.

For now, few alternatives exist. Chewing gums and lozenges help to stimulate salivary flow, as do muscarinic agonists like pilocarpine. Unfortunately, muscarinic agonists are seldom used due to cholinergic AEs. Humidifiers are effective in increasing nighttime moisture but are contraindicated in patients with dust mite allergies.³⁹ Reservoir-based devices with automated pumps funnel water and/or salivary substitutes from a fanny pack into patients’ mouths for lubrication.³⁷ Other more esoteric pharmacologic treatments include D-limonene, yohimbine, and amifostine, which purportedly protect salivary progenitor cells, increase peripheral cholinergic activity, and protect salivary glands from free-radical damage during radiation treatment, respectively. Although these agents have shown some promise, D-limonene is difficult to administer given the high dosage required for treatment, yohimbine hasn’t been seriously investigated for improving salivary secretion since 1997, and amifostine isn’t used widely due to its AE profile despite its US Food and Drug Administration approval for prevention of xerostomia.³⁹

Substance Abuse

The impact of smoking on xerostomia remains controversial. Some studies report an association between active smoking and xerostomia; others suggest that the local irritant effect of tobacco smoke may increase salivary gland output.^40,41 The same may be true for chronic alcohol use as there are no epidemiologic studies showing a causal relationship between alcohol use and xerostomia. Studies with rats that are chronically exposed to ethanol have found increased salivary flow rates.⁴² In the xerostomia cohort presented here, 30 patients (21.7%) had a documented history of substance misuse. That percentage is likely underestimated, as substance misuse is often underreported, and frequent use may not always constitute misuse. Therefore, nicotine exposure, alcohol exposure, illicit drug use, and vaping all should be considered during the workup of a patient with xerostomia.

Limitations

It is common for medications to remain in a patient’s health record long after that patient stops taking them. Developing methods to track when patients discontinue their prescriptions will be essential for clearing up uncertainty in our data and in other similar studies. This study also did not account for patients’ medication adherence and the duration of exposure to medications and illicit substances. Furthermore, the results of this veteran study are not easily generalizable as this cohort is disproportionately male, of advanced age, and especially prone to exhibiting both substance use and psychiatric diagnoses relative to the general population. As described by Viljakainen and colleagues, risk factors for xerostomia include advanced age, female gender, low body mass index (BMI), malnutrition, and depressive symptoms, but because the demographic scope of this veteran population was narrow, it was not possible to discern the impact of, for example, gender.³³ Data on variables like BMI, malnutrition, and depressive symptoms were not available. For this study, xerostomia could only be considered as an all-or-nothing phenomenon because the dataset did not describe different levels of dry mouth severity (eg, mild, moderate, severe).

Additionally, past polypharmacy studies have acknowledged an inability to tell whether xerostomia is mainly due to medications or to underlying medical conditions. For example, for emphysema, ß-adrenergic stimulation from bronchodilators could cause dry mouth by thickening saliva and decreasing salivary volume, but the pathophysiology and/or cardinal symptoms of emphysema, including chronic obstructive pulmonary disease-associated tachypnea, might contribute independently to dryness.

Though we can make inferences based on the medications taken by this cohort (eg, those taking antihypertensives have high blood pressure), this dataset did not explicitly detail comorbid conditions and ICD codes for chronic diseases that commonly arise with xerostomia. Those conditions, however, are of great clinical importance. Diabetes mellitus, HIV/AIDS, and, classically, Sjögren syndrome, all are known to cause dry mouth.⁴³ Identifying new conditions that co-occur with xerostomia would allow clinicians to describe the root causes of and risk factors for dry mouth and SDS conditions in greater detail. Patients with dry mouth without SDS problems in this dataset are of particular interest as closer examination of their medications and comorbid conditions could help us understand why some individuals and not others develop SDS problems. The subjects of how comorbidities contribute to dry mouth and how their influences can be judged independently from the effects of medications are of great interest to us and will be investigated rigorously in our future studies.

Conclusions

In this cohort, few patients with SDS problems had documentation of a concomitant xerostomia diagnosis. This could represent a true infrequency of dry mouth or more likely, an underrecognition by clinicians. Heightened physician awareness regarding the signs and symptoms of and risk factors for xerostomia is needed to improve providers’ ability to diagnose this condition. 

In particular, polypharmacy should be a major consideration when evaluating patients for xerostomia. This continues to be an important area of research, and some of the latest data on polypharmacy among older patients were compiled in a recent meta-analysis by Tan and colleagues. The authors of that systematic review reiterated the significant association between salivary gland hypofunction and the number of medications taken by patients. They also advocated for the creation of a risk score for medication-induced dry mouth to aid in medication management.⁴⁴ Per their recommendations, it is now as crucial as ever to consider the numbers and types of medications taken by patients, to discontinue unnecessary prescriptions when possible, and to continue developing new strategies for preventing and treating xerostomia.

Metrics from 2017 at the Fayetteville Veterans Affairs Heath Care Center (FVAHCC) Anticoagulation Clinic indicate that 43% of patients with atrial fibrillation (AF) who are prescribed warfarin have difficulty maintaining a therapeutic international normalized ratio (INR). These patients require frequent clinic appointments to adjust their regimens to ensure anticoagulation efficacy. FVAHCC policy requires a patient to return to the clinic for repeat INR evaluation within 5 to 14 days of the visit where INR was outside of the established therapeutic range.¹ These frequent INR monitoring appointments increase patient and health care provider burden.

Direct oral anticoagulants (DOACs) are an alternative to warfarin for patients with AF who require anticoagulation. DOACs, which do not require regular efficacy monitoring, can be beneficial to patients who struggle to maintain a therapeutic INR when taking warfarin. FVAHCC policy regarding warfarin therapy monitoring allows for a maximum of 6 weeks between appointments. This period is often extended to 3 to 6 months for patients on DOACs.¹

At FVAHCC, patients prescribed warfarin are managed in a centralized Anticoagulation Clinic led by a clinical pharmacy specialist (CPS). When a patient reports for an appointment, a clinical pharmacy technician performs point-of-care INR testing and asks standardized questions regarding therapy, including an assessment of adherence. The CPS then evaluates the patient’s INR test results, adjusts the dosage of warfarin as indicated, and determines appropriate follow-up.

A patient who is prescribed a DOAC is monitored by a CPS who works within a patient aligned care team (PACT). The PACT, a multidisciplinary team providing health care to veterans, includes physicians, nurses, pharmacists, dieticians, and mental health providers. Each CPS covers 3 or 4 PACTs. These pharmacists monitor all aspects of DOAC therapy at regular intervals, including renal and hepatic function, complete blood counts, medication adherence, and adverse effects.

Clinic and patient INR data are tracked using a time in therapeutic range (TTR) report generated by the US Department of Veterans Affairs (VA). The TTR report provides clinical information to enhance patient anticoagulation care.² The TTR report identifies patients with an active order for warfarin and a diagnosis of AF or venous thromboembolism (VTE) whose INR is within therapeutic range (between 2 and 3) < 60% of the time over the previous 160 days.² The patient must have had at least 3 INR levels drawn within that time frame for a TTR report calculation.² The report excludes patients who were first prescribed warfarin within the previous 42 days and those with mechanical heart valves. The TTR report is used by the VA to see concrete facility-level results for quality improvement efforts.²

A quality improvement screening tool was developed to identify patients with AF being treated with warfarin who may appropriately transition to DOAC therapy. Anticoagulation Clinic patients were eligible for further evaluation if they had a TTR report level of < 60% and were prescribed indefinite warfarin therapy for AF.

The national VA goal is to have patient TTR report levels read > 60%. Therefore, the primary objective of this project was to improve Anticoagulation Clinic TTR metrics by targeting patients with TTR levels below the national goal.²

Patients who were successfully converted from warfarin to a DOAC were no longer included in Anticoagulation Clinic metrics and instead were followed by a PACT CPS. Thus, it was hypothesized that the average number of monthly Anticoagulation Clinic encounters would decrease on successful implementation of the screening tool. A secondary endpoint of the study evaluated the change in the total number of encounters of those who converted from warfarin to a DOAC.

Fewer clinic encounters could increase time available for the CPS to incorporate other initiatives into workflow and could increase clinic availability for newly referred veterans.

Methods

As this undertaking was considered to be a quality improvement project, institutional review board approval was not required. During an 8-week screening period (August to September 2018), the DOAC screening tool was implemented into the Anticoagulation Clinic workflow. This screening tool (Figure 1) was established based on VA Pharmacy Benefit Management (PBM) Service’s Criteria for Use for Stroke Prevention in Nonvalvular Atrial Fibrillation, a national set of standards used to determine appropriate candidates for DOAC therapy.³

Exclusion criteria included patients with INR goals < 2 or > 3, patients with a diagnosis of VTE, and patients with weight > 120 kg. Patients with a diagnosis of VTE were excluded due to the variability in therapy duration. Weight cutoffs were based on recommendations by the International Society on Thrombosis and Haemostasis. Due to a lack of available data, it was suggested that clinical judgment be used in patients whose weight was > 120 kg.⁴

During the screening period, weekly TTR reports identified patients in the clinic who had TTR < 60%. When a patient with a TTR report results of < 60% also had a scheduled appointment within a week, a CPS then further reviewed patient eligibility using the DOAC screening tool. On arrival for an appointment, the eligible patient was counseled on DOAC medications and the differences between warfarin and DOACs, including monitoring requirements. Patients had the option to switch to DOAC therapy or remain on warfarin.

The change in the average number of monthly Anticoagulation Clinic encounters for 3 months prior to the screening period (May to July 2018) and 2 months following screening (October to November 2018) was evaluated to measure the impact of the DOAC screening tool. The total number of encounters in the clinic was assessed using the monthly VA reports and were averaged for each period. Then data from the 2 periods were compared.

The monthly encounter reports, a data tool that monitors the number of unique visits per veteran each calendar month, also were used to generate a secondary endpoint showing the number of encounters in the Anticoagulation Clinic associated with patients who switched to a DOAC, including visits prior to changing therapy, and before and after the screening period.

Student’s t test was used to compare the change in encounter frequency before and after screening tool implementation for both primary and secondary endpoints. α was defined as .05 a priori. Continuous data were presented as means and standard deviations. Data were calculated with Microsoft Excel 2016.

Results

For the 3 months before the 8-week screening period, an average of 476 Anticoagulation Clinic encounters per month were documented. Two months of data following the screening period averaged 546 encounters per month. There were an average of 70 additional encounters per month after screening tool implementation (P = .15), reflecting the study’s primary objective.

A total of 219 patients in the Anticoagulation Clinic were identified as having a TTR report results of < 60% during the 8-week screening period (Figure 2). Eighty-two of those patients (37.4%) were considered eligible to switch from warfarin to DOAC therapy. Thirty of those eligible patients (13.7%) switched to a DOAC. A total of 107 clinic encounters (22.5%) was associated with these 30 patients prior to screening and 32 associated encounters (5.9%) following screening (P = .01). Of the remaining 137 patients (62.6%) who were ineligible for DOAC therapy, the most common reason for disqualification was a diagnosis of VTE (Table).

Discussion

The general results of this quality improvement project showed that implementation of a screening tool designed to identify patients eligible for DOAC therapy did not decrease the average number of Anticoagulation Clinic encounters. Thirty of 82 eligible patients (36.6%) decided to switch to DOAC therapy during the study period. For those 30 patients, there was a statistically significant decrease in the number of individual clinic encounters. This suggests that the screening tool may positively impact Anticoagulation Clinic metrics when evaluating individual patients, potentially increasing clinic appointment availability.

Confounding Factors

Multiple confounding factors may have affected this project’s results. First, Class I recall for point-of-care test strips used by the clinic was mandated by the US Food and Drug Administration on November 1, 2018.⁵ Before the recall, investigators found that many nontherapeutic INRs using point-of-care testing later showed results that were within the therapeutic INR range using same-day venous blood collection. This may have led to increases in falsely recorded nontherapeutic INRs and lowered TTR report results. Initially, the project was designed to collect monthly clinic encounter data for 3 months following the 8-week screening period; however, data collection was stopped after 2 months because of the test strip recall.

In addition, in early December 2018, all patients were moved from the Anticoagulation Clinic to the Anticoagulation Telephone Clinic that uses venous blood draws and telephone appointments. Data from venous blood draw results had previously been excluded from this project because results were not available on the same day. Patients in this program are contacted by telephone rather than being offered a face-to-face appointment, thus reducing in-clinic encounters.

Another confounding factor was a FVAHCC policy change in August 2018 requiring that any patient initiated on a DOAC make a onetime visit to the Anticoagulation Clinic prior to establishing care with a PACT CPS. Investigators were unable to exclude these patients from monthly encounter data. Some patients transitioning from warfarin to DOAC therapy were required to continue receiving anticoagulation monitoring from the clinic because of limited PACT CPS clinic availability, thus further increasing postscreening encounters.

Health care providers outside of the Anticoagulation Clinic and uninvolved with the quality improvement project also were switching patients from warfarin to DOAC therapies. Although this may have affected encounter data positively, investigators cannot guarantee these patients would have met criteria outlined by the screening tool.

In September 2018 Hurricane Florence disrupted health care delivery during the 8-week screening period. This event disrupted numerous clinic appointments. Although screening of patients was completed during the 8-week screening period, some patients did not switch to DOAC therapies until November 2018.

Secondary Endpoint Results

Promising results can be seen by specifically looking at the secondary endpoint: the number of encounters associated with patients who chose DOAC therapy. There were 107 encounters associated with the 30 patients who switched to a DOAC prior to screening and only 32 associated encounters after screening, a reduction of 70.1%. This suggests that multiple appointment slots were freed when the screening tool led to successful conversion from warfarin to a DOAC. Further assessment is warranted.

Future Project Development

Future areas for quality improvement project development include expanding project criteria to include patients taking warfarin for VTE. Eighty-nine of 137 patients (65%) who were deemed ineligible to switch to DOAC therapy were excluded due to a diagnosis of VTE. There are existing VA/Department of Defense Criteria for Use for DOAC use in VTE recommendations. Straightforward modification of the screening tool could include this patient group and may be especially useful for patients on indefinite warfarin therapy for recurrent VTE who have poor TTR report results.⁶

Given the number of confounding factors caused by unforeseen changes to the Anticoagulation Clinic workflow, use of the DOAC screening tool was placed on hold at the conclusion of data collection. This limited the ability to analyze encounter data in the months following project conclusion. Future plans include reimplementation of the screening tool with minor adjustments to include patients on warfarin for VTE and patients with a TTR report results above 60%.

Conclusion

This quality improvement project sought to determine the impact of a screening tool on effecting Anticoagulation Clinic encounter metrics. Results of this project show that the screening tool was unsuccessful in reducing the number of overall clinic encounters. Some promise was shown when evaluating clinic encounters for patients who switched anticoagulation therapies. Numerous confounding factors may have contributed to these results.

Metrics from 2017 at the Fayetteville Veterans Affairs Heath Care Center (FVAHCC) Anticoagulation Clinic indicate that 43% of patients with atrial fibrillation (AF) who are prescribed warfarin have difficulty maintaining a therapeutic international normalized ratio (INR). These patients require frequent clinic appointments to adjust their regimens to ensure anticoagulation efficacy. FVAHCC policy requires a patient to return to the clinic for repeat INR evaluation within 5 to 14 days of the visit where INR was outside of the established therapeutic range.¹ These frequent INR monitoring appointments increase patient and health care provider burden.

Direct oral anticoagulants (DOACs) are an alternative to warfarin for patients with AF who require anticoagulation. DOACs, which do not require regular efficacy monitoring, can be beneficial to patients who struggle to maintain a therapeutic INR when taking warfarin. FVAHCC policy regarding warfarin therapy monitoring allows for a maximum of 6 weeks between appointments. This period is often extended to 3 to 6 months for patients on DOACs.¹

At FVAHCC, patients prescribed warfarin are managed in a centralized Anticoagulation Clinic led by a clinical pharmacy specialist (CPS). When a patient reports for an appointment, a clinical pharmacy technician performs point-of-care INR testing and asks standardized questions regarding therapy, including an assessment of adherence. The CPS then evaluates the patient’s INR test results, adjusts the dosage of warfarin as indicated, and determines appropriate follow-up.

A patient who is prescribed a DOAC is monitored by a CPS who works within a patient aligned care team (PACT). The PACT, a multidisciplinary team providing health care to veterans, includes physicians, nurses, pharmacists, dieticians, and mental health providers. Each CPS covers 3 or 4 PACTs. These pharmacists monitor all aspects of DOAC therapy at regular intervals, including renal and hepatic function, complete blood counts, medication adherence, and adverse effects.

Clinic and patient INR data are tracked using a time in therapeutic range (TTR) report generated by the US Department of Veterans Affairs (VA). The TTR report provides clinical information to enhance patient anticoagulation care.² The TTR report identifies patients with an active order for warfarin and a diagnosis of AF or venous thromboembolism (VTE) whose INR is within therapeutic range (between 2 and 3) < 60% of the time over the previous 160 days.² The patient must have had at least 3 INR levels drawn within that time frame for a TTR report calculation.² The report excludes patients who were first prescribed warfarin within the previous 42 days and those with mechanical heart valves. The TTR report is used by the VA to see concrete facility-level results for quality improvement efforts.²

A quality improvement screening tool was developed to identify patients with AF being treated with warfarin who may appropriately transition to DOAC therapy. Anticoagulation Clinic patients were eligible for further evaluation if they had a TTR report level of < 60% and were prescribed indefinite warfarin therapy for AF.

The national VA goal is to have patient TTR report levels read > 60%. Therefore, the primary objective of this project was to improve Anticoagulation Clinic TTR metrics by targeting patients with TTR levels below the national goal.²

Patients who were successfully converted from warfarin to a DOAC were no longer included in Anticoagulation Clinic metrics and instead were followed by a PACT CPS. Thus, it was hypothesized that the average number of monthly Anticoagulation Clinic encounters would decrease on successful implementation of the screening tool. A secondary endpoint of the study evaluated the change in the total number of encounters of those who converted from warfarin to a DOAC.

Fewer clinic encounters could increase time available for the CPS to incorporate other initiatives into workflow and could increase clinic availability for newly referred veterans.

Methods

As this undertaking was considered to be a quality improvement project, institutional review board approval was not required. During an 8-week screening period (August to September 2018), the DOAC screening tool was implemented into the Anticoagulation Clinic workflow. This screening tool (Figure 1) was established based on VA Pharmacy Benefit Management (PBM) Service’s Criteria for Use for Stroke Prevention in Nonvalvular Atrial Fibrillation, a national set of standards used to determine appropriate candidates for DOAC therapy.³

Exclusion criteria included patients with INR goals < 2 or > 3, patients with a diagnosis of VTE, and patients with weight > 120 kg. Patients with a diagnosis of VTE were excluded due to the variability in therapy duration. Weight cutoffs were based on recommendations by the International Society on Thrombosis and Haemostasis. Due to a lack of available data, it was suggested that clinical judgment be used in patients whose weight was > 120 kg.⁴

During the screening period, weekly TTR reports identified patients in the clinic who had TTR < 60%. When a patient with a TTR report results of < 60% also had a scheduled appointment within a week, a CPS then further reviewed patient eligibility using the DOAC screening tool. On arrival for an appointment, the eligible patient was counseled on DOAC medications and the differences between warfarin and DOACs, including monitoring requirements. Patients had the option to switch to DOAC therapy or remain on warfarin.

The change in the average number of monthly Anticoagulation Clinic encounters for 3 months prior to the screening period (May to July 2018) and 2 months following screening (October to November 2018) was evaluated to measure the impact of the DOAC screening tool. The total number of encounters in the clinic was assessed using the monthly VA reports and were averaged for each period. Then data from the 2 periods were compared.

The monthly encounter reports, a data tool that monitors the number of unique visits per veteran each calendar month, also were used to generate a secondary endpoint showing the number of encounters in the Anticoagulation Clinic associated with patients who switched to a DOAC, including visits prior to changing therapy, and before and after the screening period.

Student’s t test was used to compare the change in encounter frequency before and after screening tool implementation for both primary and secondary endpoints. α was defined as .05 a priori. Continuous data were presented as means and standard deviations. Data were calculated with Microsoft Excel 2016.

Results

For the 3 months before the 8-week screening period, an average of 476 Anticoagulation Clinic encounters per month were documented. Two months of data following the screening period averaged 546 encounters per month. There were an average of 70 additional encounters per month after screening tool implementation (P = .15), reflecting the study’s primary objective.

A total of 219 patients in the Anticoagulation Clinic were identified as having a TTR report results of < 60% during the 8-week screening period (Figure 2). Eighty-two of those patients (37.4%) were considered eligible to switch from warfarin to DOAC therapy. Thirty of those eligible patients (13.7%) switched to a DOAC. A total of 107 clinic encounters (22.5%) was associated with these 30 patients prior to screening and 32 associated encounters (5.9%) following screening (P = .01). Of the remaining 137 patients (62.6%) who were ineligible for DOAC therapy, the most common reason for disqualification was a diagnosis of VTE (Table).

Discussion

The general results of this quality improvement project showed that implementation of a screening tool designed to identify patients eligible for DOAC therapy did not decrease the average number of Anticoagulation Clinic encounters. Thirty of 82 eligible patients (36.6%) decided to switch to DOAC therapy during the study period. For those 30 patients, there was a statistically significant decrease in the number of individual clinic encounters. This suggests that the screening tool may positively impact Anticoagulation Clinic metrics when evaluating individual patients, potentially increasing clinic appointment availability.

Confounding Factors

Multiple confounding factors may have affected this project’s results. First, Class I recall for point-of-care test strips used by the clinic was mandated by the US Food and Drug Administration on November 1, 2018.⁵ Before the recall, investigators found that many nontherapeutic INRs using point-of-care testing later showed results that were within the therapeutic INR range using same-day venous blood collection. This may have led to increases in falsely recorded nontherapeutic INRs and lowered TTR report results. Initially, the project was designed to collect monthly clinic encounter data for 3 months following the 8-week screening period; however, data collection was stopped after 2 months because of the test strip recall.

In addition, in early December 2018, all patients were moved from the Anticoagulation Clinic to the Anticoagulation Telephone Clinic that uses venous blood draws and telephone appointments. Data from venous blood draw results had previously been excluded from this project because results were not available on the same day. Patients in this program are contacted by telephone rather than being offered a face-to-face appointment, thus reducing in-clinic encounters.

Another confounding factor was a FVAHCC policy change in August 2018 requiring that any patient initiated on a DOAC make a onetime visit to the Anticoagulation Clinic prior to establishing care with a PACT CPS. Investigators were unable to exclude these patients from monthly encounter data. Some patients transitioning from warfarin to DOAC therapy were required to continue receiving anticoagulation monitoring from the clinic because of limited PACT CPS clinic availability, thus further increasing postscreening encounters.

Health care providers outside of the Anticoagulation Clinic and uninvolved with the quality improvement project also were switching patients from warfarin to DOAC therapies. Although this may have affected encounter data positively, investigators cannot guarantee these patients would have met criteria outlined by the screening tool.

In September 2018 Hurricane Florence disrupted health care delivery during the 8-week screening period. This event disrupted numerous clinic appointments. Although screening of patients was completed during the 8-week screening period, some patients did not switch to DOAC therapies until November 2018.

Secondary Endpoint Results

Promising results can be seen by specifically looking at the secondary endpoint: the number of encounters associated with patients who chose DOAC therapy. There were 107 encounters associated with the 30 patients who switched to a DOAC prior to screening and only 32 associated encounters after screening, a reduction of 70.1%. This suggests that multiple appointment slots were freed when the screening tool led to successful conversion from warfarin to a DOAC. Further assessment is warranted.

Future Project Development

Future areas for quality improvement project development include expanding project criteria to include patients taking warfarin for VTE. Eighty-nine of 137 patients (65%) who were deemed ineligible to switch to DOAC therapy were excluded due to a diagnosis of VTE. There are existing VA/Department of Defense Criteria for Use for DOAC use in VTE recommendations. Straightforward modification of the screening tool could include this patient group and may be especially useful for patients on indefinite warfarin therapy for recurrent VTE who have poor TTR report results.⁶

Given the number of confounding factors caused by unforeseen changes to the Anticoagulation Clinic workflow, use of the DOAC screening tool was placed on hold at the conclusion of data collection. This limited the ability to analyze encounter data in the months following project conclusion. Future plans include reimplementation of the screening tool with minor adjustments to include patients on warfarin for VTE and patients with a TTR report results above 60%.

Conclusion

This quality improvement project sought to determine the impact of a screening tool on effecting Anticoagulation Clinic encounter metrics. Results of this project show that the screening tool was unsuccessful in reducing the number of overall clinic encounters. Some promise was shown when evaluating clinic encounters for patients who switched anticoagulation therapies. Numerous confounding factors may have contributed to these results.

Metrics from 2017 at the Fayetteville Veterans Affairs Heath Care Center (FVAHCC) Anticoagulation Clinic indicate that 43% of patients with atrial fibrillation (AF) who are prescribed warfarin have difficulty maintaining a therapeutic international normalized ratio (INR). These patients require frequent clinic appointments to adjust their regimens to ensure anticoagulation efficacy. FVAHCC policy requires a patient to return to the clinic for repeat INR evaluation within 5 to 14 days of the visit where INR was outside of the established therapeutic range.¹ These frequent INR monitoring appointments increase patient and health care provider burden.

Direct oral anticoagulants (DOACs) are an alternative to warfarin for patients with AF who require anticoagulation. DOACs, which do not require regular efficacy monitoring, can be beneficial to patients who struggle to maintain a therapeutic INR when taking warfarin. FVAHCC policy regarding warfarin therapy monitoring allows for a maximum of 6 weeks between appointments. This period is often extended to 3 to 6 months for patients on DOACs.¹

At FVAHCC, patients prescribed warfarin are managed in a centralized Anticoagulation Clinic led by a clinical pharmacy specialist (CPS). When a patient reports for an appointment, a clinical pharmacy technician performs point-of-care INR testing and asks standardized questions regarding therapy, including an assessment of adherence. The CPS then evaluates the patient’s INR test results, adjusts the dosage of warfarin as indicated, and determines appropriate follow-up.

A patient who is prescribed a DOAC is monitored by a CPS who works within a patient aligned care team (PACT). The PACT, a multidisciplinary team providing health care to veterans, includes physicians, nurses, pharmacists, dieticians, and mental health providers. Each CPS covers 3 or 4 PACTs. These pharmacists monitor all aspects of DOAC therapy at regular intervals, including renal and hepatic function, complete blood counts, medication adherence, and adverse effects.

Clinic and patient INR data are tracked using a time in therapeutic range (TTR) report generated by the US Department of Veterans Affairs (VA). The TTR report provides clinical information to enhance patient anticoagulation care.² The TTR report identifies patients with an active order for warfarin and a diagnosis of AF or venous thromboembolism (VTE) whose INR is within therapeutic range (between 2 and 3) < 60% of the time over the previous 160 days.² The patient must have had at least 3 INR levels drawn within that time frame for a TTR report calculation.² The report excludes patients who were first prescribed warfarin within the previous 42 days and those with mechanical heart valves. The TTR report is used by the VA to see concrete facility-level results for quality improvement efforts.²

A quality improvement screening tool was developed to identify patients with AF being treated with warfarin who may appropriately transition to DOAC therapy. Anticoagulation Clinic patients were eligible for further evaluation if they had a TTR report level of < 60% and were prescribed indefinite warfarin therapy for AF.

The national VA goal is to have patient TTR report levels read > 60%. Therefore, the primary objective of this project was to improve Anticoagulation Clinic TTR metrics by targeting patients with TTR levels below the national goal.²

Patients who were successfully converted from warfarin to a DOAC were no longer included in Anticoagulation Clinic metrics and instead were followed by a PACT CPS. Thus, it was hypothesized that the average number of monthly Anticoagulation Clinic encounters would decrease on successful implementation of the screening tool. A secondary endpoint of the study evaluated the change in the total number of encounters of those who converted from warfarin to a DOAC.

Fewer clinic encounters could increase time available for the CPS to incorporate other initiatives into workflow and could increase clinic availability for newly referred veterans.

Methods

As this undertaking was considered to be a quality improvement project, institutional review board approval was not required. During an 8-week screening period (August to September 2018), the DOAC screening tool was implemented into the Anticoagulation Clinic workflow. This screening tool (Figure 1) was established based on VA Pharmacy Benefit Management (PBM) Service’s Criteria for Use for Stroke Prevention in Nonvalvular Atrial Fibrillation, a national set of standards used to determine appropriate candidates for DOAC therapy.³

Exclusion criteria included patients with INR goals < 2 or > 3, patients with a diagnosis of VTE, and patients with weight > 120 kg. Patients with a diagnosis of VTE were excluded due to the variability in therapy duration. Weight cutoffs were based on recommendations by the International Society on Thrombosis and Haemostasis. Due to a lack of available data, it was suggested that clinical judgment be used in patients whose weight was > 120 kg.⁴

During the screening period, weekly TTR reports identified patients in the clinic who had TTR < 60%. When a patient with a TTR report results of < 60% also had a scheduled appointment within a week, a CPS then further reviewed patient eligibility using the DOAC screening tool. On arrival for an appointment, the eligible patient was counseled on DOAC medications and the differences between warfarin and DOACs, including monitoring requirements. Patients had the option to switch to DOAC therapy or remain on warfarin.

The change in the average number of monthly Anticoagulation Clinic encounters for 3 months prior to the screening period (May to July 2018) and 2 months following screening (October to November 2018) was evaluated to measure the impact of the DOAC screening tool. The total number of encounters in the clinic was assessed using the monthly VA reports and were averaged for each period. Then data from the 2 periods were compared.

The monthly encounter reports, a data tool that monitors the number of unique visits per veteran each calendar month, also were used to generate a secondary endpoint showing the number of encounters in the Anticoagulation Clinic associated with patients who switched to a DOAC, including visits prior to changing therapy, and before and after the screening period.

Student’s t test was used to compare the change in encounter frequency before and after screening tool implementation for both primary and secondary endpoints. α was defined as .05 a priori. Continuous data were presented as means and standard deviations. Data were calculated with Microsoft Excel 2016.

Results

For the 3 months before the 8-week screening period, an average of 476 Anticoagulation Clinic encounters per month were documented. Two months of data following the screening period averaged 546 encounters per month. There were an average of 70 additional encounters per month after screening tool implementation (P = .15), reflecting the study’s primary objective.

A total of 219 patients in the Anticoagulation Clinic were identified as having a TTR report results of < 60% during the 8-week screening period (Figure 2). Eighty-two of those patients (37.4%) were considered eligible to switch from warfarin to DOAC therapy. Thirty of those eligible patients (13.7%) switched to a DOAC. A total of 107 clinic encounters (22.5%) was associated with these 30 patients prior to screening and 32 associated encounters (5.9%) following screening (P = .01). Of the remaining 137 patients (62.6%) who were ineligible for DOAC therapy, the most common reason for disqualification was a diagnosis of VTE (Table).

Discussion

The general results of this quality improvement project showed that implementation of a screening tool designed to identify patients eligible for DOAC therapy did not decrease the average number of Anticoagulation Clinic encounters. Thirty of 82 eligible patients (36.6%) decided to switch to DOAC therapy during the study period. For those 30 patients, there was a statistically significant decrease in the number of individual clinic encounters. This suggests that the screening tool may positively impact Anticoagulation Clinic metrics when evaluating individual patients, potentially increasing clinic appointment availability.

Confounding Factors

Multiple confounding factors may have affected this project’s results. First, Class I recall for point-of-care test strips used by the clinic was mandated by the US Food and Drug Administration on November 1, 2018.⁵ Before the recall, investigators found that many nontherapeutic INRs using point-of-care testing later showed results that were within the therapeutic INR range using same-day venous blood collection. This may have led to increases in falsely recorded nontherapeutic INRs and lowered TTR report results. Initially, the project was designed to collect monthly clinic encounter data for 3 months following the 8-week screening period; however, data collection was stopped after 2 months because of the test strip recall.

In addition, in early December 2018, all patients were moved from the Anticoagulation Clinic to the Anticoagulation Telephone Clinic that uses venous blood draws and telephone appointments. Data from venous blood draw results had previously been excluded from this project because results were not available on the same day. Patients in this program are contacted by telephone rather than being offered a face-to-face appointment, thus reducing in-clinic encounters.

Another confounding factor was a FVAHCC policy change in August 2018 requiring that any patient initiated on a DOAC make a onetime visit to the Anticoagulation Clinic prior to establishing care with a PACT CPS. Investigators were unable to exclude these patients from monthly encounter data. Some patients transitioning from warfarin to DOAC therapy were required to continue receiving anticoagulation monitoring from the clinic because of limited PACT CPS clinic availability, thus further increasing postscreening encounters.

Health care providers outside of the Anticoagulation Clinic and uninvolved with the quality improvement project also were switching patients from warfarin to DOAC therapies. Although this may have affected encounter data positively, investigators cannot guarantee these patients would have met criteria outlined by the screening tool.

In September 2018 Hurricane Florence disrupted health care delivery during the 8-week screening period. This event disrupted numerous clinic appointments. Although screening of patients was completed during the 8-week screening period, some patients did not switch to DOAC therapies until November 2018.

Secondary Endpoint Results

Promising results can be seen by specifically looking at the secondary endpoint: the number of encounters associated with patients who chose DOAC therapy. There were 107 encounters associated with the 30 patients who switched to a DOAC prior to screening and only 32 associated encounters after screening, a reduction of 70.1%. This suggests that multiple appointment slots were freed when the screening tool led to successful conversion from warfarin to a DOAC. Further assessment is warranted.

Future Project Development

Future areas for quality improvement project development include expanding project criteria to include patients taking warfarin for VTE. Eighty-nine of 137 patients (65%) who were deemed ineligible to switch to DOAC therapy were excluded due to a diagnosis of VTE. There are existing VA/Department of Defense Criteria for Use for DOAC use in VTE recommendations. Straightforward modification of the screening tool could include this patient group and may be especially useful for patients on indefinite warfarin therapy for recurrent VTE who have poor TTR report results.⁶

Given the number of confounding factors caused by unforeseen changes to the Anticoagulation Clinic workflow, use of the DOAC screening tool was placed on hold at the conclusion of data collection. This limited the ability to analyze encounter data in the months following project conclusion. Future plans include reimplementation of the screening tool with minor adjustments to include patients on warfarin for VTE and patients with a TTR report results above 60%.

Conclusion

This quality improvement project sought to determine the impact of a screening tool on effecting Anticoagulation Clinic encounter metrics. Results of this project show that the screening tool was unsuccessful in reducing the number of overall clinic encounters. Some promise was shown when evaluating clinic encounters for patients who switched anticoagulation therapies. Numerous confounding factors may have contributed to these results.

COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and its symptoms range from mild to severe respiratory illness, fever, cough, fatigue, and shortness of breath.¹ Diarrhea is common early on with infection and loss of taste and smell have also been reported.¹ Follicular conjunctivitis has also been reported, either as an early sign of infection or during hospitalization for severe COVID-19 disease.^2-4 The incubation period of COVID-19 falls within 2 to 14 days according to the CDC.⁵

It has been confirmed that COVID-19 is transmitted through both respiratory droplets and direct contact. Another possible route of viral transmission is entry through aerosolized droplets into the tears, which then pass through the nasolacrimal ducts and into the respiratory tract.⁶

Preparations Prior to Office Visit

It is essential for the eye care provider to prioritize patient care in order of absolute necessity, such as sudden vision loss, sudden onset flashes and floaters, and eye trauma. In cases of potentially sight threatening pathology, it is in the best interest of the patient to conduct a face-to-face appointment. Therefore, it is important to implement new guidelines and protocols as we continue to see these patients (Figure 1).

Prior to the patient entering the medical facility, measures should be implemented to minimize exposure risk. This can be done over the telephone or at vehicle entrance screening stations. The triage technician answering the telephone should have a script of questions to ask. The patient should be instructed to come into the office alone unless, for physical or mental reasons, a caregiver is required.

SARS-CoV-2 Screening Questions

Preparedness through risk mitigation strategies are recommended with a targeted questionnaire and noncontact temperature check at the clinic or hospital entrance. Below are some general questions to further triage patients exposed to SARS-CoV-2.

• Do you have fever or any respiratory symptoms?
• Do you have new or worsening cough or shortness of breath?
• Do you have flulike symptoms?
• Have you been in close contact with someone, including health care workers, confirmed to have the COVID-19?

If the patient answers yes to any of the above questions, the CDC urges health care providers to immediately notify both infection control personnel at your health care facility and your local or state health department.^1,2 In regions currently managing significant outbreaks of COVID-19, the AAO recommends that eye care providers assume that any patient could be infected with SARS-CoV-2 and to proceed accordingly.² If urgent eye care is needed, a referral call should be made to a hospital or center equipped to deal with COVID-19 and urgent eye conditions. When calling the referral center, ensure adequate staffing and space and relay all pertinent information along with receiving approval from the treating physician.

Face-to-Face Office Visits

Once it has been determined that it is in the best interest of the patient to be seen in a face-to-face visit, the patient should be instructed to call the office when they arrive in the parking lot. The CDC recommends limiting points of entry upon arrival and during the visit.¹ As soon as an examination lane is ready, the patient can then be messaged to come into the office and escorted into the examination room.

An urgent or emergent ophthalmic examination for a patient with no respiratory symptoms, no fever, and no COVID-19 risk factors should include proper hand hygiene, use of personal protective equipment (PPE), and proper disinfection. Several studies have documented SARS-CoV-2 infection in asymptomatic and presymptomatic patients, making PPE of the up most importance.^2,7,8 PPE should include mask, face shield, and gloves. Currently, there are national and international shortages on PPE and a heightened topic of discussion concerning mask use, effectiveness with extended wear, and reuse. Please refer to the CDC and AAO websites for up-to-date guidelines (Table).^1,2 According to the CDC, N95 respirators are restricted to those performing or present for an aerosol-generating procedure.⁹

It is recommended that the eye care provider should only perform necessary tests and procedures. Noncontact tonometry should be avoided, as this might cause aerosolization of virus particles. The close proximity between eye care providers and their patients during slit-lamp examination may require further precautions to lower the risk of transmission via droplets or through hand to eye contact. The patient should be advised not to speak during the examination portion and the AAO also recommends a surgical mask or cloth face covering for the patient.² An additional protective device that may be used during the slit-lamp exam is a breath shield or a barrier shield (Figures 2 and 3).² Some manufacturers are offering clinicians free slit-lamp breath shields online.

Infection Prevention and Control Measures

Last, once the patient leaves the examination room, it should be properly disinfected. A disinfection checklist may be made to ensure uniform systematic cleaning. Alcohol and bleach-based disinfectants commonly used in health care settings are likely very effective against virus particles that cause COVID-19.¹⁰ During the disinfection process, gloves should be worn and careful attention paid to the contact time. Contact time is the amount of time the surface should appear visibly wet for proper disinfection. For example, Metrex CaviWipes have a recommended contact time of 3 minutes; however, this varies depending on type of virus and formulation, check labels or manufacturers’ websites for further directions.¹⁰ Also, the US Environmental Protection Agency has a database search available for disinfectants that meet their criteria for use against SARS-CoV-2.¹¹

In an ever-changing environment, we offer this article to help equip providers to deliver the best possible patient care when face-to-face encounters are necessary. Currently nonurgent eye care follow-up visits are being conducted by telephone or video clinics. It is our goal to inform fellow practitioners on options and strategies to elevate the safety of staff and patients while minimizing the risk of exposure.

COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and its symptoms range from mild to severe respiratory illness, fever, cough, fatigue, and shortness of breath.¹ Diarrhea is common early on with infection and loss of taste and smell have also been reported.¹ Follicular conjunctivitis has also been reported, either as an early sign of infection or during hospitalization for severe COVID-19 disease.^2-4 The incubation period of COVID-19 falls within 2 to 14 days according to the CDC.⁵

It has been confirmed that COVID-19 is transmitted through both respiratory droplets and direct contact. Another possible route of viral transmission is entry through aerosolized droplets into the tears, which then pass through the nasolacrimal ducts and into the respiratory tract.⁶

Preparations Prior to Office Visit

It is essential for the eye care provider to prioritize patient care in order of absolute necessity, such as sudden vision loss, sudden onset flashes and floaters, and eye trauma. In cases of potentially sight threatening pathology, it is in the best interest of the patient to conduct a face-to-face appointment. Therefore, it is important to implement new guidelines and protocols as we continue to see these patients (Figure 1).

Prior to the patient entering the medical facility, measures should be implemented to minimize exposure risk. This can be done over the telephone or at vehicle entrance screening stations. The triage technician answering the telephone should have a script of questions to ask. The patient should be instructed to come into the office alone unless, for physical or mental reasons, a caregiver is required.

SARS-CoV-2 Screening Questions

Preparedness through risk mitigation strategies are recommended with a targeted questionnaire and noncontact temperature check at the clinic or hospital entrance. Below are some general questions to further triage patients exposed to SARS-CoV-2.

• Do you have fever or any respiratory symptoms?
• Do you have new or worsening cough or shortness of breath?
• Do you have flulike symptoms?
• Have you been in close contact with someone, including health care workers, confirmed to have the COVID-19?

If the patient answers yes to any of the above questions, the CDC urges health care providers to immediately notify both infection control personnel at your health care facility and your local or state health department.^1,2 In regions currently managing significant outbreaks of COVID-19, the AAO recommends that eye care providers assume that any patient could be infected with SARS-CoV-2 and to proceed accordingly.² If urgent eye care is needed, a referral call should be made to a hospital or center equipped to deal with COVID-19 and urgent eye conditions. When calling the referral center, ensure adequate staffing and space and relay all pertinent information along with receiving approval from the treating physician.

Face-to-Face Office Visits

Once it has been determined that it is in the best interest of the patient to be seen in a face-to-face visit, the patient should be instructed to call the office when they arrive in the parking lot. The CDC recommends limiting points of entry upon arrival and during the visit.¹ As soon as an examination lane is ready, the patient can then be messaged to come into the office and escorted into the examination room.

An urgent or emergent ophthalmic examination for a patient with no respiratory symptoms, no fever, and no COVID-19 risk factors should include proper hand hygiene, use of personal protective equipment (PPE), and proper disinfection. Several studies have documented SARS-CoV-2 infection in asymptomatic and presymptomatic patients, making PPE of the up most importance.^2,7,8 PPE should include mask, face shield, and gloves. Currently, there are national and international shortages on PPE and a heightened topic of discussion concerning mask use, effectiveness with extended wear, and reuse. Please refer to the CDC and AAO websites for up-to-date guidelines (Table).^1,2 According to the CDC, N95 respirators are restricted to those performing or present for an aerosol-generating procedure.⁹

It is recommended that the eye care provider should only perform necessary tests and procedures. Noncontact tonometry should be avoided, as this might cause aerosolization of virus particles. The close proximity between eye care providers and their patients during slit-lamp examination may require further precautions to lower the risk of transmission via droplets or through hand to eye contact. The patient should be advised not to speak during the examination portion and the AAO also recommends a surgical mask or cloth face covering for the patient.² An additional protective device that may be used during the slit-lamp exam is a breath shield or a barrier shield (Figures 2 and 3).² Some manufacturers are offering clinicians free slit-lamp breath shields online.

Infection Prevention and Control Measures

Last, once the patient leaves the examination room, it should be properly disinfected. A disinfection checklist may be made to ensure uniform systematic cleaning. Alcohol and bleach-based disinfectants commonly used in health care settings are likely very effective against virus particles that cause COVID-19.¹⁰ During the disinfection process, gloves should be worn and careful attention paid to the contact time. Contact time is the amount of time the surface should appear visibly wet for proper disinfection. For example, Metrex CaviWipes have a recommended contact time of 3 minutes; however, this varies depending on type of virus and formulation, check labels or manufacturers’ websites for further directions.¹⁰ Also, the US Environmental Protection Agency has a database search available for disinfectants that meet their criteria for use against SARS-CoV-2.¹¹

In an ever-changing environment, we offer this article to help equip providers to deliver the best possible patient care when face-to-face encounters are necessary. Currently nonurgent eye care follow-up visits are being conducted by telephone or video clinics. It is our goal to inform fellow practitioners on options and strategies to elevate the safety of staff and patients while minimizing the risk of exposure.

COVID-19 is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and its symptoms range from mild to severe respiratory illness, fever, cough, fatigue, and shortness of breath.¹ Diarrhea is common early on with infection and loss of taste and smell have also been reported.¹ Follicular conjunctivitis has also been reported, either as an early sign of infection or during hospitalization for severe COVID-19 disease.^2-4 The incubation period of COVID-19 falls within 2 to 14 days according to the CDC.⁵

It has been confirmed that COVID-19 is transmitted through both respiratory droplets and direct contact. Another possible route of viral transmission is entry through aerosolized droplets into the tears, which then pass through the nasolacrimal ducts and into the respiratory tract.⁶

Preparations Prior to Office Visit

It is essential for the eye care provider to prioritize patient care in order of absolute necessity, such as sudden vision loss, sudden onset flashes and floaters, and eye trauma. In cases of potentially sight threatening pathology, it is in the best interest of the patient to conduct a face-to-face appointment. Therefore, it is important to implement new guidelines and protocols as we continue to see these patients (Figure 1).

Prior to the patient entering the medical facility, measures should be implemented to minimize exposure risk. This can be done over the telephone or at vehicle entrance screening stations. The triage technician answering the telephone should have a script of questions to ask. The patient should be instructed to come into the office alone unless, for physical or mental reasons, a caregiver is required.

SARS-CoV-2 Screening Questions

Preparedness through risk mitigation strategies are recommended with a targeted questionnaire and noncontact temperature check at the clinic or hospital entrance. Below are some general questions to further triage patients exposed to SARS-CoV-2.

• Do you have fever or any respiratory symptoms?
• Do you have new or worsening cough or shortness of breath?
• Do you have flulike symptoms?
• Have you been in close contact with someone, including health care workers, confirmed to have the COVID-19?

If the patient answers yes to any of the above questions, the CDC urges health care providers to immediately notify both infection control personnel at your health care facility and your local or state health department.^1,2 In regions currently managing significant outbreaks of COVID-19, the AAO recommends that eye care providers assume that any patient could be infected with SARS-CoV-2 and to proceed accordingly.² If urgent eye care is needed, a referral call should be made to a hospital or center equipped to deal with COVID-19 and urgent eye conditions. When calling the referral center, ensure adequate staffing and space and relay all pertinent information along with receiving approval from the treating physician.

Face-to-Face Office Visits

Once it has been determined that it is in the best interest of the patient to be seen in a face-to-face visit, the patient should be instructed to call the office when they arrive in the parking lot. The CDC recommends limiting points of entry upon arrival and during the visit.¹ As soon as an examination lane is ready, the patient can then be messaged to come into the office and escorted into the examination room.

An urgent or emergent ophthalmic examination for a patient with no respiratory symptoms, no fever, and no COVID-19 risk factors should include proper hand hygiene, use of personal protective equipment (PPE), and proper disinfection. Several studies have documented SARS-CoV-2 infection in asymptomatic and presymptomatic patients, making PPE of the up most importance.^2,7,8 PPE should include mask, face shield, and gloves. Currently, there are national and international shortages on PPE and a heightened topic of discussion concerning mask use, effectiveness with extended wear, and reuse. Please refer to the CDC and AAO websites for up-to-date guidelines (Table).^1,2 According to the CDC, N95 respirators are restricted to those performing or present for an aerosol-generating procedure.⁹

It is recommended that the eye care provider should only perform necessary tests and procedures. Noncontact tonometry should be avoided, as this might cause aerosolization of virus particles. The close proximity between eye care providers and their patients during slit-lamp examination may require further precautions to lower the risk of transmission via droplets or through hand to eye contact. The patient should be advised not to speak during the examination portion and the AAO also recommends a surgical mask or cloth face covering for the patient.² An additional protective device that may be used during the slit-lamp exam is a breath shield or a barrier shield (Figures 2 and 3).² Some manufacturers are offering clinicians free slit-lamp breath shields online.

Infection Prevention and Control Measures

Last, once the patient leaves the examination room, it should be properly disinfected. A disinfection checklist may be made to ensure uniform systematic cleaning. Alcohol and bleach-based disinfectants commonly used in health care settings are likely very effective against virus particles that cause COVID-19.¹⁰ During the disinfection process, gloves should be worn and careful attention paid to the contact time. Contact time is the amount of time the surface should appear visibly wet for proper disinfection. For example, Metrex CaviWipes have a recommended contact time of 3 minutes; however, this varies depending on type of virus and formulation, check labels or manufacturers’ websites for further directions.¹⁰ Also, the US Environmental Protection Agency has a database search available for disinfectants that meet their criteria for use against SARS-CoV-2.¹¹

In an ever-changing environment, we offer this article to help equip providers to deliver the best possible patient care when face-to-face encounters are necessary. Currently nonurgent eye care follow-up visits are being conducted by telephone or video clinics. It is our goal to inform fellow practitioners on options and strategies to elevate the safety of staff and patients while minimizing the risk of exposure.